1 00:00:05,880 --> 00:00:08,040 WELCOME BACK, EVERYONE TO DAY 2 2 00:00:08,040 --> 00:00:10,720 OF OUR BRAIN NEUROETHICS WORKING 3 00:00:10,720 --> 00:00:13,760 GROUP WORKSHOP ON CONTINUING 4 00:00:13,760 --> 00:00:14,280 TRIAL RESPONSIBILITIES. 5 00:00:14,280 --> 00:00:16,680 I WANT TO ESPECIALLY EXTEND A 6 00:00:16,680 --> 00:00:18,960 WARM WELCOME TO OUR WORKING 7 00:00:18,960 --> 00:00:25,880 GROUP CO CHAIRS DOCTORS GRADEY 8 00:00:25,880 --> 00:00:27,960 ALONG WITH OUR SPEAKERS AND 9 00:00:27,960 --> 00:00:29,280 PANELISTS, MANY OF WHOM JOINED 10 00:00:29,280 --> 00:00:31,040 US YESTERDAY AND JOINING US 11 00:00:31,040 --> 00:00:32,040 AGAIN TODAY. 12 00:00:32,040 --> 00:00:35,040 I AM NINA SHU, I AM THE 13 00:00:35,040 --> 00:00:36,200 COMMITTEE BRAIN ETHICS WORKING 14 00:00:36,200 --> 00:00:39,680 GROUP AND ACTING CO LEAD FOR THE 15 00:00:39,680 --> 00:00:40,160 NIH BRAIN INITIATIVE. 16 00:00:40,160 --> 00:00:42,720 AS MOST OF YOU MAY KNOW THE 17 00:00:42,720 --> 00:00:45,200 NEUROETHICS WORKING GROUP IS NOT 18 00:00:45,200 --> 00:00:46,840 A FORMAL ADVISORY GROUP, IT IS A 19 00:00:46,840 --> 00:00:48,360 WORKING GROUP OF THE ADVISORY 20 00:00:48,360 --> 00:00:49,920 COUNCILS AND CENTERS AND 21 00:00:49,920 --> 00:00:51,360 INSTITUTEDS THAT PARTICIPATE IN 22 00:00:51,360 --> 00:00:52,840 THE BRAIN INITIATIVE AND WAS 23 00:00:52,840 --> 00:00:54,600 ESTABLISHED BECAUSE OF THE NEED 24 00:00:54,600 --> 00:00:56,320 FOR INPUT ON NEUROETHICS 25 00:00:56,320 --> 00:00:57,400 CONSIDERATIONS RELATED TO 26 00:00:57,400 --> 00:01:00,040 RESEARCH SUPPORTED THROUGH THE 27 00:01:00,040 --> 00:01:00,480 BRAIN INITIATIVE. 28 00:01:00,480 --> 00:01:01,760 THE GROUP DELIBERATES ON ETHICAL 29 00:01:01,760 --> 00:01:03,000 QUESTIONS THAT AM CAN UP IN THE 30 00:01:03,000 --> 00:01:04,440 CONTEXT OF BRAIN RESEARCH AND 31 00:01:04,440 --> 00:01:05,520 THOSE DISCUSSIONS HAVE INFORMED 32 00:01:05,520 --> 00:01:09,520 AND SERVED AS THE FOUND FOR THIS 33 00:01:09,520 --> 00:01:10,000 WORKSHOP. 34 00:01:10,000 --> 00:01:11,600 SO JUST A FEW ZOOM OWS KEEPING 35 00:01:11,600 --> 00:01:13,240 THINGS BEFORE WE GET STARTED. 36 00:01:13,240 --> 00:01:15,120 AS A REMINDER THIS VIRTUAL 37 00:01:15,120 --> 00:01:16,520 WORKSHOP IS BEING VIDEOCAST LIVE 38 00:01:16,520 --> 00:01:19,480 AND IN THE PUBLIC DOMAIN AND THE 39 00:01:19,480 --> 00:01:21,120 RECORDING WILL BE ARCHIVED FOR 40 00:01:21,120 --> 00:01:23,080 LATER VIEWING ON THE NIH AND THE 41 00:01:23,080 --> 00:01:24,360 BRAIN WEBSITE. 42 00:01:24,360 --> 00:01:26,080 DURING PRESENTATIONS FOR 43 00:01:26,080 --> 00:01:27,240 PANELISTS, PLEASE MUTE YOUR LINE 44 00:01:27,240 --> 00:01:28,880 AND TURN OFF YOUR VIDEO WHEN 45 00:01:28,880 --> 00:01:29,720 YOU'RE NOT SPEAKING. 46 00:01:29,720 --> 00:01:32,200 THIS IS HELPFUL FOR THE 47 00:01:32,200 --> 00:01:33,400 VIDEOCAST. 48 00:01:33,400 --> 00:01:35,640 AND THEN DURING DISCUSSIONS, 49 00:01:35,640 --> 00:01:36,720 PANELISTS ARE ENCOURAGED TO TURN 50 00:01:36,720 --> 00:01:39,360 ON YOUR VIDEO DURING THE 51 00:01:39,360 --> 00:01:40,920 DISCUSSION AND TO USE IT IS 52 00:01:40,920 --> 00:01:42,000 RAISE HAND OPTION IF YOU HAVE 53 00:01:42,000 --> 00:01:43,960 QUESTIONS AND WE WILL CALL ON 54 00:01:43,960 --> 00:01:45,080 YOU TO UNMUTE YOURSELF. 55 00:01:45,080 --> 00:01:46,440 FOR ATTENDEES, I WANT TO CALL 56 00:01:46,440 --> 00:01:50,240 YOUR ATTENTION TO THE Q&A BOX, 57 00:01:50,240 --> 00:01:52,520 SO ATTENDEES CAN POST QUESTIONS 58 00:01:52,520 --> 00:01:54,040 IN THE ASK QUESTION FEATURE. 59 00:01:54,040 --> 00:01:56,120 YOU ALSO HAVE THE OPTION TO ASK 60 00:01:56,120 --> 00:01:59,320 THESE QUESTIONS ANONYMOUSLY AND 61 00:01:59,320 --> 00:02:00,640 THERE'S THE OPTION TO UP VOTE 62 00:02:00,640 --> 00:02:02,000 OTHER QUESTIONS THAT YOU SEE 63 00:02:02,000 --> 00:02:03,600 APPEAR IN THE QUESTION BOX. 64 00:02:03,600 --> 00:02:06,560 IF ANYONE IS HAVING ANY 65 00:02:06,560 --> 00:02:08,320 TECHNICAL PROBLEMS PLEASE 66 00:02:08,320 --> 00:02:09,840 CONTACT GREG RICHARDS WHO WILL 67 00:02:09,840 --> 00:02:11,240 BE ABLE TO ASSIST AND YOU ALSO 68 00:02:11,240 --> 00:02:14,240 INCLUDE HIS CONTACT INFORMATION 69 00:02:14,240 --> 00:02:14,800 IN THE CHAT. 70 00:02:14,800 --> 00:02:16,680 I KNOW EVERYBODY IS REALLY BUSY 71 00:02:16,680 --> 00:02:18,240 AND WE VERY MUCH APPRECIATE YOUR 72 00:02:18,240 --> 00:02:19,280 TIME AND YOUR INPUT BOTH 73 00:02:19,280 --> 00:02:21,760 YESTERDAY AS WELL AS TODAY. 74 00:02:21,760 --> 00:02:23,320 AND NONE OF THIS COULD HAPPEN 75 00:02:23,320 --> 00:02:24,760 WITHOUT THE REALLY FABULOUS TEAM 76 00:02:24,760 --> 00:02:27,720 THAT WE HAVE HERE AT NIH. 77 00:02:27,720 --> 00:02:29,720 I ESPECIALLY WANT TO THANK THE 78 00:02:29,720 --> 00:02:30,720 WORKSHOP PLANNING COMMITTEE FOR 79 00:02:30,720 --> 00:02:33,920 THIS GROUP WHICH INCLUDED 80 00:02:33,920 --> 00:02:34,720 PROGRAM AND REVIEW STAFF ACROSS 81 00:02:34,720 --> 00:02:40,000 SEVERAL OF THE BRAIN INSTITUTES 82 00:02:40,000 --> 00:02:46,120 AND CENTERS. 83 00:02:46,120 --> 00:02:47,960 DR. SSKIA HENDRIKs AND 84 00:02:47,960 --> 00:02:50,960 DR. JOHN NGAI, FOR HIS SUPPORT 85 00:02:50,960 --> 00:02:51,520 OF NEUROETHICS. 86 00:02:51,520 --> 00:02:53,160 WITH THAT SAID, I THINK BEFORE 87 00:02:53,160 --> 00:02:59,200 WE GET STARTED FOR DAY 2, WE 88 00:02:59,200 --> 00:03:01,760 WILL DO A BRIEF RECAP FOR THE 89 00:03:01,760 --> 00:03:02,680 REALLY RICH PRESENTATIONS AND 90 00:03:02,680 --> 00:03:03,680 DISCUSSIONS WE HEARD YESTERDAY. 91 00:03:03,680 --> 00:03:05,200 SO YOU WILL SEE MY FACE FOR A 92 00:03:05,200 --> 00:03:09,920 LITTLE BIT LONGER WHILE I GIVE 93 00:03:09,920 --> 00:03:10,200 THIS RECAP. 94 00:03:10,200 --> 00:03:13,000 SO AS MOST OF YOU MAY KNOW THIS 95 00:03:13,000 --> 00:03:14,520 WORKSHOP IS STRUCTURED AS A 96 00:03:14,520 --> 00:03:15,640 SERIES OF PROGRESSIVE PANELS 97 00:03:15,640 --> 00:03:17,160 THAT EACH BUILD UPON THE 1 98 00:03:17,160 --> 00:03:17,560 BEFORE. 99 00:03:17,560 --> 00:03:19,840 SO BEFORE WE MOVE INTO THE 100 00:03:19,840 --> 00:03:20,600 SESSIONS FOR TODAY, FOR THOSE 101 00:03:20,600 --> 00:03:23,640 WHO MAY HAVE MISSED YESTERDAY, 102 00:03:23,640 --> 00:03:27,760 OR WANT A QUICKER REFRESHER, I 103 00:03:27,760 --> 00:03:28,920 WANTED TO HIGHLIGHT KEY POINTS 104 00:03:28,920 --> 00:03:30,880 THAT WERE RAISED DURING 105 00:03:30,880 --> 00:03:32,640 YESTERDAY'S PANELS, AS WELL AS 106 00:03:32,640 --> 00:03:34,680 TO INCORPORATE THE POINTS THAT 107 00:03:34,680 --> 00:03:36,800 WERE RAISED IN THE PREMEETING 108 00:03:36,800 --> 00:03:38,080 DIALOGUES THAT FORMED THIS 109 00:03:38,080 --> 00:03:38,760 WORKSHOP. 110 00:03:38,760 --> 00:03:39,160 NEXT SLIDE, PLEASE. 111 00:03:39,160 --> 00:03:42,320 SO FIRST A QUICK REMINDER OF OUR 112 00:03:42,320 --> 00:03:43,400 OVERARCHING WORKSHOP GOAL, WE'RE 113 00:03:43,400 --> 00:03:47,040 AIMING TO BRING TOGETHER THE 114 00:03:47,040 --> 00:03:48,520 RELEVANT STAKEHOLDERS TO DISCUSS 115 00:03:48,520 --> 00:03:49,960 REASONABLE EXPECTATIONS FOR 116 00:03:49,960 --> 00:03:52,840 RESEARCH RELATED CARE PLANS THAT 117 00:03:52,840 --> 00:03:54,240 COULD EVENTUALLY INFORM BEST 118 00:03:54,240 --> 00:03:55,080 PRACTICES FOR THE RESEARCH 119 00:03:55,080 --> 00:03:55,520 COMMUNITY. 120 00:03:55,520 --> 00:03:57,560 WE'RE HOPING THIS MIGHT BE 121 00:03:57,560 --> 00:03:59,240 THROUGH POTENTIALLY THROUGH OUR 122 00:03:59,240 --> 00:04:00,080 PAPER. 123 00:04:00,080 --> 00:04:03,320 AND YESTERDAY WE HEARD SEVERAL 124 00:04:03,320 --> 00:04:04,120 POWERFUL--POWERFUL PERSPECTIVES 125 00:04:04,120 --> 00:04:05,240 FROM THOSE WHO WERE LIVING WITH 126 00:04:05,240 --> 00:04:07,000 THESE NEEDS, AND YET THE STATE 127 00:04:07,000 --> 00:04:09,280 OF THE FIELD INDICATES THAT 128 00:04:09,280 --> 00:04:10,360 THERE IS SOME HETEROGENERATED 129 00:04:10,360 --> 00:04:13,360 AITY AND THE EXTENT TO STUDIES 130 00:04:13,360 --> 00:04:14,600 PLAN FOR POST TRIAL RESEARCH 131 00:04:14,600 --> 00:04:17,000 RELATED CARE NEEDS AND WHAT 132 00:04:17,000 --> 00:04:17,840 THOSE PLANS ENTAIL. 133 00:04:17,840 --> 00:04:20,000 THESE NEEDS MIGHT OCCUR AFTER A 134 00:04:20,000 --> 00:04:22,000 TRIAL ENDS AND FOR INSTANCE, 135 00:04:22,000 --> 00:04:23,800 BEFORE THE DEVICE AS BEEN 136 00:04:23,800 --> 00:04:25,560 APPROVED FOR CLINICAL USE, IF 137 00:04:25,560 --> 00:04:27,960 THE DEVICE DOESN'T GET APPROVED 138 00:04:27,960 --> 00:04:30,920 FOR CLINICAL USE, IF THE DEVICE 139 00:04:30,920 --> 00:04:32,560 MANUFACTURE DISCONTINUES THE 140 00:04:32,560 --> 00:04:33,880 PRODUCT, OR THE COMPANY GOES OUT 141 00:04:33,880 --> 00:04:35,520 OF BUSINESS, AND IF THE DEVICE 142 00:04:35,520 --> 00:04:37,040 IS,A PROVED FOR CLINICAL CARE 143 00:04:37,040 --> 00:04:39,240 BUT THE FORMER PARTICIPANT MAY 144 00:04:39,240 --> 00:04:41,480 NOT HAVE INSURANCE COVERAGE. 145 00:04:41,480 --> 00:04:43,960 AND AND THIS INSTANCE HAS 146 00:04:43,960 --> 00:04:45,760 RELEVANCE WHEN CONSIDERING THE 147 00:04:45,760 --> 00:04:46,760 DIVERSITY OF PARTICIPANT WHO IS 148 00:04:46,760 --> 00:04:48,200 ARE RECRUITED FOR THESE STUDIES. 149 00:04:48,200 --> 00:04:50,000 THERE ARE ADDITIONAL 150 00:04:50,000 --> 00:04:51,200 CONSIDERATIONS FOR EXAMPLE, IF 151 00:04:51,200 --> 00:04:53,600 THE PI MOVES INSTITUTIONS OR IF 152 00:04:53,600 --> 00:04:55,840 THERE'S A LEADERSHIP CHANGE AT 153 00:04:55,840 --> 00:04:57,640 AN INSTITUTION AND THESE ARE 154 00:04:57,640 --> 00:04:59,840 SOME CASES WHERE WE HAVE 155 00:04:59,840 --> 00:05:00,320 CONTINGENCIES. 156 00:05:00,320 --> 00:05:02,280 NEXT SLIDE, PLEASE. 157 00:05:02,280 --> 00:05:03,720 OUR PANELISTS INDICATED 158 00:05:03,720 --> 00:05:05,680 YESTERDAY IN PANEL 1, WE 159 00:05:05,680 --> 00:05:07,200 EXAMINED WHAT NEED STUDY 160 00:05:07,200 --> 00:05:08,520 PARTICIPANTS MAY HAVE IN 161 00:05:08,520 --> 00:05:10,280 RELATION TO THEIR TRIAL 162 00:05:10,280 --> 00:05:11,800 PARTICIPATION AFTER A TRIAL ENDS 163 00:05:11,800 --> 00:05:13,320 AND THEY VOICED SOME OF THESE 164 00:05:13,320 --> 00:05:17,360 FOLLOWING NEEDS THAT ARE RELATED 165 00:05:17,360 --> 00:05:17,960 TO THAT. 166 00:05:17,960 --> 00:05:20,640 FIRST CONTINUED ACCESS TO AN 167 00:05:20,640 --> 00:05:21,240 ALREADY IMPLANTED DEVICE, 168 00:05:21,240 --> 00:05:23,080 PARTICULARLY IF THE PATIENT IS 169 00:05:23,080 --> 00:05:24,640 BENEFITING. 170 00:05:24,640 --> 00:05:26,800 ANOTHER NEED THAT WAS FOLLOW UP 171 00:05:26,800 --> 00:05:28,640 CARE AND DEVICE SUPPORT AND 172 00:05:28,640 --> 00:05:29,680 MAINTENANCE, THIS CAN INCLUDE 173 00:05:29,680 --> 00:05:33,760 THINGS LIKE HAVING ACCESS TO 174 00:05:33,760 --> 00:05:35,560 SPECIALIZED CLINICIANS, AND THIS 175 00:05:35,560 --> 00:05:37,280 COMPONENT ALSO INCLUDES THINGS 176 00:05:37,280 --> 00:05:38,480 LIKE HAVING UPTO DATE 177 00:05:38,480 --> 00:05:39,680 INFORMATION REGARDING THEIR 178 00:05:39,680 --> 00:05:41,720 MEDICAL DEVICE, FOR EXAMPLE IF 179 00:05:41,720 --> 00:05:45,120 THE MRI IS COMPATIBLE. 180 00:05:45,120 --> 00:05:48,560 ANOTHER NEED TO FOLLOW UP CARE 181 00:05:48,560 --> 00:05:50,120 IS HAVING COMPATIBLE HARDWARE 182 00:05:50,120 --> 00:05:52,080 AND REPLACEMENT PARTS AS WELL AS 183 00:05:52,080 --> 00:05:53,800 ASSOCIATED SURGERY TO PERFORM 184 00:05:53,800 --> 00:05:56,200 THOSE REPLACEMENTS OR HAVE THOSE 185 00:05:56,200 --> 00:05:56,680 REPLACEMENTS. 186 00:05:56,680 --> 00:05:58,120 ANOTHER NEED IS EMERGENCY CARE 187 00:05:58,120 --> 00:06:01,680 DUE TO SIDE EFFECTS OR DEVICE 188 00:06:01,680 --> 00:06:02,960 COMPLICATIONS, AND WE ALSO HEARD 189 00:06:02,960 --> 00:06:06,160 ABOUT THE ACCORD NATION OF CARE 190 00:06:06,160 --> 00:06:08,120 SO THIS NEED CAN INCLUDE THINGS 191 00:06:08,120 --> 00:06:11,480 LIEB HELPING PATIENTS TO 192 00:06:11,480 --> 00:06:14,080 NAVIGATE ADMINISTRATIVE NEEDS, 193 00:06:14,080 --> 00:06:15,880 NAVIGATE INSURANCE SYSTEMS, 194 00:06:15,880 --> 00:06:19,320 HELPING PATIENTS TO FIND 195 00:06:19,320 --> 00:06:19,960 ADDITIONAL CLINICAL 196 00:06:19,960 --> 00:06:20,560 OPPORTUNITIES OR TREATMENT 197 00:06:20,560 --> 00:06:22,080 OPTIONS AFTER A STUDY HAS 198 00:06:22,080 --> 00:06:23,480 COMPLETED TO HELP PATIENTS 199 00:06:23,480 --> 00:06:24,880 NAVIGATE RECEIPT OF CARE FOR 200 00:06:24,880 --> 00:06:26,560 OLDER VERSIONS OF A MEDICAL 201 00:06:26,560 --> 00:06:28,200 DEVICE, INCLUDING THOSE THAT MAY 202 00:06:28,200 --> 00:06:32,560 NOT BE FDA APPROVED. 203 00:06:32,560 --> 00:06:34,200 NEXT SLIDE, PLEASE. 204 00:06:34,200 --> 00:06:37,040 SOME ADDITIONAL NEEDS WE HEARD 205 00:06:37,040 --> 00:06:38,440 ABOUT INCLUDED DEVICE 206 00:06:38,440 --> 00:06:39,680 EXPLANTATION WHICH COULD BE 207 00:06:39,680 --> 00:06:41,680 ELECTIVE OR DUE TO MEDICAL 208 00:06:41,680 --> 00:06:42,480 INDICATION. 209 00:06:42,480 --> 00:06:45,360 WE HEARD FROM PANELISTS THAT 210 00:06:45,360 --> 00:06:46,720 EXPLANTATION, SO CASES OF 211 00:06:46,720 --> 00:06:48,720 EXPLANTATION, IT CAN BE POSSIBLE 212 00:06:48,720 --> 00:06:50,720 TO REQUEST FUNDS FOR 213 00:06:50,720 --> 00:06:52,200 EXPLANTATION BUT THIS ISN'T 214 00:06:52,200 --> 00:06:53,920 CONSISTENTLY DONE AND NOT ALL 215 00:06:53,920 --> 00:06:57,280 INVESTIGATORS MAY DO THIS, 216 00:06:57,280 --> 00:06:58,480 ANOTHER PANELIST NOTED THAT IT 217 00:06:58,480 --> 00:07:02,080 CAN BE HARD TO COME TO A QUICK 218 00:07:02,080 --> 00:07:03,600 OR RAPID DECISION ABOUT 219 00:07:03,600 --> 00:07:05,200 EXPLANTATION, SO THERE'S A NEED 220 00:07:05,200 --> 00:07:10,920 TO BE COMPASSIONATE BUT TO ALSO 221 00:07:10,920 --> 00:07:13,320 HAVE BOTH POTENTIALLY A DECISION 222 00:07:13,320 --> 00:07:15,400 TREE AS WELL AS DECISION PLANS 223 00:07:15,400 --> 00:07:15,920 FOR EXPLANTATION. 224 00:07:15,920 --> 00:07:18,360 WE HEARD ABOUT DEVICE 225 00:07:18,360 --> 00:07:19,320 REPLACEMENT REQUIRING HARDWARE 226 00:07:19,320 --> 00:07:20,800 AND SURGERY COSTS ALOS ANGELES 227 00:07:20,800 --> 00:07:24,120 AS PSYCHOLOGICAL SUPPORT FOR 228 00:07:24,120 --> 00:07:25,080 PARTICIPANTS WE HEARD ABOUT 229 00:07:25,080 --> 00:07:26,960 REASONABLE OPTIONS FOR PATIENTS, 230 00:07:26,960 --> 00:07:29,280 AS WELL AS CLARITY ABOUT THE 231 00:07:29,280 --> 00:07:30,880 FUTURE ACCESS TO CARE AND 232 00:07:30,880 --> 00:07:34,000 ASSOCIATED OUT OF POCKET 233 00:07:34,000 --> 00:07:35,440 EXPENSES THAT PARTICIPANTS MAY 234 00:07:35,440 --> 00:07:37,280 BEAR AND WE ALSO HEARD ABOUT THE 235 00:07:37,280 --> 00:07:38,360 ACCESSIBILITY OF RESEARCH 236 00:07:38,360 --> 00:07:40,960 RECORDS FOR NEW PROVIDERS TO 237 00:07:40,960 --> 00:07:43,440 HELP PROVIDE DOCUMENTATION OF 238 00:07:43,440 --> 00:07:45,840 DEVICE SETTINGS, TO HELP 239 00:07:45,840 --> 00:07:47,760 RECONCILE CLINICAL INFORMATION 240 00:07:47,760 --> 00:07:49,080 WITH TRIAL INFORMATION AND 1 WAY 241 00:07:49,080 --> 00:07:53,000 FOR THIS, MAY BE THROUGH A 242 00:07:53,000 --> 00:07:55,800 REGISTRY OR DATABASE AS 1 243 00:07:55,800 --> 00:08:01,000 POSSIBLE OPTION. 244 00:08:01,000 --> 00:08:02,080 NEXT SLIDE, PLEASE EMPLOY SOME 245 00:08:02,080 --> 00:08:03,360 OF THE ADDITIONAL CONSIDERATIONS 246 00:08:03,360 --> 00:08:04,360 FROM PANEL 1, THERE'S THE 247 00:08:04,360 --> 00:08:07,760 CONSIDERATION TO BE ABLE TO HAVE 248 00:08:07,760 --> 00:08:08,360 DIVERSE PARTICIPANTS ENROLLED. 249 00:08:08,360 --> 00:08:10,240 THAT MAY MEAN REQUIRING 250 00:08:10,240 --> 00:08:11,840 FACILITATING MORE POST TRIAL 251 00:08:11,840 --> 00:08:13,200 NEEDS GENERALLY TO BE ABLE TO 252 00:08:13,200 --> 00:08:15,040 REDUCE OR MITIGATE THE FINANCIAL 253 00:08:15,040 --> 00:08:18,480 BURDEN RELATED TO TRIAL 254 00:08:18,480 --> 00:08:18,840 PARTICIPATION. 255 00:08:18,840 --> 00:08:20,560 WE HEARD ABOUT CONSIDERING 256 00:08:20,560 --> 00:08:23,520 PATIENT INVOLVEMENT EARLY ON IN 257 00:08:23,520 --> 00:08:24,480 TRIAL DESIGN, INCLUDING 258 00:08:24,480 --> 00:08:26,840 IDENTIFYING AND PLANNING FOR 259 00:08:26,840 --> 00:08:27,640 POST TRIAL NEEDS. 260 00:08:27,640 --> 00:08:30,080 WE ALSO HEARD ABOUT CONSIDERING 261 00:08:30,080 --> 00:08:31,120 PATIENT'S LIFETIME CARE NEEDS AS 262 00:08:31,120 --> 00:08:34,880 PART OF THE TRIAL DESIGN FOR 263 00:08:34,880 --> 00:08:37,120 EXAMPLE, THROUGH A RECHARGEABLE 264 00:08:37,120 --> 00:08:38,760 BATTERIES TO HELP LIMIT THE 265 00:08:38,760 --> 00:08:39,760 NUMBER OF PROCEDURES THAT 266 00:08:39,760 --> 00:08:41,560 PARTICIPANTS MY NEED TO UNDERGO. 267 00:08:41,560 --> 00:08:43,880 WE ALSO HEARD ABOUT THE NEED FOR 268 00:08:43,880 --> 00:08:45,960 LONG-TERM RESEARCH TO BE ABLE TO 269 00:08:45,960 --> 00:08:49,440 STUDY PATIENT OUTCOMES AS WELL 270 00:08:49,440 --> 00:08:50,200 AS DEVICE SAFETY AND WE HEARD 271 00:08:50,200 --> 00:08:52,240 ABOUT THE NEED OR CONSIDERATION 272 00:08:52,240 --> 00:08:57,680 FOR ADEQUATE KEEP INFORMED 273 00:08:57,680 --> 00:08:58,200 CONSENT. 274 00:08:58,200 --> 00:08:58,680 NEXT SLIDE, PLEASE. 275 00:08:58,680 --> 00:08:59,600 I JUST WANT TO HIGHLIGHT SOME OF 276 00:08:59,600 --> 00:09:04,680 THE QUOTES THAT WE HEARD 277 00:09:04,680 --> 00:09:06,200 YESTERDAY PARTICULARLY FROM OUR 278 00:09:06,200 --> 00:09:06,760 PATIENT PARTICIPANTS WHO ARE 279 00:09:06,760 --> 00:09:07,720 PART OF THE PANEL. 280 00:09:07,720 --> 00:09:09,000 FOR ME IT'S NOT AN EXPERIMENT, 281 00:09:09,000 --> 00:09:11,200 IT'S A WAY TO KEEP ME ALIVE, WE 282 00:09:11,200 --> 00:09:13,360 KNOW THAT THIS WORKS. 283 00:09:13,360 --> 00:09:20,200 THAT WAS FROM BRANDY ELLIS, FROM 284 00:09:20,200 --> 00:09:22,680 MISS JEN FRENCH, I HAVE BEEN 285 00:09:22,680 --> 00:09:24,640 REPARALYZED 4 TIMES WHEN MY 286 00:09:24,640 --> 00:09:26,280 IMPLANT HAS FAILED BUT SINCE MY 287 00:09:26,280 --> 00:09:28,640 CLINICAL TRIAL IS ONGOING, I 288 00:09:28,640 --> 00:09:30,480 COULD BERIA IMPLANTED AND LOSS 289 00:09:30,480 --> 00:09:34,840 OF SPHUNKZ A WORRY FOR PANE 290 00:09:34,840 --> 00:09:36,040 PATIENT-PARTICIPANTS. 291 00:09:36,040 --> 00:09:37,680 AND FROM TYLER HAJJAR, AT THE 292 00:09:37,680 --> 00:09:40,520 TIME THE TRIAL STARTED, THE 293 00:09:40,520 --> 00:09:43,480 OPTIONS FOR ME WERE TRY THIS OR 294 00:09:43,480 --> 00:09:45,560 DEATH, I WASN'T THINK BEING THE 295 00:09:45,560 --> 00:09:46,920 FUTURE, NOW, 3 YEARS IN WITH A 296 00:09:46,920 --> 00:09:48,880 BATTERY THAT IS SAID TO LAST 15 297 00:09:48,880 --> 00:09:50,720 YEARS I'M THINKING ABOUT WHAT 298 00:09:50,720 --> 00:09:52,920 WILL HAPPEN 20 YEARS FROM NOW. 299 00:09:52,920 --> 00:09:56,480 AND FROM JAMES MAHONY, WHO SAID 300 00:09:56,480 --> 00:09:58,640 WHEN THESE STUDIES ARE OVER, 301 00:09:58,640 --> 00:09:59,160 THEY'RE NOT OVER. 302 00:09:59,160 --> 00:10:01,600 SO WHEN WE SHIFTED TO PANEL 2 303 00:10:01,600 --> 00:10:03,280 WHICH ASKED WHAT DO STAKEHOLDER 304 00:10:03,280 --> 00:10:04,440 PROSVIED AND WHAT COULD THAT 305 00:10:04,440 --> 00:10:07,680 PROVIDE, WE HEARD FROM A VARIETY 306 00:10:07,680 --> 00:10:09,800 OF STAKEHOLDERS INCLUDING DEVICE 307 00:10:09,800 --> 00:10:11,320 MANUFACTURES, INVESTIGATORS, 308 00:10:11,320 --> 00:10:11,920 INSURERS, INSTITUTION 309 00:10:11,920 --> 00:10:13,920 ADMINISTRATORS AS WELL AS NIH 310 00:10:13,920 --> 00:10:15,520 PROGRAM STAFF, FOR THEIR 311 00:10:15,520 --> 00:10:18,360 PERSPECTIVES ON WHAT THEIR 312 00:10:18,360 --> 00:10:19,200 RESPECTIVE GROUPS CURRENTLY 313 00:10:19,200 --> 00:10:19,440 PROVIDE. 314 00:10:19,440 --> 00:10:20,920 I WANT TO NOTE THAT WHAT WE 315 00:10:20,920 --> 00:10:23,320 HEARD WAS THAT ALL STAKEHOLDERS 316 00:10:23,320 --> 00:10:25,080 DO COVER POST TRIAL NEEDS. 317 00:10:25,080 --> 00:10:28,200 NEEDS THAT ARE GENERALLY COVERED 318 00:10:28,200 --> 00:10:29,800 FOR THINGS LIKE EMERGENCY CARE 319 00:10:29,800 --> 00:10:32,800 RELATING TO SIDE EFFECTS OR 320 00:10:32,800 --> 00:10:34,040 DEVICE COMPLICATIONS, THIS WAS 321 00:10:34,040 --> 00:10:36,840 GENERALLY COVERED BY PATIENTS 322 00:10:36,840 --> 00:10:37,320 EAS' HEALTH INSURANCE. 323 00:10:37,320 --> 00:10:39,200 ANOTHER NEED THAT WAS GENERALLY 324 00:10:39,200 --> 00:10:41,520 COVERED WAS ROUTINE MEDICAL CARE 325 00:10:41,520 --> 00:10:44,640 THAT WAS RELATED TO THE MEDICAL 326 00:10:44,640 --> 00:10:46,120 CONDITION, FOR EXAMPLE, THROUGH 327 00:10:46,120 --> 00:10:47,560 CLINICIAN APPOINTMENTS OR 328 00:10:47,560 --> 00:10:49,360 SPECIALIST APPOINTMENTS THAT A 329 00:10:49,360 --> 00:10:50,800 PATIENT WOULD BE SEEN ALSO 330 00:10:50,800 --> 00:10:54,160 COVERED BY HEALTH INSURANCE. 331 00:10:54,160 --> 00:10:56,000 AND EXPLANTATION DUE TO MEDICAL 332 00:10:56,000 --> 00:10:57,880 INDICATION WAS ALSO GENERALLY 333 00:10:57,880 --> 00:10:59,400 COVERED BY PATIENT HEALTH 334 00:10:59,400 --> 00:11:00,080 INSURANCE. 335 00:11:00,080 --> 00:11:04,120 AND OTHER POST TRIAL RESEARCH 336 00:11:04,120 --> 00:11:05,320 CARE NEEDS WHAT WE HEARD WAS 337 00:11:05,320 --> 00:11:08,880 THAT THESE WERE NOT CONSISTENTLY 338 00:11:08,880 --> 00:11:09,640 COVERED. 339 00:11:09,640 --> 00:11:10,080 NEXT SLIDE, PLEASE. 340 00:11:10,080 --> 00:11:12,560 AND THERE WERE A NUMBER OF 341 00:11:12,560 --> 00:11:13,920 FACTORS THAT DETERMINED 342 00:11:13,920 --> 00:11:15,320 DECISIONS ON COVERAGE OR 343 00:11:15,320 --> 00:11:18,520 PROVISION OF POST TRIAL CARE 344 00:11:18,520 --> 00:11:19,160 NEEDS. 345 00:11:19,160 --> 00:11:21,360 ONE WAS SUCCESS OF THE DEVICE, 346 00:11:21,360 --> 00:11:25,440 SO WE HEARD THAT FOR EXAMPLE, 347 00:11:25,440 --> 00:11:27,520 WHETHER AN FDA DEVISE IS 348 00:11:27,520 --> 00:11:29,400 APPROVED, A REVIEW OF PUBLISHED 349 00:11:29,400 --> 00:11:31,600 EVIDENCE FOR THE SUCCESS OF THE 350 00:11:31,600 --> 00:11:33,320 DEVICE WOULD EXAMINE THINGS LIKE 351 00:11:33,320 --> 00:11:35,080 QUALITY, STRENGTH AND 352 00:11:35,080 --> 00:11:36,120 IMPROVEMENT OF MEANING PATIENT 353 00:11:36,120 --> 00:11:37,640 CENTERED OUTCOMES AND THIS WOULD 354 00:11:37,640 --> 00:11:39,040 HELP DETERMINE COVERAGE FOR THAT 355 00:11:39,040 --> 00:11:40,280 DETERMINE NATION OF NEED BETWEEN 356 00:11:40,280 --> 00:11:43,920 A FRIEL ENDS AND FDA APPROVAL, 357 00:11:43,920 --> 00:11:45,680 THIS INSTANCE WILL BE EVALUATED 358 00:11:45,680 --> 00:11:48,200 MORE ON A CASE BY CASE BASIS. 359 00:11:48,200 --> 00:11:49,360 ANOTHER FACTOR DETERMINING 360 00:11:49,360 --> 00:11:51,320 COVERAGE, WAS WHETHER THE 361 00:11:51,320 --> 00:11:55,160 PATIENT HAS INSURANCE AND WHICH 362 00:11:55,160 --> 00:11:55,440 INSURANCE. 363 00:11:55,440 --> 00:11:56,840 THIS LEADS TO THINGS LIKE 364 00:11:56,840 --> 00:11:59,320 WHETHER THE DEVICE IS APPROVED 365 00:11:59,320 --> 00:12:00,800 FOR FDA CLINICAL USE AND FOR 366 00:12:00,800 --> 00:12:02,400 WHAT INDICATION AND WHETHER THE 367 00:12:02,400 --> 00:12:04,200 RESEARCH DATA IS SUFFICIENT TO 368 00:12:04,200 --> 00:12:07,160 QUALIFY FOR CMS OR PRIVATE 369 00:12:07,160 --> 00:12:08,480 HEALTH INSURANCE COVERAGE. 370 00:12:08,480 --> 00:12:09,840 WE HEARD HERE SOME 371 00:12:09,840 --> 00:12:11,240 CONSIDERATIONS FROM PAYERS THAT 372 00:12:11,240 --> 00:12:13,640 MAYBE BASED ON MAKING DECISIONS 373 00:12:13,640 --> 00:12:17,920 FOR HOW TO DISTRIBUTE FUNDS IN A 374 00:12:17,920 --> 00:12:18,360 POPULATION. 375 00:12:18,360 --> 00:12:19,680 AND HERE THE QUESTION MAY NOT 376 00:12:19,680 --> 00:12:21,680 JUST BE ABOUT EFFICACY BUT ALSO 377 00:12:21,680 --> 00:12:24,040 ABOUT COST ASSOCIATED WITH 378 00:12:24,040 --> 00:12:25,560 DURATION, LONG-TERM OUTCOMES AND 379 00:12:25,560 --> 00:12:27,520 ONGOING CARE AS WELL AS REPEAT 380 00:12:27,520 --> 00:12:27,920 SURGERIES. 381 00:12:27,920 --> 00:12:29,280 SO THE COVERAGE MAY DEPENTINE 382 00:12:29,280 --> 00:12:31,800 REGIMEN ON THE PROJECTED COST 383 00:12:31,800 --> 00:12:33,960 AND HOW THIS FOLDS INTO THE 384 00:12:33,960 --> 00:12:37,560 AVAILABLE FUNDS FOR THE GENERAL 385 00:12:37,560 --> 00:12:38,000 POPULATION. 386 00:12:38,000 --> 00:12:39,840 WE ALSO HEARD THAT ANOTHER 387 00:12:39,840 --> 00:12:41,120 FACTOR DETERMINING COVERAGE MAY 388 00:12:41,120 --> 00:12:43,680 BE FINANCIAL RESOURCES AND 389 00:12:43,680 --> 00:12:45,440 LEADERSHIP SUPPORT IN PERSONAL 390 00:12:45,440 --> 00:12:47,120 ORGANIZATIONS THAT ARE INVOLVED 391 00:12:47,120 --> 00:12:49,560 IN FACILITATING POST TRIAL CARE. 392 00:12:49,560 --> 00:12:51,880 WE ALSO HEARD ABOUT WHETHER 393 00:12:51,880 --> 00:12:53,600 POTENTIALLY AVAILABLE MECHANISMS 394 00:12:53,600 --> 00:12:54,360 ARE UTILIZED. 395 00:12:54,360 --> 00:12:56,360 MANY OF THESE MAY REQUIRE 396 00:12:56,360 --> 00:12:57,720 ADVANCE PREPARATION AT THE START 397 00:12:57,720 --> 00:13:00,680 OF THE STUDY RATHER THAN AFTER 398 00:13:00,680 --> 00:13:01,720 THE TRIAL ENDS. 399 00:13:01,720 --> 00:13:03,480 AND WE ALSO HEARD ABOUT THE 400 00:13:03,480 --> 00:13:05,720 ABILITY OF PATIENTS TO 401 00:13:05,720 --> 00:13:07,960 COORDINATE CARE AS A FACT OF 402 00:13:07,960 --> 00:13:08,440 DETERMINING COVERAGE. 403 00:13:08,440 --> 00:13:10,400 ONE OF OUR PANELISTS SPOKE TO 404 00:13:10,400 --> 00:13:14,520 THE IDEA OF CLINICAL TRIAL 405 00:13:14,520 --> 00:13:15,880 COORDINATORS BEING A CAREER PATH 406 00:13:15,880 --> 00:13:17,440 TO HELP FACILITATE THIS ABILITY 407 00:13:17,440 --> 00:13:22,280 OF PATIENTS TO COORDINATE CARE. 408 00:13:22,280 --> 00:13:23,160 NEXT SLIDE, PLEASE. 409 00:13:23,160 --> 00:13:25,080 SO SOME OF THE ADDITIONAL 410 00:13:25,080 --> 00:13:26,360 CONSIDERATIONS FROM OUR FIRST 2 411 00:13:26,360 --> 00:13:28,320 PANELS THEY THINK TO HELP DEE US 412 00:13:28,320 --> 00:13:30,200 UP OR TODAY'S SESSION IS THAT 413 00:13:30,200 --> 00:13:38,760 WHAT WE COLLECTIVELY HEARD WITH 414 00:13:38,760 --> 00:13:40,040 THAT ALL STAKEHOLDERS SHARE 415 00:13:40,040 --> 00:13:41,640 GOALS FOR THE BENEFIT OF THE 416 00:13:41,640 --> 00:13:43,200 PATIENTS AND THAT MEANS THERE'S 417 00:13:43,200 --> 00:13:44,680 A SHARED BURDEN AND SHARED 418 00:13:44,680 --> 00:13:47,600 OPPORTUNITY IN HOW WE CAN BEST 419 00:13:47,600 --> 00:13:49,920 ADDRESS THOSE POST CARE NEEDS. 420 00:13:49,920 --> 00:13:51,960 AND NEGOTIATIONS ARE CURRENTLY 421 00:13:51,960 --> 00:13:53,880 MADE ON A CASE BY CASE BASIS IN 422 00:13:53,880 --> 00:13:56,200 MANY INSTANCES AND MAY BE MADE 423 00:13:56,200 --> 00:13:57,880 ADHOC WHEN THE CARE IS NEEDED 424 00:13:57,880 --> 00:14:01,160 WHEN A NEED EMERGES OR ARISES. 425 00:14:01,160 --> 00:14:01,800 SO AN ADDITIONAL CONSIDERATION 426 00:14:01,800 --> 00:14:04,360 HERE IS A NEED TO CREATE POST 427 00:14:04,360 --> 00:14:07,440 TRIAL CARE PLANS BEFORE THE 428 00:14:07,440 --> 00:14:08,680 START OF A TRIAL AND BROADLY 429 00:14:08,680 --> 00:14:11,360 SPEAKING TO BE ABLE TO GENERATE 430 00:14:11,360 --> 00:14:14,760 ETHICALLY GROUNDED BEST 431 00:14:14,760 --> 00:14:18,000 PRACTICES AS WELL AS CONCRETE 432 00:14:18,000 --> 00:14:18,720 PRAGMATIC STRATEGIES AND OVERALL 433 00:14:18,720 --> 00:14:20,440 WE WOULD LIKE TO ENCOURAGE THE 434 00:14:20,440 --> 00:14:22,640 GROUP TO CONSIDER BENEFITS FOR 435 00:14:22,640 --> 00:14:23,800 INDIVIDUAL PARTICIPANTS VERSUS 436 00:14:23,800 --> 00:14:25,960 THE OVERALL TRIAL RESULTS 437 00:14:25,960 --> 00:14:27,480 INCLUDING BOTH CLINICAL AND 438 00:14:27,480 --> 00:14:30,200 PATIENT CENTERED OUTCOME 439 00:14:30,200 --> 00:14:30,640 MEASURES. 440 00:14:30,640 --> 00:14:33,520 SO I THINK HOPEFULLY THIS IS A 441 00:14:33,520 --> 00:14:35,200 WAY TO PRIMEUS AND SORT OF GIVE 442 00:14:35,200 --> 00:14:37,520 US SOME FOUNDATION ON WHICH TO 443 00:14:37,520 --> 00:14:39,480 BASE TODAY'S 2 SESSIONS. 444 00:14:39,480 --> 00:14:42,120 AND I THINK WITH THAT, WE CAN 445 00:14:42,120 --> 00:14:45,040 TAKE DOWN THESE SLIDES AND I AM 446 00:14:45,040 --> 00:14:48,040 GOING TO TURN IT OVER TO 447 00:14:48,040 --> 00:14:52,240 DR. KRISTIN GRADE SKPE BAKUGAN 448 00:14:52,240 --> 00:14:57,760 DR. HENDRIKs, WHO WILL BE 449 00:14:57,760 --> 00:14:58,560 CO-MODERATING PANEL 3. 450 00:14:58,560 --> 00:14:59,240 >> HELLO, EVERYBODY AND WELCOME 451 00:14:59,240 --> 00:15:03,160 TO THE SECOND DAY OF THIS 452 00:15:03,160 --> 00:15:07,120 WORKSHOP ON WORKING ON NEUROEGHT 453 00:15:07,120 --> 00:15:08,200 KICKS RESPONSIBILITIES, GREAT 454 00:15:08,200 --> 00:15:09,520 SUMMARY OF YESTERDAY'S 455 00:15:09,520 --> 00:15:09,840 DISCUSSION. 456 00:15:09,840 --> 00:15:11,120 SO PANEL 3 WE ARE VERY EXCITED 457 00:15:11,120 --> 00:15:12,960 ABOUT BECAUSE WE WILL COVER A 458 00:15:12,960 --> 00:15:17,320 QUESTION OF WHAT SHOULD BE THE 459 00:15:17,320 --> 00:15:18,920 MINIMUM IN TERMS OF RESEARCH 460 00:15:18,920 --> 00:15:19,960 RELATED CARE NEEDS THAT WE 461 00:15:19,960 --> 00:15:24,400 SHOULD BE TRYING TO FACILITATE 462 00:15:24,400 --> 00:15:26,120 AND IMPLANTING NEURAL DEVICE 463 00:15:26,120 --> 00:15:27,600 TRIALS, WHEREAS PANEL 2 464 00:15:27,600 --> 00:15:30,720 YESTERDAY WAS ABOUT 465 00:15:30,720 --> 00:15:31,560 [INDISCERNIBLE], THIS PANEL IS 466 00:15:31,560 --> 00:15:34,440 MORE ABOUT WHAT OUGHT TO BE 467 00:15:34,440 --> 00:15:35,280 PROVIDED, THEN BESIDES 468 00:15:35,280 --> 00:15:36,840 DISCUSSING WHAT THE MINIMUM IS, 469 00:15:36,840 --> 00:15:39,480 WE WOULD LIKE TO ASK THE 470 00:15:39,480 --> 00:15:41,240 PANELISTS TO THINK ABOUT WHEN 471 00:15:41,240 --> 00:15:42,800 STAKEHOLDERS WOULD HAVE 472 00:15:42,800 --> 00:15:44,240 RESPONSIBILITIES TO MAYBE 473 00:15:44,240 --> 00:15:47,120 PROVIDE TO FACILITATE MORE THAN 474 00:15:47,120 --> 00:15:47,440 THE MINIMUM. 475 00:15:47,440 --> 00:15:49,120 FOR EXAMPLE, MAYBE IF IT'S A 476 00:15:49,120 --> 00:15:49,880 TRIAL INVOLVING CHILDREN, WE 477 00:15:49,880 --> 00:15:51,480 WOULD NEED TO DO SOMETHING 478 00:15:51,480 --> 00:15:53,400 ADDITIONAL AS COMPARED TO A 479 00:15:53,400 --> 00:15:54,240 TRIAL WITH ADULTS. 480 00:15:54,240 --> 00:15:59,600 THAT'S JUST AN EXAMPLE. 481 00:15:59,600 --> 00:16:02,160 SO I WOULD LIKE TO ENCOURAGE THE 482 00:16:02,160 --> 00:16:03,200 PANELISTS AS FAR AS POSSIBLE 483 00:16:03,200 --> 00:16:05,640 CONSIDER ALL THE NEEDS THAT WE 484 00:16:05,640 --> 00:16:09,600 LEARNED ABOUT IN PANEL 1 485 00:16:09,600 --> 00:16:10,040 YESTERDAY. 486 00:16:10,040 --> 00:16:11,480 AND TO MAKE THE DISCUSSION ABOUT 487 00:16:11,480 --> 00:16:13,640 HOW BEST TO ADDRESS THOSE NEEDS 488 00:16:13,640 --> 00:16:15,120 FOR THE FORUM WHICH WILL TAKE 489 00:16:15,120 --> 00:16:17,800 PLACE THIS AFTERNOON AFTER THE 490 00:16:17,800 --> 00:16:18,080 BREAK. 491 00:16:18,080 --> 00:16:20,000 SO IN THIS SESSION, WE WANT TO 492 00:16:20,000 --> 00:16:24,000 REALLY FOCUS ON WHAT WE SHOULD 493 00:16:24,000 --> 00:16:27,520 BE PROVIDING, WHERE WE AS THE 494 00:16:27,520 --> 00:16:28,880 SHARED COMMUNITY OF PROFESSIONAL 495 00:16:28,880 --> 00:16:32,000 STAKEHOLDERS INVOLVED IN THIS 496 00:16:32,000 --> 00:16:32,240 TRIAL. 497 00:16:32,240 --> 00:16:35,400 I FORGOT TO INTRODUCE MYSELF, MY 498 00:16:35,400 --> 00:16:38,760 NAME IS SASKIA, HENDRIKs, I AM 499 00:16:38,760 --> 00:16:39,640 NIH DEPARTMENT OF BIOETHICS AND 500 00:16:39,640 --> 00:16:44,200 I ALSO WORK AS A FAC ALL THEY 501 00:16:44,200 --> 00:16:45,040 NEUROETHICS CONSULTANT AT NIAIDS 502 00:16:45,040 --> 00:16:55,560 AND WITH ME TODAY IS MY CO-CHAIR 503 00:17:00,160 --> 00:17:02,400 KRISTIN GRADEY. 504 00:17:02,400 --> 00:17:03,440 >> I'M CHRISTINE GRADEY, AND I'M 505 00:17:03,440 --> 00:17:05,360 ALSO THE CHAIR OF THE DEPARTMENT 506 00:17:05,360 --> 00:17:09,000 OF BIOETHICS AT THE NIRE 507 00:17:09,000 --> 00:17:11,040 LYNNICAL CENTER. 508 00:17:11,040 --> 00:17:13,640 AND WITH SASKIA HENDRIKs, I 509 00:17:13,640 --> 00:17:15,600 WILL CO MODERATE THIS PANEL AS 510 00:17:15,600 --> 00:17:17,200 SHE'S POINTED OUT, IT WILL BE A 511 00:17:17,200 --> 00:17:18,840 REALLY IMPORTANT PANEL AND WE 512 00:17:18,840 --> 00:17:21,600 ARE VERY LUCKY TO HAVE A NUMBER 513 00:17:21,600 --> 00:17:22,920 OF REALLY GREAT PANELISTS. 514 00:17:22,920 --> 00:17:26,120 SO I WILL START BY INTRODUCING 515 00:17:26,120 --> 00:17:27,200 OUR FIRST PANELISTS, TO SPEAK 516 00:17:27,200 --> 00:17:33,080 WITH US AND THAT'S TRACEY 517 00:17:33,080 --> 00:17:34,280 DIXON-SALAZAR, A NEUROSCIENTIST, 518 00:17:34,280 --> 00:17:36,040 A GENETICIST AND A PATIENT 519 00:17:36,040 --> 00:17:38,760 ADVOCATE, HER DESIRE TO GET HER 520 00:17:38,760 --> 00:17:41,080 Ph.D. WAS INSPIRED BY HER 521 00:17:41,080 --> 00:17:43,560 DAUGHTER SAN FRANCISCO VARMIS 522 00:17:43,560 --> 00:17:45,040 KNOWA WHO GEPPED INTRACTABLE 523 00:17:45,040 --> 00:17:48,040 SEIZURES AT THE AGE OF 2 WHICH 524 00:17:48,040 --> 00:17:49,920 ENDED UP PROGRESSING INTO A 525 00:17:49,920 --> 00:17:53,760 SYNDROME BY AGE 5. 526 00:17:53,760 --> 00:17:56,760 SHE CURRENTLY SERVING AS THE LGS 527 00:17:56,760 --> 00:17:57,160 FOWBDATION. 528 00:17:57,160 --> 00:17:59,640 THANK YOU DR. DIXON-SALAZAR. 529 00:17:59,640 --> 00:18:00,840 >> THANK YOU SO MUCH FOR HAVING 530 00:18:00,840 --> 00:18:03,240 ME, I APPRECIATE BEING HERE AND 531 00:18:03,240 --> 00:18:05,240 I REALLY APPRECIATED THE 532 00:18:05,240 --> 00:18:05,680 CONVERSATION. 533 00:18:05,680 --> 00:18:09,240 I DON'T THINK I'M GOING TO ADD 534 00:18:09,240 --> 00:18:10,920 ANYTHING TERRIBLY NEW TO THE 535 00:18:10,920 --> 00:18:11,480 CONVERSATION. 536 00:18:11,480 --> 00:18:13,520 I'M HOPING TO REFRAME IT IN MY 537 00:18:13,520 --> 00:18:15,000 TALK AND HOPEFULLY YOU CAN SEE 538 00:18:15,000 --> 00:18:19,640 MY SLIDES, AND SEE MY SCREEN. 539 00:18:19,640 --> 00:18:21,920 >> OKAY, GREAT. 540 00:18:21,920 --> 00:18:25,000 >> YES WE CAN. 541 00:18:25,000 --> 00:18:25,680 >> ALL RIGHT, GREAT. 542 00:18:25,680 --> 00:18:27,280 SO THANK YOU FOR THAT GREAT 543 00:18:27,280 --> 00:18:27,960 INTRODUCTION AS WELL, I 544 00:18:27,960 --> 00:18:29,200 SHOULDN'T TELL YOU ABOUT OUR 545 00:18:29,200 --> 00:18:30,600 JOURNEY AS I TRY TO REFRAME 546 00:18:30,600 --> 00:18:32,160 EVERYTHING I HEARD, I FEEL LIKE 547 00:18:32,160 --> 00:18:33,880 EVERYTHING'S BEEN SAID BUT MAYBE 548 00:18:33,880 --> 00:18:35,320 IT COULD USE A LITTLE BIT OF A 549 00:18:35,320 --> 00:18:36,760 SPIN, SO MY DAUGHTER SAN 550 00:18:36,760 --> 00:18:38,160 FRANCISCO VAN APPROVAL FROM SBA 551 00:18:38,160 --> 00:18:39,880 BORN TYPICALLY A HEALTHY 552 00:18:39,880 --> 00:18:42,080 DEVELOPING, I WAS A YOUNG 23 553 00:18:42,080 --> 00:18:44,200 YEAR-OLD MOM AND SHE DEVELOPED 554 00:18:44,200 --> 00:18:45,000 COMPLETELY NORMALLY UNTIL THE 555 00:18:45,000 --> 00:18:46,760 AGE OF 2 WHEN OUT OF THE BLUE 556 00:18:46,760 --> 00:18:50,720 SHE HAD HER FIRST SEIZURE. 557 00:18:50,720 --> 00:18:52,280 AND VERY QUICKLY SHE HAD A 558 00:18:52,280 --> 00:18:54,320 COUPLE MORE SEIZURES AND THEN 559 00:18:54,320 --> 00:18:55,200 SHE WENT 6 MONTHS WITHOUT HAVING 560 00:18:55,200 --> 00:18:56,560 THEM AND THEN THEY CAME BACK AT 561 00:18:56,560 --> 00:18:57,360 THE AGE OF 3. 562 00:18:57,360 --> 00:19:00,720 SHE WAS DIAGNOSED AT THAT TIME 563 00:19:00,720 --> 00:19:04,000 WITH IDIO PATHIC/CRYPTO GENIC 564 00:19:04,000 --> 00:19:04,480 INTRACTABLE EPILEPSY. 565 00:19:04,480 --> 00:19:08,560 SHE WAS HAVING HUNDREDS OF 566 00:19:08,560 --> 00:19:10,160 SEIZURES A DAY AND WE STARTED TO 567 00:19:10,160 --> 00:19:12,400 SEE DELAYS IN HER DEVELOPMENT 568 00:19:12,400 --> 00:19:14,040 AND IT COMPLETELY DERAILED OUR 569 00:19:14,040 --> 00:19:14,240 LIVES. 570 00:19:14,240 --> 00:19:16,000 SEIZURES TOOK OVER OUR LIVES, A 571 00:19:16,000 --> 00:19:18,480 GOOD DAY WAS 5 TO 10 SEIZURES, A 572 00:19:18,480 --> 00:19:20,920 BAD DAY WAS HUNDREDS OF 573 00:19:20,920 --> 00:19:21,200 SEIZURES. 574 00:19:21,200 --> 00:19:22,600 TOO MANY TO COUNT. 575 00:19:22,600 --> 00:19:24,040 WE NEVER KNEW WHAT WE WERE GOING 576 00:19:24,040 --> 00:19:26,040 TO GET FROM DAY-TO-DAY AND OUR 577 00:19:26,040 --> 00:19:27,240 LIFE BECAME FOR SEIZURES AND 578 00:19:27,240 --> 00:19:30,080 PLANNING FOR THE AFTERMATH OF 579 00:19:30,080 --> 00:19:31,360 SEIZURES WHICH INCLUDES CLEANING 580 00:19:31,360 --> 00:19:34,560 UP PEE AND POOP AND POSSIBLY 581 00:19:34,560 --> 00:19:35,520 ASPIRATION PNEUMONIA BUT IT 582 00:19:35,520 --> 00:19:37,600 BECAME A SERIES OF GOING TO THE 583 00:19:37,600 --> 00:19:40,120 HOSPITAL WHEN AT HOME EMERGENCY 584 00:19:40,120 --> 00:19:41,240 RESCUE MEDICINES DIDN'T WORK TO 585 00:19:41,240 --> 00:19:45,800 STOP THE SEIZURES AND THEN, YOU 586 00:19:45,800 --> 00:19:47,000 KNOW GETTING MORE MEDICINES IN 587 00:19:47,000 --> 00:19:49,600 THE ER AND GETTING PUT INTO 588 00:19:49,600 --> 00:19:51,240 MEDICALLY INDUCED COMAS AND 589 00:19:51,240 --> 00:19:52,960 GOING BACK HOME AND LOOKING FOR 590 00:19:52,960 --> 00:19:54,320 STABILITY, TRYING TO KEEP THIS 591 00:19:54,320 --> 00:19:54,720 CHILD ALIVE. 592 00:19:54,720 --> 00:19:56,280 IT WAS A CONSTANT CRISIS, IF YOU 593 00:19:56,280 --> 00:20:01,040 THINK ABOUT A HIERARCHY OF NEED, 594 00:20:01,040 --> 00:20:02,440 YOU KNOW MAZWELLs, WE'RE ADDED 595 00:20:02,440 --> 00:20:03,920 THE BOTTOM, TRYING TO AVOID 596 00:20:03,920 --> 00:20:06,880 CRISIS AND THIS WAS OUR LIVES 597 00:20:06,880 --> 00:20:07,360 FOR 16 YEARS. 598 00:20:07,360 --> 00:20:09,640 YOU KNOW SHE HAD MORE THAN 1 599 00:20:09,640 --> 00:20:10,720 SEIZURE TYPES. 600 00:20:10,720 --> 00:20:13,720 AT 1 POINT THE EEG PICKED UP 6 601 00:20:13,720 --> 00:20:14,520 DIFFERENT SEIZURE TYPES, 602 00:20:14,520 --> 00:20:15,440 INCLUDING 1S THAT WOULD THROW 603 00:20:15,440 --> 00:20:17,120 HER TO THE GROUND, 1 THAT WOULD 604 00:20:17,120 --> 00:20:18,920 CAUSE HER TO GO LIMP AND DROP TO 605 00:20:18,920 --> 00:20:21,920 THE GROUND AND IT WASN'T UNTIL 606 00:20:21,920 --> 00:20:31,800 AGE 5 THAT SHE WAS DIAGNOSED 607 00:20:31,800 --> 00:20:33,200 LENNOX GASTRAUT DISORDER BACK 608 00:20:33,200 --> 00:20:35,880 THEN WE KNEW IT BASED ON 609 00:20:35,880 --> 00:20:36,280 CLINICAL FEATURES. 610 00:20:36,280 --> 00:20:37,920 STARTING AT THE AGE OF 3 SHE 611 00:20:37,920 --> 00:20:39,280 FELL BEHIND IN HER DEVELOPMENT 612 00:20:39,280 --> 00:20:42,000 AND BY THE TIME SHE WAS 18 HE 613 00:20:42,000 --> 00:20:44,480 HAD MORE THAN 40,000 SEEDURES, 614 00:20:44,480 --> 00:20:48,960 SHE WAS ON 8 TREATMENTS FOR LGS 615 00:20:48,960 --> 00:20:50,960 INCLUDING MEDICATIONS, DIET, 616 00:20:50,960 --> 00:20:51,960 DEVICES, SURGERY, ALTERNATIVE 617 00:20:51,960 --> 00:20:53,720 THERAPIES, ALL THE DEVICES YOU 618 00:20:53,720 --> 00:20:57,600 WOULD THINK ABOUT WITH EPILEPSY, 619 00:20:57,600 --> 00:20:58,600 VAGUS NERVE STIMULATION, DEEP 620 00:20:58,600 --> 00:20:59,520 BRAIN STIMULATION IS MAKING A 621 00:20:59,520 --> 00:21:02,440 ROUND IN OUR COMMUNITY, TRIALS 622 00:21:02,440 --> 00:21:04,240 FOR MAGNETIC STIMULATION, YOU 623 00:21:04,240 --> 00:21:06,400 NAME IT, WE'VE CONSIDERED IT OR 624 00:21:06,400 --> 00:21:07,280 PARTICIPATED IN IT, ALONG WITH 625 00:21:07,280 --> 00:21:08,800 THE COMMUNITY THEY WORK IN AS 626 00:21:08,800 --> 00:21:10,360 THE EXECUTIVE DIRECTOR, WE HAVE 627 00:21:10,360 --> 00:21:11,160 MORE THAN 8000 FAMILIES THAT 628 00:21:11,160 --> 00:21:13,960 WE'RE WORKING WITH THAT ARE JUST 629 00:21:13,960 --> 00:21:16,920 WALKING DEVICE STORIES, ALL OF 630 00:21:16,920 --> 00:21:18,560 THEM. 631 00:21:18,560 --> 00:21:19,320 SAVANNAH WAS DEVELOPMENTALLY 632 00:21:19,320 --> 00:21:20,800 DELAYED AT THE AGE OF 18, SHE 633 00:21:20,800 --> 00:21:24,880 WAS FUNCTIONING AT ABOUT A 3 634 00:21:24,880 --> 00:21:26,760 YEAR-OLD LEVEL, DESPITE ALL 635 00:21:26,760 --> 00:21:27,760 THESE INTERVENTIONSES ARE SHE 636 00:21:27,760 --> 00:21:31,160 SLEPT AOUUT 18 ADAY AND 637 00:21:31,160 --> 00:21:32,760 HER SEIZURES PERSISTED DESPITE 638 00:21:32,760 --> 00:21:34,800 TREATMENT AND OUR FAMILIES, AT A 639 00:21:34,800 --> 00:21:37,440 CERTAIN POINT, I THINK THE FIRST 640 00:21:37,440 --> 00:21:38,680 THROUGH THERAPIES IN EPILEPSY 641 00:21:38,680 --> 00:21:41,000 ARE THOUGHT OF RATIONALLY BUT 642 00:21:41,000 --> 00:21:42,720 THEN AT A CERTAIN POINT IT 643 00:21:42,720 --> 00:21:44,480 BECOMES A DART BOARD APPROACH 644 00:21:44,480 --> 00:21:45,760 YOU PICK A MEDICATION OR TRIAL 645 00:21:45,760 --> 00:21:46,960 AND YOU CYCLE THROUGH THOSE AND 646 00:21:46,960 --> 00:21:48,720 BY AND LARGE THEY DON'T WORK, 647 00:21:48,720 --> 00:21:50,360 MORE THAN 85% OF THE PATIENTS 648 00:21:50,360 --> 00:21:52,080 CONTINUE TO HAVE SEIZURES INTO 649 00:21:52,080 --> 00:21:54,040 ADULTHOOD IF THEY LIVE. 650 00:21:54,040 --> 00:21:55,880 THERE IS A 24 X INCREASED RATE 651 00:21:55,880 --> 00:21:59,400 OF DEATH IN OUR LGS POPULATION. 652 00:21:59,400 --> 00:22:02,240 MORE THAN 95% ARE SEVERELY 653 00:22:02,240 --> 00:22:03,000 INTELLECTUALLY DISABLED SO YOU 654 00:22:03,000 --> 00:22:05,720 END UP IN THIS TREATMENT LOOP 655 00:22:05,720 --> 00:22:06,800 JUST TRYING THIS. 656 00:22:06,800 --> 00:22:09,160 SO NOT ONLY ARE YOU IN CONSTANT 657 00:22:09,160 --> 00:22:10,560 SURVIVAL MODE BUT YOU'RE IN THIS 658 00:22:10,560 --> 00:22:12,720 HEALTHCARE SYSTEM OF AN INSANE 659 00:22:12,720 --> 00:22:16,600 TREATMENT LOOP WHICH IS VERY 660 00:22:16,600 --> 00:22:17,360 DIFFICULT TO NAVIGATE. 661 00:22:17,360 --> 00:22:18,880 BY THE TIME SHE WAS 18, SHE HAD 662 00:22:18,880 --> 00:22:21,320 TRIED AND FAILED MORE THAN 26 663 00:22:21,320 --> 00:22:22,320 DIFFERENT THERAPIES AS I 664 00:22:22,320 --> 00:22:22,640 MENTIONED. 665 00:22:22,640 --> 00:22:23,760 I THINK TO COMPLETE HER STORY 666 00:22:23,760 --> 00:22:26,200 FOR YOU WHEN SHE WAS 18 WE DID 667 00:22:26,200 --> 00:22:27,640 FIND THE GENETIC MUTATIONS THAT 668 00:22:27,640 --> 00:22:30,200 WERE UNDERLYING THE SEIZURES 669 00:22:30,200 --> 00:22:32,760 THAT EVOFFED INTO HER LGS AND WE 670 00:22:32,760 --> 00:22:35,720 PUT HER ON MEDICATION, SHE HAS 671 00:22:35,720 --> 00:22:37,080 CALCIUM CHANNEL OVERACTIVATION 672 00:22:37,080 --> 00:22:39,280 DISORDER AND AS OF LAST YEAR 673 00:22:39,280 --> 00:22:41,400 PRIOR TO GETTING COVID AT THE 674 00:22:41,400 --> 00:22:43,240 AGE OF 28, SHE'S NOW 29, SHE WAS 675 00:22:43,240 --> 00:22:46,120 DOWN TO 4 MEDICATIONS, HER 676 00:22:46,120 --> 00:22:50,720 SEIZURES DROPPED BY 95%, HER 677 00:22:50,720 --> 00:22:52,680 EPIDEPTIC EPISODES DROPPED AND 678 00:22:52,680 --> 00:22:54,040 SO SHE DEVELOPED AND LEARNED 679 00:22:54,040 --> 00:22:55,520 AGAIN AND THAT MEDICATION WAS 680 00:22:55,520 --> 00:22:56,800 LIFE CHANGING AND SHE RECENTLY 681 00:22:56,800 --> 00:22:58,920 GOT COVID AND NOW WE'RE 682 00:22:58,920 --> 00:23:00,240 STRUGGLING AGAIN WITH SEEDSURES 683 00:23:00,240 --> 00:23:02,800 BUT OVER ALL, YOU CAN SAY, THAT 684 00:23:02,800 --> 00:23:04,720 THIS JOURNEY IS VERY TYPICAL OF 685 00:23:04,720 --> 00:23:05,960 THE LGS JOURNEY AND SO WHEN WE 686 00:23:05,960 --> 00:23:07,560 THINK ABOUT OUR FAMILIES 687 00:23:07,560 --> 00:23:08,200 PARTICIPATE NOTHING A CLINICAL 688 00:23:08,200 --> 00:23:10,560 TRIAL, WE HAVE TO THINK ABOUT IN 689 00:23:10,560 --> 00:23:15,400 THE CONTEXT THAT THEY'RE ALREADY 690 00:23:15,400 --> 00:23:15,880 INCREDIBLY OVERWHELM. 691 00:23:15,880 --> 00:23:16,840 AND ANYTHING--YOU KNOW AND THIS 692 00:23:16,840 --> 00:23:18,280 IS THE DESPERATE POPULATION THAT 693 00:23:18,280 --> 00:23:21,040 IS LOOKING FOR ANSWERS, FROM THE 694 00:23:21,040 --> 00:23:21,440 CLINICAL TRIAL. 695 00:23:21,440 --> 00:23:22,360 SO WHEN I STARTED TO THINK ABOUT 696 00:23:22,360 --> 00:23:24,720 WHAT IS THE MINIMUM THAT WE 697 00:23:24,720 --> 00:23:26,200 NEED, YOU KNOW I THINK THAT WE 698 00:23:26,200 --> 00:23:27,400 HAVE A GOOD BASE BOARD. 699 00:23:27,400 --> 00:23:28,720 WE HEARD FROM PATIENTS AND 700 00:23:28,720 --> 00:23:31,240 FAMILIES, WE HEARD FROM ALL THE 701 00:23:31,240 --> 00:23:33,160 STAKEHOLDERS, YOU KNOW AND BUT I 702 00:23:33,160 --> 00:23:35,280 THINK REFRAMING IT AND TO ANSWER 703 00:23:35,280 --> 00:23:36,520 THE QUESTIONS, THE MIN NUM, 704 00:23:36,520 --> 00:23:37,760 THESE ARE THE MIN NUM QUESTIONS 705 00:23:37,760 --> 00:23:39,960 THAT WE HAVE TO ANSWER BEFORE 706 00:23:39,960 --> 00:23:41,800 THE TRIAL AND THERE'S A SERIES 707 00:23:41,800 --> 00:23:42,880 OF QUESTIONS, DURING THE TRIAL 708 00:23:42,880 --> 00:23:45,560 AND THERE'S A SERIES OF 709 00:23:45,560 --> 00:23:47,040 QUESTIONS AFTER THE TRIAL AND I 710 00:23:47,040 --> 00:23:50,040 WON'T READ ALL OF THESE TO YOU 711 00:23:50,040 --> 00:23:51,200 BUT I WILL SAY THESE QUESTIONS 712 00:23:51,200 --> 00:23:53,040 ARE GOING TO BE ACROSS THE BOARD 713 00:23:53,040 --> 00:23:58,360 FOR NO MATTER WHAT YOUR DISEASE 714 00:23:58,360 --> 00:24:02,320 IS AND IF YOU WERE TO TAKE YOUR 715 00:24:02,320 --> 00:24:03,160 SCIENCE AND MEDICAL BRAIN AND 716 00:24:03,160 --> 00:24:06,800 THIS WILL BE THE QUESTIONS YOU 717 00:24:06,800 --> 00:24:08,280 WANT ANSWERED AND I THINK THAT 718 00:24:08,280 --> 00:24:09,280 CLINICAL TRIALS ARE 719 00:24:09,280 --> 00:24:10,720 INTENTIONALLY SET UP TO BE 720 00:24:10,720 --> 00:24:13,360 CONFUSING, YOU KNOW WE 721 00:24:13,360 --> 00:24:15,120 DON'T--INFORMED CONSENT IS NOT 722 00:24:15,120 --> 00:24:16,480 EASY, WE WORK WITH A LOT OF 723 00:24:16,480 --> 00:24:18,440 SPONNORS THAT ARE LOOKING FOR 724 00:24:18,440 --> 00:24:20,480 THERAPIES THANK GOD FOR LGS AND 725 00:24:20,480 --> 00:24:22,720 THEY WILL OFTEN SAY GO TO 726 00:24:22,720 --> 00:24:23,640 CLINICAL TRIALS .GOV TO LEARN 727 00:24:23,640 --> 00:24:24,840 MORE ABOUT THE TRIAL. 728 00:24:24,840 --> 00:24:27,640 I AM AN EDUCATED WOMAN WHO'S 729 00:24:27,640 --> 00:24:30,000 BEEN AN ADVOCATE FOR 30 YEARS 730 00:24:30,000 --> 00:24:31,240 AND I STILL STRUG WELCLINICAL 731 00:24:31,240 --> 00:24:33,840 TRIALS.ON GOFF. 732 00:24:33,840 --> 00:24:34,880 SO ANSWERING QUESTIONS ABOUT IS 733 00:24:34,880 --> 00:24:35,920 THIS SAVE, WHAT IS THE BURDEN 734 00:24:35,920 --> 00:24:37,520 FOR ME NOW IN TIME AND MONEY, 735 00:24:37,520 --> 00:24:40,160 WHAT'S IT GOING TO BE IN THE 736 00:24:40,160 --> 00:24:40,440 LONG-TERM. 737 00:24:40,440 --> 00:24:42,040 LOOKING OUT, WHAT WILL THIS COST 738 00:24:42,040 --> 00:24:44,520 ME IN TERMS OF TIME, QUALITY, 739 00:24:44,520 --> 00:24:46,720 MONEY AND QUALITY OF LIFE, THAT 740 00:24:46,720 --> 00:24:48,160 FINANCIAL COST COULD BE TIME, IT 741 00:24:48,160 --> 00:24:51,480 COULD BE INVEST NMENT WHAT WILL 742 00:24:51,480 --> 00:24:52,400 HAPPEN PSYCHOLOGICALLY AND OVER 743 00:24:52,400 --> 00:24:54,040 TIME AS YOU'RE DEALING WITH 744 00:24:54,040 --> 00:24:54,880 HAVING THIS DEVICE. 745 00:24:54,880 --> 00:24:56,640 YOU KNOW 1 THING THAT HASN'T 746 00:24:56,640 --> 00:24:58,920 COME UP ON OUR CONVERSATIONS 747 00:24:58,920 --> 00:25:01,120 YET, YOU KNOW AS WE TALKED ABOUT 748 00:25:01,120 --> 00:25:03,880 THIS, IS DATA SHARING, YOU KNOW 749 00:25:03,880 --> 00:25:05,160 THIS--DATA THAT IS COLLECTED BY 750 00:25:05,160 --> 00:25:07,880 ALL OF YOU GUYS, IN THE SPACE 751 00:25:07,880 --> 00:25:09,600 IS, I KNOW YOU THINK OF IT AS 752 00:25:09,600 --> 00:25:12,520 YOUR DATA, IT'S NOT YOUR DATA. 753 00:25:12,520 --> 00:25:13,920 THIS IS DATA THAT HAS BEEN BUILT 754 00:25:13,920 --> 00:25:15,120 ON THE BACKS AND BRAINING OF OUR 755 00:25:15,120 --> 00:25:18,840 CHILDREN AND OUR LOVED 1S, RIGHT 756 00:25:18,840 --> 00:25:20,600 IN LGS SPACE AND OTHER BODY 757 00:25:20,600 --> 00:25:22,000 PARTS AND OTHER PATIENTS AND 758 00:25:22,000 --> 00:25:23,600 OTHER GROUPS BUT THIS DATA HAS 759 00:25:23,600 --> 00:25:26,240 TO BE SHARED SO WHEN I GO INTO A 760 00:25:26,240 --> 00:25:27,840 TRIAL, I NOT ONLY KNOW I WILL 761 00:25:27,840 --> 00:25:29,120 GET THE DATA AND AT SOME POINT 762 00:25:29,120 --> 00:25:31,160 OTHER PEOPLE WILL GET THE DATA 763 00:25:31,160 --> 00:25:32,800 BUT THAT IT'S MAXINALLY USED IN 764 00:25:32,800 --> 00:25:33,240 A WAY. 765 00:25:33,240 --> 00:25:34,520 YOU ARE COMING TO THIS, THERE'S 766 00:25:34,520 --> 00:25:36,200 SO MUCH DATA THAT IS OUT THERE, 767 00:25:36,200 --> 00:25:37,960 EVERY TIME I GO INTO A TRIAL, I 768 00:25:37,960 --> 00:25:38,960 GET ASKED THE SAME QUESTIONS 769 00:25:38,960 --> 00:25:40,120 OVER AND OVER AND OVER AGAIN AND 770 00:25:40,120 --> 00:25:41,400 IT'S A BURDEN TO ME AND ALL THE 771 00:25:41,400 --> 00:25:43,000 OTHER PEOPLE IN A TRIAL AND SO 772 00:25:43,000 --> 00:25:44,520 ARE WE ACTIVELY MINING THE DATA 773 00:25:44,520 --> 00:25:45,920 THAT'S COME BEFORE US TO DESIGN 774 00:25:45,920 --> 00:25:47,880 THE TRIAL NOW AND ARE WE 775 00:25:47,880 --> 00:25:49,320 ACTIVELY SHARING THE DAILY BASIS 776 00:25:49,320 --> 00:25:50,760 THEA AFTER US SO THAT PATIENTS 777 00:25:50,760 --> 00:25:54,480 DON'T HAVE TO KEEP ANSWERING THE 778 00:25:54,480 --> 00:25:54,840 SAME QUESTIONS. 779 00:25:54,840 --> 00:25:56,840 SO THESE ARE THE QUESTIONS 780 00:25:56,840 --> 00:25:59,160 BEFORE, BUT THE MUST-HAVES IN MY 781 00:25:59,160 --> 00:26:00,800 MIND ARE THE SAME NO MATTER IF 782 00:26:00,800 --> 00:26:03,320 YOU ARE TALKING ABOUT BEFORE, 783 00:26:03,320 --> 00:26:06,640 DURING 784 00:26:06,640 --> 00:26:07,640 DURING OR AFTER THE TRIAL. 785 00:26:07,640 --> 00:26:09,480 THAT'S THE MIND SET. 786 00:26:09,480 --> 00:26:11,000 WE NEED TO BUILD EFFECTIVE 787 00:26:11,000 --> 00:26:12,080 COMMUNICATION, IT'S NOT 788 00:26:12,080 --> 00:26:12,320 EFFECTIVE. 789 00:26:12,320 --> 00:26:15,040 IT'S NOT AND I SPENT 20 YEARS OF 790 00:26:15,040 --> 00:26:16,520 MY LIFE, LIVING BELOW THE 791 00:26:16,520 --> 00:26:17,720 POVERTY LINE AND BEING 792 00:26:17,720 --> 00:26:19,440 UNEDUCATED AND I WORK A LOT IN 793 00:26:19,440 --> 00:26:22,520 THE COMMUNITY IN THE PEOPLE WITH 794 00:26:22,520 --> 00:26:23,480 PEOPLE OF DIFFERENT 795 00:26:23,480 --> 00:26:24,760 SOCIOECONOMIC STATUS AND IT'S 796 00:26:24,760 --> 00:26:26,880 EVEN WORSE FOR THEM FOR THEM AND 797 00:26:26,880 --> 00:26:28,920 THE WAY I WAS BACK THEN AND 798 00:26:28,920 --> 00:26:30,360 WE'RE ACTIVELY DISCRIMINATING IN 799 00:26:30,360 --> 00:26:30,720 THOSE INSTANCES. 800 00:26:30,720 --> 00:26:32,200 I THINK FAST AND EASY SERVICE IS 801 00:26:32,200 --> 00:26:35,840 A LOT OF THESE TRIALS ARE ARE 802 00:26:35,840 --> 00:26:36,840 VERY BURDENSOME, BECAUSE THAT'S 803 00:26:36,840 --> 00:26:39,080 THE WAY WE'VE ALWAYS DONE IT, 804 00:26:39,080 --> 00:26:39,360 RIGHT? 805 00:26:39,360 --> 00:26:41,240 DO WE REALLY NEED TO DO IT THAT 806 00:26:41,240 --> 00:26:43,400 WAY, IN THE BEFORE PHASE, I 807 00:26:43,400 --> 00:26:44,320 THINK MINIMAL NONAPOPTOTIC NO 808 00:26:44,320 --> 00:26:46,000 COST TO PATIENTS OTHER THAN 809 00:26:46,000 --> 00:26:47,200 TIME, SPBLGLY DESIGNED AS I 810 00:26:47,200 --> 00:26:49,200 EXPLAINED IN TERMS OF DATA USE 811 00:26:49,200 --> 00:26:49,600 AND TRANSPARENT. 