1 00:00:05,040 --> 00:00:09,800 I THANK YOU FOR JOINING OUR 2 00:00:09,800 --> 00:00:11,400 VIDEOCAST THIS AFTERNOON. 3 00:00:11,400 --> 00:00:14,720 I AM PLEASED TO SERVE AS YOUR 4 00:00:14,720 --> 00:00:19,080 VIDEOCAST MODERATOR TODAY. 5 00:00:19,080 --> 00:00:20,840 I OVERSEE OUTREACH 6 00:00:20,840 --> 00:00:22,480 COMMUNICATIONS TO THE EXTRAMURAL 7 00:00:22,480 --> 00:00:24,880 RESEARCH COMMUNITY FOR THE 8 00:00:24,880 --> 00:00:25,640 NATIONAL CENTER FOR 9 00:00:25,640 --> 00:00:27,480 COMPLEMENTARY AND INTEGRATIVE 10 00:00:27,480 --> 00:00:28,840 HEALTH IN THE DIVISION OF 11 00:00:28,840 --> 00:00:30,120 EXTRAMURAL RESEARCH. 12 00:00:30,120 --> 00:00:32,200 THIS TECHNICAL ASSISTANCE 13 00:00:32,200 --> 00:00:35,920 VIDEOCAST IS SPONSORED BY NCCIH, 14 00:00:35,920 --> 00:00:37,800 AND THE NATIONAL CENTER FOR 15 00:00:37,800 --> 00:00:39,800 ADVANCING TRANSLATIONAL SCIENCE, 16 00:00:39,800 --> 00:00:42,800 THAT'S CALLED NCATS FOR SHORT, 17 00:00:42,800 --> 00:00:46,320 AND SIX OTHER PARTNER 18 00:00:46,320 --> 00:00:47,240 INSTITUTES, CENTERS, AND ONE 19 00:00:47,240 --> 00:00:48,720 OFFICE THAT HAVE A VESTED 20 00:00:48,720 --> 00:00:50,800 INTEREST IN THIS IMPORTANT AREA 21 00:00:50,800 --> 00:00:54,000 OF SICKLE CELL RESEARCH. 22 00:00:54,000 --> 00:00:55,200 DURING THIS VIDEOCAST, YOU WILL 23 00:00:55,200 --> 00:00:58,560 HAVE THE OPPORTUNITY TO HEAR 24 00:00:58,560 --> 00:01:01,640 MORE ABOUT HELPING TO END 25 00:01:01,640 --> 00:01:04,280 ADDICTION LONG TERM OR THE HEAL 26 00:01:04,280 --> 00:01:06,400 FUNDING OPPORTUNITY RELATED TO 27 00:01:06,400 --> 00:01:09,080 SICKLE CELL DISEASE AND PAIN 28 00:01:09,080 --> 00:01:09,720 RESEARCH. 29 00:01:09,720 --> 00:01:10,920 AND DURING THE LATTER PART OF 30 00:01:10,920 --> 00:01:12,040 THIS VIDEOCAST, YOU WILL HAVE 31 00:01:12,040 --> 00:01:13,880 YOUR QUESTIONS ANSWERED BY 32 00:01:13,880 --> 00:01:18,040 PROGRAM AND REVIEW STAFF. 33 00:01:18,040 --> 00:01:19,800 BUT PLEASE NOTE YOUR ATTENDANCE 34 00:01:19,800 --> 00:01:21,400 HERE TODAY IS IN NO WAY A 35 00:01:21,400 --> 00:01:23,600 REQUIREMENT TO COMPETE FOR THIS 36 00:01:23,600 --> 00:01:26,600 PARTICULAR OPPORTUNITY. 37 00:01:26,600 --> 00:01:27,800 THE TWO HEAL FUNDING 38 00:01:27,800 --> 00:01:29,440 ANNOUNCEMENTS RELATED TO SICKLE 39 00:01:29,440 --> 00:01:31,160 CELL DISEASE AND PAIN RESEARCH, 40 00:01:31,160 --> 00:01:35,880 WE WILL DISCUSS TODAY ARE: THE 41 00:01:35,880 --> 00:01:41,760 ONE RELATED TO PRAGMATIC AND 42 00:01:41,760 --> 00:01:44,840 IMPLEMENTATION STUDIES FOR THE 43 00:01:44,840 --> 00:01:46,240 MANAGEMENT OF SICKLE CELL 44 00:01:46,240 --> 00:01:50,960 DISEASE AND PAIN, AND THAT IS A 45 00:01:50,960 --> 00:01:51,960 UG3/UH3 CLINICAL TRIALS OPTIONAL 46 00:01:51,960 --> 00:01:56,840 FUNDING MECHANISM, AND THE 47 00:01:56,840 --> 00:01:58,320 SECOND ONE IS SICKLE CELL AND 48 00:01:58,320 --> 00:02:00,600 PAIN MANAGEMENT TRIALS UTILIZING 49 00:02:00,600 --> 00:02:02,560 THE PAIN MANAGEMENT 50 00:02:02,560 --> 00:02:05,840 EFFECTIVENESS RESEARCH NETWORK. 51 00:02:05,840 --> 00:02:09,240 AND THAT ALSO IS A UG3/UH3 52 00:02:09,240 --> 00:02:11,280 FUNDING MECHANISM. 53 00:02:11,280 --> 00:02:14,120 THE RECEIPT DATE FOR BOTH IS 54 00:02:14,120 --> 00:02:18,960 NOVEMBER THE 21ST, 2022. 55 00:02:18,960 --> 00:02:20,360 THIS TECHNICAL ASSISTANCE 56 00:02:20,360 --> 00:02:21,720 VIDEOCAST IS ONE HOUR IN LENGTH 57 00:02:21,720 --> 00:02:24,880 AND WILL CONCLUDE AT 3:00 P.M. 58 00:02:24,880 --> 00:02:27,200 DURING THE FIRST HALF-HOUR OF 59 00:02:27,200 --> 00:02:32,000 THE VIDEO QAA C VIDEOCAST YOU WR 60 00:02:32,000 --> 00:02:33,840 PRESENTATIONS FROM NCCIH AND 61 00:02:33,840 --> 00:02:35,040 NCATS PROGRAM STAFF AND A MEMBER 62 00:02:35,040 --> 00:02:38,440 OF NCCIH'S REVIEW TEAM. 63 00:02:38,440 --> 00:02:40,400 THE LAST HALF OF THE VIDEOCAST 64 00:02:40,400 --> 00:02:43,120 IS ENTIRELY DEVOTED TO ANSWERING 65 00:02:43,120 --> 00:02:44,320 QUESTIONS FROM OUR VIEWING 66 00:02:44,320 --> 00:02:44,920 AUDIENCE. 67 00:02:44,920 --> 00:02:45,880 QUESTIONS CAN BE SUBMITTED ANY 68 00:02:45,880 --> 00:02:47,320 TIME THROUGHOUT THIS VIDEOCAST 69 00:02:47,320 --> 00:02:48,840 USING THE Q & A FEATURE, WHICH 70 00:02:48,840 --> 00:02:50,160 IS A TAB AT THE BOTTOM OF YOUR 71 00:02:50,160 --> 00:02:56,520 SCREEN. 72 00:02:56,520 --> 00:02:58,200 SO AT THIS TIME, I WOULD REALLY 73 00:02:58,200 --> 00:03:00,120 LIKE TO INTRODUCE OUR THREE 74 00:03:00,120 --> 00:03:01,200 VIDEOCAST SPEAKERS. 75 00:03:01,200 --> 00:03:03,560 OUR FIRST SPEAKER TO YOUR FAR 76 00:03:03,560 --> 00:03:12,920 LEFT IS DR. SEKAI CHIDEYA, 77 00:03:12,920 --> 00:03:15,480 PROGRAM DIRECTOR, CLINICAL 78 00:03:15,480 --> 00:03:18,280 RESEARCH BRANCH AT NCCIH. 79 00:03:18,280 --> 00:03:19,640 FOLLOWING IS DR. JANE ATKINSON, 80 00:03:19,640 --> 00:03:21,560 OVER TO THE FAR RIGHT, UP TO THE 81 00:03:21,560 --> 00:03:22,120 RIGHT. 82 00:03:22,120 --> 00:03:23,400 SHE IS A SENIOR SCIENTIFIC 83 00:03:23,400 --> 00:03:25,080 PROGRAM MANAGER FOR CLINICAL AND 84 00:03:25,080 --> 00:03:27,920 TRANSLATIONAL SI SCIENCE AWARDSD 85 00:03:27,920 --> 00:03:30,400 THE TRIAL INNOVATION NETWORK AT 86 00:03:30,400 --> 00:03:32,360 NCATS. 87 00:03:32,360 --> 00:03:38,720 AT THE LOWER LEFT IS DR. SONIA 88 00:03:38,720 --> 00:03:39,640 NANESCU, SCIENTIFIC REVIEW 89 00:03:39,640 --> 00:03:41,920 OFFICER IN THE OFFICE OF 90 00:03:41,920 --> 00:03:45,720 SCIENTIFIC REVIEW AT NCCIH. 91 00:03:45,720 --> 00:03:47,040 SO I'M VERY PLEASED AT THIS TIME 92 00:03:47,040 --> 00:03:51,280 TO PASS IT OVER TO DR. SEKAI 93 00:03:51,280 --> 00:03:53,920 CHIDEYA. 94 00:03:53,920 --> 00:03:55,040 >>THANK YOU, ANITA. 95 00:03:55,040 --> 00:03:55,920 GOOD AFTERNOON, EVERYONE. 96 00:03:55,920 --> 00:03:57,200 THANK YOU FOR JOINING US. 97 00:03:57,200 --> 00:03:58,320 WE'RE VERY GLAD TO HAVE YOU. 98 00:03:58,320 --> 00:04:00,960 BEFORE I DIVE INTO THE WEBINAR, 99 00:04:00,960 --> 00:04:02,480 I WANT TO JUST PROVIDE A BRIEF 100 00:04:02,480 --> 00:04:03,680 OVERVIEW OF THE AGENDA OF 101 00:04:03,680 --> 00:04:05,680 TODAY'S WEBINAR. 102 00:04:05,680 --> 00:04:07,720 FIRST I WILL DISCUSS THE 103 00:04:07,720 --> 00:04:10,800 ELIGIBILITY CRITERIA OF THE 104 00:04:10,800 --> 00:04:12,080 RFAs, THEN DR. ATKINSON AND I 105 00:04:12,080 --> 00:04:14,000 WILL GO OVER THE GOALS AND 106 00:04:14,000 --> 00:04:15,480 OBJECTIVES OF THE TWO RFAs 107 00:04:15,480 --> 00:04:17,880 WITH A PARTICULAR FOCUS ON THE 108 00:04:17,880 --> 00:04:19,280 NIH PRISSMM HEALTHCARE SYSTEMS 109 00:04:19,280 --> 00:04:21,160 RESEARCH COLLABORATORY, AND THE 110 00:04:21,160 --> 00:04:26,720 EFFECTIVENESS RESEARCH NETWORK. 111 00:04:26,720 --> 00:04:28,640 THEN WE'LL HAVE A SUMMARY OF THE 112 00:04:28,640 --> 00:04:29,920 APPLICATION AND REVIEW PROCESS, 113 00:04:29,920 --> 00:04:31,680 FOLLOWED BY PLENTY OF TIME FOR 114 00:04:31,680 --> 00:04:34,760 OUR QUESTION AND ANSWER PERIOD. 115 00:04:34,760 --> 00:04:36,480 PLEASE NOTE THAT DUE TO TIME 116 00:04:36,480 --> 00:04:37,560 CONSTRAINTS, WE ARE NOT GOING TO 117 00:04:37,560 --> 00:04:41,600 BE ABLE TO GO OVER THE 118 00:04:41,600 --> 00:04:43,040 PRIORITIES OF THE PARTICIPATING 119 00:04:43,040 --> 00:04:44,800 INSTITUTES AND CENTERS, HOWEVER, 120 00:04:44,800 --> 00:04:45,880 ALL OF THE INFORMATION FOR THOSE 121 00:04:45,880 --> 00:04:47,960 CENTERS AND INSTITUTES, 122 00:04:47,960 --> 00:04:48,960 INCLUDING THE CONTACT 123 00:04:48,960 --> 00:04:50,400 INFORMATION FOR THE PROGRAM 124 00:04:50,400 --> 00:04:52,120 DIRECTORS AT THOSE CENTERS AND 125 00:04:52,120 --> 00:04:53,720 INSTITUTES, WILL BE INCLUDED IN 126 00:04:53,720 --> 00:04:55,720 THE SLIDE DECK THAT WILL BE 127 00:04:55,720 --> 00:05:00,960 POSTED ONLINE FOR YOUR 128 00:05:00,960 --> 00:05:02,400 REFERENCE. 129 00:05:02,400 --> 00:05:02,960 BECAUSE SICKLE CELL DISEASE 130 00:05:02,960 --> 00:05:05,560 PRIMARILY IMPACTS PEOPLE OF 131 00:05:05,560 --> 00:05:11,360 AFRICAN, INDIAN AN MEDITERRANEAN 132 00:05:11,360 --> 00:05:12,240 DESCENT WE HAVE RECEIVED A 133 00:05:12,240 --> 00:05:14,360 NUMBER OF INQUIRIES FROM FOREIGN 134 00:05:14,360 --> 00:05:15,960 INSTITUTIONS AND INVESTIGATORS 135 00:05:15,960 --> 00:05:17,280 ASKING IF THEY ARE ELIGIBLE TO 136 00:05:17,280 --> 00:05:18,000 APPLY FOR THIS FUNDING 137 00:05:18,000 --> 00:05:18,560 OPPORTUNITY. 138 00:05:18,560 --> 00:05:20,040 TO CLARIFY, NON-U.S. ENTITIES 139 00:05:20,040 --> 00:05:22,440 SUCH AS FOREIGN INSTITUTIONS AND 140 00:05:22,440 --> 00:05:23,640 COMPANIES AND FOREIGN COMPONENTS 141 00:05:23,640 --> 00:05:25,960 OF U.S. ORGANIZATIONS ARE NOT 142 00:05:25,960 --> 00:05:29,200 ELIGIBLE TO APPLY AS PRIMARY 143 00:05:29,200 --> 00:05:30,280 GRANT RECIPIENTS. 144 00:05:30,280 --> 00:05:31,600 HOWEVER, FOREIGN COMPONENTS AS 145 00:05:31,600 --> 00:05:33,800 DEFINED IN THE NIH GRANTS POLICY 146 00:05:33,800 --> 00:05:36,800 STATEMENT MAY BE INCLUDED IN AN 147 00:05:36,800 --> 00:05:37,920 APPLICATION AND THE PROPOSED 148 00:05:37,920 --> 00:05:39,160 STUDY TEAM SO LONG AS THEY ARE 149 00:05:39,160 --> 00:05:42,000 NOT THE PRIMARY GRANT RECIPIENT. 150 00:05:42,000 --> 00:05:46,160 IF THIS IS THE CASE, APPLICANTS 151 00:05:46,160 --> 00:05:47,800 MUST INCLUDE A FOREIGN 152 00:05:47,800 --> 00:05:48,560 JUSTIFICATION ATTACHMENT 153 00:05:48,560 --> 00:05:49,760 DESCRIBING WHY A FOREIGN SITE IS 154 00:05:49,760 --> 00:05:50,720 MORE APPROPRIATE THAN A U.S. 155 00:05:50,720 --> 00:05:52,480 ONE. 156 00:05:52,480 --> 00:05:54,480 PLEASE CAREFULLY REVIEW SECTION 157 00:05:54,480 --> 00:05:56,560 3 OF THE RFAs TO DETERMINE 158 00:05:56,560 --> 00:06:03,080 YOUR ELIGIBILITY BEFORE 159 00:06:03,080 --> 00:06:03,680 APPLYING. 160 00:06:03,680 --> 00:06:05,400 NOW LET'S TALK ABOUT THE HEAL 161 00:06:05,400 --> 00:06:07,320 INITIATIVE, OR HELPING TO END 162 00:06:07,320 --> 00:06:10,200 ADDICTION LONG-TERM INITIATIVE. 163 00:06:10,200 --> 00:06:11,840 THIS INITIATIVE'S MISSION IS TO 164 00:06:11,840 --> 00:06:12,760 IDENTIFY EVIDENCE-BASED 165 00:06:12,760 --> 00:06:14,920 SOLUTIONS TO THE U.S. OPIOID 166 00:06:14,920 --> 00:06:16,560 CRISIS BY IMPROVING PREVENTION 167 00:06:16,560 --> 00:06:18,400 AND TREATMENT OF OPIOID MISUSE 168 00:06:18,400 --> 00:06:20,800 AND ADDICTION AND UNDERSTANDING, 169 00:06:20,800 --> 00:06:22,600 MANAGING AND TREATING PAIN. 170 00:06:22,600 --> 00:06:24,400 HEAL RESEARCH PRIORITIES INCLUDE 171 00:06:24,400 --> 00:06:27,040 BUT ARE NOT LIMITED TO: 172 00:06:27,040 --> 00:06:28,360 ACCELERATING THE DISCOVERY, 173 00:06:28,360 --> 00:06:29,440 PRE-CLINICAL DEVELOPMENT AND 174 00:06:29,440 --> 00:06:31,320 CLINICAL TRIAL CONDUCT OF 175 00:06:31,320 --> 00:06:34,160 NON-ADDICTIVE TREATMENTS FOR 176 00:06:34,160 --> 00:06:34,720 PAIN. 177 00:06:34,720 --> 00:06:36,240 ESTABLISHING BEST PAIN 178 00:06:36,240 --> 00:06:38,040 MANAGEMENT STRATEGIES FOR ACUTE 179 00:06:38,040 --> 00:06:39,760 AND CHRONIC PAIN. 180 00:06:39,760 --> 00:06:41,400 EXPANDING THERAPIES FOR 181 00:06:41,400 --> 00:06:42,720 ADDICTION, OVERDOSE PREVENTION 182 00:06:42,720 --> 00:06:44,240 AND REVERSAL. 183 00:06:44,240 --> 00:06:45,000 OPTIMIZING CURRENT AND 184 00:06:45,000 --> 00:06:46,400 DEVELOPING NEW PREVENTION AND 185 00:06:46,400 --> 00:06:47,520 TREATMENT STRATEGIES. 186 00:06:47,520 --> 00:06:49,360 AND UNDERSTANDING THE 187 00:06:49,360 --> 00:06:51,560 NEUROBIOLOGICAL UNDERPINNINGS OF 188 00:06:51,560 --> 00:06:55,160 CHRONIC PAIN. 189 00:06:55,160 --> 00:06:58,440 I TO WANT TO EMPHASIZE, THOUGH, 190 00:06:58,440 --> 00:07:01,640 THAT THE HEAL INITIATIVES ARE 191 00:07:01,640 --> 00:07:03,680 DISTINCT FROM ONGOING RESEARCH 192 00:07:03,680 --> 00:07:04,800 INCLUDING ON SICKLE CELL PAIN 193 00:07:04,800 --> 00:07:05,800 MANAGEMENT. 194 00:07:05,800 --> 00:07:07,080 TO AVOID SUBMITTING A SICKLE 195 00:07:07,080 --> 00:07:09,280 CELL PAIN MANAGEMENT TRIAL THAT 196 00:07:09,280 --> 00:07:10,160 OVERLAPSE SIGNIFICANTLY WITH 197 00:07:10,160 --> 00:07:11,360 OTHER ONGOING TRIALS, APPLICANTS 198 00:07:11,360 --> 00:07:13,440 SHOULD CAREFULLY REVIEW THE 199 00:07:13,440 --> 00:07:14,520 WEBSITES LISTED HERE. 200 00:07:14,520 --> 00:07:17,280 THAT WILL HELP ENSURE THAT THEIR 201 00:07:17,280 --> 00:07:19,760 APPLICATIONS ARE NOT DUPLICATIVE 202 00:07:19,760 --> 00:07:26,000 WITH CURRENTLY FUNDED RESEARCH. 