1 00:00:05,760 --> 00:00:57,480 >>WELCOME TO CTAC MEETING 2 00:00:57,480 --> 00:00:59,800 FOR PARTNERSHIPS IN THE 3 00:00:59,800 --> 00:01:01,080 ONCOLOGY CENTER OF THE 4 00:01:01,080 --> 00:01:02,800 EXCELLENCE WHO IS ATTENDING AS 5 00:01:02,800 --> 00:01:04,360 OUR FDA REPRESENTATIVE IN 6 00:01:04,360 --> 00:01:07,120 THE PLACE OF Dr. PASTOR TODAY. 7 00:01:07,120 --> 00:01:09,040 SO, THERE ARE A FEW HOUSEKEEPING 8 00:01:09,040 --> 00:01:12,920 ITEMS THAT I WILL NEED TO READ 9 00:01:12,920 --> 00:01:16,720 TO YOU BEFORE WE DIVE INTO THE 10 00:01:16,720 --> 00:01:17,560 MEAT OF THE SESSION. 11 00:01:17,560 --> 00:01:19,120 FIRST, I'D LIKE TO JUST REMIND 12 00:01:19,120 --> 00:01:25,280 THE COMMITTEE MEMBERS THAT YOU 13 00:01:25,280 --> 00:01:26,480 MUST -- WHEN YOUR PARTICIPATION 14 00:01:26,480 --> 00:01:28,800 AND DELIBERATIONS ON A PRODUCT, 15 00:01:28,800 --> 00:01:30,040 PROGRAM OR SPECIFIC MATTERS 16 00:01:30,040 --> 00:01:34,440 WOULD CONSTITUTE A CONFLICT OF 17 00:01:34,440 --> 00:01:35,480 INTEREST OR CREATE THE 18 00:01:35,480 --> 00:01:40,080 APPEARANCE OF ONE AND ADVISE THE 19 00:01:40,080 --> 00:01:41,040 EXECUTIVE SECRETARY Dr. 20 00:01:41,040 --> 00:01:43,560 PRINCIPLE DAVILLE AND ABSTAIN 21 00:01:43,560 --> 00:01:44,640 FROM ANY PAPTATION IN DISCUSSION 22 00:01:44,640 --> 00:01:46,680 OR ACTION REGARDING THAT MATTER. 23 00:01:46,680 --> 00:01:50,960 IN LIGHT OF THE CURRENT POLICIES 24 00:01:50,960 --> 00:01:51,680 GOVERNING CONFLICT OF INTEREST 25 00:01:51,680 --> 00:01:55,800 AND BASED ON SPECIAL GOVERNMENT 26 00:01:55,800 --> 00:02:02,280 EMPLOYEES, WHICH TURNING ALL 27 00:02:02,280 --> 00:02:03,480 DISCUSSIONS OF MATTERS THAT CAN 28 00:02:03,480 --> 00:02:06,640 IMPACT THE STATUS OF THOSE 29 00:02:06,640 --> 00:02:06,960 HOLDINGS. 30 00:02:06,960 --> 00:02:11,160 WE TRUST YOUR JUDGMENT IN THOSE 31 00:02:11,160 --> 00:02:19,360 INSTANCES AND AND DURING THIS 32 00:02:19,360 --> 00:02:21,200 MEETING A MINIMUM OF 11 33 00:02:21,200 --> 00:02:22,280 APPOINTED MEMBERS MUST BE 34 00:02:22,280 --> 00:02:24,480 PRESENT TO VOICE THEIR VOTES. 35 00:02:24,480 --> 00:02:27,120 WE CURRENTLY HAVE SUCH A QUORUM 36 00:02:27,120 --> 00:02:29,000 SO THAT SHOULD NOT BE A PROBLEM. 37 00:02:29,000 --> 00:02:31,000 NEW MEMBERS, WHO AREN'T CURRENT 38 00:02:31,000 --> 00:02:33,200 MEMBERS OF ANOTHER NCI ADVISORY 39 00:02:33,200 --> 00:02:35,040 BOARD ARE NOT VOTING UNTIL 40 00:02:35,040 --> 00:02:38,520 THEY'VE BEEN CLEARED BY THE NCI 41 00:02:38,520 --> 00:02:39,760 ETHICS' OFFICE AND THE OFFICE OF 42 00:02:39,760 --> 00:02:41,960 HUMAN RESOURCES. 