812 00:26:49,600 --> 00:26:52,000 BUT THOSE ARE THE MUST-HAVEs 813 00:26:52,000 --> 00:26:53,400 EVEN WHEN YOU'RE--THE SAME MUST 814 00:26:53,400 --> 00:26:54,680 HAVES WHEN YOU ARE LOOKING AT 815 00:26:54,680 --> 00:26:58,840 DURING THE TRIAL AND WE CAN 816 00:26:58,840 --> 00:27:00,000 IMPLEMENT THINGS LIKE BRINGING 817 00:27:00,000 --> 00:27:01,560 IN PATIENTS TO ASK THEM ABOUT 818 00:27:01,560 --> 00:27:03,200 THE TRIAL PROTOCOL, I HAVE 819 00:27:03,200 --> 00:27:04,960 ADVICE ON TRIAL PROTOCOLS, I DO 820 00:27:04,960 --> 00:27:07,360 IT FOR FREE, MOW LONG LEADS CAN 821 00:27:07,360 --> 00:27:09,160 YOU IMPLEMENT TELEHEALTH, CAN 822 00:27:09,160 --> 00:27:10,640 YOU IMPLEMENT MOBILE FLEBOT ME, 823 00:27:10,640 --> 00:27:11,320 THEY THINKS LIKE THAT. 824 00:27:11,320 --> 00:27:12,920 SO I KNOW THIS IS FOCUSING ON 825 00:27:12,920 --> 00:27:14,000 AFTER THE TRIAL, BUT HERE'S THE 826 00:27:14,000 --> 00:27:14,920 QUESTIONS AFTER THE TRIAL. 827 00:27:14,920 --> 00:27:16,960 DO I HAVE EASY ACCESS TO CARE 828 00:27:16,960 --> 00:27:18,160 WHARKS ABOUT URGENT NEEDS, 829 00:27:18,160 --> 00:27:19,880 SNRIET AND WE'VE SEEN SOLUTIONS 830 00:27:19,880 --> 00:27:22,080 FOR THAT ALREADY, BUT I THINK WE 831 00:27:22,080 --> 00:27:24,760 HAVEN'T FRAMED THE DISCUSSION SO 832 00:27:24,760 --> 00:27:26,480 FAR AROUND THE PATIENT JOURNEY. 833 00:27:26,480 --> 00:27:29,280 AM I GOING TO BE SAFE, IS THE 834 00:27:29,280 --> 00:27:31,680 DEVICE WORKING, HOW DO WE DEFINE 835 00:27:31,680 --> 00:27:32,040 WORKING. 836 00:27:32,040 --> 00:27:34,160 HOW BURDENSOME IS THIS DEVICE ON 837 00:27:34,160 --> 00:27:36,200 ME AND NOW IN THE FUTURE AND I 838 00:27:36,200 --> 00:27:36,960 THINK A RESPONSIBLE TRIAL COMES 839 00:27:36,960 --> 00:27:39,440 FROM US BEING ABLE TO ANSWER 840 00:27:39,440 --> 00:27:47,120 EACH OF THESE QUESTIONS. 841 00:27:47,120 --> 00:27:48,640 PART OF THE DISCUSSION GROUP WAS 842 00:27:48,640 --> 00:27:49,920 TO OUTLINE WHERE RESEARCH 843 00:27:49,920 --> 00:27:50,720 RELATED GROUP ISN'T PART OF IT 844 00:27:50,720 --> 00:27:51,960 AND I THINK PATIENTS ARE WILLING 845 00:27:51,960 --> 00:27:55,680 AND I THINK OTHER PEOPLE LIKE 846 00:27:55,680 --> 00:27:57,120 INSURANCE CARRIERS AND MEDICAID 847 00:27:57,120 --> 00:27:58,000 SERVICES AND THINGS LIKE THAT 848 00:27:58,000 --> 00:27:59,160 ARE WILLING TO STEP UP. 849 00:27:59,160 --> 00:28:01,960 WE CAN'T EXPECT THE SPONSOR TO 850 00:28:01,960 --> 00:28:03,440 COVER EVERYTHING FOREVER FOR ALL 851 00:28:03,440 --> 00:28:04,400 ETERNITY, THAT DOESN'T MAKE ANY 852 00:28:04,400 --> 00:28:06,520 SENSE BUT THERE ARE INSTANCES 853 00:28:06,520 --> 00:28:08,960 AND SO BUILDING THIS AROUND THE 854 00:28:08,960 --> 00:28:11,080 EXISTING ECOSYSTEM IS GREAT AND 855 00:28:11,080 --> 00:28:14,520 I LOVE DR. MORRELL'S TALK 856 00:28:14,520 --> 00:28:15,680 YESTERDAY ABOUT HOW THEY'RE 857 00:28:15,680 --> 00:28:17,640 NAVIGATING THIS WITH THE RNS 858 00:28:17,640 --> 00:28:18,040 TRIAL. 859 00:28:18,040 --> 00:28:19,200 WE'VE HEARD AND I WON'T GO OVER 860 00:28:19,200 --> 00:28:20,960 THIS AGAIN AND IT WAS SUMMARIZED 861 00:28:20,960 --> 00:28:22,040 BEAUTIFULLY THIS MORNING BUT WE 862 00:28:22,040 --> 00:28:23,040 HEARD FROM PATIENT FAMILIES 863 00:28:23,040 --> 00:28:24,360 YESTERDAY ABOUT THE THINGS THAT 864 00:28:24,360 --> 00:28:26,840 THEY WISH THEY HAD AS RELATED TO 865 00:28:26,840 --> 00:28:28,400 TRIAL AFTER CARE AND I DON'T 866 00:28:28,400 --> 00:28:29,840 EVEN THINK I HAVE THEM ALL 867 00:28:29,840 --> 00:28:32,320 LISTED HERE BUT THERE IS 868 00:28:32,320 --> 00:28:33,760 CONSENSUS, SO, YOU'VE HEARD FROM 869 00:28:33,760 --> 00:28:35,360 PATIENT FAMILIES, AND I WOULD 870 00:28:35,360 --> 00:28:38,560 IMAGINE THAT THIS CONSENSUS HAS 871 00:28:38,560 --> 00:28:40,200 BEEN SCHECTED ACTIVELY THROUGH 872 00:28:40,200 --> 00:28:42,080 VARIOUS FDA PROGRAMS, THROUGH 873 00:28:42,080 --> 00:28:43,040 VARIOUS RESEARCH PROGRAMS, YOU 874 00:28:43,040 --> 00:28:45,080 KNOW VERY MUCH THE WAY THE 875 00:28:45,080 --> 00:28:46,680 PATIENT FOCUSED DRUG DEVELOPMENT 876 00:28:46,680 --> 00:28:49,080 WORK IS GOING ON WITHIN THE FDA, 877 00:28:49,080 --> 00:28:52,120 I THINK THESE CONSENSUS 878 00:28:52,120 --> 00:28:54,240 STATEMENTS ACROSS PATIENTS 879 00:28:54,240 --> 00:28:54,680 DISEASE STATES EXIST. 880 00:28:54,680 --> 00:28:55,920 I AGREE WITH EVERYTHING THAT WAS 881 00:28:55,920 --> 00:28:59,680 SAID, AND I HAVE A PEDIATRIC 882 00:28:59,680 --> 00:29:03,640 CASE, I HAVE AN ADULT WITH 883 00:29:03,640 --> 00:29:04,280 SEVERE INTELLECTUAL DISABILITY, 884 00:29:04,280 --> 00:29:05,440 THOSE WERE NOT THE PATIENT 885 00:29:05,440 --> 00:29:06,720 ADVOCATES WE HEARD YESTERDAY BUT 886 00:29:06,720 --> 00:29:07,920 I AGREE WITH EVERYTHING THEY 887 00:29:07,920 --> 00:29:08,240 SAID. 888 00:29:08,240 --> 00:29:11,720 I THINK PATIENT VALUE FRAMEWORKS 889 00:29:11,720 --> 00:29:13,360 EXIST, RIGHT? 890 00:29:13,360 --> 00:29:16,200 SO HERE'S 1 FROM WHERE THEY HAVE 891 00:29:16,200 --> 00:29:18,400 BROKEN DOWN WHAT THE FAVORITE 892 00:29:18,400 --> 00:29:19,880 VALUE IS, THEY REALLY HAVE 893 00:29:19,880 --> 00:29:22,120 BROKEN OUT HOW YOU CAN RELATE 894 00:29:22,120 --> 00:29:25,880 VALUE, WHAT IS IT THAT PATIENTS 895 00:29:25,880 --> 00:29:28,360 VALUE AND THIS IS TAKEN INTO 896 00:29:28,360 --> 00:29:30,680 ACCOUNT AS RELATING TO PATIENT 897 00:29:30,680 --> 00:29:31,880 BLUING DEVELOPMENT WITHIN THE 898 00:29:31,880 --> 00:29:33,120 FDA AND PATIENT DEVELOPMENT 899 00:29:33,120 --> 00:29:34,840 DEVICE AS WELL AND YOU CAN BREAK 900 00:29:34,840 --> 00:29:36,320 IT DOWN ACROSS PATIENTS, THERE 901 00:29:36,320 --> 00:29:37,360 ARE THESE BUCKETS WE ALL FALL 902 00:29:37,360 --> 00:29:39,280 INTO AND YOU CAN MEASURE THOSE 903 00:29:39,280 --> 00:29:40,520 AND EACH OF THESE TOOLS ALL THE 904 00:29:40,520 --> 00:29:42,160 WAY OVER TO THE RIGHT OF THE 905 00:29:42,160 --> 00:29:45,240 SCREEN ARE WAYS CAN YOU ACTIVELY 906 00:29:45,240 --> 00:29:48,200 MEASURE THESE THINGS THAT MATTER 907 00:29:48,200 --> 00:29:49,400 TO PATIENTS. 908 00:29:49,400 --> 00:29:50,760 WE KNOW HOW TO MEASURE QUALITY 909 00:29:50,760 --> 00:29:52,600 OF LIFE IN LGS AND THAT COMES A 910 00:29:52,600 --> 00:29:53,960 LOT FROM PATIENT ADVOCATES 911 00:29:53,960 --> 00:29:54,200 PUSHING. 912 00:29:54,200 --> 00:29:55,600 SO I THINK THAT ALL OF THE BITS 913 00:29:55,600 --> 00:29:56,640 OF THE CONVERSATION ARE HERE, 914 00:29:56,640 --> 00:29:57,880 EVERYTHING THAT I HEARD 915 00:29:57,880 --> 00:30:00,160 YESTERDAY WAS SO INSPIRING, BUT 916 00:30:00,160 --> 00:30:02,080 I THINK WHAT'S MISSING, STILL IS 917 00:30:02,080 --> 00:30:03,760 AS WE MOVE FORWARD, AND AS THE 918 00:30:03,760 --> 00:30:06,640 WORK GROUP MOVES FORWARD IS TO 919 00:30:06,640 --> 00:30:08,440 REFRAME AROUND, YOU KNOW AROUND 920 00:30:08,440 --> 00:30:09,440 THE PATIENT PERSPECTIVE, RIGHT? 921 00:30:09,440 --> 00:30:10,760 SO WHAT DO PATIENTS VALUE, I 922 00:30:10,760 --> 00:30:12,760 THINK WE HAVE A LOT OF 923 00:30:12,760 --> 00:30:14,280 INFORMATION ON THAT. I THINK WE 924 00:30:14,280 --> 00:30:15,440 NEED TO DEFINE WHAT BENEFIT 925 00:30:15,440 --> 00:30:17,160 LOOKS LIKE AND I THINK A LOT OF 926 00:30:17,160 --> 00:30:18,200 THIS PREWORK HAS BEEN DONE. 927 00:30:18,200 --> 00:30:20,800 YOU SIMPLY NEED TO ASK, EACH 928 00:30:20,800 --> 00:30:21,800 DISEASE STATE ORGANIZATION, YOU 929 00:30:21,800 --> 00:30:23,440 KNOW HOW DO YOU VALUE? 930 00:30:23,440 --> 00:30:26,200 I THINK A LOT OF THIS HAS BEEN 931 00:30:26,200 --> 00:30:29,640 DONE WITH PFDD, WITH VALUE 932 00:30:29,640 --> 00:30:30,400 FRAMEWORKS, WITH IN-HOUSE 933 00:30:30,400 --> 00:30:32,680 SURVEYS WITH FOCUS GROUPS. 934 00:30:32,680 --> 00:30:34,160 BUT I THINK THAT THE PATIENT 935 00:30:34,160 --> 00:30:35,360 GROUPS AND PATIENTS THEMSELVES 936 00:30:35,360 --> 00:30:37,000 HAVE EXPERIENCE WANT TO BE CO 937 00:30:37,000 --> 00:30:39,880 CREATOR AND CO DESIGNERS IN THIS 938 00:30:39,880 --> 00:30:43,120 PROCESS AT EVERY STAGE OF THE 939 00:30:43,120 --> 00:30:45,160 LEVEL, YOU KNOW THE WEATHER, IN 940 00:30:45,160 --> 00:30:46,480 THE BASIC RESEARCH OR DESIGN OR 941 00:30:46,480 --> 00:30:48,160 EXIT OF THE TRIAL. 942 00:30:48,160 --> 00:30:49,600 PATIENTS WILL ADVISE AND HELP 943 00:30:49,600 --> 00:30:53,640 YOU TO SAVE TIME AND MONEY AND 944 00:30:53,640 --> 00:30:54,520 SUFFERING, I PROMISE YOU. 945 00:30:54,520 --> 00:30:56,400 AND THEN I THINK IF WE MAP THIS 946 00:30:56,400 --> 00:30:58,840 OUT ACROSS THE PATIENT JOURNEY, 947 00:30:58,840 --> 00:31:00,040 I THINK THAT'S USEFUL. 948 00:31:00,040 --> 00:31:01,120 A CLEAR DEFINITION OF WHEN THE 949 00:31:01,120 --> 00:31:02,960 TRIAL IS OVER I THINK IS 950 00:31:02,960 --> 00:31:04,400 IMPORTANT AND A TRANSITION PLAN, 951 00:31:04,400 --> 00:31:06,040 IT SOUNDS LIKE I WAS REMINDED A 952 00:31:06,040 --> 00:31:07,840 LOT AS WE WERE GOING THROUGH 953 00:31:07,840 --> 00:31:10,400 THIS, OF WHAT HAPPENS WHEN WE GO 954 00:31:10,400 --> 00:31:11,720 FROM PEDIATRIC NEUROLOGICAL 955 00:31:11,720 --> 00:31:13,440 CARE, TO ADULT NEUROLOGICAL CARE 956 00:31:13,440 --> 00:31:15,200 AND WE'RE GIIVE A PIECE OF PAPER 957 00:31:15,200 --> 00:31:16,960 AND THROWN OUT INTO THE ADULT 958 00:31:16,960 --> 00:31:18,080 NEUROLOGY WORLD WHICH IS VERY 959 00:31:18,080 --> 00:31:19,440 DIFFERENT AND FEELS LIKE THAT'S 960 00:31:19,440 --> 00:31:20,520 KIND OF HAPPENING. 961 00:31:20,520 --> 00:31:21,920 PATES ARE KIND OF PUSHED OUT 962 00:31:21,920 --> 00:31:23,560 INTO THE TRIAL WORLD AND THERE'S 963 00:31:23,560 --> 00:31:24,560 NOT THIS CLEAR TRANSITION PLAN 964 00:31:24,560 --> 00:31:27,400 AND WHAT DOES THAT LOOK LIKE AND 965 00:31:27,400 --> 00:31:29,040 HOW ARE YOU EQUIPPED TO MANAGE 966 00:31:29,040 --> 00:31:33,520 THIS FOR THE NEXT 30 YEARS. 967 00:31:33,520 --> 00:31:34,760 CLEAR INFORMED CONSENT, IT 968 00:31:34,760 --> 00:31:37,000 SERVES US AS DOCTORS, IT SERVES, 969 00:31:37,000 --> 00:31:38,640 YOU KNOW US THAT ARE IN THE 970 00:31:38,640 --> 00:31:43,400 RESEARCH BASE, BUT IT'S DOES NOT 971 00:31:43,400 --> 00:31:44,640 SERVE FAMILIES AT ALL. 972 00:31:44,640 --> 00:31:47,440 AN EMPHASIS I WOULD SAY ON OTHER 973 00:31:47,440 --> 00:31:49,920 POPULATIONS, AGAIN, PEDIATRIC, 974 00:31:49,920 --> 00:31:51,960 SEVERE INTELLECTUAL DISABILITY, 975 00:31:51,960 --> 00:31:53,400 LOW SES, AND 1 MORE EMPSCIZZ ON 976 00:31:53,400 --> 00:31:54,680 JUST THE MAXIMAL LEARNING, 977 00:31:54,680 --> 00:31:56,880 THERE'S SO MUCH DATA OUT THERE. 978 00:31:56,880 --> 00:32:01,160 EVERYONE HAS DAT AT ON OUR LGS 979 00:32:01,160 --> 00:32:01,600 FAMILIES EXCEPT US. 980 00:32:01,600 --> 00:32:03,520 AND WHAT I HAVE TO GO THROUGH TO 981 00:32:03,520 --> 00:32:05,880 GET MY OWN DAUGHTER'S DATA IS A 982 00:32:05,880 --> 00:32:07,680 PAIN, I CAN'T GET DATA FROM THE 983 00:32:07,680 --> 00:32:10,880 TRIALS HE'S BEEN IN, I'M FINE 984 00:32:10,880 --> 00:32:12,000 WITH EMBARGOED DATA FOR A 985 00:32:12,000 --> 00:32:13,240 CERTAIN TIME BUT I WANT THAT 986 00:32:13,240 --> 00:32:15,120 DATA AND I WANT IT SHARED IN OUR 987 00:32:15,120 --> 00:32:15,640 COMMUNITY. 988 00:32:15,640 --> 00:32:18,080 THE NUMBER 1 QUESTION WE GET IN 989 00:32:18,080 --> 00:32:19,520 THE LGS IN THE COMMUNITY IS HAVE 990 00:32:19,520 --> 00:32:21,560 YOU EVER SEEN THIS WEIRD RASH? 991 00:32:21,560 --> 00:32:23,600 AND HAVE YOU SEEN THIS BEHAVIOR? 992 00:32:23,600 --> 00:32:24,520 THAT DATA EXISTS IN THE TRIALS 993 00:32:24,520 --> 00:32:26,960 FROM THE PAST AND IT DOESN'T GET 994 00:32:26,960 --> 00:32:27,520 SHARED. 995 00:32:27,520 --> 00:32:28,680 AND THEN OFTEN WE PUBLISH A 996 00:32:28,680 --> 00:32:30,240 PAPER ON THE TRIAL OUTCOME AND 997 00:32:30,240 --> 00:32:31,720 THEN IT GETS TRANSLATED DOWN TO 998 00:32:31,720 --> 00:32:34,000 PATIENTS SO THAT'S A LOT OF WHAT 999 00:32:34,000 --> 00:32:35,880 WE DO IN THE GROUPS SO I THINK 1000 00:32:35,880 --> 00:32:36,800 I'M INSPIRED BY EVERYTHING 1001 00:32:36,800 --> 00:32:37,920 THAT'S BEEN SAID BUT I WOULD 1002 00:32:37,920 --> 00:32:39,960 LOVE TO SEE SORT OF A REFRAME 1003 00:32:39,960 --> 00:32:41,320 AROUND THE PATIENT JOURNEY WHICH 1004 00:32:41,320 --> 00:32:43,160 DID COME UP YESTERDAY AND 1005 00:32:43,160 --> 00:32:44,440 HOPEFULLY THIS TALK MAYBE SET 1006 00:32:44,440 --> 00:32:46,640 THE STAGE FOR SOME GREAT 1007 00:32:46,640 --> 00:32:48,040 DISCUSSION AROUND THAT. 1008 00:32:48,040 --> 00:32:49,040 THANK YOU. 1009 00:32:49,040 --> 00:32:52,280 >> THANK YOU SO MUCH TRACEY, 1010 00:32:52,280 --> 00:32:52,880 THAT WAS WONDERFUL. 1011 00:32:52,880 --> 00:32:57,160 DOES ANYONE HAVE A QUESTION FOR 1012 00:32:57,160 --> 00:32:57,920 DR. DIXON-SALAZAR BEFORE WE MOVE 1013 00:32:57,920 --> 00:32:59,720 TO THE NEXT SPEAKER. 1014 00:32:59,720 --> 00:33:01,520 I WOULD LOVE TO HEAR QUESTIONS 1015 00:33:01,520 --> 00:33:02,760 FROM ANYBODY IN THE AUDIENCE OR 1016 00:33:02,760 --> 00:33:13,120 ANYBODY ON THE PANEL. 1017 00:33:13,120 --> 00:33:13,600 >> THIS IS RHONDA. 1018 00:33:13,600 --> 00:33:14,400 I HAVE A QUESTION. 1019 00:33:14,400 --> 00:33:16,440 THANK YOU SO MUCH FOR YOUR 1020 00:33:16,440 --> 00:33:17,160 PRESENTATION AND THE INFORMATION 1021 00:33:17,160 --> 00:33:18,960 YOU GIVING IS VERY, VERY 1022 00:33:18,960 --> 00:33:22,040 MEANINGFUL AND VERY HELPFUL. 1023 00:33:22,040 --> 00:33:26,400 I'M JUST WONDERING PARTICULARLY 1024 00:33:26,400 --> 00:33:27,680 WITH THE COMPLEXITY OF THE 1025 00:33:27,680 --> 00:33:29,600 DISORDER THAT YOUR DAUGHTER AS 1026 00:33:29,600 --> 00:33:32,680 HAD AND - I IMAGINE THERE AREN'T 1027 00:33:32,680 --> 00:33:33,320 MANY PHYSICIANS WHO UNDERSTAND 1028 00:33:33,320 --> 00:33:38,320 OR KNOW ANYTHING ABOUT IT, IS 1029 00:33:38,320 --> 00:33:39,720 THE TRANSITION FROM POST 1030 00:33:39,720 --> 00:33:43,720 CLINICAL TRIAL TO THE REGULAR 1031 00:33:43,720 --> 00:33:45,480 PROVIDER SYSTEM ALSO A PROBLEM 1032 00:33:45,480 --> 00:33:47,280 IN TERMS OF THOSE PROVIDERS 1033 00:33:47,280 --> 00:33:53,600 BEING AWARE OF THE RESEARCH 1034 00:33:53,600 --> 00:33:54,360 , THE 1035 00:33:54,360 --> 00:33:55,320 OUTCOMES OF THE RESEARCH IN 1036 00:33:55,320 --> 00:33:59,480 TERMS OF BEING A HELPFUL CO 1037 00:33:59,480 --> 00:34:00,240 HEARING OF THIS. 1038 00:34:00,240 --> 00:34:01,480 >> YEAH, THE ANSWER IS IT IS A 1039 00:34:01,480 --> 00:34:02,960 PROBLEM ACROSS THE BOARD IN ALL 1040 00:34:02,960 --> 00:34:04,360 DISEASE STATES, I KNOW THAT 1041 00:34:04,360 --> 00:34:06,360 BECAUSE I SPENT A LOT OF TIME 1042 00:34:06,360 --> 00:34:07,960 WITH OTHER DISEASES BUT 1043 00:34:07,960 --> 00:34:08,640 ESPECIALLY WITH LGS 1044 00:34:08,640 --> 00:34:10,720 SPECIFICALLY, YOU KNOW IT 1045 00:34:10,720 --> 00:34:13,560 DEPENDS ON THE TRIAL RIGHT. 1046 00:34:13,560 --> 00:34:14,800 SO VAGUS NERVE STIMULATOR WAS 1047 00:34:14,800 --> 00:34:15,440 ALREADY APPROVED WHEN WE WENT 1048 00:34:15,440 --> 00:34:18,040 INTO THE TRIAL FOR AN EXTEBDED 1049 00:34:18,040 --> 00:34:19,200 STUDY AND SO INITIALLY WHEN IT 1050 00:34:19,200 --> 00:34:20,680 FIRST CAME ON THE MARKET, YOU 1051 00:34:20,680 --> 00:34:22,240 MET A LOT OF PATIENTS AND 1052 00:34:22,240 --> 00:34:23,840 FAMILIES WHERE IT WAS FIRST 1053 00:34:23,840 --> 00:34:25,120 APPROVED WHO WERE STRUGGLING 1054 00:34:25,120 --> 00:34:26,840 BECAUSE NOBODY KNEW ABOUT IT AND 1055 00:34:26,840 --> 00:34:28,120 NOBODY HAD THE TRIAL DATA AND 1056 00:34:28,120 --> 00:34:30,840 YOU COULD ONLY GO TO THESE 1057 00:34:30,840 --> 00:34:31,600 SPECIALIZED CENTERS, RIGHT? 1058 00:34:31,600 --> 00:34:32,920 BUT THEN IF YOU GO TO AN 1059 00:34:32,920 --> 00:34:34,000 EXTENDED TRIAL, THAT'S GOING TO 1060 00:34:34,000 --> 00:34:35,040 EXPAND THE DAILY BASIS THEA BASE 1061 00:34:35,040 --> 00:34:39,360 AND THE DATA KNOWLEDGE, NOW AT 1062 00:34:39,360 --> 00:34:40,600 LEAST THERE'S A CHUNK OF PEOPLE 1063 00:34:40,600 --> 00:34:42,280 THAT AT LEAST HEARD OF IT SO YOU 1064 00:34:42,280 --> 00:34:44,560 LESSENED IT BUT THE HANDOFF IS 1065 00:34:44,560 --> 00:34:46,440 STILL INCREDIBLE LOAMACYY 1066 00:34:46,440 --> 00:34:46,680 PAINFUL. 1067 00:34:46,680 --> 00:34:48,760 THERE'S A FEW SPECIALISTS THAT 1068 00:34:48,760 --> 00:34:50,520 EXIST IN LGS, THERE'S LIKE 20 IN 1069 00:34:50,520 --> 00:34:52,160 THE U.S. THAT I COULD NAME OFF 1070 00:34:52,160 --> 00:34:53,600 THE TOP OF MY HEAD AND EVEN THAT 1071 00:34:53,600 --> 00:34:55,080 KNOWLEDGE OF JUST THE SYNDROME 1072 00:34:55,080 --> 00:34:56,840 ITSELF, NOT THE VERY SPECIALIZE 1073 00:34:56,840 --> 00:34:58,080 TREATMENTSA ISSUES ROUND IT IS 1074 00:34:58,080 --> 00:34:59,320 JUST CONCENTRATED IN THAT BODY 1075 00:34:59,320 --> 00:35:01,840 AND YET MOST LGS PATIENTS ARE 1076 00:35:01,840 --> 00:35:06,280 TREATED BY GENERAL NEUROLOGY OR 1077 00:35:06,280 --> 00:35:06,840 EVEN GENERAL PRACTICE. 1078 00:35:06,840 --> 00:35:08,760 SO IT'S A REAL PROBLEM WITH THE 1079 00:35:08,760 --> 00:35:11,080 HANDOFF AND IT'S EVEN WORSE IF 1080 00:35:11,080 --> 00:35:12,360 YOU HAVE A TRIAL WHERE YOU WANT 1081 00:35:12,360 --> 00:35:15,600 TO CONTINUE THE STUDY SO 1082 00:35:15,600 --> 00:35:16,920 MAGNETIC STIMULATION WAS IN THE 1083 00:35:16,920 --> 00:35:19,080 LGS PATIENTS AND WE ACTUALLY HAD 1084 00:35:19,080 --> 00:35:20,160 A NUMBER OF RESPONDERS THAT 1085 00:35:20,160 --> 00:35:21,040 RESPONDED TO THIS AND WE WERE 1086 00:35:21,040 --> 00:35:23,880 PART OF THIS AS WELL AND AGAIN 1087 00:35:23,880 --> 00:35:24,840 NOT AN IMPLANTABLE DEVICE BUT 1088 00:35:24,840 --> 00:35:26,240 IT'S LIKE NOBODY KNOWS HOW TO 1089 00:35:26,240 --> 00:35:27,440 DID IT, THE TRIAL WILL NOT 1090 00:35:27,440 --> 00:35:30,440 CONTINUE, IT WAS AN ACADEMIC 1091 00:35:30,440 --> 00:35:31,720 STUDY, RIGHT? 1092 00:35:31,720 --> 00:35:32,440 AND THERE'S REALLY NOTHING TO 1093 00:35:32,440 --> 00:35:35,480 MOVE FORWARD WITH IT AND SO THE 1094 00:35:35,480 --> 00:35:36,600 PATIENTS MOBILIZE TO TRY TO GET 1095 00:35:36,600 --> 00:35:37,840 THE STUDY TO CONTINUE ON AND 1096 00:35:37,840 --> 00:35:39,040 FOUND IT BUT IT'S REALLY LIKE 1097 00:35:39,040 --> 00:35:40,280 NOW, ON TOP OF EVERYTHING ELSE 1098 00:35:40,280 --> 00:35:43,280 THAT WE'RE DEALING WITH, YOU ARE 1099 00:35:43,280 --> 00:35:44,560 HAVING TO TRY TO NOW FIGURE OUT 1100 00:35:44,560 --> 00:35:47,640 A WAY TO GET THIS FOR YOUR CHILD 1101 00:35:47,640 --> 00:35:49,000 BECAUSE YOU SAW A HUNDRED% 1102 00:35:49,000 --> 00:35:49,760 REDUCTION IN SEIZURE WHEN IS 1103 00:35:49,760 --> 00:35:52,080 YOU'RE KID WAS ON IT AND NOW 1104 00:35:52,080 --> 00:35:52,560 IT'S COMPLETELY OVER. 1105 00:35:52,560 --> 00:35:54,720 SO THERE IS NO TRANSITION PLAN. 1106 00:35:54,720 --> 00:35:56,600 IT'S SORT OF LIKE WE GET HANDED 1107 00:35:56,600 --> 00:35:58,040 THE GOODS AND TOLD TO MOVE ON 1108 00:35:58,040 --> 00:35:59,640 AND I THINK WHAT WAS GREAT 1109 00:35:59,640 --> 00:36:02,320 YESTERDAY WHEN WE SAW HOW PANE 1110 00:36:02,320 --> 00:36:03,800 PEOPLE RECALLED THE INFORMED 1111 00:36:03,800 --> 00:36:05,160 CONSENT DISCUSSION, IT HAPPENED, 1112 00:36:05,160 --> 00:36:06,320 SOMEBODY SAID WELL WE TALKED 1113 00:36:06,320 --> 00:36:07,840 ABOUT THIS, OKAY, WELL, ON THE 1114 00:36:07,840 --> 00:36:10,400 BACK DROP OF MY KID LIKE 1115 00:36:10,400 --> 00:36:11,880 STRIPPING NAKED IN THE DOCTOR'S 1116 00:36:11,880 --> 00:36:12,920 OFFICE AND THE BEHAVIOR SHE HAS 1117 00:36:12,920 --> 00:36:14,440 AT SCHOOL AND THE CLINICAL TRIAL 1118 00:36:14,440 --> 00:36:15,640 WE'RE IN AND ALL THE MEDICATIONS 1119 00:36:15,640 --> 00:36:18,840 I HAVE TO GIVE HER A DAY, I 1120 00:36:18,840 --> 00:36:21,160 DIDN'T REMEMBER THAT. 1121 00:36:21,160 --> 00:36:22,160 I'M SORRY. 1122 00:36:22,160 --> 00:36:24,000 AND SO I THINK THAT'S A LONG 1123 00:36:24,000 --> 00:36:27,720 ANSWER TO YES, IT'S A PROBLEM. 1124 00:36:27,720 --> 00:36:29,320 A TRANSITION PLAN WOULD BE 1125 00:36:29,320 --> 00:36:31,200 REALLY HELPFUL FOR EACH OF THE 1126 00:36:31,200 --> 00:36:34,080 SCENARIOS OF DEVICES OUT THERE, 1127 00:36:34,080 --> 00:36:35,440 EXTENSION STUDY, DEVICE IS 1128 00:36:35,440 --> 00:36:38,760 BRANDT SPANKING NEW AND IT 1129 00:36:38,760 --> 00:36:39,200 DIDN'T GET APPROVED. 1130 00:36:39,200 --> 00:36:41,080 >> I THINK WE HAVE TIME FOR 1 1131 00:36:41,080 --> 00:36:42,080 MORE QUESTION AND TRACEY I WILL 1132 00:36:42,080 --> 00:36:43,640 LET YOU KNOW THERE ARE A NUMBER 1133 00:36:43,640 --> 00:36:46,640 OF QUESTIONS IN THE Q&A WHEN 1134 00:36:46,640 --> 00:36:47,760 YOU'RE FINISHED, YOU CAN LOOK AT 1135 00:36:47,760 --> 00:36:52,920 THEM BUT MAYBE WE CAN ASK RONALD 1136 00:36:52,920 --> 00:36:59,040 TRIOLLO? 1137 00:36:59,040 --> 00:37:00,440 ASK HIS QUESTION. 1138 00:37:00,440 --> 00:37:02,200 >> SORRY, I RAISED MY HAND BY 1139 00:37:02,200 --> 00:37:02,920 MISTAKE. 1140 00:37:02,920 --> 00:37:03,320 SORRY ABOUT THAT. 1141 00:37:03,320 --> 00:37:05,240 MAYBE THEN WE WILL MOVE ON TO 1142 00:37:05,240 --> 00:37:05,640 THE NEXT SPEAKER. 1143 00:37:05,640 --> 00:37:08,000 >> I HAD A COMMENT. 1144 00:37:08,000 --> 00:37:08,320 >> SORRY? 1145 00:37:08,320 --> 00:37:13,400 >> I HAD A COMMENT. 1146 00:37:13,400 --> 00:37:14,920 GO AHEAD. 1147 00:37:14,920 --> 00:37:17,280 >> JOHN MARLER AT FDA, I JUST 1148 00:37:17,280 --> 00:37:19,400 NOTED TO SAY I THINK THIS GROUP 1149 00:37:19,400 --> 00:37:22,240 SHOULD REALLY LISTEN TO THE 1150 00:37:22,240 --> 00:37:24,320 MESSAGE DELIVERED HERE THAT THE 1151 00:37:24,320 --> 00:37:27,800 CLINICAL TRIALS HAVE BECOME VERY 1152 00:37:27,800 --> 00:37:28,720 INEFFICIENT. 1153 00:37:28,720 --> 00:37:33,440 THEY'RE COMPLICATED, I THINK 1154 00:37:33,440 --> 00:37:36,080 UNNECESSARILY SO AND I WHOLE 1155 00:37:36,080 --> 00:37:37,880 HEARTEDLY ENDORSE, 1 OF THE 1156 00:37:37,880 --> 00:37:39,640 MAJOR PROBLEMS WITH GETTING, 1157 00:37:39,640 --> 00:37:40,920 INTERPRETING THE RESULTS OF 1158 00:37:40,920 --> 00:37:44,760 CLINICAL TRIALS IS LARGE DROP 1159 00:37:44,760 --> 00:37:46,200 OUT RATES, LACK OF COMPLETION OF 1160 00:37:46,200 --> 00:37:50,400 THE STUDY BY PATIENTS, WE GET 1161 00:37:50,400 --> 00:37:57,000 DISCOURAGED AND LEAVE THE TRIAL, 1162 00:37:57,000 --> 00:37:59,560 SO I REALLY THINK TRACEY EAD 1163 00:37:59,560 --> 00:38:00,640 COMMENTS ARE EXTREMELY VALUABLE 1164 00:38:00,640 --> 00:38:02,640 AND WE SHOULD KEEP THOSE IN THE 1165 00:38:02,640 --> 00:38:02,960 FOREFRONT. 1166 00:38:02,960 --> 00:38:05,640 I BELIEVE THAT THE WAY TO MOVE 1167 00:38:05,640 --> 00:38:06,720 FORWARD IS TO REALLY START 1168 00:38:06,720 --> 00:38:09,800 BRINGING IN PATIENTS FROM THE 1169 00:38:09,800 --> 00:38:11,840 BEGINNING, THE DESIGN OF THIS 1170 00:38:11,840 --> 00:38:13,680 STUDY AND ALL OF THE DETAILS OF 1171 00:38:13,680 --> 00:38:16,240 IT BECAUSE IF THEY DON'T SUPPORT 1172 00:38:16,240 --> 00:38:21,680 IT, IF THEY DON'T BELIEVE IN THE 1173 00:38:21,680 --> 00:38:22,840 IMPORTANCE OF RANDOMIZATION WHEN 1174 00:38:22,840 --> 00:38:26,480 IT REQUIRED AND SO ON, IT JUST 1175 00:38:26,480 --> 00:38:28,080 DOESN'T HAPPEN EFFECTIVELY. 1176 00:38:28,080 --> 00:38:30,040 SO THAT'S MY COMMENT, THANK YOU. 1177 00:38:30,040 --> 00:38:32,520 >> THANK YOU IF ARE THAT 1178 00:38:32,520 --> 00:38:32,760 COMMENT. 1179 00:38:32,760 --> 00:38:36,240 I THINK I JUST WANT TO REMIND 1180 00:38:36,240 --> 00:38:37,000 EVERYBODY THAT PANELISTS, YOU 1181 00:38:37,000 --> 00:38:40,200 CAN ANSWER QUESTIONS IN THE Q&A. 1182 00:38:40,200 --> 00:38:43,720 IF YOU WILL WANT TO BUT WE'RE 1183 00:38:43,720 --> 00:38:44,960 ALSO FOR EVERYBODY WHOSE 1184 00:38:44,960 --> 00:38:48,000 QUESTIONS DID NOT GET ANSWERED 1185 00:38:48,000 --> 00:38:49,720 AT THIS MOMENT, I WANT TO REMIND 1186 00:38:49,720 --> 00:38:51,120 YOU WE WILL HAVE A LARGER 1187 00:38:51,120 --> 00:38:53,400 DISCUSSION AT THE END OF ALL THE 1188 00:38:53,400 --> 00:38:54,760 PANELISTS PRESENTATION,MENT SO 1189 00:38:54,760 --> 00:38:57,280 THEN IT'S MY PLEASURE TO 1190 00:38:57,280 --> 00:39:00,640 INTRODUCE THE NEXT PANELIST, 1191 00:39:00,640 --> 00:39:04,920 DR. P A TRICIO, RIFFA POSSE, WHO 1192 00:39:04,920 --> 00:39:06,360 IS ASSISTANT PROFESSOR IN THE 1193 00:39:06,360 --> 00:39:08,440 DEPARTMENT OF PSYCHIATRY AND 1194 00:39:08,440 --> 00:39:09,720 BEHAVIORAL SCIENCES AT EMORY 1195 00:39:09,720 --> 00:39:11,160 UNIVERSITY WHERE HIS CLINICAL 1196 00:39:11,160 --> 00:39:14,120 AND RESEARCH ACTIVITIES FOCUS ON 1197 00:39:14,120 --> 00:39:15,960 TREATMENT MOOD DISORDERS, THE 1198 00:39:15,960 --> 00:39:19,400 RATIONAL ISHT VENTION PSYCHIATRY 1199 00:39:19,400 --> 00:39:22,680 SERVICES AND DEPRESSION 1200 00:39:22,680 --> 00:39:25,680 COMPONENT, ALSO VICTORY IN 1201 00:39:25,680 --> 00:39:27,680 INVASIVE AND NONINVASIVE 1202 00:39:27,680 --> 00:39:28,440 NEURO[INDISCERNIBLE] TECHNIQUES 1203 00:39:28,440 --> 00:39:37,520 AND INCLUDING THE VAGUS NERVE 1204 00:39:37,520 --> 00:39:42,920 STIMULATION, ELECTIVE COMPULSIVE 1205 00:39:42,920 --> 00:39:47,720 THERAPY AND ELECTROMAGNETIC 1206 00:39:47,720 --> 00:39:50,080 TRANSLATION, AND THANK YOU FOR 1207 00:39:50,080 --> 00:39:51,440 SO MUCH FOR PARTICIPATING AND WE 1208 00:39:51,440 --> 00:39:55,240 LOOK FORWARD TO YOUR TALK. 1209 00:39:55,240 --> 00:39:56,240 >> THANK YOU DR. HENDRIKs, I 1210 00:39:56,240 --> 00:39:58,320 HOPE EVERYONE CAN SEE MY 1211 00:39:58,320 --> 00:40:02,040 PRESENTATION. 1212 00:40:02,040 --> 00:40:04,040 SO I WANT TO FIRST DO A 1213 00:40:04,040 --> 00:40:06,640 DISCLOSURE, I HAVE RECEIVED 1214 00:40:06,640 --> 00:40:08,880 CONSULTING FEES FROM JANSSEN 1215 00:40:08,880 --> 00:40:11,320 FARM SUITALS FOR DRUGS THAT ARE 1216 00:40:11,320 --> 00:40:13,280 RELATED TO THE TREATMENT OF 1217 00:40:13,280 --> 00:40:15,400 DEPRESSION AND SUICIDALLITY BUT 1218 00:40:15,400 --> 00:40:17,360 NOT RELATED TO WHAT PUTS US 1219 00:40:17,360 --> 00:40:18,920 TOGETHER IN DEEP BRAIN 1220 00:40:18,920 --> 00:40:23,800 STIMULATION OR THE 1221 00:40:23,800 --> 00:40:25,400 INTERVENTIONAL INVASIVE 1222 00:40:25,400 --> 00:40:25,800 NEUROMODDULATION. 1223 00:40:25,800 --> 00:40:29,000 THE DEVICES THAT WE HAVE WORKED 1224 00:40:29,000 --> 00:40:33,320 WITH FOR THESE YEARS AT EMORY 1225 00:40:33,320 --> 00:40:37,360 AND MT. SINAI OUR PARTNER HAVE 1226 00:40:37,360 --> 00:40:39,520 BEEN DONATED ALWAYS BY JAINT 1227 00:40:39,520 --> 00:40:41,320 JUDE MEDICAL INITIALLY AND IN 1228 00:40:41,320 --> 00:40:43,960 MORE RECENT YEARS BY MEDTRONNIC. 1229 00:40:43,960 --> 00:40:46,440 AND WE WORK UNDER AN 1230 00:40:46,440 --> 00:40:48,640 INVESTIGATIONAL DEVICE EXEMPTION 1231 00:40:48,640 --> 00:40:52,480 AND WE HAVE 2 OPEN TRIALS IN 1232 00:40:52,480 --> 00:40:53,520 CLINICAL TRIALS .GOV, SOME OF 1233 00:40:53,520 --> 00:40:56,480 THEM THAT ARE ACTIVE BUT NOT 1234 00:40:56,480 --> 00:41:00,520 RECRUITING PATIENTS AND THAT 1235 00:41:00,520 --> 00:41:02,960 INITIALLY OUR FUNDS WERE 1236 00:41:02,960 --> 00:41:05,440 ESSENTIALLY FOUNDATION GRANTS 1237 00:41:05,440 --> 00:41:07,880 FOR MANY, MANY YEARS UNTIL 1238 00:41:07,880 --> 00:41:10,760 RECENTLY, THE LAST 4 OR 5 YEARS, 1239 00:41:10,760 --> 00:41:15,600 WE WERE AWARDED UH3 GRANT WITH 1240 00:41:15,600 --> 00:41:18,040 DR. HELEN MAYBERG AND COMBINING 1241 00:41:18,040 --> 00:41:20,000 OUR WORK BETWEEN THE MT. SINAI, 1242 00:41:20,000 --> 00:41:23,520 EMORY UNIVERSITY AND GEORGIA 1243 00:41:23,520 --> 00:41:24,040 TECH. 1244 00:41:24,040 --> 00:41:25,960 SO, YOU KNOW--I KNOW THAT TODAY 1245 00:41:25,960 --> 00:41:30,120 IS SORT OF WHAT SHOULD BE THE 1246 00:41:30,120 --> 00:41:31,560 MIN NUM THAT ANY RESEARCH 1247 00:41:31,560 --> 00:41:36,400 RELATED CARE SOME HAVE. 1248 00:41:36,400 --> 00:41:38,200 AND I THINK THAT AS A SIMPLE 1249 00:41:38,200 --> 00:41:39,640 QUESTION, IT CANNOT BE ANSWERED 1250 00:41:39,640 --> 00:41:44,600 IN A STRAIGHT FORWARD WAY. 1251 00:41:44,600 --> 00:41:45,480 MOST INVESTIGATOR INITIATED 1252 00:41:45,480 --> 00:41:52,360 QUESTIONS AND IDEAS.RY SMALL 1253 00:41:52,360 --> 00:41:57,280 THESE EVOLVE OVER TIME WITH 1254 00:41:57,280 --> 00:41:58,320 INCREASING COMPLEXITY, SOMETIMES 1255 00:41:58,320 --> 00:41:59,720 IN, YOU KNOW GEOGRAPHIC 1256 00:41:59,720 --> 00:42:02,160 LOCATIONS, BUT ALSO IN TERMS OF 1257 00:42:02,160 --> 00:42:03,520 THE PARTNERSHIPS THAT WE 1258 00:42:03,520 --> 00:42:06,680 DEVELOP, THE FUNDING SOURCES AND 1259 00:42:06,680 --> 00:42:09,000 THE AVAILABILITY OF RESEARCHERS 1260 00:42:09,000 --> 00:42:12,880 TO PROVIDE COMPREHENSIVE CARE. 1261 00:42:12,880 --> 00:42:15,160 I WILL USE THE EXAMPLE OF DEEP 1262 00:42:15,160 --> 00:42:17,200 BRAIN STIMULATION FOR DEPRESSION 1263 00:42:17,200 --> 00:42:25,160 WITH SPECIFIC LOCATION IN THE 1264 00:42:25,160 --> 00:42:26,160 SUBCOLOSSAL AREA WHICH IS WHERE 1265 00:42:26,160 --> 00:42:28,400 OUR WORK HAS BEEN FOCUSED FOR 1266 00:42:28,400 --> 00:42:29,680 THE PAST 15 YEARS. 1267 00:42:29,680 --> 00:42:32,640 THE INITIAL STUDY WAS START 1268 00:42:32,640 --> 00:42:34,720 INDEED CANADA. 1269 00:42:34,720 --> 00:42:36,440 AND IN CANADA DR. MAYBERG WHO 1270 00:42:36,440 --> 00:42:38,840 CAN'T BE HERE TODAY BUT 1271 00:42:38,840 --> 00:42:41,080 DR. MAYBERG AND DR. LOZANO WHO 1272 00:42:41,080 --> 00:42:42,200 IS A NEUROSURGEON DIDN'T HAVE 1273 00:42:42,200 --> 00:42:47,320 THE NEED IT TO FILE FOR DEVICE 1274 00:42:47,320 --> 00:42:47,920 EXEMPTION. 1275 00:42:47,920 --> 00:42:49,840 THEY USED COMMERCIALLY AVAILABLE 1276 00:42:49,840 --> 00:42:50,680 DEEP BRAIN STIMULATION DEVICES 1277 00:42:50,680 --> 00:42:52,840 AND WITH THE HYPOTHESIS, THEY 1278 00:42:52,840 --> 00:42:56,800 CONDUCTED THE SURMRYS, THE 1279 00:42:56,800 --> 00:42:57,760 CONCOSTS OF SURGERIES WERE 1280 00:42:57,760 --> 00:43:00,000 ASSUMED BY THE HOSPITAL, 1281 00:43:00,000 --> 00:43:02,800 ABSORBED BY THE SYSTEM, THEY DID 1282 00:43:02,800 --> 00:43:03,720 EVERYTHING UNDER RESEARCH 1283 00:43:03,720 --> 00:43:06,000 PROTOCOL WITH PATIENTS BEING 1284 00:43:06,000 --> 00:43:07,840 CONSENTED BUT ESSENTIALLY ISSUES 1285 00:43:07,840 --> 00:43:10,960 THE COMPLEXITY OF DOING A SMALL 1286 00:43:10,960 --> 00:43:11,600 CLINICAL TRIAL TO DEMONSTRATE, 1287 00:43:11,600 --> 00:43:17,840 YOU KNOW A SMALL DEGREE OF 1288 00:43:17,840 --> 00:43:21,040 EFFICACY WAS NOT THAT 1289 00:43:21,040 --> 00:43:21,600 CONVOLUNTEERSUDED, RIGHT? 1290 00:43:21,600 --> 00:43:27,040 AND I KNOW THAT MAYBE IT WAS THE 1291 00:43:27,040 --> 00:43:28,760 NAIVEETY OF THE BEGINNING. 1292 00:43:28,760 --> 00:43:30,280 THE IMPLEMENTATION OF SUBJECTS 1293 00:43:30,280 --> 00:43:31,960 ACTUALLY GENERATED A LOT OF 1294 00:43:31,960 --> 00:43:34,520 NOISE IN THE NEUROSCIENTIFIC, 1295 00:43:34,520 --> 00:43:36,520 PSYCHIATRIC COMMUNITY, IN THE 1296 00:43:36,520 --> 00:43:40,920 NEUROSURGICAL COMMUNITY AND IT 1297 00:43:40,920 --> 00:43:43,840 WAS PUBLISHED IN NEURON IN 2005 1298 00:43:43,840 --> 00:43:46,080 SO MANY, MANY YEARS AGO AND THIS 1299 00:43:46,080 --> 00:43:47,880 OPENED UP THE POSSIBILITY OF 1300 00:43:47,880 --> 00:43:49,200 SAYING, WELL, DEEP BRAIN 1301 00:43:49,200 --> 00:43:51,080 STIMULATION MAY BE EFFECTIVE IN 1302 00:43:51,080 --> 00:43:55,560 THE TREATMENT OF PSYCHIATRIC 1303 00:43:55,560 --> 00:43:56,240 DISORDERS. 1304 00:43:56,240 --> 00:43:57,400 FOLLOWING DR. MAYBERG'S PATH, 1305 00:43:57,400 --> 00:43:59,280 SHE MOVES TO EMORY UNIVERSITY 1306 00:43:59,280 --> 00:44:03,280 WHERE SHE SPENT THE NEXT 12-13 1307 00:44:03,280 --> 00:44:03,480 YEARS. 1308 00:44:03,480 --> 00:44:07,240 AND HERE IS WHERE WE MEET. 1309 00:44:07,240 --> 00:44:09,840 AND THE INITIAL IMPLEMENTATION 1310 00:44:09,840 --> 00:44:11,560 OF THESE DEVICES, YOU KNOW ALSO 1311 00:44:11,560 --> 00:44:15,120 STARTED WITH AN INITIAL, YOU 1312 00:44:15,120 --> 00:44:16,320 KNOW COMMITMENT BY THE 1313 00:44:16,320 --> 00:44:19,080 HEALTHCARE SYSTEM IN WHICH, YOU 1314 00:44:19,080 --> 00:44:22,320 KNOW THE INVESTIGATIONAL DEVICE 1315 00:44:22,320 --> 00:44:27,160 EXEMPTION WAS FILED TO THE FDA 1316 00:44:27,160 --> 00:44:29,280 AND THE HOSPITAL SIZE, YOU KNOW 1317 00:44:29,280 --> 00:44:32,680 HERE AT EMORY AGREED TO SUPPORT 1318 00:44:32,680 --> 00:44:34,600 THE INITIAL SURGERIES, USUALLY, 1319 00:44:34,600 --> 00:44:36,880 YOU KNOW MOST HEALTHCARE SYSTEMS 1320 00:44:36,880 --> 00:44:43,360 THAT ARE INTERESTED IN 1321 00:44:43,360 --> 00:44:46,160 DEVELOPING INVASIVE 1322 00:44:46,160 --> 00:44:48,480 NEUROMODDULATION CENTERS, THEY 1323 00:44:48,480 --> 00:44:49,360 ENTICE THE PARTICIPANTS OR THE 1324 00:44:49,360 --> 00:44:50,800 FACULTY THAT THEY WANT TO BRING 1325 00:44:50,800 --> 00:44:52,440 INTO SAYING WELL, WE WILL FUND A 1326 00:44:52,440 --> 00:44:55,240 NUMBER OF SURGERIES FOR YOU AND 1327 00:44:55,240 --> 00:44:57,600 THIS IS ALWAYS OPENLY DISCUSSED 1328 00:44:57,600 --> 00:44:59,240 BECAUSE OF COURSE, GETTING FUNDS 1329 00:44:59,240 --> 00:45:01,160 FOR SURGERIES THAT CAN BE 1330 00:45:01,160 --> 00:45:03,160 UPWARDS OF A HUNDRED THOUSAND 1331 00:45:03,160 --> 00:45:04,680 DOLLARS IF 1 DOESN'T EVEN 1332 00:45:04,680 --> 00:45:11,440 CONSIDER, YOU KNOW VERY DETAILED 1333 00:45:11,440 --> 00:45:12,120 EXPERIMENTAL PROCESSES, CAN 1334 00:45:12,120 --> 00:45:16,440 DRAIN ONCE THE INITIAL START UP 1335 00:45:16,440 --> 00:45:16,960 FUNDS QUITE RAPIDLY. 1336 00:45:16,960 --> 00:45:19,960 AND THE SURGERIES WERE FUNDED BY 1337 00:45:19,960 --> 00:45:22,600 EMORY HEALTHCARE, BY FOUNDATIONS 1338 00:45:22,600 --> 00:45:25,880 RELATED TO EMORY AND BY 1339 00:45:25,880 --> 00:45:27,240 FOUNDATIONS THAT ARE WELL 1340 00:45:27,240 --> 00:45:29,680 CONNECTED AND VERY GENEROUS IN 1341 00:45:29,680 --> 00:45:34,280 THEIR SUPPORT OF THE--OF NEW 1342 00:45:34,280 --> 00:45:35,800 PSYCHIATRIC TREATMENTS, LIKE THE 1343 00:45:35,800 --> 00:45:38,480 HOPE FOUNDATION, THE DANNA 1344 00:45:38,480 --> 00:45:39,360 FOUNDATION. 1345 00:45:39,360 --> 00:45:40,760 AND WHEN WE STARTED HERE, YOU 1346 00:45:40,760 --> 00:45:44,800 KNOW AND I JOIN INDEED 2008, AT 1347 00:45:44,800 --> 00:45:46,080 THE BEGINNING THERE WAS AN'T A 1348 00:45:46,080 --> 00:45:47,400 QUESTION OF WHAT TO DO WHEN 1349 00:45:47,400 --> 00:45:48,720 THERE IS NO INSURANCE COVERAGE, 1350 00:45:48,720 --> 00:45:51,400 BUT YOU KNOW WHAT WE REALIZED IS 1351 00:45:51,400 --> 00:45:53,400 THAT WHILE THE INITIAL COSTS 1352 00:45:53,400 --> 00:45:56,560 WOULD HAVE BEEN ABSORBED BY THE 1353 00:45:56,560 --> 00:45:57,680 HEALTHCARE SYSTEM, CONTINUOUS 1354 00:45:57,680 --> 00:46:01,000 CARE OF PATIENTS THAT HAVE AN 1355 00:46:01,000 --> 00:46:03,200 IMPLANTABLE DEVICE IS NOT FREE 1356 00:46:03,200 --> 00:46:04,040 OF CHARGE. 1357 00:46:04,040 --> 00:46:08,480 FOR THE SYSTEM, FOR THE 1358 00:46:08,480 --> 00:46:10,440 INVESTIGATORS, JUST TO GIVE YOU 1359 00:46:10,440 --> 00:46:14,280 AN EXAMPLE, WHILE WE WERE USING 1360 00:46:14,280 --> 00:46:17,800 BATTERIES THAT WERE ORIGINALLY 1361 00:46:17,800 --> 00:46:18,880 DESIGNED FOR PARKINSON'S DISEASE 1362 00:46:18,880 --> 00:46:22,000 THAT HAS MUCH LOWER CURRENT 1363 00:46:22,000 --> 00:46:24,480 USAGE, AND USUALLY PATIENTS ARE 1364 00:46:24,480 --> 00:46:28,160 ALSO IMPLANTED LATER IN LIFE. 1365 00:46:28,160 --> 00:46:31,000 WHAT BRANDY ELLIS WHO IS 1 OF 1366 00:46:31,000 --> 00:46:32,320 OUR PARTICIPANTS HERE SAID, YOU 1367 00:46:32,320 --> 00:46:34,960 KNOW WHEN YOU'RE IMPLANTED IN 1368 00:46:34,960 --> 00:46:37,480 YOUR 30S AND THE AVERAGE LIFE IN 1369 00:46:37,480 --> 00:46:40,080 OUR TARGET, AT OUR SETTINGS IS 1370 00:46:40,080 --> 00:46:44,280 ABOUT NOT EVEN A YEAR AND A 1371 00:46:44,280 --> 00:46:49,480 HALF, YOU KNOW, WE FOUND THAT 1372 00:46:49,480 --> 00:46:51,720 THE--THE MANAGEMENT OF BATTERY 1373 00:46:51,720 --> 00:46:54,160 REPLACEMENTS WAS AN ONGOING 1374 00:46:54,160 --> 00:46:56,840 ISSUE, YOU KNOW, OUR 1375 00:46:56,840 --> 00:46:59,000 NEUROSURGEON WHO WASN'T BILLING 1376 00:46:59,000 --> 00:47:01,320 FOR THESE PROCEDURES WAS OPENING 1377 00:47:01,320 --> 00:47:03,720 UP O. R. DATES, I WAS GOING TO 1378 00:47:03,720 --> 00:47:05,200 THE OPERATING ROOM USUALLY ABOUT 1379 00:47:05,200 --> 00:47:06,360 ONCE A MONTH, YOU KNOW WE HAD A 1380 00:47:06,360 --> 00:47:08,840 LARGE NUMBER OF PATIENTS THAT 1381 00:47:08,840 --> 00:47:12,240 WERE COMING, YOU KNOW MORE 1382 00:47:12,240 --> 00:47:13,240 THAN--YOU KNOW EVERY YEAR AND A 1383 00:47:13,240 --> 00:47:16,440 HALF TO GET A BATTERY 1384 00:47:16,440 --> 00:47:17,680 REPLACEMENT AND THE ADDITIONAL 1385 00:47:17,680 --> 00:47:20,560 ASPECT THAT THIS WAS NOT EVEN, 1386 00:47:20,560 --> 00:47:22,080 LIKE IT'S THOUGHT OF AT THE 1387 00:47:22,080 --> 00:47:24,080 BEGINNING IS THE MORE BATTERY 1388 00:47:24,080 --> 00:47:27,560 CHANGES THAT 1 MAKES, THE HIGHER 1389 00:47:27,560 --> 00:47:29,280 THE LIKELIHOOD OF COMPLICATIONS 1390 00:47:29,280 --> 00:47:31,560 FROM THE LOCAL SURGERY WHETHER 1391 00:47:31,560 --> 00:47:32,760 IT'S MILD INFECTIONS, WHETHER 1392 00:47:32,760 --> 00:47:35,400 IT'S A LEAD BREAK, YOU KNOW THE 1393 00:47:35,400 --> 00:47:36,720 MANIPULATIONS OF THESE SYSTEMS 1394 00:47:36,720 --> 00:47:42,200 IS NOT MADE FOR FREQUENT, OPEN 1395 00:47:42,200 --> 00:47:43,400 AND CLOSE. 1396 00:47:43,400 --> 00:47:48,280 SO SPORTINATELY CHANGED WHEN WE 1397 00:47:48,280 --> 00:47:50,600 WE WERE GIVEN ACCESS TO A 1398 00:47:50,600 --> 00:47:52,480 RECHARGEABLE BATTERY BUT FOR 1399 00:47:52,480 --> 00:47:54,840 YEARS, I HAD NO IDEA WHEN THESE 1400 00:47:54,840 --> 00:47:58,320 BATTERIES WOULD BE AVAILABLE, 1401 00:47:58,320 --> 00:47:58,800 THE RECHARGEABLE BADRYS. 1402 00:47:58,800 --> 00:48:00,360 EVERY BATTERY OF A BATTERY WAS, 1403 00:48:00,360 --> 00:48:02,520 YOU KNOW WHEN DO WE GET THE 1404 00:48:02,520 --> 00:48:05,760 RECHARGEABLE, WELL, PROBABLY THE 1405 00:48:05,760 --> 00:48:07,800 NEXT 1 AND SO ON AND SO FORTH 1406 00:48:07,800 --> 00:48:09,720 BECAUSE WE HAD PATIENTS WITH 6 1407 00:48:09,720 --> 00:48:12,000 BATTERY REPLACEMENTS UNTIL THEY 1408 00:48:12,000 --> 00:48:14,720 GOT THE RECHARGEABLE BATTERIES 1409 00:48:14,720 --> 00:48:16,040 THAT WEREN'T AVAILABLE IN 2015 1410 00:48:16,040 --> 00:48:19,440 OR 16, BUT YOU KNOW WHAT 1411 00:48:19,440 --> 00:48:20,920 HAPPENED, WELL, I WILL TELL YOU 1412 00:48:20,920 --> 00:48:23,360 IN A FEW MINUTES, MEDICARE THEN 1413 00:48:23,360 --> 00:48:25,680 AGREED TO COVER THE SURGERIES IN 1414 00:48:25,680 --> 00:48:26,480 AN INDIVIDUAL SITE AGREEMENT 1415 00:48:26,480 --> 00:48:28,480 WITH US, WE WERE ABLE TO GET OUR 1416 00:48:28,480 --> 00:48:29,520 PATIENTS COVERED AND YOU KNOW 1417 00:48:29,520 --> 00:48:39,680 WHAT'S VERY IMPORTANT FOR US AND 1418 00:48:39,680 --> 00:48:41,440 ADVOCATES FOR OUR PATIENTS TO 1419 00:48:41,440 --> 00:48:43,440 GET COVERED, BUT ONCE THEY'RE 1420 00:48:43,440 --> 00:48:45,120 COVERED BY MEDICARE, WE CAN GO 1421 00:48:45,120 --> 00:48:47,440 TO THIS TO PRIVATE INSURANCES 1422 00:48:47,440 --> 00:48:49,920 AND SAY, HED CARE HAS AGREED TO 1423 00:48:49,920 --> 00:48:52,400 COVER, IF ANY PATIENT HAS A 1424 00:48:52,400 --> 00:48:53,360 MEDICARE ADVANTAGE PLAN, THEY 1425 00:48:53,360 --> 00:48:55,720 WERE COVERED AS WELL BUT IF THEY 1426 00:48:55,720 --> 00:48:57,320 HAD INSURANCE WERE NOT ON 1427 00:48:57,320 --> 00:48:58,800 DISABILITY, WE COULD USE THE 1428 00:48:58,800 --> 00:49:02,880 EVIDENCE OF MEDICARE SUPPORTING 1429 00:49:02,880 --> 00:49:03,520 OUR WORK TOWARDS GETTING 1430 00:49:03,520 --> 00:49:06,400 APPROVAL AND YOU KNOW THIS IS 1431 00:49:06,400 --> 00:49:09,200 VERY LONG PROCESS THAT FOR 1432 00:49:09,200 --> 00:49:11,160 ANYONE ESPECIALLY AS I ASSUME 1433 00:49:11,160 --> 00:49:13,840 PATIENTS WHO HAVE NAVIGATED THE 1434 00:49:13,840 --> 00:49:16,600 COMPLEXITIES OF OUR HEALTHCARE 1435 00:49:16,600 --> 00:49:17,360 SYSTEM, SOMETIMES IT'S ASKING 1436 00:49:17,360 --> 00:49:22,680 FOR A PEER TO PEER REVIEW, 1437 00:49:22,680 --> 00:49:23,360 SOMETIMES IT'S ASKING FOR YOU 1438 00:49:23,360 --> 00:49:24,880 KNOW WHETHER YOU GO THROUGH THE 1439 00:49:24,880 --> 00:49:27,360 MEDICAL PART AND YOU TALK WITH A 1440 00:49:27,360 --> 00:49:28,240 NEUROSURGEON, A PSYCHIATRIST AND 1441 00:49:28,240 --> 00:49:30,160 I AM A PSYCHIATRIST, A 1442 00:49:30,160 --> 00:49:31,080 PSYCHIATRIST WILL NEVER APPROVE 1443 00:49:31,080 --> 00:49:34,480 THIS BECAUSE THEY WILL--THEY 1444 00:49:34,480 --> 00:49:37,920 WILL BASE IT BASICALLY SAY THIS 1445 00:49:37,920 --> 00:49:38,960 IS AN EXPERIMENTAL TREATMENT 1446 00:49:38,960 --> 00:49:43,040 THAT SHOULD NEVER BE COVERED. 1447 00:49:43,040 --> 00:49:47,960 AND YOU KNOW, THE PRIVATE 1448 00:49:47,960 --> 00:49:49,040 INSURANCES ARE TENUOUS, NEVER 1449 00:49:49,040 --> 00:49:50,680 STRAIGHT FORWARD, SOME PATIENTS 1450 00:49:50,680 --> 00:49:51,960 HAD BAT RESILIENCE PLACEMENTS 1451 00:49:51,960 --> 00:49:53,640 APPROVED BEFORE AND THEN DENIED 1452 00:49:53,640 --> 00:49:56,840 AND THEN COVERED AGAIN. 1453 00:49:56,840 --> 00:49:58,960 APPEALS, APPEALS, VERY FEW CASES 1454 00:49:58,960 --> 00:50:00,120 WE'VE BEEN FORTUNATE PATIENTS 1455 00:50:00,120 --> 00:50:04,760 HAVE HAD TO FACE THE COST OF THE 1456 00:50:04,760 --> 00:50:07,360 ENTIRE PROCEDURE FOR EXAMPLE, 1457 00:50:07,360 --> 00:50:09,960 YOU KNOW, WE DON'T--WE HAVE 1458 00:50:09,960 --> 00:50:13,200 AGREED NOT TO NECESSARILY BILL 1459 00:50:13,200 --> 00:50:15,600 FOR OUR PATIENT'S WHEN IT'S DBS 1460 00:50:15,600 --> 00:50:18,120 RELATED CARE BUT ON THE OTHER 1461 00:50:18,120 --> 00:50:21,080 HAND, YOU KNOW THE DEVICE 1462 00:50:21,080 --> 00:50:22,680 COMPANIES AND AT 1 POINT THEY 1463 00:50:22,680 --> 00:50:24,360 WERE SENDING US BATTERIES EVERY 1464 00:50:24,360 --> 00:50:26,480 MONTH CAN AND THOSE BATTERIES 1465 00:50:26,480 --> 00:50:27,120 WERE NOT COMMERCIALLY AVAILABLE 1466 00:50:27,120 --> 00:50:31,520 SO THEY HAVE TO PROVIDE THAT 1467 00:50:31,520 --> 00:50:34,760 ESPECIALLY ALSO WITH EXTENSION 1468 00:50:34,760 --> 00:50:35,000 CASES. 1469 00:50:35,000 --> 00:50:37,280 SO IN PARALLEL AND I DON'T WANT 1470 00:50:37,280 --> 00:50:38,600 TO, YOU KNOW DELAY TOO MUCH BUT 1471 00:50:38,600 --> 00:50:41,400 WE WERE NOT PART OF THE INDUSTRY 1472 00:50:41,400 --> 00:50:43,520 SPONSORED CLINICAL TRIAL FOR DBS 1473 00:50:43,520 --> 00:50:46,040 AND DEPRESSION BUT IT WAS A 1474 00:50:46,040 --> 00:50:46,920 MULTICENTERRED DOUBLE PLIEND 1475 00:50:46,920 --> 00:50:50,000 TRIAL THAT YOU KNOW WAS HALTED 1476 00:50:50,000 --> 00:50:51,760 PREMATURELY DUE TO A FUTILITY 1477 00:50:51,760 --> 00:50:52,920 ANALYSIS THAT PREDICTED THIS 1478 00:50:52,920 --> 00:50:54,680 WOULD NOT WORK AND AS YOU SEE 1479 00:50:54,680 --> 00:51:00,160 HERE, IN THE CONTROL, AND IN THE 1480 00:51:00,160 --> 00:51:07,840 STIMULATION ARMS THIS DIDN'T 1481 00:51:07,840 --> 00:51:18,320 WORK SO WHEN YOU LOOK AT THE 1482 00:51:19,200 --> 00:51:20,840 OVERALL DATA, MODULATION AND 1483 00:51:20,840 --> 00:51:23,480 THESE EUROPEAN STUDIES AND THEY 1484 00:51:23,480 --> 00:51:26,000 MANAGED TO SEE, YOU KNOW BETWEEN 1485 00:51:26,000 --> 00:51:28,320 144 AND 172 PATIENTS AND YOU SEE 1486 00:51:28,320 --> 00:51:33,240 HOW THE BENEFITS ARE PERCEIVED 1487 00:51:33,240 --> 00:51:35,000 WAY BEYOND THE USUAL DURATION OF 1488 00:51:35,000 --> 00:51:35,720 A CLINICAL TRIAL. 1489 00:51:35,720 --> 00:51:37,480 THAT'S WHY, YOU KNOW WHEN I 1490 00:51:37,480 --> 00:51:41,960 THINK ABOUT THE MINIMUM 1491 00:51:41,960 --> 00:51:42,760 NECESSARY, YOU KNOW INFORMATION 1492 00:51:42,760 --> 00:51:46,120 AND SUPPORT THAT WE NEED FOR THE 1493 00:51:46,120 --> 00:51:48,320 CLINICAL TRIAL, WE NEED THESE 1494 00:51:48,320 --> 00:51:50,600 DATA COLLECTION ENTERPRISES TO 1495 00:51:50,600 --> 00:51:52,800 LAST BEYOND THE SIXTH OR 12 1496 00:51:52,800 --> 00:51:53,120 MONTHS. 1497 00:51:53,120 --> 00:51:55,200 BECAUSE OTHERWISE WE WILL NOT 1498 00:51:55,200 --> 00:51:57,160 SEE THE ABSOLUTE BENEFITS THAT 1499 00:51:57,160 --> 00:51:59,560 WE ARE OBSERVING IN DEEP BRAIN 1500 00:51:59,560 --> 00:52:00,920 STIMULATION AND THAT'S ALSO KIND 1501 00:52:00,920 --> 00:52:05,320 OF ULTIMATELY WHAT I WANT FROM 1502 00:52:05,320 --> 00:52:08,000 AN IMPLANTABLE HIGH RISK 1503 00:52:08,000 --> 00:52:11,600 POTENTIALLY COMPLICATED AND 1504 00:52:11,600 --> 00:52:12,920 ESPECIALLY EXTREMELY EXPENSIVE 1505 00:52:12,920 --> 00:52:14,040 TECHNOLOGY BUT IT DOESN'T WORK 1506 00:52:14,040 --> 00:52:16,040 IN THE LONG RUN IT'S NOT WOOTHER 1507 00:52:16,040 --> 00:52:18,480 IT BUT THERE'S NO CLINICAL TRIAL 1508 00:52:18,480 --> 00:52:19,800 FORMAT THAT WILL ALLOW FOR YEARS 1509 00:52:19,800 --> 00:52:22,160 AND YEARS OF FOLLOW UP. 1510 00:52:22,160 --> 00:52:30,560 THIS WAS REPLICATED BY US HERE 1511 00:52:30,560 --> 00:52:31,560 THIS WAS PUBLISHED A COUPLE 1512 00:52:31,560 --> 00:52:32,960 YEARS AGO AND THE OTHER THING WE 1513 00:52:32,960 --> 00:52:35,400 NOTICE IS THAT PATIENTS DO NEED 1514 00:52:35,400 --> 00:52:37,000 A BATTERY REPLACEMENT. 1515 00:52:37,000 --> 00:52:38,560 IF WE STOP STIMULATION, PATIENTS 1516 00:52:38,560 --> 00:52:39,960 BECOME DEPRESSED AGAIN SO THIS 1517 00:52:39,960 --> 00:52:45,400 REQUIRES AN ONGOING FOLLOW UP 1518 00:52:45,400 --> 00:52:48,560 BUT EVERYBODY THOUGHT THAT THE 1519 00:52:48,560 --> 00:52:50,320 TRIAL WAS NOT EFFECTIVE. 1520 00:52:50,320 --> 00:52:51,920 IT WAS THE FIRST TIME THAT 1521 00:52:51,920 --> 00:52:53,680 CLINICAL DEEP BRAIN STIMULATION 1522 00:52:53,680 --> 00:52:55,320 HAD PSYCHIATRY FUNDING AND I MAY 1523 00:52:55,320 --> 00:52:56,880 BE MISTAKEN BUT I'M PRETTY SURE 1524 00:52:56,880 --> 00:52:58,360 THIS WAS THE FIRST TIME WE WERE 1525 00:52:58,360 --> 00:53:00,640 ABLE TO MOVE FORWARD WITH NIH, 1526 00:53:00,640 --> 00:53:05,960 WITH FEDERAL FUNDING IN MEETINGS 1527 00:53:05,960 --> 00:53:06,920 WITH INDUSTRY AND THE 1528 00:53:06,920 --> 00:53:08,640 INVESTIGATORS TO MOVE THIS 1529 00:53:08,640 --> 00:53:11,000 FORWARD, OKAY? 1530 00:53:11,000 --> 00:53:11,680 LARGE TEAMS. 1531 00:53:11,680 --> 00:53:13,760 AND IN OUR EXPERIENCE, YOU KNOW 1532 00:53:13,760 --> 00:53:15,920 THE BATTERIES CHANGE, WE TART 1533 00:53:15,920 --> 00:53:17,840 WIDE 1 BADRY AND THEN THAT 1534 00:53:17,840 --> 00:53:18,800 BATTERY IS DISCONTINUED AND THEN 1535 00:53:18,800 --> 00:53:20,760 WE SWITCH TO A RECHARGEABLE 1536 00:53:20,760 --> 00:53:26,040 BATTERY BUT NOW THAT 1537 00:53:26,040 --> 00:53:27,040 RECHARGEABLE BATTERY DIDN'T 1538 00:53:27,040 --> 00:53:30,040 RECORD HAD WHICH IS THE PRIMARY 1539 00:53:30,040 --> 00:53:31,720 OBJECTIVE OF OUR TRIAL SO 1540 00:53:31,720 --> 00:53:34,760 WETHODE IMPLANT PATIENTS AGAIN 1541 00:53:34,760 --> 00:53:36,560 WITH RECORDING DEVICES THAT WILL 1542 00:53:36,560 --> 00:53:38,280 NOT BE AVAILABLE AND THE PROBLEM 1543 00:53:38,280 --> 00:53:40,160 WITH THESE BATTERIES IS THAT 1544 00:53:40,160 --> 00:53:44,720 ONCE THEY'RE NOT COMMERCIALLY 1545 00:53:44,720 --> 00:53:46,280 APPROVED PATIENTS WILL HAVE 1546 00:53:46,280 --> 00:53:47,080 DIFFICULTY GETTING MRIs FOR 1547 00:53:47,080 --> 00:53:49,600 THE REST OF THEIR LIFE SINCE 1548 00:53:49,600 --> 00:53:51,440 THEY HAVE A NONFDA APPROVED 1549 00:53:51,440 --> 00:53:55,400 DEVICE, THERE'S NEVER AN MRI 1550 00:53:55,400 --> 00:53:58,080 COMPATIBILITY SIDE. 1551 00:53:58,080 --> 00:53:59,680 AND NOW, I THINK JUST TO WRAP 1552 00:53:59,680 --> 00:54:02,240 UP, THE IMPORTANT THING IS THAT, 1553 00:54:02,240 --> 00:54:03,800 YOU KNOW THERE'S A DIFFERENCE 1554 00:54:03,800 --> 00:54:06,120 BETWEEN THE NEEDS THAT A SMALL 1555 00:54:06,120 --> 00:54:08,480 FIRST IN HUMAN STUDY WOULD HAVE 1556 00:54:08,480 --> 00:54:11,720 15 YEARS AGO TO THE WAY I WOULD 1557 00:54:11,720 --> 00:54:13,760 DESIGN A CLINICAL TRIAL TODAY IN 1558 00:54:13,760 --> 00:54:17,080 MEETING WITH THE INDUSTRY, 1559 00:54:17,080 --> 00:54:17,280 RIGHT? 1560 00:54:17,280 --> 00:54:20,200 BUT WE DON'T HAVE ANY OFFICIAL 1561 00:54:20,200 --> 00:54:22,840 SUPPORT TO MAINTAIN A RESEARCH 1562 00:54:22,840 --> 00:54:24,560 COORDINATOR TO MAINTAIN TIME 1563 00:54:24,560 --> 00:54:26,000 FROM A PSYCHIATRIST TO DEDICATE 1564 00:54:26,000 --> 00:54:27,800 TO THE ALL THE PATIENTS THAT ARE 1565 00:54:27,800 --> 00:54:29,440 IMPLANTED, WE ARE SEEING 1566 00:54:29,440 --> 00:54:32,600 PATIENTS THAT HAVE BEEN 1567 00:54:32,600 --> 00:54:35,240 IMPLANTED IN OTHER NIH STUDIES 1568 00:54:35,240 --> 00:54:36,280 THAT YOU KNOW WERE LOST TO 1569 00:54:36,280 --> 00:54:39,200 FOLLOW UP OVER THERE OR THE 1570 00:54:39,200 --> 00:54:41,160 BROADENED CLINICAL TRIAL IN DEEP 1571 00:54:41,160 --> 00:54:42,720 BRAIN STIMULATION THAT THEIR 1572 00:54:42,720 --> 00:54:43,640 SITES CLOSED OR THEIR 1573 00:54:43,640 --> 00:54:46,360 INVESTIGATORS MOVE AND THEY HAVE 1574 00:54:46,360 --> 00:54:47,000 NOWHERE TO GO. 1575 00:54:47,000 --> 00:54:49,160 SO THEY GO INTO 1576 00:54:49,160 --> 00:54:49,960 CLINICALTRIALS.GOV AND THEY COME 1577 00:54:49,960 --> 00:54:54,880 TO THE PLACE THAT KEEPS ON DOING 1578 00:54:54,880 --> 00:54:55,040 IT. 1579 00:54:55,040 --> 00:54:55,840 WE FORTUNATELY HAVE, YOU KNOW 1580 00:54:55,840 --> 00:55:03,360 THE POSSIBILITY OF DOING THIS 1581 00:55:03,360 --> 00:55:07,240 THROUGH THE TIME WE ARE DOING 1582 00:55:07,240 --> 00:55:09,600 OTHER NEUROMODDULATION AND 1583 00:55:09,600 --> 00:55:11,520 TRIALS, BUT HARDWARE CHANGES AND 1584 00:55:11,520 --> 00:55:13,720 EVOLVES BUT IT'S GREAT TO HAVE 1585 00:55:13,720 --> 00:55:15,080 RECHARGEABLE BATTERIES BUT WHAT 1586 00:55:15,080 --> 00:55:16,240 HAPPENS WHEN THEY'RE NOT 1587 00:55:16,240 --> 00:55:21,360 AVAILABLE ANYMORE, WHEN THE 1588 00:55:21,360 --> 00:55:22,880 RECHARGEABLE BATTERIES ARE NOT 1589 00:55:22,880 --> 00:55:24,720 AVAILABLE ANYMORE, THEN THE 1590 00:55:24,720 --> 00:55:26,360 RECHARGEABLE SYSTEM IS NOT 1591 00:55:26,360 --> 00:55:28,000 AVAILABLE ANYMORE AND IN THE 1592 00:55:28,000 --> 00:55:29,600 DEVICE FAILS, THEY HAVE TO WAIT 1593 00:55:29,600 --> 00:55:31,400 A MONTH KNOWING THE DEPRESSION 1594 00:55:31,400 --> 00:55:33,960 WILL RETURN, THAT'S THE XASM 1595 00:55:33,960 --> 00:55:35,240 BRANDY USED YESTERDAY OF SHARING 1596 00:55:35,240 --> 00:55:36,240 RECHARGING SYSTEM BUT WE HAVE 1597 00:55:36,240 --> 00:55:42,240 MORE THAN 30 PATIENTS, OVER 10 1598 00:55:42,240 --> 00:55:43,720 DLNCHT STATES AND SOMETIMES 1599 00:55:43,720 --> 00:55:44,960 PATIENT WEES DIDN'T EERVE CHOOSE 1600 00:55:44,960 --> 00:55:46,800 TO IMPLANT BUT THEY CAME FOR OUR 1601 00:55:46,800 --> 00:55:49,560 CARE AFTER THE INITIAL CLINICAL 1602 00:55:49,560 --> 00:55:55,360 SITE CLOSE. 