203 00:07:26,000 --> 00:07:27,600 THIS SLIDE GRAPHICALLY SHOWS THE 204 00:07:27,600 --> 00:07:30,320 TWO OBJECTIVES OF THE HEAL 205 00:07:30,320 --> 00:07:32,160 INITIATIVE, ENHANCING PAIN 206 00:07:32,160 --> 00:07:33,360 MANAGEMENT AND IMPROVING 207 00:07:33,360 --> 00:07:34,640 TREATMENTS FOR MISUSE AND 208 00:07:34,640 --> 00:07:34,920 ADDICTION. 209 00:07:34,920 --> 00:07:37,720 IN THE AREA OF ENHANCING PAIN 210 00:07:37,720 --> 00:07:38,680 MANAGEMENT, CLINICAL RESEARCH IN 211 00:07:38,680 --> 00:07:40,560 PAIN MANAGEMENT IS A PRIMARY 212 00:07:40,560 --> 00:07:41,880 FOCUS, AND THERE ARE MULTIPLE 213 00:07:41,880 --> 00:07:43,200 PROGRAMS AND ACTIVITY IN THIS 214 00:07:43,200 --> 00:07:44,600 AREA. 215 00:07:44,600 --> 00:07:47,000 SOME OF WHICH ARE LISTED HERE. 216 00:07:47,000 --> 00:07:48,880 I'D LIKE TO BRING YOUR ATTENTION 217 00:07:48,880 --> 00:07:51,360 TO THE LAST TWO, THE PRAGMATIC 218 00:07:51,360 --> 00:07:52,520 AND IMPLEMENTATION STUDIES FOR 219 00:07:52,520 --> 00:07:55,560 THE MANAGEMENT OF PAIN, OR 220 00:07:55,560 --> 00:07:58,160 PRISSMM, AND THE PAIN MANAGEMENT 221 00:07:58,160 --> 00:07:59,520 EFFECTIVENESS RESEARCH NETWORK 222 00:07:59,520 --> 00:08:03,000 OR ERN, BECAUSE THESE TWO ARE 223 00:08:03,000 --> 00:08:04,800 RELEVANT TO THE RFAs BEING 224 00:08:04,800 --> 00:08:05,720 DISCUSSED TODAY. 225 00:08:05,720 --> 00:08:07,600 SO LET'S DISCUSS THE RFAs. 226 00:08:07,600 --> 00:08:10,080 FIRST, I'LL GO OVER THE GOALS 227 00:08:10,080 --> 00:08:16,440 AND OBJECTIVES OF RF RFA-AT-23-. 228 00:08:16,440 --> 00:08:18,640 SOME HELPFUL DEFINITIONS. 229 00:08:18,640 --> 00:08:19,880 EMBEDDED PRAGMATIC CLINICAL 230 00:08:19,880 --> 00:08:20,920 TRIALS ARE THOSE THAT ARE 231 00:08:20,920 --> 00:08:22,320 CONDUCTED WITHIN THE HEALTHCARE 232 00:08:22,320 --> 00:08:23,640 DELIVER RESETTING AND ARE 233 00:08:23,640 --> 00:08:26,280 PRIMARILY DESIGNED TO DETERMINED 234 00:08:26,280 --> 00:08:29,560 EFFECTS OF AN EVIDENCE-BASED 235 00:08:29,560 --> 00:08:30,560 INTERVENTION UNDER THE USUAL 236 00:08:30,560 --> 00:08:31,760 CONDITIONS IN WHICH IT WILL BE 237 00:08:31,760 --> 00:08:32,160 APPLIED. 238 00:08:32,160 --> 00:08:33,600 THIS IS IN CONTRAST TO 239 00:08:33,600 --> 00:08:36,000 EXPLANATORY TRIALS THAT ARE 240 00:08:36,000 --> 00:08:36,800 PRIMARILY DESIGNED TO DETERMINE 241 00:08:36,800 --> 00:08:38,600 THE EFFECTS OF AN INTERVENTION 242 00:08:38,600 --> 00:08:41,160 UNDER IDEAL CIRCUMSTANCES. 243 00:08:41,160 --> 00:08:43,120 IMPLEMENTATION RESEARCH SEEKS TO 244 00:08:43,120 --> 00:08:45,200 UNDERSTAND THE BEHAVIOR OF 245 00:08:45,200 --> 00:08:46,200 PRACTITIONERS, SUPPORT STAFF AND 246 00:08:46,200 --> 00:08:47,920 OTHER STAKEHOLDERS ASCII 247 00:08:47,920 --> 00:08:49,680 INFLUENCES ON THE ADOPTION, 248 00:08:49,680 --> 00:08:50,480 IMPLEMENTATION AND 249 00:08:50,480 --> 00:08:52,720 SUSTAINABILITY OF EVIDENCE-BASED 250 00:08:52,720 --> 00:08:53,280 HEALTH INTERVENTIONS AND 251 00:08:53,280 --> 00:08:56,240 GUIDELINES. 252 00:08:56,240 --> 00:08:57,000 IMPLEMENTATION RESEARCH STUDIES 253 00:08:57,000 --> 00:08:58,960 SHOULD NOT ASSUME THAT EFFECTIVE 254 00:08:58,960 --> 00:09:00,760 INTERVENTIONS CAN BE INTEGRATE 255 00:09:00,760 --> 00:09:02,240 NEIGHBORHOOD A SERVICE SETTING 256 00:09:02,240 --> 00:09:04,960 WITHOUT ATTENTION TO THE LOCAL 257 00:09:04,960 --> 00:09:10,680 CONTEXT. 258 00:09:10,680 --> 00:09:14,720 THE PRAGMATIC AND IMPLEMENTATION 259 00:09:14,720 --> 00:09:16,040 MECHANISM IS CROSS DISCIPLINARY 260 00:09:16,040 --> 00:09:16,680 AND TRANS-NIH. 261 00:09:16,680 --> 00:09:18,120 IT IS NOT SPECIFIC TO THE HEAL 262 00:09:18,120 --> 00:09:20,640 INITIATIVE ALONE. 263 00:09:20,640 --> 00:09:22,600 THIS MECHANISM SUPPORTS A 264 00:09:22,600 --> 00:09:23,800 RESOURCE COORDINATING CENTER 265 00:09:23,800 --> 00:09:25,240 THAT LEVERAGES THE HEALTHCARE 266 00:09:25,240 --> 00:09:28,160 SYSTEM'S RESEARCH COLLABORATORY. 267 00:09:28,160 --> 00:09:29,520 ITS COLLABORATORY COORDINATING 268 00:09:29,520 --> 00:09:30,640 CENTER PROVIDES TECHNICAL 269 00:09:30,640 --> 00:09:33,640 EXPERTISE ON RESEARCH WITH 270 00:09:33,640 --> 00:09:35,320 HEALTHCARE SYSTEMS AND IS A 271 00:09:35,320 --> 00:09:36,360 CENTRAL RESOURCE FOR 272 00:09:36,360 --> 00:09:38,160 COLLABORATORY PRAGMATIC OR 273 00:09:38,160 --> 00:09:39,440 IMPLEMENTATION TRIALS. 274 00:09:39,440 --> 00:09:41,120 IT ASSISTS WITH BIOSTATISTICS 275 00:09:41,120 --> 00:09:42,640 AND STUDY DESIGN, ELECTRONIC 276 00:09:42,640 --> 00:09:45,880 HEALTH RECORDS, HEALTHCARE 277 00:09:45,880 --> 00:09:47,520 SYSTEM INTERACTIONS, 278 00:09:47,520 --> 00:09:48,280 PATIENT-CENTERED OUTCOMES AND 279 00:09:48,280 --> 00:09:50,080 ETHICS AND REGULATORY AFFAIRS. 280 00:09:50,080 --> 00:09:51,360 VERY IMPORTANTLY, THOUGH, IT 281 00:09:51,360 --> 00:09:53,040 DOES NOT PROVIDE DATA 282 00:09:53,040 --> 00:09:54,080 COORDINATION SUPPORT FOR 283 00:09:54,080 --> 00:09:59,800 INDIVIDUAL PROJECTS. 284 00:09:59,800 --> 00:10:01,880 SO SPEAKING SPECIFICALLY ABOUT 285 00:10:01,880 --> 00:10:04,160 THIS RFA, THE PRAGMATIC AND 286 00:10:04,160 --> 00:10:06,520 IMPLEMENTATION STUDIES FOR THE 287 00:10:06,520 --> 00:10:08,400 MANAGEMENT OF SICKLE CELL 288 00:10:08,400 --> 00:10:16,760 DISEASE PAIN, RFA 182-3001, THIS 289 00:10:16,760 --> 00:10:18,800 SUPPORTS MULTISITE EMBEDDED OR 290 00:10:18,800 --> 00:10:19,440 PRAGMATIC IMPLEMENTATION TRIALS 291 00:10:19,440 --> 00:10:21,240 TO PERFORM THE UPTAKE OF 292 00:10:21,240 --> 00:10:23,000 EVIDENCE-BASED PHARMACOLOGIC, 293 00:10:23,000 --> 00:10:24,280 NON-PHARMACOLOGIC AND/OR 294 00:10:24,280 --> 00:10:25,120 MULTICOMPONENT APPROACHES FOR 295 00:10:25,120 --> 00:10:27,800 ACUTE AND/OR CHRONIC SICKLE CELL 296 00:10:27,800 --> 00:10:29,320 PAIN MANAGEMENT. 297 00:10:29,320 --> 00:10:31,920 GRANTS ARE MILESTONE-DRIVEN 298 00:10:31,920 --> 00:10:32,720 PHASED COOPERATIVE AGREEMENTS. 299 00:10:32,720 --> 00:10:35,680 THIS MEANS THAT YOU ARE NOT ABLE 300 00:10:35,680 --> 00:10:36,800 TO MOVE TO THE SECOND PHASE OF 301 00:10:36,800 --> 00:10:38,720 THE STUDY UNLESS YOU HAVE 302 00:10:38,720 --> 00:10:40,480 SUCCESSFULLY MET ALL OF THE 303 00:10:40,480 --> 00:10:43,640 MILESTONES OF THE PREVIOUS 304 00:10:43,640 --> 00:10:44,600 PHASE. 305 00:10:44,600 --> 00:10:45,760 A SINGLE APPLICATION PROVIDES UP 306 00:10:45,760 --> 00:10:47,040 TO FIVE YEARS OF FUNDING. 307 00:10:47,040 --> 00:10:48,360 ONE TO TWO YEARS FOR THE 308 00:10:48,360 --> 00:10:50,440 PLANNING STAGE OR THE UG3 WITH 309 00:10:50,440 --> 00:10:52,400 DIRECT COST CAP OF $500,000 PER 310 00:10:52,400 --> 00:10:54,240 YEAR, AND TWO TO FOUR YEARS FOR 311 00:10:54,240 --> 00:10:56,880 THE STUDY CONDUCTION PHASE, OR 312 00:10:56,880 --> 00:11:00,640 THE UH3, WITH A DIRECT COST CAP 313 00:11:00,640 --> 00:11:03,240 OF $1 MILLION PER YEAR. 314 00:11:03,240 --> 00:11:04,200 APPLICATIONS MUST HAVE AT LEAST 315 00:11:04,200 --> 00:11:06,080 THREE PARTNERING HEALTHCARE 316 00:11:06,080 --> 00:11:09,040 SYSTEMS PER PROJECT UNLESS A 317 00:11:09,040 --> 00:11:11,000 STRONG JUSTIFICATION FOR FEWER 318 00:11:11,000 --> 00:11:12,200 IS PROVIDED, AND THEY SHOULD 319 00:11:12,200 --> 00:11:13,520 INCLUDE A DIVERSE PATIENT 320 00:11:13,520 --> 00:11:14,720 POPULATION THAT AAPPROXIMATES 321 00:11:14,720 --> 00:11:16,600 THE U.S. POPULATION OF PATIENTS 322 00:11:16,600 --> 00:11:17,680 WITH THE CONDITION BEING 323 00:11:17,680 --> 00:11:18,040 STUDIED. 324 00:11:18,040 --> 00:11:20,120 IN THIS CASE, SICKLE CELL 325 00:11:20,120 --> 00:11:25,400 DISEASE. 326 00:11:25,400 --> 00:11:28,400 NOW I'M GOING TO PASS THIS ON TO 327 00:11:28,400 --> 00:11:29,840 DR. ATKINSON WHO WILL DISCUSS 328 00:11:29,840 --> 00:11:34,480 THE SECOND RFA, AT-23-002. 329 00:11:34,480 --> 00:11:35,840 >>THANK YOU. 330 00:11:35,840 --> 00:11:39,200 SO THE NIH HEAL PAIN MANAGEMENT 331 00:11:39,200 --> 00:11:41,720 EFFECTIVENESS RESEARCH NETWORK 332 00:11:41,720 --> 00:11:43,360 IS -- THE GOAL OF THE PROGRAM IS 333 00:11:43,360 --> 00:11:44,880 TO SUPPORT CLINICAL TRIALS TO 334 00:11:44,880 --> 00:11:46,120 TEST THE EFFICACY OR 335 00:11:46,120 --> 00:11:47,880 EFFECTIVENESS OF INTERVENTIONS 336 00:11:47,880 --> 00:11:49,280 FOR PREVENTION OR MANAGEMENT OF 337 00:11:49,280 --> 00:11:51,240 PAIN WHILE REDUCING RELIANCE ON 338 00:11:51,240 --> 00:11:53,120 OPIOIDS. 339 00:11:53,120 --> 00:11:56,520 SPECIFIC TO THIS RFA, THE 340 00:11:56,520 --> 00:11:58,480 OVERALL GOAL IS TO INFORM 341 00:11:58,480 --> 00:12:00,240 CLINICIANS ABOUT THE EFFICACY OR 342 00:12:00,240 --> 00:12:01,320 EFFECTIVENESS OF INTERVENTIONS 343 00:12:01,320 --> 00:12:04,360 SUCH AS COORDINATED, 344 00:12:04,360 --> 00:12:06,040 MULTIDISCIPLINARY MANAGEMENT 345 00:12:06,040 --> 00:12:09,280 STRATEGIES THAT REDUCE ACUTE 346 00:12:09,280 --> 00:12:10,400 AND/OR CHRONIC SICKLE CELL 347 00:12:10,400 --> 00:12:11,480 DISEASE PAIN AND THAT CONTINUE 348 00:12:11,480 --> 00:12:15,000 TO PROVIDE ACCESS TO OPIOID PAIN 349 00:12:15,000 --> 00:12:16,320 MANAGEMENT AS NEEDED. 350 00:12:16,320 --> 00:12:18,600 CLINICAL TRIALS WILL BE 351 00:12:18,600 --> 00:12:19,360 CONDUCTED WITHIN THE 352 00:12:19,360 --> 00:12:21,360 INFRASTRUCTURE OF THE HEAL PAIN 353 00:12:21,360 --> 00:12:22,760 MANAGEMENT EFFECTIVENESS 354 00:12:22,760 --> 00:12:24,960 RESEARCH NETWORK, WHICH WE CALL 355 00:12:24,960 --> 00:12:27,360 HEAL ERN, WHICH WAS ESTABLISHED 356 00:12:27,360 --> 00:12:30,200 THROUGH EXISTING INFRASTRUCTURE 357 00:12:30,200 --> 00:12:32,800 IN THE NCATS TRIAL INNOVATION 358 00:12:32,800 --> 00:12:34,120 NETWORK, AND YOU CAN LEARN MORE 359 00:12:34,120 --> 00:12:37,960 ABOUT THE NETWORK BY GOING TO 360 00:12:37,960 --> 00:12:40,880 THAT URL LINK IN THIS SLIDE. 361 00:12:40,880 --> 00:12:42,760 NOW THIS FOA CANNOT BE USED FOR 362 00:12:42,760 --> 00:12:43,960 APPLICATIONS THAT PROPOSE 363 00:12:43,960 --> 00:12:46,360 TESTING OF INTERVENTIONS TO 364 00:12:46,360 --> 00:12:48,800 ESTABLISH INITIAL EFFICACY OF 365 00:12:48,800 --> 00:12:51,400 DRUGS, DEVICES OR BIOLOGICS FOR 366 00:12:51,400 --> 00:12:56,240 APPROVAL BY THE FOOD AND DRUG 367 00:12:56,240 --> 00:12:56,640 ADMINISTRATION. 368 00:12:56,640 --> 00:12:59,200 SO TRIALS WILL BE IMPLEMENTED AT 369 00:12:59,200 --> 00:13:02,680 THE CTSA PROGRAM HUB, WHICH ARE 370 00:13:02,680 --> 00:13:05,520 THE CLINICAL AND TRANSLATIONAL 371 00:13:05,520 --> 00:13:09,200 SCIENCE AWARD PUBS, THERE ARE 60 372 00:13:09,200 --> 00:13:10,240 ACROSS THE UNITED STATES, BUT 373 00:13:10,240 --> 00:13:11,840 WITHIN EACH HUB, YOU MAY HAVE 374 00:13:11,840 --> 00:13:12,720 MULTIPLE CLINICAL SITES AT 375 00:13:12,720 --> 00:13:14,080 DIFFERENT INSTITUTIONS THAT ARE 376 00:13:14,080 --> 00:13:17,200 AFFILIATES. 377 00:13:17,200 --> 00:13:18,000 AND PRINCIPAL INVESTIGATORS ARE 378 00:13:18,000 --> 00:13:20,840 FREE TO CHOOSE ANY OTHER 379 00:13:20,840 --> 00:13:22,240 CLINICAL SITE THAT THEY WISH TO 380 00:13:22,240 --> 00:13:24,720 INCLUDE IN THEIR STUDY TEAM. 381 00:13:24,720 --> 00:13:28,520 AWARDS WILL BE MADE AS A 382 00:13:28,520 --> 00:13:30,360 MILESTONE-DRIVEN PLANNING PHASE, 383 00:13:30,360 --> 00:13:32,320 JUST LIKE WITH THE PRISSMM 384 00:13:32,320 --> 00:13:34,280 APPLICATIONS FOR ONE OR TWO 385 00:13:34,280 --> 00:13:36,600 YEARS, WITH THE POSSIBILITY 386 00:13:36,600 --> 00:13:39,840 TRANSITION TO A CLINICAL TRIAL 387 00:13:39,840 --> 00:13:42,240 CONDUCT PHASE FOR UP TO FOUR 388 00:13:42,240 --> 00:13:47,960 ADDITIONAL YEARS. 389 00:13:47,960 --> 00:13:49,920 ONLY UG3 PROJECTS WITH A PLANNED 390 00:13:49,920 --> 00:13:51,880 VANGUARD PILOT STUDY MAY REQUEST 391 00:13:51,880 --> 00:13:53,040 TWO YEARS FOR THE PLANNING PHASE 392 00:13:53,040 --> 00:13:56,560 WITH UP TO THREE YEARS FOR THE 393 00:13:56,560 --> 00:13:57,560 IMPLEMENTATION PHASE. 394 00:13:57,560 --> 00:14:01,120 ALL OTHER PROJECTS MAY REQUEST 395 00:14:01,120 --> 00:14:02,640 ONE YEAR FOR THE UG3 PHASE WITH 396 00:14:02,640 --> 00:14:04,920 UP TO FOUR YEARS FOR THE UH3 397 00:14:04,920 --> 00:14:06,880 PHASE BUT THE TOTAL AWARD 398 00:14:06,880 --> 00:14:08,120 DURATION CANNOT EXCEED FIVE 399 00:14:08,120 --> 00:14:08,320 YEARS. 400 00:14:08,320 --> 00:14:15,960 JUST LIKE WITH THE OTHER PRISM 401 00:14:15,960 --> 00:14:19,240 FOA, PROJECTS THAT MEET THE 402 00:14:19,240 --> 00:14:20,440 SCIENTIFIC MILESTONES AND 403 00:14:20,440 --> 00:14:21,280 FEASIBILITY REQUIREMENTS WILL 404 00:14:21,280 --> 00:14:24,280 TRANSITION TO THE UH3 PHASE AND 405 00:14:24,280 --> 00:14:26,720 BOTH PHASES ARE INCLUDED AS ONE 406 00:14:26,720 --> 00:14:31,280 APPLICATION. 