43 00:02:41,960 --> 00:02:43,240 FINALLY, MEMBERS OF PUBLIC WHO 44 00:02:43,240 --> 00:02:45,520 MAY WISH TO EXPRESS THEIR VIEWS 45 00:02:45,520 --> 00:02:46,640 REGARDING ANY ITEMS DISCUSSED 46 00:02:46,640 --> 00:02:53,520 DURING THE MEETING, MAY DO SO IN 47 00:02:53,520 --> 00:02:54,880 WRITING TO THE EXECUTIVE 48 00:02:54,880 --> 00:02:56,080 SECRETARY WITHIN 10 DAYS OF THE 49 00:02:56,080 --> 00:02:57,320 MEETING AND ANY WRITTEN 50 00:02:57,320 --> 00:02:59,160 STATEMENTS BY MEMBERS OF THE 51 00:02:59,160 --> 00:03:02,440 PUBLIC WILL RECEIVE CAREFUL 52 00:03:02,440 --> 00:03:02,800 CONSIDERATION. 53 00:03:02,800 --> 00:03:04,840 THIS MEETING IS BEING BROADCAST 54 00:03:04,840 --> 00:03:06,800 AND IS CURRENTLY AVAILABLE TO 55 00:03:06,800 --> 00:03:09,480 THE PUBLIC VIA THE NIH VIDEO 56 00:03:09,480 --> 00:03:10,880 CAST WEBSITE. 57 00:03:10,880 --> 00:03:12,400 THE BRED CAST WILL ALSO BE 58 00:03:12,400 --> 00:03:14,760 ARCHIVED FOR VIEWING LATER. 59 00:03:14,760 --> 00:03:16,840 AND I CALL EVERYONE'S ATTENTION 60 00:03:16,840 --> 00:03:19,120 TO THE AGENDA WHERE THE DATES OF 61 00:03:19,120 --> 00:03:22,480 FUTURE MEETINGS ARE LISTED AND 62 00:03:22,480 --> 00:03:28,000 SEVERAL MEETING STAT DATES IN 2, 63 00:03:28,000 --> 00:03:29,280 BELIEVE IT OR NOT WE'RE ALMOST 64 00:03:29,280 --> 00:03:30,520 THERE, HAVE BEEN ADDED. 65 00:03:30,520 --> 00:03:36,680 AND THEN FINALLY, THE CHATBOX 66 00:03:36,680 --> 00:03:38,000 AND THE CHAT WILL BE USED FOR 67 00:03:38,000 --> 00:03:39,000 QUESTIONS AND DISCUSSIONS AMONG 68 00:03:39,000 --> 00:03:40,560 THE MEMBERS OF THE COMMITTEE TO 69 00:03:40,560 --> 00:03:45,560 ASK A QUESTION OR MAKE A 70 00:03:45,560 --> 00:03:48,240 COMMENT, SKATE YOU WOULD LIKE TO 71 00:03:48,240 --> 00:03:49,720 ASK A QUESTION IN THE CHATBOX. 72 00:03:49,720 --> 00:03:56,880 TO SEND YOUR QUESTION COMMENT TO 73 00:03:56,880 --> 00:03:58,240 EVERYONE RATHER THAN A CERTAIN 74 00:03:58,240 --> 00:04:00,600 PERSON IN THE CHATBOX AND I WILL 75 00:04:00,600 --> 00:04:02,680 CALL ON MEMBERS SO WE CAN 76 00:04:02,680 --> 00:04:05,720 CAPTURE YOUR COMMENTS IN THE 77 00:04:05,720 --> 00:04:07,920 MEETING SUMMARY. 78 00:04:07,920 --> 00:04:09,480 PLEASE STAY ON MUTE DURING THE 79 00:04:09,480 --> 00:04:12,600 CALL UNLESS YOU ARE CALLED ON TO 80 00:04:12,600 --> 00:04:13,720 SPEAK SO THAT WE DON'T HAVE A 81 00:04:13,720 --> 00:04:17,720 LOT OF AMBIENT BACKGROUND NOISE. 82 00:04:17,720 --> 00:04:21,280 OK, WITHOUT FURTHER ADIEU, OUR 83 00:04:21,280 --> 00:04:26,720 FIRST WERE THE FOR VOTING IS TO 84 00:04:26,720 --> 00:04:29,560 VOTE HOPEFULLY ACCEPT THE 85 00:04:29,560 --> 00:04:32,720 MEETING SUMMARY FROM THE 86 00:04:32,720 --> 00:04:35,080 MARCH 16th, CTAC MEETING. 