1603 00:55:55,360 --> 00:55:55,680 OKAY? 1604 00:55:55,680 --> 00:55:56,480 SO WHAT HAPPENS TO THE PATIENTS 1605 00:55:56,480 --> 00:55:57,480 THAT ARE LOST TO FOLLOW UP. 1606 00:55:57,480 --> 00:55:59,480 WHAT HAPPENS WITH THE PATIENTS 1607 00:55:59,480 --> 00:56:01,560 THAT ARE NOT INCLUDED IN THE 1608 00:56:01,560 --> 00:56:04,520 INITIAL CLINICAL TRIAL DATA. 1609 00:56:04,520 --> 00:56:07,760 THOSE TRIAL IS LOST AND WE DO 1610 00:56:07,760 --> 00:56:10,240 NEED THIS PARTNERSHIP BETWEEN 1611 00:56:10,240 --> 00:56:11,240 NEUROSURGERY AND PSYCHIATRY TO 1612 00:56:11,240 --> 00:56:13,520 CONTINUE TO PROVIDE SUPPORT AND 1613 00:56:13,520 --> 00:56:16,120 YOU KNOW AND HOW TO WORK IN THIS 1614 00:56:16,120 --> 00:56:20,520 FOR YOU KNOW 15 YEARS NOW. 1615 00:56:20,520 --> 00:56:24,720 I'M A TESTIMONY OF HOW THESE 1616 00:56:24,720 --> 00:56:25,720 TREATMENTS HELP OUR PATIENTS, 1617 00:56:25,720 --> 00:56:27,920 HOW THIS IS NEEDED AND SOMETIMES 1618 00:56:27,920 --> 00:56:31,080 I WORRY THAT YOU KNOW CLINICAL 1619 00:56:31,080 --> 00:56:33,160 TRIALS FROM THE NIH ARE FOCUSED 1620 00:56:33,160 --> 00:56:36,240 TOO MUCH ON GETTING THE SPECIFIC 1621 00:56:36,240 --> 00:56:38,000 SCIENTIFIC QUESTION AND ANSWER, 1622 00:56:38,000 --> 00:56:39,800 FROM INDUSTRY, IS SEEING WHAT 1623 00:56:39,800 --> 00:56:50,200 MARKET THEY WOULD HAVE. 1624 00:56:54,480 --> 00:56:55,600 --CLINICAL TRIALS AND SMALL 1625 00:56:55,600 --> 00:56:57,520 NUMBERS THROUGH NIH SPONSORED 1626 00:56:57,520 --> 00:56:59,040 TRIALS THAT ARE INCREDIBLE 1627 00:56:59,040 --> 00:57:02,040 LOAMACYY GROUND BREAKING, BUT WE 1628 00:57:02,040 --> 00:57:08,600 DON'T ADDRESS THE TOTAL NEED FOR 1629 00:57:08,600 --> 00:57:10,120 YOU KNOW PATIENTS AND THEY'RE 1630 00:57:10,120 --> 00:57:12,360 STILL DYING OF SUICIDE BEING 1631 00:57:12,360 --> 00:57:13,200 DISABLED, ET CETERA. 1632 00:57:13,200 --> 00:57:15,520 SO, YOU KNOW I THINK THAT FOR 1633 00:57:15,520 --> 00:57:17,360 THINKING ABOUT THE FUTURE, WE DO 1634 00:57:17,360 --> 00:57:20,400 NEED, YOU KNOW TO MOVE ABOUT THE 1635 00:57:20,400 --> 00:57:22,760 SCALABILITY OF THIS AND NOT, YOU 1636 00:57:22,760 --> 00:57:24,080 KNOW SOMETIMES SMALL CLINICAL 1637 00:57:24,080 --> 00:57:25,640 TRIALS THAT WILL IMPLANT, YOU 1638 00:57:25,640 --> 00:57:26,680 KNOW MAYBE 5 PATIENTS A YEAR 1639 00:57:26,680 --> 00:57:28,520 WHICH IS ALL WE CAN HANDLE WITH 1640 00:57:28,520 --> 00:57:31,160 A TEAM THAT HAS, YOU KNOW 1641 00:57:31,160 --> 00:57:33,080 SOMETIMES 30 PEOPLE DEPENDENT ON 1642 00:57:33,080 --> 00:57:33,280 THAT. 1643 00:57:33,280 --> 00:57:34,480 AND THOSE ARE THE QUESTIONS THAT 1644 00:57:34,480 --> 00:57:36,200 COME, YOU KNOW TO MY MIND WHEN I 1645 00:57:36,200 --> 00:57:40,960 THINK ABOUT THE FUTURE IN 1646 00:57:40,960 --> 00:57:42,800 RESEARCH IN DEPRESSION WITH DEEP 1647 00:57:42,800 --> 00:57:43,200 BRAIN STIMULATION. 1648 00:57:43,200 --> 00:57:43,400 OKAY? 1649 00:57:43,400 --> 00:57:46,840 SO I DON'T WANT TO TAKE MORE 1650 00:57:46,840 --> 00:57:48,440 TIME. 1651 00:57:48,440 --> 00:57:50,400 BUT I WOULD REALLY LIKE ALSO 1652 00:57:50,400 --> 00:57:51,400 COMPATIBILITY FOR THESE DEVICES 1653 00:57:51,400 --> 00:57:53,280 AND THAT'S THE LAST THING I WILL 1654 00:57:53,280 --> 00:57:53,720 SAY, ALL RIGHT. 1655 00:57:53,720 --> 00:57:59,480 SO MAYBE YOU CAN ANSWER SOME 1656 00:57:59,480 --> 00:58:03,280 QUESTIONS BEFORE DR. HSU, AND 1657 00:58:03,280 --> 00:58:05,320 DR. HENDRIKs, MOVE ON TO THE 1658 00:58:05,320 --> 00:58:05,640 NEXT PANELIST. 1659 00:58:05,640 --> 00:58:07,480 THANK YOU SO MUCH FOR INVITING 1660 00:58:07,480 --> 00:58:07,720 ME. 1661 00:58:07,720 --> 00:58:09,000 >> THANK YOU, I THINK WE HAVE 1662 00:58:09,000 --> 00:58:19,520 TIME FOR 1 QUESTION, WHO HAS A 1663 00:58:24,280 --> 00:58:24,480 QUESTION? 1664 00:58:24,480 --> 00:58:24,880 >> SARA BURN? 1665 00:58:24,880 --> 00:58:26,240 >> THANK YOU SO MUCH FOR YOUR 1666 00:58:26,240 --> 00:58:28,080 TALK, I WAS STRUCK BY WHAT 1667 00:58:28,080 --> 00:58:29,280 BRANDY SAID YESTERDAY AND WHAT 1668 00:58:29,280 --> 00:58:31,360 YOU SAID ABOUT THE TIMELINE, SO 1669 00:58:31,360 --> 00:58:34,000 SHE SAID SHE WAS GETTING 1670 00:58:34,000 --> 00:58:35,200 INCREMENTAL BENEFITS BUT SLOWLY 1671 00:58:35,200 --> 00:58:38,080 RIGHT AND IF THE TYPICAL 1672 00:58:38,080 --> 00:58:39,120 TIMELINE FOR CLINICAL TRIAL FOR 1673 00:58:39,120 --> 00:58:41,000 ASSESSMENT TO SEE WHETHER OR NOT 1674 00:58:41,000 --> 00:58:42,520 THERE'S FUTILITY OR IT'S 1675 00:58:42,520 --> 00:58:44,720 WORKING, IS MUCH SHORTER, I 1676 00:58:44,720 --> 00:58:46,760 GUESS I'M JUST TRYING TO--I'M 1677 00:58:46,760 --> 00:58:48,200 STRUGGLING TO FIGURE OUT HOW YOU 1678 00:58:48,200 --> 00:58:51,440 HANDLE THAT BECAUSE THAT SEEMS 1679 00:58:51,440 --> 00:58:54,120 LIKE A--A STRUCTURAL KIND OF 1680 00:58:54,120 --> 00:58:56,560 QUESTION, THAT ISN'T REALLY 1681 00:58:56,560 --> 00:59:00,080 ABOUT POST TRIAL, IT'S JUST--HOW 1682 00:59:00,080 --> 00:59:02,680 DO WE RECREATE TRIALS OR YOU 1683 00:59:02,680 --> 00:59:04,040 KNOW REVISION WHAT THEY WOULD 1684 00:59:04,040 --> 00:59:04,280 BE? 1685 00:59:04,280 --> 00:59:11,240 >> YEAH, AND I THINK, YOU KNOW 1686 00:59:11,240 --> 00:59:13,680 FROM A CLINICAL APPLICABILITY, 1687 00:59:13,680 --> 00:59:13,880 RIGHT? 1688 00:59:13,880 --> 00:59:16,240 MY BIG QUESTION AS A CLINICIAN, 1689 00:59:16,240 --> 00:59:18,440 AS A TRYST, AS A DOCTOR WHO SEES 1690 00:59:18,440 --> 00:59:20,160 PATIENTS IN THE DAY-TO-DAY BASIS 1691 00:59:20,160 --> 00:59:22,320 WHETHER IT'S IN THE ECT CLINIC 1692 00:59:22,320 --> 00:59:25,640 OR IN THE OUTPATIENT CLINIC, IF 1693 00:59:25,640 --> 00:59:28,360 I'M GOING TO PROPOSE THIS VERY 1694 00:59:28,360 --> 00:59:29,440 INVASIVE TREATMENT TO SOMEONE, 1695 00:59:29,440 --> 00:59:34,080 IT BETTER WORK FOR A LONG TIME 1696 00:59:34,080 --> 00:59:38,520 AND THERE IS REALLY VERY FEW, 1697 00:59:38,520 --> 00:59:40,360 YOU KNOW--THERE ARE VERY FEW 1698 00:59:40,360 --> 00:59:42,240 OPPORTUNITIES TO SAY, HOW LONG 1699 00:59:42,240 --> 00:59:43,760 SHOULD YOU COLLECT DATA. 1700 00:59:43,760 --> 00:59:45,720 WE PUBLISHED ON 8 YEARS. 1701 00:59:45,720 --> 00:59:51,920 THE VAGUS NERVE STIMULATION DATA 1702 00:59:51,920 --> 00:59:54,400 THAT PROMPTED THE NEW CED TRIAL 1703 00:59:54,400 --> 00:59:57,760 WAS BASED ON 5 YEARS OF 1704 00:59:57,760 --> 01:00:01,800 MONITORING PATIENTS, YOU KNOW 1705 01:00:01,800 --> 01:00:02,320 IMPROVEMENT. 1706 01:00:02,320 --> 01:00:03,160 THIS EXCEEDS, THE, YOU KNOW, 1707 01:00:03,160 --> 01:00:05,000 MOST OF THE PEOPLE THAT CREATED 1708 01:00:05,000 --> 01:00:07,040 THE INITIAL CLINICAL TRIALS, YOU 1709 01:00:07,040 --> 01:00:09,280 KNOW KIND OF HAD THE IDEA FROM 1710 01:00:09,280 --> 01:00:14,680 DRUG TRIALS, RIGHT? 1711 01:00:14,680 --> 01:00:16,520 TWELVE WEEKS ON THIS VERSUS 1712 01:00:16,520 --> 01:00:18,360 PLACEBO, DID YOU RESPOND, YES OR 1713 01:00:18,360 --> 01:00:18,840 NO? 1714 01:00:18,840 --> 01:00:20,000 THIS IS COMPLETELY DIFFERENT. 1715 01:00:20,000 --> 01:00:23,200 ALL OF OUR PATIENTS HAVE FAILED 1716 01:00:23,200 --> 01:00:24,600 15, 20 MEDICATIONS, 95% OF MY 1717 01:00:24,600 --> 01:00:29,720 PATIENTS HAVE DONE MANY COURSES 1718 01:00:29,720 --> 01:00:31,440 OF ECT, SO THE APPLICABILITY OF 1719 01:00:31,440 --> 01:00:35,960 SAYING WHETHER THIS WORKS IN 6 1720 01:00:35,960 --> 01:00:37,880 MONTHS, IT'S REALLY NOT 1721 01:00:37,880 --> 01:00:38,440 REALISTIC, RIGHT? 1722 01:00:38,440 --> 01:00:43,960 AND YOU KNOW FROM MY--AS BRANDY 1723 01:00:43,960 --> 01:00:45,160 SAID YESTERDAY, BRANDY TO ME WAS 1724 01:00:45,160 --> 01:00:47,120 A WINNER FROM DAY 1. 1725 01:00:47,120 --> 01:00:52,360 BUT IT TAKES A LOT OF TIME TO 1726 01:00:52,360 --> 01:00:55,360 YOU KNOW, TO REALIZE THE 1727 01:00:55,360 --> 01:00:58,400 FUNCTIONALITY IMPROVEMENTS TO 1728 01:00:58,400 --> 01:00:59,400 REALIZE THAT INDEPENDENCE 1729 01:00:59,400 --> 01:01:01,240 PATIENTS ACHIEVE TO KNOW THEY 1730 01:01:01,240 --> 01:01:02,320 ARE STANDING ON GROUND THAT IS 1731 01:01:02,320 --> 01:01:06,600 FIRM AND THEY WILL NOT BE 1732 01:01:06,600 --> 01:01:06,960 DEPRESSED AGAIN. 1733 01:01:06,960 --> 01:01:07,200 OKAY? 1734 01:01:07,200 --> 01:01:08,960 >> I KNOW WE'RE RUNNING LONG, 1735 01:01:08,960 --> 01:01:13,880 CAN I ASK A QUICK FOLLOW UP, SO 1736 01:01:13,880 --> 01:01:15,520 WOULD YOUR--WOULD 1 SOLUTION BE 1737 01:01:15,520 --> 01:01:17,960 TO TRY TO EXTEND THE TIME THAT'S 1738 01:01:17,960 --> 01:01:18,920 OFFERS FOR OBSERVING AND 1739 01:01:18,920 --> 01:01:21,080 FIGURING OUT IF THE CLINICAL 1740 01:01:21,080 --> 01:01:23,200 TRIAL IS WORKING OR IS IT ENOUGH 1741 01:01:23,200 --> 01:01:24,880 JUST TO SAY, ANY TIME THIS KIND 1742 01:01:24,880 --> 01:01:28,120 OF IMPLANT IS HAPPENING, LET'S 1743 01:01:28,120 --> 01:01:30,560 ADD THE 5 YEAR LONG-TERM FOLLOW 1744 01:01:30,560 --> 01:01:30,760 UP. 1745 01:01:30,760 --> 01:01:35,160 I DON'T KNOW WHAT WE CALL THAT 1746 01:01:35,160 --> 01:01:36,040 STUDY, RIGHT? 1747 01:01:36,040 --> 01:01:38,520 BUT I THINK ALSO JENNIFER FRENCH 1748 01:01:38,520 --> 01:01:39,560 TALKED ABOUT YESTERDAY, JUST AS 1749 01:01:39,560 --> 01:01:40,800 A MATTER OF COURSE WHICH WOULD 1750 01:01:40,800 --> 01:01:42,280 ALLOW FOR THAT KIND OF 1751 01:01:42,280 --> 01:01:42,800 OBSERVATION. 1752 01:01:42,800 --> 01:01:44,560 >> WELL WE KEEP ON--WE SEE THESE 1753 01:01:44,560 --> 01:01:46,920 PATIENTS, YOU KNOW REGULARLY, 1754 01:01:46,920 --> 01:01:48,560 NOW EVERY 6 MONTHS TO 1 YEAR, 1755 01:01:48,560 --> 01:01:50,680 SOME PATIENTS HAVE BEEN 1756 01:01:50,680 --> 01:01:51,320 IMPLANTED IN 2007. 1757 01:01:51,320 --> 01:01:53,320 SO, YOU BE AND THEY LIVE OUT OF 1758 01:01:53,320 --> 01:01:54,320 STATE. 1759 01:01:54,320 --> 01:01:56,760 YOU KNOW, NOW WITH COVID, I'VE 1760 01:01:56,760 --> 01:01:59,560 BEEN DOING ZOOMS WITH ALL OF 1761 01:01:59,560 --> 01:02:00,560 THESE PATIENTS THAT WE'VE GROWN 1762 01:02:00,560 --> 01:02:04,040 TO KNOW EACH OTHER, YOU KNOW 1763 01:02:04,040 --> 01:02:06,040 OVER TIME THEY'VE SEEN ME LOSE 1764 01:02:06,040 --> 01:02:07,560 HAIR, GAIN WEIGHT AND SO ON AND 1765 01:02:07,560 --> 01:02:09,240 O FORTH AND YOU KNOW WE STILL 1766 01:02:09,240 --> 01:02:13,040 HAVE A GREAT RELATIONSHIP, I 1767 01:02:13,040 --> 01:02:14,520 HOPE, BUT YES, I THINK THAT'S 1768 01:02:14,520 --> 01:02:15,760 THE MOST IMPORTANT THING. 1769 01:02:15,760 --> 01:02:16,640 RATHER THAN SEEING WHETHER 1770 01:02:16,640 --> 01:02:18,440 PATIENTS GET BETTER IN A MONTH 1771 01:02:18,440 --> 01:02:19,960 OR IN 2 MONTHS, THAT'S POINTLESS 1772 01:02:19,960 --> 01:02:21,800 IN A WAY FOR SOMETHING THAT 1773 01:02:21,800 --> 01:02:25,520 NEEDS TO STAY WELL FOR 10 YEARS, 1774 01:02:25,520 --> 01:02:25,760 RIGHT? 1775 01:02:25,760 --> 01:02:27,760 OR THAT THE RESPONSE IS LIMITED. 1776 01:02:27,760 --> 01:02:29,920 IF MAISHTS WERE TO GET DEPRESSED 1777 01:02:29,920 --> 01:02:31,560 AGAIN AT 1 YEAR AND NEVER GET 1778 01:02:31,560 --> 01:02:37,160 BETTER AGAIN, YOU KNOW? 1779 01:02:37,160 --> 01:02:37,360 YEAH. 1780 01:02:37,360 --> 01:02:38,320 >> ALL RIGHT. 1781 01:02:38,320 --> 01:02:40,520 I THINK WE HAVE LOTS ALREADY TO 1782 01:02:40,520 --> 01:02:41,960 DISCUSS AND WE'RE GOING TO HAVE 1783 01:02:41,960 --> 01:02:42,920 A GREAT HOPEFULLY GREAT 1784 01:02:42,920 --> 01:02:44,080 DISCUSSION BUT WE STILL HAVE A 1785 01:02:44,080 --> 01:02:46,640 FEW MORE PEOPLE TO HEAR FROM. 1786 01:02:46,640 --> 01:02:49,880 SO I WOULD LIKE TO INTRODUCE OUR 1787 01:02:49,880 --> 01:02:53,600 NEXT SPEAKERS, SARA GOERING, WHO 1788 01:02:53,600 --> 01:02:54,840 IS A PHILOSOPHER PROGRAM ETHICS 1789 01:02:54,840 --> 01:02:56,640 AT THE UNIVERSITY EVER 1790 01:02:56,640 --> 01:02:57,680 WASHINGTON AND CORE FACULTYOT 1791 01:02:57,680 --> 01:02:59,280 PROGRAM OF ETHICS AND THE 1792 01:02:59,280 --> 01:02:59,920 DISABILITIES STUDIES PROGRAM AT 1793 01:02:59,920 --> 01:03:01,920 THE UNIVERSITY OF WASHINGTON AND 1794 01:03:01,920 --> 01:03:04,800 SHE ALSO CO LEADS THE ETHICS 1795 01:03:04,800 --> 01:03:06,480 THRUST AT THE UNIVERSITY OF 1796 01:03:06,480 --> 01:03:08,760 WASHINGTON CENTER FOR 1797 01:03:08,760 --> 01:03:09,120 NEUROTECHNOLOGY. 1798 01:03:09,120 --> 01:03:17,040 AND SAN --SARA WILL BE PRESENTIG 1799 01:03:17,040 --> 01:03:20,480 WITH ISHAN DASGUPTA, WHO IS WITH 1800 01:03:20,480 --> 01:03:22,840 THE DANA FARBER FOWBDATION, SHE 1801 01:03:22,840 --> 01:03:28,320 IS LAWYER BY TRAINING AND 1802 01:03:28,320 --> 01:03:30,880 EVALUATIONS METHODOLOGY AND 1803 01:03:30,880 --> 01:03:31,520 QUANTITATIONS AND 1804 01:03:31,520 --> 01:03:33,520 PRACTICALLY--OOPS I MISSED 1805 01:03:33,520 --> 01:03:35,920 MY--AND POLICY ANALYSIS, SORRY, 1806 01:03:35,920 --> 01:03:36,120 SORRY! 1807 01:03:36,120 --> 01:03:43,760 OKAY, TAKE IT AWAY, SARA. 1808 01:03:43,760 --> 01:03:44,800 >> HI, EVERYONE, I WILL START 1809 01:03:44,800 --> 01:03:47,280 OFF SO I WOULD LIKE TO THANK THE 1810 01:03:47,280 --> 01:03:51,480 NIH FOR THIS INVITATION TO THE 1811 01:03:51,480 --> 01:03:55,640 QUESTION OF WHAT IS OWED TO 1812 01:03:55,640 --> 01:03:56,480 NEURAL INPLANTED STUDIES. 1813 01:03:56,480 --> 01:03:57,440 SO CAN MOVE TO THE NEXT SLIDE. 1814 01:03:57,440 --> 01:04:00,320 SO, YOU KNOW WHEN I WAS THINKING 1815 01:04:00,320 --> 01:04:01,280 ABOUT THIS FIRST QUESTION FOR 1816 01:04:01,280 --> 01:04:04,280 THE SESSION ABOUT WHAT IS THE 1817 01:04:04,280 --> 01:04:06,200 MINIMUM THAT'S OWED, I WAS 1818 01:04:06,200 --> 01:04:07,760 THINKING ABOUT THE FACT THAT 1819 01:04:07,760 --> 01:04:09,880 THEY WERE MENTIONING YESTERDAY 1820 01:04:09,880 --> 01:04:13,880 THAT THERE WERE NO MANDATED 1821 01:04:13,880 --> 01:04:15,400 RULES AND REGGULESS AROUND THE 1822 01:04:15,400 --> 01:04:17,360 POST TRIAL WORKSHOP, SO I LOOKED 1823 01:04:17,360 --> 01:04:19,200 AT 1 OF OUR WORKSHOPS FROM LAST 1824 01:04:19,200 --> 01:04:21,240 AND WHEN I WAS REVIEWING THE 1825 01:04:21,240 --> 01:04:23,000 BIOETHICS, THERE WAS AREA OF 1826 01:04:23,000 --> 01:04:24,160 BROAD CONSENSUS, THE CAVEAT IS 1827 01:04:24,160 --> 01:04:25,840 THAT MOST OF THIS LITERATURE 1828 01:04:25,840 --> 01:04:28,400 COMES RELATED TO THE TOPIC OF 1829 01:04:28,400 --> 01:04:29,360 CLINICAL TRIALS FOR 1830 01:04:29,360 --> 01:04:30,480 ANTIRETROVIRALS IN THE EARLY 1831 01:04:30,480 --> 01:04:32,360 2000S SO IT MIGHT NEED TO BE 1832 01:04:32,360 --> 01:04:36,760 ADJUSTED FOR THE DEVICE SETTING. 1833 01:04:36,760 --> 01:04:38,680 SO FIRST THEY SHOULD HAVE THE 1834 01:04:38,680 --> 01:04:39,600 DIGS PENS GOING BACK TO 1835 01:04:39,600 --> 01:04:40,360 YESTERDAY, WE'VE BEEN HEARING 1836 01:04:40,360 --> 01:04:42,000 THIS OVER AND OVER AGAIN, BUT IT 1837 01:04:42,000 --> 01:04:44,760 SEEMS PARTICULARLY IMPORTANT IN 1838 01:04:44,760 --> 01:04:46,200 NEURAL IMPLANT SETTING NOT JUST 1839 01:04:46,200 --> 01:04:47,000 ANTICIPATE THE LIKELY NEED BUT 1840 01:04:47,000 --> 01:04:48,560 COME UP WITH A SOLID PLAN AND 1841 01:04:48,560 --> 01:04:50,600 GIVEN THE DURATION OF THESE 1842 01:04:50,600 --> 01:04:52,440 STUDIESS, PEOPLE MIGHT LIVE WITH 1843 01:04:52,440 --> 01:04:53,600 THESE DEVICES FOR 20, 30 YEARS 1844 01:04:53,600 --> 01:04:55,080 SO IT'S IMPORTANT TO COME UP 1845 01:04:55,080 --> 01:04:58,200 WITH SOMETHING CONCRETE HERE. 1846 01:04:58,200 --> 01:05:00,240 SECOND PARTICIPANTS SHOULD BE 1847 01:05:00,240 --> 01:05:01,040 INFORMED ABOUT WHAT THOSE PLANS 1848 01:05:01,040 --> 01:05:02,840 ARE AND THEY SHOULD BE INFORMED 1849 01:05:02,840 --> 01:05:05,040 IN A WAY THEY CAN UNDERSTAND AND 1850 01:05:05,040 --> 01:05:06,080 APPRECIATE. 1851 01:05:06,080 --> 01:05:07,680 WE HAVE TO OVERCOME LEGAL-EASE 1852 01:05:07,680 --> 01:05:10,680 AND OVERLY SORT OF, YOU KNOW 1853 01:05:10,680 --> 01:05:13,440 COMPLICATED INFORMED CONSENT 1854 01:05:13,440 --> 01:05:14,920 DOCUMENTS, AND GOING BACK TO 1855 01:05:14,920 --> 01:05:16,240 GATES STUDY YESTERDAY, IN MY 1856 01:05:16,240 --> 01:05:18,360 EXPERIENCE TALKING WITH END 1857 01:05:18,360 --> 01:05:19,600 USERS, I FOUND SIMILAR STORIES 1858 01:05:19,600 --> 01:05:21,200 ABOUT PEOPLE NOT FULLY 1859 01:05:21,200 --> 01:05:22,200 UNDERSTANDING WHAT EXACTLY THEY 1860 01:05:22,200 --> 01:05:23,880 WERE SIGNING UP FOR OR SIMPLY 1861 01:05:23,880 --> 01:05:24,640 NOT REMEMBERING CONVERSATIONS 1862 01:05:24,640 --> 01:05:27,200 ABOUT WHAT HAPPENS AFTER A STUDY 1863 01:05:27,200 --> 01:05:28,120 ENDS. 1864 01:05:28,120 --> 01:05:29,520 ONE OPTION HERE IS ON THE 1865 01:05:29,520 --> 01:05:30,800 ABILITY TO CONNECT RESEARCH 1866 01:05:30,800 --> 01:05:32,040 PARTICIPANTS TO OTHER PEOPLE WHO 1867 01:05:32,040 --> 01:05:33,160 HAVE BEEN PARTS OF STUDIES SO 1868 01:05:33,160 --> 01:05:36,880 THEY CAN GET A BETTER IDEA OF 1869 01:05:36,880 --> 01:05:38,120 WHAT PARTICIPATION ACTUALLY 1870 01:05:38,120 --> 01:05:39,240 INVOLVES. 1871 01:05:39,240 --> 01:05:40,960 THE THIRD AREA IS THAT 1872 01:05:40,960 --> 01:05:42,280 PARTICIPATION SHOULD RECEIVE 1873 01:05:42,280 --> 01:05:44,280 CONTINUED ACCESS IF IT'S BENEFIT 1874 01:05:44,280 --> 01:05:45,000 TO THEM. 1875 01:05:45,000 --> 01:05:46,720 OF COURSE, CALCULATING BENEFIT 1876 01:05:46,720 --> 01:05:48,640 IS GOING TO BE A TRICKY THING 1877 01:05:48,640 --> 01:05:50,320 AND IT DEPENDS ON FACTORS SUCH 1878 01:05:50,320 --> 01:05:51,720 AS WHETHER A STUDY IS 1879 01:05:51,720 --> 01:05:52,840 THERAPEUTIC OR WHETHER, YOU KNOW 1880 01:05:52,840 --> 01:05:54,520 IT'S TRYING TO HAVE--TRYING TO 1881 01:05:54,520 --> 01:05:57,360 TEST MORE OF A PROOF OF CONCEPT, 1882 01:05:57,360 --> 01:05:59,840 AND SO, IT REALLY WILL DEPEND ON 1883 01:05:59,840 --> 01:06:01,840 THE PARTICULAR SETTING OF THE 1884 01:06:01,840 --> 01:06:03,640 TRIAL TO FIGURE OUT WHAT 1885 01:06:03,640 --> 01:06:08,360 ACTUALLY COUNTS AS BENEFIT. 1886 01:06:08,360 --> 01:06:09,160 THE BROAD CONSENSUS. 1887 01:06:09,160 --> 01:06:11,760 AROUND THE FACT THAT 1888 01:06:11,760 --> 01:06:13,160 OBLIGATIONS, DIDN'T JUST MEAN 1889 01:06:13,160 --> 01:06:14,680 ACCESS TO TREATMENTS AND IT 1890 01:06:14,680 --> 01:06:17,160 COULD INCLUDE THINGS LIKE 1891 01:06:17,160 --> 01:06:19,400 TRANSITION OF CARE AND THE 1892 01:06:19,400 --> 01:06:23,200 IMPLANT SETTING, IT MIGHT ALSO 1893 01:06:23,200 --> 01:06:24,160 INCLUDE SUPPORT FOR STWRANSITION 1894 01:06:24,160 --> 01:06:27,720 OUT OF THE STUDY ESPECIALLY FOR 1895 01:06:27,720 --> 01:06:30,480 NONTHERAPEUTIC IS ITS. 1896 01:06:30,480 --> 01:06:30,920 NEXT SLIDE, PLEASE. 1897 01:06:30,920 --> 01:06:33,720 WHEN IT COMES TO THE QUESTION OF 1898 01:06:33,720 --> 01:06:34,560 WHAT'S OFFERED BEYOND THE 1899 01:06:34,560 --> 01:06:36,200 MINIMUM, I THINK THERE WAS LESS 1900 01:06:36,200 --> 01:06:38,480 CONSENSUS IN THE TRADITIONAL 1901 01:06:38,480 --> 01:06:39,440 BIOETHICS LITERATURE. 1902 01:06:39,440 --> 01:06:42,160 BUT IN PRACTICE WHAT IS OFTEN 1903 01:06:42,160 --> 01:06:44,160 OWED OR WHAT--YOU KNOW WHAT GOES 1904 01:06:44,160 --> 01:06:45,760 BEYOND FOR THAT MINIMUM WAS 1905 01:06:45,760 --> 01:06:47,600 ACTUALLY WHAT'S IN THE INFORMED 1906 01:06:47,600 --> 01:06:50,200 CONSENT DOCUMENT, SO YOU KNOW IT 1907 01:06:50,200 --> 01:06:52,160 REALLY BOILS DOWN TO WHAT THAT 1908 01:06:52,160 --> 01:06:54,160 SPECIFIC STUDY TEAM OR 1909 01:06:54,160 --> 01:06:55,120 INVESTIGATOR ACTUALLY PROMISED 1910 01:06:55,120 --> 01:06:57,440 BUT YOU KNOW EVEN THEN WE CAN 1911 01:06:57,440 --> 01:06:59,040 SEE THAT THERE'S OFTEN PROBLEMS 1912 01:06:59,040 --> 01:07:00,200 WITH THAT, RIGHT? 1913 01:07:00,200 --> 01:07:01,800 YESTERDAY WE MENTIONED THIS 1914 01:07:01,800 --> 01:07:03,760 COMPANY, SEVERAL PEOPLE 1915 01:07:03,760 --> 01:07:04,560 MENTIONED THIS COMPANY'S SECOND 1916 01:07:04,560 --> 01:07:06,360 SITE BUT FOR OUR WORKSHOP WE 1917 01:07:06,360 --> 01:07:08,560 USED A CASE EXAMPLE FOR A 1918 01:07:08,560 --> 01:07:10,480 SIMILAR COMPANY CALLED NEURAL 1919 01:07:10,480 --> 01:07:20,320 CONTROL WITH THE FUNCTIONAL AND 1920 01:07:20,320 --> 01:07:21,160 EFFECTIVE, EFFICACY AND LEADING 1921 01:07:21,160 --> 01:07:24,720 PARTICIPANTS THAT ARE BENEFITING 1922 01:07:24,720 --> 01:07:26,520 AND WITHOUT OPTIONS SO EVEN WHEN 1923 01:07:26,520 --> 01:07:28,320 PROMISES ARE MADE IN THE 1924 01:07:28,320 --> 01:07:29,680 INFORMED CONSENT DOCUMENTS IT 1925 01:07:29,680 --> 01:07:31,200 CAN BE AN UPHILL BALGT FOR THEM 1926 01:07:31,200 --> 01:07:33,480 TO GET THAT POST TRIAL ACCESS. 1927 01:07:33,480 --> 01:07:34,760 AND SO, IN FIGURING OUT, YOU 1928 01:07:34,760 --> 01:07:40,600 KNOW WHAT WOULD BE CONSIDERED 1929 01:07:40,600 --> 01:07:41,040 AND ADDITIONAL 1930 01:07:41,040 --> 01:07:41,680 RERESPONSIBILITIES, 1 MODEL WE 1931 01:07:41,680 --> 01:07:48,080 COULD LOOK TO IS RICHARDS' ON 1932 01:07:48,080 --> 01:07:51,320 THE PARTICIPANTS AN CELLARY AND 1933 01:07:51,320 --> 01:07:52,640 AND HELP TO THOSE RESEARCHERS 1934 01:07:52,640 --> 01:08:00,520 WHEN THEY AGREE TO JOIN THE 1935 01:08:00,520 --> 01:08:01,400 STUDY. 1936 01:08:01,400 --> 01:08:02,040 RICHARDSON DEFINES ANCILLARY 1937 01:08:02,040 --> 01:08:04,120 CARE OF STUFF THAT'S NOT 1938 01:08:04,120 --> 01:08:05,760 SCIENTIFICALLY VALID TO INSURE 1939 01:08:05,760 --> 01:08:06,920 TRIAL SAFETY OR RESEARCH 1940 01:08:06,920 --> 01:08:08,400 INDUSTRIES AND THOUGH HE WAS 1941 01:08:08,400 --> 01:08:10,160 PRIMARILY WRITE NOTHING 1942 01:08:10,160 --> 01:08:11,880 REFERENCE TO ANTIRETROVIRAL 1943 01:08:11,880 --> 01:08:12,600 STUDIES, YOU KNOW BASED ON OUR 1944 01:08:12,600 --> 01:08:13,640 CONVERSATION FROM YESTERDAY AND 1945 01:08:13,640 --> 01:08:15,520 TODAY, IT'S CLEAR THAT 1946 01:08:15,520 --> 01:08:17,480 PARTICIPANTS OF THE NEURAL 1947 01:08:17,480 --> 01:08:18,680 IMPLANT STUDIES MIGHT REQUIRE 1948 01:08:18,680 --> 01:08:20,200 WHAT ARE CALLED ANCILLARY CARE 1949 01:08:20,200 --> 01:08:23,760 AND IN FACT, THE MORAL 1950 01:08:23,760 --> 01:08:24,480 ENTANGLEMENTS THAT RICHARDSON 1951 01:08:24,480 --> 01:08:25,840 DESCRIBES IN THIS WORK MAY BE 1952 01:08:25,840 --> 01:08:27,440 MORE RELEVANT IN THIS SPACE 1953 01:08:27,440 --> 01:08:28,880 BECAUSE PARTICIPATION IS 1954 01:08:28,880 --> 01:08:30,360 BURDENSOME AND PARTICIPANTS 1955 01:08:30,360 --> 01:08:35,200 BUILD LASTING RELATIONSHIPS WITH 1956 01:08:35,200 --> 01:08:35,640 RESEARCHERS. 1957 01:08:35,640 --> 01:08:36,400 >> NEXT SLIDE, PLEASE, SO WHILE 1958 01:08:36,400 --> 01:08:39,280 WE DON'T HAVE AN ANSWER TO THIS 1959 01:08:39,280 --> 01:08:39,840 QUESTION OF WHETHER THEY'RE 1960 01:08:39,840 --> 01:08:41,920 GOING TO HAVE THE MINIMUM, THERE 1961 01:08:41,920 --> 01:08:43,840 ARE FACTORS THAT MIGHT BE 1962 01:08:43,840 --> 01:08:45,640 RELEVANT IN TERMS OF FIGURING 1963 01:08:45,640 --> 01:08:46,960 OUT WHEN THAT HAPPENS. 1964 01:08:46,960 --> 01:08:48,400 SO FIRST FACTOR IS WHEN 1965 01:08:48,400 --> 01:08:49,680 PARTICIPANTS TAKE ON A 1966 01:08:49,680 --> 01:08:51,000 SIGNIFICANT RISK TO PARTICIPATE 1967 01:08:51,000 --> 01:08:53,040 IN STUDIES, THEY MAY BE OWED 1968 01:08:53,040 --> 01:08:55,320 MORE THAN THE MINIMUM, AND NOT 1969 01:08:55,320 --> 01:08:57,000 ONLY DOES PARTICIPATION IN THESE 1970 01:08:57,000 --> 01:08:59,680 STUDIES REQUIRE INVASIVE BRAIN 1971 01:08:59,680 --> 01:09:01,960 OR SPINAL SURGERY, THE 1972 01:09:01,960 --> 01:09:04,680 LITERATURE, THE NEURAL ETHICS 1973 01:09:04,680 --> 01:09:07,200 LITERATURE REPLETE WITH 1974 01:09:07,200 --> 01:09:08,360 ASSOCIATED RISK TO ADJUSTING 1975 01:09:08,360 --> 01:09:09,440 WITH THE LIVING DEVICE AND FOR 1976 01:09:09,440 --> 01:09:11,760 ALL THESE RISKS AND AS WE 1977 01:09:11,760 --> 01:09:13,480 MENTIONED, YOU KNOW THE 1978 01:09:13,480 --> 01:09:15,240 CONSIDERABLE BURDENS INVOLVED IN 1979 01:09:15,240 --> 01:09:15,920 PARTICIPATION, IT'S ACTUALLY 1980 01:09:15,920 --> 01:09:17,400 KIND OF SURPRISING TO FIND OUT 1981 01:09:17,400 --> 01:09:19,280 THAT PARTIC PLAN TO ANALYZE BY 1982 01:09:19,280 --> 01:09:21,040 AGES ARE RELATIVELY 1983 01:09:21,040 --> 01:09:22,080 UNCOMPENSATED, ESPECIALLY WHEN 1984 01:09:22,080 --> 01:09:25,040 CONSIDERING THE BCI TRIALS, YOU 1985 01:09:25,040 --> 01:09:26,440 KNOW OFTEN REQUIRE A LOT OF 1986 01:09:26,440 --> 01:09:28,040 EFFORT, YOU KNOW GOING IN 1987 01:09:28,040 --> 01:09:31,960 MULTIPLE TIMES A WEEK FOR THE 1988 01:09:31,960 --> 01:09:35,440 COURSE OF 4 OR 5 OR LONGER 1989 01:09:35,440 --> 01:09:38,720 PERIODS OF TIME, AND WITH THE 1990 01:09:38,720 --> 01:09:40,920 POSSIBILITY IT MIGHT NOT 1991 01:09:40,920 --> 01:09:42,880 CLINICALLY BENEFIT THE 1992 01:09:42,880 --> 01:09:43,480 PARTICIPANT. 1993 01:09:43,480 --> 01:09:45,120 FINALLY IF PARTICIPANTS ARE 1994 01:09:45,120 --> 01:09:46,000 DEPENDENT ON RESEARCHERS FOR 1995 01:09:46,000 --> 01:09:47,920 MORE ACCESS THERE MAY BE MORE OF 1996 01:09:47,920 --> 01:09:49,160 AN OBLIGATION, AS WE HEARD 1997 01:09:49,160 --> 01:09:50,720 YESTERDAY, IT'S OFTEN NEXT TO 1998 01:09:50,720 --> 01:09:52,360 IMPOSSIBLE TO RECEIVE THE SAME 1999 01:09:52,360 --> 01:09:53,800 CARE FROM A DIFFERENT DOCTOR LET 2000 01:09:53,800 --> 01:09:55,000 ALONE A DIFFERENT INSTITUTION 2001 01:09:55,000 --> 01:09:56,840 AND THAT DEGREE OF DEPENDENCY OR 2002 01:09:56,840 --> 01:09:59,200 LACK OF OTHER ALTERNATIVES MAY 2003 01:09:59,200 --> 01:10:01,640 ALSO SPEAK TO WHEN MORE IS 2004 01:10:01,640 --> 01:10:04,280 REQUIRED. 2005 01:10:04,280 --> 01:10:05,040 NEXT SLIDE, PLEASE. 2006 01:10:05,040 --> 01:10:06,920 SO WE WILL BRIEFLY SHARE DATA 2007 01:10:06,920 --> 01:10:08,880 FROM 2 PROJECTS WE WORKED ON AT 2008 01:10:08,880 --> 01:10:10,360 THE UNIVERSITY OF WASHINGTON. 2009 01:10:10,360 --> 01:10:11,920 BOTH ARE FUNDED BY THE NIH THE 2010 01:10:11,920 --> 01:10:14,440 FIRST HAS A MENTIONED EARLIER 2011 01:10:14,440 --> 01:10:16,840 WAS AN EXPERT WORKSHOP THAT WE 2012 01:10:16,840 --> 01:10:17,840 HOSTED USING VIRTUALLY LAST MAY, 2013 01:10:17,840 --> 01:10:20,000 AND THE SECOND IS RO1 LOOKING AT 2014 01:10:20,000 --> 01:10:21,200 ISSUES OF AGENCY, BUT WE ALSO 2015 01:10:21,200 --> 01:10:23,600 ASKED A LOT OF QUESTIONS ABOUT 2016 01:10:23,600 --> 01:10:27,360 POST TRIAL ISSUES THROUGHOUT OUR 2017 01:10:27,360 --> 01:10:31,000 INTERVIEWS. 2018 01:10:31,000 --> 01:10:31,640 NEXT SLIDE, PLEASE. 2019 01:10:31,640 --> 01:10:34,080 SO I WANTED TO TELL BUT THIS 2020 01:10:34,080 --> 01:10:34,760 WORKSHOP, SO OUR AIM WAS 2021 01:10:34,760 --> 01:10:35,960 NONAPOPTOTIC THE TO REACH 2022 01:10:35,960 --> 01:10:38,920 CONSENSUS BUT RATHER TO SORT OF 2023 01:10:38,920 --> 01:10:40,280 EXPLORE AREAS WHERE WELL PLIGHT 2024 01:10:40,280 --> 01:10:43,160 BE BROAD AGREEMENT ABOUT ETHICAL 2025 01:10:43,160 --> 01:10:45,000 JUSTIFICATION AND SO, THE 2026 01:10:45,000 --> 01:10:49,440 PRIMARY ATTENDEES FOR THIS 2027 01:10:49,440 --> 01:10:50,360 WORKSHOP WHERE NIH FUNDED 2028 01:10:50,360 --> 01:10:52,800 NEUROETHICISTS ALTHOUGH WE DID 2029 01:10:52,800 --> 01:10:54,160 INCLUDE SEVERAL CLINICIANS AND 2030 01:10:54,160 --> 01:10:56,240 REPRESENTATIVES FROM THE NIH IN 2031 01:10:56,240 --> 01:10:58,120 FACT MANY PEOPLE WHO ARE IN THIS 2032 01:10:58,120 --> 01:10:59,320 MEETING ODAY WERE IN 2033 01:10:59,320 --> 01:11:02,080 WORKSHOP AS WELL. 2034 01:11:02,080 --> 01:11:03,960 SO JUST A QUICK NOTE ABOUT 2035 01:11:03,960 --> 01:11:04,840 FORMAT, WE SHARED BACKGROUND 2036 01:11:04,840 --> 01:11:06,520 RESEARCH AND WE GAVE A QUICK 2037 01:11:06,520 --> 01:11:08,240 OVERVIEW AT THE BEGINNING OF THE 2038 01:11:08,240 --> 01:11:11,440 DAY LONG MEETING AND THEN WE HAD 2039 01:11:11,440 --> 01:11:16,480 A FULL DAY OF DISCUSSIONS 2040 01:11:16,480 --> 01:11:16,720 NSLIDE. 2041 01:11:16,720 --> 01:11:17,880 SO 4 QUESTIONS, IS THERE A 2042 01:11:17,880 --> 01:11:21,560 ABNORMALITIES LIFE ON 2043 01:11:21,560 --> 01:11:22,800 EARTHIGATION AT ALL, SECOND, IF 2044 01:11:22,800 --> 01:11:25,080 THERE IS AN OBLIGATION, IS THE 2045 01:11:25,080 --> 01:11:27,240 NEURAL IMPLANT CONTEXT UNIQUE, 2046 01:11:27,240 --> 01:11:29,000 DOES IT REQUIRE DIFFERENT 2047 01:11:29,000 --> 01:11:29,840 JUSTIFICATIONS, AND GETTING THE 2048 01:11:29,840 --> 01:11:32,440 LITTLE BIT OF TODAY'S SESSION 2049 01:11:32,440 --> 01:11:34,160 QUESTION, THE THIRD QUESTION WE 2050 01:11:34,160 --> 01:11:36,080 ASKED IF WELL IS AN OBLIGATION 2051 01:11:36,080 --> 01:11:38,240 TO PROVIDE, HOW FAR DOES THAT 2052 01:11:38,240 --> 01:11:41,240 EXTEND AND FINALLY, WE ALSO 2053 01:11:41,240 --> 01:11:43,920 ASKED OR AT LEAST INTENDED TO 2054 01:11:43,920 --> 01:11:45,800 ASK WHEN STAKEHOLDERS ARE 2055 01:11:45,800 --> 01:11:46,280 RESPONSIBILITY. 2056 01:11:46,280 --> 01:11:47,800 WE DIDN'T GET TO QUESTION 4 2057 01:11:47,800 --> 01:11:49,560 BECAUSE WE REALIZED IT'S VERY 2058 01:11:49,560 --> 01:11:51,080 DIFFICULT TO APPROACH THAT 2059 01:11:51,080 --> 01:11:53,840 QUESTION WITHOUT HAVING 2060 01:11:53,840 --> 01:11:54,960 STAKEHOLDERS IN THE ROOM. 2061 01:11:54,960 --> 01:11:55,320 SO NEXT SLIDE. 2062 01:11:55,320 --> 01:11:57,080 SO I WANT TO ACTUALLY SHARE A 2063 01:11:57,080 --> 01:11:58,480 FEW TAKE AWAYS FROM THAT MEETING 2064 01:11:58,480 --> 01:11:59,520 THAT ARE REEL KEEPSAKES STROONT 2065 01:11:59,520 --> 01:12:02,680 THIS QUESTION ABOUT WHAT MINIMUM 2066 01:12:02,680 --> 01:12:02,920 IS OWED. 2067 01:12:02,920 --> 01:12:04,200 AND I WANTED TO HIGHLIGHT THAT 2068 01:12:04,200 --> 01:12:06,720 THIS SPEAKS TO SORT OF THE BEAR 2069 01:12:06,720 --> 01:12:08,360 MINIMUM REQUIRED AND IT MIGHT 2070 01:12:08,360 --> 01:12:09,800 CHANGE DEPENDING ON THE SPECIFIC 2071 01:12:09,800 --> 01:12:11,000 CONTEXT OF THE IS IT THE AND 2072 01:12:11,000 --> 01:12:12,520 MIGHT BE SITUATIONS WHERE MORE 2073 01:12:12,520 --> 01:12:15,640 THAN THE MIN NUM IS OWED BUT 2074 01:12:15,640 --> 01:12:17,160 WORKSHOP ATTENDEES BROADLY 2075 01:12:17,160 --> 01:12:18,200 AGREED THAT IMPLANTABLE DEVICES 2076 01:12:18,200 --> 01:12:20,240 ARE UNIQUE AND THE ETHICAL JUST 2077 01:12:20,240 --> 01:12:21,320 IVENGZS FOR POST TRIAL CARE WILL 2078 01:12:21,320 --> 01:12:22,880 BE DIFFERENT FROM OTHER CONTACT 2079 01:12:22,880 --> 01:12:24,640 AND ESPECIALENTIALLY A LOT OF 2080 01:12:24,640 --> 01:12:27,080 THE LITERATURE WRITTEN AROUND 2081 01:12:27,080 --> 01:12:28,560 ANTIRETROVIRALS, AT THE VERY 2082 01:12:28,560 --> 01:12:30,320 LEAST, THERE WAS BROAD SUPPORT 2083 01:12:30,320 --> 01:12:32,680 THAT AT A BEAR MINIMUM, THERE IS 2084 01:12:32,680 --> 01:12:34,760 AN OBLIGATION TO PROVIDE 2085 01:12:34,760 --> 01:12:36,000 CONTINUED ACCESS IF THOSE ARE 2086 01:12:36,000 --> 01:12:37,400 TREATMENTS ARE PROVEN TO BE 2087 01:12:37,400 --> 01:12:37,720 BENEFICIAL. 2088 01:12:37,720 --> 01:12:39,600 NOW WE HAD A LOT OF DISCUSSION 2089 01:12:39,600 --> 01:12:41,840 ABOUT WHAT BENEFIT MEANS AND 2090 01:12:41,840 --> 01:12:43,800 GIVEN THE HETEROGENERATED AITY 2091 01:12:43,800 --> 01:12:45,440 OF THESE IN THIS SPACE, I WILL 2092 01:12:45,440 --> 01:12:47,080 MENTION THIS IS A COMPLICATED 2093 01:12:47,080 --> 01:12:48,920 CONCEPT BUT THAT BEING SAID, THE 2094 01:12:48,920 --> 01:12:50,320 FINAL TAKE AWAY I WILL SHARE IS 2095 01:12:50,320 --> 01:12:52,280 THAT BENEFIT HAD TO BE 2096 01:12:52,280 --> 01:12:53,800 UNDERSTOOD MORE BROADLY THAN 2097 01:12:53,800 --> 01:12:57,160 IT'S CURRENTLY BEING FRAMED. 2098 01:12:57,160 --> 01:12:59,280 IT CAN'T JUST BE ABOUT CLINICAL 2099 01:12:59,280 --> 01:13:01,000 BENEFIT AND AGAIN IT WILL 2100 01:13:01,000 --> 01:13:03,800 DEPENDOT CONTEXT BUT THAT BEN 2101 01:13:03,800 --> 01:13:07,360 PIT HAS TO BE UNDERSTOOD IN THE 2102 01:13:07,360 --> 01:13:10,280 WHOLISTIC SENSE. 2103 01:13:10,280 --> 01:13:12,000 AND THERE COULD BE FOR EXAMPLE, 2104 01:13:12,000 --> 01:13:13,400 PARTICIPATE NOTHING THE STUDY 2105 01:13:13,400 --> 01:13:15,160 ITSELF, HAVING THE ABILITY TO 2106 01:13:15,160 --> 01:13:16,520 PARTICIPATE AS A POTENTIAL 2107 01:13:16,520 --> 01:13:16,800 BENEFIT. 2108 01:13:16,800 --> 01:13:20,200 I'M GOING TO PASS IT ON TO MY CO 2109 01:13:20,200 --> 01:13:20,960 PRESENTER, SARA. 2110 01:13:20,960 --> 01:13:25,080 >> GREAT, SO NEXT SLIDE, PLEASE. 2111 01:13:25,080 --> 01:13:28,600 NOW I WANT TO TELL BUT 2112 01:13:28,600 --> 01:13:29,320 INTERVIEWS THAT ISHAN DID THAT 2113 01:13:29,320 --> 01:13:33,320 WE DID AS PART OF OUR RON 1 WITH 2114 01:13:33,320 --> 01:13:34,560 END USERS OF DEVICES AND I WANT 2115 01:13:34,560 --> 01:13:36,600 TO SAY HERE WE HAVE A LOT OF 2116 01:13:36,600 --> 01:13:38,720 PEOPLE WHO ARE USING BCIs FOR 2117 01:13:38,720 --> 01:13:42,880 MOTOR, CONTROL SO THEY'RE 2118 01:13:42,880 --> 01:13:44,360 CONTROLLING A CURSOR OR A 2119 01:13:44,360 --> 01:13:45,760 ROBOTIC ARM THAT MEANS THEY 2120 01:13:45,760 --> 01:13:47,960 DON'T CARRY THE DEVICE, THEY 2121 01:13:47,960 --> 01:13:49,600 CARRY IT WITH THEM BUT THEY 2122 01:13:49,600 --> 01:13:51,000 DON'T TAKE IT OUTSIDE THE LAB, 2123 01:13:51,000 --> 01:13:52,640 THEY ARE ONLY ABLE TO USE THE 2124 01:13:52,640 --> 01:13:54,040 DEVICE WHEN THEY'RE IN THE LAB 2125 01:13:54,040 --> 01:13:55,440 BUT WE ALSO INTERVIEWED PEOPLE 2126 01:13:55,440 --> 01:14:00,680 WHO HAVE AN EXPERIMENTAL CLOSED 2127 01:14:00,680 --> 01:14:03,040 LOOP DEVICE, A DBS DEVICE AND 2128 01:14:03,040 --> 01:14:05,000 IT'S TREATING A CONDITION 2129 01:14:05,000 --> 01:14:06,520 THERAPEUTICALLY AS THEY'RE 2130 01:14:06,520 --> 01:14:07,880 WALKING AROUND DAY-TO-DAY SO 2131 01:14:07,880 --> 01:14:09,320 THAT MEANS WE HAVE DIFFERENT 2132 01:14:09,320 --> 01:14:10,880 KINDS OF CONDITIONS IN HERE, 2133 01:14:10,880 --> 01:14:12,960 DIFFERENT KINDS OF STUDIES 2134 01:14:12,960 --> 01:14:23,200 REPRESENTED. 2135 01:14:26,680 --> 01:14:27,720 NEXT SLIDE, PLEASE. 2136 01:14:27,720 --> 01:14:30,160 SO SOME AREAS OF AGREEMENT FROM 2137 01:14:30,160 --> 01:14:33,120 PARTICIPANTS WE TALKED WITH, 2138 01:14:33,120 --> 01:14:35,680 COMPENSATION TR TIME AND EFFORT, 2139 01:14:35,680 --> 01:14:37,240 RECOGNITION OF PARTICIPATION OF 2140 01:14:37,240 --> 01:14:41,400 THEIR SIGNIFICANT CONTRIBUTION 2141 01:14:41,400 --> 01:14:43,960 TO WHAT'S HAPPENING AS TRACEY 2142 01:14:43,960 --> 01:14:45,640 SAID IN THE TALK EARLIER IN THE 2143 01:14:45,640 --> 01:14:47,160 PANEL, YOU DON'T GET THAT DATA 2144 01:14:47,160 --> 01:14:48,960 EXCEPT BY OFF THESE PARTICIPANTS 2145 01:14:48,960 --> 01:14:50,360 THEY HAVE TO BE THERE FOR THE 2146 01:14:50,360 --> 01:14:53,120 STUDY TO BE POSSIBLE, SO IT'S A 2147 01:14:53,120 --> 01:14:55,040 RECOGNITION OF THAT 2148 01:14:55,040 --> 01:14:55,400 CONTRIBUTION. 2149 01:14:55,400 --> 01:14:56,680 MEDICAL CARE RELATED TO THE 2150 01:14:56,680 --> 01:14:59,040 IMPLANT FOR THE REST OF THE 2151 01:14:59,040 --> 01:15:00,920 PARPANTS LIFE, THIS IS SOMETHING 2152 01:15:00,920 --> 01:15:03,000 WE HEARD REGULARLY, GIVEN IT'S 2153 01:15:03,000 --> 01:15:04,800 AN IMPLANTABLE DEVICE AND IT'S 2154 01:15:04,800 --> 01:15:06,200 TYPICALLY STAYING WITH THEM AND 2155 01:15:06,200 --> 01:15:08,000 IF THEY'RE BENEFITING CONTINUED 2156 01:15:08,000 --> 01:15:09,280 ACCESS AND UPKEEP AND 2157 01:15:09,280 --> 01:15:12,360 MAINTENANCE AS WE TALKED ABOUT 2158 01:15:12,360 --> 01:15:17,000 ALREADY. 2159 01:15:17,000 --> 01:15:18,600 NEXT SLIDE. 2160 01:15:18,600 --> 01:15:19,160 APOPTOTICKINGS, OTHER WAY. 2161 01:15:19,160 --> 01:15:20,960 I JUST WANT TO SHOW YOU A COUPLE 2162 01:15:20,960 --> 01:15:25,040 OTHER THINGS PEOPLE SAID ON THE 2163 01:15:25,040 --> 01:15:25,600 COMPENSATION POINT. 2164 01:15:25,600 --> 01:15:27,400 ONE GUY IS COMPARING HIMSELF TO 2165 01:15:27,400 --> 01:15:28,800 SOMEBODY ELSE IN THE STUDY, HE 2166 01:15:28,800 --> 01:15:31,960 SAID HE ONLY GOT GAS MONEY, THEY 2167 01:15:31,960 --> 01:15:33,880 DIDN'T GIVE HIM ANYTHING FOR HIS 2168 01:15:33,880 --> 01:15:35,880 TIME REALLY, THAT'S NOT ENTIRELY 2169 01:15:35,880 --> 01:15:36,240 FAIR. 2170 01:15:36,240 --> 01:15:37,560 I THINK THEY OWE FAIR 2171 01:15:37,560 --> 01:15:38,840 COMPENSATION AND TO LOOK AT WHAT 2172 01:15:38,840 --> 01:15:40,680 THEY'RE ASKING OF PEOPLE. 2173 01:15:40,680 --> 01:15:42,760 AGAIN THIS IS COMING FROM A BCI 2174 01:15:42,760 --> 01:15:44,400 STUDY, PEOPLE ARE THERE IT'S 2175 01:15:44,400 --> 01:15:46,760 LIKE A PART-TIME JOB, 3 TIMES A 2176 01:15:46,760 --> 01:15:48,760 WEEK, 3 HOURS A SESSION, MAYBE 2177 01:15:48,760 --> 01:15:51,240 OVER 5 YEARS, AND THAT THEY ALSO 2178 01:15:51,240 --> 01:15:54,920 NEED TO GET THERE, RIGHT? 2179 01:15:54,920 --> 01:15:56,320 OFTEN HAVE A CAREGIVER OR 2180 01:15:56,320 --> 01:15:58,360 SOMEONE ELSE WHO WILL FACILITATE 2181 01:15:58,360 --> 01:15:59,280 TRANSPORTATION AND HELP WHILE 2182 01:15:59,280 --> 01:16:04,040 THEY'RE AT THE STUDY SITE. 2183 01:16:04,040 --> 01:16:04,920 ANOTHER TELLING QUOTE, SOMETHING 2184 01:16:04,920 --> 01:16:06,640 NEEDS TO BE GIVEN BACK TO THE 2185 01:16:06,640 --> 01:16:07,440 PARTICIPANTS BUT IT CAN'T BE 2186 01:16:07,440 --> 01:16:09,080 ENOUGH TO BE A MOTIVATING FACTOR 2187 01:16:09,080 --> 01:16:10,000 FOR THEM TO GO THROUGH. 2188 01:16:10,000 --> 01:16:11,720 SO THIS IS A RECOGNITION OF THE 2189 01:16:11,720 --> 01:16:14,160 PUSH AND PULL, YOU DON'T WANT 2190 01:16:14,160 --> 01:16:17,480 REALLY HIGH COMPENSATION BECAUSE 2191 01:16:17,480 --> 01:16:19,640 YOU DON'T WANT TO HAVE UNDUE 2192 01:16:19,640 --> 01:16:22,360 INDUCEMENT TO ENTER THE TRIAL 2193 01:16:22,360 --> 01:16:23,600 FOR SOMEBODY'S WHO'S 2194 01:16:23,600 --> 01:16:24,560 IMPOVERISHED AND WOULD OTHERWISE 2195 01:16:24,560 --> 01:16:29,760 QUALIFY AND DO IT FOR THAT MONEY 2196 01:16:29,760 --> 01:16:32,280 BUT, THEY KEEP THE COMPENSATION 2197 01:16:32,280 --> 01:16:33,360 REALLY LOW. 2198 01:16:33,360 --> 01:16:35,480 IT'S ALMOST LAUGHABLE, I FEEL A 2199 01:16:35,480 --> 01:16:36,640 PARTICIPANT SHOULD BE 2200 01:16:36,640 --> 01:16:39,160 COMPENSATED, I FEEL IT SHOULD BE 2201 01:16:39,160 --> 01:16:40,560 MEASURED BASED ON THE LEVEL OF 2202 01:16:40,560 --> 01:16:42,400 RESEARCH OR THE RESEARCH THEY'RE 2203 01:16:42,400 --> 01:16:43,120 PARTICIPATING IN SO HOW MUCH 2204 01:16:43,120 --> 01:16:45,040 TIME AND EFFORT IS REQUIRED 2205 01:16:45,040 --> 01:16:45,240 THERE. 2206 01:16:45,240 --> 01:16:45,560 NEXT SLIDE. 2207 01:16:45,560 --> 01:16:47,840 PEOPLE TALKED ABOUT THE 2208 01:16:47,840 --> 01:16:48,280 RECOGNITION, RIGHT? 2209 01:16:48,280 --> 01:16:49,480 THEY'RE BUILDING THEIR CAREERS 2210 01:16:49,480 --> 01:16:51,880 OFF OF US, OFF OF TEST SUBJECTS 2211 01:16:51,880 --> 01:16:53,320 AND THESE ARE MULTIMILLION 2212 01:16:53,320 --> 01:16:54,880 DOLLAR CAREERS, WE SHOULD BE 2213 01:16:54,880 --> 01:16:57,280 THANKED AND RECOGNIZED IF ARE 2214 01:16:57,280 --> 01:16:58,000 OUR PARTICIPATION RIGHT? 2215 01:16:58,000 --> 01:17:01,160 IT'S THIS SORT OF ACKNOWLEDGMENT 2216 01:17:01,160 --> 01:17:03,560 OF THE LEVEL OF CONTRIBUTION AND 2217 01:17:03,560 --> 01:17:05,040 THE INTEGRAL NATURE OF THAT 2218 01:17:05,040 --> 01:17:05,800 CONTRIBUTION ON CONTINUED 2219 01:17:05,800 --> 01:17:07,000 MEDICAL CARE FOR AS LONG AS HAVE 2220 01:17:07,000 --> 01:17:08,520 YOU THE DEVICE IF YOU. 2221 01:17:08,520 --> 01:17:10,000 I THINK YOUR WHOLE LIFE BECAUSE 2222 01:17:10,000 --> 01:17:11,680 IT FEELS SO WEIRD IF YOU DIDN'T 2223 01:17:11,680 --> 01:17:13,760 HAVE ANYONE TO TALK TO IF 2224 01:17:13,760 --> 01:17:14,560 SOMETHING HAPPENS. 2225 01:17:14,560 --> 01:17:16,000 THIS GETS AT THE ISSUES THAT ARE 2226 01:17:16,000 --> 01:17:17,440 BROUGHT UP ABOUT EXPERTISE. 2227 01:17:17,440 --> 01:17:19,840 YOU HAVE TO HAVE SOMEBODY WHO 2228 01:17:19,840 --> 01:17:22,680 KNOWS MEN AND WOMEN TO DO. 2229 01:17:22,680 --> 01:17:24,600 SOMEBODY IN OUR STUDY SAID, IF 2230 01:17:24,600 --> 01:17:25,920 HAVE YOU AN ACCIDENT, AND YOU GO 2231 01:17:25,920 --> 01:17:28,200 TO THE E. R., YOU HAVE TO CALL 2232 01:17:28,200 --> 01:17:29,360 SOMEBODY ABOUT THE DEVICE BEFORE 2233 01:17:29,360 --> 01:17:30,480 OTHER THINGS CAN HAPPEN BECAUSE 2234 01:17:30,480 --> 01:17:32,360 YOU WANT TO PROTECT THAT DEVICE. 2235 01:17:32,360 --> 01:17:33,720 AND THEN FINALLY, THIS IS 2236 01:17:33,720 --> 01:17:35,400 SOMEBODY WHO'S TREATED WITH A 2237 01:17:35,400 --> 01:17:37,040 DEVICE, CARRIED WITH HIM THAT'S 2238 01:17:37,040 --> 01:17:38,880 THERAPEUTIC, I WOULD RATHER BE 2239 01:17:38,880 --> 01:17:40,880 DEAD THAN NOT TO HAVE THIS. 2240 01:17:40,880 --> 01:17:41,600 WHEN WE WERE TALKING ABOUT THE 2241 01:17:41,600 --> 01:17:43,520 POSSIBILITY OF NOT HAVING 2242 01:17:43,520 --> 01:17:46,840 ACCESS, HE'S ECHOING SOMETHING 2243 01:17:46,840 --> 01:17:49,160 THAT WE HEARD YESTERDAY FROM 2244 01:17:49,160 --> 01:17:49,600 OTHER PARTICIPANTS. 2245 01:17:49,600 --> 01:17:52,520 ALL RIGHT, NEXT SLIDE. 2246 01:17:52,520 --> 01:17:54,080 SO WHEN WE WOULD HAVE 2247 01:17:54,080 --> 01:17:56,000 RESPONSIBILITIES TO PROVIDE OR 2248 01:17:56,000 --> 01:17:56,480 FACILITATE MORE? 2249 01:17:56,480 --> 01:17:57,880 SOME OF THE THINGS PEOPLE TALKED 2250 01:17:57,880 --> 01:17:59,920 ABOUT THAT SEEM RELEVANT TO 2251 01:17:59,920 --> 01:18:01,000 PROVIDING EVEN MORE THAN THE MIN 2252 01:18:01,000 --> 01:18:03,480 NUM IS JUST THE HIGH BURDEN OF 2253 01:18:03,480 --> 01:18:05,040 TIME AND ENERGY, THE VERY CLOSE 2254 01:18:05,040 --> 01:18:06,080 RELATIONSHIPS THEY BUILD, THE 2255 01:18:06,080 --> 01:18:09,600 STUDY TEAMS OVER 5 YEARS OR 2256 01:18:09,600 --> 01:18:12,760 BEYOND AND THE MINIMAL POTENTIAL 2257 01:18:12,760 --> 01:18:13,400 CLINICAL BENEFIT ESPECIALLY FOR 2258 01:18:13,400 --> 01:18:15,040 THE PEOPLE IN THE BCI LAB. 2259 01:18:15,040 --> 01:18:16,360 NEXT SLIDE AND THIS IS MY LAST 1 2260 01:18:16,360 --> 01:18:18,480 AND THEN WE WILL CLOSE. 2261 01:18:18,480 --> 01:18:19,640 SO RELATIONSHIPS WITH 2262 01:18:19,640 --> 01:18:20,720 RESEARCHERS, IF I LEFT THIS 2263 01:18:20,720 --> 01:18:22,400 STUDY AND WE DIDN'T HAVE SOME 2264 01:18:22,400 --> 01:18:23,640 TYPE OF SOCIAL CONNECTION 2265 01:18:23,640 --> 01:18:25,200 AFTERWARD, YEAH, I WOULD BE 2266 01:18:25,200 --> 01:18:25,920 DISAPPOINTED BECAUSE I THINK 2267 01:18:25,920 --> 01:18:28,000 THAT OVER THIS TIME WE'VE BECOME 2268 01:18:28,000 --> 01:18:28,640 MORE LIKE FAMILY. 2269 01:18:28,640 --> 01:18:30,480 THIS JUST SPEAKS TO HOW 2270 01:18:30,480 --> 01:18:33,040 ENTANGLED PEOPLE ARE AFTER THAT 2271 01:18:33,040 --> 01:18:38,320 LONG PERIOD AND THEN I WANT TO 2272 01:18:38,320 --> 01:18:40,400 ADD HERE IS FOR PEOPLE IN BCI 2273 01:18:40,400 --> 01:18:42,760 STUDIES IT MIGHT NOT HAVE A 2274 01:18:42,760 --> 01:18:43,560 CLINICAL UTILITY PER SE BECAUSE 2275 01:18:43,560 --> 01:18:45,120 THEY'RE NOT CARRYING IT WITH 2276 01:18:45,120 --> 01:18:46,800 THEM, BUT THAT PARTICIPATION 2277 01:18:46,800 --> 01:18:48,200 ITSELF CAN BE LIFE ALTERING, IT 2278 01:18:48,200 --> 01:18:50,400 CAN GIVE PEOPLE A SENSE OF 2279 01:18:50,400 --> 01:18:51,840 MATTERING, YOU KNOW THE THINGS 2280 01:18:51,840 --> 01:18:54,520 THAT PEOPLE SAY ABOUT HOW IT 2281 01:18:54,520 --> 01:18:55,240 TURNED THEIR LIFE AROUND, BEING 2282 01:18:55,240 --> 01:19:05,000 ABLE TO BE PART OF THAT AND I 2283 01:19:05,000 --> 01:19:06,920 WILL TURN IT OVER FOR THE WRAP 2284 01:19:06,920 --> 01:19:07,520 UP. 2285 01:19:07,520 --> 01:19:08,600 >> SO SUMMING UP, TAKE WAIRKSES 2286 01:19:08,600 --> 01:19:09,880 FROM BOTH OUR QUALITATIVE 2287 01:19:09,880 --> 01:19:12,280 INTERVIEWS AS WELL AS THE EXPERT 2288 01:19:12,280 --> 01:19:14,040 WORKSHOP BEING HELD, THERE ARE A 2289 01:19:14,040 --> 01:19:16,640 FEW THINGS WE KNOW. 2290 01:19:16,640 --> 01:19:18,000 PARITS PANTS AND ETHICS, 2291 01:19:18,000 --> 01:19:20,280 ETHICISTS ALIKE RECOGNIZE THAT 2292 01:19:20,280 --> 01:19:22,640 IMPLANTING DEVICE INTO SOMEONE'S 2293 01:19:22,640 --> 01:19:24,600 BRAIN RAISES OBLIGATIONS BEYOND 2294 01:19:24,600 --> 01:19:27,480 TYPICAL CLINICAL TRIALS. 2295 01:19:27,480 --> 01:19:28,640 AND THAT PARTICIPATION IS 2296 01:19:28,640 --> 01:19:29,280 RECOGNITION FOR EFFORT, PERHAP 2297 01:19:29,280 --> 01:19:30,720 THIS IS TAKES THE FORM OF 2298 01:19:30,720 --> 01:19:32,200 COMPENSATION FOR THEIR WORK, AND 2299 01:19:32,200 --> 01:19:33,880 MAYBE IT TAKES A FORM OF ACCESS 2300 01:19:33,880 --> 01:19:35,680 TO THE DEVICE IF IT'S WORKING 2301 01:19:35,680 --> 01:19:39,200 AND BENEFICIAL, BEYOND THE STUDY 2302 01:19:39,200 --> 01:19:39,560 PERIOD. 2303 01:19:39,560 --> 01:19:41,240 BUT IT ALSO PERHAPS INCLUDE 2304 01:19:41,240 --> 01:19:42,440 THINGS LIKE ACCESS SUPPORT AND 2305 01:19:42,440 --> 01:19:44,160 CARE AFTER THE TRIAL AND A LAST 2306 01:19:44,160 --> 01:19:47,120 TAKE HOME IS THAT YOU KNOW BRAIN 2307 01:19:47,120 --> 01:19:49,240 BIONEARS IN PARTICIPANTS IN THIS 2308 01:19:49,240 --> 01:19:50,280 SPACE ARE RISKING--TAKING RISKS 2309 01:19:50,280 --> 01:19:52,080 AND INVESTING EFFORT TO HELP 2310 01:19:52,080 --> 01:19:53,840 MOVE THE SCIENCE AND TECHNOLOGY 2311 01:19:53,840 --> 01:19:54,200 FORWARD. 2312 01:19:54,200 --> 01:19:56,800 AND YOU KNOW THEIR EFFORT 2313 01:19:56,800 --> 01:20:00,040 DESERVES PROPER RECOGNITION 2314 01:20:00,040 --> 01:20:06,040 COMPENSATION. 2315 01:20:06,040 --> 01:20:06,400 MY LAST SLIDE. 2316 01:20:06,400 --> 01:20:08,040 BUT THERE ARE A FEW PIECES WE 2317 01:20:08,040 --> 01:20:09,880 NEED TO FIGURE OUT AND TO PUSH 2318 01:20:09,880 --> 01:20:11,880 THIS CONVERSATION FORWARD FROM 2319 01:20:11,880 --> 01:20:13,120 ETHICAL PRINCIPLES TO ACTUAL 2320 01:20:13,120 --> 01:20:14,320 POLICY AND CAME OUT OF OUR 2321 01:20:14,320 --> 01:20:15,800 WORKSHOP AS WELL AND QUICKLY, 2322 01:20:15,800 --> 01:20:17,200 THE 4 THINGS THAT YOU KNOW THAT 2323 01:20:17,200 --> 01:20:20,520 WE STILL NEED MORE DATA ON IS 2324 01:20:20,520 --> 01:20:23,360 REALLY SORT OF FIGURING OUT HOW 2325 01:20:23,360 --> 01:20:25,360 MUCH DO THESE--HOW MUCH WILL 2326 01:20:25,360 --> 01:20:28,960 THIS ACCESS AND POST TRIAL CARE 2327 01:20:28,960 --> 01:20:29,800 ACTUALLY COST? 2328 01:20:29,800 --> 01:20:31,640 YOU KNOW WE DEFINITELY NEED MORE 2329 01:20:31,640 --> 01:20:33,840 DATA FROM ACTUAL RESEARCH 2330 01:20:33,840 --> 01:20:34,760 PARTICIPANTS, FAMILIES, CARE 2331 01:20:34,760 --> 01:20:36,520 TAKERS ABOUT, YOU KNOW WHAT THEY 2332 01:20:36,520 --> 01:20:38,240 WANT AFTER A TRIAL AND WHAT THEY 2333 01:20:38,240 --> 01:20:39,920 WISHED THEY HAD KNOWN BEFORE 2334 01:20:39,920 --> 01:20:41,680 THEY SIGNED UP FOR A CLINICAL 2335 01:20:41,680 --> 01:20:45,480 TRIAL LIKE THIS. 2336 01:20:45,480 --> 01:20:47,560 AS WELL AS DATA FOR THIS POST 2337 01:20:47,560 --> 01:20:49,680 TRIAL ERA AND AS WELL AS 2338 01:20:49,680 --> 01:20:50,480 INFORMATION ABOUT WHAT IS 2339 01:20:50,480 --> 01:20:52,800 REQUIRED IN TERMS OF AN 2340 01:20:52,800 --> 01:20:53,720 INFRASTRUCTURE OF PROVIDING 2341 01:20:53,720 --> 01:20:55,640 CARE, EVEN IF WE HAVE FUNDING 2342 01:20:55,640 --> 01:20:55,880 FOR IT. 2343 01:20:55,880 --> 01:20:57,160 THANK YOU SO MUCH FOR INVITING 2344 01:20:57,160 --> 01:21:04,800 US AND WE WOULD BE HAPPY TO TAKE 2345 01:21:04,800 --> 01:21:05,080 QUESTIONS. 2346 01:21:05,080 --> 01:21:05,440 >> WONDERFUL. 2347 01:21:05,440 --> 01:21:08,920 THANK YOU VERY MUCH ISHAN AND 2348 01:21:08,920 --> 01:21:09,120 SARA. 2349 01:21:09,120 --> 01:21:19,120 ANYONE HAVE A QUESTION FOR THEM? 2350 01:21:19,120 --> 01:21:21,040 OR WE CAN JUST ADMIRE THAT GREAT 2351 01:21:21,040 --> 01:21:23,240 GROUP OF PEOPLE THERE. 2352 01:21:23,240 --> 01:21:23,800 >> ALSO GO, TOO. 2353 01:21:23,800 --> 01:21:26,200 >> I HAVE A QUESTION, I REALLY 2354 01:21:26,200 --> 01:21:29,040 APPRECIATED BOTH THE SUMMARY OF 2355 01:21:29,040 --> 01:21:30,240 WHAT YOU CAME UP WITH THE 2356 01:21:30,240 --> 01:21:31,760 WORKSHOP YOU HAD BUT ALSO THE 2357 01:21:31,760 --> 01:21:32,960 DATA HAVE YOU THAT KIND OF 2358 01:21:32,960 --> 01:21:34,800 SUPPORTS WHAT YOU CAME UP WITH 2359 01:21:34,800 --> 01:21:37,160 FROM THE WORKSHOP, SO, 1 TAKE 2360 01:21:37,160 --> 01:21:39,120 WAIRKS IS THAT THIS IS A UNIQUE 2361 01:21:39,120 --> 01:21:39,840 SPACE, RIGHT? 2362 01:21:39,840 --> 01:21:41,240 THAT THERE'S SOMETHING DIFFERENT 2363 01:21:41,240 --> 01:21:44,000 ABOUT THIS HAN ANOTHER CLINICAL 2364 01:21:44,000 --> 01:21:47,760 TRIALS AND I THINK I HEARD ISHAN 2365 01:21:47,760 --> 01:21:49,760 SAY, THAT THE MORAL 2366 01:21:49,760 --> 01:21:51,120 ENTANGLEMENTS ARE MORE DEEP OR 2367 01:21:51,120 --> 01:21:53,240 COMP LITICATED OR SOMETHING LIKE 2368 01:21:53,240 --> 01:21:56,440 THAT. 2369 01:21:56,440 --> 01:21:57,920 I GUESS, IS THE THEN CONCLUSION 2370 01:21:57,920 --> 01:22:04,240 THAT WE OWE MORE TO PEOPLE 2371 01:22:04,240 --> 01:22:04,800 BECAUSE OF THAT? 2372 01:22:04,800 --> 01:22:05,480 >> I WOULD SAY SO. 2373 01:22:05,480 --> 01:22:07,200 AND I THINK THIS IS BORNE OUT BY 2374 01:22:07,200 --> 01:22:09,440 SOME OF THE DATA THAT WE 2375 01:22:09,440 --> 01:22:10,880 RECEIVED AND YOU KNOW SARA 2376 01:22:10,880 --> 01:22:12,520 POINTED TO SOME OF THESE QUOTES. 2377 01:22:12,520 --> 01:22:14,440 WHEN I TALK TO PARTICIPANTS THEY 2378 01:22:14,440 --> 01:22:17,640 REALIZE THAT THEY ARE DOING 2379 01:22:17,640 --> 01:22:19,720 SOMETHING UNIQUE, AND THEIR 2380 01:22:19,720 --> 01:22:20,800 CONTRIBUTION IS VERY SPECIAL. 2381 01:22:20,800 --> 01:22:22,000 I MEAN JUST JUSTICE, I WAS 2382 01:22:22,000 --> 01:22:23,200 THINKING ABOUT, YOU KNOW LOOKING 2383 01:22:23,200 --> 01:22:24,880 AT SOMETHING ON TWITTER ABOUT 2384 01:22:24,880 --> 01:22:28,200 HOW THE NUMBER OF PEOPLE 2385 01:22:28,200 --> 01:22:29,640 IMPLANTABLE BCI TRIAL SYSTEM 2386 01:22:29,640 --> 01:22:30,880 SOMETHING LIKE 30 OR 40 IN THE 2387 01:22:30,880 --> 01:22:33,760 ENTIRE WORLD, SO I THINK, YOU 2388 01:22:33,760 --> 01:22:36,840 KNOW THIS SORT OF--THIS UNIQUE, 2389 01:22:36,840 --> 01:22:39,240 DATA THAT PARTICIPANTS ARE 2390 01:22:39,240 --> 01:22:41,600 PROVIDING DOE SORT OF 2391 01:22:41,600 --> 01:22:42,240 NECESSITATE FURTHER OBLIGATIONS, 2392 01:22:42,240 --> 01:22:44,400 AND IT'S NOT JUST THE DATA THAT 2393 01:22:44,400 --> 01:22:46,680 THEY'RE PROVIDING BUT IT'S THE 2394 01:22:46,680 --> 01:22:47,360 DAY-TO-DAY RELATIONSHIP, IT'S 2395 01:22:47,360 --> 01:22:50,240 THE TIME, THE EFFORT, THE 2396 01:22:50,240 --> 01:22:52,080 STUDIES THEMSELVES CAN BE VERY 2397 01:22:52,080 --> 01:22:53,200 MENTALLY AND PHYSICALLY TAXING 2398 01:22:53,200 --> 01:22:54,280 SO I THINK, YOU KNOW WHEN YOU 2399 01:22:54,280 --> 01:22:55,920 TAKE ALL OF THOSE THINGS 2400 01:22:55,920 --> 01:22:58,240 TOGETHER, I DO THINK THERE'S AN 2401 01:22:58,240 --> 01:23:01,760 ETHICAL OBLIGATION TO DO MORE. 2402 01:23:01,760 --> 01:23:02,040 >> OKAY. 2403 01:23:02,040 --> 01:23:03,680 THANK YOU VERY MUCH. 2404 01:23:03,680 --> 01:23:09,560 JENNIFER FRENCH, HAVE YOU A 2405 01:23:09,560 --> 01:23:10,240 QUESTION SNO, SORRY ABOUT THAT, 2406 01:23:10,240 --> 01:23:12,240 THANK YOU SO MUCH FOR THE TALK, 2407 01:23:12,240 --> 01:23:13,160 I REALLY APPRECIATE SHARING THE 2408 01:23:13,160 --> 01:23:14,640 WORK THAT YOU'VE DONE IN THE 2409 01:23:14,640 --> 01:23:16,440 PAST AND GETTING SOME FEEDBACK 2410 01:23:16,440 --> 01:23:18,120 FROM THOSE WITH LIVED 2411 01:23:18,120 --> 01:23:18,720 EXPERIENCE. 