407 00:14:31,280 --> 00:14:32,240 NEXT SLIDE? 408 00:14:32,240 --> 00:14:33,400 OH. 409 00:14:33,400 --> 00:14:35,120 SO THE BUDGET IS A LITTLE MORE 410 00:14:35,120 --> 00:14:37,360 COMPLICATED THAN PRISSMM. 411 00:14:37,360 --> 00:14:39,480 THE TRIAL INNOVATION NETWORK 412 00:14:39,480 --> 00:14:41,920 WHICH IS PROVIDING A LOT OF 413 00:14:41,920 --> 00:14:43,080 INFRASTRUCTURE WILL PROVIDE 414 00:14:43,080 --> 00:14:46,320 THESE RESOURCES TO ALL AWARDEES. 415 00:14:46,320 --> 00:14:50,760 SINGLE IRB SERVICES FOR THE 416 00:14:50,760 --> 00:14:52,160 UNITED STATES SITES IF THE 417 00:14:52,160 --> 00:14:54,560 APPLICATION WISHES ASSISTANCE 418 00:14:54,560 --> 00:14:57,080 WITH THE EXECUTION OF A MASTER 419 00:14:57,080 --> 00:14:57,840 CLINICAL TRIAL AGREEMENT WITH 420 00:14:57,840 --> 00:14:58,920 THE U.S. CLINICAL SITE, 421 00:14:58,920 --> 00:15:00,120 DEVELOPING THE FINAL STUDY 422 00:15:00,120 --> 00:15:02,640 PROTOCOL WITH THE STUDY TEAM, 423 00:15:02,640 --> 00:15:03,640 FINALIZING RECRUITMENT AND 424 00:15:03,640 --> 00:15:05,080 RETENTION PLANS WITH 425 00:15:05,080 --> 00:15:07,400 INVESTIGATORS BEFORE TRIAL 426 00:15:07,400 --> 00:15:08,760 INITIATION, PROVIDING SUPPORT 427 00:15:08,760 --> 00:15:12,080 FOR STUDY DESIGN, THEY WILL DO 428 00:15:12,080 --> 00:15:15,000 THE FINAL STATISTICAL ANALYSES 429 00:15:15,000 --> 00:15:16,440 INDEPENDENTLY, AND HELP WITH 430 00:15:16,440 --> 00:15:17,760 INTERPRETATION OF RESULT FOR 431 00:15:17,760 --> 00:15:19,800 MANUSCRIPTS AND PUBLICATIONS. 432 00:15:19,800 --> 00:15:22,040 AND THEY DEVELOP THE ASSOCIATED 433 00:15:22,040 --> 00:15:23,240 TRIAL DOCUMENTS THAT YOU NEED 434 00:15:23,240 --> 00:15:26,040 FOR IMPLEMENTATION SUCH AS A 435 00:15:26,040 --> 00:15:28,040 MANUAL OF PROCEDURES. 436 00:15:28,040 --> 00:15:30,320 YOU DO NOT NEED LETTERS OF 437 00:15:30,320 --> 00:15:31,520 SUPPORT FROM THE TRIAL 438 00:15:31,520 --> 00:15:32,280 INNOVATION NETWORK FOR YOUR 439 00:15:32,280 --> 00:15:38,200 APPLICATION. 440 00:15:38,200 --> 00:15:42,560 THEY WILL ALSO PROVIDE TRAINING 441 00:15:42,560 --> 00:15:44,120 SUPPORT, DEVELOPING AND 442 00:15:44,120 --> 00:15:45,360 MAINTAINING THE DATA SYSTEM FOR 443 00:15:45,360 --> 00:15:47,280 DATA COLLECTION STORAGE AND 444 00:15:47,280 --> 00:15:50,560 ADVERSE EVENT REPORTING, 445 00:15:50,560 --> 00:15:51,800 PROVIDING RANDOMIZATION SUPPORT, 446 00:15:51,800 --> 00:15:53,000 PROVIDING SUPPORT FOR CLINICAL 447 00:15:53,000 --> 00:15:54,280 OPERATIONS AND MONITORING OF 448 00:15:54,280 --> 00:15:56,600 U.S. SITES, PROJECT MANAGEMENT 449 00:15:56,600 --> 00:15:59,360 AND TRIAL IMPLEMENTATION IN THE 450 00:15:59,360 --> 00:16:00,080 UNITED STATES. 451 00:16:00,080 --> 00:16:02,160 AND THIS INCLUDES FINDING 452 00:16:02,160 --> 00:16:03,280 ADDITIONAL SITES IF YOU NEED 453 00:16:03,280 --> 00:16:04,560 THEM, NOT ONLY DURING THE 454 00:16:04,560 --> 00:16:06,320 PLANNING PHASE BUT DURING 455 00:16:06,320 --> 00:16:12,000 IMPLEMENTATION PHASES TWO MEET 456 00:16:12,000 --> 00:16:12,400 ENROLLMENT GOALS. 457 00:16:12,400 --> 00:16:14,440 IN FACT, WE'RE CURRENTLY 458 00:16:14,440 --> 00:16:15,160 SUPPORTING FIVE TRIALS AND I 459 00:16:15,160 --> 00:16:16,040 THINK THREE OF THE FIVE HAVE 460 00:16:16,040 --> 00:16:18,440 GONE BACK TO FIND ADDITIONAL 461 00:16:18,440 --> 00:16:18,760 SITES. 462 00:16:18,760 --> 00:16:21,240 THEY WILL MANAGE THE DATA AND 463 00:16:21,240 --> 00:16:22,600 SAFETY MONITORING BOARDS AND 464 00:16:22,600 --> 00:16:23,720 PROVIDE LOGISTICS FOR 465 00:16:23,720 --> 00:16:25,880 FACE-TO-FACE MEETINGS. 466 00:16:25,880 --> 00:16:29,920 DO NOT INCLUDE MANAGEMENT COSTS 467 00:16:29,920 --> 00:16:37,160 IN YOUR INDIVIDUAL BUDGET. 468 00:16:37,160 --> 00:16:40,000 LIKE THE OTHER FOA, BUDGETS WILL 469 00:16:40,000 --> 00:16:47,680 NOT EXCEED MORE THAN $5 $500,00N 470 00:16:47,680 --> 00:16:51,040 DIRECT COSTS FOR THE UG3 YEARS 471 00:16:51,040 --> 00:16:52,920 AND $1 MILLION IN DIRECT COSTS 472 00:16:52,920 --> 00:16:56,840 FOR THE UH3 YEARS. 473 00:16:56,840 --> 00:17:00,240 STUDY COSTS FOR STUDY TEAM AND A 474 00:17:00,240 --> 00:17:01,360 TRIAL STATISTICIAN WHO WILL WORK 475 00:17:01,360 --> 00:17:03,000 WITH THE TIN STA TISHES SHOULD 476 00:17:03,000 --> 00:17:03,760 BE INCLUDED. 477 00:17:03,760 --> 00:17:05,600 COSTS TO CLINICAL SITES FOR 478 00:17:05,600 --> 00:17:07,120 ENROLLMENT AND EVALUATION OF 479 00:17:07,120 --> 00:17:08,480 PARTICIPANTS OR COSTS SUCH AS 480 00:17:08,480 --> 00:17:10,840 CORE LABORATORY COSTS, 481 00:17:10,840 --> 00:17:12,280 BIOSPECIMEN SHIPPING COST OR 482 00:17:12,280 --> 00:17:13,600 COST FOR ACQUIRING AND SHIPPING 483 00:17:13,600 --> 00:17:14,560 STUDY AGENTS SHOULD BE INCLUDED 484 00:17:14,560 --> 00:17:15,760 AS STUDY COSTS. 485 00:17:15,760 --> 00:17:16,960 COSTS AT THE CLINICAL SITES 486 00:17:16,960 --> 00:17:18,520 SHOULD BE BUDGETED ON A 487 00:17:18,520 --> 00:17:20,280 PER-SUBJECT OR PER-PROCEDURE 488 00:17:20,280 --> 00:17:20,680 BASIS. 489 00:17:20,680 --> 00:17:25,520 SPESPECIMENS COLLECTED BEYOND TE 490 00:17:25,520 --> 00:17:26,920 NEEDED WILL BE SHIPPED AND 491 00:17:26,920 --> 00:17:29,120 STORED IN THE NIH HEAL COMMON 492 00:17:29,120 --> 00:17:29,800 REPOSITORY. 493 00:17:29,800 --> 00:17:30,640 PLEASE INCLUDE COSTS FOR 494 00:17:30,640 --> 00:17:31,840 SHIPPING TO THE REPOSITORY. 495 00:17:31,840 --> 00:17:38,280 AND TRAVEL COSTS SHOULD INCLUDE 496 00:17:38,280 --> 00:17:40,920 ONE INVESTIGATOR TEAM TO ATTEND 497 00:17:40,920 --> 00:17:43,680 THE NIH HEAL MEETING AS WELL AS 498 00:17:43,680 --> 00:17:46,400 AN ANNUAL ONE-DAY, IN-PERSON ERN 499 00:17:46,400 --> 00:17:47,920 STUDY INVESTIGATOR MEETING. 500 00:17:47,920 --> 00:17:52,400 THIS IS JUST A TABLE I'VE 501 00:17:52,400 --> 00:17:53,520 INCLUDED, I'M NOT GOING TO GO 502 00:17:53,520 --> 00:17:54,800 OVER EVERYTHING, I'VE ALREADY 503 00:17:54,800 --> 00:17:56,360 INCLUDED IT, SO IT MAKES IT 504 00:17:56,360 --> 00:17:57,560 EASIER TO FIGURE OUT THE BUDGET 505 00:17:57,560 --> 00:18:05,040 FOR YOUR APPLICATION. 506 00:18:05,040 --> 00:18:06,280 OTHER FACTORS TO NOTE. 507 00:18:06,280 --> 00:18:08,040 IT'S EXPECTED THAT EACH TRIAL 508 00:18:08,040 --> 00:18:10,440 WILL BE OVERSEEN BY A DATA AND 509 00:18:10,440 --> 00:18:12,640 SAFETY MONITORING BOARD, WHICH 510 00:18:12,640 --> 00:18:15,080 THE TIN WILL SET UP AND MANAGE 511 00:18:15,080 --> 00:18:15,720 AND THEY'LL PROVIDE THE REPORTS 512 00:18:15,720 --> 00:18:17,680 FOR THE MEETINGS. 513 00:18:17,680 --> 00:18:19,760 PLEASE READ THE RFA CAREFULLY, 514 00:18:19,760 --> 00:18:21,520 INCLUDING REVIEW CRITERIA. 515 00:18:21,520 --> 00:18:22,920 AND NOTICE THE GOVERNANCE 516 00:18:22,920 --> 00:18:24,040 STRUCTURE THAT'S OUTLINED IN 517 00:18:24,040 --> 00:18:27,760 TERMS AND CONDITIONS. 518 00:18:27,760 --> 00:18:28,720 SO THAT'S IT FOR ME. 519 00:18:28,720 --> 00:18:37,800 I'M GOING TO TURN IT BACK TO DR. 520 00:18:37,800 --> 00:18:39,600 >>THANK YOU SO MUCH, 521 00:18:39,600 --> 00:18:40,000 DR. ATKINSON. 522 00:18:40,000 --> 00:18:40,880 SO WHICH FUNDING OPPORTUNITIES 523 00:18:40,880 --> 00:18:42,200 SHOULD YOU APPLY TO? 524 00:18:42,200 --> 00:18:43,400 YOU PROBABLY ALREADY HAVE SOME 525 00:18:43,400 --> 00:18:44,800 THOUGHTS IN YOUR MIND, BUT 526 00:18:44,800 --> 00:18:46,120 HOPEFULLY THIS TABLE AND 527 00:18:46,120 --> 00:18:48,320 DISCUSSION WILL HELP SOLIDIFY 528 00:18:48,320 --> 00:18:50,360 THAT FOR YOU. 529 00:18:50,360 --> 00:18:52,240 APPROPRIATE TYPES OF STUDIES 530 00:18:52,240 --> 00:18:58,360 SUPPORTED BY RFA AT23001 INCLUDE 531 00:18:58,360 --> 00:18:59,760 EMBEDDED PRAGMATIC TRIALS OR 532 00:18:59,760 --> 00:19:00,320 IMPLEMENTATION TRIALS OF 533 00:19:00,320 --> 00:19:01,200 EVIDENCE HIGH PRESSURE BASED 534 00:19:01,200 --> 00:19:02,320 INTERVENTIONS WITH ESTABLISHED 535 00:19:02,320 --> 00:19:03,720 EFFECTIVENESS. 536 00:19:03,720 --> 00:19:05,920 IT ALSO INCLUDES INTERVENTIONS 537 00:19:05,920 --> 00:19:07,000 EMBEDDED IN HEALTHCARE SYSTEMS 538 00:19:07,000 --> 00:19:10,000 IN REAL WORLD SETTINGS. 539 00:19:10,000 --> 00:19:10,840 PRAGMATIC TRIALS THAT COLLECT 540 00:19:10,840 --> 00:19:12,080 MOST OF THE REQUIRED RESEARCH 541 00:19:12,080 --> 00:19:15,080 DATA AS PART OF ROUTINE CLINICAL 542 00:19:15,080 --> 00:19:16,440 CAROL, DATA THAT WOULD BE 543 00:19:16,440 --> 00:19:18,720 OBTAINED PRIMARILY THROUGH 544 00:19:18,720 --> 00:19:20,360 ELECTRONIC HEALTH RECORDS. 545 00:19:20,360 --> 00:19:21,680 AND IMPLEMENTATION TRIALS THAT 546 00:19:21,680 --> 00:19:23,720 HAVE IMPLEMENTATION FOCUSED MAIN 547 00:19:23,720 --> 00:19:25,600 OUTCOMES, MOST LIKELY AT A 548 00:19:25,600 --> 00:19:26,720 SYSTEM OR INDIVIDUAL PROVIDER 549 00:19:26,720 --> 00:19:29,120 LEVEL. 550 00:19:29,120 --> 00:19:30,960 APPROPRIATE TYPES OF STUDIES FOR 551 00:19:30,960 --> 00:19:35,440 THE OTHER RFA, AT-23-002, 552 00:19:35,440 --> 00:19:37,960 INCLUDE EFFICACY OR 553 00:19:37,960 --> 00:19:38,720 EFFECTIVENESS RESEARCH TRIALS. 554 00:19:38,720 --> 00:19:41,240 IN THIS CASE, MOST OF THE 555 00:19:41,240 --> 00:19:42,640 STUDIES WILL RANDOMIZE 556 00:19:42,640 --> 00:19:44,320 INDIVIDUAL PARTICIPANTS, COLLECT 557 00:19:44,320 --> 00:19:45,400 DATA POINTS FOR RESEARCH 558 00:19:45,400 --> 00:19:46,920 DIRECTLY FROM PARTICIPANTS, AND 559 00:19:46,920 --> 00:19:48,240 DELIVER AN INTERVENTION IN A 560 00:19:48,240 --> 00:19:53,920 STANDARDIZED FASHION. 561 00:19:53,920 --> 00:19:59,280 IN TERMS OF INFRASTRUCTURE, RFA 562 00:19:59,280 --> 00:19:59,920 AT23001 TRIALS ARE CONDUCTED 563 00:19:59,920 --> 00:20:00,720 WITHIN THE INFRASTRUCTURE OF THE 564 00:20:00,720 --> 00:20:06,400 HEAL INITIATIVE COORDINATING 565 00:20:06,400 --> 00:20:07,280 CENTER. 566 00:20:07,280 --> 00:20:10,560 AWARDEES WORK WITH THE PRISM 567 00:20:10,560 --> 00:20:12,160 PRAGMATIC TRIALS COLLABORATORY 568 00:20:12,160 --> 00:20:13,280 COORDINATING CENTER TO PLAN AND 569 00:20:13,280 --> 00:20:14,720 REFINE THE TRIBAL IN PARTNERSHIP 570 00:20:14,720 --> 00:20:17,800 WITH THE HEALTHCARE SYSTEMS N 571 00:20:17,800 --> 00:20:20,360 CONTRAST, RFA AT23002, CLINICAL 572 00:20:20,360 --> 00:20:21,600 TRIALS ARE CONDUCTED WITHIN THE 573 00:20:21,600 --> 00:20:24,120 INFRASTRUCTURE OF THE HEAL ERN, 574 00:20:24,120 --> 00:20:25,840 AND AWARDEES WORK WITH THE 575 00:20:25,840 --> 00:20:27,400 NATIONAL CENTER FOR ADVANCING 576 00:20:27,400 --> 00:20:28,600 TRANSLATIONAL SCIENCES TRIAL 577 00:20:28,600 --> 00:20:33,120 INOINNOVATION NETWORK FOR CLINI, 578 00:20:33,120 --> 00:20:34,280 BIOSTATISTICAL AND RECRUITMENT 579 00:20:34,280 --> 00:20:36,480 SUPPORT. 580 00:20:36,480 --> 00:20:37,680 SO NOW HOPEFULLY YOU HAVE SOME 581 00:20:37,680 --> 00:20:38,880 IDEAS IN YOUR MIND ABOUT WHICH 582 00:20:38,880 --> 00:20:40,960 ONE YOU'RE GOING TO APPLY FOR. 583 00:20:40,960 --> 00:20:45,400 I'M GOING TO PASS THIS ON TO GO 584 00:20:45,400 --> 00:20:46,640 OVER THE APPLICATION REVIEW 585 00:20:46,640 --> 00:20:48,640 PROCESS. 586 00:20:48,640 --> 00:20:52,680 >>DR. NANESCU, BEFORE YOU 587 00:20:52,680 --> 00:20:53,840 START, I WANT TO REMIND THE 588 00:20:53,840 --> 00:20:55,200 AUDIENCE YOU CAN SUBMIT YOUR 589 00:20:55,200 --> 00:20:56,480 QUESTIONS AT ANY TIME DURING THE 590 00:20:56,480 --> 00:20:58,880 PRESENTATIONS SO THAT WE CAN 591 00:20:58,880 --> 00:21:00,440 DELVE RIGHT INTO THEM WHEN THE 592 00:21:00,440 --> 00:21:00,960 PRESENTATIONS END. 593 00:21:00,960 --> 00:21:01,880 SO WE'D APPRECIATE THAT VERY 594 00:21:01,880 --> 00:21:06,680 MUCH. 595 00:21:06,680 --> 00:21:08,200 >>THANK YOU SO MUCH FOR YOUR 596 00:21:08,200 --> 00:21:09,720 ATTENTION SO FAR TO THIS 597 00:21:09,720 --> 00:21:13,760 WEBINAR, AND THANK YOU FOR 598 00:21:13,760 --> 00:21:14,640 PRESENTING THE PROGRAM 599 00:21:14,640 --> 00:21:15,080 PERSPECTIVE. 600 00:21:15,080 --> 00:21:16,600 WE WILL NOW GO THROUGH THE 601 00:21:16,600 --> 00:21:18,560 REVIEW PERSPECTIVE. 602 00:21:18,560 --> 00:21:20,360 THE FACTORS THAT IMPACT THE 603 00:21:20,360 --> 00:21:22,000 REVIEW OF APPLICATIONS ARE 604 00:21:22,000 --> 00:21:25,800 RESPONSIVENESS, COMPLIANCE, AND 605 00:21:25,800 --> 00:21:26,240 COMPLETENESS. 606 00:21:26,240 --> 00:21:28,000 IF NOT FOLLOWED COULD RESULT IN 607 00:21:28,000 --> 00:21:29,520 YOUR APPLICATION BEING WITHDRAWN 608 00:21:29,520 --> 00:21:31,480 AND I'LL COVER THIS IN THE NEXT 609 00:21:31,480 --> 00:21:32,680 FEW SLIDES SO YOU CAN MAKE SURE 610 00:21:32,680 --> 00:21:34,880 THIS DOESN'T HAPPEN. 