87 00:04:35,080 --> 00:04:37,960 I'D LIKE A MOTION TO ACCEPT. 88 00:04:37,960 --> 00:04:39,480 >>SO MOVED. 89 00:04:39,480 --> 00:04:40,320 >>THANK YOU. 90 00:04:40,320 --> 00:04:42,280 AND TO WE HAVE A SECOND. 91 00:04:42,280 --> 00:04:43,880 >>SECOND. 92 00:04:43,880 --> 00:04:45,480 >>GREAT. 93 00:04:45,480 --> 00:04:47,320 WOULD ANYBODY LIKE TO DISCUSS 94 00:04:47,320 --> 00:04:49,920 ANY OF THE CONTENT OF THE 95 00:04:49,920 --> 00:04:54,280 MEETING SUMMARY FROM EARLIER 96 00:04:54,280 --> 00:04:59,040 THIS YEAR? 97 00:04:59,040 --> 00:05:01,320 IF NOT, I'M GOING TO ASK WITH A 98 00:05:01,320 --> 00:05:04,240 SHOW OF HANDS, IF ANYONE TUESDAY 99 00:05:04,240 --> 00:05:06,200 NOT ACCEPT THE SUMMARY, SO WE'RE 100 00:05:06,200 --> 00:05:08,520 LOOKING FOR THE NAYS HERE. 101 00:05:08,520 --> 00:05:09,960 IS THERE ANYONE WHO DOES NOT 102 00:05:09,960 --> 00:05:13,960 BELIEVE WE SHOULD ACCEPT THIS 103 00:05:13,960 --> 00:05:21,040 SUMMARY? 104 00:05:21,040 --> 00:05:23,000 THANK YOU. 105 00:05:23,000 --> 00:05:25,840 AND IS THERE ANYONE WHO WISHES 106 00:05:25,840 --> 00:05:32,040 TO ABSTAIN FROM THE VOTE, PLEASE 107 00:05:32,040 --> 00:05:38,000 SHOW OF HANDS. 108 00:05:38,000 --> 00:05:38,160 OK. 109 00:05:38,160 --> 00:05:39,840 WE WILL CONSIDER THE MEETING 110 00:05:39,840 --> 00:05:44,160 SUMMARY FROM MARCH 16th, 2022, 111 00:05:44,160 --> 00:05:45,040 TO BE ACCEPTED. 112 00:05:45,040 --> 00:05:45,760 ALL RIGHT. 113 00:05:45,760 --> 00:05:48,080 I'D LIKE TO MOVE ONTO THE NEXT 114 00:05:48,080 --> 00:05:58,000 AGENDA ITEM WHICH IS OUR NCI 115 00:05:58,000 --> 00:05:59,440 DIRECTORS' REPORT AND I'D LIKE 116 00:05:59,440 --> 00:06:06,560 TO WELCOME Dr. MONICABERTOLLI 117 00:06:06,560 --> 00:06:08,320 AND FOR THE MEMBERS OF THE 118 00:06:08,320 --> 00:06:11,240 COMMITTEE, WE'LL HAVE AMPLE TIME 119 00:06:11,240 --> 00:06:14,400 FOR DISCUSSION WITH MONICA AFTER 120 00:06:14,400 --> 00:06:17,960 HER REMARKS. 121 00:06:17,960 --> 00:06:18,360 SO, ALL YOURS. 122 00:06:18,360 --> 00:06:19,520 >>THANK YOU, NEIL. 123 00:06:19,520 --> 00:06:20,120 THANK YOU SO MUCH. 124 00:06:20,120 --> 00:06:22,440 I AM SO DELIGHTED TO BE HERE AND 125 00:06:22,440 --> 00:06:26,400 TO SEE SO MANY FRIENDS. 126 00:06:26,400 --> 00:06:28,640 I'VE BEEN IN THIS POSITION AS N 127 00:06:28,640 --> 00:06:39,880 DISTRICT OR E.