2412 01:23:18,720 --> 01:23:20,840 ONE QUESTION I HAVE IS IN REGARD 2413 01:23:20,840 --> 01:23:22,360 TO COMPENSATION, WE ALL GET 2414 01:23:22,360 --> 01:23:24,600 SQUIRMY ABOUT THAT AND YOU DID 2415 01:23:24,600 --> 01:23:27,080 HIGHLIGHT THE KIND OF PUSH-PULL 2416 01:23:27,080 --> 01:23:28,480 THAT HAPPENS IN THAT SPACE BUT 2417 01:23:28,480 --> 01:23:29,920 WE HAVE A WEIRD SYSTEM HERE IN 2418 01:23:29,920 --> 01:23:32,480 THE U.S. WHERE SOME PEOPLE 2419 01:23:32,480 --> 01:23:34,120 CANNOT TAKE CASH COMPENSATION, 2420 01:23:34,120 --> 01:23:35,320 SO I'M CURIOUS WITH THOSE THAT 2421 01:23:35,320 --> 01:23:37,240 YOU INTERVIEWED THAT ACTUALLY 2422 01:23:37,240 --> 01:23:38,520 HAVE HIGH LEVEL DISABILITIES, 2423 01:23:38,520 --> 01:23:40,960 DID THAT TOPIC COME UP AND WERE 2424 01:23:40,960 --> 01:23:45,040 THERE ANY DISCUSSIONS AROUND IT? 2425 01:23:45,040 --> 01:23:46,840 >> CAN I TALK--HE'S THE 1 WHO 2426 01:23:46,840 --> 01:23:48,400 DID THE INTERVIEWS MAYBE, YOU 2427 01:23:48,400 --> 01:23:50,120 KNOWS OTHER THINGS BUT I THINK 2428 01:23:50,120 --> 01:23:50,880 PEOPLE DO RECOGNIZE, LIKE 2429 01:23:50,880 --> 01:23:52,280 SOMEBODY SAID IN THE CHAT, TOO, 2430 01:23:52,280 --> 01:23:56,440 YOU KNOW FOR SOME PEOPLE, ON 2431 01:23:56,440 --> 01:23:58,360 MEDICARE THAT YOU CAN'T TAKE 2432 01:23:58,360 --> 01:23:59,240 COMPENSATION AT LEAST ABOVE A 2433 01:23:59,240 --> 01:24:01,800 CERTAIN LEVEL OR YOU WILL LOSE 2434 01:24:01,800 --> 01:24:02,680 YOUR ELIGIBILITY FOR BENEFIT SO 2435 01:24:02,680 --> 01:24:03,920 WE HAVE TO BE CONSCIOUS OF THAT, 2436 01:24:03,920 --> 01:24:05,680 I THINK SOME OF THE PARTICIPANTS 2437 01:24:05,680 --> 01:24:07,440 AS YOU ALL WERE SAYING 2438 01:24:07,440 --> 01:24:08,880 YESTERDAY, TALK ABOUT 2439 01:24:08,880 --> 01:24:10,120 COMPENSATION NOT JUST FOR HOURS 2440 01:24:10,120 --> 01:24:11,240 WORKED ALTHOUGH PEOPLE SOMETIMES 2441 01:24:11,240 --> 01:24:13,480 DO TALK ABOUT IT LIKE IT'S A 2442 01:24:13,480 --> 01:24:17,600 JOB, BUT ALSO FOR COVERAGE OF 2443 01:24:17,600 --> 01:24:18,040 NEEDS, RIGHT? 2444 01:24:18,040 --> 01:24:20,400 SO 1 OF THE PEOPLE TALKS ABOUT 2445 01:24:20,400 --> 01:24:21,680 PAYING A PERSONAL ATTENDANT TO 2446 01:24:21,680 --> 01:24:23,400 HELP GET HIM THERE AND HE'S 2447 01:24:23,400 --> 01:24:28,440 PAYING HER SO MUCH MORE AND HE 2448 01:24:28,440 --> 01:24:29,840 GETS THIS TINY LITTLE PITTANCE 2449 01:24:29,840 --> 01:24:31,520 OF FUND THAGOREAN DIDN'T EVEN 2450 01:24:31,520 --> 01:24:32,640 COME CLOSE TO OFFSETTING THE 2451 01:24:32,640 --> 01:24:34,000 BURDEN ON HIM TO GET TO THE 2452 01:24:34,000 --> 01:24:35,680 STUDY SITE AND DO THE WORK. 2453 01:24:35,680 --> 01:24:37,480 SO I DON'T THINK IT ALL HAS TO 2454 01:24:37,480 --> 01:24:40,080 BE DIRECTLY TO HIM, BUT, YOU 2455 01:24:40,080 --> 01:24:42,640 KNOW THINKING MORE CREATIVELY 2456 01:24:42,640 --> 01:24:44,040 ABOUT WAYS TO MAKE IT MORE 2457 01:24:44,040 --> 01:24:47,800 FEASIBLE FOR PEOPLE WHO ARE 2458 01:24:47,800 --> 01:24:49,160 OTHERWISE RELATIVELY WEALTHY TO 2459 01:24:49,160 --> 01:24:52,560 DO THESE STUDIES SEEMS REALLY 2460 01:24:52,560 --> 01:24:53,400 IMPORTANT. 2461 01:24:53,400 --> 01:24:54,200 >> GREAT. 2462 01:24:54,200 --> 01:24:57,080 I SEE SHIRLEY Mc CARTNEY HAS A 2463 01:24:57,080 --> 01:24:57,520 QUESTION? 2464 01:24:57,520 --> 01:24:59,840 >> I DO, CAN YOU HEAR ME? 2465 01:24:59,840 --> 01:25:00,200 >> YES. 2466 01:25:00,200 --> 01:25:06,400 >> I HAVE A QUESTION AND I 2467 01:25:06,400 --> 01:25:06,760 COMMENT. 2468 01:25:06,760 --> 01:25:08,520 IF AS A STUDY PARTIC PLAN TO 2469 01:25:08,520 --> 01:25:16,520 ANALYZE BY AGE YOU RECEIVE MORE 2470 01:25:16,520 --> 01:25:18,680 THAN $600 YOU HAVE TO FILE IT 2471 01:25:18,680 --> 01:25:20,920 WITH YOUR TAXES AND IT'S 2472 01:25:20,920 --> 01:25:22,760 RIDICULOUS, IT'S A LIAISON DICK 2473 01:25:22,760 --> 01:25:24,760 LOWS AMOUNT OF MONEY, I 2474 01:25:24,760 --> 01:25:25,760 MENTIONED THIS YESTERDAY, 2475 01:25:25,760 --> 01:25:26,760 GEOGRAPHY IS A CHALLENGE AND 2476 01:25:26,760 --> 01:25:29,800 WHAT I FIND IS THAT WHEN I'M 2477 01:25:29,800 --> 01:25:31,520 NEGOTIATING BUJ FETS AND MORE 2478 01:25:31,520 --> 01:25:34,440 AND MORE I'M NOT EVEN 2479 01:25:34,440 --> 01:25:35,480 NEGOTIATING BUDGETS DIRECTLY 2480 01:25:35,480 --> 01:25:37,040 WITH THE SPONSOR, I'M 2481 01:25:37,040 --> 01:25:38,600 NEGOTIATING BUDGETS WITH THE 2482 01:25:38,600 --> 01:25:40,960 CLINICAL RESEARCH ORGANIZATION 2483 01:25:40,960 --> 01:25:44,200 WHO IS WORKING AS A KIND OF 2484 01:25:44,200 --> 01:25:46,240 MIDDLE PERSON BROKER AND I'M 2485 01:25:46,240 --> 01:25:48,440 SCOTTISH SO I'LL BE REALLY 2486 01:25:48,440 --> 01:25:54,960 FRANK, I JUST GET LOW BALLED ALL 2487 01:25:54,960 --> 01:25:55,240 THE TIME. 2488 01:25:55,240 --> 01:25:57,880 AND PUSH BACK AND COMPENSATION 2489 01:25:57,880 --> 01:25:58,160 FOR TRAVEL. 2490 01:25:58,160 --> 01:26:00,520 SO I'VE HAD STUDIES WHERE A 2491 01:26:00,520 --> 01:26:03,120 THIRD PARTY, A TRAVEL AGENT HAS 2492 01:26:03,120 --> 01:26:04,640 BEEN IN CHARGE OF THE TRAVEL 2493 01:26:04,640 --> 01:26:07,000 WHICH IS ACTUALLY MUCH EASIER ON 2494 01:26:07,000 --> 01:26:08,840 MY STUDY TEAM, OTHERWISE MY 2495 01:26:08,840 --> 01:26:13,240 STUDY TEAM IS TAKING A RESEECHTS 2496 01:26:13,240 --> 01:26:15,800 FOR HOTELS AND TRAVEL AND FOOD 2497 01:26:15,800 --> 01:26:19,320 AND REDACTING THEM AND THATY'S 2498 01:26:19,320 --> 01:26:22,320 AGAIN, I WANT TO GET RID OF ALL 2499 01:26:22,320 --> 01:26:23,920 THE ADMINISTRATION AS A RESEARCH 2500 01:26:23,920 --> 01:26:25,440 ADMINISTRATOR SO THEN THERE'S A 2501 01:26:25,440 --> 01:26:30,400 BURDEN ON MY STUDY TEAM TO DO 2502 01:26:30,400 --> 01:26:31,720 ADMINISTRATIVE WORK TO ASSURE 2503 01:26:31,720 --> 01:26:33,000 THAT SUBJECTS ARE COMPENSATED 2504 01:26:33,000 --> 01:26:35,720 AND WE WANT THEM TO BE 2505 01:26:35,720 --> 01:26:36,600 COMPENSATED BUT THE $600 LIMIT 2506 01:26:36,600 --> 01:26:38,960 IS JUST SOMETHING THAT NEEDS TO 2507 01:26:38,960 --> 01:26:44,240 BE CHANGED IN CONGRESS. 2508 01:26:44,240 --> 01:26:46,320 AND I HAD 1 OTHER THOUGHT BUT IT 2509 01:26:46,320 --> 01:26:49,760 NOW ESCAPED MY BRAIN--OH, 2510 01:26:49,760 --> 01:26:50,080 TRAVEL. 2511 01:26:50,080 --> 01:26:52,040 WE HAD TO PLEAD AND BEG RECENTLY 2512 01:26:52,040 --> 01:26:53,320 FOR A SUBJECT WHO'S COMING OUT 2513 01:26:53,320 --> 01:26:56,880 OF STATE FOR A BRAIN TUMOR STUDY 2514 01:26:56,880 --> 01:26:58,800 TO GET REIMBURSEMENT FOR THEIR 2515 01:26:58,800 --> 01:27:03,480 TRAVEL FEES AND UNBENOUNS TO US, 2516 01:27:03,480 --> 01:27:05,240 BECAUSE WE TOOK OVER THE STUDY, 2517 01:27:05,240 --> 01:27:06,760 THE PATIENT HAD BEEN PAYING FOR 2518 01:27:06,760 --> 01:27:08,720 THE TICKET THEMSELVES AND OF 2519 01:27:08,720 --> 01:27:10,960 COURSE AIRLINE COSTS WENT UP SO 2520 01:27:10,960 --> 01:27:13,400 THEN AGAIN, I'M 2521 01:27:13,400 --> 01:27:14,760 NEGOTIATING--IESM LIKE JUST 2522 01:27:14,760 --> 01:27:16,360 PLEASE JUST GIVE US SOILY HERE 2523 01:27:16,360 --> 01:27:22,560 TO GET THE PATIENT TO HER 2524 01:27:22,560 --> 01:27:22,880 CLINIC. 2525 01:27:22,880 --> 01:27:25,880 AND IT'S A LOT OF TYPING ROUND 2526 01:27:25,880 --> 01:27:30,440 IN ROUND IN CIRCLES BEGGING FOR 2527 01:27:30,440 --> 01:27:32,280 MONEY FOR THE PATIENT'S BEHALF 2528 01:27:32,280 --> 01:27:33,400 AND I FEEL LIKE IT'S NOT 2529 01:27:33,400 --> 01:27:35,240 SOMETHING WE SHOULD HAVE TO DO. 2530 01:27:35,240 --> 01:27:37,720 AND I WOULDN'T BLAME IT ALL THE 2531 01:27:37,720 --> 01:27:39,720 TIME WITH THE SPONSOR, A LOT OF 2532 01:27:39,720 --> 01:27:41,400 TIMES I'M NOT DEALING WITH THE 2533 01:27:41,400 --> 01:27:42,520 SPONSOR, I'M DEALING WITH 2534 01:27:42,520 --> 01:27:43,680 SOMEBODY ELSE IN THE MIDDLE 2535 01:27:43,680 --> 01:27:45,240 WHO'S TAKING A PERCENTAGE OF THE 2536 01:27:45,240 --> 01:27:46,760 MONEY OUT THERE, TOO, WE THANK 2537 01:27:46,760 --> 01:27:48,880 AND YOU IT'S JUST INTHG TO THINK 2538 01:27:48,880 --> 01:27:49,280 ABOUT. 2539 01:27:49,280 --> 01:27:50,240 >> IT'S FANTASTIC AND IT CALLS 2540 01:27:50,240 --> 01:27:51,400 OUR ATTENTION, I WOULD SAY IF 2541 01:27:51,400 --> 01:27:52,520 WE'RE IN A PANEL WHERE WE'RE 2542 01:27:52,520 --> 01:27:54,320 TALKING ABOUT WHAT SHOULD BE, WE 2543 01:27:54,320 --> 01:27:56,960 DO WANT TO RECOGNIZE WHAT THE 2544 01:27:56,960 --> 01:28:00,920 REQUIREMENTS AND RULES ARE FOR 2545 01:28:00,920 --> 01:28:03,480 ELIGIBILITY, NOW, BUT WE DON'T 2546 01:28:03,480 --> 01:28:04,960 HAVE TO ACCEPT THOSE RULES WE 2547 01:28:04,960 --> 01:28:07,200 COULD AS A GROUP PUSH FOR 2548 01:28:07,200 --> 01:28:08,960 CHANGES THERE AND I AGREE IN 2549 01:28:08,960 --> 01:28:11,000 THINK BEING HOW TO COMPENSATE 2550 01:28:11,000 --> 01:28:12,360 PEOPLE FOR TRAVEL AND CAREGIVER 2551 01:28:12,360 --> 01:28:15,120 COSTS AND OTHER THINGS JUST TO 2552 01:28:15,120 --> 01:28:17,360 MAKE IT ACTUALLY AN EQUAL 2553 01:28:17,360 --> 01:28:18,200 OPPORTUNITY ACCESS KIND OF 2554 01:28:18,200 --> 01:28:19,960 THING, WE SHOULD BE DOING THAT. 2555 01:28:19,960 --> 01:28:23,560 THIS IS THE PANEL THAT SHOULD. 2556 01:28:23,560 --> 01:28:23,840 >> YEAH. 2557 01:28:23,840 --> 01:28:26,040 >> SO 1 MORE QUESTION FROM 2558 01:28:26,040 --> 01:28:27,920 TRACEY AND THEN WE WILL MOVE ON 2559 01:28:27,920 --> 01:28:29,720 TO OUR OTHER SPEAKER. 2560 01:28:29,720 --> 01:28:31,120 >> YEAH, I HAD--I THINK I HAD 2561 01:28:31,120 --> 01:28:36,520 MORE OF A COMMENT BUT I'M 2562 01:28:36,520 --> 01:28:38,040 CURIOUS ABOUT SARA AND--THIS 2563 01:28:38,040 --> 01:28:39,600 FEELS LIKE, I LOVE THAT THE LAST 2564 01:28:39,600 --> 01:28:40,960 COMMENTER WAS SAYING WE NEED TO 2565 01:28:40,960 --> 01:28:42,840 GO TO CONGRESS BECAUSE NOW IF 2566 01:28:42,840 --> 01:28:43,840 THERE'S PATIENTS WE DON'T EVEN 2567 01:28:43,840 --> 01:28:45,000 KNOW THERE'S SOMETHING TO FIGHT 2568 01:28:45,000 --> 01:28:46,480 FOR, IT'S GREAT FOR HAVING THESE 2569 01:28:46,480 --> 01:28:47,400 GROUP DISCUSSIONS BUT IT FEELS 2570 01:28:47,400 --> 01:28:48,960 LIKE THIS IS A LARGER 2571 01:28:48,960 --> 01:28:49,880 CONVERSATION BECAUSE MOSTLY COME 2572 01:28:49,880 --> 01:28:51,880 INTO THIS, YOU KNOW THERE'S 2573 01:28:51,880 --> 01:28:53,560 THERE IDEA OF ALTRUISM BUT THE 2574 01:28:53,560 --> 01:28:56,120 REALITY IN OUR COMMUNITY IS IT'S 2575 01:28:56,120 --> 01:28:56,840 DESPERATION, IT'S DESPERATION 2576 01:28:56,840 --> 01:28:58,520 FOR SOME SORT OF IMPROVEMENT, WE 2577 01:28:58,520 --> 01:29:00,080 HAVE NO OTHER OPTIONS, THAT'S 2578 01:29:00,080 --> 01:29:01,720 THE TRIEEVER IN OUR COMMUNITY SO 2579 01:29:01,720 --> 01:29:02,640 WE DON'T NECESSARILY FEEL LIKE 2580 01:29:02,640 --> 01:29:06,480 WE NEED TO GET PAID BUT THERE IS 2581 01:29:06,480 --> 01:29:07,120 AN OVERARCHING PREVAILING 2582 01:29:07,120 --> 01:29:08,840 ATTITUDE THAT EVERYBODY'S MAKING 2583 01:29:08,840 --> 01:29:10,960 MONEY ON OUR DATA EXCEPT US 2584 01:29:10,960 --> 01:29:11,160 RIGHT? 2585 01:29:11,160 --> 01:29:15,160 SO IS THIS AN OPPORTUNITY FOR 2586 01:29:15,160 --> 01:29:16,160 EDUCATION AND TRANSPARENCY ABOUT 2587 01:29:16,160 --> 01:29:17,160 TRIAL COSTS AND RIGHT? 2588 01:29:17,160 --> 01:29:20,640 AND THINGS LIKE THAT AND DO YOU 2589 01:29:20,640 --> 01:29:22,640 BEING THAT WOULD HAVE SHIFTED, 2590 01:29:22,640 --> 01:29:24,000 WAS IT CLEAR TO THE PEOPLE I 2591 01:29:24,000 --> 01:29:26,200 WERE SPEAKING TO ABOUT THE 2592 01:29:26,200 --> 01:29:27,440 TRANSPARENCY OF TRIAL COSTS AND 2593 01:29:27,440 --> 01:29:28,800 WHERE THIS MONEY GOES AND DO YOU 2594 01:29:28,800 --> 01:29:29,760 THINK THAT WOULD HAVE SHIFTED 2595 01:29:29,760 --> 01:29:34,760 THEIR WAY OF THINKING? 2596 01:29:34,760 --> 01:29:36,800 >> ISHAN DO YOU WANT TO SAY IF 2597 01:29:36,800 --> 01:29:37,360 YOU THINK-- 2598 01:29:37,360 --> 01:29:37,640 >> SURE. 2599 01:29:37,640 --> 01:29:41,720 I MEAN THE PEOPLE WE SPOKE TO 2600 01:29:41,720 --> 01:29:42,880 PRETTY CONSISTENTLY SAID THAT 2601 01:29:42,880 --> 01:29:45,160 COMPENSATION ACTUALLY WAS NOT A 2602 01:29:45,160 --> 01:29:45,760 FACTOR AT ALL. 2603 01:29:45,760 --> 01:29:47,000 I THINK YOU'RE COMPLETELY RIGHT 2604 01:29:47,000 --> 01:29:48,840 THAT IT WAS OUT OF DESPERATION, 2605 01:29:48,840 --> 01:29:50,680 IT WAS OUT OF TRYING ANYTHING 2606 01:29:50,680 --> 01:29:52,000 THAT COULD WORK, IT WAS OUT OF 2607 01:29:52,000 --> 01:29:56,280 YOU KNOW THE DESIRE TO 2608 01:29:56,280 --> 01:29:57,000 PARTICIPATE IN SOMETHING. 2609 01:29:57,000 --> 01:29:58,360 BUT I THINK THAT BEING SAID, YOU 2610 01:29:58,360 --> 01:30:01,000 KNOW MOST OF OUR PARTICIPANTS 2611 01:30:01,000 --> 01:30:02,240 SAID, HEY, BUT I'M FRONTING A 2612 01:30:02,240 --> 01:30:04,680 LOT OF THESE COSTS OUT OF 2613 01:30:04,680 --> 01:30:05,240 POCKET. 2614 01:30:05,240 --> 01:30:06,800 I'M ACTUALLY AT BEST MAYBE 2615 01:30:06,800 --> 01:30:08,880 BREAKING EVEN BUT PROBABLY NOT. 2616 01:30:08,880 --> 01:30:10,800 YOU KNOW, ACTUALLY FUNDING A LOT 2617 01:30:10,800 --> 01:30:13,160 OF THIS ON MY OWN, AND WHILE 2618 01:30:13,160 --> 01:30:14,720 THAT'S NOT, YOU KNOW THAT 2619 01:30:14,720 --> 01:30:16,920 WOULDN'T HAVE PREVENTED ME FROM 2620 01:30:16,920 --> 01:30:17,720 PARTICIPATING, IT CERTAINLY 2621 01:30:17,720 --> 01:30:19,120 SOMETHING THAT THEY THINK ABOUT 2622 01:30:19,120 --> 01:30:20,360 AND THEY DEFINITELY THINK THAT 2623 01:30:20,360 --> 01:30:30,840 YOU KNOW THERE SHOULD BE MORE 2624 01:31:00,880 --> 01:31:01,200 DONE THERE. 2625 01:31:01,200 --> 01:31:02,360 >> THANK YOU FOR THE 2626 01:31:02,360 --> 01:31:04,120 INTRODUCTION, AM I SUCCESSFULLY 2627 01:31:04,120 --> 01:31:04,800 SHARING MY SCREEN? 2628 01:31:04,800 --> 01:31:15,040 >> YOU ARE. 2629 01:31:24,000 --> 01:31:24,240 >> GREAT. 2630 01:31:24,240 --> 01:31:30,480 --I AM GOING TO TALK ABOUT 2631 01:31:30,480 --> 01:31:32,520 LARGELY THE MINIMUM WHAT FDA 2632 01:31:32,520 --> 01:31:33,800 LOOKS AT OR POST TRIAL 2633 01:31:33,800 --> 01:31:38,480 PROTECTION OF PATIENTS AND THEN 2634 01:31:38,480 --> 01:31:40,080 TALK ABOUT SOME OF THE POTENTIAL 2635 01:31:40,080 --> 01:31:45,640 RISK WE SPOTTED WITH DEVICES, 2636 01:31:45,640 --> 01:31:46,800 IMPLANTED DEVICES AND THEN TALK 2637 01:31:46,800 --> 01:31:47,880 ABOUT POSSIBLE MEASURES TO 2638 01:31:47,880 --> 01:31:50,960 PROTECT THE TRIAL SUBJECTS AFTER 2639 01:31:50,960 --> 01:31:51,440 THIS STUDY ENDS. 2640 01:31:51,440 --> 01:31:52,840 I THINK I DO HAVE SOMETHING TO 2641 01:31:52,840 --> 01:31:57,520 ADD, I DON'T KNOW IF IT WILL BE 2642 01:31:57,520 --> 01:31:58,600 VALUABLE, BUT, THE FIRST PART OF 2643 01:31:58,600 --> 01:32:01,080 THIS IS WHAT FDA HAS TO SAY. 2644 01:32:01,080 --> 01:32:03,920 AND THE SECOND PART IS MY VIEW. 2645 01:32:03,920 --> 01:32:12,240 SO DON'T HOLD FDA RESPONSIBLE. 2646 01:32:12,240 --> 01:32:14,320 REGULATIONS, I CONSULTED OUR 2647 01:32:14,320 --> 01:32:16,280 REGULATORY OFFICE AT CDRH AND 2648 01:32:16,280 --> 01:32:20,840 PEOPLE WHO FEEL IN PARTICULAR 2649 01:32:20,840 --> 01:32:22,280 WITH THE IDEs, THAT RESULT 2650 01:32:22,280 --> 01:32:26,680 THAT ARE THE BASIS FOR THE FDA 2651 01:32:26,680 --> 01:32:27,440 APPROVAL OF TRIALS. 2652 01:32:27,440 --> 01:32:29,920 AND THE FDA REGULATIONS DO NOT 2653 01:32:29,920 --> 01:32:32,120 SPECIFICALLY ADDRESS THE CONCERN 2654 01:32:32,120 --> 01:32:33,320 FOR DOWN STREAM ADVERSE EVENT 2655 01:32:33,320 --> 01:32:35,280 WHEN IS DEVICES ARE LEFT IN 2656 01:32:35,280 --> 01:32:38,080 PLACE AFTER A TRIAL ENDS. 2657 01:32:38,080 --> 01:32:39,200 THEY DID MENTION, THOUGH THAT 2658 01:32:39,200 --> 01:32:42,960 THERE IS AN FDA GUIDANCE ON 2659 01:32:42,960 --> 01:32:44,040 INVESTIGATE RESPONSIBILITY WHICH 2660 01:32:44,040 --> 01:32:46,160 STATES THAT SUBJECTS SHOULD 2661 01:32:46,160 --> 01:32:48,640 RECEIVE APPROPRIATE MEDICAL 2662 01:32:48,640 --> 01:32:50,880 EVALUATION AND TREATMENT UNTIL 2663 01:32:50,880 --> 01:32:52,240 RESOLUTION OF ANY EMERGENT 2664 01:32:52,240 --> 01:32:54,120 CONDITION RELATED TO THE STUDY 2665 01:32:54,120 --> 01:32:55,640 INTERVENTION THAT DEVELOPS 2666 01:32:55,640 --> 01:32:57,440 DURING OR AFTER THE COURSE OF 2667 01:32:57,440 --> 01:32:59,280 THEIR PARTICIPATION IN THE 2668 01:32:59,280 --> 01:33:01,840 STUDY, EVEN IF THE FOLLOW UP 2669 01:33:01,840 --> 01:33:03,440 PERIOD EXTENDS BEYOND THE END OF 2670 01:33:03,440 --> 01:33:07,240 THIS STUDY AT THE INVESTIGATIVE 2671 01:33:07,240 --> 01:33:07,440 SITE. 2672 01:33:07,440 --> 01:33:17,960 SO, YOU KNOW THERE'S A LITTLE 2673 01:33:17,960 --> 01:33:18,920 HINT IN THERE FOR RESPONSIBILITY 2674 01:33:18,920 --> 01:33:20,680 BUT IT'S NOT HARD FOR US TO 2675 01:33:20,680 --> 01:33:22,640 CARRY THAT THROUGH AND IMPLEMENT 2676 01:33:22,640 --> 01:33:22,960 IT. 2677 01:33:22,960 --> 01:33:24,200 IT PLACES THE RESPONSIBILITY 2678 01:33:24,200 --> 01:33:28,080 MORE ON THE INVESTIGATOR THAN IT 2679 01:33:28,080 --> 01:33:29,280 DOES ON US. 2680 01:33:29,280 --> 01:33:30,600 THERE IS 1 INTERESTING PROCESS 2681 01:33:30,600 --> 01:33:34,280 THAT GOES ON, IT'S CALLED 2682 01:33:34,280 --> 01:33:36,400 MEDICAL DEVICE TRACKING. 2683 01:33:36,400 --> 01:33:39,560 AND IT DESCRIBES PATIENT DEVICE 2684 01:33:39,560 --> 01:33:40,760 TRACKING FOR CLEARED OR APPROVED 2685 01:33:40,760 --> 01:33:44,040 DEVICES AND THESE ARE DEVICES 2686 01:33:44,040 --> 01:33:45,520 THAT ARE PRETTY MUCH THE 1S 2687 01:33:45,520 --> 01:33:47,120 WE'RE TALKING ABOUT WHEN YOU 2688 01:33:47,120 --> 01:33:48,160 TALK ABOUT NEUROLOGY OR 2689 01:33:48,160 --> 01:33:50,240 PSYCHIATRY AND THEY ARE THE 1S 2690 01:33:50,240 --> 01:33:52,400 THAT WHEN THEY--AFTER THEY ARE 2691 01:33:52,400 --> 01:33:53,320 APPROVED FROM MARKETING, THERE 2692 01:33:53,320 --> 01:33:57,440 MAY BE SOME LONG-TERM ADVERSE 2693 01:33:57,440 --> 01:34:01,880 EVENTS THAT NEED TO BE TRACKED 2694 01:34:01,880 --> 01:34:03,360 AND FDA HAS A GUIDANCE ABOUT 2695 01:34:03,360 --> 01:34:07,920 WHEN THEY CAN DO THAT AND I 2696 01:34:07,920 --> 01:34:10,520 DON'T KNOW ANY EVIDENCE, I 2697 01:34:10,520 --> 01:34:13,080 HAVEN'T EXPERIENCED THAT IN MY 2698 01:34:13,080 --> 01:34:17,240 YEARS HERE AT CDRH, SO I DON'T 2699 01:34:17,240 --> 01:34:18,960 KNOW MUCH DETAILS ABOUT THAT BUT 2700 01:34:18,960 --> 01:34:23,600 I WILL TRY TO CIRCULATE THESE 2701 01:34:23,600 --> 01:34:25,160 LINKS, THERE'S IDEAS IN MEDICAL 2702 01:34:25,160 --> 01:34:29,360 DEVICE TRACK THAGOREAN MIGHT BE 2703 01:34:29,360 --> 01:34:33,440 EXTENDED BACKWARD OR FORWARD TO 2704 01:34:33,440 --> 01:34:34,920 IDE STT STUDIES, MY FIRST JOB 2705 01:34:34,920 --> 01:34:36,920 WAS IN THE ARROW SPACE INDUSTRY, 2706 01:34:36,920 --> 01:34:41,560 THESE ARE WHAT ARE CALLED SPACE 2707 01:34:41,560 --> 01:34:44,920 DEBRIS, LOTS OF DEVICES UP THERE 2708 01:34:44,920 --> 01:34:46,760 CIRCLING THE EITHER, NO LONGER 2709 01:34:46,760 --> 01:34:48,320 FUNCTIONING OR RUNNING INTO EACH 2710 01:34:48,320 --> 01:34:58,760 OTHER AND CAUSING A LOT OF 2711 01:34:59,520 --> 01:34:59,800 PROBLEMS. 2712 01:34:59,800 --> 01:35:03,480 I WAS GOING TO POINT OUT WHEN WE 2713 01:35:03,480 --> 01:35:05,200 DO THESE IDEs, EXEMPT FORMS 2714 01:35:05,200 --> 01:35:06,840 AND OTHER DOCUMENTS, THERE'S 2715 01:35:06,840 --> 01:35:12,680 THINGS WE CONSIDER, FIRST OF ALL 2716 01:35:12,680 --> 01:35:14,720 SAFE TO EXPORT A DEVICE, IT'S 2717 01:35:14,720 --> 01:35:16,240 NOT A GO OR NO GO BUT IT'S 2718 01:35:16,240 --> 01:35:19,040 SOMETHING TO THINK ABOUT AS WE 2719 01:35:19,040 --> 01:35:20,560 REVIEW IT. 2720 01:35:20,560 --> 01:35:23,360 ARE THERE PLANS FOR DEVICE 2721 01:35:23,360 --> 01:35:24,640 MAINTENANCE OR REMOVAL AND DOES 2722 01:35:24,640 --> 01:35:26,760 THE CONSENT FORM DESCRIBE ALL 2723 01:35:26,760 --> 01:35:30,880 THE POTENTIAL RISKS AND I THINK 2724 01:35:30,880 --> 01:35:36,440 THIS IS WHERE WE--THERE ARE A 2725 01:35:36,440 --> 01:35:45,080 LOT OF PROBLEMS YOU ALL 2726 01:35:45,080 --> 01:35:47,320 IDENTIFIED WELL AND WE THERE 2727 01:35:47,320 --> 01:35:47,960 ISN'T A SOLUTION AVAILABLE FOR 2728 01:35:47,960 --> 01:35:49,120 MANY OF THESE PROBLEMS SO WHERE 2729 01:35:49,120 --> 01:35:50,560 WE LEAVE IT IS WE WANT TO BE 2730 01:35:50,560 --> 01:35:54,160 SURE THE PATIENT KNOWS ABOUT THE 2731 01:35:54,160 --> 01:35:56,760 LONG-TERM CONSEQUENCES OF THESE 2732 01:35:56,760 --> 01:35:58,160 RISKS, THE POTENTIAL SAFETY 2733 01:35:58,160 --> 01:36:00,760 IMPLICATIONS FOR THEIR LIVES AND 2734 01:36:00,760 --> 01:36:03,000 ALSO THE POTENTIAL COST. 2735 01:36:03,000 --> 01:36:05,360 AND THEN THE OTHER THING WE 2736 01:36:05,360 --> 01:36:07,640 WOULD GET, IS THE POSSIBILITY 2737 01:36:07,640 --> 01:36:14,320 RISK BALANCE BY THE POSSIBLE 2738 01:36:14,320 --> 01:36:16,120 BENEFIT, AND REVIEW INTERIM AND 2739 01:36:16,120 --> 01:36:24,480 FINAL REPORTS TO IDENTIFY 2740 01:36:24,480 --> 01:36:25,200 PROBLEMS. 2741 01:36:25,200 --> 01:36:27,800 WE HAVE A HARD TIME GETTING 2742 01:36:27,800 --> 01:36:29,120 REPORTS ON STUDIES THAT ARE NOT 2743 01:36:29,120 --> 01:36:30,960 COMPLETED BUT IT DOES GIVE US A 2744 01:36:30,960 --> 01:36:32,360 PICTURE OF SOME OF THE SAFETY 2745 01:36:32,360 --> 01:36:32,760 COMPLICATIONS. 2746 01:36:32,760 --> 01:36:38,800 I WAS GOING TO GO ON NOW TO MY 2747 01:36:38,800 --> 01:36:40,480 VIEWS, LEAVES BEHIND FDA, IN 2748 01:36:40,480 --> 01:36:44,040 PARTICULAR, BUT I JUST, YOU 2749 01:36:44,040 --> 01:36:45,520 KNOW, SIBS I HEARD ABOUT THIS 2750 01:36:45,520 --> 01:36:47,440 CONFERENCE, I'VE BEEN KEEPING MY 2751 01:36:47,440 --> 01:36:49,960 EARS OPEN TO THE KIND OF THINGS 2752 01:36:49,960 --> 01:36:54,160 WE'VE ENCOUNTERED AS THESE 2753 01:36:54,160 --> 01:36:56,000 DEVICES ARE APPROVED OR THINGS 2754 01:36:56,000 --> 01:36:57,920 WE HAVE MENTIONED AS 2755 01:36:57,920 --> 01:36:59,480 ANTICIPATING WHEN WE APPROVE A 2756 01:36:59,480 --> 01:37:03,920 STUDY TO BEGIN FOR DEVICE THAT 2757 01:37:03,920 --> 01:37:04,400 ISN'T YET MARKETED. 2758 01:37:04,400 --> 01:37:09,000 AND THERE ARE DEVICES THAT THE 2759 01:37:09,000 --> 01:37:10,480 ENGINEERS LOOK AT, THE 2760 01:37:10,480 --> 01:37:13,320 DEGRADATION OVER THE YEARS, 2761 01:37:13,320 --> 01:37:14,480 BATTERY FAILURE, 1 THAT I 2762 01:37:14,480 --> 01:37:16,560 HAVEN'T HEARD MENTIONED HERE IS 2763 01:37:16,560 --> 01:37:18,640 THAT THAT YOU HAVE A DEVICE 2764 01:37:18,640 --> 01:37:21,960 IMPLANTED IN THE BRAIN, 2765 01:37:21,960 --> 01:37:28,800 SOMETIMES MRI SCANS ARE EITHER 2766 01:37:28,800 --> 01:37:38,320 COMPLETELY IMPOSSIBLE AND IT'S 2767 01:37:38,320 --> 01:37:39,880 TURNED OFF AND MRI SCANS OF 2768 01:37:39,880 --> 01:37:41,000 BRAIN ARE LIMITED OR IMPONL 2769 01:37:41,000 --> 01:37:43,840 EARLY IN LIFE AND THEN HAVE A 2770 01:37:43,840 --> 01:37:45,360 DISEASE THAT INVOLVE FREQUENT 2771 01:37:45,360 --> 01:37:47,640 MRI SCANS IT CAN HAVE A 2772 01:37:47,640 --> 01:37:51,360 SIGNIFICANT EFFECT ON YOUR 2773 01:37:51,360 --> 01:37:51,840 HEGHT. 2774 01:37:51,840 --> 01:37:54,160 THERE ARE MANY INCREASINGLY, 2775 01:37:54,160 --> 01:37:59,840 THERE ARE DEVICES THAT CAN BE 2776 01:37:59,840 --> 01:38:00,200 SAFELY REMOVED. 2777 01:38:00,200 --> 01:38:01,840 YOUR STORIES THAT PATIENT HAVE A 2778 01:38:01,840 --> 01:38:03,880 DEVICE AND THEY DON'T--THEY 2779 01:38:03,880 --> 01:38:05,880 DON'T REMEMBER WHAT IT WAS, THEY 2780 01:38:05,880 --> 01:38:07,760 DON'T--THEY DON'T HAVE ANY 2781 01:38:07,760 --> 01:38:12,560 ACCESS TO THE DEVICE LABELING 2782 01:38:12,560 --> 01:38:17,160 AND YOU KNOW, I'VE HEARD OF 2783 01:38:17,160 --> 01:38:18,960 PATIENTS ACTUALLY SOME 2784 01:38:18,960 --> 01:38:21,640 COLLEAGUES WHO FORGOT TO MENTION 2785 01:38:21,640 --> 01:38:25,640 THEY HAD A DEVICE IMPLANTED AND 2786 01:38:25,640 --> 01:38:27,080 THEY HAVEN'T HEARD THAT 2787 01:38:27,080 --> 01:38:28,600 HAPPENING WITH BRAIN DEVICES, 2788 01:38:28,600 --> 01:38:32,680 BRAIN AND SPINAL CORD DEVICES 2789 01:38:32,680 --> 01:38:33,800 BUT IF YOU LIVE WITH THESE 2790 01:38:33,800 --> 01:38:36,080 THINGS FOR A YEAR, THEY'RE NOT 2791 01:38:36,080 --> 01:38:46,560 ALWAYS THAT APPARENT TO YOU. 2792 01:38:57,520 --> 01:38:59,080 --YOU KNOW YOU--THERE'S THE LOSS 2793 01:38:59,080 --> 01:39:00,880 OF CARE, WE HAVE BEEN VERY 2794 01:39:00,880 --> 01:39:02,680 CONSISTENT ABOUT MENTIONING 2795 01:39:02,680 --> 01:39:10,440 THAT, FROM WHAT I'VE HEARD. 2796 01:39:10,440 --> 01:39:12,160 BUT THERE'S ALSO A RECK 2797 01:39:12,160 --> 01:39:14,080 COLLECTION OF THE DESIGN OF 2798 01:39:14,080 --> 01:39:15,920 DETAIL AND DEVICE, SO 10 OR 15 2799 01:39:15,920 --> 01:39:17,520 YEARS LATER WHEN THE COMPANY'S 2800 01:39:17,520 --> 01:39:19,480 OUT OF BUSINESS AND THERE ARE 2801 01:39:19,480 --> 01:39:20,400 PROBLEMS THE CLINICIANS DON'T 2802 01:39:20,400 --> 01:39:22,080 KNOW WHAT THEY'RE DEALING WITH, 2803 01:39:22,080 --> 01:39:23,800 THEY MAY NOT BE ABLE TO FIND THE 2804 01:39:23,800 --> 01:39:29,240 NAME OF THE DEVICE OR WHO 2805 01:39:29,240 --> 01:39:29,640 MANUFACTURED IT. 2806 01:39:29,640 --> 01:39:33,200 DEVICES, THERE ARE DEVICES THAT 2807 01:39:33,200 --> 01:39:37,120 YOU GET IDENTIFIED BY IMAGING OR 2808 01:39:37,120 --> 01:39:40,080 SCANNING. 2809 01:39:40,080 --> 01:39:42,840 THERE'S DEVICES THAT YOU KNOW OF 2810 01:39:42,840 --> 01:39:44,760 YOUR--THERE'S THE RISK THAT YOU 2811 01:39:44,760 --> 01:39:47,600 WILL GET THE BETA VERSION AND 2812 01:39:47,600 --> 01:39:52,120 THEN, WHAT GETS APPROVED IS THE 2813 01:39:52,120 --> 01:39:53,000 BETTER VERSION THE PATIENT 2814 01:39:53,000 --> 01:39:54,240 PROBABLY NEEDS TO KNOW THAT 2815 01:39:54,240 --> 01:39:55,360 THEIR TESTING OF DATA VERSION 2816 01:39:55,360 --> 01:39:56,760 AND THEY'RE LIKELY TO BE 2817 01:39:56,760 --> 01:39:58,560 IMPROVEMENTS THAT THEY WON'T BE 2818 01:39:58,560 --> 01:40:01,680 ABLE TO GET IF THE CURRENT 2819 01:40:01,680 --> 01:40:04,760 DEVICE CAN'T BE EXPLANTED OR 2820 01:40:04,760 --> 01:40:08,480 CAN'T--CAN'T WORK IN ADDITION TO 2821 01:40:08,480 --> 01:40:10,160 ANOTHER IMPLANTATION OF THE SAME 2822 01:40:10,160 --> 01:40:11,120 DEVICE. 2823 01:40:11,120 --> 01:40:15,760 AND THEN THERE'S--YOU KNOW 2824 01:40:15,760 --> 01:40:16,600 THERE'S SIMPLELE THINGS, 2825 01:40:16,600 --> 01:40:18,360 EVOLUTION OF OPERATING SYSTEMS 2826 01:40:18,360 --> 01:40:21,000 AND AS WE HEARD YESTERDAY, I 2827 01:40:21,000 --> 01:40:25,520 MEAN, CD ROMS ARE NOT GOING TO 2828 01:40:25,520 --> 01:40:29,200 WORK LOOKING DEFINITELY INTO THE 2829 01:40:29,200 --> 01:40:29,480 FUTURE. 2830 01:40:29,480 --> 01:40:30,680 POSSIBLE, I WAS GOING TO GO 2831 01:40:30,680 --> 01:40:31,920 AHEAD AND TALK ABOUT THOUGHTS 2832 01:40:31,920 --> 01:40:34,480 THAT CROSSED MY MIND, POSSIBLE 2833 01:40:34,480 --> 01:40:35,800 MEASURES TO PROTECT TRIAL 2834 01:40:35,800 --> 01:40:39,760 MEASUREMENTS AFTER THE STUDY 2835 01:40:39,760 --> 01:40:39,960 ENDS. 2836 01:40:39,960 --> 01:40:41,160 AND I HEARD THIS YESTERDAY, AND 2837 01:40:41,160 --> 01:40:43,080 I CAN'T TELL YOU HOW MUCH, I 2838 01:40:43,080 --> 01:40:50,920 THINK IT'S IMPORTANT TO GIVE 2839 01:40:50,920 --> 01:40:52,320 PATIENTS A VOICE INDEPENDENT 2840 01:40:52,320 --> 01:40:53,440 FDA, MANUFACTURES AND 2841 01:40:53,440 --> 01:40:59,440 INVESTIGATIONS FOR THEIR 2842 01:40:59,440 --> 01:41:05,240 DEVICES, YOU KNOW, IT'S HARD, 2843 01:41:05,240 --> 01:41:06,120 WHEN YOU'RE REVIEWING YOU OFTEN 2844 01:41:06,120 --> 01:41:08,160 GO TO SEE WHAT ADVERSE EVENTS 2845 01:41:08,160 --> 01:41:09,440 THESE PATIENTS ARE REPORTING 2846 01:41:09,440 --> 01:41:10,640 THEMSELVES AND THEIR BLOGS AND 2847 01:41:10,640 --> 01:41:13,160 IT'S REALLY HARD TO FIND THOSE, 2848 01:41:13,160 --> 01:41:16,280 THEY AREN'T READILY INDEXED BY 2849 01:41:16,280 --> 01:41:19,560 GOOGLE AND I THINK THAT, YOU 2850 01:41:19,560 --> 01:41:23,520 KNOW THAT NEEDS TO BE DONE 2851 01:41:23,520 --> 01:41:23,880 SOMEHOW. 2852 01:41:23,880 --> 01:41:25,120 CERTAINLY--I DON'T THINK IT'S A 2853 01:41:25,120 --> 01:41:27,160 ROLE OF FDA IN FACT, PROBABLY 2854 01:41:27,160 --> 01:41:28,600 FDA SHOULD BE INDEPENDENT OF IT, 2855 01:41:28,600 --> 01:41:30,280 INDEPENDENT OF THE MANUFACTURE 2856 01:41:30,280 --> 01:41:32,560 AND INVESTIGATORS, SO THAT--IT 2857 01:41:32,560 --> 01:41:36,600 COULD BE A FREE EXCHANGE. 2858 01:41:36,600 --> 01:41:38,200 BUT, PERSONALLY I'VE BEEN DOING 2859 01:41:38,200 --> 01:41:43,760 CLINICAL TRIALS FOR ALMOST MY 2860 01:41:43,760 --> 01:41:44,960 WHOLE PROFESSIONAL LIFE AND I 2861 01:41:44,960 --> 01:41:50,120 HAVE JUST WATCHED THEM GET MORE 2862 01:41:50,120 --> 01:41:51,520 AND MORE COMPLICATED MORE AND 2863 01:41:51,520 --> 01:41:53,080 MORE EXPENSIVE AND THE DISTANCE 2864 01:41:53,080 --> 01:41:57,160 BETWEEN INVESTIGATORS AND 2865 01:41:57,160 --> 01:41:58,800 PATIENTS NOT NECESSARILY AND THE 2866 01:41:58,800 --> 01:42:03,040 SPONSORS GETTING MORE AND MORE 2867 01:42:03,040 --> 01:42:03,960 JUST COMPLICATED AND DIFFICULT I 2868 01:42:03,960 --> 01:42:09,560 THINK THERE NEEDS TO BE A 2869 01:42:09,560 --> 01:42:10,880 RESETTING WHERE WHERE WE CHANGE 2870 01:42:10,880 --> 01:42:12,320 THE WHOLE ORGANIZATION AND START 2871 01:42:12,320 --> 01:42:13,000 INVOLVING PATIENTS IN THE 2872 01:42:13,000 --> 01:42:13,720 BEGINNING. 2873 01:42:13,720 --> 01:42:15,480 IF THE PATIENTS DON'T UNDERSTAND 2874 01:42:15,480 --> 01:42:16,840 THE DESIGN OF THE STUDY AND HOW 2875 01:42:16,840 --> 01:42:19,920 IMPORTANT IT IS TO DO THINGS 2876 01:42:19,920 --> 01:42:21,560 THAT MAY NOT SEEM RELEVANT TO 2877 01:42:21,560 --> 01:42:22,880 THEIR HEALTH IN ORDER TO GET THE 2878 01:42:22,880 --> 01:42:24,720 ANSWER, THE STUDY TO BE 2879 01:42:24,720 --> 01:42:26,120 SUCCESSFUL, AND ANSWER THE 2880 01:42:26,120 --> 01:42:27,120 QUESTION, IT'S JUST NOT GOING TO 2881 01:42:27,120 --> 01:42:28,720 HAPPEN AND WE'RE GOING TO END UP 2882 01:42:28,720 --> 01:42:31,240 WITH POOR QUALITY RESULTS THAT 2883 01:42:31,240 --> 01:42:32,880 ARE HARD TO INTERPRET. 2884 01:42:32,880 --> 01:42:35,160 THERE'S NOTHING MORE BURDENSOME 2885 01:42:35,160 --> 01:42:37,120 TO A SPONSOR THAN TO FINISH A 2886 01:42:37,120 --> 01:42:38,960 STUDY AND FIND OUT THAT THERE 2887 01:42:38,960 --> 01:42:41,600 ARE SOME MANY DROP OUTS AND SUCH 2888 01:42:41,600 --> 01:42:43,560 POOR DATA QUALITY, THAT FDA 2889 01:42:43,560 --> 01:42:44,720 CAN'T DESIGN WHETHER THEIR 2890 01:42:44,720 --> 01:42:49,760 DEVICE IS EFFECTIVE OR NOT. 2891 01:42:49,760 --> 01:42:52,200 I AM GOING TO BEGIN TALKING MORE 2892 01:42:52,200 --> 01:42:53,280 WITH MY ENGINEERING COLLEAGUES, 2893 01:42:53,280 --> 01:42:55,000 IT SEEMS TO ME AT THE BEGINNING 2894 01:42:55,000 --> 01:42:56,800 WE COULD BE DESIGNING DEVICES 2895 01:42:56,800 --> 01:43:03,560 FOR SAFE AND EASY REMOVAL I 2896 01:43:03,560 --> 01:43:04,840 REALIZE THAT WON'T ALWAYS BE 2897 01:43:04,840 --> 01:43:12,080 POSSIBLE BUT CERTAINLY WE SHOULD 2898 01:43:12,080 --> 01:43:13,920 THINK ABOUT IT WHERE THEY HAVE 2899 01:43:13,920 --> 01:43:15,400 AN IMPLANTED DEVICE AND THEY 2900 01:43:15,400 --> 01:43:16,800 HAVE LEADS, THEY HAVE ELECTRODES 2901 01:43:16,800 --> 01:43:19,400 AND THEY HAVE WIRES, LEADS, AND 2902 01:43:19,400 --> 01:43:21,440 THEN THE DEVICE THAT'S 2903 01:43:21,440 --> 01:43:24,680 IMPLANTED, AND THEY'RE 2904 01:43:24,680 --> 01:43:24,960 CONNECTED. 2905 01:43:24,960 --> 01:43:26,840 AND THEY DON'T HAVE THE 2906 01:43:26,840 --> 01:43:28,640 EQUIVALENT OF USB CONNECTORS OR 2907 01:43:28,640 --> 01:43:31,240 OR SO ON, EACH DEVICE HAS A 2908 01:43:31,240 --> 01:43:32,800 DIFFERENT CONNECTOR AND YOU KNOW 2909 01:43:32,800 --> 01:43:34,240 DIFFERENT CONNECTORS TO THE 2910 01:43:34,240 --> 01:43:37,080 BATTERY AND SO, I DON'T REALLY 2911 01:43:37,080 --> 01:43:39,080 KNOW THAT EFFORTS HAVEN'T BEEN 2912 01:43:39,080 --> 01:43:45,160 MADE TO STUDY, TO START MAKING 2913 01:43:45,160 --> 01:43:46,160 INDUSTRY STAND--INTERCHANGEABLE 2914 01:43:46,160 --> 01:43:47,600 PARTS ESPECIALENTIALLY BATTERIES 2915 01:43:47,600 --> 01:43:49,280 AND CONNECTIONS, YOU KNOW. 2916 01:43:49,280 --> 01:43:52,760 WOULDN'T BE NICE IF IPHONES HAD 2917 01:43:52,760 --> 01:43:53,840 BATTERIES THAT YOU COULD 2918 01:43:53,840 --> 01:43:59,160 REPLACE, I DON'T KNOW. 2919 01:43:59,160 --> 01:44:01,440 HAVE SOURCES OF EXTERNAL 2920 01:44:01,440 --> 01:44:03,240 COMPONENTS, FOR THOSE THAT ARE 2921 01:44:03,240 --> 01:44:06,960 LOST OR DAMAGED OR AVAILABLE, 2922 01:44:06,960 --> 01:44:10,920 AND AFTER THE DEVICE IS NOT 2923 01:44:10,920 --> 01:44:13,480 MARKETED AND NO LONGER 2924 01:44:13,480 --> 01:44:14,240 MANUFACTURED AND SOMEHOW, YOU 2925 01:44:14,240 --> 01:44:15,760 KNOW WHEN YOU'RE PLANNING THE 2926 01:44:15,760 --> 01:44:18,080 BETA VERSION OF A DEVICE, BE 2927 01:44:18,080 --> 01:44:21,360 THINKING ABOUT WELL, HOW ARE YOU 2928 01:44:21,360 --> 01:44:22,320 GOING TO IMPLEMENT IMPROVEMENTS, 2929 01:44:22,320 --> 01:44:24,640 WHAT, YOU KNOW WHAT CONNECTIONS, 2930 01:44:24,640 --> 01:44:27,040 WHAT WAYS DO YOU HAVE OF 2931 01:44:27,040 --> 01:44:36,480 UPGRADING THE SOFTWARE DEVICE. 2932 01:44:36,480 --> 01:44:37,640 HAVE A DEVICE IEE, AUDIENCE 2933 01:44:37,640 --> 01:44:41,720 DENTIFICATION NUMBER ON THE 2934 01:44:41,720 --> 01:44:42,080 DEVICE. 2935 01:44:42,080 --> 01:44:44,840 BE SURE TO HAVE AN IMMORTAL 2936 01:44:44,840 --> 01:44:45,840 WEBSITE FOR DEVICES AND 2937 01:44:45,840 --> 01:44:50,360 REPLACEMENTS CAN BE PRODUCED, 2938 01:44:50,360 --> 01:44:52,600 PROVIDE FOR EASY RECOGNITION AND 2939 01:44:52,600 --> 01:44:55,720 THE DEVICE SOFTWARE VERSION 2940 01:44:55,720 --> 01:44:56,440 MANUFACTURING, MANUFACTURER 2941 01:44:56,440 --> 01:44:58,440 STOPS THE WORK, PROVIDES 2942 01:44:58,440 --> 01:45:00,840 RESOURCES FOR PRECISION, FOR 2943 01:45:00,840 --> 01:45:04,440 PATIENTS FOR CARE AFTERSTUDY AND 2944 01:45:04,440 --> 01:45:05,920 CONTACT WITH INVESTIGATORS THAT 2945 01:45:05,920 --> 01:45:07,760 ARE LOSS AND FEW I'M MENTIONING, 2946 01:45:07,760 --> 01:45:13,520 AND THE LAST 1 ARE BASICALLY YOU 2947 01:45:13,520 --> 01:45:17,120 KNOW INTERNET, WEB-BASED 2948 01:45:17,120 --> 01:45:19,080 RESOURCES. 2949 01:45:19,080 --> 01:45:21,600 MAIP TIANYL A RESOURCE EVENT 2950 01:45:21,600 --> 01:45:23,760 THAT IDENTIFIES IT AS A PLANET 2951 01:45:23,760 --> 01:45:26,080 FOR EACH PATIENT AND PROVIDE IT 2952 01:45:26,080 --> 01:45:27,360 CONNECTS TO THE LABELING AND IF 2953 01:45:27,360 --> 01:45:37,360 YOU HAVE A PILL, YOU CAN TAKE A 2954 01:45:37,360 --> 01:45:47,720 PICTURE OF IT AND I'M 2955 01:45:49,200 --> 01:45:50,240 ENCOURAGING THE GROUP TO STOP 2956 01:45:50,240 --> 01:45:53,720 THINK BEING INDIVIDUAL SOLUTIONS 2957 01:45:53,720 --> 01:45:59,840 TO THIS PROBLEM, BECAUSE IT'S 2958 01:45:59,840 --> 01:46:04,880 VERY AND I THINK THERE ARE THESE 2959 01:46:04,880 --> 01:46:06,600 IN THE DRUG WORLD THAT COMPANIES 2960 01:46:06,600 --> 01:46:13,080 OF ALL SIZES HAVE COME TOGETHER 2961 01:46:13,080 --> 01:46:14,800 AND FORMED WAYS TO ACCOMPLISH 2962 01:46:14,800 --> 01:46:21,320 THE SOLUTION OF THESE PROBLEMS 2963 01:46:21,320 --> 01:46:22,160 WHICH, YOU KNOW IT'S A PROBLEM 2964 01:46:22,160 --> 01:46:26,160 TO THEM AS WELL, BUT AN 2965 01:46:26,160 --> 01:46:28,320 INDEPENDENT NATIONAL GROUP AND 2966 01:46:28,320 --> 01:46:30,640 ACKNOWLEDGE THE INDIVIDUAL 2967 01:46:30,640 --> 01:46:31,840 MANUFACTURE INSTITUTION 2968 01:46:31,840 --> 01:46:38,440 INVESTMENT CAN'T SOLVE THESE 2969 01:46:38,440 --> 01:46:38,720 PROBLEMS. 2970 01:46:38,720 --> 01:46:40,200 THE OTHER 1 TO BE CONCERNED 2971 01:46:40,200 --> 01:46:42,200 ABOUT IS THERE'S A BIT OF 2972 01:46:42,200 --> 01:46:52,400 SALESMANSHIP GOING ON HERE AND 2973 01:46:52,400 --> 01:46:53,600 PEOPLE PEOPLE WHAT UPSETS THEM 2974 01:46:53,600 --> 01:46:56,720 THE MOST IS A SURPRISE, FINDING 2975 01:46:56,720 --> 01:46:58,640 OUT, SOMETHING HAPPENED THAT 2976 01:46:58,640 --> 01:47:00,680 THEY WEREN'T TOLD ABOUT OR WERE 2977 01:47:00,680 --> 01:47:02,440 NOT ADEQUATELY INFORMED ABOUT 2978 01:47:02,440 --> 01:47:12,800 HOW SERIOUS IT IS AND 2979 01:47:32,640 --> 01:47:33,520 SO--ADEQUATE BEFORE THAT AND I 2980 01:47:33,520 --> 01:47:37,200 WOULD LIKE TO THINK FROM THE FDA 2981 01:47:37,200 --> 01:47:40,760 POINT OF VIEW THAT WE HAVE THE 2982 01:47:40,760 --> 01:47:42,240 MAXIMUM POSSIBLE SOLUTION TO THE 2983 01:47:42,240 --> 01:47:44,520 PROBLEM, IT MAY NOT BE ABLE TO 2984 01:47:44,520 --> 01:47:45,800 AVOID ALL THESE LONG-TERM 2985 01:47:45,800 --> 01:47:46,640 COMPLICATIONS ABOUT YOU IT 2986 01:47:46,640 --> 01:47:50,080 CERTAINLY CAN BE WORKING 2987 01:47:50,080 --> 01:47:56,560 PROACTIVELY TO ANTICIPATE AND 2988 01:47:56,560 --> 01:47:57,480 AVOID THEM. 2989 01:47:57,480 --> 01:48:02,920 I WAS SORRY TO HEAR THAT 2990 01:48:02,920 --> 01:48:03,720 CLINICALTRIALS.GOV ISN'T 2991 01:48:03,720 --> 01:48:05,320 NECESSARILY THAT PATIENT 2992 01:48:05,320 --> 01:48:08,560 FRIENDLY, BUT I THINK THAT 2993 01:48:08,560 --> 01:48:11,560 COMPANIES CAN MAKE VOLUNTARY 2994 01:48:11,560 --> 01:48:13,160 ADDITIONS SORE MAYBE EVEN CREATE 2995 01:48:13,160 --> 01:48:16,360 A WHOLE NEW DEVICE OR NEW 2996 01:48:16,360 --> 01:48:18,240 WEBSITE WHERE THIS INFORMATION 2997 01:48:18,240 --> 01:48:21,040 ABOUT THEIR DEVICES COULD KIND 2998 01:48:21,040 --> 01:48:23,240 OF BE PUT ONLINE IN PERTUITY AND 2999 01:48:23,240 --> 01:48:33,800 WIDELY ACCEPTABLE FOR THOSE WHO 3000 01:48:34,320 --> 01:48:35,920 OR EVEN DEVICES THAT ARE 3001 01:48:35,920 --> 01:48:39,920 APPROVED OR STILL UNDER 3002 01:48:39,920 --> 01:48:41,880 INVESTIGATION TIME FRAME. 3003 01:48:41,880 --> 01:48:42,760 I IMAGINE AT LEAST FOR A WHILE 3004 01:48:42,760 --> 01:48:47,000 IT WOULD HAVE TO BE VOLUNTARY. 3005 01:48:47,000 --> 01:48:49,000 EVENTUALLY, I BELIEVE THE LAWS 3006 01:48:49,000 --> 01:48:51,600 ARE MOVING TOWARD SPONSORS OF 3007 01:48:51,600 --> 01:48:52,400 MARKETED DEVICES HAVING TO 3008 01:48:52,400 --> 01:48:54,640 PROVIDE THE DATA FOR THEIR 3009 01:48:54,640 --> 01:48:55,040 STUDIES. 3010 01:48:55,040 --> 01:48:59,000 WE'RE SEEING THAT MORE IN THE 3011 01:48:59,000 --> 01:48:59,360 JOURNALS. 3012 01:48:59,360 --> 01:49:01,240 BLUE ACKNOWLEDGE THE LIMITED 3013 01:49:01,240 --> 01:49:02,520 CAPABILITIES OF THOSE MANAGING A 3014 01:49:02,520 --> 01:49:04,120 SINGLE TRIAL AND MUCH MORE IS 3015 01:49:04,120 --> 01:49:06,520 NEEDED TO PROVIDE MAX NUM 3016 01:49:06,520 --> 01:49:09,480 SAFETY, COST LIMITATIONS COME 3017 01:49:09,480 --> 01:49:11,160 UP, THE CONCERN SHOULDN'T-HEVER 3018 01:49:11,160 --> 01:49:13,440 OR DOESN'T SHIFT FROM PATIENT 3019 01:49:13,440 --> 01:49:16,720 WELFARE TO INVESTIGATOR OR 3020 01:49:16,720 --> 01:49:17,600 MANUFACTURE WELFARE, ALWAYS 3021 01:49:17,600 --> 01:49:24,920 THINK OF TERMS OF PATIENT 3022 01:49:24,920 --> 01:49:25,200 SAFETY. 3023 01:49:25,200 --> 01:49:27,000 AND THIS IS MY DEPICTION OF ALL 3024 01:49:27,000 --> 01:49:29,080 THE DEVICES WE HAVE ORBITING THE 3025 01:49:29,080 --> 01:49:29,440 EARTH. 3026 01:49:29,440 --> 01:49:33,360 MANY OF THEM UNIDENTIFIED MANY 3027 01:49:33,360 --> 01:49:35,600 OF THEM NO LONGER USEFUL AND YET 3028 01:49:35,600 --> 01:49:39,560 IN THE WAY OF PROGRESS THAT'S 3029 01:49:39,560 --> 01:49:41,280 ADEQUATE AND THAT'S WHAT I HAD 3030 01:49:41,280 --> 01:49:41,560 ON MY MIND. 3031 01:49:41,560 --> 01:49:46,920 THANK AND YOU THAT'S ALL I HAVE 3032 01:49:46,920 --> 01:49:47,280 TO SAY. 3033 01:49:47,280 --> 01:49:50,400 >> THANK YOU SO MUCH. 3034 01:49:50,400 --> 01:50:00,800 DO HAVE A QUESTION FOR 3035 01:50:04,400 --> 01:50:04,960 DR. MARLER? 3036 01:50:04,960 --> 01:50:07,000 >> THIS IS A RELIEF, I THOUGHT I 3037 01:50:07,000 --> 01:50:09,440 VALID TO DEFEND THE FDA SO MEAS 3038 01:50:09,440 --> 01:50:10,800 GO TO TO OTHER PEOPLE'S 3039 01:50:10,800 --> 01:50:11,120 QUESTIONS. 3040 01:50:11,120 --> 01:50:13,880 >> SO I GUESS I HAVE A QUESTION. 3041 01:50:13,880 --> 01:50:16,760 AND I CAN START WITH YOU ABOUT, 3042 01:50:16,760 --> 01:50:19,240 WE'RE GOING TO ASK IT TO THE 3043 01:50:19,240 --> 01:50:22,960 ENTIRE PANEL NEXT, SO, I 3044 01:50:22,960 --> 01:50:24,360 APPRECIATE YOUR POINT ABOUT THE 3045 01:50:24,360 --> 01:50:25,920 MIN NUM, BUT I THINK WE DO KIND 3046 01:50:25,920 --> 01:50:29,320 OF NEED TO START SOMEWHERE, WE 3047 01:50:29,320 --> 01:50:31,560 HAVE A WHOLE LIST OF NEEDS THAT 3048 01:50:31,560 --> 01:50:33,560 WE'VE IDENTIFIED AND WE HAVE TO 3049 01:50:33,560 --> 01:50:34,400 START SOMEWHERE WHERE, MAYBE WE 3050 01:50:34,400 --> 01:50:39,200 SHOULD START WITH SOME OF THE 3051 01:50:39,200 --> 01:50:40,560 MOST IMPORTANT 1S. 3052 01:50:40,560 --> 01:50:44,480 SO WHAT'S YOUR TWO-CENTS, WHERE 3053 01:50:44,480 --> 01:50:46,080 WE MIGHT START BECAUSE IT'S 3054 01:50:46,080 --> 01:50:52,320 IMPORTANT BECAUSE IT'S LOW 3055 01:50:52,320 --> 01:50:52,680 HANGING FRUIT? 3056 01:50:52,680 --> 01:50:56,560 >> WELL, I'VE BEEN THINK BEING 3057 01:50:56,560 --> 01:50:57,240 THIS FOR DECADES. 3058 01:50:57,240 --> 01:51:00,200 YOU KNOW I DID WHAT WAS THE 3059 01:51:00,200 --> 01:51:04,080 PROJECT LEADER FOR A VERY 3060 01:51:04,080 --> 01:51:05,960 SUCCESSFUL SERIES OF CLINICAL 3061 01:51:05,960 --> 01:51:07,040 TRIALS THAT DEVELOPED THE FIRST 3062 01:51:07,040 --> 01:51:13,200 TREATMENT FOR ACUTE STROKE. 3063 01:51:13,200 --> 01:51:14,720 [INDISCERNIBLE] THERAPY AND I 3064 01:51:14,720 --> 01:51:17,680 WAS INVOLVED IN EVERY NIESH H 3065 01:51:17,680 --> 01:51:19,360 FUNDED, ANY NEUROLOGY INSTITUTE 3066 01:51:19,360 --> 01:51:21,800 FOR KLINEAL TRIAL AND IT WAS 3067 01:51:21,800 --> 01:51:28,440 FUND TO UP THROUGH 2010, SO, I 3068 01:51:28,440 --> 01:51:30,960 GUESS TO ANSWER YOUR QUESTION 3069 01:51:30,960 --> 01:51:41,440 ABOUT THE MINIMUM, WHAT I HAVE 3070 01:51:43,680 --> 01:51:45,360 LEARNED IS IF YOU DRIEB WHAT 3071 01:51:45,360 --> 01:51:47,800 YOUR VISION IS, MAKE A PICTURE, 3072 01:51:47,800 --> 01:51:50,400 MAKE A MOON SHOT OF IT, IT 3073 01:51:50,400 --> 01:51:56,360 BECOMES MORE APPARENT, WHAT ARE 3074 01:51:56,360 --> 01:51:56,880 THE INTERMEDIATE STEPS? 3075 01:51:56,880 --> 01:51:58,560 BUT RIGHT NOTICE WE HEARD 3076 01:51:58,560 --> 01:51:59,720 DESCRIBE THE DIFFICULTIES 3077 01:51:59,720 --> 01:52:02,520 CONFRONTING CLINICAL TRIALS, 3078 01:52:02,520 --> 01:52:04,320 THEY'RE INCREASING LACK 3079 01:52:04,320 --> 01:52:04,920 OF--INCREASING LACK OF KREDET 3080 01:52:04,920 --> 01:52:05,960 ENHANCEMENT INTELLECTUAL OF 3081 01:52:05,960 --> 01:52:09,040 THEIR RESULTS EITHER BECAUSE OF 3082 01:52:09,040 --> 01:52:10,760 THE POOR CONDUCT OR POOR DESIGN 3083 01:52:10,760 --> 01:52:15,280 OF THE STUDIES BUT, AND--FOR 3084 01:52:15,280 --> 01:52:19,120 WHATEVER REASON AND I THINK THAT 3085 01:52:19,120 --> 01:52:22,920 THE MOST IMPORTANT THING I HEARD 3086 01:52:22,920 --> 01:52:28,120 TODAY WAS GETTING PATIENTS 3087 01:52:28,120 --> 01:52:29,160 INVOLVED FROM THE BEGINNING. 3088 01:52:29,160 --> 01:52:32,320 THEY WILL TELL YOU WHEN YOU'RE 3089 01:52:32,320 --> 01:52:33,640 DESIGNING THE TRIAL, WHETHER 3090 01:52:33,640 --> 01:52:35,560 IT'S WORTH THE RISK OF NOT 3091 01:52:35,560 --> 01:52:36,960 HAVING A DEVICE IN YOU THAT YOU 3092 01:52:36,960 --> 01:52:39,000 CAN NEVER HAVE TAKEN OUT AND IT 3093 01:52:39,000 --> 01:52:42,480 MAY NOT WORK, YOU KNOW? 3094 01:52:42,480 --> 01:52:46,760 AND MAKE THAT AND HOW TO--HOW TO 3095 01:52:46,760 --> 01:52:48,840 DETERMINE HOW TO GET THEM TO 3096 01:52:48,840 --> 01:52:50,920 PARTICIPATE IN THE TRIAL AND 3097 01:52:50,920 --> 01:52:59,320 MAKE THE TRIAL WORK. 3098 01:52:59,320 --> 01:53:01,280 AND I JUST DON'T SEE THAT 3099 01:53:01,280 --> 01:53:01,520 HAPPENING. 3100 01:53:01,520 --> 01:53:03,120 I THINK THAT'S ALL I HAVE TO 3101 01:53:03,120 --> 01:53:05,760 SAY, THINK ABOUT AND GET THE 3102 01:53:05,760 --> 01:53:08,440 INDIVIDUALS THAT WILL BE USING 3103 01:53:08,440 --> 01:53:09,400 THE DEVICES HELPING YOU FIGURE 3104 01:53:09,400 --> 01:53:12,880 OUT HOW TO GET TO YOUR GOAL, 3105 01:53:12,880 --> 01:53:16,120 WHAT THEIR IMMEDIATE STEPS ARE. 3106 01:53:16,120 --> 01:53:17,960 I WAS INVOLVED IN A PROJECT THAT 3107 01:53:17,960 --> 01:53:26,360 USED SOMETHING CALLED HUMAN 3108 01:53:26,360 --> 01:53:26,840 CENTERED DESIGN. 3109 01:53:26,840 --> 01:53:29,240 IT ATTEMPTED TO DO EXACTLY WHAT 3110 01:53:29,240 --> 01:53:31,880 I WAS TALKING ABOUT, IT WAS DONE 3111 01:53:31,880 --> 01:53:38,040 UNDER CONTRACT WITH NINDS, IT 3112 01:53:38,040 --> 01:53:41,600 DIDN'T GET SUSTAINED FUNDING BUT 3113 01:53:41,600 --> 01:53:47,440 THE ORGANIZATION OF PARENTS AND 3114 01:53:47,440 --> 01:53:49,400 FAMILY PUT TOGETHER, AND I THINK 3115 01:53:49,400 --> 01:53:52,200 15 YEARS LATER, TURNED OUT TO BE 3116 01:53:52,200 --> 01:53:58,040 THE ORGANIZATION THAT RAN THE 3117 01:53:58,040 --> 01:53:59,440 CLINICAL TRIAL; THE VERY 3118 01:53:59,440 --> 01:54:00,280 RIGOROUS CLINICAL TRIAL THAT WAS 3119 01:54:00,280 --> 01:54:04,560 USED TO GET A NEW TREATMENT FOR 3120 01:54:04,560 --> 01:54:08,560 S MA APPROVED, [INDISCERNIBLE], 3121 01:54:08,560 --> 01:54:11,520 SO IT--I THINK THERE IS SOME 3122 01:54:11,520 --> 01:54:21,360 SUGGESTION THAT IT HAS SOME 3123 01:54:21,360 --> 01:54:21,760 POSITIVE OUTCOMES. 3124 01:54:21,760 --> 01:54:23,600 >> SO I WOULD LIKE TO INVITE ALL 3125 01:54:23,600 --> 01:54:25,200 THE PANELISTS FROM PANEL 3 TO 3126 01:54:25,200 --> 01:54:26,360 TURN ON THEIR CAMERAS AND BE 3127 01:54:26,360 --> 01:54:28,680 READY TO HAVE A DISCUSSION ABOUT 3128 01:54:28,680 --> 01:54:31,280 THE THINGS THAT WE WERE FOCUSING 3129 01:54:31,280 --> 01:54:34,880 ON, WHAT SHOULD BE PROVIDED AND 3130 01:54:34,880 --> 01:54:36,360 WHEN SHOULD SOMETHING BE ABOVE 3131 01:54:36,360 --> 01:54:38,160 THE MINIMUM, BUT BEFORE WE TURN 3132 01:54:38,160 --> 01:54:39,480 TO THAT DISCUSSION, I HAVE 2 3133 01:54:39,480 --> 01:54:41,440 HANDS UP THAT I SEE SO I WILL 3134 01:54:41,440 --> 01:54:43,960 CALL ON THOSE 2 AND THEN TAKE IT 3135 01:54:43,960 --> 01:54:45,360 FROM THERE. 3136 01:54:45,360 --> 01:54:48,240 SO, I CAN'T TELL WHO WAS FIRST, 3137 01:54:48,240 --> 01:54:50,560 I BELIEVE CAROLINE WAS FIRST AND 3138 01:54:50,560 --> 01:54:55,600 THEN JENNIFER FRENCH. 3139 01:54:55,600 --> 01:54:55,920 >> YES. 3140 01:54:55,920 --> 01:54:59,280 >> CHRISTINE AND MY QUESTION IS 3141 01:54:59,280 --> 01:55:01,200 FOR DR. MARLER, THANK YOU FOR 3142 01:55:01,200 --> 01:55:04,440 YOUR TALK DR. MARLER, I WAS 3143 01:55:04,440 --> 01:55:05,880 CURIOUS TO HEAR, I READ LAST 3144 01:55:05,880 --> 01:55:09,440 YEAR ABOUT A PROPOSED FDA 3145 01:55:09,440 --> 01:55:10,280 NEUROSCIENCE CENTER OF 3146 01:55:10,280 --> 01:55:12,240 EXCELLENCE, I THINK THE AMERICAN 3147 01:55:12,240 --> 01:55:16,360 BRAIN COALITION WAS INVOLVED IN 3148 01:55:16,360 --> 01:55:17,760 HELPING TO ADVOCATE FOR THIS, I 3149 01:55:17,760 --> 01:55:19,080 WAS CURIOUS TO HEAR, WHETHER YOU 3150 01:55:19,080 --> 01:55:21,040 KNOW ANYTHING ABOUT THE STATUS 3151 01:55:21,040 --> 01:55:23,640 OF THIS CENTER, AND IF SO, 3152 01:55:23,640 --> 01:55:25,920 WHETHER THE AIMS FOR THIS WOULD 3153 01:55:25,920 --> 01:55:29,280 BE ABLE TO ADDRESS SOME OF THE 3154 01:55:29,280 --> 01:55:30,640 CONCERNS IN THE CLINICAL TRIAL 3155 01:55:30,640 --> 01:55:33,560 ISSUES THAT WERE BROUGHT UP 3156 01:55:33,560 --> 01:55:34,520 TODAY AND YESTERDAY, RANGING 3157 01:55:34,520 --> 01:55:41,280 FROM DESIGN TO POST TRIAL CARE? 3158 01:55:41,280 --> 01:55:51,640 I WOULD BE CURIOUS. 3159 01:55:52,920 --> 01:55:53,280 >> YOU'RE ON MUTE. 3160 01:55:53,280 --> 01:55:53,720 >> SORRY. 3161 01:55:53,720 --> 01:55:55,720 I'M NOT AWARE OF ALL OF THOSE 3162 01:55:55,720 --> 01:55:56,640 PROGRAMS GOING ON, THERE ARE A 3163 01:55:56,640 --> 01:56:05,040 LOT OF EFFORTS TO TRY TO INVOLVE 3164 01:56:05,040 --> 01:56:05,400 PATIENTS. 3165 01:56:05,400 --> 01:56:08,840 MYSELF AND MY CAREER, THE FDA 3166 01:56:08,840 --> 01:56:14,880 AND THE NIH, I REALLY HAVE MADE 3167 01:56:14,880 --> 01:56:17,120 THAT 1 ATTEMPT I DESCRIBE WIDE 3168 01:56:17,120 --> 01:56:23,400 YOU IN CENTERED DESIGN BUT IT'S 3169 01:56:23,400 --> 01:56:25,080 VERY HARD TO REACH OUT AND GET 3170 01:56:25,080 --> 01:56:27,880 PATIENTS UP FRONT IN THE DESIGN 3171 01:56:27,880 --> 01:56:30,320 AND CONDUCT OF CLINICAL STUDIES. 3172 01:56:30,320 --> 01:56:31,840 SHOULD--I GUESS IT COULD BE 3173 01:56:31,840 --> 01:56:33,600 DONE, BUT I'M NOT AWARE OF ANY 3174 01:56:33,600 --> 01:56:42,840 PRESENTLY IN THE GOVERNMENT TO 3175 01:56:42,840 --> 01:56:43,280 DO THAT. 3176 01:56:43,280 --> 01:56:43,920 >> THANK YOU. 3177 01:56:43,920 --> 01:56:46,120 >> SO JENNIFER DO YOU HAVE I 3178 01:56:46,120 --> 01:56:49,120 QUESTION FOR DR. MARLAER OR THE 3179 01:56:49,120 --> 01:56:51,080 OTHER PANELISTS. 3180 01:56:51,080 --> 01:56:51,280 I. 3181 01:56:51,280 --> 01:56:53,120 >> SURE, I CAN DIRECT IT TO 3182 01:56:53,120 --> 01:56:54,280 DR. MARLAER BUT OTHER PANELISTS 3183 01:56:54,280 --> 01:56:55,520 CAN WEIGH IN AS WELL, THANK YOU 3184 01:56:55,520 --> 01:56:56,800 IF ARE SHARING YOUR THOUGHTS TO 3185 01:56:56,800 --> 01:57:00,720 YOU AND THE FDA, BUT HATS OFF TO 3186 01:57:00,720 --> 01:57:01,920 CDH FOR PUTTING OUT GUIDANCE 3187 01:57:01,920 --> 01:57:03,960 LAST YEAR TO PATIENT ENGAGEMENT. 3188 01:57:03,960 --> 01:57:10,920 SO, IT'S NICE TO SEE THAT THE 3189 01:57:10,920 --> 01:57:13,360 FDA IS MY GUIDANCE SAID IT'S 3190 01:57:13,360 --> 01:57:16,280 VOLUNTARY, AND THE PROCESS OF 3191 01:57:16,280 --> 01:57:17,400 DEVELOPING MEDICAL DEVICES, WISH 3192 01:57:17,400 --> 01:57:19,520 IT WAS MORE MANTATORY, SO MY 3193 01:57:19,520 --> 01:57:21,520 QUESTION TO YOU AND THE REST OF 3194 01:57:21,520 --> 01:57:23,520 THE PANELISTS ARE, YOU MENTIONED 3195 01:57:23,520 --> 01:57:25,120 IN SOME OF YOUR COMMENTS AT THE 3196 01:57:25,120 --> 01:57:28,720 END OF THE TALK ABOUT HOW THE 3197 01:57:28,720 --> 01:57:31,520 DRUG WORLD HAS COME AND THE DRUG 3198 01:57:31,520 --> 01:57:32,680 INDUSTRY AND INVESTIGATORS CAME 3199 01:57:32,680 --> 01:57:34,160 TOGETHER TO SOLVE THESE HARDER 3200 01:57:34,160 --> 01:57:37,120 PROBLEMS WITH EARLY STUDIES AND 3201 01:57:37,120 --> 01:57:39,640 I'M CURIOUS IF HAVE YOU OPINIONS 3202 01:57:39,640 --> 01:57:41,080 OR ANY INSIGHT OF LESSONS 3203 01:57:41,080 --> 01:57:42,400 LEARNED FROM THE DRUG INDUSTRY 3204 01:57:42,400 --> 01:57:44,000 THAT WE MIGHT BE ABLE TO BLEED 3205 01:57:44,000 --> 01:57:54,440 OVER TO MEDICAL DEVICES? 3206 01:57:55,200 --> 01:57:57,480 >> I WAS WITH CDER FOR DRUGS 3207 01:57:57,480 --> 01:57:59,680 BEFORE I CAME TO CDRH, BECAUSE 3208 01:57:59,680 --> 01:58:02,120 OF MY INTEREST IN STROKE AND 3209 01:58:02,120 --> 01:58:03,120 STROKE DEVICES. 