611 00:21:34,880 --> 00:21:38,800 THE REVIEW CRITERIA AND THE 612 00:21:38,800 --> 00:21:41,240 REVIEW PANEL COMPOSITION -- WE 613 00:21:41,240 --> 00:21:45,120 WILL ALSO HAVE -- TIMELINE 614 00:21:45,120 --> 00:21:46,120 TOWARDS THE END OF MY 615 00:21:46,120 --> 00:21:49,440 PRESENTATION. 616 00:21:49,440 --> 00:21:51,800 THIS IS A REMINDER TO PLEASE PAY 617 00:21:51,800 --> 00:21:53,240 ATTENTION TO RESPONSIVENESS 618 00:21:53,240 --> 00:21:56,880 CRITERIA SINCE BOTH STATE 619 00:21:56,880 --> 00:21:58,200 APPLICATIONS THAT ARE 620 00:21:58,200 --> 00:21:59,800 NONRESPONSIVE WILL NOT MOVE 621 00:21:59,800 --> 00:22:00,600 FORWARD TO REVIEW. 622 00:22:00,600 --> 00:22:03,240 YOU CAN SEE EXAMPLES THAT ARE 623 00:22:03,240 --> 00:22:04,640 NOT RESPONSIVE IN THE RFAs OP 624 00:22:04,640 --> 00:22:05,480 THIS SLIDE. 625 00:22:05,480 --> 00:22:07,680 WHILE THE FINAL DECISION ON 626 00:22:07,680 --> 00:22:08,680 RESPONSIVENESS IS MADE BY 627 00:22:08,680 --> 00:22:11,400 PROGRAM STAFF IN COLLABORATION 628 00:22:11,400 --> 00:22:12,720 WITH -- STAFF, IN ORDER TO MAKE 629 00:22:12,720 --> 00:22:17,520 SURE THAT YOUR APPLICATION IS 630 00:22:17,520 --> 00:22:18,640 RESPONSIVE, PLEASE PAY CRITICAL 631 00:22:18,640 --> 00:22:20,520 ATTENTION TO ALL STATEMENTS LIKE 632 00:22:20,520 --> 00:22:24,720 MUST, REQUIRE, NEED, AND 633 00:22:24,720 --> 00:22:25,320 NONRESPONSIVE. 634 00:22:25,320 --> 00:22:27,040 YOU CAN SEE EXAMPLES HERE AS 635 00:22:27,040 --> 00:22:27,360 WELL. 636 00:22:27,360 --> 00:22:28,720 YOU CAN SEE IN THESE EXAMPLES 637 00:22:28,720 --> 00:22:31,760 THAT BOTH RFAs HAVE HEAL 638 00:22:31,760 --> 00:22:34,160 CLINICAL PAIN CORE COMMON DATA 639 00:22:34,160 --> 00:22:34,920 ELEMENTS REQUIREMENTS. 640 00:22:34,920 --> 00:22:37,240 BOTH RFAs ALSO HAVE SLIGHTLY 641 00:22:37,240 --> 00:22:42,240 DIFFERENT RESPONSIVENESS 642 00:22:42,240 --> 00:22:42,680 REQUIREMENTS. 643 00:22:42,680 --> 00:22:47,920 THE BUDGET AND DURATION FOR THE 644 00:22:47,920 --> 00:22:49,120 UG3 WERE COVERED PREVIOUSLY. 645 00:22:49,120 --> 00:22:50,480 I WILL DRAW YOUR ATTENTION THIS 646 00:22:50,480 --> 00:22:51,920 SLIDE IS ON TRAVEL BUDGET 647 00:22:51,920 --> 00:22:53,920 REQUIREMENTS. 648 00:22:53,920 --> 00:22:55,520 THOSE RFAs REQUIRE FOR 649 00:22:55,520 --> 00:22:57,480 ALLOCATING BUDGET FOR TRAVEL FOR 650 00:22:57,480 --> 00:22:59,400 PRINCIPAL INVESTIGATORS TO 651 00:22:59,400 --> 00:23:00,760 ATTEND THE INVESTIGATORS' 652 00:23:00,760 --> 00:23:02,800 MEETING IN WASHINGTON, D.C. 653 00:23:02,800 --> 00:23:04,160 SINCE THE AWARDED APPLICATIONS 654 00:23:04,160 --> 00:23:08,480 FROM THE RFA AT-23-001 WILL BE 655 00:23:08,480 --> 00:23:11,360 CONDUCTED WITH INFRASTRUCTURE OF 656 00:23:11,360 --> 00:23:12,800 PRISM AND WILL ALSO WORK WITH 657 00:23:12,800 --> 00:23:17,600 THE HEALTHCARE SYSTEM'S RESEARCH 658 00:23:17,600 --> 00:23:18,280 COLLABORATORY CENTER, PRINCIPAL 659 00:23:18,280 --> 00:23:19,080 INVESTIGATORS FOR THESE 660 00:23:19,080 --> 00:23:20,640 APPLICATIONS MUST ALSO BUDGET TO 661 00:23:20,640 --> 00:23:31,040 ATTEND THE PRISM CLINIC. 662 00:23:31,440 --> 00:23:33,360 I WILL REMIND YOU THAT FOREIGN 663 00:23:33,360 --> 00:23:35,280 INSTITUTIONS ARE NOT ELIGIBLE TO 664 00:23:35,280 --> 00:23:40,560 APPLY BUT FOREIGN COMPONENTS ARE 665 00:23:40,560 --> 00:23:41,240 ALLOWED. 666 00:23:41,240 --> 00:23:47,880 LIMITATIONS FOR THE RFA 667 00:23:47,880 --> 00:23:49,120 AT-23-001, THE RESEARCH STRATEGY 668 00:23:49,120 --> 00:23:54,120 SECTION IS LIMITED TO 30 PAGES. 669 00:23:54,120 --> 00:23:55,440 PLEASE KEEP IN MIND, HOWEVER, 670 00:23:55,440 --> 00:23:57,400 THAT BOTH RFAs HAVE THE SAME 671 00:23:57,400 --> 00:23:59,360 REQUIREMENT FOR ONLY ONE PAGE 672 00:23:59,360 --> 00:24:00,920 FOR THE SPECIFIC AIMS FOR BOTH 673 00:24:00,920 --> 00:24:02,960 PHASES TOGETHER. 674 00:24:02,960 --> 00:24:05,280 THERE IS ALSO A REQUIREMENT FOR 675 00:24:05,280 --> 00:24:07,360 THE MINIMUM LEVEL OF EFFORT FROM 676 00:24:07,360 --> 00:24:08,800 THE PRINCIPAL INVESTIGATOR OR 677 00:24:08,800 --> 00:24:11,200 FOR MULTIPLE PRINCIPAL 678 00:24:11,200 --> 00:24:13,600 INVESTIGATORS ON THE RFA 679 00:24:13,600 --> 00:24:17,520 AT-23-001, FOR A COMBINED LEVEL 680 00:24:17,520 --> 00:24:24,960 OF EFFORT MINIMUM OF 20% 681 00:24:24,960 --> 00:24:25,600 ANNUALLY. 682 00:24:25,600 --> 00:24:27,800 PLEASE KEEP AN EYE ON THE NIH 683 00:24:27,800 --> 00:24:32,080 COVID-19 FLEXIBILITIES AND -- 684 00:24:32,080 --> 00:24:34,560 THE APPLICATIONS -- THE CURRENT 685 00:24:34,560 --> 00:24:36,760 POLICY ON COVID-19 FLEXIBILITIES 686 00:24:36,760 --> 00:24:39,600 FOR APPLICATIONS DUE WHEN 687 00:24:39,600 --> 00:24:41,040 JANUARY COMES AROUND WHICH HAS 688 00:24:41,040 --> 00:24:42,240 NOT BEEN EXTENDED YET BUT IT 689 00:24:42,240 --> 00:24:47,160 COULD BE FOR THE MAY COUNCIL. 690 00:24:47,160 --> 00:24:51,560 ONE PAGE UPDATE, TYPICAL 691 00:24:51,560 --> 00:24:57,320 MATERIAL SUCH AS USE OF AN 692 00:24:57,320 --> 00:24:58,960 ARTICLE ALSO APPLY. 693 00:24:58,960 --> 00:25:01,360 THE RFAs ALLOW FOR MATERIAL 694 00:25:01,360 --> 00:25:03,760 FOR AN UPDATED CLINICAL TRIAL 695 00:25:03,760 --> 00:25:09,600 EXPERIENCE TABLE FOR THE RFA 696 00:25:09,600 --> 00:25:11,240 001, CLINICAL EXPERIENCE TABLE 697 00:25:11,240 --> 00:25:13,640 FOR CLINICAL TRIALS, AND BOTH 698 00:25:13,640 --> 00:25:15,200 RFAs ALLOW FOR AN UPDATED 699 00:25:15,200 --> 00:25:17,920 MILESTONE PLAN. 700 00:25:17,920 --> 00:25:20,640 PLEASE REMEMBER THAT ALL 701 00:25:20,640 --> 00:25:22,600 MATERIALS SHOULD BE SUBMITTED 30 702 00:25:22,600 --> 00:25:32,240 DAYS BEFORE THE MEETING DATE. 703 00:25:32,240 --> 00:25:33,680 IN ORDER FOR AN APPLICATION TO 704 00:25:33,680 --> 00:25:36,280 BE COMPLETE IT NEEDS AT LEAST 705 00:25:36,280 --> 00:25:39,240 ONE HUMAN SUBJECTS STUDY RECORD 706 00:25:39,240 --> 00:25:41,640 IF HUMAN SUBJECTS ARE INVOLVED. 707 00:25:41,640 --> 00:25:45,880 THE RFA 001 STATES -- PROPOSED 708 00:25:45,880 --> 00:25:47,920 FOR EACH CLINICAL TRIAL SO IF 709 00:25:47,920 --> 00:25:52,600 BOTH THE UG3 PHASE AND -- HAVE 710 00:25:52,600 --> 00:25:53,560 CLINICAL TRIALS PROPOSED THE 711 00:25:53,560 --> 00:25:54,760 RECORDS SHOW -- FOR EACH OF THE 712 00:25:54,760 --> 00:25:56,640 PHASES. 713 00:25:56,640 --> 00:25:58,160 IF THE APPLICATION SUBMITTED TO 714 00:25:58,160 --> 00:26:00,040 THE RFA WITH A CLINICAL TRIAL 715 00:26:00,040 --> 00:26:02,280 OPTION IS A CLINICAL TRIAL, THEN 716 00:26:02,280 --> 00:26:04,280 THE REQUIRED CLINICAL TRIAL 717 00:26:04,280 --> 00:26:05,880 ATTACHMENTS ARE THE CLINICAL 718 00:26:05,880 --> 00:26:06,800 EXPERIENCE TABLE AND THE 719 00:26:06,800 --> 00:26:10,160 MILESTONES PLAN. 720 00:26:10,160 --> 00:26:16,280 SINCE THE RFA AT23002 IS A 721 00:26:16,280 --> 00:26:17,960 CLINICAL TRIAL -- THE CLINICAL 722 00:26:17,960 --> 00:26:18,720 TRIAL ATTACHMENTS MUST BE 723 00:26:18,720 --> 00:26:20,560 INCLUDED ARE THE SCHEDULE OF 724 00:26:20,560 --> 00:26:24,520 EVENTS AND MILESTONES PLAN. 725 00:26:24,520 --> 00:26:28,240 IN ORDER FOR APPLICATION TO BE 726 00:26:28,240 --> 00:26:30,000 COMPLETE AND TO COMPLY WITH THE 727 00:26:30,000 --> 00:26:31,400 HEAL SHARING REQUIREMENTS, ALL 728 00:26:31,400 --> 00:26:33,040 APPLICATIONS FOR BOTH RFAs 729 00:26:33,040 --> 00:26:37,760 MUST INCLUDE THE DATA MANAGEMENT 730 00:26:37,760 --> 00:26:39,080 AND SHARING PLAN HOW THE DATA 731 00:26:39,080 --> 00:26:41,680 WILL BE MANAGED AND SHARED. 732 00:26:41,680 --> 00:26:45,920 THE RFA AT23001 ALSO REQUIRES 733 00:26:45,920 --> 00:26:47,600 LETTERS OF SUPPORT FROM EACH OF 734 00:26:47,600 --> 00:26:54,480 THE HEALTHCARE SYSTEM PARTNERS. 735 00:26:54,480 --> 00:26:58,320 BOTH RFAs -- AS WELL AS THE 736 00:26:58,320 --> 00:27:00,640 ADDITIONAL CRITERIA SUCH AS 737 00:27:00,640 --> 00:27:03,120 MILESTONES ARE ALL TAKEN INTO 738 00:27:03,120 --> 00:27:04,160 CONSIDERATION BY REVIEWERS WHEN 739 00:27:04,160 --> 00:27:05,440 THEY DETERMINE THE OVERALL 740 00:27:05,440 --> 00:27:05,840 IMPACT SCORE. 741 00:27:05,840 --> 00:27:08,600 SO PLEASE MAKE SURE THAT YOU 742 00:27:08,600 --> 00:27:10,040 WOULD ALSO TAKE THESE INTO 743 00:27:10,040 --> 00:27:10,680 ACCOUNT. 744 00:27:10,680 --> 00:27:15,920 ALL APPLICATIONS WILL RECEIVE 745 00:27:15,920 --> 00:27:17,280 ONE OVERALL IMPACT SCORE FOR 746 00:27:17,280 --> 00:27:20,400 BOTH PHASES TOGETHER. 747 00:27:20,400 --> 00:27:24,720 QUITE A BIT OF ADDITIONAL 748 00:27:24,720 --> 00:27:26,880 LANGUAGE HAS BEEN -- AN EXAMPLE 749 00:27:26,880 --> 00:27:29,200 OF THE LANGUAGE FOR SIGNIFICANCE 750 00:27:29,200 --> 00:27:30,600 IN DARK BLUE FOR BOTH OF THE 751 00:27:30,600 --> 00:27:31,880 RFAs HERE. 752 00:27:31,880 --> 00:27:36,840 REVIEWERS WILL BE ASKED TO 753 00:27:36,840 --> 00:27:38,440 ADDRESS LANGUAGE IF THE 754 00:27:38,440 --> 00:27:40,960 APPLICATION IS A CLINICAL TRIAL 755 00:27:40,960 --> 00:27:44,280 IN STANDARD LANGUAGE. 756 00:27:44,280 --> 00:27:46,880 -- WILL MATCH WHAT YOU AS 757 00:27:46,880 --> 00:27:47,960 APPLICANTS ARE ASKED TO ADDRESS 758 00:27:47,960 --> 00:27:49,880 IN THE APPLICATION BUT IT MAY BE 759 00:27:49,880 --> 00:27:51,040 HELPFUL FOR YOUR APPLICATIONS IF 760 00:27:51,040 --> 00:27:52,920 YOU TAKE A LOOK AT THE REVIEW 761 00:27:52,920 --> 00:27:54,440 CRITERIA AS WELL AND 762 00:27:54,440 --> 00:27:55,760 PARTICULARLY TO THIS ADDED 763 00:27:55,760 --> 00:27:59,280 LANGUAGE. 764 00:27:59,280 --> 00:28:01,000 THIS IS AN EXAMPLE OF HOW THE 765 00:28:01,000 --> 00:28:05,200 ASPECTS THAT -- WILL MATCH WHAT 766 00:28:05,200 --> 00:28:07,160 APPLICANTS ARE ASKED TO ADDRESS 767 00:28:07,160 --> 00:28:07,800 IN THE APPLICATION. 768 00:28:07,800 --> 00:28:10,080 SO PLEASE MAKE SURE THAT YOU 769 00:28:10,080 --> 00:28:12,840 READ SECTION 4 OF THE RFA. 770 00:28:12,840 --> 00:28:17,360 SO FOR RFA AT23001, IF 771 00:28:17,360 --> 00:28:18,280 APPLICANTS WERE ADVISED IN THE 772 00:28:18,280 --> 00:28:19,600 RESEARCH PLAN TO PROVIDE 773 00:28:19,600 --> 00:28:21,920 SUFFICIENT RATIONALE FOR THE 774 00:28:21,920 --> 00:28:23,200 HEALTHCARE SYSTEM SELECTED, THIS 775 00:28:23,200 --> 00:28:28,240 WILL BE ADDRESSED IN THE 776 00:28:28,240 --> 00:28:29,200 ENVIRONMENT SECTION OF THE 777 00:28:29,200 --> 00:28:30,640 CRITIQUES. 778 00:28:30,640 --> 00:28:34,480 IF THE RFA-AT-23-002 ASKS FOR 779 00:28:34,480 --> 00:28:35,560 DISCUSSION OF HOW THE RESULTS OF 780 00:28:35,560 --> 00:28:37,960 THE TRIAL WILL INFORM THE 781 00:28:37,960 --> 00:28:39,280 GUIDELINES IN SECTION 4, THE 782 00:28:39,280 --> 00:28:40,680 REVIEWERS WOULD ALSO ADDRESS 783 00:28:40,680 --> 00:28:42,120 THIS IN THE ENVIRONMENT SECTION 784 00:28:42,120 --> 00:28:47,240 OF THEIR CRITIQUES. 785 00:28:47,240 --> 00:28:49,720 I WILL NOT GO OVER EACH OF THE 786 00:28:49,720 --> 00:28:51,560 NEW CRITERIA FOR THE RFAs, AND 787 00:28:51,560 --> 00:28:54,160 I WILL ONLY BRIEFLY ADDRESS 788 00:28:54,160 --> 00:28:54,800 MILESTONES. 789 00:28:54,800 --> 00:28:57,320 AS A REMINDER, MILESTONES DO 790 00:28:57,320 --> 00:29:00,840 ENFLEUNS THE OVERALL IMPACT 791 00:29:00,840 --> 00:29:03,880 SCORE, AND ADDITIONAL CRITERIA 792 00:29:03,880 --> 00:29:05,840 SPECIFIC TO BOTH OF THE RFAs. 793 00:29:05,840 --> 00:29:07,240 HEERY VIEWERS WILL ADDRESS THE 794 00:29:07,240 --> 00:29:13,840 MILESTONES ACTUA, ARE THEY CLEAY 795 00:29:13,840 --> 00:29:15,600 DEFINED, FEASIBLE, WELL 796 00:29:15,600 --> 00:29:16,880 DEVELOPED AND QUANTIFIABLE WITH 797 00:29:16,880 --> 00:29:19,520 REGARD TO THE GOALS OF THE 798 00:29:19,520 --> 00:29:20,280 APPLICATION. 799 00:29:20,280 --> 00:29:25,760 ARE ADEQUATE CRITERIA PROVIDED 800 00:29:25,760 --> 00:29:26,640 IN EACH PHASE? 801 00:29:26,640 --> 00:29:28,080 THE REVIEW OF THESE APPLICATIONS 802 00:29:28,080 --> 00:29:30,800 WILL TAKE PLACE AT NCCIH AND 803 00:29:30,800 --> 00:29:33,080 REVIEWERS WILL BE SELECTED BASED 804 00:29:33,080 --> 00:29:34,840 ON THE SPECIFIC AREA OF 805 00:29:34,840 --> 00:29:36,920 EXPERTISE IN THE TARGET AREAS 806 00:29:36,920 --> 00:29:39,200 FROM THE RFAs AND THE SCIENCE 807 00:29:39,200 --> 00:29:40,320 PROPOSED IN THE APPLICATIONS. 