>>I'VE BEEN GRATL 128 00:06:44,720 --> 00:06:46,680 THE COLLEAGUES AT NCI WHO ARE 129 00:06:46,680 --> 00:06:49,000 TRYING TO GET ME UP TO SPEED ON 130 00:06:49,000 --> 00:06:52,960 AN INCREDIBLY COMPLEX AND DEEP 131 00:06:52,960 --> 00:06:54,680 ORGANIZATION AND YOU KNOW, SO, 132 00:06:54,680 --> 00:06:56,720 BE PATIENT WITH ME, I'M STILL 133 00:06:56,720 --> 00:06:58,200 VERY MUCH IN THE LEARNING PHASE. 134 00:06:58,200 --> 00:06:59,680 THE GOOD THING ABOUT THAT IS I'M 135 00:06:59,680 --> 00:07:02,520 VERY MUCH IN THE LISTENING PHASE 136 00:07:02,520 --> 00:07:04,080 AND THAT'S A LOT OF WHAT I WANT 137 00:07:04,080 --> 00:07:06,200 TO DO HERE TODAY. 138 00:07:06,200 --> 00:07:07,440 SHARE THOUGHTS WITH YOU ABOUT 139 00:07:07,440 --> 00:07:10,040 SOME THINGS THAT I'VE LEARNED 140 00:07:10,040 --> 00:07:17,520 AND ALSO HEAR FROM YOU. 141 00:07:17,520 --> 00:07:18,320 SO, YOU KNOW, I'VE BEEN A MEMBER 142 00:07:18,320 --> 00:07:22,480 OF THE EXTRAMURAL NCI COMMUNITY 143 00:07:22,480 --> 00:07:24,160 AND YOU KNOW, THE FIRST THING 144 00:07:24,160 --> 00:07:27,600 THAT I THOUGHT OF, ON TAKING ON 145 00:07:27,600 --> 00:07:29,280 A JOB LIKE THIS, IS TO JUST GO 146 00:07:29,280 --> 00:07:31,240 BACK TO CORE PRINCIPLES AND 147 00:07:31,240 --> 00:07:32,800 THINK ABOUT WHY WE'RE ALL HERE. 148 00:07:32,800 --> 00:07:37,240 BECAUSE YOU CAN IMAGINE, IT'S -- 149 00:07:37,240 --> 00:07:39,680 WE ALL GET BUFFETED BY THE WIND 150 00:07:39,680 --> 00:07:43,480 WHEN WE'RE IN OUR JOB AND CORE 151 00:07:43,480 --> 00:07:45,160 PRINCIPLES KEEP US GROUNDED IN 152 00:07:45,160 --> 00:07:46,400 WHAT WE'RE HERE TO DO. 153 00:07:46,400 --> 00:07:48,600 A COUPLE OF THOUGHTS, FIRST OF 154 00:07:48,600 --> 00:07:50,840 ALL, RIGHT NOW, WE HAVE A 155 00:07:50,840 --> 00:07:51,560 PRESIDENT, PRESIDENT JOE BIDEN, 156 00:07:51,560 --> 00:07:54,880 WHO IS MAKING -- MADE ENDING 157 00:07:54,880 --> 00:08:00,040 CANCER AS WE KNOW IT, A REALLY 158 00:08:00,040 --> 00:08:02,600 SIGNATURE OBJECTIVE, WOW, THAT'S 159 00:08:02,600 --> 00:08:03,680 AN AMAZING OPPORTUNITY FOR ALL 160 00:08:03,680 --> 00:08:06,400 OF US WHO SHARE THAT GOAL. 161 00:08:06,400 --> 00:08:09,520 AND WE WANT TO MAKE THE VERY 162 00:08:09,520 --> 00:08:14,160 BEST USE OF THIS OPPORTUNITY. 163 00:08:14,160 --> 00:08:15,480 AGAIN, CORE PRINCIPLES, WE'RE 164 00:08:15,480 --> 00:08:19,160 HERE TO PREVENT CANCER WE'RE 165 00:08:19,160 --> 00:08:22,320 HERE TO HELP EVERYONE WHO HAS 166 00:08:22,320 --> 00:08:25,520 HAD OR HAS CANCER TO LIVE FULL 167 00:08:25,520 --> 00:08:28,000 AND ACTIVE LIVES. 168 00:08:28,000 --> 00:08:30,720 FREE FROM CANCER'S HARMFUL 169 00:08:30,720 --> 00:08:30,960 EFFECTS. 170 00:08:30,960 --> 00:08:33,440 THAT IS REALLY WHAT EVERYTHING 171 00:08:33,440 --> 00:08:37,360 WE DO IS GEARED TOWARDS. 