3210 01:58:03,120 --> 01:58:13,680 NO, I JUST HAD THE SAYING THAT I 3211 01:58:14,640 --> 01:58:16,120 WAS AWARE SO YOU KNOW WHEN YOU 3212 01:58:16,120 --> 01:58:18,600 GO OUT THERE AND THEY'RE IN 3213 01:58:18,600 --> 01:58:24,720 WEBSITES, RUN BY I THINK 3214 01:58:24,720 --> 01:58:26,400 THERE'S--THERE ARE MAYBE PHARMA, 3215 01:58:26,400 --> 01:58:28,040 MAY BE THE NAME OF THE 3216 01:58:28,040 --> 01:58:29,080 ORGANIZATION BUT THERE ARE 3217 01:58:29,080 --> 01:58:30,880 WEBSITES OUT THERE THAT PROVIDE 3218 01:58:30,880 --> 01:58:32,040 INFORMATION ABOUT DRUGS THAT ARE 3219 01:58:32,040 --> 01:58:34,320 INDEPENDENT OF THE FDA WEBSITE. 3220 01:58:34,320 --> 01:58:37,360 I DON'T KNOW THAT THAT'S USEFUL 3221 01:58:37,360 --> 01:58:40,480 OR ANYTHING, HOW ELSE DO THEY 3222 01:58:40,480 --> 01:58:41,560 BECOME ACTIVE. 3223 01:58:41,560 --> 01:58:49,320 I THINK THEY PARTICIPATE IN 3224 01:58:49,320 --> 01:58:51,640 DIALOGUES AS IN SETTING OUT IN 3225 01:58:51,640 --> 01:58:53,240 MEETINGS AND THEY RESPOND TO 3226 01:58:53,240 --> 01:58:55,040 DRAFT GUIDANCES FROM FDA AND SO 3227 01:58:55,040 --> 01:58:56,840 ON, SO I DON'T KNOW THAT MUCH 3228 01:58:56,840 --> 01:59:01,120 ABOUT IT, I'M SORRY, WHEN YOU'RE 3229 01:59:01,120 --> 01:59:02,760 AN FDA EMPLOYEE, YOU'RE 3230 01:59:02,760 --> 01:59:06,840 INSULATED FROM THESE 3231 01:59:06,840 --> 01:59:13,920 ORGANIZATIONS, APPROPRIATELY SO. 3232 01:59:13,920 --> 01:59:15,520 >> MAYBE WE CAN INVITE OTHERS TO 3233 01:59:15,520 --> 01:59:17,640 TURN ON THEIR CAMERAS AND JOIN 3234 01:59:17,640 --> 01:59:28,000 US IN THIS DISCUSSION. 3235 01:59:29,040 --> 01:59:32,080 >> I PUT IN THE CHAT THE LIST 3236 01:59:32,080 --> 01:59:34,680 THAT NINA PRESENTED EARLIER THIS 3237 01:59:34,680 --> 01:59:36,400 MORNING, IN PANEL 1, YESTERDAY, 3238 01:59:36,400 --> 01:59:39,400 AND I JUST WOULD LIKE TO 3239 01:59:39,400 --> 01:59:43,080 ENCOURAGE US ALL TO THINK ABOUT 3240 01:59:43,080 --> 01:59:44,680 DO WE NEED LIKE SHOULD WE 3241 01:59:44,680 --> 01:59:46,320 COVER--DO WE NEED TO COVER ALL 3242 01:59:46,320 --> 01:59:49,480 OF THESE NEEDS IN ALL TRIALS OR 3243 01:59:49,480 --> 01:59:52,600 ARE SOME OF THEM PERHAPS MORE 3244 01:59:52,600 --> 01:59:55,880 IMPORTANT THAN OTHERS, FOR 3245 01:59:55,880 --> 01:59:57,560 EXAMPLE, MAYBE IT'S ESPECIALLY 3246 01:59:57,560 --> 02:00:01,640 IMPORTANT TO INSURE THAT IT'S 3247 02:00:01,640 --> 02:00:05,120 COMPATIBLE HARDWARE BECAUSE IF 3248 02:00:05,120 --> 02:00:07,200 IT SUBJECT THAT'S THE END OF THE 3249 02:00:07,200 --> 02:00:08,520 STORY FOR SOME, WHERE SOME 3250 02:00:08,520 --> 02:00:09,160 PATIENTS HAVE DIFFERENT 3251 02:00:09,160 --> 02:00:10,680 OPPORTUNITIES TO TRY TO PURSUE A 3252 02:00:10,680 --> 02:00:14,840 CERTAIN GOAL OR MAYBE WE WANT TO 3253 02:00:14,840 --> 02:00:16,160 PRIORITIZE SOME OF THE ITEMS ON 3254 02:00:16,160 --> 02:00:19,480 THIS LIST THAT RELATE TO HARMS 3255 02:00:19,480 --> 02:00:21,040 THAT COULD COME TO PATIENTS. 3256 02:00:21,040 --> 02:00:24,160 I JUST WANT TO ENCOURAGE THE 3257 02:00:24,160 --> 02:00:26,400 PANEL TO REFLECT A LITTLE BIT ON 3258 02:00:26,400 --> 02:00:27,440 THIS LIST AND SEE. 3259 02:00:27,440 --> 02:00:29,440 CAN WE TAKE THIS BEYOND THE 3260 02:00:29,440 --> 02:00:30,800 HIGHER LEVEL PRINCIPLES THAT 3261 02:00:30,800 --> 02:00:32,800 WE'VE ALL BEEN AGREEING UPON FOR 3262 02:00:32,800 --> 02:00:34,840 YEARS, AND TRY TO GET A LITTLE 3263 02:00:34,840 --> 02:00:45,160 BIT MORE SPECIFIC. 3264 02:00:45,800 --> 02:00:47,640 I CAN START SINCE NOBODY'S ELSE 3265 02:00:47,640 --> 02:00:48,720 IS STARTING, 1 TECHNOLOGY 3266 02:00:48,720 --> 02:00:49,880 TRANSFER THAT STRIKES ME BECAUSE 3267 02:00:49,880 --> 02:00:50,480 WE ARE VERY DIFFERENT PEOPLE 3268 02:00:50,480 --> 02:00:52,120 THAT ARE IN THE STUDY THAN THE 3269 02:00:52,120 --> 02:00:53,720 PARTICIPANTS FROM YESTERDAY IS 3270 02:00:53,720 --> 02:00:57,400 THAT WHEN PEOPLE ARE GETTING A 3271 02:00:57,400 --> 02:00:59,280 CLINICAL BENEFIT, AND A LIFE 3272 02:00:59,280 --> 02:01:00,200 SAVING CLINICAL BENEFIT, THAT 3273 02:01:00,200 --> 02:01:04,200 HAS TO BE OUR PRIORITY, 3274 02:01:04,200 --> 02:01:06,240 IT'S--YOU KNOW THE BCI STUDY 3275 02:01:06,240 --> 02:01:07,440 PARTICIPANTS WHO USE THE DEVICE 3276 02:01:07,440 --> 02:01:09,840 IN THE LAB HAVE A LIFE ALTERING 3277 02:01:09,840 --> 02:01:11,840 EXPERIENCE AND THEY, YOU KNOW 3278 02:01:11,840 --> 02:01:13,840 GAIN A LOT OF MEANING AND 3279 02:01:13,840 --> 02:01:14,720 PURPOSE AND THAT SORT OF THING 3280 02:01:14,720 --> 02:01:18,600 FROM THE STUDY AND I THINK WE 3281 02:01:18,600 --> 02:01:20,280 HAVE TO REALLY PAY ATTENTION TO 3282 02:01:20,280 --> 02:01:22,800 THEIR TRANSITION OUT OF THE 3283 02:01:22,800 --> 02:01:24,520 STUDY WHEN THEY DON'T HAVE THE 3284 02:01:24,520 --> 02:01:26,160 ROBOTIC ARM OR THE CAPACITY TO 3285 02:01:26,160 --> 02:01:27,440 USE THE DEVICE AT HOME. 3286 02:01:27,440 --> 02:01:29,520 I THINK WE HAVE TO PAY ATTENTION 3287 02:01:29,520 --> 02:01:31,160 TO, YOU KNOW ACCORD NATION OF 3288 02:01:31,160 --> 02:01:33,760 CARE AFTER THAT JUST LIKE 3289 02:01:33,760 --> 02:01:34,440 PSYCHOLOGICAL SUPPORT AND 3290 02:01:34,440 --> 02:01:35,560 LEAVING AND ALL THOSE SORTS OF 3291 02:01:35,560 --> 02:01:36,920 THINGS BUT I THINK THE PRIORITY 3292 02:01:36,920 --> 02:01:39,560 HAS N BE O KEEPING THE PEOPLE 3293 02:01:39,560 --> 02:01:44,320 WHO HAVE ACCESS TO LIFE, TO 3294 02:01:44,320 --> 02:01:46,440 DEVICES THAT ARE LIFE CHANGING 3295 02:01:46,440 --> 02:01:50,520 AND IN AN ONGOING WAY, SO LIKE 3296 02:01:50,520 --> 02:01:52,440 GENERATED FER TALKED ABOUT 3297 02:01:52,440 --> 02:01:54,800 YESTERDAY AND BRANDY TALKED 3298 02:01:54,800 --> 02:01:56,840 ABOUT YESTERDAY, 1 OF OUR 3299 02:01:56,840 --> 02:01:58,400 PARTICIPANTS, I THINK WITH ISHAN 3300 02:01:58,400 --> 02:02:03,960 WAS ASKING ABOUT THE POSSIBILITY 3301 02:02:03,960 --> 02:02:06,480 THAT THE DEVICES IS NO LONGER 3302 02:02:06,480 --> 02:02:07,880 AVAILABLE WHETHER THE COMPANY 3303 02:02:07,880 --> 02:02:09,280 GOES UNDER OR THE STUDY ENDS, 3304 02:02:09,280 --> 02:02:12,480 YOU KNOW IT'S REMARKABLE TO 3305 02:02:12,480 --> 02:02:13,920 LISTEN TO THE AUDIO RECORDING 3306 02:02:13,920 --> 02:02:15,480 BECAUSE THEY'RE JUST CRICKETS AS 3307 02:02:15,480 --> 02:02:21,200 IF THIS PERSON HAS NEVER HAD THE 3308 02:02:21,200 --> 02:02:22,920 THOUGHT THAT THIS THING THAT IS 3309 02:02:22,920 --> 02:02:24,880 LIFE SAVING COULD BE JUST GONE, 3310 02:02:24,880 --> 02:02:25,280 RIGHT? 3311 02:02:25,280 --> 02:02:27,320 IT MIGHT NOT BE SUSTAINABLE AND 3312 02:02:27,320 --> 02:02:30,640 YOU KNOW THAT TO ME HAS TO BE 3313 02:02:30,640 --> 02:02:30,960 OUR PRIORITY. 3314 02:02:30,960 --> 02:02:32,720 I DO THINK THERE ARE REALLY 3315 02:02:32,720 --> 02:02:33,960 SIGNIFICANT ISSUES ABOUT THE 3316 02:02:33,960 --> 02:02:34,960 OTHER DEVICE TRIAL MEMBERS AND I 3317 02:02:34,960 --> 02:02:36,200 THINK WE JUST, YOU KNOW SOME OF 3318 02:02:36,200 --> 02:02:38,280 IT IS THINKING ABOUT HOW WE 3319 02:02:38,280 --> 02:02:39,680 SHIFT SOME OF THE RULES AND 3320 02:02:39,680 --> 02:02:42,080 REGULATIONS THAT ARE OUT THERE 3321 02:02:42,080 --> 02:02:43,280 AROUND HOW TO SUPPORT PEOPLE WHO 3322 02:02:43,280 --> 02:02:46,120 ARE IN THESE STUDIES. 3323 02:02:46,120 --> 02:02:49,840 SO THAT EVEN IF IT'S NOT 3324 02:02:49,840 --> 02:02:52,240 MONETARY COMPENSATION AS IN PAY, 3325 02:02:52,240 --> 02:02:53,160 IT'S FACILITATING WHAT THEY NEED 3326 02:02:53,160 --> 02:02:55,640 IN ORDER TO BE ABLE TO 3327 02:02:55,640 --> 02:02:57,160 PARTICIPATE WITHOUT BEARING THE 3328 02:02:57,160 --> 02:02:57,760 COST. 3329 02:02:57,760 --> 02:02:58,720 THEY'RE ALREADY BEARINGA I LOT 3330 02:02:58,720 --> 02:03:01,520 OF COSTS IN TAKING ON THAT RISK 3331 02:03:01,520 --> 02:03:04,120 AND I DON'T THINK IT'S--WE DON'T 3332 02:03:04,120 --> 02:03:05,320 HAVE SYSTEMS THAT RECOGNIZE THAT 3333 02:03:05,320 --> 02:03:15,480 NOW, SO I THINK WE HAVE TO 3334 02:03:15,480 --> 02:03:18,360 PRIORITIZE THOSE THINGS. 3335 02:03:18,360 --> 02:03:18,640 >> TYLER? 3336 02:03:18,640 --> 02:03:19,800 >> OKAY, LET'S SEE, I HAVE AM 3337 02:03:19,800 --> 02:03:21,320 JUST TRYING TO ABSORB EVERYTHING 3338 02:03:21,320 --> 02:03:22,920 AND I CHARGED BY BATTERY LAST 3339 02:03:22,920 --> 02:03:26,200 NIGHT SO HOPEFULLY IT'S WORKING 3340 02:03:26,200 --> 02:03:27,760 PRETTY WELL, BUT I FEEL LIKE 3341 02:03:27,760 --> 02:03:29,480 I'VE BEEN VERY FORTUNATE IN THE 3342 02:03:29,480 --> 02:03:34,200 PAST 3 YEARS WITH MY EXPERIENCE 3343 02:03:34,200 --> 02:03:44,760 BECAUSE AGAIN, DR. RI VA POSSE, 3344 02:03:45,960 --> 02:03:47,560 PRETTY MUCH SAVED BY LIFE, I HAD 3345 02:03:47,560 --> 02:03:51,000 HIM ON SPEED DIAL AND IF 3346 02:03:51,000 --> 02:03:52,920 QUESTIONS OR CONCERNS I COULD 3347 02:03:52,920 --> 02:03:56,320 ASK HIM WITH THAT AND I FEEL 3348 02:03:56,320 --> 02:03:56,840 REALLY FORTUNATE. 3349 02:03:56,840 --> 02:03:59,640 I'M 1 OF THOSE PEOPLE FOR A 3350 02:03:59,640 --> 02:04:01,920 COUPLE DAYS AGO OR IN THE 3351 02:04:01,920 --> 02:04:03,320 PREMEETING, I THOUGHT, WHAT IF 3352 02:04:03,320 --> 02:04:05,000 THEY STOP MAKING THIS, WHAT IS 3353 02:04:05,000 --> 02:04:05,280 GOING ON? 3354 02:04:05,280 --> 02:04:07,320 SO I THINK HAVING A REGISTRY OF 3355 02:04:07,320 --> 02:04:09,080 THE TECHNOLOGY JUST LIKE YOU DO 3356 02:04:09,080 --> 02:04:13,400 MEDICATION WOULD BE EXTREMELY 3357 02:04:13,400 --> 02:04:13,800 VALUABLE. 3358 02:04:13,800 --> 02:04:16,560 AND I ALSO THOUGHT ABOUT, AGAIN, 3359 02:04:16,560 --> 02:04:18,040 WILLINGNESS, YOU KNOW, AGAIN 3360 02:04:18,040 --> 02:04:21,800 BRANDY HAD MENTIONED HER 3361 02:04:21,800 --> 02:04:24,000 WILLINGNESS AND YOU KNOW TO GO 3362 02:04:24,000 --> 02:04:26,000 THROUGH THESE STUDIES AND A LOT 3363 02:04:26,000 --> 02:04:27,880 OF PATIENTS WITH TREATMENT 3364 02:04:27,880 --> 02:04:30,160 RESISTANT DEPRESSION HAVE BEEN 3365 02:04:30,160 --> 02:04:31,600 THROUGH THE RINGER AND I'VE HAD 3366 02:04:31,600 --> 02:04:34,280 DISCUSSIONS WITH A LOT OF PEOPLE 3367 02:04:34,280 --> 02:04:36,000 WHO HAD ISSUES WITH DEPRESSION 3368 02:04:36,000 --> 02:04:37,720 AND THEY'RE LIKE, YOU HAD BRAIN 3369 02:04:37,720 --> 02:04:39,520 SURGERY THAT,'S CRAZY, WELL IT'S 3370 02:04:39,520 --> 02:04:40,280 THAT OR DIE. 3371 02:04:40,280 --> 02:04:42,040 FOR ME IT'S A NO BRAINER BUT FOR 3372 02:04:42,040 --> 02:04:43,960 A LOT OF PATIENTS IT'S LIKE ARE 3373 02:04:43,960 --> 02:04:45,280 THEY WILLING TO GO THROUGH IT, 3374 02:04:45,280 --> 02:04:49,680 AND I THINK THAT WILLINGNESS 3375 02:04:49,680 --> 02:04:51,280 WOULD CHANGE, IT WOULD BE 3376 02:04:51,280 --> 02:04:53,120 IMPACTED IF AGAIN, MORE AND MORE 3377 02:04:53,120 --> 02:04:53,960 DATA AND MORE REASSURANCE WOULD 3378 02:04:53,960 --> 02:04:58,280 BE HEY, YOU'RE NOT ALONE IN 3379 02:04:58,280 --> 02:05:00,800 THIS, WE'RE GOING TO HELP TAKE 3380 02:05:00,800 --> 02:05:02,040 CARE OF THINGS, AGAIN 3381 02:05:02,040 --> 02:05:03,640 FINANCIALLY, YOU KNOW WE WILL 3382 02:05:03,640 --> 02:05:05,560 OFFER YOU AGAIN THAT 3383 02:05:05,560 --> 02:05:06,920 PSYCHOLOGICAL CARE, I HAVE BEEN 3384 02:05:06,920 --> 02:05:09,400 SO BLESSED TO HAVE THE TEAM THAT 3385 02:05:09,400 --> 02:05:11,320 I DO THAT HAS BEEN ABLE TO OFFER 3386 02:05:11,320 --> 02:05:11,520 THAT. 3387 02:05:11,520 --> 02:05:13,080 I'VE NEVER FELT LIKE I WAS ALONE 3388 02:05:13,080 --> 02:05:15,440 IN THIS OR THAT AFTER THE 3389 02:05:15,440 --> 02:05:17,160 SURGERY, OR AFTER IT'S ALL SAID 3390 02:05:17,160 --> 02:05:18,720 AND DONE, ALL RIGHT, KICK YOU TO 3391 02:05:18,720 --> 02:05:19,000 THE CURB. 3392 02:05:19,000 --> 02:05:21,720 YOU KNOW MY FATHER AND I HAVE 3393 02:05:21,720 --> 02:05:23,240 HAD MANY CONVERSATIONS WITH 3394 02:05:23,240 --> 02:05:24,600 DR. RIVA WHERE WE JUST CALL 3395 02:05:24,600 --> 02:05:26,080 INDEED AND SAID, HEY THIS IS 3396 02:05:26,080 --> 02:05:27,400 WHAT'S GOING ON HE'S BEEN THERE 3397 02:05:27,400 --> 02:05:29,120 TO OFFER A SOLUTION OR BEEN 3398 02:05:29,120 --> 02:05:31,120 WILLING TO HELP IN ANY WAY THAT 3399 02:05:31,120 --> 02:05:32,480 HE COULD. 3400 02:05:32,480 --> 02:05:35,320 AND THEN, AGAIN, IS PARAMOUNT. 3401 02:05:35,320 --> 02:05:37,040 JUST LIKE ANYBODY GOING THROUGH 3402 02:05:37,040 --> 02:05:38,480 ANY KIND OF ILLNESS, IT'S THAT 3403 02:05:38,480 --> 02:05:40,560 SUPPORT SYSTEM AND BEING ABLE TO 3404 02:05:40,560 --> 02:05:42,280 OFFER THAT FROM THE GET-GO AND 3405 02:05:42,280 --> 02:05:44,600 SAY, LOOK, THIS IS WHAT IT IS, 3406 02:05:44,600 --> 02:05:46,680 INSTEAD OF A--KIND OF A BLAND, 3407 02:05:46,680 --> 02:05:48,200 ALL RIGHT, WE WILL TRY THIS, WE 3408 02:05:48,200 --> 02:05:52,760 HAVE GOOD RESULTS, WE WILL LET 3409 02:05:52,760 --> 02:06:01,800 YOU KNOW, I THINK IT'S EXTREMELY 3410 02:06:01,800 --> 02:06:02,120 IMPORTANT. 3411 02:06:02,120 --> 02:06:09,320 I LOLLED --WOULD LOVE TO HEAR YE 3412 02:06:09,320 --> 02:06:11,280 AND TRACEY'S TAKE IF IN THE 3413 02:06:11,280 --> 02:06:12,720 PROCESS, ANYONE WAS TO LAY OUT 3414 02:06:12,720 --> 02:06:15,040 THE LIFE LONG NEED FOR SURGERIES 3415 02:06:15,040 --> 02:06:16,160 AND BATTERY REPLACEMENTS AND 3416 02:06:16,160 --> 02:06:16,920 OBLIGATIONS SOLESTIMATE THAD 3417 02:06:16,920 --> 02:06:18,480 ENSEL AND ALL THAT STUFF, HOW 3418 02:06:18,480 --> 02:06:22,320 WOULD YOU DEAL WITH THAT ON THE 3419 02:06:22,320 --> 02:06:22,640 FRONT END? 3420 02:06:22,640 --> 02:06:24,640 DO YOU SEE WHAT I'M ASKING? 3421 02:06:24,640 --> 02:06:26,120 MAYBE TRACE SCHESTART AND TYLER 3422 02:06:26,120 --> 02:06:28,440 CAN JUMP IN, I ALREADY SPOKE, 3423 02:06:28,440 --> 02:06:30,560 TRACEY GO FIRST. 3424 02:06:30,560 --> 02:06:31,160 >> OKAY, THANKS, TYLER. 3425 02:06:31,160 --> 02:06:33,880 YEAH, I MEAN I THINK IT'S A 3426 02:06:33,880 --> 02:06:35,400 FRONT END, YOU HAVE TO. 3427 02:06:35,400 --> 02:06:39,000 WE ETHICALLY HAVE TO HAVE THAT 3428 02:06:39,000 --> 02:06:41,200 CONVERSATION AND SO MAYBE IT'S 3429 02:06:41,200 --> 02:06:43,000 NOT THE VERY FIRST CONVERSATION, 3430 02:06:43,000 --> 02:06:43,600 MAYBE THE INFORMED CONSENT 3431 02:06:43,600 --> 02:06:44,560 CONVERSATION IS THAT WE'RE GOING 3432 02:06:44,560 --> 02:06:45,640 TO BE HAVING THIS CONVERSATION 3433 02:06:45,640 --> 02:06:50,160 WITH YOU, BUT THERE ARE ISSUES 3434 02:06:50,160 --> 02:06:50,880 THAT RELATE TO TRANSITION OF 3435 02:06:50,880 --> 02:06:52,360 THIS AND THESE ARE THE THINGS 3436 02:06:52,360 --> 02:06:53,960 THAT MIGHT ARISE AND RATHER THAN 3437 02:06:53,960 --> 02:06:55,360 GOING THROUGH RIKE THE WHOLE 3438 02:06:55,360 --> 02:06:55,680 PLAN, RIGHT? 3439 02:06:55,680 --> 02:06:57,440 BUT THESE ARE THE ISSUES BUT I 3440 02:06:57,440 --> 02:06:58,600 DON'T--I DON'T THINK THAT WE CAN 3441 02:06:58,600 --> 02:07:00,840 GET AWAY WITH NOT DOING THAT NOW 3442 02:07:00,840 --> 02:07:03,280 THAT WE'VE HEARD THAT WE HAVE TO 3443 02:07:03,280 --> 02:07:04,200 DO THAT. 3444 02:07:04,200 --> 02:07:05,480 TYLER DID YOU WANT TO? 3445 02:07:05,480 --> 02:07:06,640 I HAD ANOTHER COMMENT BUT I 3446 02:07:06,640 --> 02:07:09,240 WANTED TO WAIT FOR TYLER WITH 3447 02:07:09,240 --> 02:07:09,640 THIS CONVERSATION. 3448 02:07:09,640 --> 02:07:13,120 >> AGAIN, WITH MY EXPERIENCE, 3449 02:07:13,120 --> 02:07:15,960 DR. RIVA, POSSE AND DR. MAYBURG, 3450 02:07:15,960 --> 02:07:18,520 THE MENTAL STATE I WAS IN I 3451 02:07:18,520 --> 02:07:19,240 COULDN'T ABSORB EVERYTHING, I 3452 02:07:19,240 --> 02:07:20,600 KNEW WHRAFS ANYTHING ON AND I 3453 02:07:20,600 --> 02:07:21,560 HAD GIVEN MY CONSENT FOR 3454 02:07:21,560 --> 02:07:22,600 EVERYTHING BUT I WAS FORTUNATE 3455 02:07:22,600 --> 02:07:25,040 TO HAVE THE SUPPORT SYSTEM OF 3456 02:07:25,040 --> 02:07:27,080 THE FAMILY SYSTEM OF MY FATHER 3457 02:07:27,080 --> 02:07:28,280 AND MOTHER PRESENT. 3458 02:07:28,280 --> 02:07:31,880 SO AGAIN, FROM WHAT I RECALL, 3459 02:07:31,880 --> 02:07:33,520 EVERYTHING WAS KIND OF LAID OUT 3460 02:07:33,520 --> 02:07:35,440 FLAT FOR ME, THIS IS WHAT WE'RE 3461 02:07:35,440 --> 02:07:38,120 GOING TO BE DOING, THAT WILL 3462 02:07:38,120 --> 02:07:39,960 LAST--YOUR BATTERY WILL LAST 3463 02:07:39,960 --> 02:07:40,560 X-AMOUNT OF TIME. 3464 02:07:40,560 --> 02:07:42,720 IT WILL NEED TO BE CHANGED OUT. 3465 02:07:42,720 --> 02:07:44,040 AND WE WILL CROSS THAT BRIDGE 3466 02:07:44,040 --> 02:07:46,280 WHEN WE COME TO IT AND SURE 3467 02:07:46,280 --> 02:07:48,720 ENOUGH WHEN I HAD TO HAVE IT 3468 02:07:48,720 --> 02:07:50,760 CHANGED OUT I WAS SO CONCERNED 3469 02:07:50,760 --> 02:07:52,240 LIKE OH GOSH WHAT'S MY LIFE 3470 02:07:52,240 --> 02:07:55,240 GOING TO BE LIKE WHEN THIS THING 3471 02:07:55,240 --> 02:07:55,480 DAYS? 3472 02:07:55,480 --> 02:07:57,720 WILL I COMPLETE LE REVERT? 3473 02:07:57,720 --> 02:08:00,000 WHEN AGAIN WHEN I TALKED TO 3474 02:08:00,000 --> 02:08:01,600 DR. RIVA, WE WILL GET YOU IN 3475 02:08:01,600 --> 02:08:02,960 QUICK AND YOU HAVE PLENTY OF 3476 02:08:02,960 --> 02:08:04,200 TIME AND SPACE BETWEEN THE 3477 02:08:04,200 --> 02:08:06,360 BATTERY CHANGE WHERE YOU'RE NOT 3478 02:08:06,360 --> 02:08:08,960 GOING TO BE DEGRADE IF YOU WILL 3479 02:08:08,960 --> 02:08:10,880 BACK TO THAT FORMER MENTAL AND 3480 02:08:10,880 --> 02:08:12,480 EMOTIONAL STATE AND AGAIN I WAS 3481 02:08:12,480 --> 02:08:13,560 PROMPTLY TAKEN CARE OF. 3482 02:08:13,560 --> 02:08:14,880 AGAIN, THIS IS JUST MY OWN 3483 02:08:14,880 --> 02:08:15,320 EXPERIENCE. 3484 02:08:15,320 --> 02:08:18,160 I KNOW IT HAS NOT BEEN THE SAME 3485 02:08:18,160 --> 02:08:19,240 FOR OTHERS JUST FROM LISTENING 3486 02:08:19,240 --> 02:08:21,200 AND I KNOW IT'S NOT ALWAYS THE 3487 02:08:21,200 --> 02:08:27,720 CASE BUT THAT'S REALLY JUST MY 3488 02:08:27,720 --> 02:08:28,400 EXPERIENCE WITH IT. 3489 02:08:28,400 --> 02:08:32,560 BUT I DO VALUE THAT AND IT'S 3490 02:08:32,560 --> 02:08:33,080 EXTREMELY EXPRNT I CANNOT 3491 02:08:33,080 --> 02:08:34,560 IMAGINE NOT HAVING THAT. 3492 02:08:34,560 --> 02:08:36,800 , TRACEY DID YOU WANT TO MAKE A 3493 02:08:36,800 --> 02:08:39,840 DIFFERENT POINT UNLESS DR. RIVA 3494 02:08:39,840 --> 02:08:41,520 POSSE WANTED TO RESPOND, I 3495 02:08:41,520 --> 02:08:42,760 WASN'T SURE IF YOU HAD YOUR 3496 02:08:42,760 --> 02:08:43,400 FINGER UP. 3497 02:08:43,400 --> 02:08:47,160 >> YES, SORRY, I DON'T KNOW IF 3498 02:08:47,160 --> 02:08:48,400 DR. DIXON-SALAZAR HAS SOMETHING 3499 02:08:48,400 --> 02:08:55,400 ELSE TO SAY, BUT YOU KNOW THE 3500 02:08:55,400 --> 02:08:59,880 CONSENT PROCESS IS ESPECIALLY IN 3501 02:08:59,880 --> 02:09:01,160 IMPLANTABLE NEUROMODDULATION 3502 02:09:01,160 --> 02:09:08,360 DEVICES, SOMETHING WE TAKE VERY 3503 02:09:08,360 --> 02:09:08,880 SERIOUSLY. 3504 02:09:08,880 --> 02:09:12,840 AS SERIOUSLY AS 1 CAN TAKE IT, 3505 02:09:12,840 --> 02:09:14,440 IT'S NEVER A 1 TIME DEAL IN 3506 02:09:14,440 --> 02:09:16,600 WHICH ALL QUESTIONS ARE ANSWERED 3507 02:09:16,600 --> 02:09:19,920 AND ALL DOUBTS HAVE BEEN CLEARED 3508 02:09:19,920 --> 02:09:24,200 BECAUSE THERE WILL ALSO BE A 3509 02:09:24,200 --> 02:09:25,000 PARTICULAR SCENARIO OR DOUBT 3510 02:09:25,000 --> 02:09:26,680 THAT WILL COME UP MANY TIMES, 3511 02:09:26,680 --> 02:09:34,160 YOU KNOW YEARS LATER YOU KNOW, 3512 02:09:34,160 --> 02:09:36,640 AND THE CONSENTS PROCESS TO ME 3513 02:09:36,640 --> 02:09:39,680 IS NOT JUST AND WE REQUIRE, WE 3514 02:09:39,680 --> 02:09:41,880 STRONGLY ENCOURAGE PATIENTS TO 3515 02:09:41,880 --> 02:09:47,280 COME WITH LOVED 1S, ADVOCATES, 3516 02:09:47,280 --> 02:09:49,360 FRIENDS, USUALLY FAMILY TO 3517 02:09:49,360 --> 02:09:50,160 DISCUSS EACH CASE. 3518 02:09:50,160 --> 02:09:53,240 WE GIVE THEM COPIES, IN ADVANCE 3519 02:09:53,240 --> 02:09:54,880 FOR THEM TO READ AND REGARDLESS, 3520 02:09:54,880 --> 02:10:00,000 AS MUCH AS I CAN, YOU KNOW 3521 02:10:00,000 --> 02:10:02,200 DEDICATE AFTER EACH PHOTOGRAPH 3522 02:10:02,200 --> 02:10:03,560 AN OPENING FOR CLARIFICATION, 3523 02:10:03,560 --> 02:10:05,880 THERE WILL ALWAYS BE ASPECTS 3524 02:10:05,880 --> 02:10:07,760 THAT WILL BE ADDRESSED LATER, 3525 02:10:07,760 --> 02:10:09,680 YOU KNOW AND I WILL HAVE TO SAY, 3526 02:10:09,680 --> 02:10:17,680 HEY, WE TALKED ABOUT THIS IN THE 3527 02:10:17,680 --> 02:10:18,480 CONSENT. 3528 02:10:18,480 --> 02:10:19,360 THE--IT'S A FRAGILE SITUATION IN 3529 02:10:19,360 --> 02:10:21,720 WHICH PATIENTS ARE ASKED TO 3530 02:10:21,720 --> 02:10:23,680 PARTICIPATE IN A CLINICAL TRIAL 3531 02:10:23,680 --> 02:10:27,400 BECAUSE THEY FAILED EVERYTHING 3532 02:10:27,400 --> 02:10:32,600 ELSE. 3533 02:10:32,600 --> 02:10:33,920 AND YOU KNOW I HAVE NOT SEEN 3534 02:10:33,920 --> 02:10:39,440 PAICIALTS THAT CAME TO THE 3535 02:10:39,440 --> 02:10:40,880 CONSENT PROCESS, KNOWING THAT 3536 02:10:40,880 --> 02:10:42,400 THERE'S SURGERY AND THEN SAID, 3537 02:10:42,400 --> 02:10:43,880 YOU KNOW WHAT THE COMPENSATION 3538 02:10:43,880 --> 02:10:45,600 TAKE ME OFF, I WON'T TAKE THE 3539 02:10:45,600 --> 02:10:46,720 OPPORTUNITY TO PARTICIPATE IN 3540 02:10:46,720 --> 02:10:47,920 THIS TRIAL. 3541 02:10:47,920 --> 02:10:49,000 SORE, YOU KNOW I DON'T KNOW 3542 02:10:49,000 --> 02:10:50,720 WHAT'S GOING TO HAPPEN WITH 3543 02:10:50,720 --> 02:10:52,280 BATTERY REPLACEMENTS LATER ON, 3544 02:10:52,280 --> 02:10:55,120 PATIENTS ARE, YOU KNOW IN A VERY 3545 02:10:55,120 --> 02:10:56,520 VULNERABLE SITUATION, YOU KNOW, 3546 02:10:56,520 --> 02:10:57,800 THEY ARE SUFFERING TODAY, AND 3547 02:10:57,800 --> 02:10:59,560 THERE ARE ONLY THINKING ABOUT 3548 02:10:59,560 --> 02:11:05,560 THE TODAY, THE TOMORROW, THE 3549 02:11:05,560 --> 02:11:06,360 SURGERY, IT'S INCREDIBLY 3550 02:11:06,360 --> 02:11:08,600 DIFFICULT TO PUT EVERYTHING INTO 3551 02:11:08,600 --> 02:11:09,200 PERSPECTIVE. 3552 02:11:09,200 --> 02:11:11,240 I DON'T KNOW, YOU KNOW IF I WERE 3553 02:11:11,240 --> 02:11:14,600 ON THE OTHER SIDE, YOU KNOW AND 3554 02:11:14,600 --> 02:11:16,560 I'M TRYING TO CAUTIOUSLY BE 3555 02:11:16,560 --> 02:11:19,280 LAYING OUT ALL THESE THINGS, YOU 3556 02:11:19,280 --> 02:11:21,480 KNOW WE'VE DONE 15 YEARS OF 3557 02:11:21,480 --> 02:11:22,920 SURGERIES AND WE LEARN AND 1 OF 3558 02:11:22,920 --> 02:11:24,520 THE IMPORTANT THINGS THAT THAT'S 3559 02:11:24,520 --> 02:11:26,920 WHY I'M SO THANKFUL FOR HAVING 3560 02:11:26,920 --> 02:11:30,280 TYLER AND BRANDY IN THIS PANELS 3561 02:11:30,280 --> 02:11:32,600 IS YOU KNOW I OPENLY TELL THE 3562 02:11:32,600 --> 02:11:35,080 PATIENTS AND THEIR FAMILIES THAT 3563 02:11:35,080 --> 02:11:37,320 WE WHAT--WAKIND WE ARE GOING, 3564 02:11:37,320 --> 02:11:39,800 WHEN A PARTNERSHIP TOGETHER. 3565 02:11:39,800 --> 02:11:40,360 YOU KNOW? 3566 02:11:40,360 --> 02:11:45,880 WE'RE LEARNING, I LEARN FROM 3567 02:11:45,880 --> 02:11:47,840 THEM AND THEY MAY GET SOME 3568 02:11:47,840 --> 02:11:51,160 BENEFIT FROM THE THERAPY BUT YOU 3569 02:11:51,160 --> 02:11:53,920 KNOW IT'S A LIFE LONG 3570 02:11:53,920 --> 02:11:56,880 COMMITMENT, COMPLETELY LIFE LONG 3571 02:11:56,880 --> 02:11:58,840 COMMITMENT THAT GOES BEYOND AN 3572 02:11:58,840 --> 02:11:59,680 ARBITRARY END OF A CLINICAL 3573 02:11:59,680 --> 02:12:04,720 TRIAL AND THIS IS WHAT WE'RE 3574 02:12:04,720 --> 02:12:05,640 TALKING ABOUT TODAY. 3575 02:12:05,640 --> 02:12:09,000 LIFE LONG DISABLING COB DITIONS 3576 02:12:09,000 --> 02:12:10,080 WHETHER THERE'S NEUROLOGICAL, 3577 02:12:10,080 --> 02:12:12,520 PSYCHIATRIC OR WHATEVER ARE NOT 3578 02:12:12,520 --> 02:12:16,200 DECIDED AT THE END AND THAT'S 3579 02:12:16,200 --> 02:12:17,640 SIMILAR TO CONSENT, IT'S AN 3580 02:12:17,640 --> 02:12:19,760 ONGOING PROCESS, YOU KNOW, SOME 3581 02:12:19,760 --> 02:12:21,880 PATIENTS WILL CHOOSE TO STOP 3582 02:12:21,880 --> 02:12:23,200 PARTICIPATE NOTHING A TRIAL MANY 3583 02:12:23,200 --> 02:12:24,600 YEARS LATER AND THEY WANT TO DO 3584 02:12:24,600 --> 02:12:31,520 IT AT THE BEGINNING. 3585 02:12:31,520 --> 02:12:31,960 >> THANK YOU. 3586 02:12:31,960 --> 02:12:39,640 I FEEL LIKE I SHOULD QUANTIFY Y 3587 02:12:39,640 --> 02:12:40,520 STATEMENTS, I THINK WHAT'S MISS 3588 02:12:40,520 --> 02:12:42,000 SUGGEST THAT THESE WERE CREATED 3589 02:12:42,000 --> 02:12:44,000 TO BE USEFUL TO CERTAIN 3590 02:12:44,000 --> 02:12:45,560 AUDIENCES AND THEY'RE OVERSEEN, 3591 02:12:45,560 --> 02:12:47,400 RIGHT BY PROFESSIONALS WHO 3592 02:12:47,400 --> 02:12:50,760 UNDERSTAND THE SYSTEM. 3593 02:12:50,760 --> 02:12:52,600 THEY'RE NOT PATIENT FRIENDLY. 3594 02:12:52,600 --> 02:12:54,080 INFORMED CONSENT IS DICTATED 3595 02:12:54,080 --> 02:13:00,800 MOSTLY BY THE IRB AND WHATEVER'S 3596 02:13:00,800 --> 02:13:02,080 ON CLINICALTRIALS.GOV AND THE 3597 02:13:02,080 --> 02:13:04,040 FDA IS DICTATED BY WHAT IT NEEDS 3598 02:13:04,040 --> 02:13:05,040 FOR TRIAL INFORMATION BUT IF 3599 02:13:05,040 --> 02:13:06,960 YOU'RE TRYING TO RELATE TO A 3600 02:13:06,960 --> 02:13:08,960 BROAD RANGE OF PEOPLE WHO HAVE 3601 02:13:08,960 --> 02:13:10,440 VARYING EDUCATION OUT THERE, 3602 02:13:10,440 --> 02:13:11,880 IT'S NOT BEEN MADE PATIENT 3603 02:13:11,880 --> 02:13:12,800 FRIENDLY IT'S NOT IN LAY 3604 02:13:12,800 --> 02:13:17,800 LANGUAGE AND IT'S NOT REALLY SET 3605 02:13:17,800 --> 02:13:20,840 UP IN A WAY WHERE IF YOU THINK 3606 02:13:20,840 --> 02:13:21,800 ABOUT TIKTOK OR YOU THE WAY YOU 3607 02:13:21,800 --> 02:13:24,600 WANT TO GO ON IT A WEBSITE YOU 3608 02:13:24,600 --> 02:13:26,360 WANT TO BE ADVERTISED TO FOR 3609 02:13:26,360 --> 02:13:28,080 YOUR IPHONE SO YOU'RE IN A 3610 02:13:28,080 --> 02:13:29,080 CULTURE WHERE PEOPLE ARE 3611 02:13:29,080 --> 02:13:31,680 EDUCATED AND USED TO BEING 3612 02:13:31,680 --> 02:13:34,680 EDUCATED IN A CERTAIN WAY AND-- 3613 02:13:34,680 --> 02:13:35,800 >> HOW MANY TIMES DO WE AGREEN 3614 02:13:35,800 --> 02:13:38,320 CELLS TO THE TERMS AND 3615 02:13:38,320 --> 02:13:40,760 CONDITIONS, GET THIS THING, FIX 3616 02:13:40,760 --> 02:13:42,440 THIS, YOU PROMISED ME, I TRUST 3617 02:13:42,440 --> 02:13:45,160 YOU JUST DO IT, YOU KNOW AND 3618 02:13:45,160 --> 02:13:46,960 YEAH. 3619 02:13:46,960 --> 02:13:47,600 >> YEAH, GOOD POINT. 3620 02:13:47,600 --> 02:13:49,080 >> LET'S GET US BACK TO THE MAIN 3621 02:13:49,080 --> 02:13:51,040 DISCUSSION QUESTIONS IF WE CAN. 3622 02:13:51,040 --> 02:13:53,840 ALTHOUGH THIS IS A REALLY 3623 02:13:53,840 --> 02:13:55,160 IMPORTANT DISCUSSION AROUND 3624 02:13:55,160 --> 02:13:58,600 INFORMED CONSENT. 3625 02:13:58,600 --> 02:13:59,920 I THINK, HANK, YOU WERE NEXT, 3626 02:13:59,920 --> 02:14:01,360 BUT I DON'T BEING I WILL GO BACK 3627 02:14:01,360 --> 02:14:02,960 TO THE DISCUSSION QUESTIONS BUT 3628 02:14:02,960 --> 02:14:04,040 THERE'S A FACTUAL QUESTION 3629 02:14:04,040 --> 02:14:05,120 THAT'S IMPORTANT TO ME IN THINK 3630 02:14:05,120 --> 02:14:06,440 BEING THE NEXT PANEL FOR THE 3631 02:14:06,440 --> 02:14:07,600 OPEN FORUM, I DON'T KNOW THE 3632 02:14:07,600 --> 02:14:13,680 ANSWER TO IT, I THINK MAYBE 3633 02:14:13,680 --> 02:14:15,480 SHOULD OF THE RESEARCHERS 3634 02:14:15,480 --> 02:14:18,840 INVOLVED IN RUNNING THESE TRIALS 3635 02:14:18,840 --> 02:14:20,880 THAT THEY MIGHT--THE 3636 02:14:20,880 --> 02:14:23,600 PARTICIPANTS ARE GETTING BCI OR 3637 02:14:23,600 --> 02:14:25,960 DEEP BRAIN STIMULATION FOR VERY 3638 02:14:25,960 --> 02:14:27,000 SERIOUS CONDITIONS, WHAT 3639 02:14:27,000 --> 02:14:28,640 PERCENTAGE OF PARTICIPANTS DO WE 3640 02:14:28,640 --> 02:14:33,920 THINK ARE COVERED BY MEDICARE AS 3641 02:14:33,920 --> 02:14:35,160 BEING LONG-TERM DISABLED? 3642 02:14:35,160 --> 02:14:37,760 I DON'T EXPECT SOMEBODY TO SAY 3643 02:14:37,760 --> 02:14:39,280 63.7% BUT, DO PEOPLE HAVE A 3644 02:14:39,280 --> 02:14:41,640 SENSE OF HOW MANY OF THE 3645 02:14:41,640 --> 02:14:44,560 PARTICIPANTS, WHETHER IT'S MOST, 3646 02:14:44,560 --> 02:14:55,000 HALF, A FEW, HAVE MEDICARE 3647 02:14:55,520 --> 02:14:56,200 COVERAGE. 3648 02:14:56,200 --> 02:14:57,800 >> AND OUR COMMUNITY IS--SO I 3649 02:14:57,800 --> 02:14:59,000 LIVE IN CALIFORNIA, SO 3650 02:14:59,000 --> 02:15:00,240 CALIFORNIA HAS CHILDREN'S 3651 02:15:00,240 --> 02:15:01,880 SERVICES AND THEN AS SOON AS 3652 02:15:01,880 --> 02:15:05,280 THEY REACH THE AGE OF 18, 3653 02:15:05,280 --> 02:15:07,960 MAJORITY OF THEM ARE DISABLED 3654 02:15:07,960 --> 02:15:18,480 AND ON MEDICARE OR MEDIICAL. 3655 02:15:20,840 --> 02:15:22,040 ANYBODY ELSE? 3656 02:15:22,040 --> 02:15:24,080 >> I GUESS I WAS CURIOUS ABOUT A 3657 02:15:24,080 --> 02:15:27,080 STUDY WE HEARD ABOUT IN CANADA. 3658 02:15:27,080 --> 02:15:28,600 IS COST CONSIDERATION THERE WITH 3659 02:15:28,600 --> 02:15:30,920 THEIR NATIONAL HEALTH SYSTEM? 3660 02:15:30,920 --> 02:15:34,800 >> NOT AS FAR AS I AM CONCERNED. 3661 02:15:34,800 --> 02:15:38,720 THERE IS A DIFFERENT APPROACH TO 3662 02:15:38,720 --> 02:15:39,360 INVESTIGATOR INITIATED STUDIES, 3663 02:15:39,360 --> 02:15:43,880 THAT ARE NOT, YOU KNOW AN EXPERT 3664 02:15:43,880 --> 02:15:46,480 ON CANADIAN REGULATIONS BUT, YOU 3665 02:15:46,480 --> 02:15:51,520 KNOW THERE ARE--DR. LOZANO WHO'S 3666 02:15:51,520 --> 02:15:53,480 A PIONEER AND NEUROSURGEON IN 3667 02:15:53,480 --> 02:15:55,640 DEEP BRAIN STIMULATION HAS DONE 3668 02:15:55,640 --> 02:15:58,240 A NUMBER OF SMALL CLINICAL 3669 02:15:58,240 --> 02:16:02,280 TRIALS, STUDIES IN A WAY, YOU 3670 02:16:02,280 --> 02:16:03,800 KNOW THE CLINICAL TRIAL WILL 3671 02:16:03,800 --> 02:16:05,200 SOMETIMES CONFUSE THIS IS NOT 3672 02:16:05,200 --> 02:16:08,680 SOMETIMES TO TRY TO DEMONSTRATE 3673 02:16:08,680 --> 02:16:11,760 AGAINST, YOU KNOW SHAM OR ACTIVE 3674 02:16:11,760 --> 02:16:14,760 STIMULATION BUT MANY TIMES PROOF 3675 02:16:14,760 --> 02:16:16,280 OF CONCEPT APPROACHES ISSUES 3676 02:16:16,280 --> 02:16:16,480 RIGHT? 3677 02:16:16,480 --> 02:16:22,280 AND HE'S DONE IT IN ALZHEIMERS 3678 02:16:22,280 --> 02:16:24,560 BEILEMMIA, ANOREXIA NERVOSA, IN 3679 02:16:24,560 --> 02:16:31,160 DEPRESSION OF COURSE, SO, THE 3680 02:16:31,160 --> 02:16:38,520 COSTS THERE ARE MUCH MORE 3681 02:16:38,520 --> 02:16:39,840 DILUTED IN THE SYSTEM. 3682 02:16:39,840 --> 02:16:41,120 >> SO, YEAH I WAS TRYING TO FIND 3683 02:16:41,120 --> 02:16:42,560 AN ANSWER TO THE ORIGINAL 3684 02:16:42,560 --> 02:16:43,760 QUESTION WHERE A HUNDRED% OF 3685 02:16:43,760 --> 02:16:47,840 PEOPLE ARE ON SOCIAL SECURITY 3686 02:16:47,840 --> 02:16:48,240 ESSENTIALLY BUT. 3687 02:16:48,240 --> 02:16:51,560 >> BUT NOT IN OUR CASE FOR DEEP 3688 02:16:51,560 --> 02:16:52,040 BRAIN STIMULATION. 3689 02:16:52,040 --> 02:16:54,160 OF COURSE PEDIATRIC POPULATIONS 3690 02:16:54,160 --> 02:16:57,240 MAY HAVE BETTER COVERAGE BUT IN 3691 02:16:57,240 --> 02:17:00,440 OUR CASE, A LARGE NUMBER OF OUR 3692 02:17:00,440 --> 02:17:01,680 PARTICIPANTS IN DEEP BRAIN 3693 02:17:01,680 --> 02:17:03,840 STIMULATION FOR DEPRESSION WERE 3694 02:17:03,840 --> 02:17:09,520 NOT ENROLLED IN MEDICARE OR 3695 02:17:09,520 --> 02:17:10,400 FLEXIBILITY FOR LONG-TERM 3696 02:17:10,400 --> 02:17:11,880 FLEXIBILITY, RIGHT NOW, I 3697 02:17:11,880 --> 02:17:14,400 HAVE--I AM INCLUDING PATIENTS 3698 02:17:14,400 --> 02:17:16,360 THAT CAN ONLY HAVE MEDICARE FOR 3699 02:17:16,360 --> 02:17:18,440 EXAMPLE, FOR THE VAGUS NERVE 3700 02:17:18,440 --> 02:17:22,880 STIMULATION WHICH IS, YOU KNOW 3701 02:17:22,880 --> 02:17:25,400 JUST SPONSORED IN PARTNERSHIP 3702 02:17:25,400 --> 02:17:27,400 WITH THE COMPANY SO PATIENTS CAN 3703 02:17:27,400 --> 02:17:30,440 ONLY BE MEDICARE RECIPIENTS AND 3704 02:17:30,440 --> 02:17:32,520 THAT, YOU KNOW HAS--I CAN ONLY 3705 02:17:32,520 --> 02:17:34,000 RECRUIT PATIENTS FROM THERE, 3706 02:17:34,000 --> 02:17:35,960 WHICH YOU KNOW, WOULD GENERATE A 3707 02:17:35,960 --> 02:17:38,040 PROBLEM OF COURSE WITH EQUITY 3708 02:17:38,040 --> 02:17:43,320 AND ACCESS TO HEALTHCARE, BUT 3709 02:17:43,320 --> 02:17:45,920 YOU KNOW IT'S THE SITUATION 3710 02:17:45,920 --> 02:17:46,320 GIVEN THE SPONSOR. 3711 02:17:46,320 --> 02:17:47,760 >> SO WE ARE GOING TO MOVE ON 3712 02:17:47,760 --> 02:17:48,840 BECAUSE WE HAVE 300S UP AND 3713 02:17:48,840 --> 02:17:50,600 WE'RE RUNNING OUT OF TIME OF 3714 02:17:50,600 --> 02:17:52,840 COURSE, SO BELIEVE GABE WAS NEXT 3715 02:17:52,840 --> 02:17:54,720 AND THEN WINSTON AND TRACEY I'M 3716 02:17:54,720 --> 02:17:56,360 SORRY IF WE GOT YOU MIXED UP AND 3717 02:17:56,360 --> 02:17:57,600 I WILL CALL EVERYBODY BY THEIR 3718 02:17:57,600 --> 02:18:01,120 FIRST NAME SO I DON'T CREW UP 3719 02:18:01,120 --> 02:18:01,480 AGAIN. 3720 02:18:01,480 --> 02:18:02,720 >> YEAH, WINSTON WERE YOU FIRST, 3721 02:18:02,720 --> 02:18:06,040 IF YOU WERE FIRST PLEASE GO 3722 02:18:06,040 --> 02:18:06,280 AHEAD. 3723 02:18:06,280 --> 02:18:10,560 >> OKAY, SO I WILL GO. 3724 02:18:10,560 --> 02:18:12,120 SO 2 COMMENTS, 1 GOING BACK TO 3725 02:18:12,120 --> 02:18:13,520 THE CHILDREN BUT BRIEFLY, SO AS 3726 02:18:13,520 --> 02:18:15,400 I MENTIONED THERE WERE A NUMBER 3727 02:18:15,400 --> 02:18:19,960 OF--WE SAW A NUMBER OF PATIENTS 3728 02:18:19,960 --> 02:18:20,720 PARTICIPATING IMPLANTABLE DEVICE 3729 02:18:20,720 --> 02:18:22,800 TRIALS THAT DID NOT RECALL EVEN 3730 02:18:22,800 --> 02:18:24,160 HAVING A CONVERSATION ABOUT 3731 02:18:24,160 --> 02:18:25,160 DEVICE MAINTENANCE AND SO I 3732 02:18:25,160 --> 02:18:27,160 THINK WE NEED TO--THERE ARE 3733 02:18:27,160 --> 02:18:28,680 CERTAIN THING THAT WE NEED TO 3734 02:18:28,680 --> 02:18:30,000 PRIORITIZE IN THE CONSENT 3735 02:18:30,000 --> 02:18:31,080 PROCESS APPROXIMATE AND WHAT'S 3736 02:18:31,080 --> 02:18:32,440 GOING TO HAPPEN A YEAR AND HALF 3737 02:18:32,440 --> 02:18:34,920 FROM NOW WHEN THE TRIAL IS OVER, 3738 02:18:34,920 --> 02:18:37,400 I THINK IT'S 1 OF THEM THAT'S 3739 02:18:37,400 --> 02:18:38,760 VERY IMPORTANT, MAYBE HAVING, 3740 02:18:38,760 --> 02:18:41,520 YOU KNOW THE CARE PARTNERS 3741 02:18:41,520 --> 02:18:42,360 SOMEONE ELSE THERE, HELPING 3742 02:18:42,360 --> 02:18:43,680 THROUGH THAT PROCESS SO THAT 3743 02:18:43,680 --> 02:18:45,000 THEY ARE AWARE OF WHAT'S GOING 3744 02:18:45,000 --> 02:18:45,280 TO HAPPEN. 3745 02:18:45,280 --> 02:18:47,240 I THINK IT'S A REALLY IMPORTANT 3746 02:18:47,240 --> 02:18:47,440 PART. 3747 02:18:47,440 --> 02:18:50,600 NOW WHAT SHOULD BE THE MIN NUM 3748 02:18:50,600 --> 02:18:52,040 COVERAGE, I THINK PARTICULARLY 3749 02:18:52,040 --> 02:18:53,400 FOR PATIENT WHO IS HAVE 3750 02:18:53,400 --> 02:18:54,120 TREATMENT RESISTANT CONDITION 3751 02:18:54,120 --> 02:18:56,920 THAT ARE GOING IN, HAVE NOT 3752 02:18:56,920 --> 02:18:57,840 RESPONDED TO ANYTHING AND 3753 02:18:57,840 --> 02:18:59,160 THERAPY AND BENEFITING FROM THIS 3754 02:18:59,160 --> 02:18:59,520 DEVICE. 3755 02:18:59,520 --> 02:19:04,960 THIS IS THE ONLY THING THAT THEY 3756 02:19:04,960 --> 02:19:05,320 HAVE AVAILABLE. 3757 02:19:05,320 --> 02:19:07,400 I THINK WE NEED TO MAKE SUREAT 3758 02:19:07,400 --> 02:19:08,720 E COVER WHATEVER 3759 02:19:08,720 --> 02:19:09,480 MAINTENANCE IS NECESSARY. 3760 02:19:09,480 --> 02:19:12,840 NOW WHO PAYS I THINK IS THE 3761 02:19:12,840 --> 02:19:14,560 QUESTION, OR WE COVER WHATEVER 3762 02:19:14,560 --> 02:19:16,480 MAINTENANCE IS NECESSARY UNTIL, 3763 02:19:16,480 --> 02:19:18,960 YOU KNOW THE PRODUCT BECOMES 3764 02:19:18,960 --> 02:19:20,720 COMMERCIALLY AVAILABLE OR 3765 02:19:20,720 --> 02:19:21,360 THERE'S FDA APPROVAL. 3766 02:19:21,360 --> 02:19:22,360 OF COURSE THERE WILL BE A NUMBER 3767 02:19:22,360 --> 02:19:23,800 OF DIFFERENT GROUPS THAT CAN 3768 02:19:23,800 --> 02:19:26,600 CHIP IN, BUT I THINK THIS SHOULD 3769 02:19:26,600 --> 02:19:28,760 BE PART OF THE COST OF DOING 3770 02:19:28,760 --> 02:19:29,680 BUSINESS, YOU KNOW, IF WE ARE 3771 02:19:29,680 --> 02:19:32,480 GOING TO WORK WITH THESE 3772 02:19:32,480 --> 02:19:33,400 PATIENTS, THIS IS A COMMITMENT 3773 02:19:33,400 --> 02:19:35,960 THAT WE NEED TO MAKE TO THIS 3774 02:19:35,960 --> 02:19:39,000 PATIENT POPULATION AND WE CAN'T 3775 02:19:39,000 --> 02:19:41,960 JUST BE THINKING ABOUT THE COST 3776 02:19:41,960 --> 02:19:45,240 OF THE TRIAL OR FAILING FAST AND 3777 02:19:45,240 --> 02:19:48,520 THEN JUST MOVING ON TO ANOTHER 3778 02:19:48,520 --> 02:19:51,080 DEVICE, WE NEED TO BE COMMITTED 3779 02:19:51,080 --> 02:19:54,640 TO THE PATIENT POPULATION, FIRST 3780 02:19:54,640 --> 02:19:56,000 AND THEN IF, I KNOW THIS IS NOT 3781 02:19:56,000 --> 02:19:58,240 THE WAY THAT PEOPLE THINK BUT, 3782 02:19:58,240 --> 02:20:00,000 YOU KNOW IT'S REALLY IMPORTANT 3783 02:20:00,000 --> 02:20:02,600 THAT THE MAINTENANCE OF THAT 3784 02:20:02,600 --> 02:20:03,880 DEVICE BE INSURED FOR THE 3785 02:20:03,880 --> 02:20:11,200 DURATION OF THIS PERSON'S LIFE 3786 02:20:11,200 --> 02:20:12,320 OR UNTIL SOMEONE ELSE CAN COVER 3787 02:20:12,320 --> 02:20:14,360 IT IF THEY CAN'T COVER IT 3788 02:20:14,360 --> 02:20:15,280 THEMSELVES. 3789 02:20:15,280 --> 02:20:15,880 >> GREAT. 3790 02:20:15,880 --> 02:20:16,120 WINSTON? 3791 02:20:16,120 --> 02:20:17,600 >> THIS MIGHT BE A QUESTION MORE 3792 02:20:17,600 --> 02:20:19,320 FOR THE NEXT PANEL, BUT WE'RE 3793 02:20:19,320 --> 02:20:21,120 TALKING ABOUT WHAT NEEDS TO BE 3794 02:20:21,120 --> 02:20:21,920 PROVIDED WE'RE PROBABLY TALKING 3795 02:20:21,920 --> 02:20:24,560 ABOUT WHAT IS OWED TO PEOPLE AND 3796 02:20:24,560 --> 02:20:25,880 PART OF WHAT GOES INTO LAWN 3797 02:20:25,880 --> 02:20:27,360 MOWER IS OWED TO PEOPLE IS THE 3798 02:20:27,360 --> 02:20:28,840 RELATIONSHIP WE BEAR TO THEM, SO 3799 02:20:28,840 --> 02:20:30,080 WHEY OWE FROM MY CHILDREN IS 3800 02:20:30,080 --> 02:20:31,480 DIFFERENT THAN WHAT I OWE TO MY 3801 02:20:31,480 --> 02:20:33,400 PATIENTS AND MY CLINIC AND I 3802 02:20:33,400 --> 02:20:34,920 HAVE BEEN LISTENING TO A LOT OF 3803 02:20:34,920 --> 02:20:35,840 PEOPLE AND THINKING ABOUT THE 3804 02:20:35,840 --> 02:20:37,640 DIFFERENT TERMS THAT WE'RE USING 3805 02:20:37,640 --> 02:20:39,120 FOR THE DIFFERENT KIND OF 3806 02:20:39,120 --> 02:20:40,680 METAPHORS FOR THE RELATIONSHIP. 3807 02:20:40,680 --> 02:20:41,560 SO SOMETIMES WE'RE TALKING ABOUT 3808 02:20:41,560 --> 02:20:43,920 PEOPLE WHO PARTICIPATE IN THESE 3809 02:20:43,920 --> 02:20:46,520 STUDIES AS TEAM MEMBERS OR 3810 02:20:46,520 --> 02:20:47,560 COWORKERS, SOMETIMES WE'RE 3811 02:20:47,560 --> 02:20:48,760 THINKING ABOUT THEM AS 3812 02:20:48,760 --> 02:20:50,800 VOLUNTEERS THAT,'S COME UP LESS 3813 02:20:50,800 --> 02:20:53,120 BUT I THINK AMONG OTHER THINGS, 3814 02:20:53,120 --> 02:20:58,480 TRACEY--I'M SORRY THE PANELISTS 3815 02:20:58,480 --> 02:21:00,640 YESTERDAY BRANDY AND JEN TALKING 3816 02:21:00,640 --> 02:21:05,000 ABOUT HOW A VOLUNTEERIST 3817 02:21:05,000 --> 02:21:05,720 APPROACH AFFECTS THE 3818 02:21:05,720 --> 02:21:07,000 PARTICIPATION IN THESE STUDIES 3819 02:21:07,000 --> 02:21:08,760 SO WE'VE SEEN VOLUNTEERING AS A 3820 02:21:08,760 --> 02:21:09,720 WEAKNESS MODEL AND THEN WE 3821 02:21:09,720 --> 02:21:10,960 TALKED ABOUT PEOPLE IN THESE 3822 02:21:10,960 --> 02:21:13,440 STUDIES AS PATIENTS AND I THINK, 3823 02:21:13,440 --> 02:21:14,640 YOU KNOW 1 QUESTION FOR NOW AND 3824 02:21:14,640 --> 02:21:17,200 MAYBE 1 QUESTION FOR THE NEXT 3825 02:21:17,200 --> 02:21:19,440 PANEL IS WHAT'S THE RIGHT WAY OF 3826 02:21:19,440 --> 02:21:21,080 THINK BEING THE RELATIONSHIP 3827 02:21:21,080 --> 02:21:21,880 THAT WE STAND BOTH THE 3828 02:21:21,880 --> 02:21:25,200 INVESTIGATORS IN THE STUDY AND 3829 02:21:25,200 --> 02:21:26,120 MAYBE THE BROADER SOCIETY STAND 3830 02:21:26,120 --> 02:21:28,920 IN TO THE PEOPLE WHO ARE ENGAGED 3831 02:21:28,920 --> 02:21:31,080 IN THIS VERY LONG RANGE AND IN 3832 02:21:31,080 --> 02:21:34,480 SOME CASES HIGH RISK RESEARCH. 3833 02:21:34,480 --> 02:21:37,400 SO THAT WAS 1 THOUGHT IN TERMS 3834 02:21:37,400 --> 02:21:39,280 OF EMBEDDING THE DISCUSSION AND 3835 02:21:39,280 --> 02:21:40,200 THAT MIGHT ALSO RELATE US TO 3836 02:21:40,200 --> 02:21:41,800 TURNOVER QUESTIONS ABOUT THE 3837 02:21:41,800 --> 02:21:43,120 VIRTUES, I THINK I HAVE BEEN 3838 02:21:43,120 --> 02:21:44,520 HEARING ABOUT IN THE CONTEXT OF 3839 02:21:44,520 --> 02:21:46,240 WHEN THE STUDIES ARE CONDUCTED 3840 02:21:46,240 --> 02:21:48,600 WELL, AND YOU KNOW WHAT MAKES 3841 02:21:48,600 --> 02:21:50,040 FOR A FRUITFUL RELATIONSHIP THAT 3842 02:21:50,040 --> 02:21:51,200 IS, YOU KNOW HOPEFULLY 3843 02:21:51,200 --> 02:21:53,280 BENEFICIAL TO THE PEOPLE WHO 3844 02:21:53,280 --> 02:21:54,400 VOLUNTEERED IN THESE STUDIES. 3845 02:21:54,400 --> 02:21:56,280 THERE I GO, THE PEOPLE WHO ARE 3846 02:21:56,280 --> 02:22:00,080 INVOLVE IN THESE STADS AND THEIR 3847 02:22:00,080 --> 02:22:00,560 INVOLVEMENT. 3848 02:22:00,560 --> 02:22:01,240 >> GREAT. 3849 02:22:01,240 --> 02:22:03,160 THANK YOU WINSTON. 3850 02:22:03,160 --> 02:22:03,840 TRAIZY. 3851 02:22:03,840 --> 02:22:04,600 >> I JUST WANT TO BRICK IT BACK 3852 02:22:04,600 --> 02:22:08,800 TO THE QUESTION THAT WAS 3853 02:22:08,800 --> 02:22:11,560 ORIGINALLY ASKED IS IT'S REALLY 3854 02:22:11,560 --> 02:22:13,240 HARD AS I PATIENT ADVOCATE TO 3855 02:22:13,240 --> 02:22:15,600 PRIORITIZE THIS LIST AND HAVING 3856 02:22:15,600 --> 02:22:19,400 LOOKED BACK ON OUR OWN VAGUS 3857 02:22:19,400 --> 02:22:21,200 NERVE STIMULATOR AND OUR OWN 3858 02:22:21,200 --> 02:22:21,840 SPECIALIZED EQUIPMENT AND 3859 02:22:21,840 --> 02:22:24,440 JOURNEY AND TRIALS IT'S BEEN A 3860 02:22:24,440 --> 02:22:25,280 STEAMY HOT MESS BUT THERE ARE 3861 02:22:25,280 --> 02:22:27,200 THINGS THAT CAN BE DONE RIGHT 3862 02:22:27,200 --> 02:22:27,480 NOW, RIGHT? 3863 02:22:27,480 --> 02:22:30,120 SO MODIFICATIONS TO MAKE MORE 3864 02:22:30,120 --> 02:22:31,720 INFORMED CONSENT MORE PATIENT 3865 02:22:31,720 --> 02:22:37,840 FAMILY WOULD BE GREAT. 3866 02:22:37,840 --> 02:22:40,280 BRING IN AND TWEAKING THE 3867 02:22:40,280 --> 02:22:41,960 EXISTING SYSTEM, COMING UP WITH 3868 02:22:41,960 --> 02:22:43,520 A ROOP MAP AND WE WRITE DOWN 3869 02:22:43,520 --> 02:22:44,840 WHAT'S HAPPENING IN THIS MEETING 3870 02:22:44,840 --> 02:22:49,000 SOME OF THIS IS LOW HANGING 3871 02:22:49,000 --> 02:22:50,880 FRUIT, LIKE LIKE HOW HARD IS THE 3872 02:22:50,880 --> 02:22:52,640 STUDY TO CONNECT THE PATIENTS 3873 02:22:52,640 --> 02:22:54,720 TOGETHER SO THEY CAN FORM A 3874 02:22:54,720 --> 02:22:56,840 SUPPORT SYSTEM FOR EACH OTHER 3875 02:22:56,840 --> 02:22:57,680 AND OFFERING OTHER PSYCHOLOGICAL 3876 02:22:57,680 --> 02:22:59,960 SUPPORT AND IMAGINE WHAT SORT 3877 02:22:59,960 --> 02:23:01,600 OF--WE'RE LIVING TRAUMATIZED 3878 02:23:01,600 --> 02:23:02,680 LIVES SO SOMETHING--ANYTHING 3879 02:23:02,680 --> 02:23:03,720 BEYOND CONNECTING THE PATIENTS, 3880 02:23:03,720 --> 02:23:05,920 YOU KNOW IS HARD AND WHEN YOU 3881 02:23:05,920 --> 02:23:07,200 THINK ABOUT IT, IT'S, YOU KNOW 3882 02:23:07,200 --> 02:23:08,560 ALL RIGHT, SO YOU'RE A NAWR O 3883 02:23:08,560 --> 02:23:10,760 SURGEON, WHO DO YOU WANT TO LNCH 3884 02:23:10,760 --> 02:23:11,960 FROM, WHO DO YOU WANT TO HEAR 3885 02:23:11,960 --> 02:23:14,120 FROM, WHO YOU WANT TO HEAR FROM 3886 02:23:14,120 --> 02:23:14,840 ANOTHER NEUROSURGEON WHO'S BEEN 3887 02:23:14,840 --> 02:23:16,480 THERE AND DONE THAT, PATIENTS IN 3888 02:23:16,480 --> 02:23:17,960 ARE IN THE SAME BOAT SO WHEN YOU 3889 02:23:17,960 --> 02:23:18,640 APPROACH THINGS CAN YOU THINK 3890 02:23:18,640 --> 02:23:19,920 ABOUT PATIENT WHO IS HAVE BEEN 3891 02:23:19,920 --> 02:23:21,000 THERE AND DONE THAT I REMEMBER 3892 02:23:21,000 --> 02:23:22,760 WHEN WE WENT IN THE VNS TRIAL 3893 02:23:22,760 --> 02:23:24,040 AND THEY WERE LIKE, YEAH, SHE 3894 02:23:24,040 --> 02:23:26,360 WILL HAVE TO HAVE HER BATTERY 3895 02:23:26,360 --> 02:23:28,080 REPLACE, IT DIDN'T TOWN ON ME 3896 02:23:28,080 --> 02:23:30,480 FOLLOW A FEW YEARS LATE BUT SHE 3897 02:23:30,480 --> 02:23:32,400 HAS TO HAVE SURGERY TO EVERY 4 3898 02:23:32,400 --> 02:23:34,000 TO 5 YEARS TO REPLACE THE 3899 02:23:34,000 --> 02:23:36,400 BATTERY AND THE BATTERY CHANGES 3900 02:23:36,400 --> 02:23:37,720 AND NOW SHE HAS TONS OF SCAR 3901 02:23:37,720 --> 02:23:40,920 TISSUE IN THE AREA, OH MY GOD IT 3902 02:23:40,920 --> 02:23:41,800 THERE'S AN EMERGENCY, THE 3903 02:23:41,800 --> 02:23:42,760 BATTERY HAS RIPPED THROUGH THE 3904 02:23:42,760 --> 02:23:44,640 SURFACE OF THE SKIN AND NOW WHAT 3905 02:23:44,640 --> 02:23:47,160 WHAT DO WE DO AND THEN, YOU KNOW 3906 02:23:47,160 --> 02:23:48,760 THERE HAVE BEEN ISSUES WITH,A 3907 02:23:48,760 --> 02:23:51,800 PROVAL AND SO THE DEVICE WAS 3908 02:23:51,800 --> 02:23:53,320 APPROVED FOR SEIZURES BUT MY 3909 02:23:53,320 --> 02:23:55,240 DAUGHTER HAS A DIAGNOSIS OF LGS 3910 02:23:55,240 --> 02:23:57,080 SO NOW THE COMPANY WON'T TALK TO 3911 02:23:57,080 --> 02:23:59,440 US ANYMORE, I SAID SHE HAS IT 3912 02:23:59,440 --> 02:24:01,840 FOR FOCUS SEIZURES WE DON'T HAVE 3913 02:24:01,840 --> 02:24:04,240 AN INDICATION OF LGS, LGS MEANS 3914 02:24:04,240 --> 02:24:05,480 HAVE YOU SEIZURES AND SOME OTHER 3915 02:24:05,480 --> 02:24:10,560 STUFF, YOU KNOW SO, I THINK 3916 02:24:10,560 --> 02:24:12,240 IMAGINING HOW TO--WHAT TO DO 3917 02:24:12,240 --> 02:24:14,280 WHEN THEY'RE IN-CARE IS HARD AND 3918 02:24:14,280 --> 02:24:15,520 MAYBE THAT'S ANOTHER STRONG 3919 02:24:15,520 --> 02:24:16,520 CONVERSATION BUT YOU COULD 3920 02:24:16,520 --> 02:24:17,840 CERTAINLY COME UP WITH A 3921 02:24:17,840 --> 02:24:18,840 TRANSITION PLAN NOW FOR HOW ARE 3922 02:24:18,840 --> 02:24:20,360 WE GOING TO START THINK BEING 3923 02:24:20,360 --> 02:24:21,520 THIS AND INCLUDING PATIENTS IN 3924 02:24:21,520 --> 02:24:23,000 THE CONVERSATION SO YOU COULD DO 3925 02:24:23,000 --> 02:24:28,520 IT IN THE BEST WAY POSSIBLE. 3926 02:24:28,520 --> 02:24:28,800 >> GREAT. 3927 02:24:28,800 --> 02:24:31,560 SO I HAVE THE UNENVIABLE TASK TO 3928 02:24:31,560 --> 02:24:32,840 TRY TO SUMMARIZE WHAT WE'VE BEEN 3929 02:24:32,840 --> 02:24:34,640 TALKING ABOUT FOR THE LAST 2 3930 02:24:34,640 --> 02:24:36,760 HOURS BEFORE WE MOVE ON TO A 3931 02:24:36,760 --> 02:24:39,120 BREAK AND I THINK TRACEY JUST 3932 02:24:39,120 --> 02:24:39,400 HELP MEDE. 3933 02:24:39,400 --> 02:24:45,960 SHE JUST DID SOME OF IT, I DO 3934 02:24:45,960 --> 02:24:48,680 THINK WHAT'S MINIMUM WE SHOULD 3935 02:24:48,680 --> 02:24:50,040 PROVIDE WAS ACTUALLY IN SOME 3936 02:24:50,040 --> 02:24:51,120 RESPECTS SET UP IN THE BEGINNING 3937 02:24:51,120 --> 02:24:55,960 OF THE DAY AND R ITERATED BY 3938 02:24:55,960 --> 02:24:56,960 ISHAN AND OTHERS AND THAT IS 3939 02:24:56,960 --> 02:25:00,320 THERE NEEDS TO BE A PLAN AND 3940 02:25:00,320 --> 02:25:03,600 PRETTY ROBUST INFORMED CONSENT. 3941 02:25:03,600 --> 02:25:05,360 I ALSO HEARD VERY CLEARLY THAT, 3942 02:25:05,360 --> 02:25:08,280 THERE NEEDS TO BE A PLAN THAT 3943 02:25:08,280 --> 02:25:11,960 INCLUDES HOW PEOPLE WILL GET 3944 02:25:11,960 --> 02:25:14,280 BATTERIES CHANGED OR THE KINDS 3945 02:25:14,280 --> 02:25:15,920 OF MAINTENANCE THEY WOULD BE 3946 02:25:15,920 --> 02:25:18,200 HURT IF THEY DIDN'T GET AND THAT 3947 02:25:18,200 --> 02:25:23,880 SEEMS LIKE A MINIMUM. 3948 02:25:23,880 --> 02:25:26,160 A GOOD QUESTION OF WHEN DO WE GO 3949 02:25:26,160 --> 02:25:26,760 ABOVE THE MINIMUM. 3950 02:25:26,760 --> 02:25:28,160 I HEARD A LOT OF PEOPLE SAY THIS 3951 02:25:28,160 --> 02:25:29,800 WHOLE SPACE IS A SPACE IN WHICH 3952 02:25:29,800 --> 02:25:33,600 WE GO ABOVE THE MINIMUM OF WHAT 3953 02:25:33,600 --> 02:25:35,200 WE'RE NORMALLY--WHAT WE NORMALLY 3954 02:25:35,200 --> 02:25:36,840 OWE TO PEOPLE BASED ON THE 3955 02:25:36,840 --> 02:25:39,200 LANGUAGE THAT WINSTON JUST 3956 02:25:39,200 --> 02:25:41,040 SUGGESTED IN ANY CLINICAL TRIAL. 3957 02:25:41,040 --> 02:25:42,240 SO IN ANY CLINICAL TRIAL, WE OWE 3958 02:25:42,240 --> 02:25:45,040 PEOPLE SOME OF WHAT I JUST SAID, 3959 02:25:45,040 --> 02:25:48,480 AND WE ALSO OWE THEM LOTS OF 3960 02:25:48,480 --> 02:25:48,720 RESPECT. 3961 02:25:48,720 --> 02:25:50,680 WE OWE THEM, YOU KNOW LISTENING 3962 02:25:50,680 --> 02:25:52,680 TO THEIR VOICES, ET CETERA, BUT 3963 02:25:52,680 --> 02:25:58,520 IN THIS SPACE, BECAUSE THE MORAL 3964 02:25:58,520 --> 02:26:02,320 ENTANGLEMENTS ARE DIFFERENT AND 3965 02:26:02,320 --> 02:26:04,080 THE DEPENDENCEOT DEVICE IS A 3966 02:26:04,080 --> 02:26:05,000 DIFFERENT KIND OF DEPENDENCE 3967 02:26:05,000 --> 02:26:06,600 THAN SOMEONE MIGHT HAVE IF THEY 3968 02:26:06,600 --> 02:26:08,400 WERE DEPENDENT ON A DRUG, WE OWE 3969 02:26:08,400 --> 02:26:08,680 THEM MORE. 3970 02:26:08,680 --> 02:26:10,800 SO WHAT MORE DO WE OWE THEM IS 3971 02:26:10,800 --> 02:26:14,040 STILL I THINK AN OPEN QUESTION. 3972 02:26:14,040 --> 02:26:16,000 I HEARD ALSO A NUMBER OF THINGS 3973 02:26:16,000 --> 02:26:22,480 I THINK ARE REALLY IMPORTANT 3974 02:26:22,480 --> 02:26:25,400 THAT WE SHOULD CONTINUE TO TALK 3975 02:26:25,400 --> 02:26:25,640 ABOUT. 3976 02:26:25,640 --> 02:26:27,040 ONE OF THEM WAS IN DISCUSSIONS 3977 02:26:27,040 --> 02:26:30,280 AND IN A LOT OF THE Q&A COMMENTS 3978 02:26:30,280 --> 02:26:34,320 AND THAT IS WHEN IS A TRIAL 3979 02:26:34,320 --> 02:26:34,760 REALLY OVER? 3980 02:26:34,760 --> 02:26:35,760 SOMEBODY SAID THAT YESTERDAY, 3981 02:26:35,760 --> 02:26:36,800 YOU KNOW TRIALS NEVER REALLY 3982 02:26:36,800 --> 02:26:39,280 OVER IN A CERTAIN WAY. 3983 02:26:39,280 --> 02:26:41,760 SO THE SORT OF ARBITRARINESS OF 3984 02:26:41,760 --> 02:26:43,360 WHEN A TRIAL IS OVER IS 3985 02:26:43,360 --> 02:26:49,920 SOMETHING THAT IS WORTH TALKING 3986 02:26:49,920 --> 02:26:50,240 ABOUT. 3987 02:26:50,240 --> 02:26:51,600 WHETHER OR NOT THE TRIALS IN 3988 02:26:51,600 --> 02:26:53,120 THIS SPACE SHOULD BE THOUGHT OF 3989 02:26:53,120 --> 02:26:54,640 AS DIFFERENT IN TERMS OF THEIR 3990 02:26:54,640 --> 02:26:55,520 LENGTH IS SOMETHING THAT MAYBE 3991 02:26:55,520 --> 02:27:00,840 WE COULD THINK ABOUT MORE 3992 02:27:00,840 --> 02:27:01,120 CAREFULLY. 3993 02:27:01,120 --> 02:27:03,440 ANOTHER 1 IS WHAT EXACTLY IS 3994 02:27:03,440 --> 02:27:03,680 BENEFIT. 3995 02:27:03,680 --> 02:27:05,560 I MEAN THIS AM CANS UP ON ALL 3996 02:27:05,560 --> 02:27:07,120 THE TIME AND QUIET IS, WHAT DOES 3997 02:27:07,120 --> 02:27:11,520 IT MEAN IN THIS CONTEXT BUT ALSO 3998 02:27:11,520 --> 02:27:13,240 WHO GETS TO DECIDE WHAT'S 3999 02:27:13,240 --> 02:27:14,480 BENEFIT IN THAT SEEMS LIKE 4000 02:27:14,480 --> 02:27:15,840 SOMETHING THAT HAS BEEN COMING 4001 02:27:15,840 --> 02:27:20,800 UP OVER AND OVER AGAIN. 4002 02:27:20,800 --> 02:27:22,000 AND THEN THERE WERE LOTS OF 4003 02:27:22,000 --> 02:27:23,520 OTHER RELATED AND I THINK 4004 02:27:23,520 --> 02:27:24,520 IMPORTANT THINGS TO THINK ABOUT 4005 02:27:24,520 --> 02:27:26,880 IN THE CONTEXT OF WHAT WE OWE 4006 02:27:26,880 --> 02:27:30,120 PEOPLE, THAT MAY OR MAY NOT BE 4007 02:27:30,120 --> 02:27:31,360 DIRECTLY RELATED TO WHAT WE OWE 4008 02:27:31,360 --> 02:27:32,680 THEM WHEN THE TRIAL IS 4009 02:27:32,680 --> 02:27:36,840 CONTINUING OR OVER OR SOMETHING 4010 02:27:36,840 --> 02:27:37,120 LIKE THAT. 4011 02:27:37,120 --> 02:27:42,240 FOR EXAMPLE, THE QUESTIONS OF 4012 02:27:42,240 --> 02:27:42,640 COMPENSATION. 