808 00:29:40,320 --> 00:29:43,200 SO PLEASE KEEP THIS IN MIND TO 809 00:29:43,200 --> 00:29:44,600 ADDRESS HOW YOUR APPLICATION 810 00:29:44,600 --> 00:29:46,760 WILL BE IMPACTFUL CONSIDERING 811 00:29:46,760 --> 00:29:51,680 THE GOALS OF THE RFA, AND SINCE 812 00:29:51,680 --> 00:29:55,080 REVIEWERS -- THEIR ASSESSMENT OF 813 00:29:55,080 --> 00:29:56,600 ADDITIONAL REVIEW LANGUAGE AND 814 00:29:56,600 --> 00:29:57,960 ADDITIONAL REVIEW CRITERIA 815 00:29:57,960 --> 00:30:05,040 SPECIFIC TO THE RFA. 816 00:30:05,040 --> 00:30:07,080 WE ENCOURAGE AND APPRECIATE IF 817 00:30:07,080 --> 00:30:08,640 YOU SUBMIT -- THIS ALLOWS US TO 818 00:30:08,640 --> 00:30:09,920 BETTER PREPARE FOR THE REVIEW OF 819 00:30:09,920 --> 00:30:11,800 THE APPLICATIONS. 820 00:30:11,800 --> 00:30:12,800 BUT THIS IS NOT REQUIRED. 821 00:30:12,800 --> 00:30:15,640 IF YOU WOULD LIKE TO SUBMIT A 822 00:30:15,640 --> 00:30:19,800 LETTER OF INTENT, PLEASE ADDRESS 823 00:30:19,800 --> 00:30:23,080 TO MARTINA SCHMIDT. 824 00:30:23,080 --> 00:30:24,560 HER EMAIL ADDRESS IS LISTED ON 825 00:30:24,560 --> 00:30:26,160 THE SLIDE AND THE APPLICATION 826 00:30:26,160 --> 00:30:27,880 FOR THE RFAs. 827 00:30:27,880 --> 00:30:29,440 THE APPLICATION IS DUE 828 00:30:29,440 --> 00:30:30,480 NOVEMBER 21ST AND SCIENTIFIC 829 00:30:30,480 --> 00:30:32,280 REVEUL AFTER THE APPLICATION DUE 830 00:30:32,280 --> 00:30:35,440 DATE DURING WHICH NIH WOULD 831 00:30:35,440 --> 00:30:36,840 CONSIDER ACCEPTING LATE 832 00:30:36,840 --> 00:30:37,520 APPLICATIONS. 833 00:30:37,520 --> 00:30:39,480 THE DECISION TO APPROVE LATE 834 00:30:39,480 --> 00:30:40,680 APPLICATIONS WITHIN THIS 835 00:30:40,680 --> 00:30:43,640 TWO-WEEK WINDOW WILL BE MADE 836 00:30:43,640 --> 00:30:46,600 BY -- FROM CSR DOES NOT DEPEND 837 00:30:46,600 --> 00:30:48,880 ON NCCIH AND COULD NOT BE GIVEN 838 00:30:48,880 --> 00:30:49,560 IN ADVANCE. 839 00:30:49,560 --> 00:30:51,000 AND WITH THIS, I WILL THANK YOU 840 00:30:51,000 --> 00:30:52,800 AGAIN FOR THE PATIENCE AND 841 00:30:52,800 --> 00:30:55,360 ATTENTION TO THE WEBINAR. 842 00:30:55,360 --> 00:30:57,200 I WILL HAND OVER THE MICROPHONE 843 00:30:57,200 --> 00:30:59,920 TO OUR MODERATOR FOR THE NEXT 844 00:30:59,920 --> 00:31:03,680 SEBTION OFSECTION OF THE WEBINA. 845 00:31:03,680 --> 00:31:05,080 >>THANK YOU, AND I ALSO WANT TO 846 00:31:05,080 --> 00:31:15,560 THANK OUR THREE SPEAKERS, DID 847 00:31:19,120 --> 00:31:25,200 SEKAI CHIDEYA, DR. ATKINSON, AND 848 00:31:25,200 --> 00:31:26,920 THESE ARE OUR PARTNERS THAT HAVE 849 00:31:26,920 --> 00:31:28,680 A VESTED INTEREST FROM THE 850 00:31:28,680 --> 00:31:30,760 STANDPOINT OF THEIR INSTITUTES, 851 00:31:30,760 --> 00:31:32,320 CENTER OR OFFICE OF SICKLE CELL 852 00:31:32,320 --> 00:31:34,280 DISEASE RESEARCH AND PAIN. 853 00:31:34,280 --> 00:31:35,880 FIRST BEFORE I INTRODUCE THEM, 854 00:31:35,880 --> 00:31:40,360 I'D LIKE TO INTRODUCE DR. WENDY 855 00:31:40,360 --> 00:31:42,120 WEBER, BRANCH CHIEF OF THE 856 00:31:42,120 --> 00:31:43,280 CLINICAL BRANCH AT THE NATIONAL 857 00:31:43,280 --> 00:31:46,600 CENTER FOR INTEGRATIVE MEDICINE, 858 00:31:46,600 --> 00:31:48,960 DR. WEBER, WELCOME. 859 00:31:48,960 --> 00:31:50,960 >>GOOD AFTERNOON, EVERYONE, OR 860 00:31:50,960 --> 00:31:51,760 GOOD MORNING DEPENDING ON WHERE 861 00:31:51,760 --> 00:31:53,520 YOU ARE. 862 00:31:53,520 --> 00:31:54,920 ANITA, ONCE YOU DO 863 00:31:54,920 --> 00:31:56,560 INTRODUCTIONS, WE CAN OPEN IT UP 864 00:31:56,560 --> 00:31:58,520 TO JUST A COUPLE OF -- IF ANYONE 865 00:31:58,520 --> 00:32:00,480 WANTS TO ADD ANY SORT OF 866 00:32:00,480 --> 00:32:01,480 CLARIFICATIONS OR ADD ANY 867 00:32:01,480 --> 00:32:02,320 ADDITIONAL COMMENTS, THAT WOULD 868 00:32:02,320 --> 00:32:02,640 BE GREAT. 869 00:32:02,640 --> 00:32:04,760 >>I THINK THAT'S GREAT. 870 00:32:04,760 --> 00:32:06,400 I DON'T HAVE A FORMAL 871 00:32:06,400 --> 00:32:07,720 INTRODUCTION. 872 00:32:07,720 --> 00:32:09,160 ONCE I CALL YOUR FIRST NAME, IF 873 00:32:09,160 --> 00:32:13,600 YOU CAN JUST INTRODUCE YOURSELF, 874 00:32:13,600 --> 00:32:14,720 YOUR IC AND IF YOU HAVE ANYTHING 875 00:32:14,720 --> 00:32:17,240 ELSE TO ADD TO YOUR AREA OF 876 00:32:17,240 --> 00:32:17,680 SPECIAL INTEREST. 877 00:32:17,680 --> 00:32:18,880 AND LET ME JUST START WITH 878 00:32:18,880 --> 00:32:21,600 KAREN. 879 00:32:21,600 --> 00:32:23,160 >>GOOD MORNING OR AFTERNOON. 880 00:32:23,160 --> 00:32:26,760 MY NAME IS KAREN KAYLE FROM THE 881 00:32:26,760 --> 00:32:27,560 NATIONAL INSTITUTE OF NURSING 882 00:32:27,560 --> 00:32:29,080 RESEARCH. 883 00:32:29,080 --> 00:32:32,160 >>NEXT UP IS SUSAN. 884 00:32:32,160 --> 00:32:33,440 >>HI. 885 00:32:33,440 --> 00:32:37,080 I AM SUE SHERRO FROM THE 886 00:32:37,080 --> 00:32:38,360 NATIONAL HEART, LUNG AND BLOOD 887 00:32:38,360 --> 00:32:39,800 INSTITUTE AND I'M IN THE CENTER 888 00:32:39,800 --> 00:32:41,320 FOR TRANSLATION RESEARCH AND 889 00:32:41,320 --> 00:32:47,480 IMPLEMENTATION SCIENCE THERE. 890 00:32:47,480 --> 00:32:49,520 >>ANITA, YOU NEED TO COME OFF 891 00:32:49,520 --> 00:32:50,080 MUTE, PLEASE. 892 00:32:50,080 --> 00:32:51,520 >>I'M SORRY. 893 00:32:51,520 --> 00:32:51,880 YOLANDA? 894 00:32:51,880 --> 00:32:52,800 THANK YOU. 895 00:32:52,800 --> 00:32:54,600 >>GOOD AFTERNOON, EVERYONE, AND 896 00:32:54,600 --> 00:32:57,920 THANK YOU FOR JOINING US. 897 00:32:57,920 --> 00:33:04,880 I AMYOLAN DAI AM FROM THE HEAL . 898 00:33:04,880 --> 00:33:05,240 >>THANK YOU. 899 00:33:05,240 --> 00:33:10,400 AND I HOPE I DON'T BUTCHER YOUR 900 00:33:10,400 --> 00:33:12,240 NAME, BUT PRISHKA? 901 00:33:12,240 --> 00:33:13,440 >>I'M AT THE NATIONAL INSTITUTE 902 00:33:13,440 --> 00:33:15,560 OF MINORITY HEALTH AND HEALTH 903 00:33:15,560 --> 00:33:18,400 DISPARITIES. 904 00:33:18,400 --> 00:33:21,520 >>YOU A. SO NEXT UP IS PHIL. 905 00:33:21,520 --> 00:33:29,760 >>THANK YOU. 906 00:33:29,760 --> 00:33:32,280 I'M WITH THE DIVISION OF BLOOD 907 00:33:32,280 --> 00:33:32,560 RESOURCES. 908 00:33:32,560 --> 00:33:34,360 >>THANK YOU VERY MUCH FOR THOSE 909 00:33:34,360 --> 00:33:35,040 BRIEF INTRODUCTIONS. 910 00:33:35,040 --> 00:33:37,520 WE HAVE A FORTRESS BEHIND US, SO 911 00:33:37,520 --> 00:33:39,200 YOU'VE HEARD EXCELLENT 912 00:33:39,200 --> 00:33:41,360 PRESENTATIONS THAT WERE WELL 913 00:33:41,360 --> 00:33:43,640 PREPARED BY NCATS AND NCCIH, SO 914 00:33:43,640 --> 00:33:45,240 WE ARE READY NOW TO ENTERTAIN 915 00:33:45,240 --> 00:33:48,040 YOUR QUESTIONS AND LOOK FORWARD 916 00:33:48,040 --> 00:33:48,560 TO THEM. 917 00:33:48,560 --> 00:33:50,440 LET ME JUST GET STARTED. 918 00:33:50,440 --> 00:33:52,520 FIRST QUESTION, WILL THE PDF 919 00:33:52,520 --> 00:33:54,280 SLIDES BE AVAILABLE AFTER THE 920 00:33:54,280 --> 00:33:56,760 PRESENTATION? 921 00:33:56,760 --> 00:33:58,080 WE CAN CERTAINLY MAKE THOSE 922 00:33:58,080 --> 00:33:59,840 AVAILABLE TO YOU, CAN'T WE, 923 00:33:59,840 --> 00:34:00,920 DR. WEBER? 924 00:34:00,920 --> 00:34:03,560 WE HAVE THE LIST OF PEOPLE WHO 925 00:34:03,560 --> 00:34:04,760 REGISTERED, BUT I ALSO WANT TO 926 00:34:04,760 --> 00:34:11,440 REMIND YOU THAT THE NIH -- IT IS 927 00:34:11,440 --> 00:34:13,400 AN NIH VIDEOCAST SO IT WILL BE 928 00:34:13,400 --> 00:34:14,400 ARCHIVED AND AVAILABLE FOR YOUR 929 00:34:14,400 --> 00:34:16,600 VIEWING UNDER PAST EVENTS IN 930 00:34:16,600 --> 00:34:17,640 PROBABLY ABOUT 24 HOURS. 931 00:34:17,640 --> 00:34:20,720 SO YOU CAN DO THE REPLAY. 932 00:34:20,720 --> 00:34:28,400 THE NEXT QUESTION IS, FOR RFA 933 00:34:28,400 --> 00:34:37,160 AT23002, IF THE CTSA10/HEAL ERN 934 00:34:37,160 --> 00:34:38,880 CAN HANDLE ALL DATA MANAGEMENT, 935 00:34:38,880 --> 00:34:40,320 HOW SHOULD WE FRAME THE DATA 936 00:34:40,320 --> 00:34:42,280 SHARING PLAN, FOR EXAMPLE, WHO 937 00:34:42,280 --> 00:34:48,640 DOES TIN/ERN DATA SHARING? 938 00:34:48,640 --> 00:34:52,240 >>SO THE DATA COORDINATING 939 00:34:52,240 --> 00:34:53,960 CENTER AT THE UNIVERSITY OF UTAH 940 00:34:53,960 --> 00:34:57,480 WILL HELP PREPARE THE SETS, 941 00:34:57,480 --> 00:34:59,640 AND -- BUT THE DATA OFFICIALLY 942 00:34:59,640 --> 00:35:01,760 BELONGS TO THE PRINCIPAL 943 00:35:01,760 --> 00:35:03,080 INVESTIGATOR OF THE GRANT, SO 944 00:35:03,080 --> 00:35:04,400 THEY HAVE TO STILL HAVE A PLAN 945 00:35:04,400 --> 00:35:07,360 FOR SHARING THE DATA. 946 00:35:07,360 --> 00:35:08,760 IT BECOMES A LITTLE TRICKY WHEN 947 00:35:08,760 --> 00:35:10,240 YOU HAVE CERTAIN POPULATIONS 948 00:35:10,240 --> 00:35:11,640 INVOLVED THAT MAY HAVE 949 00:35:11,640 --> 00:35:13,360 RESTRICTIONS ON DATA SHARING 950 00:35:13,360 --> 00:35:13,840 TOO. 951 00:35:13,840 --> 00:35:15,360 SO THOSE WOULD ALL NEED TO BE 952 00:35:15,360 --> 00:35:16,800 WORKED OUT BY THE PRINCIPAL 953 00:35:16,800 --> 00:35:19,400 INVESTIGATOR. 954 00:35:19,400 --> 00:35:21,040 >>THANK YOU. 955 00:35:21,040 --> 00:35:23,240 IF THE APPLICATION HAS MULTIPLE 956 00:35:23,240 --> 00:35:25,080 PRINCIPAL INVESTIGATORS, DOES 957 00:35:25,080 --> 00:35:26,840 EACH PRINCIPAL INVESTIGATOR HAVE 958 00:35:26,840 --> 00:35:32,680 TO CONTRIBUTE A 20% LEVEL OF 959 00:35:32,680 --> 00:35:32,880 EFFORT? 960 00:35:32,880 --> 00:35:34,200 >>I CAN ANSWER THIS QUESTION. 961 00:35:34,200 --> 00:35:36,720 AND SO, NO, THE REQUIREMENT IS 962 00:35:36,720 --> 00:35:41,120 FOR 20% COMBINED EFFORT. 963 00:35:41,120 --> 00:35:43,040 >>WHILE I HAVE YOU THERE, IS 964 00:35:43,040 --> 00:35:44,960 THE LETTER OF INTENT REQUIRED? 965 00:35:44,960 --> 00:35:46,760 >>ABSOLUTELY NOT. 966 00:35:46,760 --> 00:35:47,560 ABSOLUTELY NOT REQUIRED. 967 00:35:47,560 --> 00:35:53,320 BUT WE DO APPRECIATE ANY LETTER 968 00:35:53,320 --> 00:35:54,640 OF INTENT WITH AT MUCH 969 00:35:54,640 --> 00:35:55,320 INFORMATION AS YOU CAN. 970 00:35:55,320 --> 00:35:56,720 IT HELPS US PREPARE, BUT ONCE 971 00:35:56,720 --> 00:35:59,440 AGAIN, NO, ABC LIGHT NOT 972 00:35:59,440 --> 00:36:02,040 REQUIABSOLUTELY NOTREQUIRED. 973 00:36:02,040 --> 00:36:03,720 >>I LIKE TO SAY NOT REQUIRED 974 00:36:03,720 --> 00:36:05,360 BUT DESIRED. 975 00:36:05,360 --> 00:36:08,240 SO THE NEXT QUESTION, DOES EACH 976 00:36:08,240 --> 00:36:09,520 COINVESTIGATOR LISTED IN THE 977 00:36:09,520 --> 00:36:10,720 APPLICATION NEED TO SUBMIT A 978 00:36:10,720 --> 00:36:21,040 LETTER OF SUPPORT? 979 00:36:21,800 --> 00:36:25,720 >>SONIA, IF YOU WANT TO TAKE 980 00:36:25,720 --> 00:36:26,000 THAT ONE? 981 00:36:26,000 --> 00:36:27,800 >>THE QUESTION WAS FOR THE -- 982 00:36:27,800 --> 00:36:28,680 WHICH OF THE RFAs? 983 00:36:28,680 --> 00:36:30,000 I DON'T THINK I HEARD THE ENTIRE 984 00:36:30,000 --> 00:36:33,840 QUESTION. 985 00:36:33,840 --> 00:36:35,360 >>I THINK IT WAS FOR EITHER, DO 986 00:36:35,360 --> 00:36:36,560 THEY NEED LETTERS OF SUPPORT 987 00:36:36,560 --> 00:36:38,440 FROM EACH OF THE 988 00:36:38,440 --> 00:36:39,080 COINVESTIGATORS, I THINK WAS THE 989 00:36:39,080 --> 00:36:39,440 QUESTION. 990 00:36:39,440 --> 00:36:41,160 I THINK IT'S A GENERAL QUESTION 991 00:36:41,160 --> 00:36:44,240 ABOUT APPLICATION. 992 00:36:44,240 --> 00:36:48,040 >>NO. 993 00:36:48,040 --> 00:36:49,360 THE RFA-AT-23-001 REQUIRES 994 00:36:49,360 --> 00:36:50,680 LETTERS OF SUPPORT FROM EACH OF 995 00:36:50,680 --> 00:36:52,520 THE HEALTHCARE SYSTEM PARTNERS, 996 00:36:52,520 --> 00:36:53,840 BUT ONLY THAT RFA. 997 00:36:53,840 --> 00:36:55,280 AND IT'S JUST THE HEALTHCARE 998 00:36:55,280 --> 00:36:57,200 SYSTEM PARTNERS, NOT ALL THE 999 00:36:57,200 --> 00:36:58,000 INVESTIGATORS WOULD NEED TO 1000 00:36:58,000 --> 00:36:59,680 SUBMIT THAT AS A SUPPORT. 1001 00:36:59,680 --> 00:37:01,920 >>THANK YOU, SONIA. 1002 00:37:01,920 --> 00:37:04,640 THANKS FOR THE CLARIFICATION. 1003 00:37:04,640 --> 00:37:05,240 , 1004 00:37:05,240 --> 00:37:05,480 DR. WEBER. 1005 00:37:05,480 --> 00:37:09,400 >>ANITA, CAN I INSERT A 1006 00:37:09,400 --> 00:37:10,360 CLARIFICATION I WANTED TO MAKE 1007 00:37:10,360 --> 00:37:12,080 ABOUT A CHANGE WE MADE FROM 1008 00:37:12,080 --> 00:37:13,960 THIS -- FROM LAST YEAR'S RFA TO 1009 00:37:13,960 --> 00:37:17,560 THIS YEAR'S RFA, AND JANE AND 1010 00:37:17,560 --> 00:37:18,400 YOLANDA, YOU MIGHT WANT TO 1011 00:37:18,400 --> 00:37:19,920 COMMENT ON THIS AS WELL OR 1012 00:37:19,920 --> 00:37:21,320 OTHERS MAY WANT TO COMMENT ON 1013 00:37:21,320 --> 00:37:21,760 IT. 1014 00:37:21,760 --> 00:37:22,760 ONE OF THE BIG CHANGES THAT WE 1015 00:37:22,760 --> 00:37:25,280 MADE THIS YEAR WITH THE RFA IS 1016 00:37:25,280 --> 00:37:27,760 WE'RE ALLOWING UP TO TWO YEARS 1017 00:37:27,760 --> 00:37:31,000 IN THE UG3 PLANNING PHASE. 