4013 02:27:42,640 --> 02:27:46,360 BUT ALSO THE IDEA THAT 4014 02:27:46,360 --> 02:27:47,160 PARTICIPANTS SHOULD BE INVOLVED 4015 02:27:47,160 --> 02:27:50,040 FROM THE VERY, VERY BEGINNING IN 4016 02:27:50,040 --> 02:27:51,960 DESIGNING STUDIES IN TALKING 4017 02:27:51,960 --> 02:27:52,800 ABOUT WHAT'S IMPORTANT IN THE 4018 02:27:52,800 --> 02:27:56,200 DESIGN OF THE STUDY AND IN 4019 02:27:56,200 --> 02:27:57,880 THINKING ABOUT HOW THEY FIT INTO 4020 02:27:57,880 --> 02:28:00,400 A STUDY THAT'S BEING PUT 4021 02:28:00,400 --> 02:28:00,920 TOGETHER. 4022 02:28:00,920 --> 02:28:02,400 AND I HEARD 1 OTHER THING FROM 4023 02:28:02,400 --> 02:28:06,760 DR. MARLAER THAT I WANT --MARLET 4024 02:28:06,760 --> 02:28:08,600 I WANT TO PUT ON THE TABLE THAT 4025 02:28:08,600 --> 02:28:09,600 MAYBE THERE SHOULD BE CERTAIN 4026 02:28:09,600 --> 02:28:10,600 REQUIREMENTS IN THE DESIGN OF 4027 02:28:10,600 --> 02:28:15,320 TRIALS OF THIS NATURE IN TERMS 4028 02:28:15,320 --> 02:28:18,600 OF COMPATIBILITY IN TERMS OF 4029 02:28:18,600 --> 02:28:20,440 SAFE TO REMOVE, CERTAIN THINGS 4030 02:28:20,440 --> 02:28:23,720 THAT MIGHT, YOU KNOW MAYBE BE ON 4031 02:28:23,720 --> 02:28:25,040 THE FRONT END IN TERMS OF THESE 4032 02:28:25,040 --> 02:28:28,000 ARE THINGS THAT SHOULD BE 4033 02:28:28,000 --> 02:28:31,920 CONSIDERED WHEN WE'RE DESIGNING 4034 02:28:31,920 --> 02:28:32,640 TRIALS. 4035 02:28:32,640 --> 02:28:35,520 SO I JUST--I WOULD LOVE TO HEAR 4036 02:28:35,520 --> 02:28:36,920 SASKIA, IF YOU WANT TO ADD 4037 02:28:36,920 --> 02:28:38,120 ANYTHING TO THAT AND THEN TURN 4038 02:28:38,120 --> 02:28:41,720 IT OVER TO NINA TO GET US TO THE 4039 02:28:41,720 --> 02:28:42,320 BREAK. 4040 02:28:42,320 --> 02:28:42,720 >> IT WAS GREAT. 4041 02:28:42,720 --> 02:28:46,840 I WILL TURN IT TO NINA, AND THEN 4042 02:28:46,840 --> 02:28:50,680 RESTART US AFTER THE BREAK. 4043 02:28:50,680 --> 02:28:51,560 >> OKAY. 4044 02:28:51,560 --> 02:28:52,200 >> WONDERFUL, YES, OKAY, THANK 4045 02:28:52,200 --> 02:28:56,720 YOU ALL FOR THE REALLY RICH AND 4046 02:28:56,720 --> 02:28:59,040 THOUGHTFUL CONVERSATIONS TO BE 4047 02:28:59,040 --> 02:29:00,600 CONTINUED IN OUR LAST SESSION 4048 02:29:00,600 --> 02:29:02,560 WHICH WILL BEGIN AT 3:00 P.M. 4049 02:29:02,560 --> 02:29:04,320 EASTERN TIME SO WE WILL TAKE A 4050 02:29:04,320 --> 02:29:06,200 BREAK FOR THE NEXT 27 MINUTES OR 4051 02:29:06,200 --> 02:29:06,560 SO. 4052 02:29:06,560 --> 02:29:09,160 AND THEN WE WILL SEE EVERYBODY 4053 02:29:09,160 --> 02:29:09,520 AGAIN SHORTLY. 4054 02:29:09,520 --> 02:29:12,040 THANK YOU SO MUCH. 4055 02:29:12,040 --> 02:29:16,480 >>WE CAN BEGIN 4056 02:29:16,480 --> 02:29:18,960 WITH THE LAST SESSION FOR 4057 02:29:18,960 --> 02:29:21,400 TODAY'S PORTION OF THE WORKSHOP. 4058 02:29:21,400 --> 02:29:23,120 SO I HOPE EVERYBODY ENJOYED THE 4059 02:29:23,120 --> 02:29:25,960 BREAK, GOT A TIME TO STRETCH A 4060 02:29:25,960 --> 02:29:27,800 LITTLE BIT AND THIS LAST SESSION 4061 02:29:27,800 --> 02:29:30,200 IS I THINK, YOU KNOW AS WE 4062 02:29:30,200 --> 02:29:31,400 TALKED ABOUT EARLIER, BUILDS 4063 02:29:31,400 --> 02:29:32,880 UPON EVERYTHING WE'VE HEARD SO 4064 02:29:32,880 --> 02:29:34,120 FAR SO FIRST KNOWING WHAT THE 4065 02:29:34,120 --> 02:29:36,600 NEEDS, WHAT IS IN PLACE, AND 4066 02:29:36,600 --> 02:29:38,120 THIS MOST RECENT PANEL IS 4067 02:29:38,120 --> 02:29:39,160 DISCUSSING WHAT SHOULD BE IN 4068 02:29:39,160 --> 02:29:39,360 PLACE. 4069 02:29:39,360 --> 02:29:41,240 SO, WE WOULD LIKE TO SPEND A 4070 02:29:41,240 --> 02:29:43,040 LITTLE BIT OF TIME WITH THIS 4071 02:29:43,040 --> 02:29:45,360 DISCUSSION AND SESSION TO TALK A 4072 02:29:45,360 --> 02:29:48,240 LITTLE BIT MORE ABOUT THOSE 4073 02:29:48,240 --> 02:29:49,560 IDENTIFIED GAPS AND UNMET NEEDS 4074 02:29:49,560 --> 02:29:51,600 SO FOR THIS SESSION I WILL TURN 4075 02:29:51,600 --> 02:29:57,920 IT OVER TO DR. HANK GREELY, AND 4076 02:29:57,920 --> 02:29:58,400 DR. SASKIA HENDRIKs,. 4077 02:29:58,400 --> 02:30:01,680 >> STARTING WITH, IS ASKIA. 4078 02:30:01,680 --> 02:30:02,120 >> HEY, EVERYBODY. 4079 02:30:02,120 --> 02:30:03,000 I APOLOGIZE, I'M HAVING SOME 4080 02:30:03,000 --> 02:30:06,600 TROUBLE WITH MY CAMERA. 4081 02:30:06,600 --> 02:30:17,120 BUT I AM GOING TO PRESENT SOME 4082 02:30:26,560 --> 02:30:27,000 SLIDES. 4083 02:30:27,000 --> 02:30:28,360 >> THEY'RE STILL LOADING IN. 4084 02:30:28,360 --> 02:30:31,280 >> THERE THEY ARE MPLET. 4085 02:30:31,280 --> 02:30:32,120 >> SO WE'VE ATTEMPTED TO 4086 02:30:32,120 --> 02:30:35,880 SUMMARIZE SOME OF THE DISCUSSION 4087 02:30:35,880 --> 02:30:40,200 FROM THE LAST PANEL. 4088 02:30:40,200 --> 02:30:42,360 I THANK YOU ALL FOR WORKING ON 4089 02:30:42,360 --> 02:30:43,320 THIS WITH ME. 4090 02:30:43,320 --> 02:30:44,600 AND WE'VE ATTEMPTED TO SUMMARIZE 4091 02:30:44,600 --> 02:30:48,120 SOME OF THE DISCUSSION FROM 4092 02:30:48,120 --> 02:30:50,240 PANEL 3 IN AS FAR AS IN RELEVANT 4093 02:30:50,240 --> 02:30:55,120 FOR THE PANEL THAT WE'RE ABOUT 4094 02:30:55,120 --> 02:30:55,520 TO HEAD INTO. 4095 02:30:55,520 --> 02:30:57,800 SO I WANT TO START WITH SOME--I 4096 02:30:57,800 --> 02:31:01,440 WOULD SAY INITIAL REALITIES. 4097 02:31:01,440 --> 02:31:03,560 FIRST OF ALL, TO ACKNOWLEDGE 4098 02:31:03,560 --> 02:31:05,440 THRA THERE MAY NOT BE ANY 4099 02:31:05,440 --> 02:31:09,480 PERFECT SOLUTIONS IN A SENSE 4100 02:31:09,480 --> 02:31:11,920 THAT THERE MAY ALWAYS BE THINGS 4101 02:31:11,920 --> 02:31:12,800 THAT HAPPEN, SCENARIOS THAT 4102 02:31:12,800 --> 02:31:14,160 UNFOLD THAT WE HAVE NOT 4103 02:31:14,160 --> 02:31:19,520 PARTICIPATED AND PLANNED FOR. 4104 02:31:19,520 --> 02:31:20,440 IT'S IMPORTANT TO ACKNOWLEDGE 4105 02:31:20,440 --> 02:31:21,840 HERE AS WELL, THE 4106 02:31:21,840 --> 02:31:22,400 RESPONSIBILITIES THAT WE'RE 4107 02:31:22,400 --> 02:31:24,680 TALKING ABOUT MUST BE SHARED. 4108 02:31:24,680 --> 02:31:26,280 BUT ALSO TO ACKNOWLEDGE THAT 4109 02:31:26,280 --> 02:31:28,280 EACH OF THE PROFESSIONAL 4110 02:31:28,280 --> 02:31:29,480 STAKEHOLDERS INVOLVED HAS LIMITS 4111 02:31:29,480 --> 02:31:34,320 BUT RELATED TO THEIR MISSIONS 4112 02:31:34,320 --> 02:31:35,560 AND THEIR RESOURCES FINALLY, I 4113 02:31:35,560 --> 02:31:37,520 THINK IT'S IMPORTANT TO NOTE 4114 02:31:37,520 --> 02:31:39,840 HERE THAT BASED ON THIS ENTIRE 4115 02:31:39,840 --> 02:31:41,760 MEETING IT SOUNDS LIKE THERE WAS 4116 02:31:41,760 --> 02:31:44,160 MORE THAT WE MUST DO WHETHER IT 4117 02:31:44,160 --> 02:31:46,160 COMES TO POST TRIAL CARE THAN 4118 02:31:46,160 --> 02:31:52,520 WHAT'S CURRENTLY BEING DONE. 4119 02:31:52,520 --> 02:31:53,640 OKAY, SO HERE ARE SOME OF THE 4120 02:31:53,640 --> 02:31:54,760 THINGS WE HEARD THAT PEOPLE HAVE 4121 02:31:54,760 --> 02:31:58,160 ARGUED THAT WE SHOULD BE 4122 02:31:58,160 --> 02:31:59,600 PROVIDING FOR PARTICIPANTS AFTER 4123 02:31:59,600 --> 02:32:01,440 TRIALS AND IT SOUNDED LIKE THERE 4124 02:32:01,440 --> 02:32:02,800 WAS A COUPLE CONSENSUS ON THESE 4125 02:32:02,800 --> 02:32:04,280 POINTS, IF THERE WAS NOT, FEEL 4126 02:32:04,280 --> 02:32:06,960 FREE TO LET ME KNOW DURING THE 4127 02:32:06,960 --> 02:32:08,680 DITION CUSHION THAT FOLLOWS. 4128 02:32:08,680 --> 02:32:10,040 SO FIRST OF THIS IS A FAMILIAR 4129 02:32:10,040 --> 02:32:11,640 WITH, WE SHOULD PLAN FOR POST 4130 02:32:11,640 --> 02:32:14,800 TRIAL CARE AHEAD OF THE TRIAL. 4131 02:32:14,800 --> 02:32:18,440 SECOND, IT SOUNDS LIKE WE NEED 4132 02:32:18,440 --> 02:32:19,720 TO IMPROVE PROPER CONSENT WHEN 4133 02:32:19,720 --> 02:32:25,000 IT COMES TO POST TRIAL CARE AND 4134 02:32:25,000 --> 02:32:27,800 ALSO INCLUDES CLARIFYING FUTUREK 4135 02:32:27,800 --> 02:32:30,840 SESES TO CARE AND ASSOCIATED OUT 4136 02:32:30,840 --> 02:32:31,280 OF POCKET EXPENSES. 4137 02:32:31,280 --> 02:32:35,920 >> AND BECAUSE OF THE FEATURES 4138 02:32:35,920 --> 02:32:43,800 FOR THE RISKS INVOLVED, OF 4139 02:32:43,800 --> 02:32:44,360 IMPLANTING DEVICES, AND--AS 4140 02:32:44,360 --> 02:32:47,280 COMPARED TO MAYBE RESEARCH IN 4141 02:32:47,280 --> 02:32:49,360 GENERAL, IN WHICH SOME 4142 02:32:49,360 --> 02:32:51,760 RESPONSIBILITIES DO EXIST, THESE 4143 02:32:51,760 --> 02:32:55,680 TYPES OF TRANSFER REQUIRE MORE 4144 02:32:55,680 --> 02:33:02,160 THAN MAYBE AVERAGE TRIAL . 4145 02:33:02,160 --> 02:33:03,560 SO PEOPLE HAVE ARGUE THAD WE 4146 02:33:03,560 --> 02:33:06,200 NEED TO INSURE POST-TRIAL ACCESS 4147 02:33:06,200 --> 02:33:10,720 TO DEVICES AND DEVICES TO THE 4148 02:33:10,720 --> 02:33:11,000 BENEFITS. 4149 02:33:11,000 --> 02:33:12,800 AND ALL NECESSARY HARDWARE, 4150 02:33:12,800 --> 02:33:19,840 SOFTWAREND ASSOCIATED CARE. 4151 02:33:19,840 --> 02:33:21,600 FURTHER MORE, FOR THOSE PATIENTS 4152 02:33:21,600 --> 02:33:23,560 WHO DO NOT GET HALF THE TYPES OF 4153 02:33:23,560 --> 02:33:25,800 BENEFITS AND MAY NOT GET POST 4154 02:33:25,800 --> 02:33:28,360 TRIAL ACCESS NEED TO SUPPORT THE 4155 02:33:28,360 --> 02:33:29,000 CONVERSATION AS THEY'RE MOVING 4156 02:33:29,000 --> 02:33:33,600 OUT OF THE TRIAL. 4157 02:33:33,600 --> 02:33:37,840 WHICH CURRENTLY WE'VE HAD TO 4158 02:33:37,840 --> 02:33:39,000 SUPPORT TRANSPLANTATION, IN MOST 4159 02:33:39,000 --> 02:33:40,880 CASES IT'S ALREADY COVERED BY 4160 02:33:40,880 --> 02:33:42,600 PATIENTS INSURANCE, AND THERE'S 4161 02:33:42,600 --> 02:33:46,040 I THINK WE HAVEN'T HAD MUCH 4162 02:33:46,040 --> 02:33:46,800 DISCUSSION ABOUT WHETHER THIS 4163 02:33:46,800 --> 02:33:49,920 SHOULD ALSO BE COVERED BY THE 4164 02:33:49,920 --> 02:33:53,120 STAKEHOLDERS IF IT'S AN ELECT 4165 02:33:53,120 --> 02:33:53,640 IMPEDIMENTS EXPLANTATION. 4166 02:33:53,640 --> 02:33:55,360 WE HEARD THAT WE HAVE TO INVOLVE 4167 02:33:55,360 --> 02:33:58,560 PATIENT PARTICIPANTS FROM THE 4168 02:33:58,560 --> 02:34:00,640 TRAVEL SAME, NEED TO SEEK 4169 02:34:00,640 --> 02:34:01,400 SIGNIFY VERSITY IN OUR 4170 02:34:01,400 --> 02:34:02,920 PARTICIPANTS AND WE NEED TO 4171 02:34:02,920 --> 02:34:05,000 IMPROVE THE ABILITY OF RESEARCH 4172 02:34:05,000 --> 02:34:08,520 DATA FOR PARTICIPANTS AND 4173 02:34:08,520 --> 02:34:08,800 OTHERS. 4174 02:34:08,800 --> 02:34:11,200 THERE'S A COUPLE THINGS WE 4175 02:34:11,200 --> 02:34:13,000 SHOULD ALSO CONSIDER, THERE'S 4176 02:34:13,000 --> 02:34:14,720 PROBABLY MORE THAT WE'VE HEARD 4177 02:34:14,720 --> 02:34:17,840 MANY GREAT SUGGESTIONS THAT WE 4178 02:34:17,840 --> 02:34:20,400 WILL CAPTURE SO I APOLOGIZE IF 4179 02:34:20,400 --> 02:34:22,040 WE DIDN'T CAPTURE ALL OF THEM 4180 02:34:22,040 --> 02:34:28,600 BUT THINGS WE SHOULD CONSIDER 4181 02:34:28,600 --> 02:34:31,720 INCLUDE DESIGN OF TRIAL, USE 4182 02:34:31,720 --> 02:34:32,440 INTERCHANGEABLE HARDWARE 4183 02:34:32,440 --> 02:34:33,440 COMPONENTS IF POSSIBLE, DESIGN 4184 02:34:33,440 --> 02:34:35,880 DEVICES FOR SAFE AND EASY 4185 02:34:35,880 --> 02:34:37,920 REMOVAL AND INVOLVE CMS TO 4186 02:34:37,920 --> 02:34:41,560 CAPTURE METRICS THEY NEED TO 4187 02:34:41,560 --> 02:34:43,040 DECIDE ON COVERAGE WE ALSO 4188 02:34:43,040 --> 02:34:44,240 SHOULD CONSIDER MORE LONG-TERM 4189 02:34:44,240 --> 02:34:49,080 FOR LONG FOR SOME OF THESE 4190 02:34:49,080 --> 02:34:52,080 RESEARCH TRIALS. 4191 02:34:52,080 --> 02:34:53,320 OKAY, WITH THAT, 1 MORE SLIDE, I 4192 02:34:53,320 --> 02:34:57,320 HOPE CAN YOU SEE IT HERE WHICH 4193 02:34:57,320 --> 02:34:58,240 FORMULATES THE MAIN DISCUSSION 4194 02:34:58,240 --> 02:35:04,800 QUESTIONS FOR THIS FORUM: WHAT, 4195 02:35:04,800 --> 02:35:07,400 I GUESS I HAVE DONE A PROPOSAL 4196 02:35:07,400 --> 02:35:12,240 FOR NEEDS THAT AREN'T COVERED 4197 02:35:12,240 --> 02:35:13,880 AND SHOULD BE COVERED AND I 4198 02:35:13,880 --> 02:35:15,760 WOULD LIKE TO SEE THE BEST 4199 02:35:15,760 --> 02:35:19,280 SOLUTIONS, SO HOW DO WE BEST 4200 02:35:19,280 --> 02:35:21,320 ADDRESS THESE ITEMS THAT I JUST 4201 02:35:21,320 --> 02:35:21,840 HIGHLIGHTED? 4202 02:35:21,840 --> 02:35:24,280 SO WITH THAT, I WOULD LIKE TO 4203 02:35:24,280 --> 02:35:27,320 OPEN IT UP FOR DISCUSSION AND 4204 02:35:27,320 --> 02:35:30,280 INVITE ALL NUMBERS AND ALL 4205 02:35:30,280 --> 02:35:32,120 PANELISTS TO PARTICIPATE. 4206 02:35:32,120 --> 02:35:33,160 THIS REALLY--WE'VE SPECIFICALLY 4207 02:35:33,160 --> 02:35:35,520 INVITED A COUPLE OF PARTICIPANTS 4208 02:35:35,520 --> 02:35:36,880 TO MAKE SURE THAT 4209 02:35:36,880 --> 02:35:38,720 REPRESENTATIVES OF EACH OF THE 4210 02:35:38,720 --> 02:35:40,200 DIFFERENT STAKEHOLDER GROUPS 4211 02:35:40,200 --> 02:35:42,560 WILL BE AVAILABLE BUT WE'RE 4212 02:35:42,560 --> 02:35:44,360 HOPING ALL PANELISTS AND NEW 4213 02:35:44,360 --> 02:35:45,400 PANELISTS WILL PARTICIPATE IN 4214 02:35:45,400 --> 02:35:46,880 THIS DISCUSSION ABOUT SOLUTIONS. 4215 02:35:46,880 --> 02:35:49,360 >> AND WE HAVE ABOUT 75 MINUTES 4216 02:35:49,360 --> 02:35:53,480 TO SOLVE EVERYTHING. 4217 02:35:53,480 --> 02:35:53,640 SO. 4218 02:35:53,640 --> 02:36:03,520 ARE THE'S GO FOR IT. 4219 02:36:03,520 --> 02:36:03,920 HANDS? 4220 02:36:03,920 --> 02:36:05,800 >> I DON'T SEE HANDS BUT I WILL 4221 02:36:05,800 --> 02:36:06,520 SAY 1 THING. 4222 02:36:06,520 --> 02:36:08,600 I MEAN, I THINK THE BRAIN 4223 02:36:08,600 --> 02:36:11,680 INITIATIVE, THIS JUST COVERS 4224 02:36:11,680 --> 02:36:14,520 PART OF IT BUT NIH IN GENERAL 4225 02:36:14,520 --> 02:36:20,400 HAS A LOT OF POWER HERE IN TERMS 4226 02:36:20,400 --> 02:36:23,080 OF OBVIOUSLY PAYMENT FOR, YOU 4227 02:36:23,080 --> 02:36:24,560 KNOW KIND OF THE FUNDING THAT 4228 02:36:24,560 --> 02:36:26,160 GOES INTO MANY OF THESE TRIALS 4229 02:36:26,160 --> 02:36:29,160 AND THESE STUDIES AND THE 4230 02:36:29,160 --> 02:36:30,880 COMPANIES THAT THE DEVICE 4231 02:36:30,880 --> 02:36:31,760 MANUFACTURES WILL GENERALLY 4232 02:36:31,760 --> 02:36:37,640 DONATE THE DEVICES BUT I THINK, 4233 02:36:37,640 --> 02:36:48,040 NIH COULD ESTABLISH SOME 4234 02:36:49,480 --> 02:36:50,320 RESTRICTIONS ABOUT RULEGIVING 4235 02:36:50,320 --> 02:36:52,000 THIS GRANT SOMETHING BOTH MENTAL 4236 02:36:52,000 --> 02:36:53,240 DEVICE MANUFACTURES IF YOU ARE 4237 02:36:53,240 --> 02:36:54,680 GOING TO BE INVOLVED, YOU ARE 4238 02:36:54,680 --> 02:36:58,280 BENEFITING IN SOME WAYS FROM THE 4239 02:36:58,280 --> 02:36:59,880 DATA THAT'S BEING COLLECTED AND 4240 02:36:59,880 --> 02:37:02,000 THEN HOPEFULLY GETTING AT LEAST 4241 02:37:02,000 --> 02:37:06,720 SOME COMMITMENT FROM THE 4242 02:37:06,720 --> 02:37:08,240 COMPANIES THAT THE HARDWARE AND 4243 02:37:08,240 --> 02:37:10,520 BATTERIES, ET CETERA WILL BE 4244 02:37:10,520 --> 02:37:12,440 AVAILABLE AT LEAST FOR A CERTAIN 4245 02:37:12,440 --> 02:37:12,960 AMOUNT OF TIME. 4246 02:37:12,960 --> 02:37:16,520 I THINK THAT WOULD BE, YOU KNOW 4247 02:37:16,520 --> 02:37:17,800 THAT THAT WOULD NOT SOLVE THE 4248 02:37:17,800 --> 02:37:22,400 ENTIRE PROBLEM BUT IT WOULD AT 4249 02:37:22,400 --> 02:37:24,280 LEAST PROVIDE ACCESS AND 4250 02:37:24,280 --> 02:37:26,280 MAINTENANCE AVAILABILITY OF THE 4251 02:37:26,280 --> 02:37:36,720 HARDWARE AT LEAST FOR SOME 4252 02:37:37,240 --> 02:37:37,760 PERIOD OF TIME. 4253 02:37:37,760 --> 02:37:40,200 >> I'M SORRY DID YOU--DID YOU 4254 02:37:40,200 --> 02:37:42,560 CALL ON SOMEBODY TO SPEAK? 4255 02:37:42,560 --> 02:37:44,960 >> YES, I ASKED IF JOHN WOULD 4256 02:37:44,960 --> 02:37:46,160 LIKE TO RESPOND? 4257 02:37:46,160 --> 02:37:48,400 >> SORRY, ZOOM WAS GIVING ME THE 4258 02:37:48,400 --> 02:37:50,520 SPINNING BEACH BALL OF DEATH FOR 4259 02:37:50,520 --> 02:37:53,560 A FEW MINUTES IT HAD ME GOING. 4260 02:37:53,560 --> 02:37:56,800 YEAH, THAT'S A GREAT POINT. 4261 02:37:56,800 --> 02:38:00,280 WHAT WE WOULD LIKE TO DO THEN, 4262 02:38:00,280 --> 02:38:02,040 THE ISSUE IS, WHICH IS EXPLAINED 4263 02:38:02,040 --> 02:38:04,080 TO ME BY PEOPLE WAY ABOVE MY PAY 4264 02:38:04,080 --> 02:38:08,400 GRADE IS THAT NIH IS NOT ABLE TO 4265 02:38:08,400 --> 02:38:09,480 ENFORCE CERTAIN CONDITIONS 4266 02:38:09,480 --> 02:38:12,000 BEYOND THE ACTUAL PROJECT 4267 02:38:12,000 --> 02:38:12,320 PERIOD. 4268 02:38:12,320 --> 02:38:14,600 SO, I'M NOT LOOKING AT THAT AS 4269 02:38:14,600 --> 02:38:17,480 SO MUCH OF AN OBSTACLE AS A 4270 02:38:17,480 --> 02:38:17,880 CHALLENGE, RIGHT? 4271 02:38:17,880 --> 02:38:21,520 SO RIGHT NOW, WE ARE WORKING ON 4272 02:38:21,520 --> 02:38:22,440 A VARIOUS WORK AROUNDS. 4273 02:38:22,440 --> 02:38:23,760 I MEAN THE REALITY IS, THERE ARE 4274 02:38:23,760 --> 02:38:24,800 SOME THINGS WHERE I THINK 4275 02:38:24,800 --> 02:38:26,200 THERE'S WIGGLE ROOM AND OTHER 4276 02:38:26,200 --> 02:38:27,560 THINGS WHERE WE JUST DON'T HAVE 4277 02:38:27,560 --> 02:38:28,920 IT BUT THAT'S NOT TO SAY WE'RE 4278 02:38:28,920 --> 02:38:30,480 NOT LOOKING FOR CERTAIN WORK 4279 02:38:30,480 --> 02:38:31,000 AROUNDS. 4280 02:38:31,000 --> 02:38:33,840 I MEAN THE HUGE PROBLEM IS, WHEN 4281 02:38:33,840 --> 02:38:37,280 A COMPANY GOES OUT OF BUSINESS, 4282 02:38:37,280 --> 02:38:37,480 RIGHT? 4283 02:38:37,480 --> 02:38:39,760 AND THERE'S NO PARTS, NOBODY TO 4284 02:38:39,760 --> 02:38:43,520 UPDATE, NOBODY TO MAINTAIN, 4285 02:38:43,520 --> 02:38:44,600 LIMITED LIABILITY, OR ANOTHER 4286 02:38:44,600 --> 02:38:47,680 TRICKY SITUATION WHERE A COMPANY 4287 02:38:47,680 --> 02:38:49,120 DECIDES, WELL THEY'RE NOT GOING 4288 02:38:49,120 --> 02:38:50,120 TO SUPPORT THE INSTRUMENT 4289 02:38:50,120 --> 02:38:51,520 ANYMORE OR THEY WILL GET OUT OF 4290 02:38:51,520 --> 02:38:53,280 THE SPACE ALTOGETHER AND THIS 4291 02:38:53,280 --> 02:38:56,360 LEAVESERB IN A LURCH AND THIS IS 4292 02:38:56,360 --> 02:38:58,080 THE SITUATION WHERE I THINK 4293 02:38:58,080 --> 02:39:00,240 ANYTIME WE'RE DEALING WITH ANY 4294 02:39:00,240 --> 02:39:01,400 ENTITY, IT'S A KNOWN RISK, 4295 02:39:01,400 --> 02:39:01,600 RIGHT? 4296 02:39:01,600 --> 02:39:04,640 AND THE ISSUE IS, IF WE 4297 02:39:04,640 --> 02:39:05,960 ELIMINATE ALL RISK WE DON'T DO 4298 02:39:05,960 --> 02:39:07,840 ANY OF THESE EXPERIMENTS SO THE 4299 02:39:07,840 --> 02:39:09,840 CHALLENGE FOR US, ALL OF US, ALL 4300 02:39:09,840 --> 02:39:11,240 STAKEHOLDER SYSTEM TO ASSESS THE 4301 02:39:11,240 --> 02:39:12,520 RISK OF FINDING WAYS TO MITIGATE 4302 02:39:12,520 --> 02:39:21,960 IT AS MUCH AS POSSIBLE. 4303 02:39:21,960 --> 02:39:24,440 WE CAN GO ON, AND I'M HAPPY TO 4304 02:39:24,440 --> 02:39:25,560 DISCUSS SPECIFICS YOU BUT THE 4305 02:39:25,560 --> 02:39:27,080 REALITY IS THAT WE HAVE TO GO ON 4306 02:39:27,080 --> 02:39:29,560 AND IN SOME CASES OUR HANDS ARE 4307 02:39:29,560 --> 02:39:31,360 NOT JUST TIED BUT THEY ARE HAND 4308 02:39:31,360 --> 02:39:33,160 CUFFED BUT WE ARE LOOKING FOR 4309 02:39:33,160 --> 02:39:35,320 WORK AROUNDS IN THIS SPACE AND I 4310 02:39:35,320 --> 02:39:36,920 THINK IT'S UNCUMBENT ON ALL OF 4311 02:39:36,920 --> 02:39:39,000 US TO LOOK AT WORK AROUNDS, FROM 4312 02:39:39,000 --> 02:39:42,080 OUR POINT OF VIEW, COMPANIES, 4313 02:39:42,080 --> 02:39:42,920 INSURERS, CMS, FDA, EVERYBODY 4314 02:39:42,920 --> 02:39:44,160 MPLET THE REASON WHY WE'RE 4315 02:39:44,160 --> 02:39:45,640 HAVING TO WORKSHOP IS BECAUSE WE 4316 02:39:45,640 --> 02:39:47,400 ARE VERY FRUSTRATED BY THE 4317 02:39:47,400 --> 02:39:57,840 CURRENT STATE OF AFFAIRS. 4318 02:39:59,080 --> 02:39:59,480 >> DR. DIXON-SALAZAR? 4319 02:39:59,480 --> 02:40:00,560 >> I AGREE WITH JOHN. 4320 02:40:00,560 --> 02:40:02,760 I THINK WE RUN INTO TROUBLE IF 4321 02:40:02,760 --> 02:40:04,360 THE DEVICE DOESN'T GET FDA 4322 02:40:04,360 --> 02:40:05,760 APPROVED RIGHT AND WE HAVE QUITE 4323 02:40:05,760 --> 02:40:07,560 A FEW RESPONDERS IN OUR 4324 02:40:07,560 --> 02:40:08,360 COMMUNITY TO CERTAIN 4325 02:40:08,360 --> 02:40:10,560 THERAPEUTICS THAT GOT 4326 02:40:10,560 --> 02:40:11,680 DISCONTINUED AND THEN THAT'S 4327 02:40:11,680 --> 02:40:13,440 WHERE THEY REALLY GET IN 4328 02:40:13,440 --> 02:40:13,800 TROUBLE. 4329 02:40:13,800 --> 02:40:15,000 BUT THERE'S ALSO THIS 4330 02:40:15,000 --> 02:40:16,440 TRANSITION, SO LET'S SAY THE 4331 02:40:16,440 --> 02:40:18,200 DEVICE DOES GET APPROVED AND NOW 4332 02:40:18,200 --> 02:40:19,800 YOU HAVE TO TRANSITION OVER FROM 4333 02:40:19,800 --> 02:40:23,920 THE TRIAL TO IT BEING COVERED, 4334 02:40:23,920 --> 02:40:26,080 THAT WHOLE PROCESS IS DOABLE AND 4335 02:40:26,080 --> 02:40:29,280 REASONABLE, BUT IT'S REALLY SORT 4336 02:40:29,280 --> 02:40:30,880 OF THROWN AT THE HANDS OF 4337 02:40:30,880 --> 02:40:32,160 PATIENTS, AT LEAST IT HAS BEEN 4338 02:40:32,160 --> 02:40:33,840 IN OUR INSTANCES AND IT REQUIRES 4339 02:40:33,840 --> 02:40:38,600 A VERY SAVVY PATIENT TO BE ABLE 4340 02:40:38,600 --> 02:40:40,400 TO NAVIGATE THAT, EXITING THE 4341 02:40:40,400 --> 02:40:42,400 TRIAL, ENTERING THE INSURANCE 4342 02:40:42,400 --> 02:40:43,960 WORLD MAZE SO ANY HELP THAT CAN 4343 02:40:43,960 --> 02:40:46,440 BE DONE THERE I THINK WOULD BE 4344 02:40:46,440 --> 02:40:48,600 REALLY CRITICAL AND THEN I WOULD 4345 02:40:48,600 --> 02:40:49,880 JUST SAY, TOO, THAT YOU KNOW 4346 02:40:49,880 --> 02:40:52,880 THAT NOW WE'RE ENTERING A PHASE 4347 02:40:52,880 --> 02:40:56,480 IN LGS WHERE THE DEVICES DBS HAS 4348 02:40:56,480 --> 02:40:59,840 BEEN APPROVE INDEED EPILEMESY, 4349 02:40:59,840 --> 02:41:00,040 RIGHT? 4350 02:41:00,040 --> 02:41:02,160 AND RNS HAS BEEN APPROVE INDEED 4351 02:41:02,160 --> 02:41:03,440 ELLEPSY O OUR FAMILIES ARE 4352 02:41:03,440 --> 02:41:04,800 RUSHING TO GET THEM OFF LABEL IF 4353 02:41:04,800 --> 02:41:06,960 THEY CAN WHICH REQUIRES A VERY 4354 02:41:06,960 --> 02:41:08,280 SAVVY PATIENT AND DISKRIM FLAITS 4355 02:41:08,280 --> 02:41:09,840 AGAINST MOST OF OUR FAMILIES, 4356 02:41:09,840 --> 02:41:11,360 BUT ALSO NOW THERE'S TRIALS 4357 02:41:11,360 --> 02:41:13,080 BEING STARTED AND SO THAT--THAT 4358 02:41:13,080 --> 02:41:15,800 SEEMS TO BE SORT OF AN EASIER 4359 02:41:15,800 --> 02:41:18,360 ASK BECAUSE THE TRIALS NOW IS 4360 02:41:18,360 --> 02:41:24,600 ACTUALLY, THERE'S A MARKET FOR 4361 02:41:24,600 --> 02:41:25,760 AN APPROVED--FOR IMPROVED DEVICE 4362 02:41:25,760 --> 02:41:27,280 ALREADY SO I DON'T KNOW YOU NEED 4363 02:41:27,280 --> 02:41:29,240 TO SPEND AS MUCH TIME IN THAT 4364 02:41:29,240 --> 02:41:30,400 AREA BUT THOSE FIRST 2 AREAS 4365 02:41:30,400 --> 02:41:32,080 COULD REALLY HELP AND I THINK 4366 02:41:32,080 --> 02:41:32,880 PATIENTS EXPECTATIONS ARE 4367 02:41:32,880 --> 02:41:33,160 REASONABLE. 4368 02:41:33,160 --> 02:41:34,800 I DON'T EXPECT YOU LIKE ALL 4369 02:41:34,800 --> 02:41:37,600 RIGHT, SO IF MY KID HAD A HUGE 4370 02:41:37,600 --> 02:41:38,360 SEIZURE REDUCTION, I DON'T 4371 02:41:38,360 --> 02:41:39,920 EXPECT YOU TO MAINTAIN IT FOR 30 4372 02:41:39,920 --> 02:41:41,200 YEARS IF THE COMPANY HAS GONE 4373 02:41:41,200 --> 02:41:43,600 OUT OF BUSINESS, BUT, I MEAN, 4374 02:41:43,600 --> 02:41:44,840 WHAT AGREEMENT CAN WE COME TO 4375 02:41:44,840 --> 02:41:47,600 WHERE ALL OF A SUDDEN 1 DAY I 4376 02:41:47,600 --> 02:41:48,960 JUST DON'T HAVE ACCESS ANYMORE. 4377 02:41:48,960 --> 02:41:51,040 AND I WAS BT NECESSARILY EVEN 4378 02:41:51,040 --> 02:42:00,200 PREPARED FOR IT WHEN IT 4379 02:42:00,200 --> 02:42:00,480 HAPPENED. 4380 02:42:00,480 --> 02:42:02,680 >> WOB OF THE THINGS WE TALKED 4381 02:42:02,680 --> 02:42:04,280 ABOUT IN A LITTLE BIT OF THE 4382 02:42:04,280 --> 02:42:05,800 PAST HALF HOUR IS PART OF WHAT 4383 02:42:05,800 --> 02:42:07,840 SHE SAID IS THAT MAYBE TRIAL 4384 02:42:07,840 --> 02:42:09,320 PARTICIPANTS SHOULD HAVE SOME 4385 02:42:09,320 --> 02:42:10,320 SPECIAL STATUS, SOME SPECIAL 4386 02:42:10,320 --> 02:42:15,360 PLACE IN LINE WHEN SOMETHING 4387 02:42:15,360 --> 02:42:16,400 ACTUALLY BECOMES APPROVED THE 4388 02:42:16,400 --> 02:42:17,520 SPONSORS SHOULD HAVE AN 4389 02:42:17,520 --> 02:42:19,000 ABNORMALITIES LIGATION TO REACH 4390 02:42:19,000 --> 02:42:20,320 OUT TO THEM FIRST AND EXPLAIN TO 4391 02:42:20,320 --> 02:42:22,840 THEM AND MAKE IT EASY FOR THEM 4392 02:42:22,840 --> 02:42:24,520 TO TRANSITION THAN TO THE 4393 02:42:24,520 --> 02:42:25,880 APPROVED OR PERHAPS EVEN IN SOME 4394 02:42:25,880 --> 02:42:27,640 CASES IF THERE'S A SECOND TRIAL 4395 02:42:27,640 --> 02:42:30,240 WITH THE NEW AND IMPROVED DEVICE 4396 02:42:30,240 --> 02:42:32,120 FOR WHICH THEY'RE NOT CONTRA 4397 02:42:32,120 --> 02:42:34,880 INDICATE THAD THEY SHOULD HAVE A 4398 02:42:34,880 --> 02:42:36,200 SPECIAL STATUS WITH RESPECT TO 4399 02:42:36,200 --> 02:42:38,360 BEING INFORMED ABOUT AND 4400 02:42:38,360 --> 02:42:38,920 POTENTIALLY ELIGIBLE FOR. 4401 02:42:38,920 --> 02:42:43,720 SO I THINK THAT'S A GOOD THING 4402 02:42:43,720 --> 02:42:45,560 TO BE THINKING ABOUT. 4403 02:42:45,560 --> 02:42:47,160 THEY PUT THREZ BODIES AND BRAINS 4404 02:42:47,160 --> 02:42:49,080 ON THE LINE THEY DESERVE, THEY 4405 02:42:49,080 --> 02:42:59,800 SHOULD BE ABLE TO CUT IN LINE. 4406 02:42:59,800 --> 02:42:59,960 I THINK. 4407 02:42:59,960 --> 02:43:03,080 >> MARK DID YOU WANT TO RESPOND. 4408 02:43:03,080 --> 02:43:03,440 >> AND THEN-- 4409 02:43:03,440 --> 02:43:05,680 >> I DID, A COUPLE COMMENTS, 4410 02:43:05,680 --> 02:43:06,960 THERE ARE 2 SCENARIOS FOR 4411 02:43:06,960 --> 02:43:10,240 COMPANIES AND 1 IS THAT THE 4412 02:43:10,240 --> 02:43:12,520 COMPANY IS INTERESTED IN 4413 02:43:12,520 --> 02:43:14,520 SUPPORTING A TRIAL BECAUSE IN 4414 02:43:14,520 --> 02:43:16,520 GENERAL, THEY WANT SOME EARLY 4415 02:43:16,520 --> 02:43:19,960 EXPERIENCE TO UNDERSTAND WHETHER 4416 02:43:19,960 --> 02:43:21,760 THIS IS SOMETHING THEY WANT TO 4417 02:43:21,760 --> 02:43:24,360 INVEST A HUGE AMOUNT OF MONEY 4418 02:43:24,360 --> 02:43:25,480 INTO EXPLORING TOWARDS AN 4419 02:43:25,480 --> 02:43:26,600 INDICATION FOR USE. 4420 02:43:26,600 --> 02:43:30,280 THAT'S 1 SITUATION. 4421 02:43:30,280 --> 02:43:32,000 THE OTHER SITUATION AND I THINK 4422 02:43:32,000 --> 02:43:32,800 MANY DEVICE MANUFACTURES HAVE 4423 02:43:32,800 --> 02:43:34,440 RUN INTO THIS, IS THAT HAVE YOU 4424 02:43:34,440 --> 02:43:35,240 A PLATFORM TECHNOLOGY AND THERE 4425 02:43:35,240 --> 02:43:36,520 ARE A NUMBER OF RESEARCHERS OUT 4426 02:43:36,520 --> 02:43:38,360 THERE WHO WANT TO USE IT FOR 4427 02:43:38,360 --> 02:43:43,080 THEIR OWN PURPOSES, THAT 4428 02:43:43,080 --> 02:43:45,120 MAY--THE COMPANY MAY NOT THINK 4429 02:43:45,120 --> 02:43:46,480 THAL WOULD MAKE SENSE FOR THE 4430 02:43:46,480 --> 02:43:47,600 COMPANY TO PURSUE. 4431 02:43:47,600 --> 02:43:50,000 IT ARE MAY BE TOTALLY OUTSIDE OF 4432 02:43:50,000 --> 02:43:50,680 THE DISEASE STATE. 4433 02:43:50,680 --> 02:43:51,640 SO IT CERTAINLY HAS BEEN THE 4434 02:43:51,640 --> 02:43:53,200 EXPERIENCE WE HAVE AT NEUROPACE, 4435 02:43:53,200 --> 02:43:56,240 I BELIEVE IT'S ALSO BEEN THE 4436 02:43:56,240 --> 02:43:58,160 EXPERIENCE WITH MEDTRONNIC THAT 4437 02:43:58,160 --> 02:43:59,840 THERE ARE REQUESTS, MANY OF 4438 02:43:59,840 --> 02:44:02,440 THEM, PLEASE LET ME USE THIS 4439 02:44:02,440 --> 02:44:04,600 DEVICE FOR THIS CONDITION. 4440 02:44:04,600 --> 02:44:07,640 IF WE ARE REQUIRING TO THE 4441 02:44:07,640 --> 02:44:09,240 COMPANY PROVIDE SOME TYPE OF OR 4442 02:44:09,240 --> 02:44:12,320 HAVE SOME TYPE OF FINANCIAL 4443 02:44:12,320 --> 02:44:15,880 OBLIGATION TO PATIENTS FOR THOSE 4444 02:44:15,880 --> 02:44:17,280 STUDIES, ALREADY THERE'S A 4445 02:44:17,280 --> 02:44:17,960 DISINSENT TESTIFY SUPPORT THAT 4446 02:44:17,960 --> 02:44:19,600 BECAUSE IT REQUIRES TIME. 4447 02:44:19,600 --> 02:44:22,320 IT REQUIRES TIME FROM PEOPLE 4448 02:44:22,320 --> 02:44:26,560 WHOSE JOBS ARE FOCUSED 4449 02:44:26,560 --> 02:44:26,840 ELSEWHERE. 4450 02:44:26,840 --> 02:44:30,480 BUT, I THINK COMPANIES ARE MORE 4451 02:44:30,480 --> 02:44:34,360 OR LESS WILLING TO HELP SOMEBODY 4452 02:44:34,360 --> 02:44:36,480 PURSUE THEIR RESEARCH BUT IF 4453 02:44:36,480 --> 02:44:39,040 THERE IS AN ADDITION A FINANCIAL 4454 02:44:39,040 --> 02:44:40,440 OBLIGATION, THAT WILL MAKE IT 4455 02:44:40,440 --> 02:44:43,080 VERY HARD TO SUPPORT A LOT OF 4456 02:44:43,080 --> 02:44:48,680 THIS STUFF THAT IS SECONDARY TO 4457 02:44:48,680 --> 02:44:59,000 WHAT THE COMPANIES MISSION IS. 4458 02:44:59,000 --> 02:45:00,960 >> COULD I JUST ADD TO WHAT 4459 02:45:00,960 --> 02:45:02,360 MARTY JUST SAID ON THE INDUSTRY 4460 02:45:02,360 --> 02:45:04,920 SIDE AND I HAVE A COUPLE OTHER 4461 02:45:04,920 --> 02:45:05,160 COMMENTS. 4462 02:45:05,160 --> 02:45:06,360 YOU KNOW 1 THING WE COULD 4463 02:45:06,360 --> 02:45:09,000 LOAMACY BEINGA FROM AN 4464 02:45:09,000 --> 02:45:11,800 INTERAGENCY STANDPOINT IS THAT 4465 02:45:11,800 --> 02:45:13,640 ORPHAN DRUGS HAVE TAX INCENTIVES 4466 02:45:13,640 --> 02:45:15,720 AND FINANCIAL INCENTIVES FOR 4467 02:45:15,720 --> 02:45:17,480 COMPANIES AND PRIVATE INDUSTRIES 4468 02:45:17,480 --> 02:45:19,160 TO PURSUE, WE DON'T HAVE THAT IN 4469 02:45:19,160 --> 02:45:20,480 ORPHAN DEVICES SO WE COULD START 4470 02:45:20,480 --> 02:45:23,240 TO MIMIC WHAT WE HAVE IN ORPHAN 4471 02:45:23,240 --> 02:45:24,520 DRUGS WITH ORPHAN POPULATIONS 4472 02:45:24,520 --> 02:45:27,800 FOR DEVICES AND THAT MIGHT BE A 4473 02:45:27,800 --> 02:45:29,160 POTENTIAL INDUSTRY INCENTIVE TO 4474 02:45:29,160 --> 02:45:32,880 PURSUE SOME OF THE SMALLER 4475 02:45:32,880 --> 02:45:33,360 MARKETS. 4476 02:45:33,360 --> 02:45:36,160 ALSO THERE'S IT PROTECTION THAT 4477 02:45:36,160 --> 02:45:38,360 COMES ALONG WITH AN ORPHAN DRUG 4478 02:45:38,360 --> 02:45:40,320 I BELIEVE IT'S 7 YEARS ONCE IT'S 4479 02:45:40,320 --> 02:45:42,080 APPROVED BUT COULD ALSO BE AN 4480 02:45:42,080 --> 02:45:44,600 INCENTIVE FOR INDUSTRY TO GO 4481 02:45:44,600 --> 02:45:46,800 AFTER YOU KNOW SMALLER 4482 02:45:46,800 --> 02:45:48,560 POPULATIONS LIKE SPINAL CORD 4483 02:45:48,560 --> 02:45:48,920 INJURIES. 4484 02:45:48,920 --> 02:45:51,080 BUT I ALMS WANTED TO ADD A 4485 02:45:51,080 --> 02:45:53,520 COUPLE OTHER COMMENTS TO THE 4486 02:45:53,520 --> 02:45:55,480 CONVERSATION, WE'VE TAKED A LOT 4487 02:45:55,480 --> 02:45:58,480 AROUND INVOLVING PEOPLE WITH 4488 02:45:58,480 --> 02:46:01,000 LIVED EXPERIENCE EARLY IN ON THE 4489 02:46:01,000 --> 02:46:03,120 PROCESS AND I THINK NIH HAS A 4490 02:46:03,120 --> 02:46:04,560 REALLY UNIQUE OPPORTUNITY AS PAY 4491 02:46:04,560 --> 02:46:06,120 FUNDER TO BE ABLE TO PUT 4492 02:46:06,120 --> 02:46:08,400 GUIDANCE OUT THERE FOR THE 4493 02:46:08,400 --> 02:46:10,160 CLINICAL TRIALS DESIGN. 4494 02:46:10,160 --> 02:46:12,080 THERE ARE FUNDING AGENCIES LIKE 4495 02:46:12,080 --> 02:46:15,440 THE D.O.D. CDMRP WHICH DOES 4496 02:46:15,440 --> 02:46:18,760 REQUIRE IN SOME OF THEIR FUNDING 4497 02:46:18,760 --> 02:46:21,160 MECHANISMS, TO HAVE PEOPLE WITH 4498 02:46:21,160 --> 02:46:22,880 LIVED EXPERIENCE INVOLVED IN THE 4499 02:46:22,880 --> 02:46:25,000 RESEARCH, SO I THINK IT'S--IT'S 4500 02:46:25,000 --> 02:46:29,600 NOT A HUGE ASK TO HAVE NIH START 4501 02:46:29,600 --> 02:46:31,720 TO TAKE THIS STANCE AS WELL TO 4502 02:46:31,720 --> 02:46:35,760 REALLY START TO EMBED SOME 4503 02:46:35,760 --> 02:46:36,480 UNDERSTANDING OF THE PATIENT 4504 02:46:36,480 --> 02:46:37,480 EXPERIENCE AS THEY'RE GOING 4505 02:46:37,480 --> 02:46:46,800 THROUGH THE DESIGN OF TRIAL. 4506 02:46:46,800 --> 02:46:49,040 AND ALSO WHILE I'M ON THE TOPIC 4507 02:46:49,040 --> 02:46:50,160 OF PROTOCOL DESIGN, WE CAN COME 4508 02:46:50,160 --> 02:46:51,440 UP WITH A ROADMAP OF WHAT THAT 4509 02:46:51,440 --> 02:46:52,440 NEEDS TO LOOK LIKE. 4510 02:46:52,440 --> 02:46:53,800 TRACEY MENTIONED THAT EARLIER 4511 02:46:53,800 --> 02:47:02,880 BUT FIRST, LOOKING AT PLABTED 4512 02:47:02,880 --> 02:47:06,080 DEVICES TO HAVE A PLAN FOR WHAT 4513 02:47:06,080 --> 02:47:08,360 THOSE DEVICES MIGHT BE AND TR 4514 02:47:08,360 --> 02:47:09,200 TRACKING, I'M NOT COMPLETELY 4515 02:47:09,200 --> 02:47:11,520 CLEAR ON THIS BUT I BELIEVE THE 4516 02:47:11,520 --> 02:47:13,160 EUROPEAN MODEL HAS SOMETHING 4517 02:47:13,160 --> 02:47:15,000 SIMILAR TO THIS, THAT IF YOU'RE 4518 02:47:15,000 --> 02:47:21,800 GOING TO HAVE IMPLANTED DEVICES 4519 02:47:21,800 --> 02:47:23,680 FROM A SAFETY PERSPECTIVE ALSO 4520 02:47:23,680 --> 02:47:24,920 WE TALKED ABOUT PATIENT JOURNEY 4521 02:47:24,920 --> 02:47:25,160 MAPPING. 4522 02:47:25,160 --> 02:47:26,320 THIS IS WHERE A LOT OF THE 4523 02:47:26,320 --> 02:47:30,080 BURDEN CAN BE FOUND. 4524 02:47:30,080 --> 02:47:34,680 I CAN'T TELL YOU HO YOU MANY 4525 02:47:34,680 --> 02:47:35,840 SPINAL CORD INJURY TRIALS THEY 4526 02:47:35,840 --> 02:47:37,600 HAVE AND HOW DIFFICULT IT IS TO 4527 02:47:37,600 --> 02:47:39,600 TRANSPORT SOMEONE WITH A FINAL 4528 02:47:39,600 --> 02:47:41,720 CORD INJURY WITH A POWER CHAIR 4529 02:47:41,720 --> 02:47:43,760 FROM 1 PLACE TO ANOTHER AND IT'S 4530 02:47:43,760 --> 02:47:45,280 A HUGE FINANCIAL BURDEN FOR 4531 02:47:45,280 --> 02:47:46,920 PEOPLE TO PARTICIPATE BUT 4532 02:47:46,920 --> 02:47:48,160 TYPICALLY THAT'S NOT FOUND UNTIL 4533 02:47:48,160 --> 02:47:50,160 YOU MAP OUT THE PATIENT JOURNEY 4534 02:47:50,160 --> 02:47:51,560 SO THAT'S ANOTHER STANDARD WE 4535 02:47:51,560 --> 02:47:56,200 CAN PUT IN PLACE LOOKING AT THE 4536 02:47:56,200 --> 02:47:58,280 FUNDING AND DESIGN OF TRIALS AND 4537 02:47:58,280 --> 02:47:59,640 FINALLY MY LAST POINT IS, 1 OF 4538 02:47:59,640 --> 02:48:01,200 THE POINTS YOU BROUGHT UP FOR 4539 02:48:01,200 --> 02:48:02,200 THE DISCUSSION IS LONG-TERM 4540 02:48:02,200 --> 02:48:03,840 FOLLOW UP AND AGAIN, I WANT TO 4541 02:48:03,840 --> 02:48:08,480 BRING THIS UP IS THAT I THINK 4542 02:48:08,480 --> 02:48:10,120 WE'RE MISSING AN OPPORTUNITY TO 4543 02:48:10,120 --> 02:48:13,040 COLLECT LONG-TERM DATA USE OF 4544 02:48:13,040 --> 02:48:13,920 IMPLANTED DEVICES WHERE WE CAN 4545 02:48:13,920 --> 02:48:15,960 LEARN A LOT ABOUT THESE EARLY 4546 02:48:15,960 --> 02:48:17,320 STAGE DEVICES AND IF, YOU KNOW 4547 02:48:17,320 --> 02:48:19,920 IF WE HAVE THESE FOLLOW ON 4548 02:48:19,920 --> 02:48:21,160 STUDIES, THAT PARTICIPANTS ARE 4549 02:48:21,160 --> 02:48:23,920 REQUIRED TO PARTICIPATE IN THAT 4550 02:48:23,920 --> 02:48:25,160 AND SHARE THEIR DATA. 4551 02:48:25,160 --> 02:48:27,560 SO I THINK THAT'S ANOTHER 4552 02:48:27,560 --> 02:48:28,400 POSSIBILITY WHERE WE ARE STILL 4553 02:48:28,400 --> 02:48:31,800 IN KIND OF THE EARLY STAGES OF 4554 02:48:31,800 --> 02:48:33,360 NEUROMODDULATION AND A LOT OF 4555 02:48:33,360 --> 02:48:34,440 THESE BRAIN TECHNOLOGIES THAT WE 4556 02:48:34,440 --> 02:48:36,880 CAN LEARN A LOT ALONG THE WAY IF 4557 02:48:36,880 --> 02:48:47,320 WE START ATRACKING THEM. 4558 02:48:48,840 --> 02:48:49,520 THANK YOU. 4559 02:48:49,520 --> 02:48:51,480 >> THOSE ARE GREAT SUGGESTIONS. 4560 02:48:51,480 --> 02:48:53,440 HANK DID YOU WANT TO COMMENT? 4561 02:48:53,440 --> 02:48:54,760 >> I'M NOT SURE I UNDERSTOOD IT 4562 02:48:54,760 --> 02:48:56,960 FULLY BUT THE IDEA OF 4563 02:48:56,960 --> 02:48:58,040 PARTICIPANTS BEING REQUIRED TO 4564 02:48:58,040 --> 02:49:02,120 CONTINUE IN LONG-TERM STUDIES IS 4565 02:49:02,120 --> 02:49:04,200 PROBLEMATIC AND THE COMMON RULE 4566 02:49:04,200 --> 02:49:05,160 GUARANTEES ANY RESEARCH 4567 02:49:05,160 --> 02:49:08,320 PARTICIPANT THE RIGHT TO 4568 02:49:08,320 --> 02:49:09,040 WITHDRAW. 4569 02:49:09,040 --> 02:49:09,840 >> EXACTLY. 4570 02:49:09,840 --> 02:49:10,680 SIEM SORRY, DON'T MISS 4571 02:49:10,680 --> 02:49:11,840 UNDERSTOOD ME THEY HAVE THE 4572 02:49:11,840 --> 02:49:13,120 OPTION FOR A LONG-TERM STUDY, SO 4573 02:49:13,120 --> 02:49:14,880 THEY WOULD SIGN UP FOR IT, SO IF 4574 02:49:14,880 --> 02:49:17,000 THERE IS AN OBLIGATION THAT OH, 4575 02:49:17,000 --> 02:49:18,000 OKAY, WE WILL SUPPORT THIS 4576 02:49:18,000 --> 02:49:19,440 DEVICE FOR THE NEXT 5 YEARS 4577 02:49:19,440 --> 02:49:22,360 AFTER THE STUDY, THERE SHOULD BE 4578 02:49:22,360 --> 02:49:22,960 AN OBLIGATIONOT PARTICIPANTS 4579 02:49:22,960 --> 02:49:24,560 PART THAT THEY NEED TO BE, YOU 4580 02:49:24,560 --> 02:49:27,160 KNOW IN ON THE PARTICIPATION AND 4581 02:49:27,160 --> 02:49:29,160 SHARE THEIR DATA AS WELL. 4582 02:49:29,160 --> 02:49:31,160 I HOPE THAT CLARIFIED. 4583 02:49:31,160 --> 02:49:41,680 >> YES, THANKS FOR CLARIFYING 4584 02:49:45,400 --> 02:49:45,520 THAT. 4585 02:49:45,520 --> 02:49:46,080 >> BRANDY ELLIS? 4586 02:49:46,080 --> 02:49:48,640 >> URGTER TO THAT, IT MATCHES UP 4587 02:49:48,640 --> 02:49:50,240 WITH MY SUGGESTION WHICH IS AT 4588 02:49:50,240 --> 02:49:56,000 THE END OF THE TRIAL, THERE IS 4589 02:49:56,000 --> 02:49:57,280 NO, LIKE THE CONSENT TO START 4590 02:49:57,280 --> 02:50:00,480 BUT AT THE END THERE'S NO LIKE, 4591 02:50:00,480 --> 02:50:01,200 GOODBYE. 4592 02:50:01,200 --> 02:50:02,680 LIKE I DON'T RECEIVE PAPERWORK 4593 02:50:02,680 --> 02:50:03,880 THAT SAYS, HERE'S WHAT YOU DID, 4594 02:50:03,880 --> 02:50:04,960 HERE'S WHAT YOU HAVE, WHATEVER, 4595 02:50:04,960 --> 02:50:11,600 AND I DO THINK THAT THAT END OF 4596 02:50:11,600 --> 02:50:12,960 TRIAL CONTACT IS AN OPPORTUNITY 4597 02:50:12,960 --> 02:50:14,440 TO SAY, ALL RIGHT, HERE'S 4598 02:50:14,440 --> 02:50:17,160 INFORMATION THAT YOU MIGHT NEED 4599 02:50:17,160 --> 02:50:19,640 BUT THAT'S ALSO TO THE PREVIOUS 4600 02:50:19,640 --> 02:50:22,080 POINT, THAT'S AN OPPORTUNITY TO 4601 02:50:22,080 --> 02:50:24,440 GO AND HERE'S A CONSENT FOR 4602 02:50:24,440 --> 02:50:29,160 GENERIC LONG-TERM FOLLOW UP 4603 02:50:29,160 --> 02:50:29,520 STUDY. 4604 02:50:29,520 --> 02:50:31,080 AND YOU WILL CONTINUE TO 4605 02:50:31,080 --> 02:50:33,320 PARTICIPATE IN THIS NEW 4606 02:50:33,320 --> 02:50:36,760 LONG-TERM FOLLOW UP THAT YOU'RE 4607 02:50:36,760 --> 02:50:38,040 CONSENTED INTO, THEN THESE ARE 4608 02:50:38,040 --> 02:50:42,480 THE BENEFITS THAT YOU GET IN 4609 02:50:42,480 --> 02:50:44,480 THAT IF YOU'RE DEVICE, YOU KNOW 4610 02:50:44,480 --> 02:50:46,400 IS DISCONTINUED, YOU KNOW, WE 4611 02:50:46,400 --> 02:50:49,640 WILL KEEP YOU ABREAST OF 4612 02:50:49,640 --> 02:50:51,560 ALTERNATIVES, SO, RIGHT NOW, AT 4613 02:50:51,560 --> 02:50:56,480 THE END OF A TRIAL IS SORT OF 4614 02:50:56,480 --> 02:50:57,280 LIKE, BYE. 4615 02:50:57,280 --> 02:50:58,400 SO POST TRIAL RESPONSIBILITIES, 4616 02:50:58,400 --> 02:51:02,480 IF WE'RE GOING TO OUTLINE THEM, 4617 02:51:02,480 --> 02:51:05,520 THAT'S GOING TO NECESSITATE SOME 4618 02:51:05,520 --> 02:51:08,880 END OF TRIAL DOCUMENTATION AND 4619 02:51:08,880 --> 02:51:15,800 THAT IS AN OPPORTUNITY TO 4620 02:51:15,800 --> 02:51:20,640 ACTIVELY TRANSITION FROM 4621 02:51:20,640 --> 02:51:21,840 PATIENTS EXPECTATIONS INSIDE THE 4622 02:51:21,840 --> 02:51:22,640 TRIAL TO EXPECTATIONS OUTSIDE 4623 02:51:22,640 --> 02:51:24,640 THE TRIAL AND IT MAKES IT VERY 4624 02:51:24,640 --> 02:51:28,920 CLEAR WHO IS RESPONSIBLE FOR 4625 02:51:28,920 --> 02:51:30,480 WHAT, WHEN, BECAUSE YES, I WOULD 4626 02:51:30,480 --> 02:51:32,320 GLAD HE CONTINUE TO DO FOLLOW 4627 02:51:32,320 --> 02:51:34,400 UPS IF IN EXCHANGE FOR THAT, I 4628 02:51:34,400 --> 02:51:35,720 WAS GUARANTEED THAT I WASN'T 4629 02:51:35,720 --> 02:51:37,680 GOING TO HAVE TO FRONT A HUNDRED 4630 02:51:37,680 --> 02:51:39,480 THOUSAND DOLLARS SERGEANTRY ON 4631 02:51:39,480 --> 02:51:41,280 MY OWN UPFRONT, YOU KNOW IN CASE 4632 02:51:41,280 --> 02:51:44,840 OF AN EMERGENCY. 4633 02:51:44,840 --> 02:51:46,760 SO, OR EVEN JUST TO PROVIDE THE 4634 02:51:46,760 --> 02:51:48,320 DATA OF, YOU KNOW NOBODY KNOWS 4635 02:51:48,320 --> 02:51:50,320 IF 50 YEARS FROM NOW, IT'S LIKE, 4636 02:51:50,320 --> 02:51:57,680 OH IT HAD A 50 YEAR LIFE SPAN. 4637 02:51:57,680 --> 02:51:59,600 SO HAVING A WAY TO DOCUMENT AND 4638 02:51:59,600 --> 02:52:02,240 TO TRANSITION I THINK IS A 4639 02:52:02,240 --> 02:52:03,800 VIABLE SOLUTION WHERE EVERYBODY 4640 02:52:03,800 --> 02:52:06,680 KNOWS WHERE EVERYBODY STANDS, 4641 02:52:06,680 --> 02:52:10,520 AND IFOU WANT OUT, YOU'RE OUT 4642 02:52:10,520 --> 02:52:12,480 AND YOU DON'T HAVE TO PROVIDE 4643 02:52:12,480 --> 02:52:14,760 FOLLOW UP CARE AND YOU CAN 4644 02:52:14,760 --> 02:52:17,000 DECIDE THAT YOU KNOW, YOU ARE 4645 02:52:17,000 --> 02:52:18,400 EITHER GOING TO LEAVE THE DEVICE 4646 02:52:18,400 --> 02:52:21,840 IN AND YOU KNOW WHAT HAPPENS OR 4647 02:52:21,840 --> 02:52:23,360 EXPLANTED, LIKE THOSE THINGS CAN 4648 02:52:23,360 --> 02:52:25,440 BE OUTLINED AND PLANNING FOR 4649 02:52:25,440 --> 02:52:27,200 THAT DOCUMENT AND PLANNING FOR 4650 02:52:27,200 --> 02:52:30,000 WHAT IT'S GOT TO ENCOMPASS HELPS 4651 02:52:30,000 --> 02:52:36,480 EVERYBODY THINK ABOUT IT AT THE 4652 02:52:36,480 --> 02:52:37,800 BEGINNING. 4653 02:52:37,800 --> 02:52:38,680 >> SO I'M CURIOUS WHAT PEOPLE 4654 02:52:38,680 --> 02:52:43,440 THINK ABOUT THIS, I MEAN 1 OF 4655 02:52:43,440 --> 02:52:44,600 THE CREATIVE SOLUTIONS FOR 4656 02:52:44,600 --> 02:52:47,520 [INDISCERNIBLE] WILL BE ANOTHER 4657 02:52:47,520 --> 02:52:48,280 TRIAL THAT PARTICIPANTS COULD 4658 02:52:48,280 --> 02:52:50,200 ENROLL IN, AND MAYBE WE COULD 4659 02:52:50,200 --> 02:52:52,680 SPEBD TIME ON THAT POTENTIAL 4660 02:52:52,680 --> 02:52:53,360 SOLUTION, FROM MY PERSPECTIVE 1 4661 02:52:53,360 --> 02:52:54,480 OF THE CHALLENGE SYSTEM THAT WE 4662 02:52:54,480 --> 02:52:57,520 WANT TO HAVE A POST TRIAL PLAN 4663 02:52:57,520 --> 02:52:59,880 AHEAD OF THE START OF THE FIRST 4664 02:52:59,880 --> 02:53:01,400 TRIAL, SO TO SAY, RIGHT? 4665 02:53:01,400 --> 02:53:04,240 THAT'S 1 OF OUR PREMISES AND 4666 02:53:04,240 --> 02:53:05,200 THEN I THINK 1 OF THE CHALLENGES 4667 02:53:05,200 --> 02:53:06,800 IS THAT THOSE TYPES OF FOLLOW UP 4668 02:53:06,800 --> 02:53:10,880 STUDIES, AT LEAST THE CURRENT 4669 02:53:10,880 --> 02:53:14,640 1S, THEY'RE USUALLY NOT DECIDED 4670 02:53:14,640 --> 02:53:18,080 UPON, UNTIL MAYBE JUST BEFORE, 4671 02:53:18,080 --> 02:53:22,040 LIKE THE END OF THE STUDY, SO I 4672 02:53:22,040 --> 02:53:24,160 WONDER, HUGH CAN WE MAKE THIS 4673 02:53:24,160 --> 02:53:27,400 WORK BETTER AS THE LONG-TERM 4674 02:53:27,400 --> 02:53:28,320 SOLUTION. 4675 02:53:28,320 --> 02:53:30,720 IN MY SENSE, IT REALLY--I WAS 4676 02:53:30,720 --> 02:53:32,880 INTENDING IT TO BE THE SAME AS 4677 02:53:32,880 --> 02:53:36,240 THE REGISTRY I DISCUSSED IS IT 4678 02:53:36,240 --> 02:53:38,320 IS ANOTHER--IT DOESN'T HAVE TO 4679 02:53:38,320 --> 02:53:40,440 BE A TRIAL. 4680 02:53:40,440 --> 02:53:44,680 IT CAN BE A SORT OF WHETHER 4681 02:53:44,680 --> 02:53:46,520 THAT'S THE REGISTRY THAT YOU'RE 4682 02:53:46,520 --> 02:53:47,320 PARTICIPATING IN THIS ORDER TO 4683 02:53:47,320 --> 02:53:50,200 HAVE YOUR DATA THERE, BUT ALSO, 4684 02:53:50,200 --> 02:53:53,480 YOU KNOW TO IDENTIFY THAT YOU 4685 02:53:53,480 --> 02:53:55,120 ARE A PARTICIPANT AND ARE 4686 02:53:55,120 --> 02:53:56,640 AVAILABLE FOR BENEFITS OF THAT, 4687 02:53:56,640 --> 02:53:59,280 SO THEY OVERLAP IN THAT. 4688 02:53:59,280 --> 02:54:03,200 SO IT'S A WAY FOR IF A TRIAL 4689 02:54:03,200 --> 02:54:05,320 TEAM CAN'T SUPPORT IT ANYMORE, I 4690 02:54:05,320 --> 02:54:07,480 AM VERY FORTUNATE TO MY TRIAL 4691 02:54:07,480 --> 02:54:10,200 TEAM IS STILL DOING THIS AND IS 4692 02:54:10,200 --> 02:54:11,600 INTERACTING WITH ME EVEN POST 4693 02:54:11,600 --> 02:54:13,800 TRIAL BUT FOR THOSE TRIALS THAT 4694 02:54:13,800 --> 02:54:16,440 ENDED IN THE TRIAL TEAM AND NO 4695 02:54:16,440 --> 02:54:18,040 LONGER AVAILABLE, YOU KNOW THAT 4696 02:54:18,040 --> 02:54:19,680 IT DOESN'T MATTER WHO IT IS, IT 4697 02:54:19,680 --> 02:54:21,360 COULD BE THE TRIAL TEAM, 4698 02:54:21,360 --> 02:54:24,320 MAINTAINS FOLLOW UP, IT COULD BE 4699 02:54:24,320 --> 02:54:26,480 THAT NO, OTHER ENTITY, THE 4700 02:54:26,480 --> 02:54:29,240 REGISTRY MAINTAINS FOLLOW UP, 4701 02:54:29,240 --> 02:54:35,600 BUT, THAT THE IDEA OF REGARDLESS 4702 02:54:35,600 --> 02:54:39,400 OF CIRCUMSTANCES, THERE IS 4703 02:54:39,400 --> 02:54:41,440 SOMEBODY WHO CAN, YOU KNOW 4704 02:54:41,440 --> 02:54:44,680 PROVIDE THE SUPPORT AND 4705 02:54:44,680 --> 02:54:48,680 ASSISTANCE IN TRANSITION, AND IS 4706 02:54:48,680 --> 02:54:52,480 IT A CLEARINGHOUSE FOR THE DATA. 4707 02:54:52,480 --> 02:54:53,960 >> SO I THINK THE LONG-TERM SIDE 4708 02:54:53,960 --> 02:54:55,200 OF THIS IS VERY INTERESTING BUT 4709 02:54:55,200 --> 02:54:58,240 I DON'T WANT US TO LOSE A VERY 4710 02:54:58,240 --> 02:55:06,440 CONCRETE SHORT-TERM SUGGESTION 4711 02:55:06,440 --> 02:55:09,800 YOU MADE WHICH WAS AND THAT 4712 02:55:09,800 --> 02:55:11,440 HAPPEN BUT SORT OF BY THE 4713 02:55:11,440 --> 02:55:15,160 DISCUSSION WITH THE PARTICIPANT 4714 02:55:15,160 --> 02:55:16,720 OKAY THE TRIALS OVER HERE'S HOW 4715 02:55:16,720 --> 02:55:17,600 THINGS STAND AND HOW THEY'LL 4716 02:55:17,600 --> 02:55:24,360 LOOK IN THE FUTURE. 4717 02:55:24,360 --> 02:55:31,120 THAT SEEMS TO ME AN INTERESTING 4718 02:55:31,120 --> 02:55:32,160 A VERY POSSIBLE POSSIBILITY. 4719 02:55:32,160 --> 02:55:34,400 I LIKE THE IDEA. 4720 02:55:34,400 --> 02:55:37,120 I SEE SOME HANDS UP, DO SOME OF 4721 02:55:37,120 --> 02:55:43,640 THE HANDS RESPHOND THIS 4722 02:55:43,640 --> 02:55:47,640 PARTICULAR POINT OR I DO, I HAVE 4723 02:55:47,640 --> 02:55:49,200 A COUPLE COMMENTS. 4724 02:55:49,200 --> 02:55:51,800 >> TO JENNIFER'S POINT, THE 4725 02:55:51,800 --> 02:55:54,000 PARALLEL OF ORPHAN DRUG SYSTEM 4726 02:55:54,000 --> 02:55:54,640 VERY INTERESTING. 4727 02:55:54,640 --> 02:55:57,520 I KNOW MY INSTITUTION AN ORPHAN 4728 02:55:57,520 --> 02:56:01,160 DRUG WAS USED AND IT BECAME 4729 02:56:01,160 --> 02:56:04,600 VERY, VERY SUCCESSFUL, I MEAN 4730 02:56:04,600 --> 02:56:06,120 VERY SUCCESSFUL AND MADE MONEYY 4731 02:56:06,120 --> 02:56:08,160 FOR THE INSTITUTION AND THE 4732 02:56:08,160 --> 02:56:11,560 COMPANY, OF COURSE, PATIENT'S 4733 02:56:11,560 --> 02:56:12,360 BENEFITED OUTSIDE OF THE STUDY 4734 02:56:12,360 --> 02:56:13,880 BECAUSE IT WAS APPROVED AND USED 4735 02:56:13,880 --> 02:56:17,240 TO TREAT IN STANDARD OF CARE AND 4736 02:56:17,240 --> 02:56:20,320 SO RELATED TO THAT, WHAT TRULY 4737 02:56:20,320 --> 02:56:21,800 IS THE MISSION OF THE DRUG 4738 02:56:21,800 --> 02:56:24,960 COMPANY AND THE DEVICE COMPANY 4739 02:56:24,960 --> 02:56:28,960 IS THE MISSION TO BE BEHOLDEN TO 4740 02:56:28,960 --> 02:56:34,840 THEIR SHAREHOLDERS OR IS THERE 4741 02:56:34,840 --> 02:56:37,800 MISSION TO BE A CONDUIT TO 4742 02:56:37,800 --> 02:56:40,080 IMPROVE MEDICAL CARE, SO LET 4743 02:56:40,080 --> 02:56:43,520 ME--LET ME PULL THE SCENARIO TO 4744 02:56:43,520 --> 02:56:45,440 YOU COMPANY E IS VERY 4745 02:56:45,440 --> 02:56:49,800 SUCCESSFUL, HAS A DEVICE THAT'S 4746 02:56:49,800 --> 02:56:50,200 APPROVED. 4747 02:56:50,200 --> 02:56:58,320 AND MAKES MILLIONS OF DOLLARS IN 4748 02:56:58,320 --> 02:57:01,640 EASTERNINGS AND ALSO USES THE 4749 02:57:01,640 --> 02:57:02,840 DOUBLE IRISH TAXATION AGREEMENT 4750 02:57:02,840 --> 02:57:06,040 TO AVOID PAYING TAXES SO THEY'RE 4751 02:57:06,040 --> 02:57:07,520 VERY SUCCESSFUL, THEY'RE MAKING 4752 02:57:07,520 --> 02:57:07,960 MONEY. 4753 02:57:07,960 --> 02:57:09,320 IS PART OF THEIR MISSION THAT 4754 02:57:09,320 --> 02:57:10,920 THE FUNDS SHOULD FUNNEL BACK TO 4755 02:57:10,920 --> 02:57:12,560 PATIENTS TO SUPPORT THEM, I KNOW 4756 02:57:12,560 --> 02:57:21,720 THAT'S A SLIPPERY SLOPE? 4757 02:57:21,720 --> 02:57:23,360 AND I HAD 1 OTHER COMMENT, YOU 4758 02:57:23,360 --> 02:57:24,440 SAID SOMETHING ABOUT REGISTRY, 4759 02:57:24,440 --> 02:57:28,040 OH I KNOW WHAT DID WAS, REGISTRY 4760 02:57:28,040 --> 02:57:29,720 THIS DOES HAPPEN IN DRUG STUDIES 4761 02:57:29,720 --> 02:57:34,680 SO OFTEN TIMES FOR DRUG STUDIES 4762 02:57:34,680 --> 02:57:38,920 THERE'S LIKE THE PHASE 2, PHASE 4763 02:57:38,920 --> 02:57:41,400 3 AND WITH A SHIFT OVER TO 4764 02:57:41,400 --> 02:57:43,120 REGISTRIES BUT AGAIN, BRAND YOU 4765 02:57:43,120 --> 02:57:45,640 YOU BRING UP A GOOD POINT, THE 4766 02:57:45,640 --> 02:57:46,880 DATA IS NOT THERE FOR THE 4767 02:57:46,880 --> 02:57:48,520 PATIENTS TO ACCESS WHICH IS A 4768 02:57:48,520 --> 02:57:50,040 HUGE FEELING, YOU'RE PROVIDING 4769 02:57:50,040 --> 02:57:52,080 THE DATA AND YOU ALTRUISTICALLY 4770 02:57:52,080 --> 02:57:56,000 WANT TO PROVIDE THE DATA AND 4771 02:57:56,000 --> 02:57:56,760 WE'VE BEEN TALKING ABOUT LAWN 4772 02:57:56,760 --> 02:57:59,400 MOWER IS GOOD OR WHAT IS WORTH 4773 02:57:59,400 --> 02:58:02,240 AND REALLY, I THINK IT GOES EVEN 4774 02:58:02,240 --> 02:58:06,720 BEYOND THAT, I DON'T EVEN THINK 4775 02:58:06,720 --> 02:58:07,600 TECHNICALLY, IT'S YOURS ALREADY, 4776 02:58:07,600 --> 02:58:11,280 YOU SHOULD BE GETTING IT ALREADY 4777 02:58:11,280 --> 02:58:12,840 WHETHER IT'S THE CLINICAL 4778 02:58:12,840 --> 02:58:13,760 BENEFIT YOU'RE GETTING OR 4779 02:58:13,760 --> 02:58:15,280 COMPENSATION ACCESS TO YOUR DATA 4780 02:58:15,280 --> 02:58:16,600 AND WE HAVE ALL FAILED BY NOT 4781 02:58:16,600 --> 02:58:24,760 HAVING THAT BE THERE ALREADY. 4782 02:58:24,760 --> 02:58:26,360 OT POINTER OF THE REGISTRY, I 4783 02:58:26,360 --> 02:58:29,200 WANT TO POINT THAT THERE IS A 4784 02:58:29,200 --> 02:58:37,760 REGISTRY FOR THE FDA HAS IT'S 4785 02:58:37,760 --> 02:58:40,680 CALLED THAT DOES COLLECT 4786 02:58:40,680 --> 02:58:41,480 INFORMATION ABOUT DEVICES, IT'S 4787 02:58:41,480 --> 02:58:42,680 NOT ALL THE THINGS WE'RE 4788 02:58:42,680 --> 02:58:43,800 DISCUSSING IN THIS SESSION, I 4789 02:58:43,800 --> 02:58:52,600 JUST WANTED TO RAISE IT FOR YOUR 4790 02:58:52,600 --> 02:58:53,240 AWARENESS. 4791 02:58:53,240 --> 02:58:54,840 >> I'M A PHILOSOPHY, SO I'M NOT 4792 02:58:54,840 --> 02:58:56,120 IN THE MONEY WORLD AND I GET 4793 02:58:56,120 --> 02:58:57,640 WHAT EVERYBODY'S SAYING BUT THE 4794 02:58:57,640 --> 02:58:58,360 ACADEMIC INSTITUTIONS OR 4795 02:58:58,360 --> 02:58:59,400 HOSPITALS SHOULD BE PAYING MORE 4796 02:58:59,400 --> 02:59:00,560 BUT THE COMPANIES SHOULD BE 4797 02:59:00,560 --> 02:59:11,080 PAYING MORE AND IT SEEMS TO ME I 4798 02:59:11,840 --> 02:59:13,280 WOULD TAKE THEIR PRACTICE AS A 4799 02:59:13,280 --> 02:59:14,480 MODEL AND LET'S FIGURE OUT HOW 4800 02:59:14,480 --> 02:59:19,960 WE FUND THAT AND THEN I WAS 4801 02:59:19,960 --> 02:59:20,920 THINKING ABOUT SO THAT THE 4802 02:59:20,920 --> 02:59:23,120 DEFAULT IS IF YOU ARE GETTING 4803 02:59:23,120 --> 02:59:24,600 SOMETHING IMPLABTED IN YOUR 4804 02:59:24,600 --> 02:59:25,280 BRAIN AND SPINAL COLUMN, YOU 4805 02:59:25,280 --> 02:59:27,160 KNOW YOU'RE GOING TO BE FOLLOWED 4806 02:59:27,160 --> 02:59:30,520 AND YOU'RE GOING TO BE CARED FOR 4807 02:59:30,520 --> 02:59:41,040 IF YOU ARE GETTING BENEFIT FROM 4808 02:59:41,040 --> 02:59:41,240 THIS. 4809 02:59:41,240 --> 02:59:43,680 AND THERE ARE TRIALS, THERE ARE 4810 02:59:43,680 --> 02:59:45,440 INDIVIDUALS THAT SHOW 4811 02:59:45,440 --> 02:59:46,280 SIGNIFICANT CLINICAL BENEFIT AND 4812 02:59:46,280 --> 02:59:47,680 OVER ALL IT'S NOT THAT WAY AND I 4813 02:59:47,680 --> 02:59:49,960 GUESS SOME OF THE SOLUTION HAS 4814 02:59:49,960 --> 02:59:52,240 TO COME FROM YOU KNOW SO NOW 4815 02:59:52,240 --> 02:59:53,560 THERE'S THE LONG-TERM CARE PLAN 4816 02:59:53,560 --> 02:59:59,520 THAT'S PART OF THE NIH FUNDING 4817 02:59:59,520 --> 03:00:01,440 AND REVIEW BUT HAVING WITHIN 4818 03:00:01,440 --> 03:00:05,560 THAT PLAN, I THINK SOMETIMES THE 4819 03:00:05,560 --> 03:00:06,560 PLAN IS TO EXPLANT EVERYBODY AT 4820 03:00:06,560 --> 03:00:08,400 THE END OF THE STUDY AND OUR 4821 03:00:08,400 --> 03:00:10,080 PLAN IF SOMEBODY DOESN'T WANT TO 4822 03:00:10,080 --> 03:00:11,120 GET EXPLANTED AT THAT TIME 4823 03:00:11,120 --> 03:00:13,000 BECAUSE CLEARLY THEYAV WOULD 4824 03:00:13,000 --> 03:00:16,120 TO CONSENT TO TO GIVE THEM A 4825 03:00:16,120 --> 03:00:17,280 YEAR LONG WINDOW OR SOMETHING, 4826 03:00:17,280 --> 03:00:20,360 TO ME THAT'S NOT A SUFFICIENT 4827 03:00:20,360 --> 03:00:23,480 PLAN. 4828 03:00:23,480 --> 03:00:26,880 SO IF WE SO IF WE FIGURE OUT A 4829 03:00:26,880 --> 03:00:28,480 WAY FOR THESE TRIALS TO ALLOW 4830 03:00:28,480 --> 03:00:34,120 LONGER TERM, I DON'T KNOW WHAT 4831 03:00:34,120 --> 03:00:35,320 THEY'RE CALLED OR KEEP THE TRIAL 4832 03:00:35,320 --> 03:00:36,760 OPEN, I DON'T KNOW THE ONTOLOGY 4833 03:00:36,760 --> 03:00:37,840 OF TRIALS TO FIGURE SOMETHING 4834 03:00:37,840 --> 03:00:39,040 LIKE THAT OUT BUT SOMETHING LIKE 4835 03:00:39,040 --> 03:00:49,360 THAT AS THE DEFAULT OPTION SO 4836 03:00:49,360 --> 03:00:50,440 THEN HEARING ABOUT WHAT THEY 4837 03:00:50,440 --> 03:00:52,560 CAME BACK FROM NIH PACE AND SAID 4838 03:00:52,560 --> 03:00:54,080 WE WON'T DO THIS UNTIL WE FIGURE 4839 03:00:54,080 --> 03:00:55,840 OUT THIS BETTER LONG-TERM CARE 4840 03:00:55,840 --> 03:00:58,080 PLAN AND IT SOUNDS LIKE IT WAS 4841 03:00:58,080 --> 03:00:58,760 INCREDIBLE LOAMACYY DIFFICULT 4842 03:00:58,760 --> 03:01:00,640 AND SHE DIDN'T THINK IT WAS 4843 03:01:00,640 --> 03:01:08,360 NECESSARILY EQUITABLE AT THE END 4844 03:01:08,360 --> 03:01:10,560 BUT IF THERE ARE MODELS FOR THAT 4845 03:01:10,560 --> 03:01:11,760 AND THEN CAN YOU GO TO THE 4846 03:01:11,760 --> 03:01:12,960 ACADEM INDUSTRY AND THE PARTNER 4847 03:01:12,960 --> 03:01:15,280 AND SAY, LOOK, THIS IS WHAT THE, 4848 03:01:15,280 --> 03:01:16,600 IN IH RECOMMENDS AND THIS IS 4849 03:01:16,600 --> 03:01:18,600 WHAT HAS BEEN DONE IN THE PAST, 4850 03:01:18,600 --> 03:01:19,800 WE'RE CREATING A NORM THAT I 4851 03:01:19,800 --> 03:01:21,280 THINK PEOPLE CAN FOLLOW, I GET 4852 03:01:21,280 --> 03:01:24,400 THAT I'M NOT OFFERING DETAILS ON 4853 03:01:24,400 --> 03:01:30,400 EXACTLY WHAT THOSE PROPORTIONS 4854 03:01:30,400 --> 03:01:30,600 ARE. 4855 03:01:30,600 --> 03:01:32,600 >> I WOULD LIKE TO FROM THE 4856 03:01:32,600 --> 03:01:37,000 RESEARCHER STANDPOINT TO CLARIFY 4857 03:01:37,000 --> 03:01:38,960 SOMETHING, AND AS A CLINICIAN, 4858 03:01:38,960 --> 03:01:40,440 MY FIRST AND FOREMOST INTEREST 4859 03:01:40,440 --> 03:01:45,920 IS FOR THE PATIENTS WELL BEING, 4860 03:01:45,920 --> 03:01:47,560 HOWEVER, AS A RESEARCHER WEARING 4861 03:01:47,560 --> 03:01:50,200 THE OTHER HAT, THE HYPOTHESIS 4862 03:01:50,200 --> 03:01:52,680 THAT I SRO TO BE LAID OUT IN A 4863 03:01:52,680 --> 03:01:54,280 REASONABLE WAY THAT I WILL GET, 4864 03:01:54,280 --> 03:01:56,240 YOU KNOW DESIGN THAT'S GOING TO 4865 03:01:56,240 --> 03:02:01,680 WORK TO ANSWER THE QUESTION 4866 03:02:01,680 --> 03:02:04,560 WOULD BE UNIQUE ETHICAL 4867 03:02:04,560 --> 03:02:05,960 FRAMEWORK THAT SOMETIMES THE WAY 4868 03:02:05,960 --> 03:02:13,040 I HAVE TO ANSWER THOSE QUESTIONS 4869 03:02:13,040 --> 03:02:14,600 IS WORKING ALONG PATIENTS OR 4870 03:02:14,600 --> 03:02:15,880 PARTICIPANTS THAT ARE EXTREMELY 4871 03:02:15,880 --> 03:02:17,800 SICK AND HAVE FAILED MOST 4872 03:02:17,800 --> 03:02:18,280 TRIALS. 4873 03:02:18,280 --> 03:02:21,480 LIKE IN ANY NOVEL TREATMENT, 4874 03:02:21,480 --> 03:02:29,680 SOMETIMES YOU START YOU START AT 4875 03:02:29,680 --> 03:02:30,000 THE TIME. 4876 03:02:30,000 --> 03:02:31,880 >> THE GOAL FOR ME RINNING THESE 4877 03:02:31,880 --> 03:02:33,360 CLINICAL TRIALS OR THESE 4878 03:02:33,360 --> 03:02:36,600 STUDIES, IS 2 FOLD, 1 IS, YOU 4879 03:02:36,600 --> 03:02:38,400 KNOW I WANT TO I WANT TO SUNDAY 4880 03:02:38,400 --> 03:02:40,240 WHAT GOES ON IN THE BRAIN AND 4881 03:02:40,240 --> 03:02:41,040 WHAT HAPPENS IN DEPRESSION AND 4882 03:02:41,040 --> 03:02:42,920 WHAT HAPPENS IN THE 4883 03:02:42,920 --> 03:02:43,720 ELECTROPHYSIOLOGY OF THE CERTAIN 4884 03:02:43,720 --> 03:02:45,200 AREAS IN THE BRAIN AND THAT'S 4885 03:02:45,200 --> 03:02:48,800 SORT OF, YOU KNOW THE SCIENTIFIC 4886 03:02:48,800 --> 03:02:52,200 QUESTION, FOR WHICH NIH IS VERY 4887 03:02:52,200 --> 03:02:53,720 INTERESTED IN FINDING THAT. 4888 03:02:53,720 --> 03:02:57,560 ON THE OTHER HAND. 4889 03:02:57,560 --> 03:02:58,920 I WANT TO MAKE THIS TREATMENT 4890 03:02:58,920 --> 03:03:01,840 THEY THINK IT WORKS FOR A 4891 03:03:01,840 --> 03:03:03,200 MAJORITY OF PATIENTS BUT A LARGE 4892 03:03:03,200 --> 03:03:04,600 NUMBER OF PATIENTS, I WANT TO 4893 03:03:04,600 --> 03:03:06,040 MAKE IT AVAILABLE FOR PATIENTS 4894 03:03:06,040 --> 03:03:14,320 OUTSIDE OF A CLINICAL TRIAL. 4895 03:03:14,320 --> 03:03:19,520 THE GOAL FOR ME IS NOT TO RUN N 4896 03:03:19,520 --> 03:03:20,840 SMALL CLINICAL TRIALS IN WHICH I 4897 03:03:20,840 --> 03:03:24,520 HAVE 40 PATIENTS OVER 15 YEARS, 4898 03:03:24,520 --> 03:03:26,120 BECAUSE THAT WILL NEVER, YOU 4899 03:03:26,120 --> 03:03:28,400 KNOW ADD TOO HELPING THE 4900 03:03:28,400 --> 03:03:30,600 COMMUNITY, YOU KNOW OVERALL, THE 4901 03:03:30,600 --> 03:03:32,400 PATIENTS WITH TREATMENT 4902 03:03:32,400 --> 03:03:34,440 RESISTANT DEPRESSION OR WITH 4903 03:03:34,440 --> 03:03:36,680 LGS, IF EVERY PATIENT WITH LGS 4904 03:03:36,680 --> 03:03:40,320 NEEDED TO PARTICIPATE IN THE 4905 03:03:40,320 --> 03:03:41,920 TRIAL OR ANY PATIENT WITH LOCKED 4906 03:03:41,920 --> 03:03:44,240 IN SYNDROME, OR WHATEVER, THE 4907 03:03:44,240 --> 03:03:45,000 PARTICIPATION IN THE CLINICAL 4908 03:03:45,000 --> 03:03:48,440 TRIAL OF EACH OF THESE PATIENTS, 4909 03:03:48,440 --> 03:03:49,920 IS TECH HAD NIICALLY IMPOSSIBLE 4910 03:03:49,920 --> 03:03:51,440 SO WE HAVE TO THINK 2 WAYS, WHAT 4911 03:03:51,440 --> 03:03:54,120 CAN WE MAKE THE CLINICAL TRIAL 4912 03:03:54,120 --> 03:03:58,000 TO OPTIMIZE, YOU KNOW THE SIGNAL 4913 03:03:58,000 --> 03:03:59,360 DETECTION THAT WILL THEN HELP 4914 03:03:59,360 --> 03:04:02,640 MAYBE THE INDUSTRY, YOU KNOW 4915 03:04:02,640 --> 03:04:03,800 CMS, WHOEVER, STAKEHOLDER WILL 4916 03:04:03,800 --> 03:04:07,280 FUND A TRIAL AND THEN TAKE IT TO 4917 03:04:07,280 --> 03:04:10,040 THE GENERAL POPULATION BUT WE 4918 03:04:10,040 --> 03:04:10,800 CANNOT THINK INDEFINITELY 4919 03:04:10,800 --> 03:04:12,280 BECAUSE IT'S NOT PRACTICAL. 4920 03:04:12,280 --> 03:04:15,480 WE DON'T HAVE ENOUGH 4921 03:04:15,480 --> 03:04:17,360 PSYCHIATRISTS AND IMAGING 4922 03:04:17,360 --> 03:04:18,800 SCIENTISTS AND THE 4923 03:04:18,800 --> 03:04:19,840 ELECTROPHYSIOLOGISTS, ET CETERA 4924 03:04:19,840 --> 03:04:21,520 TO RUN A CLINICAL TRIAL IN EVERY 4925 03:04:21,520 --> 03:04:24,520 PATIENT THAT NEEDS THAT WOULD BE 4926 03:04:24,520 --> 03:04:25,520 ELIGIBLE, SO EEIVETTUALLY WE 4927 03:04:25,520 --> 03:04:28,040 HAVE TO MAKE IT, YOU KNOW 4928 03:04:28,040 --> 03:04:29,320 AVAILABLE FOR MORE PEOPLE. 4929 03:04:29,320 --> 03:04:33,280 WHAT IS THE ROLE OF EACH, YOU 4930 03:04:33,280 --> 03:04:36,840 KNOW AGENT WHETHER IT'S FDA, 4931 03:04:36,840 --> 03:04:37,560 NIH, CMS, [INDISCERNIBLE], AND 4932 03:04:37,560 --> 03:04:40,200 THEN TO MAKE IT AVAILABLE FOR 4933 03:04:40,200 --> 03:04:41,840 MORE PEOPLE THAT.'S WHAT I WOULD 4934 03:04:41,840 --> 03:04:43,680 LIKE TO UNDERSTAND BECAUSE 4935 03:04:43,680 --> 03:04:46,200 OTHERWISE, I FEEL LIKE, YOU 4936 03:04:46,200 --> 03:04:49,320 KNOW, INDEFINITELY, I COULD HAVE 4937 03:04:49,320 --> 03:04:51,080 A CAREER IMPLANTING 12 PATIENTS 4938 03:04:51,080 --> 03:04:53,080 A YEAR, 4 THE NEXT, YOU KNOW 40 4939 03:04:53,080 --> 03:04:55,720 YEARS OF MY LIFE, AND IT WILL 4940 03:04:55,720 --> 03:04:57,120 NOT MAKE A DIFFERENCE IN THE 4941 03:04:57,120 --> 03:04:58,440 GENERAL CHANGE OF POPULATION, 4942 03:04:58,440 --> 03:05:00,800 YOU KNOW AT LEAST THAT'S WHAT I 4943 03:05:00,800 --> 03:05:01,160 FEEL SOMETIMES. 4944 03:05:01,160 --> 03:05:02,360 I WANT TO IMPLANT MORE PEOPLE. 4945 03:05:02,360 --> 03:05:03,960 I WANT TO HELP MORE PEOPLE AND 4946 03:05:03,960 --> 03:05:06,040 FOR ME ALONE, YOU KNOW WORKING 4947 03:05:06,040 --> 03:05:16,600 IN AN IVORY TOWER IS NOT ENOUGH. 4948 03:05:17,280 --> 03:05:19,680 >> SO WE WOULD LIKE TO GO BACK 4949 03:05:19,680 --> 03:05:21,280 AND ASK RHONDA ABOUT SOMETHING 4950 03:05:21,280 --> 03:05:25,320 SHE BROUGHT UP IN PANEL 3, ABOUT 4951 03:05:25,320 --> 03:05:26,600 CONTINUUM OF CARE. 4952 03:05:26,600 --> 03:05:27,800 RHONDA ARE YOU THERE AND ABLE TO 4953 03:05:27,800 --> 03:05:29,640 SAY MORE ABOUT THAT? 4954 03:05:29,640 --> 03:05:40,160 IT SEEMS RELEVANT TO THE RECENT 4955 03:05:40,760 --> 03:05:41,400 DISCUSSION? 4956 03:05:41,400 --> 03:05:41,800 >> MAYBE NOT. 4957 03:05:41,800 --> 03:05:47,680 WELL WHILE THAT SIRCHGS IN,. 4958 03:05:47,680 --> 03:05:49,200 >> MAYBE I COULD--MARGT YOU HAD 4959 03:05:49,200 --> 03:05:52,640 A COMMENT IN THE Q&A THAT I 4960 03:05:52,640 --> 03:05:54,520 THINK MIGHT BE HELPFUL TO SHARE 4961 03:05:54,520 --> 03:05:57,040 WITH THE GROUP WHILE WE WAIT AND 4962 03:05:57,040 --> 03:06:05,720 SEE IF DR. BEIL CAN COME BACK 4963 03:06:05,720 --> 03:06:05,920 ON? 4964 03:06:05,920 --> 03:06:08,080 YEAH AND I WAS JUST WRITING A 4965 03:06:08,080 --> 03:06:09,440 FOLLOW UP TO THE COMMENT THAT 4966 03:06:09,440 --> 03:06:11,560 JOHN MADE TO MY FOLLOW UP. 4967 03:06:11,560 --> 03:06:12,960 I THINK THE CONCERN HERE IS THE 4968 03:06:12,960 --> 03:06:13,800 FIRST THING EVERYBODY NEEDS TO 4969 03:06:13,800 --> 03:06:15,600 KNOW IS WHAT IS THE RISK, HOW 4970 03:06:15,600 --> 03:06:16,800 LIKELY IS IT THAT A PATIENT IS 4971 03:06:16,800 --> 03:06:20,480 GOING TO HAVE AN ADVERSE EVENT 4972 03:06:20,480 --> 03:06:22,320 THAT WOULD REQUIRE SOME TYPE OF 4973 03:06:22,320 --> 03:06:23,200 MEDICAL INTERVENTION. 4974 03:06:23,200 --> 03:06:28,280 HOW FREQUENTLY IS A BATTERY 4975 03:06:28,280 --> 03:06:29,440 REPLACEMENT LIKELY TO--LIKELY TO 4976 03:06:29,440 --> 03:06:31,080 BE NEEDED, I MEAN, ALL OF THESE 4977 03:06:31,080 --> 03:06:33,840 THINGS, YOU KNOW HOW MANY 4978 03:06:33,840 --> 03:06:34,560 INDIVIDUALS WILL CHOOSE TO 4979 03:06:34,560 --> 03:06:35,000 CONTINUE TREATMENT. 4980 03:06:35,000 --> 03:06:37,560 IF YOU HAVE ALL OF THESE PIECES 4981 03:06:37,560 --> 03:06:38,520 OF INFORMATION, CAN YOU 4982 03:06:38,520 --> 03:06:41,440 CALCULATE THIS IS THE RISK AND 4983 03:06:41,440 --> 03:06:44,120 THEN CAN YOU MAKE A DECISION, 4984 03:06:44,120 --> 03:06:46,360 EXCEPT THE 1 IS THAT IF A 4985 03:06:46,360 --> 03:06:48,760 PATIENT IS NOT COVERED BY THEIR 4986 03:06:48,760 --> 03:06:51,400 INSURER OR COVERED BY MEDICARE 4987 03:06:51,400 --> 03:06:52,160 OR MEDICAID. 4988 03:06:52,160 --> 03:06:54,000 WHICH MEANS IT'S THE COMPANY OR 4989 03:06:54,000 --> 03:06:58,320 THE PATIENT WHOSE PAYING, THEN 4990 03:06:58,320 --> 03:07:00,520 THE CHARGES ARE GENERALLY HIGHER 4991 03:07:00,520 --> 03:07:02,280 THAN THEY WOULD BE IF IT WAS--IF 4992 03:07:02,280 --> 03:07:04,080 THE PATIENT WAS COVERED BY SOME 4993 03:07:04,080 --> 03:07:06,160 ORGANIZATION THAT WAS ABLE TO DO 4994 03:07:06,160 --> 03:07:08,280 NEGOTIATED RATE AND WHEN I SAY 4995 03:07:08,280 --> 03:07:10,280 HIGHER, I MEAN CONSIDERABLILY 4996 03:07:10,280 --> 03:07:11,640 HIGHER. 4997 03:07:11,640 --> 03:07:14,000 SO, YOU KNOW, THE NUMBER, A 4998 03:07:14,000 --> 03:07:14,960 HUNDRED THOUSAND DOLLARS WAS 4999 03:07:14,960 --> 03:07:16,760 THROWN OUT, WELL, I SUSPECT THAT 5000 03:07:16,760 --> 03:07:17,720 A HUNDRED THOUSAND DOLLARS 5001 03:07:17,720 --> 03:07:21,160 CHARGED TO LOCATION OR TO 5002 03:07:21,160 --> 03:07:23,440 ACCOMPANY IS NOT WHAT UNITED 5003 03:07:23,440 --> 03:07:26,600 HEALTHCARE OR MEDICARE WILL PAY. 5004 03:07:26,600 --> 03:07:29,520 AND IT'S RANDOM. 5005 03:07:29,520 --> 03:07:32,200 IT'S--THE ORGANIZATIONS THAT THE 5006 03:07:32,200 --> 03:07:33,040 CARE PROVIDING ORGANIZATIONS CAN 5007 03:07:33,040 --> 03:07:38,040 CHARGE WHATEVER THEY WANT. 5008 03:07:38,040 --> 03:07:39,840 SO THAT'S WHERE THE RISK CAN'T 5009 03:07:39,840 --> 03:07:41,720 BE CONTROLLED AND EVERYBODY GETS 5010 03:07:41,720 --> 03:07:42,680 REALLY NERVOUS IF YOU DON'T KNOW 5011 03:07:42,680 --> 03:07:46,840 WHAT THE RISK IS. 5012 03:07:46,840 --> 03:07:48,360 SO, WHAT WE'VE PROPOSED IN OUR 5013 03:07:48,360 --> 03:07:50,160 STUDIES IS THAT IF PATIENTS 5014 03:07:50,160 --> 03:07:52,160 COULD NOT BE COVERED BY 5015 03:07:52,160 --> 03:07:54,160 INSURANCE THAT THE COMPANY WOULD 5016 03:07:54,160 --> 03:07:56,720 BE THE PAIR OF LAST RESORT BUT 5017 03:07:56,720 --> 03:07:59,600 THAT THAT WOULD BE TIED TO 5018 03:07:59,600 --> 03:08:04,440 SOMETHING RELATED TO MEDICARE 5019 03:08:04,440 --> 03:08:06,520 RATE, EITHER MEDICARE RATE OR 5020 03:08:06,520 --> 03:08:11,280 SOMETHING + 10%, SOMETHING TO 5021 03:08:11,280 --> 03:08:11,600 START WITH. 5022 03:08:11,600 --> 03:08:12,680 AND IF THAT AGREEMENT WITH THE 5023 03:08:12,680 --> 03:08:14,280 INSTITUTION CAN BE REACHED, THEN 5024 03:08:14,280 --> 03:08:16,400 WE WILL MOVE AHEAD AND ALLOW 5025 03:08:16,400 --> 03:08:18,160 THAT INSTITUTION TO BE A TRIAL 5026 03:08:18,160 --> 03:08:19,520 SITE BUT MANY INSTITUTIONS WILL 5027 03:08:19,520 --> 03:08:29,840 NOT AGREE WITH THAT. 5028 03:08:39,640 --> 03:08:41,240 AND WE SHOULD CONTINUE TO MOVE 5029 03:08:41,240 --> 03:08:42,640 AHEAD WITH THESE INVESTIGATIONS. 5030 03:08:42,640 --> 03:08:43,440 SO REDUCING RISK. 5031 03:08:43,440 --> 03:08:47,320 I THINK WE NEED AN INSURANCE 5032 03:08:47,320 --> 03:08:54,440 ACTUARIAL ON THIS PANEL. 5033 03:08:54,440 --> 03:08:55,880 OR CONSIDERING RISK IS WHAT I 5034 03:08:55,880 --> 03:08:56,160 WILL SAY. 5035 03:08:56,160 --> 03:09:04,240 >> I THINK THERE WILL BE GOOD TO 5036 03:09:04,240 --> 03:09:05,800 TALK ABOUT POTENTIAL INSURANCE A 5037 03:09:05,800 --> 03:09:12,200 BIT MORE BUT FIRST I WANT TO 5038 03:09:12,200 --> 03:09:16,800 GIVE THE FLOOR TO SAMEER, 5039 03:09:16,800 --> 03:09:17,240 SHETH,. 5040 03:09:17,240 --> 03:09:19,080 >> YES, I APOLOGIZE FOR MISSING 5041 03:09:19,080 --> 03:09:20,680 SOME TODAY AND YESTERDAY, 5042 03:09:20,680 --> 03:09:22,480 BECAUSE I'VE BEEN DOING CLINICAL 5043 03:09:22,480 --> 03:09:23,760 STUFF, BUT THE QUESTION I HAD, 5044 03:09:23,760 --> 03:09:24,840 AND MAYBE PEOPLE HAD ENOUGH 5045 03:09:24,840 --> 03:09:26,200 EXPERIENCE TO ANSWER THIS IS 5046 03:09:26,200 --> 03:09:29,520 THAT, I STARTED GETTING INTO 5047 03:09:29,520 --> 03:09:31,080 THIS YESTERDAY A BIT BUT I THINK 5048 03:09:31,080 --> 03:09:32,480 WE STOPPED SHORT OF SPECIFICS 5049 03:09:32,480 --> 03:09:38,240 WHICH IS A STUDY THAT COVERED BY 5050 03:09:38,240 --> 03:09:39,760 AN IAED, YOU GUYS WON'T BE ABLE 5051 03:09:39,760 --> 03:09:43,280 TO SPEAK TO THIS BUT WHEN 5052 03:09:43,280 --> 03:09:49,280 THERE'S IDE COVERAGE FOR A 5053 03:09:49,280 --> 03:09:52,280 STUDY, THERE'S A CMS PATHWAY TO 5054 03:09:52,280 --> 03:09:53,920 COVER THE SURGICAL COST FOR 5055 03:09:53,920 --> 03:09:55,200 FUTURE BATTERY RECHANGE OR 5056 03:09:55,200 --> 03:10:00,240 REVISION REQUIRED FOR MEDICAL 5057 03:10:00,240 --> 03:10:01,320 REASON INFECTION, WHATEVER. 5058 03:10:01,320 --> 03:10:03,320 THIS IS FAIRLY ROUTINE, WE ARE 5059 03:10:03,320 --> 03:10:05,880 HAVE DONE THIS IN OUR OCD TRIAL 5060 03:10:05,880 --> 03:10:06,960 THAT WE'RE RUNNING, IS THIS A 5061 03:10:06,960 --> 03:10:09,880 PRACTICE THAT IS USED OFTEN AND 5062 03:10:09,880 --> 03:10:13,880 PEOPLE KNOW ABOUT ROUTINELY, THE 5063 03:10:13,880 --> 03:10:15,520 DEVICE HAS TO COME SOMEWHERE, 5064 03:10:15,520 --> 03:10:16,440 DONATED BY THE MANUFACTURE WOULD 5065 03:10:16,440 --> 03:10:18,560 BE 1 WAY, BUT THE ACTUAL 5066 03:10:18,560 --> 03:10:20,000 HOSPITAL IS SURGICAL COSTS GET 5067 03:10:20,000 --> 03:10:24,640 COVERED YOU TEENLY I BELIEVE, IS 5068 03:10:24,640 --> 03:10:25,120 THAT YOUR EXPERIENCE? 5069 03:10:25,120 --> 03:10:29,480 >> I DON'T BE IF WE HAVE OUR CMS 5070 03:10:29,480 --> 03:10:30,040 REBECCA REPRESENTATIVE HERE. 5071 03:10:30,040 --> 03:10:32,080 >> THE NAME IS IN A BOX, I THINK 5072 03:10:32,080 --> 03:10:36,200 HE'S HERE. 5073 03:10:36,200 --> 03:10:36,520 >> OKAY. 5074 03:10:36,520 --> 03:10:39,400 >> SO EXPERIENCE HAS BEEN THAT 5075 03:10:39,400 --> 03:10:46,400 WE SUBMIT THIS REQUEST TO CMS. 5076 03:10:46,400 --> 03:10:48,640 AND THUS FAR IT HAS ALWAYS BEEN 5077 03:10:48,640 --> 03:10:50,160 SUCCESSFUL BUT PERHAPS WE SHOULD 5078 03:10:50,160 --> 03:10:51,400 HEAR FROM THE PERSON WHO 5079 03:10:51,400 --> 03:10:52,840 ACTUALLY HAS THE ANSWER. 5080 03:10:52,840 --> 03:10:53,240 >> RIGHT. 5081 03:10:53,240 --> 03:10:54,960 SO I DON'T KNOW IF YOU CAN HEAR 5082 03:10:54,960 --> 03:10:55,120 ME. 5083 03:10:55,120 --> 03:10:58,960 >> YES, YES. 5084 03:10:58,960 --> 03:11:00,440 >> ALL RIGHT, GOOD. 5085 03:11:00,440 --> 03:11:03,360 SO YES, IF WE APPROVE THE IDE 5086 03:11:03,360 --> 03:11:06,760 FOR MEDICARE COVERAGE THEN 5087 03:11:06,760 --> 03:11:07,880 WE--IT DEPENDING ON THE 5088 03:11:07,880 --> 03:11:09,040 SITUATION WE USUALLY COVER THE 5089 03:11:09,040 --> 03:11:13,280 DEVICE IN ADDITION TO THE 5090 03:11:13,280 --> 03:11:14,920 ROUTINE SERVICES RELATED TO THE 5091 03:11:14,920 --> 03:11:17,000 DEVICE, DEPENDING ON THE 5092 03:11:17,000 --> 03:11:19,800 SITUATION, HOW WE DEFINE ROUTINE 5093 03:11:19,800 --> 03:11:20,800 SERVICES IS DEPENDENTOT 5094 03:11:20,800 --> 03:11:25,760 PARTICULAR STUDY, SO, WHYS THAT 5095 03:11:25,760 --> 03:11:26,840 DOES OCCUR ROUTINELY. 5096 03:11:26,840 --> 03:11:32,280 >> MAY I ASK, HOW OFTEN THAT A 5097 03:11:32,280 --> 03:11:33,600 COMPANY WILL MAKE THAT REQUEST 5098 03:11:33,600 --> 03:11:43,520 IS NOT ABLE TO GET IT APPROVED? 5099 03:11:43,520 --> 03:11:45,440 >> I CAN'T GIVE YOU A SPECIFIC 5100 03:11:45,440 --> 03:11:47,480 NUMBER BUT THERE ARE SOME TIMES 5101 03:11:47,480 --> 03:11:49,560 WHEN IT'S NOT APPROVED OR NOT 5102 03:11:49,560 --> 03:11:55,040 COVERED BY CMS BUT THAT'S FOR 5103 03:11:55,040 --> 03:11:55,960 REASONS RELATED TO THE TRIAL 5104 03:11:55,960 --> 03:11:59,520 DESIGN AND THE TYPE OF DEVICE, 5105 03:11:59,520 --> 03:12:04,200 FOR INSTANCE IF IT'S NEVER BEEN 5106 03:12:04,200 --> 03:12:05,400 USED IN HUMANS, WE WOULD THEN 5107 03:12:05,400 --> 03:12:07,720 NOT APPROVE IT BECAUSE THERE'S 5108 03:12:07,720 --> 03:12:10,560 NO CLINICAL DATA, THERE'S NO 5109 03:12:10,560 --> 03:12:11,760 DATA ON HUMANS. 5110 03:12:11,760 --> 03:12:13,440 >> DR. LI, I WOULD LIKE TO SAY 5111 03:12:13,440 --> 03:12:14,320 SOMETHING IMPORTANT. 5112 03:12:14,320 --> 03:12:16,640 SO WE HAVE SECURED COVERAGE FOR 5113 03:12:16,640 --> 03:12:19,160 MEDICARE FOR OUR SURGERIES, 5114 03:12:19,160 --> 03:12:23,120 HOWEVER, IF THE DEVICES ARE NOT 5115 03:12:23,120 --> 03:12:24,600 COMMERCIALLY AVAILABLE OR 5116 03:12:24,600 --> 03:12:26,800 COVERED, THERE'S NO WAY TO 5117 03:12:26,800 --> 03:12:28,160 PURCHASE THOSE DEVICES OR TO 5118 03:12:28,160 --> 03:12:30,360 BILL FOR THOSE DEVICES. 5119 03:12:30,360 --> 03:12:33,760 THEY HAVE TO BE NECESSARILY 5120 03:12:33,760 --> 03:12:35,160 DONATED BY THE MANUFACTURER AND 5121 03:12:35,160 --> 03:12:37,160 THEY'RE STUCK WITH THAT UNTIL 5122 03:12:37,160 --> 03:12:40,480 THEY DECIDE TO DISCONTINUE, YOU 5123 03:12:40,480 --> 03:12:41,920 KNOW, THE PRODUCTION OF THAT 5124 03:12:41,920 --> 03:12:43,480 DEVICE IF THEY DECIDE, RIGHT? 5125 03:12:43,480 --> 03:12:46,040 OR THEY GET THE FDA, THE FDA 5126 03:12:46,040 --> 03:12:52,160 APPROVAL AND THEN THAT DEVICE IS 5127 03:12:52,160 --> 03:12:52,640 COMMERCIALLY AVAILABLE. 5128 03:12:52,640 --> 03:12:58,000 THAT'S THE TRICKY THING OF THE 5129 03:12:58,000 --> 03:12:58,840 COVERAGE OF SURGERIES. 5130 03:12:58,840 --> 03:13:00,720 WHEN WHEN HARDWARE IS NOT--YOU 5131 03:13:00,720 --> 03:13:02,600 KNOW IT'S STILL VERY 5132 03:13:02,600 --> 03:13:03,240 EXPERIMENTAL. 5133 03:13:03,240 --> 03:13:09,280 >> SO CARL, MAY I ASK A 5134 03:13:09,280 --> 03:13:10,600 QUESTION, AND SINCE YOU 5135 03:13:10,600 --> 03:13:11,640 REPRESENT ALL OF CMS AND 5136 03:13:11,640 --> 03:13:17,360 WHATEVER YOU SAY HERE IS BEING 5137 03:13:17,360 --> 03:13:19,600 RECORDED, IS IT EVEN CONCEIVABLE 5138 03:13:19,600 --> 03:13:21,760 THAT IF CMS DETERMINES THAT 5139 03:13:21,760 --> 03:13:24,440 THERE'S AN IDE STUDY AND WILL 5140 03:13:24,440 --> 03:13:27,000 COVER, THAT INDIVIDUALS WHO HAVE 5141 03:13:27,000 --> 03:13:29,200 PARTICIPATED IN THAT STUDY, NOT 5142 03:13:29,200 --> 03:13:30,680 NEW PEOPLE BUT INDIVIDUAL WHO IS 5143 03:13:30,680 --> 03:13:32,440 HAVE BEEN PART OF THAT STUDY 5144 03:13:32,440 --> 03:13:35,200 WOULD BE ABLE TO RECEIVE SOME 5145 03:13:35,200 --> 03:13:37,040 TYPE OF CMS COVERAGE OR THERE 5146 03:13:37,040 --> 03:13:40,240 WOULD BE A CMS FAVORABLE 5147 03:13:40,240 --> 03:13:43,920 COVERAGE DECISION FOR THEIR POST 5148 03:13:43,920 --> 03:13:45,600 TRIAL CARE. 5149 03:13:45,600 --> 03:13:47,800 >> I'M SORRY, GUESS I'M NOT SURE 5150 03:13:47,800 --> 03:13:48,760 I UNDERSTAND THE QUESTION. 5151 03:13:48,760 --> 03:13:50,040 IF YOU DON'T MIND-- 5152 03:13:50,040 --> 03:13:51,800 >> IT MAY BE BECAUSE I'M VERY 5153 03:13:51,800 --> 03:13:52,240 CONFUSED. 5154 03:13:52,240 --> 03:13:53,680 SO RIGHT NOW MY UNDERSTANDING 5155 03:13:53,680 --> 03:13:58,320 AND MY EXPERIENCE HAS BEEN THAT 5156 03:13:58,320 --> 03:14:03,080 CMS WILL IN MOST CASES PROVIDE 5157 03:14:03,080 --> 03:14:05,200 COVERAGE FOR PATIENTS WITH CLASS 5158 03:14:05,200 --> 03:14:08,040 3 MEDICAL DEVICES WHRO ARE IN 5159 03:14:08,040 --> 03:14:09,240 WELL DESIGNED IDE STUDIES AND 5160 03:14:09,240 --> 03:14:14,200 MOST, NOT MOST BUT MANY, MAYBE 5161 03:14:14,200 --> 03:14:16,800 MOST OF THE INSHERRERS WILL 5162 03:14:16,800 --> 03:14:17,920 FOLLOW MEDICARE'S GUIDE LINE, I 5163 03:14:17,920 --> 03:14:19,480 WOULD SAY MOST OF THE LARGER 5164 03:14:19,480 --> 03:14:21,160 INSURERS DO SO AND MAID CADE 5165 03:14:21,160 --> 03:14:22,880 GENERALLY DOES AS WELL. 5166 03:14:22,880 --> 03:14:25,320 BUT THEN WHEN THE STUDY ENDS, 5167 03:14:25,320 --> 03:14:27,000 THAT'S WHERE THE PROBLEM IS. 5168 03:14:27,000 --> 03:14:28,560 NOW GENERALLY FOR THESE DEVICE 5169 03:14:28,560 --> 03:14:33,640 STUDIES, WE ARE NOT TALKING 5170 03:14:33,640 --> 03:14:34,920 ABOUT 3000 PATIENTS AS IS THE 5171 03:14:34,920 --> 03:14:37,080 CASE WITH MANY PHARMA STUDIES, 5172 03:14:37,080 --> 03:14:38,200 WE'RE USUALLY TALKING ABOUT A 5173 03:14:38,200 --> 03:14:40,480 HUNDRED OR 200 PATIENTS OR A 5174 03:14:40,480 --> 03:14:43,320 HUNDRED OR 50 PATIENTS WHO WANT 5175 03:14:43,320 --> 03:14:46,040 TO CONTINUE TO RECEIVE CARE. 5176 03:14:46,040 --> 03:14:46,920 >> OR 10. 5177 03:14:46,920 --> 03:14:47,280 >> OR 10. 5178 03:14:47,280 --> 03:14:49,720 >> AND WE KNOW WHO THOSE PEOPLE 5179 03:14:49,720 --> 03:14:53,320 ARE, SO, ARE WE REALLY TALKING 5180 03:14:53,320 --> 03:14:53,880 ABOUT BIG BUCS? 5181 03:14:53,880 --> 03:14:59,120 I MEAN THIS IS NOT EVEN IN CMS'S 5182 03:14:59,120 --> 03:15:00,640 ROUND OFF AND IS IT POSSIBLE FOR 5183 03:15:00,640 --> 03:15:02,920 THERE TO BE SOME POLICY THAT 5184 03:15:02,920 --> 03:15:04,520 THOSE FEW PATIENT WHO IS HAVE 5185 03:15:04,520 --> 03:15:06,240 GONE THROUGH ALL OF THIS, WILL 5186 03:15:06,240 --> 03:15:12,000 HAVE SOME KIND OF A CARB OUT 5187 03:15:12,000 --> 03:15:14,200 WHERE CMS WOULD STILL COVER AT 5188 03:15:14,200 --> 03:15:20,240 LEAST SOME PORTION OF DEVICE 5189 03:15:20,240 --> 03:15:20,640 RELATED CARE. 5190 03:15:20,640 --> 03:15:22,680 >> MOST OF IT I HAVE TO GIVE A 5191 03:15:22,680 --> 03:15:23,160 QUESTION SOME THOUGHT. 5192 03:15:23,160 --> 03:15:25,800 I THINK THERE'S A LOT OF NUANCES 5193 03:15:25,800 --> 03:15:29,920 THAT ARE GOING HERE IN THAT THE 5194 03:15:29,920 --> 03:15:32,520 IDE IS TO--IS FOR FDA, 5195 03:15:32,520 --> 03:15:34,040 TECHNICALLY IT'S FDA CLEARED 5196 03:15:34,040 --> 03:15:34,520 DEVICES. 5197 03:15:34,520 --> 03:15:35,720 I MEAN THEY'RE TRYING TO GET 5198 03:15:35,720 --> 03:15:40,680 FULL APPROVAL AND SO, ONCE THAT 5199 03:15:40,680 --> 03:15:43,960 STUDY ENDS, I MEAN IT'S--WE ONLY 5200 03:15:43,960 --> 03:15:45,320 COVER IT DURING THE TRIAL. 5201 03:15:45,320 --> 03:15:52,040 I MEAN THAT FALLS FALLS WITHINR 5202 03:15:52,040 --> 03:15:52,480 REGULATIONS. 5203 03:15:52,480 --> 03:15:53,840 WE CAN'T--MY UNDERSTANDING IS, 5204 03:15:53,840 --> 03:16:03,520 THAT'S WHERE OUR AUTHORITY 5205 03:16:03,520 --> 03:16:03,920 FALLS. 5206 03:16:03,920 --> 03:16:04,880 AND YOU KNOW COMPANIES ARE 5207 03:16:04,880 --> 03:16:08,840 TRYING TO GET FDA APPROVAL. 5208 03:16:08,840 --> 03:16:10,280 NOW, I GUESS I WOULD HAVE TO 5209 03:16:10,280 --> 03:16:14,680 GIVE THAT THOUGHT FOR POST TRIAL 5210 03:16:14,680 --> 03:16:16,920 SUPPORT WITHIN THE CONFINES OF 5211 03:16:16,920 --> 03:16:19,320 AN IDERKS E TRIAL, WHETHER IT'S 5212 03:16:19,320 --> 03:16:21,040 A PIVOTAL TRIAL OR FEASIBILITY 5213 03:16:21,040 --> 03:16:22,560 TRIAL, I GUESS I WOULD HAVE TO 5214 03:16:22,560 --> 03:16:24,480 GIVE THAT SOME THOUGHT FOR POST 5215 03:16:24,480 --> 03:16:24,800 TRIAL CARE. 5216 03:16:24,800 --> 03:16:28,280 >> AND YOU KNOW THEN PERHAPS 5217 03:16:28,280 --> 03:16:29,000 ANOTHER--ANOTHER OPTION SINCE 5218 03:16:29,000 --> 03:16:30,880 SERVE'S GOT TO BE PART OF THIS 5219 03:16:30,880 --> 03:16:33,240 SOLUTION, AND OF COURSE, I 5220 03:16:33,240 --> 03:16:35,840 REPRESENT ALL INDUSTRY AND I 5221 03:16:35,840 --> 03:16:38,160 REPRESENT--NO, I DON'T I AM 5222 03:16:38,160 --> 03:16:41,720 SPEAKING FOR MYSELF RIGHT NOW 5223 03:16:41,720 --> 03:16:42,960 BUT IF THERE WAS AN 5224 03:16:42,960 --> 03:16:46,600 UNDERSTANDING THAT AFTER THE 5225 03:16:46,600 --> 03:16:48,320 OFFICIAL STUDY IS CONCLUDED 5226 03:16:48,320 --> 03:16:53,000 THERE WOULD BE SOME TYPE OF 5227 03:16:53,000 --> 03:16:54,480 EXTENSION AND THAT SOME COVERAGE 5228 03:16:54,480 --> 03:16:56,240 WOULD BE PROVIDED DURING THAT 5229 03:16:56,240 --> 03:16:56,640 EXTENSION. 5230 03:16:56,640 --> 03:16:58,440 I MEAN FROM A COMPANY 5231 03:16:58,440 --> 03:16:59,960 PERSPECTIVE, IT CAN TAKE A VERY 5232 03:16:59,960 --> 03:17:01,920 LONG TIME FROM THE TIME YOUR 5233 03:17:01,920 --> 03:17:03,480 STUDY ENDS UNTIL YOU GET TO THE 5234 03:17:03,480 --> 03:17:05,560 POINT WHERE FDA MAKES AN 5235 03:17:05,560 --> 03:17:06,040 APPROVAL DECISION. 5236 03:17:06,040 --> 03:17:09,760 THERE'S A LOT OF STUFF THAT HAS 5237 03:17:09,760 --> 03:17:13,400 TO HAPPEN AND ALSO, FOR DEVICES, 5238 03:17:13,400 --> 03:17:15,040 IT'S VERY STANDARD FOR FDA TO 5239 03:17:15,040 --> 03:17:16,720 REQUIRE SOME TYPE OF POST 5240 03:17:16,720 --> 03:17:19,320 APPROVAL STUDY AS A CONDITION OF 5241 03:17:19,320 --> 03:17:22,200 APPROVAL TO COLLECT ADDITIONAL 5242 03:17:22,200 --> 03:17:24,120 SAFETY AND EFFECTIVENESS DATA. 5243 03:17:24,120 --> 03:17:25,760 SO IT'S IN A LOT OF PEOPLE'S 5244 03:17:25,760 --> 03:17:26,600 INTEREST, PARTICULARLY THE 5245 03:17:26,600 --> 03:17:27,640 PERSON WHO'S BEING TREATED WITH 5246 03:17:27,640 --> 03:17:30,440 THE DEVICE TO CONTINUE TO GATHER 5247 03:17:30,440 --> 03:17:33,960 INFORMATION ON SAFETY AND 5248 03:17:33,960 --> 03:17:34,600 EFFECTIVENESS. 5249 03:17:34,600 --> 03:17:36,800 IF THERE IS SOME ABILITY FOR THE 5250 03:17:36,800 --> 03:17:41,280 COMPANY TO RECEIVE THE FINANCIAL 5251 03:17:41,280 --> 03:17:43,080 RECOGNITION FROM CMS, IN A STUDY 5252 03:17:43,080 --> 03:17:45,800 THAT IS A LONG-TERM EXTENSION, 5253 03:17:45,800 --> 03:17:47,520 UNTIL THERE IS SOME DECISION 5254 03:17:47,520 --> 03:17:51,040 ABOUT APPROVAL OR NOT, THEN, YOU 5255 03:17:51,040 --> 03:17:53,560 KNOW I THINK THIS COULD BE VERY 5256 03:17:53,560 --> 03:17:55,960 ATTRACTIVE FOR EVERYBODY, 5257 03:17:55,960 --> 03:17:57,640 INCLUDING FDA SO WHEN THEY MAKE 5258 03:17:57,640 --> 03:17:58,400 THEIR DETERMINE NATION, THEY 5259 03:17:58,400 --> 03:18:00,800 WILL HAVE THAT MUCH MORE SAFETY 5260 03:18:00,800 --> 03:18:04,320 AND EFFECTIVENESS DATA TO 5261 03:18:04,320 --> 03:18:04,680 CONSIDER. 5262 03:18:04,680 --> 03:18:07,280 >> SO I WANT TO MAKE SURE WE'RE 5263 03:18:07,280 --> 03:18:11,400 NOT FOCUSING SOLELY ON CMS FOR 5264 03:18:11,400 --> 03:18:14,880 US AS A PART OF THIS EXPERIENCE 5265 03:18:14,880 --> 03:18:15,160 BUT-- 5266 03:18:15,160 --> 03:18:16,440 >> AGAIN I QUICK COMMENT, I 5267 03:18:16,440 --> 03:18:17,840 APPRECIATE THAT THOUGHT THOUGH, 5268 03:18:17,840 --> 03:18:19,320 BY THE WAY, YESTERDAY WAS A 5269 03:18:19,320 --> 03:18:27,200 DIFFERENT ISSUE BUT ANYWAY, SO 5270 03:18:27,200 --> 03:18:29,880 WE--I PERSONALLY IN OUR GROUP WE 5271 03:18:29,880 --> 03:18:32,080 DO REVIEW IDE APPLICATIONS SOME 5272 03:18:32,080 --> 03:18:34,560 OF THESE INVOLVE EARLIER 5273 03:18:34,560 --> 03:18:36,560 APPROVAL TRIAL BUT POST APPROVAL 5274 03:18:36,560 --> 03:18:38,200 STUDIES AND SO IF A XUSM DOES 5275 03:18:38,200 --> 03:18:40,200 APPLY FOR A POST APPROVAL 5276 03:18:40,200 --> 03:18:42,240 COVERAGE THROUGH MEDICARE, YOU 5277 03:18:42,240 --> 03:18:47,280 KNOW AND IF IT'S APPROVED THEN 5278 03:18:47,280 --> 03:18:48,960 WE APPROVE POST APPROVAL 5279 03:18:48,960 --> 03:18:50,520 STUDIES, THEY HAVE TO APPLY FOR 5280 03:18:50,520 --> 03:18:53,880 CMS FOR THAT COVERAGE. 5281 03:18:53,880 --> 03:18:55,400 >> WELL, SASKIA, THE REASON I'VE 5282 03:18:55,400 --> 03:18:56,840 BEEN PICKING ON CARL, AND NOT 5283 03:18:56,840 --> 03:18:59,360 REALLY PICKING ON HIM IS THAT. 5284 03:18:59,360 --> 03:19:00,160 >> AGENCY. 5285 03:19:00,160 --> 03:19:04,680 >> THAT I THINK WE'RE OFTEN 5286 03:19:04,680 --> 03:19:05,760 OTHER INSURERS ARE VERY 5287 03:19:05,760 --> 03:19:08,960 INTERESTED IN WHAT CMS DECIDES 5288 03:19:08,960 --> 03:19:19,480 AND WILL VER OFTEN FOLLOW THAT 5289 03:19:20,880 --> 03:19:21,080 LEAD. 5290 03:19:21,080 --> 03:19:24,080 >> YES, I CAN CONFIRM THAT, MANY 5291 03:19:24,080 --> 03:19:25,360 AGENCIES TEND TO FOLLOW US AND 5292 03:19:25,360 --> 03:19:26,520 WE ARE FULLY AWARE OF THAT AND 5293 03:19:26,520 --> 03:19:30,680 WE ARE AWARE OF IT. 5294 03:19:30,680 --> 03:19:33,120 >> DON'T GET ME WRONG, IT WILL 5295 03:19:33,120 --> 03:19:34,920 BE WOBDERFUL IF CMS COULD PLAY A 5296 03:19:34,920 --> 03:19:36,040 LARGER ROLE IN THIS AREA. 5297 03:19:36,040 --> 03:19:37,480 >> I KNOW IT'S GOING IN THE 5298 03:19:37,480 --> 03:19:38,840 TRANSCRIPT BUT I THINK WE DO 5299 03:19:38,840 --> 03:19:40,120 PLAY A PRETTY LARGE ROLE. 5300 03:19:40,120 --> 03:19:43,080 WE ARE THE LARGEST HEALTH 5301 03:19:43,080 --> 03:19:44,480 INSURANCE AGENCY I THINK IN THE 5302 03:19:44,480 --> 03:19:45,160 UNITED STATES. 5303 03:19:45,160 --> 03:19:47,880 SO I KNOW THAT'S GOING IN THE 5304 03:19:47,880 --> 03:19:53,040 TRANSCRIPT SO, I WILL SAY THAT. 5305 03:19:53,040 --> 03:19:54,480 >> I SEE 2 HANDS UP, BRANDY 5306 03:19:54,480 --> 03:20:02,560 ELLIS WOULD YOU LIKE TO GO 5307 03:20:02,560 --> 03:20:02,800 FIRST? 5308 03:20:02,800 --> 03:20:03,960 >> YEAH, I WOULD LIKE TO TIE IT 5309 03:20:03,960 --> 03:20:05,680 BACK TO SORT OF MY CORE CONCERN 5310 03:20:05,680 --> 03:20:08,880 WHICH IS, I HAVE PRIVATE HEALTH 5311 03:20:08,880 --> 03:20:10,200 INSURANCE AND I HAVE ATTEMPTED 5312 03:20:10,200 --> 03:20:11,840 TO APPLY FOR SOCIAL SECURITY, 5313 03:20:11,840 --> 03:20:16,440 DISABILITY WHEN I WAS DISABLED 5314 03:20:16,440 --> 03:20:17,880 AND SURPRISE TO LITERALLY NO 1, 5315 03:20:17,880 --> 03:20:20,120 IT WAS NOT APPROVED BUT ALSO I 5316 03:20:20,120 --> 03:20:21,480 WAS SICK BEFORE PARITY WAS 5317 03:20:21,480 --> 03:20:23,440 REQUIRED AND WE STILL HAVE 5318 03:20:23,440 --> 03:20:26,880 ISSUES WITH MENTAL DISORDERS AND 5319 03:20:26,880 --> 03:20:27,280 PARITY. 5320 03:20:27,280 --> 03:20:30,000 BUT MY CONCERN IS THIS, I HAVE 5321 03:20:30,000 --> 03:20:31,920 PRIVATE HEALTH INSURANCE AND AT 5322 03:20:31,920 --> 03:20:34,120 ANY TIME DESPITE MEDICARE 5323 03:20:34,120 --> 03:20:35,800 COVERING IT, FDA APPROVED ANY OF 5324 03:20:35,800 --> 03:20:37,560 THOSE THINGS, MY INSURER CAN 5325 03:20:37,560 --> 03:20:41,600 DECIDE THAT THEY'RE NOT GOING TO 5326 03:20:41,600 --> 03:20:42,960 COVER MAINTENANCE OR IF I NEED 5327 03:20:42,960 --> 03:20:46,480 IT REPLACED OR ANYTHING LIKE 5328 03:20:46,480 --> 03:20:47,360 THAT. 5329 03:20:47,360 --> 03:20:49,920 SO MY WORST CASE SCENARIO IS 5330 03:20:49,920 --> 03:20:53,240 THAT I GET ILL AGAIN, I HAVE TO 5331 03:20:53,240 --> 03:20:56,680 BECOME COMPLETELY DISABLED, I 5332 03:20:56,680 --> 03:20:59,400 HAVE TO THEN GET DISABILITY AND 5333 03:20:59,400 --> 03:21:02,640 THEN 24 MONTHS OF BEING ON 5334 03:21:02,640 --> 03:21:05,000 DISABILITY BEFORE MEDICARE WILL 5335 03:21:05,000 --> 03:21:08,120 COVER IT, AND SO ESSENTIALLY, IN 5336 03:21:08,120 --> 03:21:12,000 THE ABSENCE OF ME BEING ABLE TO 5337 03:21:12,000 --> 03:21:13,960 PAY FOR WHATEVER TREATMENT OUT 5338 03:21:13,960 --> 03:21:16,200 OF POCKET, IF MY PRIVATE INSURER 5339 03:21:16,200 --> 03:21:20,000 DOESN'T WANT TO COVER SOMETHING 5340 03:21:20,000 --> 03:21:23,600 THAT I'M LOOKING AT YEARS OF 5341 03:21:23,600 --> 03:21:25,800 UTTER DISABILITY ON THE HOPE 5342 03:21:25,800 --> 03:21:28,880 THAT MEDICARE WILL COVER IT. 5343 03:21:28,880 --> 03:21:33,520 AND YOU KNOW, IF--AND THAT'S NOT 5344 03:21:33,520 --> 03:21:34,600 AN UNREASONABLE FEAR. 5345 03:21:34,600 --> 03:21:35,600 LIKE THAT ABSOLUTELY COULD OCCUR 5346 03:21:35,600 --> 03:21:39,680 AND THERE'S NOTHING TO STEP IN 5347 03:21:39,680 --> 03:21:41,000 AND STOP THAT. 5348 03:21:41,000 --> 03:21:43,400 SO IF ME BEING PART OF THIS 5349 03:21:43,400 --> 03:21:45,440 TRIAL, IF I HAD ANYTHING THAT 5350 03:21:45,440 --> 03:21:47,280 SAID, HEY, WE'RE POST TRIAL 5351 03:21:47,280 --> 03:21:49,320 PARTICIPANTS, ARE IN A 5352 03:21:49,320 --> 03:21:52,480 MARKETPLACE HEALTH INSURANCE 5353 03:21:52,480 --> 03:21:53,840 PROGRAM THAT WILL COVER THIS, 5354 03:21:53,840 --> 03:21:55,560 YOU KNOW, YOU HAVE THIS 5355 03:21:55,560 --> 03:21:56,800 INSURANCE AND PRIVATE INSURERS 5356 03:21:56,800 --> 03:21:59,200 DON'T HAVE TO DEAL WITH IT, 5357 03:21:59,200 --> 03:21:59,400 FINE. 5358 03:21:59,400 --> 03:22:02,400 IF IT'S, YOU KNOW ACCESS TO 5359 03:22:02,400 --> 03:22:06,040 MEDICARE AS A POST TRIAL 5360 03:22:06,040 --> 03:22:07,600 PARTICIPANT, IF MY PRIVATE 5361 03:22:07,600 --> 03:22:09,720 INSURANCE WON'T COVER IT LIKE 5362 03:22:09,720 --> 03:22:10,720 FOR JUST THIS 1 THING BECAUSE 5363 03:22:10,720 --> 03:22:12,200 I'M IN MY 40S, YOU KNOW AND THIS 5364 03:22:12,200 --> 03:22:13,720 HAPPENED WHEN I WAS IN MY 30S, 5365 03:22:13,720 --> 03:22:18,120 IS I DON'T HAVE TO BE A MEDICARE 5366 03:22:18,120 --> 03:22:19,840 PATIENT BUT I CAN COUNT ON THEM 5367 03:22:19,840 --> 03:22:22,800 WHEN THEY DECIDED THAT THIS 5368 03:22:22,800 --> 03:22:25,720 QUALIFIED, THAT I'M NOT AT THE 5369 03:22:25,720 --> 03:22:27,920 MERCY OF PRIVATE HEALTH 5370 03:22:27,920 --> 03:22:29,200 INSURANCE, DECIDING WHETHER OR 5371 03:22:29,200 --> 03:22:33,560 NOT MY QUALITY OF LIFE IS 5372 03:22:33,560 --> 03:22:38,160 SUFFICIENT BECAUSE THESE ARE 5373 03:22:38,160 --> 03:22:39,280 VERY EXPENSIVE SURGERIES. 5374 03:22:39,280 --> 03:22:42,280 SO ANYTHING, ANY WAY THAT WE CAN 5375 03:22:42,280 --> 03:22:52,440 GET TO THE POINT WHERE IT'S NOT 5376 03:22:52,440 --> 03:22:53,560 RUSSIAN ROULETTE, AS TO WHETHER 5377 03:22:53,560 --> 03:22:55,280 A STAY ALIVE, SO IT CAN BE 5378 03:22:55,280 --> 03:22:57,520 MEDICARE, IT CAN BE AN INSURANCE 5379 03:22:57,520 --> 03:22:59,200 POLICY, HOWEVER WE CAN GET TO 5380 03:22:59,200 --> 03:23:02,280 THE POINT WHERE IT'S NOT 5381 03:23:02,280 --> 03:23:04,320 SOMEBODY ELSE DECIDING WHETHER 5382 03:23:04,320 --> 03:23:14,840 OR NOT THIS DEVICE IS WORTH IT 5383 03:23:24,400 --> 03:23:24,840 FOR MY LIFE. 5384 03:23:24,840 --> 03:23:27,120 >> I THINK IT BRINGS BACK UP A 5385 03:23:27,120 --> 03:23:28,600 SUGGESTION THAT WAS RAISED 5386 03:23:28,600 --> 03:23:33,600 EARLIER TO TODAY AND YESTERDAY 5387 03:23:33,600 --> 03:23:37,960 ABOUT WHAT IT COULD BE LIKE A 5388 03:23:37,960 --> 03:23:41,240 SPECIFIC INSURANCE POLICY, JUST 5389 03:23:41,240 --> 03:23:43,280 FOR POST TRIAL CARE THAT 5390 03:23:43,280 --> 03:23:43,960 DIFFERENT STAKEHOLDERS CAN 5391 03:23:43,960 --> 03:23:45,000 COMPARE IT TO AND THAT MIGHT 5392 03:23:45,000 --> 03:23:48,520 ALSO BE A WAY, I THINK TO SPREAD 5393 03:23:48,520 --> 03:23:52,640 SOME OF THE FINANCIAL RISK AS IT 5394 03:23:52,640 --> 03:23:55,400 COULD BE, IT COULD BE TRIAL 5395 03:23:55,400 --> 03:23:57,520 SPECIFIC OR IT COULD BE COVERING 5396 03:23:57,520 --> 03:24:05,480 LIKE THESE TYPES OF TRIALS. 5397 03:24:05,480 --> 03:24:06,000 ARE THERE ANY-- 5398 03:24:06,000 --> 03:24:07,880 >> SOMEBODY I THINK TALKED ABOUT 5399 03:24:07,880 --> 03:24:09,320 YESTERDAY, I CAN'T REMEMBER WHO 5400 03:24:09,320 --> 03:24:11,280 IT WAS HAVING TRIED TO DO THAT 5401 03:24:11,280 --> 03:24:15,240 THROUGH LLOYDS OF LONDON OR 5402 03:24:15,240 --> 03:24:16,280 SWISS-- 5403 03:24:16,280 --> 03:24:16,840 >> THAT WAS ME. 5404 03:24:16,840 --> 03:24:18,720 >> OKAY, SO CAN YOU SAY MORE 5405 03:24:18,720 --> 03:24:19,560 ABOUT THAT EXPERIENCE? 5406 03:24:19,560 --> 03:24:21,680 >> WELL THERE WERE SOME HUGE 5407 03:24:21,680 --> 03:24:23,920 INSURANCE COMPANIES THAT INSURED 5408 03:24:23,920 --> 03:24:25,760 STRANGE THINGS LIKE OCEAN LINE 5409 03:24:25,760 --> 03:24:27,520 CRUISERS AND YOU KNOW HOLLYWOOD 5410 03:24:27,520 --> 03:24:31,240 STARS WITH DRUG ADDICTION AND 5411 03:24:31,240 --> 03:24:33,760 MOVIE SETS, STUFF LIKE THAT, BUT 5412 03:24:33,760 --> 03:24:35,160 THE ISSUE IS THAT THEY NEED TO 5413 03:24:35,160 --> 03:24:38,720 BE ABLE TO CALCULATE RISK. 5414 03:24:38,720 --> 03:24:39,960 AND WE DON'T HAVE THE 5415 03:24:39,960 --> 03:24:41,600 INFORMATION TO GIVE THEM TO 5416 03:24:41,600 --> 03:24:42,240 CALCULATE RISK. 5417 03:24:42,240 --> 03:24:46,640 AND THE OTHER ISSUE IS, IT'S TOO 5418 03:24:46,640 --> 03:24:48,040 SMALL BECAUSE, YOU KNOW AS I 5419 03:24:48,040 --> 03:24:50,320 SAID, WELL WE'RE TALKING ABOUT A 5420 03:24:50,320 --> 03:24:52,360 HUNDRED PATIENTS AND SAMEER SAID 5421 03:24:52,360 --> 03:24:56,360 10 AND I THINK SAMEER'S ESTIMATE 5422 03:24:56,360 --> 03:25:00,320 IS VERY OFTEN ACTUALLY THE 5423 03:25:00,320 --> 03:25:02,360 NUMBER SO IT'S VERY DIFFICULT TO 5424 03:25:02,360 --> 03:25:06,000 GET A SMECIAL INSURER TO DO 5425 03:25:06,000 --> 03:25:10,960 THAT, HOWEVER THERE CERTAINLY 5426 03:25:10,960 --> 03:25:13,080 ARE SETTLEMENTS FOR, YOU KNOWIME 5427 03:25:13,080 --> 03:25:14,560 JUST THINKING ABOUT 9/11 5428 03:25:14,560 --> 03:25:18,160 DISASTER WHEN THERE WAS A FUND 5429 03:25:18,160 --> 03:25:22,720 AND THE PROCEEDS OF THAT FUND 5430 03:25:22,720 --> 03:25:25,520 ARE DISTRIBUTED BY A AN 5431 03:25:25,520 --> 03:25:27,400 EXECUTIVE WHO'S APPOINTED TO DO 5432 03:25:27,400 --> 03:25:30,160 SO, DOES NOT REPRESENT ANY OF 5433 03:25:30,160 --> 03:25:34,360 THE PARTIES SO KERRY ASHMONT WHO 5434 03:25:34,360 --> 03:25:36,080 WAS SO HELPFUL WITH US AND WE 5435 03:25:36,080 --> 03:25:37,440 WERE TALKING ABOUT IT AND I SAID 5436 03:25:37,440 --> 03:25:39,640 COULD WE PUT IT IN AN ESCROW 5437 03:25:39,640 --> 03:25:41,560 ACCOUNT AND COULD IT BE MANAGED 5438 03:25:41,560 --> 03:25:43,480 BY NIH AND SHE SPOKE ABOUT IT 5439 03:25:43,480 --> 03:25:45,760 WITH NIH AND IT DIDN'T SEEM TO 5440 03:25:45,760 --> 03:25:47,360 BE A GOOD FIT, AND THEN WE 5441 03:25:47,360 --> 03:25:48,320 THOUGHT WELL MAYBE IT COULD BE 5442 03:25:48,320 --> 03:25:51,280 MANAGED BY 1 OF OUR PROFESSIONAL 5443 03:25:51,280 --> 03:25:53,080 ORGANIZATIONS LIKE TD AMERICAN 5444 03:25:53,080 --> 03:25:55,840 EPILEPSY SOCIETY OR SOMETHING, 5445 03:25:55,840 --> 03:25:58,120 SOME DISINTERESTED, INTERESTED 5446 03:25:58,120 --> 03:25:58,880 BUT NOT INDIVIDUALLY INVOLVED 5447 03:25:58,880 --> 03:26:00,760 PARTY BUT YOU CAN SEE IS YOU 5448 03:26:00,760 --> 03:26:06,200 START TO SPIN THIS OUT THAT IT'S 5449 03:26:06,200 --> 03:26:09,000 VERY COMPLICATED TO FIGURE OUT 5450 03:26:09,000 --> 03:26:16,560 WHERE THOSE FUNDS WOULD REST IN 5451 03:26:16,560 --> 03:26:17,120 DECISIONHUMAN DISTRIBUTION. 5452 03:26:17,120 --> 03:26:19,200 >> BASES ON RULES, PROCEDURES 5453 03:26:19,200 --> 03:26:23,040 AND IT GETS COMPLICATED BUT THAT 5454 03:26:23,040 --> 03:26:24,160 DOESN'T MISCELLANEOUSLY MEAN 5455 03:26:24,160 --> 03:26:25,840 IT'S IMPOSSIBLE. 5456 03:26:25,840 --> 03:26:27,720 >> IF I COULD JUST COMMENT TO 5457 03:26:27,720 --> 03:26:30,720 MARTHA, THE IDEA OF PREFUNDING 5458 03:26:30,720 --> 03:26:32,080 AN INSURANCE POLICY HAS COME UP. 5459 03:26:32,080 --> 03:26:34,600 IT'S ROUGH BECAUSE AS YOU SAY 5460 03:26:34,600 --> 03:26:35,920 THE WHOLE IDEA OF INSURANCE IS 5461 03:26:35,920 --> 03:26:36,920 TO SPREAD THE RISK AND IF YOU 5462 03:26:36,920 --> 03:26:39,120 HAVE A SMALL POOL OF PATES ALL 5463 03:26:39,120 --> 03:26:41,280 OF WHOM ARE AT HIGH RISK, AND 5464 03:26:41,280 --> 03:26:42,760 LOOK AT CALIFORNIA RIGHT NOW 5465 03:26:42,760 --> 03:26:43,760 GETTING EARTHQUAKE AND FIRE 5466 03:26:43,760 --> 03:26:45,120 INSURANCE, CAN YOU GET IT BUT 5467 03:26:45,120 --> 03:26:46,520 IT'S GOING TO COST YOU AN ARM 5468 03:26:46,520 --> 03:26:48,640 AND A LEG SO MANY PEOPLE JUST 5469 03:26:48,640 --> 03:26:48,960 DON'T BOTHER. 5470 03:26:48,960 --> 03:26:50,200 SO I THINK THESE ARE SOME OF THE 5471 03:26:50,200 --> 03:26:53,720 THINGS WE SHOULD KEEP PURSUING, 5472 03:26:53,720 --> 03:26:55,480 I MEAN NOT I DON'T THINK WE 5473 03:26:55,480 --> 03:26:57,480 SHOULD THROW IN THE TOWEL ON 5474 03:26:57,480 --> 03:26:58,040 ANYTHING YET. 5475 03:26:58,040 --> 03:27:02,440 THE REALITY IS THIS IS HOW THE 5476 03:27:02,440 --> 03:27:03,440 INSURANCE INDUSTRY WORKS THIS IS 5477 03:27:03,440 --> 03:27:04,960 ALL ABOUT SPREADING THE RISK AND 5478 03:27:04,960 --> 03:27:06,880 THIS IS A HIGH RISK POOL OF 5479 03:27:06,880 --> 03:27:07,840 EVERYBODY AND WE DON'T 5480 03:27:07,840 --> 03:27:08,960 NECESSARILY HAVE A LOW RISK POOL 5481 03:27:08,960 --> 03:27:14,560 TO PAY FOR THAT, RIGHT? 5482 03:27:14,560 --> 03:27:14,880 SO-- 5483 03:27:14,880 --> 03:27:15,960 >> I'M WONDERING IF NOT ALL 5484 03:27:15,960 --> 03:27:18,760 PATIENTS WOULD NEED TO RELY ON 5485 03:27:18,760 --> 03:27:22,400 THE PULL TO THE SAME EXTENT SO 5486 03:27:22,400 --> 03:27:24,400 SOME VARIATION TO THE EXTENT TO 5487 03:27:24,400 --> 03:27:26,800 WHICH PATIENTS WOULD NEED 5488 03:27:26,800 --> 03:27:27,720 SOMETHING LIKE THAT. 5489 03:27:27,720 --> 03:27:28,480 >> I THINK-- 5490 03:27:28,480 --> 03:27:30,560 >> I THINK WE DON'T KNOW, DO WE 5491 03:27:30,560 --> 03:27:31,200 KNOW? 5492 03:27:31,200 --> 03:27:34,880 DO WE KNOW HOW OFTEN PATIENTS 5493 03:27:34,880 --> 03:27:37,480 END UP IN THIS SITUATION, 5494 03:27:37,480 --> 03:27:38,160 PATIENTS PARTICIPATE NOTHING 5495 03:27:38,160 --> 03:27:39,320 THESE TRIALS END UP IN A 5496 03:27:39,320 --> 03:27:43,160 SITUATION WHERE THEY'RE FACED 5497 03:27:43,160 --> 03:27:44,280 WITH COVERING LARGE MEDICAL 5498 03:27:44,280 --> 03:27:47,480 BILLS BY THEMSELVES. 5499 03:27:47,480 --> 03:27:49,920 I KNOW IT HAPPENS, BUT DO WE 5500 03:27:49,920 --> 03:27:50,360 KNOW HOW OFTEN? 5501 03:27:50,360 --> 03:27:55,280 >> YEAH, I THINK THAT'S A BIG 5502 03:27:55,280 --> 03:27:56,640 CHALLENGE, I JUST WANT TO 5503 03:27:56,640 --> 03:27:58,240 HIGHLIGHT THAT, THESE STEPS OF 5504 03:27:58,240 --> 03:27:59,400 INSURANCE POLICIES DO SEEM TO 5505 03:27:59,400 --> 03:28:00,880 EXIST IN AT LEAST IN OTHER 5506 03:28:00,880 --> 03:28:04,040 COUNTRIES AND THERE WAS 1 PERSON 5507 03:28:04,040 --> 03:28:07,520 YESTERDAY IN THE QAA WHO SAID HE 5508 03:28:07,520 --> 03:28:08,720 FOUND AN INSURER AND I DON'T 5509 03:28:08,720 --> 03:28:11,240 THINK IT WAS IN THE U.S. CONTEXT 5510 03:28:11,240 --> 03:28:15,960 AND HIS APPLICATION WAS NOT AND 5511 03:28:15,960 --> 03:28:18,080 I WANTED TO HIGHLIGHT THAT, I 5512 03:28:18,080 --> 03:28:19,720 DON'T WANT TO LET GO OF THE IDEA 5513 03:28:19,720 --> 03:28:23,080 BECAUSE I THINK IT MIGHT HELP 5514 03:28:23,080 --> 03:28:23,480 US. 5515 03:28:23,480 --> 03:28:26,480 >> COULD I JUMP IN, SO 1 THING 5516 03:28:26,480 --> 03:28:28,480 IS THAT MAYBE WE DON'T SEE IT, 5517 03:28:28,480 --> 03:28:30,280 MAYBE WE DON'T SEE IT IN THIS 5518 03:28:30,280 --> 03:28:34,480 CONTEXT AS A WAY TO SPREAD THE 5519 03:28:34,480 --> 03:28:35,720 RISK RIGHT, OR DISTRIBUTE THE 5520 03:28:35,720 --> 03:28:40,520 RISK, MAYBE WE SEE IT MORE AS A 5521 03:28:40,520 --> 03:28:42,400 FUND LIKE MARTY BROUGHT UP WHERE 5522 03:28:42,400 --> 03:28:48,080 LET'S SAY EACH COMPANY WILL 5523 03:28:48,080 --> 03:28:49,600 CONTRIBUTE SOME AMOUNT PER 5524 03:28:49,600 --> 03:28:51,280 PATIENT, OBVIOUSLY IT WOULD 5525 03:28:51,280 --> 03:28:53,640 REQUIRE DOG THE ASSESSMENT THAT 5526 03:28:53,640 --> 03:28:57,880 MARTY WAS BRINGING UP ABOUT SORT 5527 03:28:57,880 --> 03:28:59,360 OF QUANTIFYING THE RISK BUT HEY, 5528 03:28:59,360 --> 03:29:02,880 IF THERE'S SOMETHING WE'RE GOOD 5529 03:29:02,880 --> 03:29:04,880 AT IN THE UNITED STATES THEN WE 5530 03:29:04,880 --> 03:29:07,760 WANT TO VALUE THINGS SO WE CAN, 5531 03:29:07,760 --> 03:29:11,960 YOU KNOW WE CAN QUANTIFY THAT OR 5532 03:29:11,960 --> 03:29:13,960 THE DEVICE MANUFACTURE OR NIH IF 5533 03:29:13,960 --> 03:29:17,320 THEY'RE BEING THE SPONSOR, ET 5534 03:29:17,320 --> 03:29:19,120 CETERA, CAN CONTRIBUTE A SMALL 5535 03:29:19,120 --> 03:29:21,040 AMOUNT, NOT SMALL OR WHATEVER, 5536 03:29:21,040 --> 03:29:23,880 THE AMOUNT ENDS UP BEING ONCE WE 5537 03:29:23,880 --> 03:29:25,920 QUANTIFY IT, PER PATIENT AND 5538 03:29:25,920 --> 03:29:28,720 THEN ON A--YOU KNOW OBVIOUSLY IF 5539 03:29:28,720 --> 03:29:30,480 THEY NEED THE FUNDS LETTER ON, 5540 03:29:30,480 --> 03:29:36,720 THE PATIENT CAN APPLY TO COVER 5541 03:29:36,720 --> 03:29:37,920 WHATEVER THE INSURANCE WHATEVER 5542 03:29:37,920 --> 03:29:40,200 THEY CAN BE, THERE CAN BE AN 5543 03:29:40,200 --> 03:29:42,840 AMALSIS OF WHATEVER THE PATIENT, 5544 03:29:42,840 --> 03:29:43,440 THEMSELVES, ET CETERA HAVE MONEY 5545 03:29:43,440 --> 03:29:50,280 TO MAKE SOME OF THESE PAYMENTS. 5546 03:29:50,280 --> 03:29:52,080 SO THERE SEEMS TO BE A CMS 5547 03:29:52,080 --> 03:29:53,720 OPTION AS WELL, MAYBE THERE'S A 5548 03:29:53,720 --> 03:29:55,040 POLICING CHANGE THERE AND MAYBE 5549 03:29:55,040 --> 03:29:56,080 IT'S SOMETHING WE CAN WORK 5550 03:29:56,080 --> 03:29:57,520 TOGETHER ON CRAFTING WHAT THIS 5551 03:29:57,520 --> 03:30:02,320 WOULD LOOK LIKE AND WE CAN TRY 5552 03:30:02,320 --> 03:30:05,880 TO ARGUE FOR THAT SO THAT WE CAN 5553 03:30:05,880 --> 03:30:08,040 PROMODE--THE COMPANIES AND THESE 5554 03:30:08,040 --> 03:30:09,240 RESEARCHERS ARE DOING IS 5555 03:30:09,240 --> 03:30:12,440 MAGNIFICENT FOR THESE PATIENTS 5556 03:30:12,440 --> 03:30:14,360 SO IT'S SOMETHING WE NEED TO 5557 03:30:14,360 --> 03:30:15,680 CONTINUE, THESE ARE PEOPLE WHO 5558 03:30:15,680 --> 03:30:16,640 REALLY NEED THESE TREATMENTS AND 5559 03:30:16,640 --> 03:30:19,200 WE JUST NEED TO COMMUNICATE WITH 5560 03:30:19,200 --> 03:30:22,280 EACH OTHER TO TRY TO TWEAK HERE 5561 03:30:22,280 --> 03:30:23,880 AND THERE SO THAT WE CAN INSURE 5562 03:30:23,880 --> 03:30:25,440 THAT WE CAN HAVE ACCESS TO 5563 03:30:25,440 --> 03:30:35,960 THESE, YOU KNOW DEVICES IN THE 5564 03:30:37,320 --> 03:30:37,840 LONG-TERM. 5565 03:30:37,840 --> 03:30:39,840 >> IN THINKING ABOUT INSURANCE 5566 03:30:39,840 --> 03:30:41,760 POSSIBILITIES THERE'S A MODEL 5567 03:30:41,760 --> 03:30:42,680 LIKE THE COMPENSATION FUND WHICH 5568 03:30:42,680 --> 03:30:47,600 IS A TRUST, I BELIEVE AND I 5569 03:30:47,600 --> 03:30:49,200 THINK IT'S I SHOULD KNOW MORE 5570 03:30:49,200 --> 03:30:52,200 ABOUT IT THAN I DO, IT'S HOSTED 5571 03:30:52,200 --> 03:30:53,560 IF THAT'S THE RIGHT WORD, I 5572 03:30:53,560 --> 03:30:54,640 THINK BY THE FEDERAL GOVERNMENT. 5573 03:30:54,640 --> 03:30:56,040 NOW THERE'S A LOT OF CRITERIA, 5574 03:30:56,040 --> 03:30:59,960 YOU KNOW PEOPLE HAVE TO 5575 03:30:59,960 --> 03:31:01,480 DEMONSTRATE AND PASS CRITERIA TO 5576 03:31:01,480 --> 03:31:03,920 GET COMPENSATED BUT THERE IS 5577 03:31:03,920 --> 03:31:06,320 MONEY THERE FOR COMPENSATION 5578 03:31:06,320 --> 03:31:09,120 WHEN IN FACT THEY PASS CRITERIA, 5579 03:31:09,120 --> 03:31:10,120 SO MAYBE THERE'S A MODEL 5580 03:31:10,120 --> 03:31:15,040 THINKING OUT OF THE BOX SORT OF 5581 03:31:15,040 --> 03:31:15,600 LIKE THAT. 5582 03:31:15,600 --> 03:31:17,400 >> ALTHOUGH THERE WAS SOMETHING 5583 03:31:17,400 --> 03:31:19,960 ADOPTED THROUGH CONGRESSIONAL 5584 03:31:19,960 --> 03:31:20,880 LEGISLATION, IT'S POSSIBLE MODEL 5585 03:31:20,880 --> 03:31:24,000 BUT NOT AN EASY 1. 5586 03:31:24,000 --> 03:31:25,080 >> AND WILL REQUIRE POLITICAL 5587 03:31:25,080 --> 03:31:29,680 WILL AS WELL. 5588 03:31:29,680 --> 03:31:30,160 >> YEAH. 5589 03:31:30,160 --> 03:31:32,280 >> PERHAPS I CAN MAKE A REQUEST 5590 03:31:32,280 --> 03:31:33,560 OF THE EMPHASIS HERE BECAUSE 5591 03:31:33,560 --> 03:31:37,120 THIS IS A NEW WRINKLE SO WE'VE 5592 03:31:37,120 --> 03:31:39,120 TAKEN THE POLICY AS A SMALL 5593 03:31:39,120 --> 03:31:43,640 COMPANY THAT FOR OUR STUDIES SO 5594 03:31:43,640 --> 03:31:46,640 THAT WE WOULD REQUIRE THAT 5595 03:31:46,640 --> 03:31:48,840 INSURANCE REIMBURSEMENT BE 5596 03:31:48,840 --> 03:31:50,720 SOUGHT AND THAT THE PHYSICIAN 5597 03:31:50,720 --> 03:31:54,440 AND TEAM MAKE EVERY EFFORT AND 5598 03:31:54,440 --> 03:31:56,720 IF INSURANCE COULD NOT BE 5599 03:31:56,720 --> 03:31:57,840 ATTAINED THAT THE COMPANY WOULD 5600 03:31:57,840 --> 03:31:59,240 BE THE PAYOR OF LAST RESORT, 5601 03:31:59,240 --> 03:32:01,000 WHAT HAS HAPPENED NOW IS ABOUT A 5602 03:32:01,000 --> 03:32:02,800 THIRD OF THE INSTITUTIONS HAVE 5603 03:32:02,800 --> 03:32:05,360 REJECTED THAT BECAUSE THEY SAY 5604 03:32:05,360 --> 03:32:08,600 IT'S INEQUITABLE AND THEY WOULD 5605 03:32:08,600 --> 03:32:11,720 AGREE TO DO THE STUDY IF ONLY 5606 03:32:11,720 --> 03:32:15,160 INSURED PATIENTS WERE ABLE TO 5607 03:32:15,160 --> 03:32:16,520 PARTICIPATE SORE IF THE COMPANY 5608 03:32:16,520 --> 03:32:18,560 AGREED TO PAY FOR EVERYTHING BUT 5609 03:32:18,560 --> 03:32:19,960 NOT IF THERE WERE SOME PATIENTS 5610 03:32:19,960 --> 03:32:23,320 WHO WERE PAID BY INSURERS AND 5611 03:32:23,320 --> 03:32:24,040 ANOTHER GROUP OF PATIENT WHO IS 5612 03:32:24,040 --> 03:32:27,560 ARE PAID FOR BY THE COMPANY. 