1018 00:37:31,000 --> 00:37:32,280 THE FULL TOTAL TIME OF THE AWARD 1019 00:37:32,280 --> 00:37:35,880 IS STILL UP TO FIVE YEARS, SO IF 1020 00:37:35,880 --> 00:37:37,520 YOU REQUEST TWO YEARS IN THAT 1021 00:37:37,520 --> 00:37:38,520 PLANNING PHASE, THAT MEANS YOU 1022 00:37:38,520 --> 00:37:39,840 ONLY HAVE THREE YEARS TO CONDUCT 1023 00:37:39,840 --> 00:37:41,880 THE TRIAL IN THE UH3 PHASE, SO 1024 00:37:41,880 --> 00:37:43,040 YOU HAVE TO SORT OF PLAN FOR 1025 00:37:43,040 --> 00:37:43,920 THAT. 1026 00:37:43,920 --> 00:37:46,480 BUT ONE OF THE THINGS WE 1027 00:37:46,480 --> 00:37:47,080 RECOGNIZE IS THAT THERE WAS A 1028 00:37:47,080 --> 00:37:49,720 NEED TO ALLOW FOR PILOT STUDIES 1029 00:37:49,720 --> 00:37:53,080 IN FIRST PHASE, AND THAT 1030 00:37:53,080 --> 00:37:54,960 SOMETIMES APPLICANTS OR MORE 1031 00:37:54,960 --> 00:37:57,160 IMPORTANTLY REVIEWERS WERE 1032 00:37:57,160 --> 00:37:59,120 LOOKING FOR PILOT DATA 1033 00:37:59,120 --> 00:37:59,960 SPECIFICALLY IN THE SICKLE CELL 1034 00:37:59,960 --> 00:38:01,920 PATIENT POPULATION, AND SOME OF 1035 00:38:01,920 --> 00:38:03,040 THE APPLICATIONS COMING IN 1036 00:38:03,040 --> 00:38:05,480 DIDN'T HAVE THAT PILOT DATA, AND 1037 00:38:05,480 --> 00:38:09,080 SO REVIEWERS HAD QUESTIONS ABOUT 1038 00:38:09,080 --> 00:38:10,720 SORT OF WHILE THERE MAY BE GREAT 1039 00:38:10,720 --> 00:38:11,960 DATA IN OTHER PAIN POPULATIONS, 1040 00:38:11,960 --> 00:38:13,360 THEY DIDN'T KNOW WHAT THE 1041 00:38:13,360 --> 00:38:15,880 ACCEPTABILITY AND UPTAKE WOULD 1042 00:38:15,880 --> 00:38:19,280 BE IN PATIENTS WHO HAD SICKLE 1043 00:38:19,280 --> 00:38:20,280 CELL DISEASE THAT HAD PAIN. 1044 00:38:20,280 --> 00:38:21,720 SO THAT'S WHY WE'VE ALLOWED TO 1045 00:38:21,720 --> 00:38:23,880 HAVE PILOT STUDIES HAPPEN IN THE 1046 00:38:23,880 --> 00:38:25,440 UG3 PORTION OF THE APPLICATION, 1047 00:38:25,440 --> 00:38:28,720 AND SO IT IS SOMETHING TO THINK 1048 00:38:28,720 --> 00:38:30,160 ABOUT IF YOU DON'T ALREADY HAVE 1049 00:38:30,160 --> 00:38:31,960 PILOT DATA OF THIS INTERVENTION 1050 00:38:31,960 --> 00:38:33,440 THAT YOU'RE LOOKING AT IN THE 1051 00:38:33,440 --> 00:38:35,200 PATIENT POPULATION WITH SICKLE 1052 00:38:35,200 --> 00:38:36,920 CELL, YOU MIGHT WANT TO STRONGLY 1053 00:38:36,920 --> 00:38:40,000 CONSIDER CONDUCTING A PILOT 1054 00:38:40,000 --> 00:38:41,840 STUDY IN THE UG3 PORTION TO JUST 1055 00:38:41,840 --> 00:38:43,640 DEMONSTRATE THAT YOU CAN GET 1056 00:38:43,640 --> 00:38:45,240 PARTICIPANTS TO DO THE 1057 00:38:45,240 --> 00:38:45,680 INTERVENTION. 1058 00:38:45,680 --> 00:38:47,440 I DON'T KNOW IF ANYBODY ELSE 1059 00:38:47,440 --> 00:38:51,280 WANTS TO ADD TO THAT IN TERMS OF 1060 00:38:51,280 --> 00:38:55,040 QUESTIONS. 1061 00:38:55,040 --> 00:39:00,600 >>ANYONE ELSE WANT TO ADD TON? 1062 00:39:00,600 --> 00:39:02,240 TO ADD ON? 1063 00:39:02,240 --> 00:39:03,960 IF SOMEONE HAS A 1064 00:39:03,960 --> 00:39:06,080 SUPPLEMENT-BASED THERAPEUTIC NOT 1065 00:39:06,080 --> 00:39:08,400 YET APPROVED BY THE FDA BUT 1066 00:39:08,400 --> 00:39:10,240 APPROVED OVERSEAS SUCH AS INDIA 1067 00:39:10,240 --> 00:39:12,320 OR AUSTRALIA, CAN THEY PUT 1068 00:39:12,320 --> 00:39:13,000 TOGETHER AN APPLICATION THAT 1069 00:39:13,000 --> 00:39:14,720 ONLY INCLUDES SITES IN THOSE 1070 00:39:14,720 --> 00:39:17,240 COUNTRIES WITH THE INTENT TO GET 1071 00:39:17,240 --> 00:39:19,320 APPROVAL FROM THE FDA DURING THE 1072 00:39:19,320 --> 00:39:27,520 TRIAL PERIOD? 1073 00:39:27,520 --> 00:39:31,920 GO TO FOR OUR RFA, THE ANSWER WE 1074 00:39:31,920 --> 00:39:32,120 NO. 1075 00:39:32,120 --> 00:39:37,760 >>AND I IMAGINE AND DR. W WEBER 1076 00:39:37,760 --> 00:39:39,800 PLEASE CHIME IN, BUT I IMAGINE 1077 00:39:39,800 --> 00:39:42,000 THE ANSWER WOULD ALSO BE NO FOR 1078 00:39:42,000 --> 00:39:43,840 THE PRAGMATIC TRIALS AND 1079 00:39:43,840 --> 00:39:46,920 IMPLEMENTATION STUDIES INTERVIEW 1080 00:39:46,920 --> 00:39:49,560 RFAs, BECAUSE AS IT 1081 00:39:49,560 --> 00:39:52,840 EMPHASIZED, IT IS LOOKING AT THE 1082 00:39:52,840 --> 00:39:54,840 IMPLEMENTATION OF ALREADY PROVEN 1083 00:39:54,840 --> 00:39:56,560 EVIDENCE-BASED INTERVENTIONS, 1084 00:39:56,560 --> 00:39:58,520 NOT INTERVENTIONS THAT ARE STILL 1085 00:39:58,520 --> 00:40:00,080 GOING THROUGH TRIALS IN THIS OR 1086 00:40:00,080 --> 00:40:04,040 OTHER COUNTRIES. 1087 00:40:04,040 --> 00:40:05,560 >>YEAH, I WOULD AGREE. 1088 00:40:05,560 --> 00:40:13,800 THETRIALS NEEDED TO GET FDA 1089 00:40:13,800 --> 00:40:15,200 APPROVAL FOR A NEW INCATION OR 1090 00:40:15,200 --> 00:40:19,120 FOR A NEW COMPOUND, AND WITH 1091 00:40:19,120 --> 00:40:21,640 FEDERAL FUNDING OF U.S. DOLLARS, 1092 00:40:21,640 --> 00:40:23,840 YOU WOULD ALREADY -- EVEN IF IT 1093 00:40:23,840 --> 00:40:25,920 WAS BEING DONE IN INTERNATIONAL 1094 00:40:25,920 --> 00:40:27,360 SITES, THERE WOULD STILL NEED TO 1095 00:40:27,360 --> 00:40:29,080 BE FDA REGULATORY OVERSIGHT IN 1096 00:40:29,080 --> 00:40:30,880 THE U.S., AND SO WE DON'T 1097 00:40:30,880 --> 00:40:31,960 ANTICIPATE THAT ANY OF THE 1098 00:40:31,960 --> 00:40:33,360 STUDIES FUNDED UNDER THESE 1099 00:40:33,360 --> 00:40:35,360 FUNDING MECHANISMS WOULD BE DONE 1100 00:40:35,360 --> 00:40:36,360 UNDER AN INVESTIGATIONAL NEW 1101 00:40:36,360 --> 00:40:36,920 DRUG APPLICATION. 1102 00:40:36,920 --> 00:40:38,920 DOES THAT SOUND RIGHT, JANE AND 1103 00:40:38,920 --> 00:40:39,120 YOLANDA? 1104 00:40:39,120 --> 00:40:42,080 >>YES. 1105 00:40:42,080 --> 00:40:45,360 BUT YOU CAN APPLY TO EPIC NET, 1106 00:40:45,360 --> 00:40:50,800 WHICH IS FOR APPROVAL OF NEW 1107 00:40:50,800 --> 00:40:52,680 COMPOUNDS, AND IT'S MAINLY PHASE 1108 00:40:52,680 --> 00:40:54,560 TWO THAT MIGHT BE AN APPROPRIATE 1109 00:40:54,560 --> 00:40:57,440 MECHANISM TO THINK ABOUT. 1110 00:40:57,440 --> 00:40:58,680 >>YOU CAN CHECK THE HEAL 1111 00:40:58,680 --> 00:40:59,800 WEBSITE FOR MORE INFORMATION 1112 00:40:59,800 --> 00:41:00,880 ABOUT EPIC NET. 1113 00:41:00,880 --> 00:41:03,440 >>YEAH. 1114 00:41:03,440 --> 00:41:06,200 GLO. 1115 00:41:06,200 --> 00:41:07,480 >>GOOD IDEA. 1116 00:41:07,480 --> 00:41:07,960 >>THANK YOU. 1117 00:41:07,960 --> 00:41:12,000 IS PILOT DATA COLLECTED ALLOWED 1118 00:41:12,000 --> 00:41:14,200 IN THE UG PHASE OF BOTH 1119 00:41:14,200 --> 00:41:17,160 MECHANISMS? 1120 00:41:17,160 --> 00:41:17,600 >>YES. 1121 00:41:17,600 --> 00:41:18,280 RIGHT, WENDY? 1122 00:41:18,280 --> 00:41:18,560 >>YEP. 1123 00:41:18,560 --> 00:41:19,360 >>OKAY. 1124 00:41:19,360 --> 00:41:25,480 >>WE ALLOWED IT IN BOTH. 1125 00:41:25,480 --> 00:41:27,680 I WILL SAY THAT WHILE PILOT DATA 1126 00:41:27,680 --> 00:41:30,080 IS ALLOWED, I WOULD SAY THAT A 1127 00:41:30,080 --> 00:41:32,920 BRAND NEW INTERVENTION PILOT 1128 00:41:32,920 --> 00:41:35,040 PROBABLY WOULD HAVE A TOUGH TIME 1129 00:41:35,040 --> 00:41:37,760 IN PEER REVIEW. 1130 00:41:37,760 --> 00:41:39,280 I THINK THE PRELIMINARY DATA 1131 00:41:39,280 --> 00:41:41,080 THAT SEEMED TO BE LACKING IN 1132 00:41:41,080 --> 00:41:44,000 PREVIOUS ROUNDS WAS REALLY 1133 00:41:44,000 --> 00:41:45,520 SPECIFICALLY IN THIS POPULATION, 1134 00:41:45,520 --> 00:41:48,160 THAT THERE'S A LOT OF OTHER DATA 1135 00:41:48,160 --> 00:41:49,520 ABOUT THE INTERVENTION AND MAYBE 1136 00:41:49,520 --> 00:41:51,400 EVEN SOME REALLY GREAT EFFICACY 1137 00:41:51,400 --> 00:41:55,400 DATA ABOUT PAIN MANAGEMENT WITH 1138 00:41:55,400 --> 00:41:57,520 SOME OF THE INTERVENTIONS BUT 1139 00:41:57,520 --> 00:41:59,600 MAYBE NOT AS MANY AS THEY'D LIKE 1140 00:41:59,600 --> 00:42:02,320 IN THE SICKLE CELL POPULATION 1141 00:42:02,320 --> 00:42:02,640 SPECIFICALLY. 1142 00:42:02,640 --> 00:42:04,840 >>PLEASE PAY ATTENTION TO 1143 00:42:04,840 --> 00:42:06,040 RESPONSIVENESS CRITERIA SINCE 1144 00:42:06,040 --> 00:42:09,680 THE RFA STATES STUDIES TO ASSIST 1145 00:42:09,680 --> 00:42:11,680 INITIAL FEASIBILITY OF THE 1146 00:42:11,680 --> 00:42:12,880 INTERVENTION ARE NOT RESPONSIVE. 1147 00:42:12,880 --> 00:42:14,600 SO JUST MAKE SURE THAT YOU DO 1148 00:42:14,600 --> 00:42:16,920 HAVE SOME DATA. 1149 00:42:16,920 --> 00:42:18,000 >>NEXT QUESTION. 1150 00:42:18,000 --> 00:42:21,760 IS THE UG3/UH3 INTENDED TO 1151 00:42:21,760 --> 00:42:31,560 SUPPORT WORK OF CLINICIANS OR 1152 00:42:31,560 --> 00:42:31,960 INTERVENTIONISTS? 1153 00:42:31,960 --> 00:42:33,520 >>THAT PROBABLY DEPENDS A 1154 00:42:33,520 --> 00:42:35,200 LITTLE BIT ON WHICH FOA WE'RE 1155 00:42:35,200 --> 00:42:38,240 TALKING ABOUT. 1156 00:42:38,240 --> 00:42:44,080 SO THE PRISSMM TO 001 RFA, IT 1157 00:42:44,080 --> 00:42:45,280 REALLY IS EXPECTED THAT THE 1158 00:42:45,280 --> 00:42:46,200 INTERVENTIONS WILL BE DELIVERED 1159 00:42:46,200 --> 00:42:52,320 AS PART OF HEALTHCARE DELIVERY 1160 00:42:52,320 --> 00:42:52,880 AND SO 1161 00:42:52,880 --> 00:42:54,200 TYPICALLY THE HEALTHCARE SYSTEMS 1162 00:42:54,200 --> 00:42:55,520 ARE DELIVERS THOSE INTERVENTIONS 1163 00:42:55,520 --> 00:42:56,800 AS PART OF GENERAL HEALTHCARE 1164 00:42:56,800 --> 00:42:57,800 DELIVERY AND IT'S NOT VERY 1165 00:42:57,800 --> 00:43:03,040 COMMON FOR PEOPLE TO INCLUDE 1166 00:43:03,040 --> 00:43:03,720 PAIN INTERVENTIONISTS AS PART OF 1167 00:43:03,720 --> 00:43:04,920 THE RESEARCH BUDGET. 1168 00:43:04,920 --> 00:43:05,800 I THINK THAT'S QUITE DIFFERENT 1169 00:43:05,800 --> 00:43:08,760 FOR THE EFFECTIVENESS RESEARCH 1170 00:43:08,760 --> 00:43:09,000 NETWORK. 1171 00:43:09,000 --> 00:43:12,840 JANE OREO LAN OR YOLANDA, YOU WO 1172 00:43:12,840 --> 00:43:13,960 ANSWER THAT? 1173 00:43:13,960 --> 00:43:18,520 >>I'M TRYING TO THINK. 1174 00:43:18,520 --> 00:43:22,720 SO WOULD THE GRANT SUPPORT THE 1175 00:43:22,720 --> 00:43:23,680 ACTUAL INTERVENTION BEING 1176 00:43:23,680 --> 00:43:26,120 DELIVERED? 1177 00:43:26,120 --> 00:43:28,080 >>TYPICALLY. 1178 00:43:28,080 --> 00:43:33,200 I GUESS FOR ACUPUNCTURE OR 1179 00:43:33,200 --> 00:43:36,040 FOR -- A LOT OF THESE ARE -- I'M 1180 00:43:36,040 --> 00:43:37,920 JUST THINKING LIKE A CASE 1181 00:43:37,920 --> 00:43:45,120 MANAGER OR IMPLEMENTATION OF A 1182 00:43:45,120 --> 00:43:46,560 MULTIMODAL INTERVENTIONIST, A 1183 00:43:46,560 --> 00:43:47,800 NAVIGATOR, THAT WOULD BE COVERED 1184 00:43:47,800 --> 00:43:50,840 BY THE RESEARCH BUDGET. 1185 00:43:50,840 --> 00:43:55,120 DOES THAT HELP YOUR QUESTION? 1186 00:43:55,120 --> 00:43:56,640 >>I THINK THAT'S WHAT THEY WERE 1187 00:43:56,640 --> 00:43:57,080 LOOKING FOR. 1188 00:43:57,080 --> 00:44:01,480 >>THAT'S A GOOD ANSWER, YES. 1189 00:44:01,480 --> 00:44:05,840 >>SO THE NEXT QUESTION IS FOR 1190 00:44:05,840 --> 00:44:07,280 THE 001 RFA WHICH IS THE ONE 1191 00:44:07,280 --> 00:44:09,160 THAT RELATES TO THE PAIN 1192 00:44:09,160 --> 00:44:10,480 MANAGEMENT OF SICKLE CELL 1193 00:44:10,480 --> 00:44:12,320 DISEASE. 1194 00:44:12,320 --> 00:44:13,840 ARE INTERVENTIONS THAT INCLUDE 1195 00:44:13,840 --> 00:44:16,040 IMPROVING PAIN MANAGEMENT WITH 1196 00:44:16,040 --> 00:44:20,760 OPIOIDS ALLOWED? 1197 00:44:20,760 --> 00:44:25,480 >>YES, THEY ARE. 1198 00:44:25,480 --> 00:44:28,200 RFAs OR FUNDING OPPORTUNITIES 1199 00:44:28,200 --> 00:44:31,840 ALLOWED FOR THE CONTINUED USE OF 1200 00:44:31,840 --> 00:44:37,760 OPIOID MEDICATIONS AND THOSE 1201 00:44:37,760 --> 00:44:38,320 UNDER INVESTIGATION. 1202 00:44:38,320 --> 00:44:43,400 >>I THINK A GOOD DISTINCTION, 1203 00:44:43,400 --> 00:44:44,560 IT WOULD PROBABLY BE IN ADDITION 1204 00:44:44,560 --> 00:44:46,800 TO ANY OPIOIDS THAT THE 1205 00:44:46,800 --> 00:44:50,640 PARTICIPANTS MAY ALREADY BE ON. 1206 00:44:50,640 --> 00:44:52,840 AND I DON'T KNOW THAT EITHER OF 1207 00:44:52,840 --> 00:44:54,080 THE FOAs ARE REALLY LOOKING 1208 00:44:54,080 --> 00:44:57,160 FOR STUDIES SPECIFICALLY OF 1209 00:44:57,160 --> 00:44:59,880 OPIOIDS ALONE FOR THE TREATMENT 1210 00:44:59,880 --> 00:45:01,680 OF SICKLE CELL-RELATED PAIN 1211 00:45:01,680 --> 00:45:02,880 MANAGE WILL. 1212 00:45:02,880 --> 00:45:04,160 I THINK WE'RE HOPING TO ADD ON 1213 00:45:04,160 --> 00:45:06,920 AND STUDY OTHER INTERVENTIONS IN 1214 00:45:06,920 --> 00:45:09,240 ADDITION TO TRY TO IMPROVE PAIN 1215 00:45:09,240 --> 00:45:09,760 MANAGEMENT. 1216 00:45:09,760 --> 00:45:10,840 DOES IT SOUND LIKE PRIORITIES 1217 00:45:10,840 --> 00:45:12,160 FOR ALL OF THE INSTITUTES AND 1218 00:45:12,160 --> 00:45:15,360 CENTERS? 1219 00:45:15,360 --> 00:45:17,000 I'M SEEING LOTS OF HEADS 1220 00:45:17,000 --> 00:45:17,640 NODDING, SO GOOD. 1221 00:45:17,640 --> 00:45:20,720 >>IN UNISON. 1222 00:45:20,720 --> 00:45:22,160 SO WE'LL MOVE ON TO THE NEXT 1223 00:45:22,160 --> 00:45:22,760 QUESTION. 1224 00:45:22,760 --> 00:45:25,360 HOW WOULD YOU HANDLE A PROPOSAL 1225 00:45:25,360 --> 00:45:26,560 FOR LONG TERM CHRONIC 1226 00:45:26,560 --> 00:45:29,080 ADMINISTRATION OF AN AGENT 1227 00:45:29,080 --> 00:45:32,720 DESIGNED TO PREVENT THE 1228 00:45:32,720 --> 00:45:38,840 PATHOPSYCHOLOGICALLY LEADING TO 1229 00:45:38,840 --> 00:45:40,080 PAIN? 1230 00:45:40,080 --> 00:45:49,800 PATHOPHYSIOLOGY LEADING TO PAIN. 1231 00:45:49,800 --> 00:45:51,680 >>JUST TO CLARIFY, I KNOW IT 1232 00:45:51,680 --> 00:45:52,720 MAY NOT BE THERE IN THE QUESTION 1233 00:45:52,720 --> 00:45:54,880 FOR YOU TO CLARIFY FOR US, 1234 00:45:54,880 --> 00:45:57,280 ANITA, IT SOUNDS AS THOUGH THEY 1235 00:45:57,280 --> 00:45:58,480 WERE INTERESTED IN ESTABLISHING 1236 00:45:58,480 --> 00:46:01,560 THE EFFICACY OR EFFECTIVENESS OF 1237 00:46:01,560 --> 00:46:05,480 THIS TREATMENT FOR LONG TERM -- 1238 00:46:05,480 --> 00:46:08,480 THIS LONG TERM TREATMENT FOR 1239 00:46:08,480 --> 00:46:09,920 PATHOPHYSIOLOGY OR -- AGAIN, IT 1240 00:46:09,920 --> 00:46:10,720 REALLY -- THE DISTINCTION 1241 00:46:10,720 --> 00:46:11,760 BETWEEN THE TWO FUNDING 1242 00:46:11,760 --> 00:46:15,800 OPPORTUNITIES IS REALLY -- IS 1243 00:46:15,800 --> 00:46:17,360 THE INTERVENTION IN QUESTION 1244 00:46:17,360 --> 00:46:18,600 ALREADY EVIDENCE-BASED? 1245 00:46:18,600 --> 00:46:24,600 DO YOU HAVE ESTABLISHED EVIDENCE 1246 00:46:24,600 --> 00:46:27,360 FORTY IMPACT IN THE WAY THAT YOU 1247 00:46:27,360 --> 00:46:30,520 ARE INTERESTED IN. 1248 00:46:30,520 --> 00:46:32,200 SO IF YOU NEED TO PRIMARILY 1249 00:46:32,200 --> 00:46:34,480 ESTABLISH ITS EFFICACY OR 1250 00:46:34,480 --> 00:46:36,120 EVIDENCE FOR, YOU KNOW, 1251 00:46:36,120 --> 00:46:38,320 LONG-TERM USE FOR THE MANAGEMENT 1252 00:46:38,320 --> 00:46:42,320 OF PAIN, THEN THAT WOULD 1253 00:46:42,320 --> 00:46:43,520 PROBABLY FALL MORE ALONG THE 1254 00:46:43,520 --> 00:46:45,280 LINES OF RFA-002. 1255 00:46:45,280 --> 00:46:46,520 BUT I'M NOT SURE I UNDERSTAND 1256 00:46:46,520 --> 00:46:47,200 THE QUESTION. 1257 00:46:47,200 --> 00:46:50,440 >>I THINK IN THIS CASE, IT 1258 00:46:50,440 --> 00:46:52,040 MIGHT BE A MORE COMPLICATED 1259 00:46:52,040 --> 00:46:53,080 DESIGN AND I WOULD ENCOURAGE YOU 1260 00:46:53,080 --> 00:46:56,040 TO REACH OUT TO THE PROGRAM 1261 00:46:56,040 --> 00:46:57,240 OFFICIAL OF THE INSTITUTE THAT 1262 00:46:57,240 --> 00:46:59,320 YOU INTEND TO TARGET. 1263 00:46:59,320 --> 00:47:01,520 SO YOU CAN HAVE A MORE IN DEPTH 1264 00:47:01,520 --> 00:47:03,440 CONVERSATION. 1265 00:47:03,440 --> 00:47:04,360 >>THANK YOU, JANE. 1266 00:47:04,360 --> 00:47:06,720 >>ABOUT THE AGENT, WHAT IT'S 1267 00:47:06,720 --> 00:47:10,880 USED FOR ALREADY. 1268 00:47:10,880 --> 00:47:12,400 >>WELL, THANK YOU FOR THAT. 1269 00:47:12,400 --> 00:47:17,040 >>I'M WONDERING, PHIL, IF NHLBI 1270 00:47:17,040 --> 00:47:18,120 WOULD BE MORE INTERESTED IN 1271 00:47:18,120 --> 00:47:19,240 APPLICATIONS THAT MIGHT ADDRESS 1272 00:47:19,240 --> 00:47:21,400 SORT OF THE UNDERLYING 1273 00:47:21,400 --> 00:47:23,640 PATHOPHYSIOLOGY THAT LEADS TO 1274 00:47:23,640 --> 00:47:27,360 PAIN, OR SORT OF ADDRESSING THE 1275 00:47:27,360 --> 00:47:27,960 PATHOPHYSIOLOGY OF SICKLE CELL 1276 00:47:27,960 --> 00:47:29,360 DISEASE, THAT IN THE LONG RUN, 1277 00:47:29,360 --> 00:47:31,680 ENDS UP WITH -- YOU THINK YOU 1278 00:47:31,680 --> 00:47:32,840 MIGHT BE THE RIGHT PROGRAM 1279 00:47:32,840 --> 00:47:34,040 PERSON TO TALK TO THIS ONE? 1280 00:47:34,040 --> 00:47:34,800 WHAT DO YOU THINK? 1281 00:47:34,800 --> 00:47:38,120 >>YES, YES, YOU CAN REACH OUT 1282 00:47:38,120 --> 00:47:40,520 AND GIVE ME A CALL AND WE CAN 1283 00:47:40,520 --> 00:47:48,840 DISCUSS IT IN FURTHER DETAIL. 1284 00:47:48,840 --> 00:47:49,320 >>GREAT. 1285 00:47:49,320 --> 00:47:50,720 NEXT QUESTION, IS IT NECESSARY 1286 00:47:50,720 --> 00:47:53,080 TO BUDGET FOR A BIOSTATISTICIAN 1287 00:47:53,080 --> 00:47:56,000 OR WILL ONE BE PROVIDED? 1288 00:47:56,000 --> 00:48:01,960 B 1289 00:48:01,960 --> 00:48:03,440 >>SO USUALLY THE STUDY TEAM 1290 00:48:03,440 --> 00:48:05,640 LEADS FOR THE ERN, THE STUDY 1291 00:48:05,640 --> 00:48:07,080 TEAM NEEDS A STATISTICIAN TO 1292 00:48:07,080 --> 00:48:09,480 WORK WITH THE INVESTIGATORS AT 1293 00:48:09,480 --> 00:48:11,680 THE INSTITUTION. 1294 00:48:11,680 --> 00:48:14,520 AND I'M BECOMING MORE AND MORE 1295 00:48:14,520 --> 00:48:17,920 ACQUAINT WITH STATISTICAL TEAMS 1296 00:48:17,920 --> 00:48:20,080 IN TRIALS, SO WHAT WE REALLY 1297 00:48:20,080 --> 00:48:23,040 WANT IS AN INDEPENDENT ANALYSIS 1298 00:48:23,040 --> 00:48:26,160 OF THE DATA, BUT SECONDARY 1299 00:48:26,160 --> 00:48:30,640 PAPERS USUALLY ARE DRIVEN AND 1300 00:48:30,640 --> 00:48:38,120 LED BY THE INDIVIDUAL P.I. 1301 00:48:38,120 --> 00:48:40,400 >>AND I WOULD ADD TO JANE'S 1302 00:48:40,400 --> 00:48:42,400 COMMENT THAT THE STUDY TEAM 1303 00:48:42,400 --> 00:48:45,440 STATISTICIAN WOULD BE EXPECTED 1304 00:48:45,440 --> 00:48:48,760 TO COLLABORATE WITH THE HEAL ERN 1305 00:48:48,760 --> 00:48:51,160 STATISTICIANS AS WELL THROUGHOUT 1306 00:48:51,160 --> 00:48:55,440 THE TENURE OF THE PROJECT. 1307 00:48:55,440 --> 00:48:59,160 >>I WAS GOING TO SAY, FOR THE 1308 00:48:59,160 --> 00:49:01,360 001 RFA FOR PRISM, YOU 1309 00:49:01,360 --> 00:49:03,920 ABSOLUTELY NEED AT LEAST ONE 1310 00:49:03,920 --> 00:49:06,440 BIOSTATISTICIAN TO HELP YOU IN 1311 00:49:06,440 --> 00:49:07,560 PLANNING THE DESIGN AND CONDUCT 1312 00:49:07,560 --> 00:49:10,400 OF THE STUDY AND THAT SIMILARLY 1313 00:49:10,400 --> 00:49:13,000 THAT BIOSTATISTICIAN WILL WORK 1314 00:49:13,000 --> 00:49:17,280 WITH THE COORDINATING CENTER'S 1315 00:49:17,280 --> 00:49:18,320 BIOSTATISTICAL EXPERTISE TEAM TO 1316 00:49:18,320 --> 00:49:20,280 HELP REFINE THE STUDY PROTOCOL 1317 00:49:20,280 --> 00:49:21,920 AND ANALYTIC PLANS AND THOSE 1318 00:49:21,920 --> 00:49:22,880 TYPES OF THINGS. 1319 00:49:22,880 --> 00:49:25,280 WE'VE FOUND THAT THAT -- YOU GET 1320 00:49:25,280 --> 00:49:27,000 TO MEET WITH EVERYBODY'S 1321 00:49:27,000 --> 00:49:27,880 BIOSTATISTICIANS SO IT'S SORT OF 1322 00:49:27,880 --> 00:49:30,960 LIKE THIS AMAZING THINK TANK OF 1323 00:49:30,960 --> 00:49:33,360 BIOSTATISTICAL ADVICE THAT YOU 1324 00:49:33,360 --> 00:49:34,440 GET AS PARTICIPATING IN PART OF 1325 00:49:34,440 --> 00:49:35,800 THE PROGRAM, SO ALL OF OUR 1326 00:49:35,800 --> 00:49:36,920 STATISTICIANS HAVE REALLY 1327 00:49:36,920 --> 00:49:38,120 ENJOYED THE OPPORTUNITY TO 1328 00:49:38,120 --> 00:49:40,160 REALLY ADVANCE THE SCIENCE IN 1329 00:49:40,160 --> 00:49:42,200 THE DESIGN AND ANALYTIC METHODS 1330 00:49:42,200 --> 00:49:45,040 OF THE PROJECTS. 1331 00:49:45,040 --> 00:49:45,680 >>THANK YOU. 1332 00:49:45,680 --> 00:49:48,600 I'D LIKE TO SAY THE QUESTIONS WE 1333 00:49:48,600 --> 00:49:49,880 WERE STRUGGLING WITH THIS WAY OR 1334 00:49:49,880 --> 00:49:51,240 THAT WAY, THE INDIVIDUAL SAID 1335 00:49:51,240 --> 00:49:53,240 THAT IT WAS VERY HELPFUL, THE 1336 00:49:53,240 --> 00:49:56,080 RESPONSES THAT HE WAS GIVEN. 1337 00:49:56,080 --> 00:49:57,680 THE NEXT QUESTION IS, AS A 1338 00:49:57,680 --> 00:50:00,000 FOLLOW-UP, WE'RE HOPING TO 1339 00:50:00,000 --> 00:50:02,000 IMPLEMENT EVIDENCE-BASED 1340 00:50:02,000 --> 00:50:04,680 GUIDELINES FOR TREATMENT OF VOC 1341 00:50:04,680 --> 00:50:07,720 IN THE E.D. AND FREE HEALTHCARE 1342 00:50:07,720 --> 00:50:08,360 SYSTEMS. 1343 00:50:08,360 --> 00:50:10,240 THE GUIDELINES RECOMMEND 1344 00:50:10,240 --> 00:50:11,560 INDIVIDUALIZED OPIOID DOSING. 1345 00:50:11,560 --> 00:50:14,960 SO THE GUIDELINES ARE MOSTLY BUT 1346 00:50:14,960 --> 00:50:17,400 NOT ALL OPIOID-FOCUSED. 1347 00:50:17,400 --> 00:50:20,000 IS THIS TOO FOCUSED ON OPIOIDS 1348 00:50:20,000 --> 00:50:27,560 IS THE QUESTION. 1349 00:50:27,560 --> 00:50:29,920 >>IF YOU WANT TO TAKE THAT ONE 1350 00:50:29,920 --> 00:50:33,360 ABOUT THE IMPLEMENTATION 1351 00:50:33,360 --> 00:50:33,680 GUIDELINES? 1352 00:50:33,680 --> 00:50:36,600 >>TO THE EXTENT NHLBI WE'RE 1353 00:50:36,600 --> 00:50:38,480 INTERESTED IN GUIDELINE 1354 00:50:38,480 --> 00:50:39,320 IMPLEMENTATION AND 1355 00:50:39,320 --> 00:50:39,920 EVIDENCE-BASED RECOMMENDATIONS 1356 00:50:39,920 --> 00:50:40,520 FROM GUIDELINES. 1357 00:50:40,520 --> 00:50:43,280 SO IF THE GUIDELINE ITSELF IS 1358 00:50:43,280 --> 00:50:45,800 FOCUSED ON OPIOID BUT IT DOESN'T 1359 00:50:45,800 --> 00:50:47,120 REALLY PRECLEUMED MAYBE ADDING 1360 00:50:47,120 --> 00:50:50,200 OTHER APPROACHES OR -- SORT OF 1361 00:50:50,200 --> 00:50:52,520 DIFFERENT APPROACHES, SO I MEAN, 1362 00:50:52,520 --> 00:50:55,240 I WOULD CERTAINLY BE HAPPY TO 1363 00:50:55,240 --> 00:50:56,880 TALK FURTHER ABOUT MORE 1364 00:50:56,880 --> 00:50:59,040 SPECIFICS BUT I THINK FROM THE 1365 00:50:59,040 --> 00:51:00,520 GUIDELINE AND IMPLEMENTATION 1366 00:51:00,520 --> 00:51:02,840 PERSPECTIVE, WE ARE INTERESTED 1367 00:51:02,840 --> 00:51:04,040 THERE, MAYBE WE CAN TALK ABOUT 1368 00:51:04,040 --> 00:51:05,280 WHAT TYPE OF APPROACHES YOU'RE 1369 00:51:05,280 --> 00:51:13,360 THINKING ABOUT. 1370 00:51:13,360 --> 00:51:15,680 >>THAT SOUNDS GREAT. 1371 00:51:15,680 --> 00:51:16,960 >>NEXT QUESTION, DO 1372 00:51:16,960 --> 00:51:19,280 APPLICATIONS NEED TO INCLUDE A 1373 00:51:19,280 --> 00:51:23,680 COMPLEMENTARY HEALTH APPROACH? 1374 00:51:23,680 --> 00:51:27,160 >>I CAN TAKE THAT ONE. 1375 00:51:27,160 --> 00:51:28,400 SO WHILE THESE FUNDING 1376 00:51:28,400 --> 00:51:29,640 ANNOUNCEMENTS ARE BEING ISSUED 1377 00:51:29,640 --> 00:51:33,960 BY NCCIH AND OUR TEAM IS HELPING 1378 00:51:33,960 --> 00:51:35,560 TO DO ALL OF THE REVIEWS, AS YOU 1379 00:51:35,560 --> 00:51:38,280 CAN SEE FROM THE WIDE RANGE OF 1380 00:51:38,280 --> 00:51:41,480 INSTITUTES AND CENTERS ON THE 1381 00:51:41,480 --> 00:51:45,680 CALL, WE HAVE A BROAD RANGE OF 1382 00:51:45,680 --> 00:51:46,720 INTERESTS AND THE APPLICATION 1383 00:51:46,720 --> 00:51:48,160 DOES NOT HAVE TO INCLUDE A 1384 00:51:48,160 --> 00:51:49,400 COMPLEMENTARY HEALTH 1385 00:51:49,400 --> 00:52:00,280 APPROACHMENT WE'RE APPROACH.WOFE 1386 00:52:00,280 --> 00:52:02,480 INTERESTED IN THAT BUT EVERYBODY 1387 00:52:02,480 --> 00:52:03,360 ELSE HAS DIFFERENT INTERESTS 1388 00:52:03,360 --> 00:52:05,800 ACROSS THE DIFFERENT INSTITUTES 1389 00:52:05,800 --> 00:52:06,080 AND CENTERS. 1390 00:52:06,080 --> 00:52:07,760 >>AND THEY'RE ALL NOTED IN THE 1391 00:52:07,760 --> 00:52:09,720 FUNDING OPPORTUNITY 1392 00:52:09,720 --> 00:52:10,280 ANNOUNCEMENTS, THE SPECIFIC 1393 00:52:10,280 --> 00:52:11,640 AREAS OF INTEREST. 1394 00:52:11,640 --> 00:52:13,040 NEXT QUESTION, DO ALL SOFTWARE 1395 00:52:13,040 --> 00:52:15,040 TOOLS NEEDED FOR IMPLEMENTATION 1396 00:52:15,040 --> 00:52:18,640 NEED TO BE DEVELOPED DURING THE 1397 00:52:18,640 --> 00:52:21,600 PLANNING PHASE, OR CAN THESE BE 1398 00:52:21,600 --> 00:52:22,720 DEVELOPED AFTER A PROJECT IS 1399 00:52:22,720 --> 00:52:26,880 SELECTED FOR TRANSITION TO THE 1400 00:52:26,880 --> 00:52:37,280 UH3 TRIAL CONDUCT PHASE? 1401 00:52:38,440 --> 00:52:45,680 >>SO IN THE ERN, THE DATA 1402 00:52:45,680 --> 00:52:47,040 COORDINATING CENTER IS GOING TO 1403 00:52:47,040 --> 00:52:50,960 START DEVELOPING A DATA SYSTEM 1404 00:52:50,960 --> 00:52:56,120 SORT OF AT RISK DURING THE UG3 1405 00:52:56,120 --> 00:52:57,000 PHASE. 1406 00:52:57,000 --> 00:53:03,720 BECAUSE WE'VE FOUND THAT TRIAL 1407 00:53:03,720 --> 00:53:04,720 IMPLEMENTATION USUALLY TAKES 1408 00:53:04,720 --> 00:53:05,800 LONGER THAN WE THINK IT'S GOING 1409 00:53:05,800 --> 00:53:07,200 TO AND WE WANT TO HIT THE GROUND 1410 00:53:07,200 --> 00:53:07,640 RUNNING. 1411 00:53:07,640 --> 00:53:14,240 THE GOAL FOR US IS TO HAVE -- 1412 00:53:14,240 --> 00:53:16,440 IT'S REALLY NICE IF YOU CAN GET 1413 00:53:16,440 --> 00:53:18,520 SINGLE IRB APPROVAL OF THE MAIN 1414 00:53:18,520 --> 00:53:19,400 STUDY PROTOCOL, MAYBE NOT ALL 1415 00:53:19,400 --> 00:53:20,520 THE RELIANCE AGREEMENTS WILL BE 1416 00:53:20,520 --> 00:53:24,440 IN PLACE, BUT HAVING A DATA AND 1417 00:53:24,440 --> 00:53:25,920 SAFETY MONITORING BOARD AT LEAST 1418 00:53:25,920 --> 00:53:31,760 ONE MEETING AND THEN WE WOULD 1419 00:53:31,760 --> 00:53:32,960 REALLY LIKE TO START RECRUITMENT 1420 00:53:32,960 --> 00:53:39,200 IN OCTOBER OR NOVEMBER OF THE 1421 00:53:39,200 --> 00:53:39,920 UH3 FIRST YEAR. 1422 00:53:39,920 --> 00:53:42,680 >>I WOULD ALSO ADD TO JANE'S 1423 00:53:42,680 --> 00:53:44,480 COMMENT THAT THROUGH THE HEAL 1424 00:53:44,480 --> 00:53:46,560 ERN, THE RESOURCES ARE ALREADY 1425 00:53:46,560 --> 00:53:48,640 IN PLACE THROUGH THE RECRUITMENT 1426 00:53:48,640 --> 00:53:52,600 RESOURCE CENTER, INCLUDING 1427 00:53:52,600 --> 00:53:54,000 SOFTWARE, SITE SELECTION, ET 1428 00:53:54,000 --> 00:53:55,120 CETERA WILL ALREADY BE IN PLACE 1429 00:53:55,120 --> 00:54:03,920 AND AVAILABLE. 