5613 03:32:27,560 --> 03:32:30,760 AND THIS IS--WE'RE AT THIS 5614 03:32:30,760 --> 03:32:34,840 MOMENT IN TIME, I AM WORKING 5615 03:32:34,840 --> 03:32:37,120 WITH CENTERS FOR A VERY LARGE 5616 03:32:37,120 --> 03:32:38,600 STUDY FOR AN IMPORTANT 5617 03:32:38,600 --> 03:32:41,960 INDICATION AND THIS HAS BEEN 5618 03:32:41,960 --> 03:32:42,960 VERY PERPLEXING AND THE 5619 03:32:42,960 --> 03:32:48,800 COMMENTS, WAS THAT THIS IS A 5620 03:32:48,800 --> 03:32:49,680 VERY UNETHICAL POSITION. 5621 03:32:49,680 --> 03:32:54,360 SO PERHAPS WE COULD HAVE AN 5622 03:32:54,360 --> 03:32:55,160 ETHICAL DISCUSSION ABOUT 5623 03:32:55,160 --> 03:32:56,600 PATIENTS WHO AT THE BEGINNING OF 5624 03:32:56,600 --> 03:32:59,520 THE STUDY WHERE PATIENTS FALL 5625 03:32:59,520 --> 03:33:01,680 INTO 2 CLASSES THOSE WITH 5626 03:33:01,680 --> 03:33:07,400 INSURANCE AND THOSE WITHOUT. 5627 03:33:07,400 --> 03:33:08,640 >> I BELIEVE I CAN SAY SOMETHING 5628 03:33:08,640 --> 03:33:10,920 ABOUT THAT I THINK I KNOW 5629 03:33:10,920 --> 03:33:11,680 ANOTHER INTERESTING ASPECT OF 5630 03:33:11,680 --> 03:33:13,240 THAT IS THAT MANY OF THESE 5631 03:33:13,240 --> 03:33:15,640 INSTITUTIONS ARE INSTITUTION 5632 03:33:15,640 --> 03:33:18,800 SAYS THAT REQUIRE INSURANCE TO 5633 03:33:18,800 --> 03:33:19,880 PROVIDE CARE, THEMSELVES, SOME 5634 03:33:19,880 --> 03:33:24,040 KIND OF EMERGENCY SO USUALLY 5635 03:33:24,040 --> 03:33:25,080 IT'S VERY DIFFICULT TO GET TO 5636 03:33:25,080 --> 03:33:27,120 THE CLINICIANS THAT ARE OFFERING 5637 03:33:27,120 --> 03:33:28,760 THESE TRIALS, ET CETERA, IN THE 5638 03:33:28,760 --> 03:33:31,080 FIRST PLACE, UNLESS YOU HAVE 5639 03:33:31,080 --> 03:33:34,040 INSURANCE, SO I THINK 5640 03:33:34,040 --> 03:33:35,080 THAT'S--DEFINITELY SOMETHING 5641 03:33:35,080 --> 03:33:35,760 THAT INSTITUTIONS NEED TO START 5642 03:33:35,760 --> 03:33:38,440 LOOKING AT MORE AND MORE, MORE 5643 03:33:38,440 --> 03:33:42,560 IN TERMS OF RISK AND BENEFITS 5644 03:33:42,560 --> 03:33:44,280 FOR THE SCIENCE, RIGHT AND WHAT 5645 03:33:44,280 --> 03:33:47,200 POPULATIONS ARE YOU TRYING TO 5646 03:33:47,200 --> 03:33:49,280 HELP HERE, WHERE WHY ARE YOU 5647 03:33:49,280 --> 03:33:52,400 TRYING TO GET IT FOR TRYING TO 5648 03:33:52,400 --> 03:33:54,040 GET THIS APPROVED AND SOMETIMES 5649 03:33:54,040 --> 03:33:57,320 THERE ARE PEOPLE FOR TREATMENT 5650 03:33:57,320 --> 03:33:58,520 RESISTANT CONDITIONS WHICH 5651 03:33:58,520 --> 03:34:02,560 GENERALLY THESE DEVICES WILL BE 5652 03:34:02,560 --> 03:34:04,800 FOR SYSTEM CONDITIONS WHERE THIS 5653 03:34:04,800 --> 03:34:08,320 IS REALLY NEEDED AND SO, I THINK 5654 03:34:08,320 --> 03:34:09,600 THE IRB, YOU KNOW MAYBE THERE'S 5655 03:34:09,600 --> 03:34:14,120 A WAY THAT WE CAN ALSO TRY TO 5656 03:34:14,120 --> 03:34:16,080 APPROACH IRBs OR PUT SOMETHING 5657 03:34:16,080 --> 03:34:19,880 TOGETHER WHERE THERE CAN BE SOME 5658 03:34:19,880 --> 03:34:21,040 KIND OF PRIORITY FOR DEVICES 5659 03:34:21,040 --> 03:34:25,400 THAT ARE TRYING TO ADDRESS 5660 03:34:25,400 --> 03:34:26,240 TREATMENT RESISTANT CONDITIONS. 5661 03:34:26,240 --> 03:34:36,720 EVEN IF THERE'S ISSUES WITH 5662 03:34:38,400 --> 03:34:38,760 INSURANCE. 5663 03:34:38,760 --> 03:34:43,040 BUT I WOULD JUST ADD I THINK 5664 03:34:43,040 --> 03:34:45,520 IT'S JUST ON PRINCIPLE FAIR TO 5665 03:34:45,520 --> 03:34:47,120 EXCLUDE PEOPLE BECAUSE THEY 5666 03:34:47,120 --> 03:34:48,960 CAN'T PAY OR THEY DON'T HAVE 5667 03:34:48,960 --> 03:34:51,560 INSURANCE, IF THEY HAVE NEEDS 5668 03:34:51,560 --> 03:34:53,440 MEDICAL NEEDS THAT ARE RELEVANT 5669 03:34:53,440 --> 03:34:55,240 AND IT ALSO GOES AGAINST THE 5670 03:34:55,240 --> 03:34:56,400 COMMENT THAT WAS MADE YESTERDAY 5671 03:34:56,400 --> 03:35:04,840 ABOUT THE NEED TO DIVERSIFY 5672 03:35:04,840 --> 03:35:06,120 TRIAL POPULATIONS. 5673 03:35:06,120 --> 03:35:08,960 >> WE ANTICIPATE THE 40% OR 5674 03:35:08,960 --> 03:35:12,280 INDIVIDUALS WHO WOULD BE INJURED 5675 03:35:12,280 --> 03:35:14,880 AND PARTICIPATING THE STUDY WILL 5676 03:35:14,880 --> 03:35:23,440 NOT BE SURE SO BASED ON THAT THE 5677 03:35:23,440 --> 03:35:24,640 COMPANY WHO MADE A STUDY WHO 5678 03:35:24,640 --> 03:35:25,800 WOULD BE IN THE STUDY WOULD HAVE 5679 03:35:25,800 --> 03:35:31,560 THE OPPORTUNITY TO DO SO AND 5680 03:35:31,560 --> 03:35:33,320 THEN WE FIND MANY IN THE 5681 03:35:33,320 --> 03:35:36,040 INSTITUTION WHERE THEY HAVE A 5682 03:35:36,040 --> 03:35:38,720 MEDICAL STANCE. 5683 03:35:38,720 --> 03:35:41,760 AND AND THAT FOR ETHICAL 5684 03:35:41,760 --> 03:35:45,040 REASONS, THEY WILL NOT CONSIDER 5685 03:35:45,040 --> 03:35:45,320 THAT. 5686 03:35:45,320 --> 03:35:47,200 SO I FERS HOPING AS PART OF 5687 03:35:47,200 --> 03:35:48,000 THIS, THERE COULD BE SOMETHING 5688 03:35:48,000 --> 03:35:54,040 THAT COMES OUT OF THIS ABOUT 5689 03:35:54,040 --> 03:35:58,880 WHAT IS--WHAT TYPE OF COMPANY 5690 03:35:58,880 --> 03:36:00,480 INVOLVEMENT IN PROVIDING SUPPORT 5691 03:36:00,480 --> 03:36:04,920 FOR THESE STUDIES, FINANCIAL 5692 03:36:04,920 --> 03:36:05,760 SUPPORT IS ETHICAL. 5693 03:36:05,760 --> 03:36:08,960 >> COULD I JUST CLARIFY FOR MY 5694 03:36:08,960 --> 03:36:10,360 UNDERSTANDING, THEY'RE SAYING 5695 03:36:10,360 --> 03:36:12,680 IT'S UNETHICAL TO HAVE 2 CLASSES 5696 03:36:12,680 --> 03:36:15,440 OF CITIZEN OR IT'S UNETHICAL TO 5697 03:36:15,440 --> 03:36:17,560 EXCLUDE PEOPLE WHO DON'T HAVE 5698 03:36:17,560 --> 03:36:20,520 INSURANCE? 5699 03:36:20,520 --> 03:36:21,320 >> NO, NO, THE FIRST. 5700 03:36:21,320 --> 03:36:25,640 SO YEAH, IF WE WENT FORWARD AND 5701 03:36:25,640 --> 03:36:27,920 FOR MANY INSTITUTIONS IF WE SAID 5702 03:36:27,920 --> 03:36:29,440 ALL RIGHT, WE'RE NOT PAYING FOR 5703 03:36:29,440 --> 03:36:35,480 ANYTHING, THEN THEY HAVE NO 5704 03:36:35,480 --> 03:36:35,960 PROBLEM WITH THAT. 5705 03:36:35,960 --> 03:36:37,000 BECAUSE IT'S THE SAME FOR 5706 03:36:37,000 --> 03:36:39,200 EVERYBODY, THERE'S NO PROBLEM 5707 03:36:39,200 --> 03:36:41,040 WITH ETHICS BECAUSE IT'S PEOPLE 5708 03:36:41,040 --> 03:36:43,680 INTERNAL AUDIT SURANCE BUT IF WE 5709 03:36:43,680 --> 03:36:45,360 SAY, WE WILL COVER THOSE WHO DO 5710 03:36:45,360 --> 03:36:47,240 NOT HAVE INSURANCE SO THEY CAN 5711 03:36:47,240 --> 03:36:48,600 PARTICIPATE BECAUSE IT'S 5712 03:36:48,600 --> 03:36:50,560 UNETHICAL BECAUSE WE HAVE 2 5713 03:36:50,560 --> 03:36:51,600 CLASSES, AND THEN THEY ALSO 5714 03:36:51,600 --> 03:36:53,640 RAISE THE CONCERN WHICH I THINK 5715 03:36:53,640 --> 03:36:54,760 IS LEGITIMATE IS THAT WELL, 5716 03:36:54,760 --> 03:36:55,960 THEN, YOU ARE SAYING THAT THE 5717 03:36:55,960 --> 03:36:57,240 PEOPLE WITH INSURANCE WILL BE 5718 03:36:57,240 --> 03:36:59,680 RESPONSIBLE FOR WHATEVER THEIR 5719 03:36:59,680 --> 03:37:00,200 CO-PAY IS. 5720 03:37:00,200 --> 03:37:01,440 BUT YOU'RE PAYING FOR THESE 5721 03:37:01,440 --> 03:37:02,720 OTHER PEOPLE WHO HAVE NO 5722 03:37:02,720 --> 03:37:03,480 INSURANCE SO THEY'RE NOT 5723 03:37:03,480 --> 03:37:05,880 RESPONSIBLE FOR THE CO-PAY AND 5724 03:37:05,880 --> 03:37:09,040 THAT'S NOT FAIR AND THEREFORE 5725 03:37:09,040 --> 03:37:10,000 THAT IS UNETHICAL. 5726 03:37:10,000 --> 03:37:11,000 NOW NAIS NOT EVERY INSTITUTION 5727 03:37:11,000 --> 03:37:14,200 BUT I WILL TELL YOU IT'S ABOUT 5728 03:37:14,200 --> 03:37:15,000 ONE-THIRD. 5729 03:37:15,000 --> 03:37:16,600 >> WE'VE HAD THAT DISCUSSION 5730 03:37:16,600 --> 03:37:19,440 HERE AND IN CONVERSATIONS WITH 5731 03:37:19,440 --> 03:37:23,640 OUR INSTITUTIONS AS WELL AND WE 5732 03:37:23,640 --> 03:37:25,760 SAY, WELL, THAT EXPENSE TOWARDS 5733 03:37:25,760 --> 03:37:28,760 THE INSURANCE GOES TOWARDS THE 5734 03:37:28,760 --> 03:37:31,240 PATIENT'S LIFETIME COVERAGE AND 5735 03:37:31,240 --> 03:37:36,800 IF YOU'RE--WE'RE TALKING ABOUT 5736 03:37:36,800 --> 03:37:38,280 CO POTENTIAL COMPLICATIONS OF 5737 03:37:38,280 --> 03:37:40,280 BRAIN SURGERY, THAT THEY COULD 5738 03:37:40,280 --> 03:37:42,080 EASILY BE RAMPING TOWARDS THE 5739 03:37:42,080 --> 03:37:46,120 MAXIMUM COVER BY THAT INSURANCE. 5740 03:37:46,120 --> 03:37:47,480 AND YOU KNOW THAT HAS BEEN 1 OF 5741 03:37:47,480 --> 03:37:49,120 THE THINGS THAT HAS BEEN RAISED 5742 03:37:49,120 --> 03:37:51,240 TO US AS THE POSSIBILITY OF, YOU 5743 03:37:51,240 --> 03:37:55,040 KNOW NOT BEING ABLE TO COVER, 5744 03:37:55,040 --> 03:37:56,040 YOU KNOW SEPARATELY PATIENTS 5745 03:37:56,040 --> 03:38:00,320 WITHOUT INSURANCE OR WITH 5746 03:38:00,320 --> 03:38:01,000 INSURANCE. 5747 03:38:01,000 --> 03:38:01,880 >> I LIKE TO TRANSITION US TO 5748 03:38:01,880 --> 03:38:03,560 CONSIDER WHAT THE NEXT STEPS 5749 03:38:03,560 --> 03:38:07,160 ARE, AS WE'RE GOING TO--THIS 5750 03:38:07,160 --> 03:38:12,040 WORKSHOP IS GOING TO END IN 5751 03:38:12,040 --> 03:38:15,600 ABOUT 50 MINUTES MAYBE--15 5752 03:38:15,600 --> 03:38:17,160 MINUTES MAYBE SO WHAT ARE THE 5753 03:38:17,160 --> 03:38:19,440 COMPLETE NEXT STEPS THAT WE 5754 03:38:19,440 --> 03:38:24,760 SHOULD ALL TAKE, WE SHOULD TAKE 5755 03:38:24,760 --> 03:38:32,280 1 SUGGESTION HAS BEEN TO GET 5756 03:38:32,280 --> 03:38:33,360 CLARIFICATION, THE FINANCIAL 5757 03:38:33,360 --> 03:38:35,280 LIKE THE AMOUNT OF CARE 5758 03:38:35,280 --> 03:38:36,480 PARTICIPANTS REQUIRE AND THE 5759 03:38:36,480 --> 03:38:39,920 FINANCIAL COSTS ASSOCIATE WIDE 5760 03:38:39,920 --> 03:38:43,200 THE CARE, I WOULD LOVE TO HEAR 5761 03:38:43,200 --> 03:38:53,680 SUGGESTIONS FOR NEXT STEPS. 5762 03:38:57,120 --> 03:39:00,400 >> I THINK 1 WONDERFUL THING 5763 03:39:00,400 --> 03:39:01,520 ABOUT THE QUAWRNTIFICATION AND 5764 03:39:01,520 --> 03:39:02,960 MAYBE 1 CONCRETE STEP IS MAYBE 5765 03:39:02,960 --> 03:39:04,920 GOING BACK TO THE SPONSORS OR 5766 03:39:04,920 --> 03:39:05,800 THE RESEARCHERS AND SEE IF THERE 5767 03:39:05,800 --> 03:39:13,840 IS A WAY TO IDENTIFY HOW OFTEN 5768 03:39:13,840 --> 03:39:15,240 DOES THAT HAPPEN THAT THE PERSON 5769 03:39:15,240 --> 03:39:17,000 LOSES ACCESS TO THE DEVICE OR 5770 03:39:17,000 --> 03:39:21,280 HAS ISSUES WITH INSURANCE, ET 5771 03:39:21,280 --> 03:39:21,520 CETERA. 5772 03:39:21,520 --> 03:39:23,360 SO HOW MANY PATIENTS ARE WE 5773 03:39:23,360 --> 03:39:25,920 TALKING ABOUT? 5774 03:39:25,920 --> 03:39:28,560 HOW MANY PATIENTS ARE GETTING 5775 03:39:28,560 --> 03:39:30,440 THIS DEVICE, I DON'T KNOW THAT 5776 03:39:30,440 --> 03:39:31,520 THERE'S A SINGLE PLACE WHERE WE 5777 03:39:31,520 --> 03:39:32,560 GET THAT INFORMATION SO I THINK 5778 03:39:32,560 --> 03:39:34,120 KNOWING THE NUMBER OF PATIENTS 5779 03:39:34,120 --> 03:39:37,360 THAT ARE GETTING, YOU KNOW 5780 03:39:37,360 --> 03:39:38,600 DEVICES, NEURAL DEVICES 5781 03:39:38,600 --> 03:39:41,040 IMPLANTED AND KNOWING HOW MANY 5782 03:39:41,040 --> 03:39:42,800 OF THESE PATIENTS YOU KNOW WHICH 5783 03:39:42,800 --> 03:39:44,240 CONDITIONS AND HOW MANY OF THESE 5784 03:39:44,240 --> 03:39:45,720 PATIENTS MAY BE LOSING ACCESS 5785 03:39:45,720 --> 03:39:47,800 AND WHY CAN HELP US START 5786 03:39:47,800 --> 03:39:50,640 QUANTIFYING THIS SO THAT THEN WE 5787 03:39:50,640 --> 03:39:53,880 CAN TAKE ACTUAL STEPS TO FIND 5788 03:39:53,880 --> 03:39:56,800 SOLUTIONS AND YOU KNOW, 5789 03:39:56,800 --> 03:39:57,600 UNFORTUNATELY WE NEED--WE NEED 5790 03:39:57,600 --> 03:40:00,840 TO KNOW HOW MUCH THIS WILL COST. 5791 03:40:00,840 --> 03:40:03,960 I MEAN THERE COULD BE SOME KIND 5792 03:40:03,960 --> 03:40:07,080 OF, YOU KNOW RULE WHERE WE JUST 5793 03:40:07,080 --> 03:40:08,640 START ARGUING AS BIOETHICISTS 5794 03:40:08,640 --> 03:40:09,360 WHATEVER, SOMETIMES PEOPLE CAN 5795 03:40:09,360 --> 03:40:12,680 ARGUE FOR THINGS THAT ARE JUST 5796 03:40:12,680 --> 03:40:14,080 NOT FEASIBLE, THAT'S DEFINITELY 5797 03:40:14,080 --> 03:40:16,560 NOT MY STYLE BUT I KNOW THAT 5798 03:40:16,560 --> 03:40:19,000 IT'S APPEALING AND YOU KNOW TO 5799 03:40:19,000 --> 03:40:21,160 TALK ABOUT PATIENT RIGHTS, 5800 03:40:21,160 --> 03:40:22,240 PERIOD. 5801 03:40:22,240 --> 03:40:24,840 BUT WE NEED TO, IF WE ARE GOING 5802 03:40:24,840 --> 03:40:25,800 TO MAKE ANY PROGRESS AND WE'VE 5803 03:40:25,800 --> 03:40:27,680 BEEN TALKING ABOUT THIS, YOU 5804 03:40:27,680 --> 03:40:31,160 KNOW FOR YEARS, NOW, IT'S 5805 03:40:31,160 --> 03:40:35,000 SOMETHING THAT MAKES IT KIND 5806 03:40:35,000 --> 03:40:36,280 OF--YOU KNOW IT GETS ME RILED UP 5807 03:40:36,280 --> 03:40:37,040 BECAUSE IT'S SOMETHING THEY 5808 03:40:37,040 --> 03:40:38,440 THINK WE NEED TO DO SOMETHING 5809 03:40:38,440 --> 03:40:42,000 ABOUT, BUT WE ALSO NEED TO TAKE 5810 03:40:42,000 --> 03:40:43,040 THE CLEAR STEPS AND MAKE SURE 5811 03:40:43,040 --> 03:40:45,760 THAT WE HAVE ALL OF THE 5812 03:40:45,760 --> 03:40:46,600 STAKEHOLDERS INVOLVED IN THIS 5813 03:40:46,600 --> 03:40:48,160 BECAUSE IF WE DON'T WORK 5814 03:40:48,160 --> 03:40:50,080 TOGETHER, WITH THE DEVICE 5815 03:40:50,080 --> 03:40:51,240 MANUFACTURES ON CMS AND EVERYONE 5816 03:40:51,240 --> 03:40:55,960 ELSE, WE'RE NOT GOING TO GET 5817 03:40:55,960 --> 03:40:56,240 ANYWHERE. 5818 03:40:56,240 --> 03:40:57,560 >> YEAH BUT I THINK THE DAILY 5819 03:40:57,560 --> 03:40:58,320 BASIS THEA GATHERING POINT IS A 5820 03:40:58,320 --> 03:41:01,480 GOOD 1 BUT I JUST WONDER IF A 5821 03:41:01,480 --> 03:41:04,040 RESEARCH GROUP FUNDED BY SAY A 5822 03:41:04,040 --> 03:41:05,760 NEUROETHICS GRANT FROM THE BRAIN 5823 03:41:05,760 --> 03:41:07,080 INITIATIVE WERE TO GO OUT AND 5824 03:41:07,080 --> 03:41:09,440 ASK YOU GUYS, SO TELL US HOW 5825 03:41:09,440 --> 03:41:11,160 MANY TRIAL SUBJECTS HAVE YOU HAD 5826 03:41:11,160 --> 03:41:12,520 WHO HAD TROUBLE WITH THIS AND 5827 03:41:12,520 --> 03:41:15,800 WHAT ARE THERE PROBLEMS? 5828 03:41:15,800 --> 03:41:18,520 AND GIVE US THE INFORMATION YOU 5829 03:41:18,520 --> 03:41:19,760 CAN WOULD WE GET THAT FROM YOU 5830 03:41:19,760 --> 03:41:22,000 OR WOULD YOUR INSTITUTION'S 5831 03:41:22,000 --> 03:41:23,520 LAWYERS START STREAMING ABOUT 5832 03:41:23,520 --> 03:41:24,600 HIPAA? 5833 03:41:24,600 --> 03:41:28,640 >> YOU KNOW, I MEAN MY 5834 03:41:28,640 --> 03:41:29,640 EXPERIENCE INTERVIEWING 5835 03:41:29,640 --> 03:41:31,000 RESEARCHERS THAT, HEY, ARE THEY 5836 03:41:31,000 --> 03:41:36,080 GIVING YOU THE SPECIFIC NUMBERS. 5837 03:41:36,080 --> 03:41:37,240 I DON'T KNOW LIKE WE WOULD HAVE 5838 03:41:37,240 --> 03:41:38,920 TO GO AND LOOK AT THOSE NUMBERS, 5839 03:41:38,920 --> 03:41:40,280 LOOK AT THE DIFFERENT TRIALS OF 5840 03:41:40,280 --> 03:41:40,640 THIS. 5841 03:41:40,640 --> 03:41:41,640 SO THIS WOULD BE SOMETHING 5842 03:41:41,640 --> 03:41:44,640 DIFFERENT BUT IN TERMS OF 5843 03:41:44,640 --> 03:41:45,680 NEUROETHICS AND CONDUCTING THE 5844 03:41:45,680 --> 03:41:47,480 INTERVIEWS WITH THE RESEARCHERS, 5845 03:41:47,480 --> 03:41:49,080 THEY HAVE BEEN EXTREMELY OPEN 5846 03:41:49,080 --> 03:41:50,800 WITH US, WITH COVID MANY 5847 03:41:50,800 --> 03:41:52,400 DIFFERENT--I MEAN WE COVERED 5848 03:41:52,400 --> 03:41:56,360 POST TRIAL ISSUES, WE'VE COVERED 5849 03:41:56,360 --> 03:41:59,000 MANY, YOU KNOW ISSUES ABOUT 5850 03:41:59,000 --> 03:42:00,400 REGRETS ABOUT LIKE HAVING 5851 03:42:00,400 --> 03:42:01,440 OFFERED DBS AND THAT KIND OF 5852 03:42:01,440 --> 03:42:04,280 THING AND I THINK THEY'VE BEEN 5853 03:42:04,280 --> 03:42:07,640 INCREDIBLY TRANSPARENT ABOUT IT. 5854 03:42:07,640 --> 03:42:09,000 OBVIOUSLY, IT'S DEIDENTIFIED BUT 5855 03:42:09,000 --> 03:42:10,640 THEY'VE BEEN VERY TRANSPARENT 5856 03:42:10,640 --> 03:42:20,440 AND WILLING TO ADDRESS THOSE 5857 03:42:20,440 --> 03:42:20,920 ISSUES. 5858 03:42:20,920 --> 03:42:21,320 >> YOU'RE MUTED. 5859 03:42:21,320 --> 03:42:22,280 >> SO SOMEONE SIGNED A CONSENT 5860 03:42:22,280 --> 03:42:26,400 FORM TO BE PART OF A TRIAL THEN 5861 03:42:26,400 --> 03:42:28,600 THE HIPAA REGULATIONS ARE 5862 03:42:28,600 --> 03:42:29,200 DIFFERENT. 5863 03:42:29,200 --> 03:42:34,760 AND IF THE CONSENT FORMS WERE 5864 03:42:34,760 --> 03:42:37,640 MODIFIED, TO INCLUDE THAT YOUR 5865 03:42:37,640 --> 03:42:41,640 INFORMATION MAY BE MADE 5866 03:42:41,640 --> 03:42:45,920 AVAILABLE TO NIH, THE FUNDING 5867 03:42:45,920 --> 03:42:47,360 ORGANIZATIONS TO DETERMINE 5868 03:42:47,360 --> 03:42:49,000 WHETHER--WELL, ACTUALLY LET ME 5869 03:42:49,000 --> 03:42:50,040 BACK UP, EVERY DEVICE 5870 03:42:50,040 --> 03:42:52,160 MANUFACTURE KNOWS EVERY TIME THE 5871 03:42:52,160 --> 03:42:53,120 DEVICE IS PLANTED WHETHER IT'S 5872 03:42:53,120 --> 03:42:55,880 SUPPOSED TO AND THAT'S AN FDA 5873 03:42:55,880 --> 03:42:59,960 REQUIREMENT TO TRACK DEVICES. 5874 03:42:59,960 --> 03:43:04,440 SO, IT'S NEVER FULL PROOF BUT 5875 03:43:04,440 --> 03:43:06,400 YOU NEED TO KNOW WHERE THAT 5876 03:43:06,400 --> 03:43:07,600 DEVICE IS AND THAT MEANS YOU 5877 03:43:07,600 --> 03:43:10,560 NEED TO KNOW WHICH PATIENT HAS 5878 03:43:10,560 --> 03:43:12,960 THE DEVICE AND WHERE THEY ARE 5879 03:43:12,960 --> 03:43:16,640 AND HOW CAN YOU CONTACT THEM IN 5880 03:43:16,640 --> 03:43:18,360 CASE THERE'S DEVICE PROBLEM. 5881 03:43:18,360 --> 03:43:21,000 SO YOU WILL NOT FIND IN PHARMA, 5882 03:43:21,000 --> 03:43:22,520 THE ABILITY TO TRACK PATIENTS 5883 03:43:22,520 --> 03:43:24,520 LIKE YOU CAN WITH DEVICES AND IT 5884 03:43:24,520 --> 03:43:27,600 WOULD SEEM TO ME, WE NEED TO BE 5885 03:43:27,600 --> 03:43:29,360 VERY REASONABLE AS PART OF NIH 5886 03:43:29,360 --> 03:43:32,000 AS PART OF A CLINICAL TRIAL TO 5887 03:43:32,000 --> 03:43:33,920 HAVE IN THERE SOME REQUIREMENT 5888 03:43:33,920 --> 03:43:39,600 THAT THE INVESTIGATOR PROVIDE 5889 03:43:39,600 --> 03:43:41,640 SOME INFORMATION ABOUT PATIENT 5890 03:43:41,640 --> 03:43:43,320 STATUS BUT PARTICULARLY FDA, WE 5891 03:43:43,320 --> 03:43:45,800 HAVE TO PROVIDE ANNUAL REPORTS 5892 03:43:45,800 --> 03:43:46,880 FOR FDA THAT REVIEW EVERYTHING 5893 03:43:46,880 --> 03:43:47,720 THAT'S HAPPENED TO ALL THE 5894 03:43:47,720 --> 03:43:49,000 PATIENTS FOR THAT YEAR. 5895 03:43:49,000 --> 03:43:52,080 AND THEY GO IN EVERY SINGLE 5896 03:43:52,080 --> 03:43:52,600 YEAR. 5897 03:43:52,600 --> 03:43:54,600 SO FDA ACTUALLY HAS THIS 5898 03:43:54,600 --> 03:43:56,920 INFORMATION FROM ALL OF THESE 5899 03:43:56,920 --> 03:43:57,120 STUDIES. 5900 03:43:57,120 --> 03:43:59,160 AND THEN LET'S TURN TO 5901 03:43:59,160 --> 03:44:02,640 PUBLICATIONS, THE TRIALS, IF YOU 5902 03:44:02,640 --> 03:44:03,800 FOLLOW THE CONCERT REQUIREMENT 5903 03:44:03,800 --> 03:44:05,000 WHEN YOU PUBLISH YOUR TRIAL YOU 5904 03:44:05,000 --> 03:44:06,720 HAVE TO HAVE A TABLE IN THERE 5905 03:44:06,720 --> 03:44:08,320 THAT SHOWS HOW MANY PEOPLE 5906 03:44:08,320 --> 03:44:10,960 DISCONTINUED IN THE REASONS THEY 5907 03:44:10,960 --> 03:44:11,400 DISCONTINUED. 5908 03:44:11,400 --> 03:44:14,920 SO THERE ARE SOURCES OF 5909 03:44:14,920 --> 03:44:15,640 INFORMATION. 5910 03:44:15,640 --> 03:44:18,080 I THINK WHERE I STRUGGLE IS TO 5911 03:44:18,080 --> 03:44:20,680 FIND OUT HOW MANY PEOPLE HAVE 5912 03:44:20,680 --> 03:44:22,240 EXPERIENCED WHAT BRANDY IS 5913 03:44:22,240 --> 03:44:24,160 AFRAID OF BECAUSE THAT'S OF 5914 03:44:24,160 --> 03:44:25,640 COURSE THE NIGHTMARE WE ALL 5915 03:44:25,640 --> 03:44:29,600 HAVE, IT'S THE NIGHTMARE THAT 5916 03:44:29,600 --> 03:44:31,760 BRANDY HAS AND BUT WE CAN NARROW 5917 03:44:31,760 --> 03:44:33,160 IT DOWN TO A POOL OF PEOPLE WHO 5918 03:44:33,160 --> 03:44:43,640 MIGHT HAVE BEEN AT RISK FOR 5919 03:44:47,400 --> 03:44:47,520 THAT. 5920 03:44:47,520 --> 03:44:49,160 >> I GUESS TO LOOK AT 1 THING, 5921 03:44:49,160 --> 03:44:51,520 TO SURVEY THE LANDSCAPE, TO KEEP 5922 03:44:51,520 --> 03:44:53,080 IN MIND FROM THE BRAIN 5923 03:44:53,080 --> 03:44:54,080 INITIATIVE SIDE OF THING SYSTEM 5924 03:44:54,080 --> 03:44:58,120 THAT EVERY PROJECT THAT IS DOING 5925 03:44:58,120 --> 03:44:59,120 THESE SORTS OF EXPERIMENTAL 5926 03:44:59,120 --> 03:45:03,760 STUDIES IN MUSEUM MANS WITH THE 5927 03:45:03,760 --> 03:45:05,160 CLINICAL TRIALS IS STILL 5928 03:45:05,160 --> 03:45:06,440 GENERALLY ACTIVE SO NONE OF THE 5929 03:45:06,440 --> 03:45:08,880 PROJECTS SINCE THE START OF THE 5930 03:45:08,880 --> 03:45:10,080 BRAIN INITIATIVE HAVE ACTUALLY 5931 03:45:10,080 --> 03:45:11,800 REACHED THE END OF THE STUDY 5932 03:45:11,800 --> 03:45:13,880 WHERE PATIENTS COULD RUN INTO 5933 03:45:13,880 --> 03:45:14,960 THOSE CHALLENGES, AT LEAST IN 5934 03:45:14,960 --> 03:45:17,840 TEMPERATURES OF GETTING HIT WITH 5935 03:45:17,840 --> 03:45:19,600 UNEXPLAINED COSTS AND SO ANY OF 5936 03:45:19,600 --> 03:45:22,800 THE 1S THAT ANY OF THE 5937 03:45:22,800 --> 03:45:23,880 UNEXPLAINED OR UNEXPECTED COSTS 5938 03:45:23,880 --> 03:45:26,080 HAVE AT LEAST BEEN ABLE TO BE 5939 03:45:26,080 --> 03:45:27,520 EITHER REBUDGETTED IN THE 5940 03:45:27,520 --> 03:45:29,120 EXISTING GRANT OR LIKE I SAID 5941 03:45:29,120 --> 03:45:31,720 YESTERDAY, YOU KNOW WE CAN 5942 03:45:31,720 --> 03:45:32,840 CONSIDER SUPPLEMENTAL FUNDING TO 5943 03:45:32,840 --> 03:45:34,000 ADDRESS SOME OF THOSE ISSUES, 5944 03:45:34,000 --> 03:45:36,200 YOU KNOW WITHOUT GETTING INTO 5945 03:45:36,200 --> 03:45:39,760 ANY INDIVIDUAL PROJECT AWARD OR 5946 03:45:39,760 --> 03:45:40,120 PATIENT ASPECTS. 5947 03:45:40,120 --> 03:45:42,600 SO, YOU KNOW IN LOOKING AT THAT 5948 03:45:42,600 --> 03:45:45,440 LANDSCAPE, IT IS A--YOU KNOW A 5949 03:45:45,440 --> 03:45:47,760 POTENTIAL FUTURE QUESTION OR 5950 03:45:47,760 --> 03:45:50,600 CONCERN BUT THE POPULATIONS TO 5951 03:45:50,600 --> 03:45:55,600 SURVEY MAY INVOLVE GOING BACK 5952 03:45:55,600 --> 03:45:57,880 FURTHER IN TIME TO EARLIER STAGE 5953 03:45:57,880 --> 03:46:00,800 PATIENTS FROM THE ORIGINAL STUDY 5954 03:46:00,800 --> 03:46:02,760 OF DBS FOR PARKINSONS OR THOSE 5955 03:46:02,760 --> 03:46:03,800 POPULATIONS TO FIGURE OUT WHAT 5956 03:46:03,800 --> 03:46:11,600 SOME OF THAT RISK MAY ACTUALLY 5957 03:46:11,600 --> 03:46:11,760 BE. 5958 03:46:11,760 --> 03:46:12,720 DID EMPLOY. 5959 03:46:12,720 --> 03:46:13,960 >> I'VE GOT JENNIFER, KAREN, 5960 03:46:13,960 --> 03:46:19,160 SARAH AND THEN I THINK WE WILL 5961 03:46:19,160 --> 03:46:19,560 WRAP UP. 5962 03:46:19,560 --> 03:46:20,200 >> THANKS I THINK THE QUESTION 5963 03:46:20,200 --> 03:46:22,800 ON THE TABLE RIGHT NOW ARE WHAT 5964 03:46:22,800 --> 03:46:25,360 ARE ACTIONABLE ITEMS THAT CAN BE 5965 03:46:25,360 --> 03:46:25,560 TAKEN. 5966 03:46:25,560 --> 03:46:27,080 I THINK IT'S NO DOUBT FOR THE 5967 03:46:27,080 --> 03:46:28,760 LAST 2 DAYS THIS IS AN EXTREMELY 5968 03:46:28,760 --> 03:46:31,680 COMPLEX ISSUE WITH A LOT OF 5969 03:46:31,680 --> 03:46:33,920 STAKEHOLDERS SO I APPLAUD YOU 5970 03:46:33,920 --> 03:46:36,240 GUYS FOR BRINGING SO MANY 5971 03:46:36,240 --> 03:46:37,080 STAKEHOLDERS TOGETHER TO HAVE 5972 03:46:37,080 --> 03:46:38,040 THIS DISCUSSION BUT I WOULD HATE 5973 03:46:38,040 --> 03:46:39,920 FOR IT TO GO TO THE WAY SIDE AND 5974 03:46:39,920 --> 03:46:41,040 I THINK IT'S REALLY IMPORTANT 5975 03:46:41,040 --> 03:46:42,720 THAT WE MAP OUT WHAT WE 5976 03:46:42,720 --> 03:46:44,080 DISCUSSED IN THE LAST 2 DAYS, 5977 03:46:44,080 --> 03:46:47,080 WHERE ARE THOSE ISSUES AND HAVE 5978 03:46:47,080 --> 03:46:47,920 ACTIONABLE ITEMS ON THEM BECAUSE 5979 03:46:47,920 --> 03:46:49,400 I DON'T THINK IT'S A SIMPLE 5980 03:46:49,400 --> 03:46:51,360 ANSWER THAT OH, WE CAN DO X, Y, 5981 03:46:51,360 --> 03:46:53,000 Z AND BE ABLE TO SOLVE THE 5982 03:46:53,000 --> 03:46:54,640 PROBLEM, BUT I THINK IT'S VERY 5983 03:46:54,640 --> 03:46:55,560 APPARENT THAT THERE'S SOME 5984 03:46:55,560 --> 03:46:56,920 THINGS ONCE WE MAP THIS OUT AND 5985 03:46:56,920 --> 03:46:58,960 LOOK AT OUR DISCUSSIONS THAT WE 5986 03:46:58,960 --> 03:47:01,440 CAN IMPLEMENT VERY QUICKLY. 5987 03:47:01,440 --> 03:47:02,720 BUT THAT CAN'T HAPPEN UNTIL WE 5988 03:47:02,720 --> 03:47:04,920 DO A FULL ASSESSMENT OF THESE 5989 03:47:04,920 --> 03:47:08,680 WHOLE DISCUSSIONS SO I THINK 5990 03:47:08,680 --> 03:47:12,280 THERE'S PROBABLY THE PRIORITY OF 5991 03:47:12,280 --> 03:47:13,200 ACTIONABLE ITEMS COMING AWAY 5992 03:47:13,200 --> 03:47:14,640 FROM THIS, OF WHERE ARE SOME OF 5993 03:47:14,640 --> 03:47:17,760 THE THINGS WE CAN SOLVE QUICKLY 5994 03:47:17,760 --> 03:47:19,560 AND THEN HOW ARE WE GOING TO 5995 03:47:19,560 --> 03:47:20,920 TACKLE SOME OF THESE MORE 5996 03:47:20,920 --> 03:47:22,520 COMPLEX 1S WHICH WILL REQUIRE A 5997 03:47:22,520 --> 03:47:26,240 LOT OF DIFFERENT AGENCIES 5998 03:47:26,240 --> 03:47:27,200 INDUSTRY, INSTITUTIONS TO BE 5999 03:47:27,200 --> 03:47:33,480 INVOLVED IN THE COMING UP WITH 6000 03:47:33,480 --> 03:47:33,840 THE SOLUTION. 6001 03:47:33,840 --> 03:47:36,040 >> THANK YOU AND JUST TO CLARIFY 6002 03:47:36,040 --> 03:47:36,880 MYSELF AND SEVERAL OTHER PEOPLE 6003 03:47:36,880 --> 03:47:41,560 ON THIS CALL WILL BE GOING BACK 6004 03:47:41,560 --> 03:47:43,480 TO WORK AND RELISTEN TO THESE 6005 03:47:43,480 --> 03:47:45,480 CONVERSATIONS WE'VE HAD AND SEE, 6006 03:47:45,480 --> 03:47:48,320 WHAT WE'VE LEARNED AND WHAT WE 6007 03:47:48,320 --> 03:47:49,680 COULD DO. 6008 03:47:49,680 --> 03:47:52,000 JUST TO CLARIFY. 6009 03:47:52,000 --> 03:47:54,600 THAT IS WHY WE DO THIS. 6010 03:47:54,600 --> 03:47:54,960 YEAH. 6011 03:47:54,960 --> 03:47:58,480 KAREN, PLEASE GO AHEAD? 6012 03:47:58,480 --> 03:47:59,600 >> HI, ALSO WANTED TO THANK 6013 03:47:59,600 --> 03:48:01,680 EVERYBODY FOR I THINK 1 OF THE 6014 03:48:01,680 --> 03:48:04,640 BEST WORKSHOPS I'VE BEEN AT FOR 6015 03:48:04,640 --> 03:48:06,640 THE NEUROETHICS WORKING GROUP, 6016 03:48:06,640 --> 03:48:08,240 JUST A GREAT STELLAR GROUP OF 6017 03:48:08,240 --> 03:48:09,680 PEOPLE AND OUT OF THE BOX 6018 03:48:09,680 --> 03:48:10,960 THINKERS AND PEOPLE WHO HAVE 6019 03:48:10,960 --> 03:48:11,680 BEEN LONG MISS FREE RADICALS 6020 03:48:11,680 --> 03:48:13,440 GENERATED OUR CONVERSATION SO 6021 03:48:13,440 --> 03:48:15,680 I'M SO FLAD TO HAVE OUR PATIENT 6022 03:48:15,680 --> 03:48:17,080 PARTICIPANTS HERE, LIVED 6023 03:48:17,080 --> 03:48:20,360 EXPERIENCE ADVOCATES AND ALSO 6024 03:48:20,360 --> 03:48:21,120 REPRESENTATIVES FROM INDUSTRY, 6025 03:48:21,120 --> 03:48:23,160 PEOPLE HAVE BEEN IN THE FIELD 6026 03:48:23,160 --> 03:48:24,840 TRYING TO SOLVE THESE PROBLEMS 6027 03:48:24,840 --> 03:48:25,760 LIKE MARTY. 6028 03:48:25,760 --> 03:48:27,240 SO I WOULD--I KNEW YOU WOULD 6029 03:48:27,240 --> 03:48:29,360 CREATE A GREAT MAP AND I KNEW 6030 03:48:29,360 --> 03:48:30,560 YOU ALL WOULD CAREFULLY COME 6031 03:48:30,560 --> 03:48:33,840 THROUGH AND I WAS GOING TO 6032 03:48:33,840 --> 03:48:35,440 REQUEST THAT MAYBE THERE BE KIND 6033 03:48:35,440 --> 03:48:39,400 OF A TABLE OR GRID THAT IS 6034 03:48:39,400 --> 03:48:41,840 CREATED THAT MAPS OUT LIKE GEN 6035 03:48:41,840 --> 03:48:43,280 SAID NEAR TERM, ISHT MEDIATE 6036 03:48:43,280 --> 03:48:44,360 TERM AND LONGER TOMORROW 6037 03:48:44,360 --> 03:48:46,760 PROJECTS AND SO, WHILE WE 6038 03:48:46,760 --> 03:48:47,560 CAN'T--IF A PROBLEM WE'RE TRYING 6039 03:48:47,560 --> 03:48:50,280 TO SOLVE IS KIND OF OFFERING 6040 03:48:50,280 --> 03:48:52,560 SOME KIND OF SECURITY BASICALLY 6041 03:48:52,560 --> 03:48:54,720 OR PROTECTION AND DERISKING THE 6042 03:48:54,720 --> 03:49:00,960 LONG-TERM CARE OF OUR 6043 03:49:00,960 --> 03:49:02,920 PARTICIPANTS OR WHATEVER 6044 03:49:02,920 --> 03:49:05,280 NOMENCLATURE WE SHOULDN'T LOSE 6045 03:49:05,280 --> 03:49:06,720 THAT LIKE WINSTON MENTIONED AND 6046 03:49:06,720 --> 03:49:10,080 WHO KNOWS WHO GETS TO DECIDE 6047 03:49:10,080 --> 03:49:11,560 WHAT THAT NOMENCLATURE IS, BUT 6048 03:49:11,560 --> 03:49:12,640 IN THE NEAR TERM THERE ARE 6049 03:49:12,640 --> 03:49:15,440 THINGS WE CAN DO WHICH IS JEN 6050 03:49:15,440 --> 03:49:17,520 AND BRANDY WERE A WEALTH AND 6051 03:49:17,520 --> 03:49:18,800 KNOWLEDGE AND WISDOM OF WAYS TO 6052 03:49:18,800 --> 03:49:20,080 THINK OUTSIDE OF THE BOX, THEY 6053 03:49:20,080 --> 03:49:21,200 SHOULDN'T HAVE BEEN PUT IN THAT 6054 03:49:21,200 --> 03:49:24,000 POSITION BUT THEY WERE. 6055 03:49:24,000 --> 03:49:25,200 AND I'VE HEARD JUST GREAT 6056 03:49:25,200 --> 03:49:26,240 INSIGHT FROM THEM AND 1 OF THE 6057 03:49:26,240 --> 03:49:27,720 THINGS THAT WAS MENTIONED THAT 6058 03:49:27,720 --> 03:49:29,840 WAS LOW HANGING FRUIT WERE THESE 6059 03:49:29,840 --> 03:49:32,400 REGISTRIES OR KIND OF COMMUNITY 6060 03:49:32,400 --> 03:49:33,920 SUPPORT SO MAYBE THESE ALREADY 6061 03:49:33,920 --> 03:49:35,560 EXIST TO SOME EXTENT AND SOME OF 6062 03:49:35,560 --> 03:49:37,480 THEM MIGHT BUT TO JUST AT LEAST 6063 03:49:37,480 --> 03:49:38,480 IN THE IMMEDIATE TERM, PEOPLE 6064 03:49:38,480 --> 03:49:41,320 CAN SAY WHAT ARE YOU DOING NOW 6065 03:49:41,320 --> 03:49:42,880 BECAUSE, YOU KNOW AND BRANDY 6066 03:49:42,880 --> 03:49:45,320 CAN'T FIELD ALL OF THEM BUT YOU 6067 03:49:45,320 --> 03:49:46,640 THIS IS WHAT I'M DOING NOW, 6068 03:49:46,640 --> 03:49:48,320 LET'S HELP EACH OTHER IN THE 6069 03:49:48,320 --> 03:49:51,360 SAME WAY YOU LET EACH OTHER 6070 03:49:51,360 --> 03:49:52,040 BORROW BATTERY PACKS. 6071 03:49:52,040 --> 03:49:53,440 IT WOULD BE--I KNOW WE WORRY 6072 03:49:53,440 --> 03:49:59,520 ABOUT THAT KIND OF INTERRUPTING 6073 03:49:59,520 --> 03:50:00,920 TRIALS ISSUES THE SCIENTIFIC 6074 03:50:00,920 --> 03:50:01,880 ABILITY, WE DON'T WANT PATIENTS 6075 03:50:01,880 --> 03:50:03,160 TALKING TO EACH OTHER BUT MAYBE 6076 03:50:03,160 --> 03:50:05,360 THERE IS SOMETHING THAT CAN BE 6077 03:50:05,360 --> 03:50:07,440 CREATED, MAYBE FROM THE NIH, 6078 03:50:07,440 --> 03:50:08,520 FROM FUNDING ENTITIES AND I HAVE 6079 03:50:08,520 --> 03:50:09,760 A NUMBER OF OTHER THINGS THAT 6080 03:50:09,760 --> 03:50:12,040 COULD BE NEAR TERM AND THERE'S 6081 03:50:12,040 --> 03:50:13,120 CLEAR RESEARCH AREAS THAT YOU 6082 03:50:13,120 --> 03:50:14,880 ALL MAP OUT. 6083 03:50:14,880 --> 03:50:16,920 I THINK, YOU KNOW IN THE 6084 03:50:16,920 --> 03:50:18,760 INTERMEDIATE TERM, MAYBE THERE'S 6085 03:50:18,760 --> 03:50:23,040 SOME THINGS OF NIH, A BUNCH OF 6086 03:50:23,040 --> 03:50:23,960 STAKEHOLDERS HERE, THE CITY 6087 03:50:23,960 --> 03:50:26,720 MODEL THAT WAS MENTIONED BY JEN, 6088 03:50:26,720 --> 03:50:28,680 THEY USED THIS MODEL WITH 6089 03:50:28,680 --> 03:50:30,760 PARTICIPANT LIVED EXPERIENCE 6090 03:50:30,760 --> 03:50:31,920 ADVOCATES, PARTICIPATING IN THE 6091 03:50:31,920 --> 03:50:35,880 GRANT REVIEWS AND I PERSONALLY 6092 03:50:35,880 --> 03:50:37,960 HAVE BEEN THE BIOETHICS REVIEWER 6093 03:50:37,960 --> 03:50:39,880 IN THERE ALONG WITH WALTER 6094 03:50:39,880 --> 03:50:41,800 JOHNSON AND WE'VE SEEN HOW 6095 03:50:41,800 --> 03:50:42,760 IMPORTANT THOSE PARTICIPANTS 6096 03:50:42,760 --> 03:50:44,720 WERE IN SHAPING THOSE GRANTS, 6097 03:50:44,720 --> 03:50:46,760 REALLY GOOD IDEAS WHERE 6098 03:50:46,760 --> 03:50:47,880 SOMETHING WAS FUNDAMENTALLY 6099 03:50:47,880 --> 03:50:49,880 FLAWED WHERE EVEN THE CLINICIANS 6100 03:50:49,880 --> 03:50:51,160 WRITING THEM DIDN'T HAVE ENOUGH 6101 03:50:51,160 --> 03:50:52,520 INSIDER KNOWLEDGE OF THE LIVED 6102 03:50:52,520 --> 03:50:53,280 EXPERIENCE SO MAYBE THAT'S 6103 03:50:53,280 --> 03:50:54,640 SOMETHING WE COULD DO IN THIS 6104 03:50:54,640 --> 03:50:55,960 CASE WITH THE POST TRIALS AND 6105 03:50:55,960 --> 03:50:57,520 LONGER TERM, I THINK THE HARDEST 6106 03:50:57,520 --> 03:51:03,960 1 IS WHAT JOHN SAID, THE 6107 03:51:03,960 --> 03:51:05,480 HORRIBLE INSURANCE AND 6108 03:51:05,480 --> 03:51:07,400 HEALTHCARE INSURANCEFRASTRUCTURT 6109 03:51:07,400 --> 03:51:09,720 LIFT UP BY OURSELVES BUT MAYBE 6110 03:51:09,720 --> 03:51:11,560 WE COULD SHIP AWAY AT 6111 03:51:11,560 --> 03:51:12,000 UNDERSTANDING THAT. 6112 03:51:12,000 --> 03:51:12,760 RHONDA WHO COME ACROSS THE 6113 03:51:12,760 --> 03:51:14,640 FLOOR, WE TALKED TO HER BEFORE 6114 03:51:14,640 --> 03:51:16,320 ABOUT BILLING ISSUES FOR 6115 03:51:16,320 --> 03:51:17,480 FUNCTIONAL OR NEUROLOGICAL 6116 03:51:17,480 --> 03:51:18,640 PATIENTS. 6117 03:51:18,640 --> 03:51:20,040 I MEAN, SHE IS A RICH RESOURCE 6118 03:51:20,040 --> 03:51:26,920 THAT WE COULD TALK WITH HER AND 6119 03:51:26,920 --> 03:51:28,760 CARL LI, THOSE ARE LONGER HARDER 6120 03:51:28,760 --> 03:51:29,960 STRUCTURES BUT SETTING THEM OUT 6121 03:51:29,960 --> 03:51:31,200 PIECE BY PIECE IN TIME FRAMES 6122 03:51:31,200 --> 03:51:33,800 MIGHT BE THE WAY TO MAKE THIS 6123 03:51:33,800 --> 03:51:34,560 FEEL MORE MANAGEABLE AND I'M 6124 03:51:34,560 --> 03:51:36,880 HAPPY OF COURSE TO, EVEN THOUGH 6125 03:51:36,880 --> 03:51:39,320 I'M UP IN THE MIDDLE OF THE 6126 03:51:39,320 --> 03:51:41,080 NIGHT, AND I'M HAPPY TO HELP YOU 6127 03:51:41,080 --> 03:51:42,480 ALL LATER THROUGH E-MAIL AND 6128 03:51:42,480 --> 03:51:42,680 STUFF. 6129 03:51:42,680 --> 03:51:53,040 SO PUT ME IN COACHES. 6130 03:51:56,800 --> 03:51:57,400 >> SARA? 6131 03:51:57,400 --> 03:51:59,640 >> SO I JUST WANTED TO MAKE A 6132 03:51:59,640 --> 03:52:01,800 COUPLE LAST POINTINGS, I REALLY 6133 03:52:01,800 --> 03:52:03,520 APPRECIATED THE 22 DAYS, 2, 1 IS 6134 03:52:03,520 --> 03:52:06,400 THAT WE SHOULD REALLY PAY 6135 03:52:06,400 --> 03:52:07,680 ATTENTION TO LOBBYING WHOMEVER 6136 03:52:07,680 --> 03:52:10,880 WE LOBBY TO CHANGE THE 6137 03:52:10,880 --> 03:52:13,960 COMPENSATION, THE VERY, VERY LOW 6138 03:52:13,960 --> 03:52:16,520 COMPENSATION RULES IN THIS 6139 03:52:16,520 --> 03:52:18,920 DOMAIN, AND I JUST THINK 6140 03:52:18,920 --> 03:52:21,760 COVERING THE COSTS OF CAREGIVERS 6141 03:52:21,760 --> 03:52:25,440 IS HIGH, YOU KNOW, PERSONAL 6142 03:52:25,440 --> 03:52:26,400 ATTENDANCE AND IT GOES BEYOND 6143 03:52:26,400 --> 03:52:29,680 GAS AND PARKING AND 6144 03:52:29,680 --> 03:52:30,400 THAT'S--THAT'S JUST BASIC 6145 03:52:30,400 --> 03:52:30,760 PARTICIPATION. 6146 03:52:30,760 --> 03:52:32,440 I THINK THAT SHOULD BE MADE 6147 03:52:32,440 --> 03:52:37,520 AVAILABLE FOR PEOPLE WHO ARE IN 6148 03:52:37,520 --> 03:52:37,880 THESE STUDIES. 6149 03:52:37,880 --> 03:52:40,800 I ALSO THINK IT WAS DAVID 6150 03:52:40,800 --> 03:52:42,480 Mc MULLINS IN THE Q&A WHO SAID 6151 03:52:42,480 --> 03:52:45,880 WE SHOULD HAVE SOME MODEL PLANS 6152 03:52:45,880 --> 03:52:46,000 FOR POST TRIAL COVERAGE, YOU 6153 03:52:46,000 --> 03:52:47,720 KNOW I WAS SAYING, MAYBE WE TAKE 6154 03:52:47,720 --> 03:52:48,120 HELEN AND PATRICIO AS A MODEL IS 6155 03:52:48,120 --> 03:52:49,800 PATHWAY GIVES TRIESIO SAID THIS 6156 03:52:49,800 --> 03:52:50,920 WASN'T SUSTAINABLE, BUT HAVING 6157 03:52:50,920 --> 03:52:53,600 SOMETHING SHORT-TERM OF HERE'S A 6158 03:52:53,600 --> 03:52:55,320 MODEL OF HOW WE'VE DONE THIS 6159 03:52:55,320 --> 03:52:57,160 SUCCESSFULLY EVEN IF IT'S NOT 6160 03:52:57,160 --> 03:52:58,040 LONG, LONG-TERM SUCCESSFUL WOULD 6161 03:52:58,040 --> 03:53:00,000 BE GREAT AND I THINK TO DO THAT 6162 03:53:00,000 --> 03:53:02,560 WELL, ACTUALLY WE NEED TO DO 6163 03:53:02,560 --> 03:53:04,480 SOME WORK ON TAXONOMY OF 6164 03:53:04,480 --> 03:53:06,040 DIFFERENT KINDS OF IMPLANTABLE 6165 03:53:06,040 --> 03:53:08,000 DEVICE STUDIES BECAUSE I THINK 6166 03:53:08,000 --> 03:53:09,680 THEY JUST--THE ISSUES ARE 6167 03:53:09,680 --> 03:53:11,840 DIFFERENT DEPENDING ON WHETHER 6168 03:53:11,840 --> 03:53:15,800 IT REALLY IS THE INDIVIDUAL 6169 03:53:15,800 --> 03:53:16,680 PARTICIPANT HAS THE POSSIBILITY 6170 03:53:16,680 --> 03:53:18,320 OF GETTING A HUGE THERAPEUTIC 6171 03:53:18,320 --> 03:53:21,000 BENEFIT THAT THEY CARRY WITH 6172 03:53:21,000 --> 03:53:24,240 THEM 24/7 OR IF THEY'RE REALLY 6173 03:53:24,240 --> 03:53:25,200 TRIALING SOMETHING THAT'S 6174 03:53:25,200 --> 03:53:26,960 TOTALLY NEW IN TERMS OF A WAY TO 6175 03:53:26,960 --> 03:53:28,560 MOVE OR MOVE SOMETHING ELSE THAT 6176 03:53:28,560 --> 03:53:31,480 THEY ONLY DO IN THE LAB, I THINK 6177 03:53:31,480 --> 03:53:32,520 THERE ARE REALLY INTERESTING 6178 03:53:32,520 --> 03:53:33,560 QUESTIONS FOR BOTH AND THEN I 6179 03:53:33,560 --> 03:53:35,160 THINK THERE ARE THINGS IN THE 6180 03:53:35,160 --> 03:53:36,920 MIDDLE WHERE DEVICES THAT ARE 6181 03:53:36,920 --> 03:53:38,920 DESOONED FOR SAY, STIMULATING 6182 03:53:38,920 --> 03:53:41,400 NEURAL PLASTICITY BUT THEN MIGHT 6183 03:53:41,400 --> 03:53:43,240 NOT BE NEEDED ARE--THEY'RE JUST 6184 03:53:43,240 --> 03:53:45,840 A DIFFERENT THING, TOO BECAUSE 6185 03:53:45,840 --> 03:53:47,320 THEY'RE POTENTIALLY VERY 6186 03:53:47,320 --> 03:53:48,560 THERAPEUTIC BUT NOT LONG-TERM 6187 03:53:48,560 --> 03:53:49,880 NECESSARY, SO I THINK WE'LLVILLE 6188 03:53:49,880 --> 03:53:52,960 TO HAVE DO SOME OF THAT 6189 03:53:52,960 --> 03:53:56,120 CONCEPTUAL WORK SAID THE 6190 03:53:56,120 --> 03:53:59,280 PHILOSOPHER. 6191 03:53:59,280 --> 03:53:59,520 THANKS. 6192 03:53:59,520 --> 03:54:03,280 >> SO, I THINK WITH THAT, IT'S 6193 03:54:03,280 --> 03:54:03,760 4:30. 6194 03:54:03,760 --> 03:54:09,600 SO, LET ME START TO WRAP UP, 6195 03:54:09,600 --> 03:54:11,200 JOHN WILL ALSO HAVE A WORD AFTER 6196 03:54:11,200 --> 03:54:11,440 ME. 6197 03:54:11,440 --> 03:54:13,080 LET ME START TO WRAP UP AND 6198 03:54:13,080 --> 03:54:14,960 THANKING EVERYBODY FOR TAKING 6199 03:54:14,960 --> 03:54:16,400 THE TIME DURING THESE 2 DAYS TO 6200 03:54:16,400 --> 03:54:20,000 WORK WITH US ON THIS REALLY 6201 03:54:20,000 --> 03:54:21,880 COMPLICATED TOPIC, INCLUDING ALL 6202 03:54:21,880 --> 03:54:23,080 OF THE PROFESSIONALS FROM 6203 03:54:23,080 --> 03:54:25,560 DIFFERENT AREAS AND VERY MUCH 6204 03:54:25,560 --> 03:54:28,320 ALSO ORIGINAL OUR PATIENT 6205 03:54:28,320 --> 03:54:30,040 PARTICIPANTS WHO ARE SHARE THEIR 6206 03:54:30,040 --> 03:54:33,120 INSIGHTS IN A WAY THAT OTHERWISE 6207 03:54:33,120 --> 03:54:35,080 WE COULDN'T HAVE HAD AS RICH A 6208 03:54:35,080 --> 03:54:37,120 DISCUSSION AND AS MEANINGFUL A 6209 03:54:37,120 --> 03:54:38,880 DISCUSSION SO I'M VERY GRATEFUL 6210 03:54:38,880 --> 03:54:40,040 FOR THAT. 6211 03:54:40,040 --> 03:54:42,840 MY PERSONAL OPINION IS THAT WE 6212 03:54:42,840 --> 03:54:44,160 MADE SOME PROGRESS, EVEN IF WE 6213 03:54:44,160 --> 03:54:46,600 STILL HAVE SOME WAYS TO GO 6214 03:54:46,600 --> 03:54:52,560 TOWARDS SOLVING THESE ISSUES 6215 03:54:52,560 --> 03:54:54,680 THAT WE CLARIFIED AND I'M EAGER 6216 03:54:54,680 --> 03:54:57,080 TO START WORKING ON THESE NEXT 6217 03:54:57,080 --> 03:54:58,400 STEPS AND AM GRATEFUL FOR MANY 6218 03:54:58,400 --> 03:55:01,280 OF YOU WHO IN THE CHAT HAVE 6219 03:55:01,280 --> 03:55:05,840 SAID, IT WOULD BE EAGER TO BE 6220 03:55:05,840 --> 03:55:09,160 INVOLVED MOVING FORWARD, SO 6221 03:55:09,160 --> 03:55:09,880 THANK YOU. 6222 03:55:09,880 --> 03:55:12,800 AND TO BE CONTINUED. 6223 03:55:12,800 --> 03:55:17,080 WITH THAT, I ALSO WANT TO THANK 6224 03:55:17,080 --> 03:55:21,960 NINNA WHO'S BEEN HELPING US 6225 03:55:21,960 --> 03:55:23,120 LEADING THE ORGANIZATION OF THIS 6226 03:55:23,120 --> 03:55:24,600 WORKSHOP, ALL THE NEW MEMBERS, 6227 03:55:24,600 --> 03:55:27,000 ALL THE PANELISTS AND THEN, 6228 03:55:27,000 --> 03:55:31,360 PASSING IT OVER TO YOU JOHN. 6229 03:55:31,360 --> 03:55:32,760 >> THANK SASKIA, AND I ALSO WANT 6230 03:55:32,760 --> 03:55:37,000 TO THANK EVERYBODY HERE FOR 6231 03:55:37,000 --> 03:55:38,480 THEIR PARTICIPATION AND 6232 03:55:38,480 --> 03:55:38,800 ORGANIZATION. 6233 03:55:38,800 --> 03:55:41,600 I LEARNED A TON. 6234 03:55:41,600 --> 03:55:42,720 THIS WAS--THESE HAVE BEEN ISSUES 6235 03:55:42,720 --> 03:55:45,640 THAT HAVE BEEN ON OUR MINDS FOR 6236 03:55:45,640 --> 03:55:47,120 A WHILE AND REALLY IT IS SO 6237 03:55:47,120 --> 03:55:48,840 HELPFUL TO HEAR ALL THE 6238 03:55:48,840 --> 03:55:50,360 DIFFERENT AND SIGNIFY VERSE 6239 03:55:50,360 --> 03:55:52,920 PERSPECTIVES FROM EVERYBODY HERE 6240 03:55:52,920 --> 03:55:54,440 TODAY, ESPECIALLY FROM OUR 6241 03:55:54,440 --> 03:56:00,240 PATIENTS AND PATIENT ADVOCACY 6242 03:56:00,240 --> 03:56:01,520 REPRESENTATIVES AND IT GOES 6243 03:56:01,520 --> 03:56:02,840 WITHOUT SAYING AND I SHOULD SAY 6244 03:56:02,840 --> 03:56:05,280 IT AND UNDERSCORE IT, YOU'RE THE 6245 03:56:05,280 --> 03:56:06,560 CRITICAL PARTNERS HERE WITH UTR 6246 03:56:06,560 --> 03:56:08,120 YOUR INVOLVED AND YOU'RE 6247 03:56:08,120 --> 03:56:09,480 COMMITTED NOT JUST YOUR 6248 03:56:09,480 --> 03:56:11,680 INVOFMENT, NONE OF THIS WOULD AT 6249 03:56:11,680 --> 03:56:12,040 ALL BE POSSIBLE. 6250 03:56:12,040 --> 03:56:15,200 THE 1 ISSUE I FOUND REALLY EYE 6251 03:56:15,200 --> 03:56:16,320 OPENING IS THAT WHEN WE'RE 6252 03:56:16,320 --> 03:56:17,480 TALKING ABOUT THE LENGTH OF THE 6253 03:56:17,480 --> 03:56:19,440 TRIAL PERIOD, YOU KNOW THE POST 6254 03:56:19,440 --> 03:56:20,360 TRIAL PERIOD, WE'RE NOT JUST 6255 03:56:20,360 --> 03:56:22,600 TALKING ABOUT A FEW YEARS, WHICH 6256 03:56:22,600 --> 03:56:24,600 YOU MIGHT IMAGINE, WE CAN 6257 03:56:24,600 --> 03:56:25,960 NAVIGATE AROUND BUT DECADES, 30 6258 03:56:25,960 --> 03:56:29,680 YEARS OR MORE AND THAT REALLY IS 6259 03:56:29,680 --> 03:56:32,360 TO BE SOBERING AND REALLY 6260 03:56:32,360 --> 03:56:33,240 UNDERSCORES HOW IMPORTANT IT IS 6261 03:56:33,240 --> 03:56:34,640 THAT WE ADDRESS THESE ISSUES. 6262 03:56:34,640 --> 03:56:36,640 I'M ALSO REMINDED ABOUT THE 6263 03:56:36,640 --> 03:56:38,360 INIQUITIES THAT ARE INHERENT IN 6264 03:56:38,360 --> 03:56:39,560 OUR HEALTHCARE SYSTEM THAT MUST 6265 03:56:39,560 --> 03:56:41,120 BE OVERCOME, NOT JUST IN TERMS 6266 03:56:41,120 --> 03:56:43,280 OF PATIENT'S ABILITY TO PAY OR 6267 03:56:43,280 --> 03:56:45,080 NOT PAY, BUT ALSO HAVING THE 6268 03:56:45,080 --> 03:56:47,720 RESOURCES TO SEEK OUT AND 6269 03:56:47,720 --> 03:56:49,200 ADVOCATE WHAT'S OUT THERE IT 6270 03:56:49,200 --> 03:56:51,120 THAT MAY BE LIFE SAVING TO THEM. 6271 03:56:51,120 --> 03:56:52,600 SO MANY OF US THAT ARE IN THE 6272 03:56:52,600 --> 03:56:57,040 BUSINESS AS IT WERE, BEING ABLE 6273 03:56:57,040 --> 03:56:59,600 TO ADVOCATE FOR 1'S SELF-WHETHER 6274 03:56:59,600 --> 03:57:01,960 IT INVOLVES YOU OR A LOVED 1 IS 6275 03:57:01,960 --> 03:57:03,840 NO EASY TASK AND THIS IS FOR 6276 03:57:03,840 --> 03:57:04,800 PEOPLE THAT HAVE ACCESS TO ALL 6277 03:57:04,800 --> 03:57:06,280 THE INFORMATION AND MUCH OF THE 6278 03:57:06,280 --> 03:57:08,720 INFORMATION THAT OTHERS DON'T. 6279 03:57:08,720 --> 03:57:09,840 SO I REALLY THINK THAT'S 6280 03:57:09,840 --> 03:57:13,520 SOMETHING WE NEED TO KEEP IN 6281 03:57:13,520 --> 03:57:13,800 MIND. 6282 03:57:13,800 --> 03:57:14,880 BRAIN HAS A COMMITMENT THAT THE 6283 03:57:14,880 --> 03:57:16,720 RESOURCES THAT WE INVEST IN OUR 6284 03:57:16,720 --> 03:57:19,280 RESEARCH FOR THE PURPOSE OF 6285 03:57:19,280 --> 03:57:20,320 HELPING HUMANS SHOULD NOT BE 6286 03:57:20,320 --> 03:57:23,000 GOING TO JUST THE PRIVILEGED 6287 03:57:23,000 --> 03:57:24,720 FEW, SO WE REALLY--THIS IS 6288 03:57:24,720 --> 03:57:29,800 REALLY PART OF OUR MISSION IS TO 6289 03:57:29,800 --> 03:57:32,480 PROVIDE RESOURCES AND EVENTUALLY 6290 03:57:32,480 --> 03:57:36,280 CURES FOR THE BENEFIT OF ALL. 6291 03:57:36,280 --> 03:57:38,560 AND BRAIN IS ALSO OCCUPYING THIS 6292 03:57:38,560 --> 03:57:39,000 UNIQUE SPACE, RIGHT? 6293 03:57:39,000 --> 03:57:41,280 IN EMERGING ITS OF INVASIVE 6294 03:57:41,280 --> 03:57:43,120 NEUROTECHNOLOGIES, I MEAN THESE 6295 03:57:43,120 --> 03:57:45,600 ARE POTENTIALLY GAME CHANGING 6296 03:57:45,600 --> 03:57:47,080 TECHNIQUES AND TECHNOLOGIES, 6297 03:57:47,080 --> 03:57:48,080 LIFE CHANGING TECHNOLOGIES, THAT 6298 03:57:48,080 --> 03:57:50,000 BY NATURE ARE IN THE EARLIEST 6299 03:57:50,000 --> 03:57:51,240 PHASES OF DEVELOPMENT, THESE ARE 6300 03:57:51,240 --> 03:57:52,960 THE ONLY THINGS WE FUND WHEREAS 6301 03:57:52,960 --> 03:57:53,760 EARLY PHASE DEVELOPMENT IN 6302 03:57:53,760 --> 03:57:55,720 HUMANS AND THIS GIVES RISE AS WE 6303 03:57:55,720 --> 03:57:58,720 HEARD OVER THE LAST FEW DAYS TO 6304 03:57:58,720 --> 03:58:00,560 VERY UNIQUE RISKS AS WELL AS 6305 03:58:00,560 --> 03:58:01,640 UNCERTAINTIES AND THIS IS I 6306 03:58:01,640 --> 03:58:07,040 THINK WHERE WE, YOU KNOW, GETS 6307 03:58:07,040 --> 03:58:07,400 QUITE COMPLEX. 6308 03:58:07,400 --> 03:58:09,680 I THINK WE WILL ALL AGREE THAT 6309 03:58:09,680 --> 03:58:10,840 ALL STAKEHOLDERS HAVE A 6310 03:58:10,840 --> 03:58:12,880 RESPONSIBILITY TO BETTER ADDRESS 6311 03:58:12,880 --> 03:58:15,240 POST TRIAL OR AS THE NAME OF THE 6312 03:58:15,240 --> 03:58:16,720 WORKSHOP IMPLIES CONTINUING 6313 03:58:16,720 --> 03:58:17,480 TRIAL RESPONSIBILITIES. 6314 03:58:17,480 --> 03:58:19,600 WE CHOSE THAT NAME VERY 6315 03:58:19,600 --> 03:58:22,680 INTENTIONALLY, CONTINUING TRIAL 6316 03:58:22,680 --> 03:58:24,320 RESPONSIBILITIES, AND THIS IS TO 6317 03:58:24,320 --> 03:58:26,320 REFLECT THE FACT THAT THE 6318 03:58:26,320 --> 03:58:28,760 PATIENT'S INVOLVEMENT GOES 6319 03:58:28,760 --> 03:58:29,760 BEYOND--OFTEN GOES BEYOND THE 6320 03:58:29,760 --> 03:58:30,760 LIFETIME OF A FORMAL TRIAL AND 6321 03:58:30,760 --> 03:58:33,280 THIS IS SOMETHING WE NEED TO 6322 03:58:33,280 --> 03:58:34,080 TAKE INTO ACCOUNT. 6323 03:58:34,080 --> 03:58:35,280 I SHOULD ALSO NOTE THAT WE HEARD 6324 03:58:35,280 --> 03:58:37,720 A LOT OF ISSUES THAT HAVE COME 6325 03:58:37,720 --> 03:58:40,800 UP AND NOT ALL CONTINGENCIES CAN 6326 03:58:40,800 --> 03:58:41,800 BE ACCOUNTED FOR. 6327 03:58:41,800 --> 03:58:45,520 THIS IS--THIS COULD BE THE ENEMY 6328 03:58:45,520 --> 03:58:47,920 OF BETTER OR GOOD ENOUGH TO 6329 03:58:47,920 --> 03:58:50,440 PERFECTION AND THERE WILL LIKELY 6330 03:58:50,440 --> 03:58:51,400 NOT BE 1 PERFECT SOLUTION TO 6331 03:58:51,400 --> 03:58:53,160 ADDRESS ALL THE GAPS WE 6332 03:58:53,160 --> 03:58:54,880 IDENTIFIED OVER THE PAST FEW 6333 03:58:54,880 --> 03:58:56,480 DAYS AND WHAT MANY OF YOU HAVE 6334 03:58:56,480 --> 03:58:57,480 BEEN LIVING THROUGH PERSONALLY 6335 03:58:57,480 --> 03:59:00,280 BUT I THINK FROM WHAT WE LEARNED 6336 03:59:00,280 --> 03:59:01,280 HERE, I'M HOPE EMPLOY WE WILL 6337 03:59:01,280 --> 03:59:03,400 AND CAN COME UP WITH CREATIVE 6338 03:59:03,400 --> 03:59:04,160 SOLUTIONS AND I REMIND MYSELF 6339 03:59:04,160 --> 03:59:06,360 AND ALL THE FOLKS THAT I WORK 6340 03:59:06,360 --> 03:59:10,120 WITH ON A PRETTY REGULAR BASIS 6341 03:59:10,120 --> 03:59:11,760 THAT INNOVATION OF BRAIN DOES 6342 03:59:11,760 --> 03:59:13,640 NOT STOP WITH THE--DURING THE 6343 03:59:13,640 --> 03:59:15,520 ACTUAL SCIENCE, WE HAVE TO FIND 6344 03:59:15,520 --> 03:59:17,600 CREATIVE SOLUTIONS, WE NEED TO 6345 03:59:17,600 --> 03:59:19,200 INNOVATE IN THIS SPACE AS WELL, 6346 03:59:19,200 --> 03:59:20,840 SO JUST IN CLOSING FROM BRAIN'S 6347 03:59:20,840 --> 03:59:22,480 POINT OF VIEW, FROM MY POINT OF 6348 03:59:22,480 --> 03:59:24,840 VIEW, THIS WORKSHOP SITS MORE 6349 03:59:24,840 --> 03:59:26,280 TOWARD THE BEGINNING AND NOT THE 6350 03:59:26,280 --> 03:59:27,880 END OF A VERY IMPORTANT 6351 03:59:27,880 --> 03:59:28,360 CONVERSATION. 6352 03:59:28,360 --> 03:59:29,720 OUR DISCUSSIONS WITHIN OUR 6353 03:59:29,720 --> 03:59:31,920 PROGRAM, ACROSS NIH MORE BROADLY 6354 03:59:31,920 --> 03:59:33,120 FOR LONGER TERM SOLUTIONS AS 6355 03:59:33,120 --> 03:59:34,440 WELL AS WORK AROUNDS IN THE MEAN 6356 03:59:34,440 --> 03:59:37,240 TIME THESE ARE ALL ACTIVE AND 6357 03:59:37,240 --> 03:59:38,840 ONGOING, I CAN ASSURE YOU WE ARE 6358 03:59:38,840 --> 03:59:43,520 POKING AROUND AND SEEING WHAT WE 6359 03:59:43,520 --> 03:59:45,520 CAN DO WHILE WE WORK TOWARD 6360 03:59:45,520 --> 03:59:48,400 THESE LONGER SOLUTIONS WHICH 6361 03:59:48,400 --> 03:59:50,160 WILL TAKE STAKEHOLDERSERS LONGER 6362 03:59:50,160 --> 03:59:51,560 INVOLVEMENT TO GET DONE. 6363 03:59:51,560 --> 03:59:54,200 AND YOU CAN SEE MORE OF THIS 6364 03:59:54,200 --> 03:59:56,320 ABOUT THE WORK IN PART OF OUR 6365 03:59:56,320 --> 03:59:57,160 GREAT NEUROETHICS WORKING GROUP 6366 03:59:57,160 --> 03:59:58,120 AND I WANT TO THANK YOU AGAIN 6367 03:59:58,120 --> 04:00:03,520 FOR BEING HERE AS WELL AS FOR 6368 04:00:03,520 --> 04:00:05,880 OUR NEURY ETHICS WORKING GROUP 6369 04:00:05,880 --> 04:00:07,480 AND OUR CHAIRS CHRISTINE GRADE 6370 04:00:07,480 --> 04:00:11,320 SKPE BAKUGAN HANK GREELY, I WILL 6371 04:00:11,320 --> 04:00:12,440 LEAVE IT AT THAT. WE HAVE A LOT 6372 04:00:12,440 --> 04:00:13,960 OF WORK TO DO, WE HAVE GREAT 6373 04:00:13,960 --> 04:00:16,040 IDEAS AND AS MANY OF YOU 6374 04:00:16,040 --> 04:00:16,920 MENTIONED HERE, LET'S NOT LET 6375 04:00:16,920 --> 04:00:18,880 THIS FALL BY THE WAY SIDE, LET'S 6376 04:00:18,880 --> 04:00:20,680 USE WHAT WE LEARNED HERE AS A 6377 04:00:20,680 --> 04:00:22,640 STIMULUS TO REALLY GET GOING ON 6378 04:00:22,640 --> 04:00:33,080 SOLVING THIS SET OF PROBLEMS. 6379 04:00:33,080 --> 04:00:33,960 >> THANK YOU SO MUCH JOHN. 6380 04:00:33,960 --> 04:00:35,920 AND WITH THAT I WILL ECHO WHAT 6381 04:00:35,920 --> 04:00:38,080 WE HEARD FROM OUR CO MODERATORS 6382 04:00:38,080 --> 04:00:40,960 AND FROM JOHN, IT'S BEEN A 6383 04:00:40,960 --> 04:00:42,000 REALLY HUMBLING AND RICH 6384 04:00:42,000 --> 04:00:44,440 DISCUSSION THAT I WILL BE 6385 04:00:44,440 --> 04:00:46,000 DIGESTING FOR A VERY LONG TIME 6386 04:00:46,000 --> 04:00:46,840 AFTER THIS. 6387 04:00:46,840 --> 04:00:47,840 I REALLY LOVED YOUR COMMENT, 6388 04:00:47,840 --> 04:00:50,800 JOHN THAT SHOULD THE BEGINNING 6389 04:00:50,800 --> 04:00:52,880 OF THE CONVERSATION SO AGAIN, A 6390 04:00:52,880 --> 04:01:00,600 HUGE THANK YOU TO EVERYBODY, OUR 6391 04:01:00,600 --> 04:01:01,720 PANELISTS, THE NEWG, TO EVERYONE 6392 04:01:01,720 --> 04:01:03,560 AND NIH STAFF AND WE ARE 6393 04:01:03,560 --> 04:01:03,920 ADJOURNED. 6394 04:01:03,920 --> 04:01:14,320 THANK YOU AGAIN SO MUCH