1430 00:54:03,920 --> 00:54:07,640 >>FOR THE RFA001 FOR ERN, YOU 1431 00:54:07,640 --> 00:54:09,200 NEED TO HAVE EVERYTHING READY TO 1432 00:54:09,200 --> 00:54:11,040 GO, REALLY, BY THE TIME YOU MAKE 1433 00:54:11,040 --> 00:54:11,720 THAT TRANSITION. 1434 00:54:11,720 --> 00:54:13,480 SO IF YOU NEED TO DEVELOP 1435 00:54:13,480 --> 00:54:16,800 SOFTWARE FOR, LIKE, CLINICIAN 1436 00:54:16,800 --> 00:54:18,520 DECISION SUPPORT TOOLS OR OTHER 1437 00:54:18,520 --> 00:54:20,240 THINGS THAT ARE EMBEDDED IN THE 1438 00:54:20,240 --> 00:54:21,720 ELECTRONIC HEALTH RECORD, THAT 1439 00:54:21,720 --> 00:54:23,760 ABSOLUTELY NEEDS TO BE DONE IN 1440 00:54:23,760 --> 00:54:27,120 THE UG3 PHASE SO THAT YOU'RE 1441 00:54:27,120 --> 00:54:28,480 READY TO GO WHEN THE STUDY 1442 00:54:28,480 --> 00:54:29,520 LAUNCHES. 1443 00:54:29,520 --> 00:54:30,720 WE DO KNOW THAT THERE'S A FEW 1444 00:54:30,720 --> 00:54:32,000 THINGS THAT NEED TO HAPPEN AS 1445 00:54:32,000 --> 00:54:34,080 YOU TRANSITION TO THE UH3 PHASE 1446 00:54:34,080 --> 00:54:35,160 LIKE THE EXECUTING YOUR 1447 00:54:35,160 --> 00:54:36,480 CONTRACTS AND SOME THINGS LIKE 1448 00:54:36,480 --> 00:54:40,000 THAT, BUT WE ALSO WANT PEOPLE TO 1449 00:54:40,000 --> 00:54:41,320 START RECRUITMENT AND BE ABLE TO 1450 00:54:41,320 --> 00:54:42,680 LAUNCH THE TRIAL WITHIN THE 1451 00:54:42,680 --> 00:54:44,960 FIRST FEW MONTHS OF THE UH3 1452 00:54:44,960 --> 00:54:49,400 PHASE IN THAT SECOND PHASE. 1453 00:54:49,400 --> 00:54:51,120 >>NEXT QUESTION, CAN THE 1454 00:54:51,120 --> 00:54:53,640 PRAGMATIC TRIAL BE EMBEDDED ON 1455 00:54:53,640 --> 00:54:56,840 AN ONGOING PROJECT, LOOKING AT 1456 00:54:56,840 --> 00:54:57,640 DECENTRALIZATION AND 1457 00:54:57,640 --> 00:54:59,040 STRENGTHENING CARE AT DIFFERENT 1458 00:54:59,040 --> 00:55:09,320 LEVELS OF CARE? 1459 00:55:09,760 --> 00:55:16,480 >>I'M RE-READING THE QUESTION. 1460 00:55:16,480 --> 00:55:18,320 I THINK THIS IS ONE WE MAY NEED 1461 00:55:18,320 --> 00:55:22,520 A FOLLOW-UP CALL BECAUSE I'M NOT 1462 00:55:22,520 --> 00:55:23,960 100% SURE. 1463 00:55:23,960 --> 00:55:30,960 DOES ANYONE ELSE HAVE -- 1464 00:55:30,960 --> 00:55:32,360 DECENTRALIZATION OF CARE. 1465 00:55:32,360 --> 00:55:33,480 CERTAINLY MULTILEVEL 1466 00:55:33,480 --> 00:55:35,040 INTERVENTIONS THAT TARGET CARE 1467 00:55:35,040 --> 00:55:37,760 AT DIFFERENT GROUPS OR 1468 00:55:37,760 --> 00:55:38,960 MULTILEVEL INTERVENTIONS THAT 1469 00:55:38,960 --> 00:55:40,920 MIGHT TARGET AT THE PATIENT, 1470 00:55:40,920 --> 00:55:42,880 PROVIDER OR CLINIC LEVEL, FOR 1471 00:55:42,880 --> 00:55:50,400 EXAMPLE, COULD BE INCLUDED. 1472 00:55:50,400 --> 00:55:51,800 I THINK THE TRIAL CERTAINLY CAN 1473 00:55:51,800 --> 00:55:54,400 BE EMBEDDED INTO EXISTING 1474 00:55:54,400 --> 00:55:56,360 REGISTRIES OR BE EMBEDDED INTO 1475 00:55:56,360 --> 00:55:58,240 EXISTING COHORTS AND ADD TRIALS 1476 00:55:58,240 --> 00:56:00,320 IN AS A WAY TO RECRUIT FROM 1477 00:56:00,320 --> 00:56:01,120 THOSE POPULATIONS, BUT WE MAY 1478 00:56:01,120 --> 00:56:03,720 NEED TO HAVE A FOLLOW-UP EMAIL 1479 00:56:03,720 --> 00:56:05,160 DIRECTLY WITH THIS INDIVIDUAL TO 1480 00:56:05,160 --> 00:56:14,240 BETTER UNDERSTAND. 1481 00:56:14,240 --> 00:56:17,160 >>WE'RE COMING NEAR THE END OF 1482 00:56:17,160 --> 00:56:21,400 THE WEBINAR HOUR, SO I'M GOING 1483 00:56:21,400 --> 00:56:22,120 TO ASK THIS QUESTION. 1484 00:56:22,120 --> 00:56:24,400 IS THE PLAN TO FUND THREE 1485 00:56:24,400 --> 00:56:26,600 APPLICATIONS FOR EACH FOA, SO A 1486 00:56:26,600 --> 00:56:30,360 TOTAL OF SIX, OR TO PICK THREE 1487 00:56:30,360 --> 00:56:39,000 ACROSS BOTH THE FOAs? 1488 00:56:39,000 --> 00:56:41,040 >>I BELIEVE THE PLAN IS TO FUND 1489 00:56:41,040 --> 00:56:48,120 THREE APPLICATIONS FOR EACH FOA. 1490 00:56:48,120 --> 00:56:51,840 >>I'M NOT SURE, PART OF IT IS 1491 00:56:51,840 --> 00:56:53,160 GOING TO DEPEND ON WHAT FUNDS 1492 00:56:53,160 --> 00:56:54,160 ARE AVAILABLE IN THE NEXT YEAR. 1493 00:56:54,160 --> 00:56:56,600 I THINK WE'LL LOOK ACROSS BOTH 1494 00:56:56,600 --> 00:56:57,680 FOAs AND LOOK FOR THE 1495 00:56:57,680 --> 00:56:58,680 STRONGEST SCIENCE ACROSS BOTH OF 1496 00:56:58,680 --> 00:56:59,520 THE FOAs. 1497 00:56:59,520 --> 00:57:04,320 JANE, DO YOU REMEMBER, WAS IT 1498 00:57:04,320 --> 00:57:04,640 THREE TOTAL -- 1499 00:57:04,640 --> 00:57:10,280 >>I THINK IT WAS THREE TOTAL. 1500 00:57:10,280 --> 00:57:14,080 SO, YEAH. 1501 00:57:14,080 --> 00:57:15,080 SOUNDS LIKE THAT'S TO BE 1502 00:57:15,080 --> 00:57:16,960 DETERMINED, DEPENDING ON THE 1503 00:57:16,960 --> 00:57:18,520 FINAL FUNDING? 1504 00:57:18,520 --> 00:57:20,120 >>EVERY YEAR THE BUDGET IS KIND 1505 00:57:20,120 --> 00:57:21,280 OF A BIG QUESTION MARK, SO WE 1506 00:57:21,280 --> 00:57:23,160 JUST HAVE TO SEE HOW MUCH -- 1507 00:57:23,160 --> 00:57:27,280 WHAT THE FUNDING IS LIKE. 1508 00:57:27,280 --> 00:57:28,480 >>OKAY. 1509 00:57:28,480 --> 00:57:30,000 I GUESS THE ANSWER IS WE'LL FUND 1510 00:57:30,000 --> 00:57:30,800 AS MANY AS WE CAN. 1511 00:57:30,800 --> 00:57:33,480 >>YEAH. 1512 00:57:33,480 --> 00:57:36,120 >>AND WE ABSOLUTELY WANT TO GET 1513 00:57:36,120 --> 00:57:37,440 AS MANY GREAT APPLICATIONS AS 1514 00:57:37,440 --> 00:57:39,520 POSSIBLE, AND IF WE GET REALLY 1515 00:57:39,520 --> 00:57:40,640 EXCELLENT APPLICATIONS, WE CAN 1516 00:57:40,640 --> 00:57:42,320 TRY TO MAKE THE CASE TO FUND 1517 00:57:42,320 --> 00:57:44,920 MORE. 1518 00:57:44,920 --> 00:57:47,240 SO PLEASE WE WOULD LOVE TO GET A 1519 00:57:47,240 --> 00:57:48,360 LOT OF GREAT APPLICATIONS IN. 1520 00:57:48,360 --> 00:57:50,520 >>AND THAT'S A GREAT TRANSITION 1521 00:57:50,520 --> 00:57:52,840 INTO MY CLOSING REMARKS, 1522 00:57:52,840 --> 00:57:53,120 DR. WEBER. 1523 00:57:53,120 --> 00:57:55,840 DOES ANYONE HERE, OUR IC 1524 00:57:55,840 --> 00:57:57,920 PARTNERS OR OUR SPEAKERS, HAVE 1525 00:57:57,920 --> 00:57:59,440 ANYTHING BURNING THEY WANT TO 1526 00:57:59,440 --> 00:58:01,000 SAY BEFORE I CLOSE OUT THE 1527 00:58:01,000 --> 00:58:05,400 VIDEOCAST? 1528 00:58:05,400 --> 00:58:06,640 ANYTHING, ANY MESSAGE THIS THEY 1529 00:58:06,640 --> 00:58:09,240 WANT TO DELIVER THAT WASN'T 1530 00:58:09,240 --> 00:58:11,000 ALREADY ELOQUENTLY DONE IN YOUR 1531 00:58:11,000 --> 00:58:13,400 TALK? 1532 00:58:13,400 --> 00:58:14,000 OKAY. 1533 00:58:14,000 --> 00:58:17,240 THAT BEING SAID, I REALLY -- 1534 00:58:17,240 --> 00:58:19,160 >>MAY I JUST REMIND PEOPLE, I 1535 00:58:19,160 --> 00:58:20,480 KNOW YOU'VE ALREADY SAID IT BUT 1536 00:58:20,480 --> 00:58:22,160 I JUST WANT TO REMIND THE 1537 00:58:22,160 --> 00:58:23,920 AUDIENCE MEMBERS THAT THE 1538 00:58:23,920 --> 00:58:24,680 CONTACT INFORMATION FOR ALL OF 1539 00:58:24,680 --> 00:58:27,320 THE PROGRAM DIRECTORS OF THE 1540 00:58:27,320 --> 00:58:29,560 SUPPORTING INSTITUTES AND 1541 00:58:29,560 --> 00:58:31,080 CENTERS WILL BE INCLUDED IN THE 1542 00:58:31,080 --> 00:58:32,800 SLIDE DECK THAT WOULD BE POSTED 1543 00:58:32,800 --> 00:58:34,080 ONLINE AND PROVIDED TO YOU. 1544 00:58:34,080 --> 00:58:36,040 SO YOU WILL HAVE THE ABILITY TO 1545 00:58:36,040 --> 00:58:36,920 REACH OUT. 1546 00:58:36,920 --> 00:58:38,000 I KNOW SOMEONE POTENTIALLY IS 1547 00:58:38,000 --> 00:58:42,120 GOING TO REACH OUT TO PHIL, AND 1548 00:58:42,120 --> 00:58:44,840 MAYBE OTHER PROGRAM DIRECTORS. 1549 00:58:44,840 --> 00:58:45,840 SO THE PROGRAM INFORMATION WILL 1550 00:58:45,840 --> 00:58:47,520 BE IN THE SLIDE DECK PROVIDED 1551 00:58:47,520 --> 00:58:48,160 ONLINE FOR YOUR REFERENCE. 1552 00:58:48,160 --> 00:58:50,800 >>THANK YOU. 1553 00:58:50,800 --> 00:58:52,600 >>ANITA, YOU MADE ME THINK OF 1554 00:58:52,600 --> 00:58:53,440 ONE OTHER THING THAT WE ALWAYS 1555 00:58:53,440 --> 00:58:55,080 TRY TO SAY, WHICH IS, IT'S 1556 00:58:55,080 --> 00:58:57,320 ALWAYS A REALLY GOOD IDEA TO 1557 00:58:57,320 --> 00:58:58,280 TALK TO A PROGRAM OFFICIAL 1558 00:58:58,280 --> 00:58:59,120 BEFORE YOU SUBMIT AN 1559 00:58:59,120 --> 00:58:59,640 APPLICATION. 1560 00:58:59,640 --> 00:59:01,600 I SEE LOTS OF HEADS NODDING. 1561 00:59:01,600 --> 00:59:04,240 SO PLEASE FEEL FREE TO SEND US 1562 00:59:04,240 --> 00:59:06,280 YOUR ONE-PAGE SPECIFIC AIMS IF 1563 00:59:06,280 --> 00:59:07,360 YOU'RE TRYING TO FIGURE OUT 1564 00:59:07,360 --> 00:59:08,360 WHICH INSTITUTE OR CENTER IS 1565 00:59:08,360 --> 00:59:10,000 MAYBE THE BEST FIT. 1566 00:59:10,000 --> 00:59:11,480 IN SOME WAYS YOU DON'T NEED TO 1567 00:59:11,480 --> 00:59:12,680 WORRY TOO MUCH ABOUT THIS. 1568 00:59:12,680 --> 00:59:14,120 THEY'LL ALL GET REVIEWED AND 1569 00:59:14,120 --> 00:59:17,280 WE'LL FIND THE BEST FIT FOR 1570 00:59:17,280 --> 00:59:17,840 THEM. 1571 00:59:17,840 --> 00:59:19,080 BUT IT'S REALLY HELPFUL TO TALK 1572 00:59:19,080 --> 00:59:20,640 TO A PROGRAM OFFICIAL BEFORE YOU 1573 00:59:20,640 --> 00:59:22,560 SUBMIT YOUR APPLICATION JUST TO 1574 00:59:22,560 --> 00:59:23,720 MAKE SURE YOU'VE SELECTED MAYBE 1575 00:59:23,720 --> 00:59:24,920 THE RIGHT FUNDING ANNOUNCEMENT 1576 00:59:24,920 --> 00:59:27,680 FOR THE SCIENCE THAT YOU WANT TO 1577 00:59:27,680 --> 00:59:29,200 DO, AS WELL AS TO MAKE SURE THAT 1578 00:59:29,200 --> 00:59:30,120 WHAT YOU'RE PROPOSING IS GOING 1579 00:59:30,120 --> 00:59:31,680 TO BE RESPONSIVE AND THEN IT 1580 00:59:31,680 --> 00:59:35,760 DOES MAKE TO SONIA'S TEAM AND 1581 00:59:35,760 --> 00:59:36,440 ACTUALLY GETS REVIEWED. 1582 00:59:36,440 --> 00:59:37,960 SO THAT WOULD BE THE ONE BIT OF 1583 00:59:37,960 --> 00:59:39,160 ADVICE I WOULD GIVE EVERYBODY, 1584 00:59:39,160 --> 00:59:40,400 IS TO BE SURE TO REACH OUT. 1585 00:59:40,400 --> 00:59:41,360 WE'D LOVE TO HEAR FROM YOU. 1586 00:59:41,360 --> 00:59:42,920 >>AND REACH OW NOW AND MAKE 1587 00:59:42,920 --> 00:59:44,440 THAT CONTACT NOW. 1588 00:59:44,440 --> 00:59:48,800 DON'T WAIT UNTIL THE DEADLINE 1589 00:59:48,800 --> 00:59:50,720 NOVEMBER 21ST AND THEY'RE MAKING 1590 00:59:50,720 --> 00:59:51,280 THANKSGIVING HOLIDAY PLANS. 1591 00:59:51,280 --> 00:59:52,280 SO I ENCOURAGE YOU TO THINK 1592 00:59:52,280 --> 00:59:54,040 ABOUT IT AND REACH OUT. 1593 00:59:54,040 --> 00:59:55,920 SO WITH THAT SAID, I JUST WANT 1594 00:59:55,920 --> 01:00:00,080 TO THANK EVERYONE WHO JOINED THE 1595 01:00:00,080 --> 01:00:01,040 VIDEOCAST TODAY. 1596 01:00:01,040 --> 01:00:02,960 THERE WERE OVER 90 OF YOU THAT 1597 01:00:02,960 --> 01:00:03,960 REGISTERED AND WE REALLY 1598 01:00:03,960 --> 01:00:04,720 APPRECIATE IT. 1599 01:00:04,720 --> 01:00:06,320 PLEASE NOTE THAT THE ENTIRE 1600 01:00:06,320 --> 01:00:07,960 VIDEOCAST WILL BE ARCHIVED ON 1601 01:00:07,960 --> 01:00:11,240 THE NIH VIDEOCAST WEBSITE, 1602 01:00:11,240 --> 01:00:12,280 PROBABLY IN ABOUT 24 HOURS, SO 1603 01:00:12,280 --> 01:00:13,560 YOU CAN LOOK AT IT AGAIN, SHARE 1604 01:00:13,560 --> 01:00:16,400 IT WITH YOUR FRIENDS, AND AS 1605 01:00:16,400 --> 01:00:18,320 MENTIONED, WE WILL SEND YOU A 1606 01:00:18,320 --> 01:00:22,040 PDF OF THE SLIDESET THAT WERE 1607 01:00:22,040 --> 01:00:23,240 PRESENTED BY OUR SPEAKERS TODAY. 1608 01:00:23,240 --> 01:00:28,000 I DO WANT TO THANK OUR SPEAKERS 1609 01:00:28,000 --> 01:00:32,680 PERSONALLY. 1610 01:00:32,680 --> 01:00:34,120 EXCELLENT PRESENTATIONS, REALLY 1611 01:00:34,120 --> 01:00:35,960 PROVIDING THE REAL GOOD NITTY 1612 01:00:35,960 --> 01:00:37,120 GRITTY DETAILS FOR THE AUDIENCE. 1613 01:00:37,120 --> 01:00:39,120 SO WE REALLY DO LOOK FORWARD TO 1614 01:00:39,120 --> 01:00:40,760 SOME EXCELLENT APPLICATIONS 1615 01:00:40,760 --> 01:00:42,760 COMING ACROSS THE BOARD TO OUR 1616 01:00:42,760 --> 01:00:45,600 PARTNER ICs AND TO NCCIH. 1617 01:00:45,600 --> 01:00:47,920 SO THANK YOU AGAIN. 1618 01:00:47,920 --> 01:00:50,480 I HOPE YOU ENJOY THE DAY 1619 01:00:50,480 --> 01:00:52,280 ENJOYED THIS WEBCAST. 1620 01:00:52,280 --> 01:01:05,680 THANK YOU.