172 00:08:37,360 --> 00:08:38,800 NCI DOES THIS BY FUNDING 173 00:08:38,800 --> 00:08:40,880 RESEARCH ALSO I THINK CRITICALLY 174 00:08:40,880 --> 00:08:43,640 BY PARTNERING WITH EVERYONE WHO 175 00:08:43,640 --> 00:08:45,520 SHARES THAT GOAL. 176 00:08:45,520 --> 00:08:47,840 NCI CAN'T DO IT ALONE AND IT HAS 177 00:08:47,840 --> 00:08:52,960 A CRITICAL PARTNERING ROLE AND 178 00:08:52,960 --> 00:08:53,840 I'M SURE YOU KNOW THIS BECAUSE 179 00:08:53,840 --> 00:08:55,800 YOU ARE AMONG THE BIGGEST 180 00:08:55,800 --> 00:08:56,280 PARTNERS. 181 00:08:56,280 --> 00:08:58,480 I SEE NCI AS SUPPORTING THE BEST 182 00:08:58,480 --> 00:09:02,360 PEOPLE IN RESEARCH AND MAKING IT 183 00:09:02,360 --> 00:09:03,720 POSSIBLE FOR THEM TO DO THIS 184 00:09:03,720 --> 00:09:04,880 RESEARCH THROUGH THE COURSES 185 00:09:04,880 --> 00:09:09,320 THAT CAN BE PROVIDED. 186 00:09:09,320 --> 00:09:18,600 IT'S ABSOLUTE ESSENTIAL THAT WEE 187 00:09:18,600 --> 00:09:19,520 ENGAGE THE BRIGHTEST MINDS WITH 188 00:09:19,520 --> 00:09:21,000 THE BIGGEST HEARTS. 189 00:09:21,000 --> 00:09:25,600 ENDING HUMAN CANCER A IS A HUMAN 190 00:09:25,600 --> 00:09:26,800 AND SCIENTIFIC ENDEAVOUR AND 191 00:09:26,800 --> 00:09:28,080 IT'S ALSO A CORE PRINCIPLE THAT 192 00:09:28,080 --> 00:09:32,120 I KNOW YOU SHARE. 193 00:09:32,120 --> 00:09:33,920 FOR MANY YEARS NOW, WE'VE ALL 194 00:09:33,920 --> 00:09:35,600 HEARD, WE'RE AT AN INFLECTION 195 00:09:35,600 --> 00:09:37,360 POINT IN CANCER RESEARCH. 196 00:09:37,360 --> 00:09:40,280 THERE'S SO MUCH POSSIBILITY AND 197 00:09:40,280 --> 00:09:41,880 I HAD A FEW PEOPLE CHALLENGE ME, 198 00:09:41,880 --> 00:09:43,920 COME ON, WE'VE BEEN HEARING THAT 199 00:09:43,920 --> 00:09:44,920 HYPE FOREVER WHAT'S IS REALLY 200 00:09:44,920 --> 00:09:45,320 HAPPENING. 201 00:09:45,320 --> 00:09:47,120 I THINK ABOUT WHEN I FIRST 202 00:09:47,120 --> 00:09:51,840 STARTED, AS A BRAND NEW SURGICAL 203 00:09:51,840 --> 00:09:54,680 ONCOLOGIST, THINK BACK, AND THEN 204 00:09:54,680 --> 00:09:56,000 FAST FORWARD TO TODAY AND I 205 00:09:56,000 --> 00:10:01,440 THINK ALL OF CAN YOU CAN THINK 206 00:10:01,440 --> 00:10:02,520 HOW DIFFERENT THE WORLD OF BEING 207 00:10:02,520 --> 00:10:06,920 A CANCER CLINICIAN AND HOPEFULLY 208 00:10:06,920 --> 00:10:08,480 FOR SOME BEING A CANCER PATIENT 209 00:10:08,480 --> 00:10:10,160 IS TODAY, THAN IT WAS WHEN WE 210 00:10:10,160 --> 00:10:10,880 FIRST STARTED. 211 00:10:10,880 --> 00:10:15,120 WHEN YOU THINK IN THE LONG 212 00:10:15,120 --> 00:10:16,640 SWEEP, THERE'S BEEN AMAZING 213 00:10:16,640 --> 00:10:17,280 PROGRESS MADE. 214 00:10:17,280 --> 00:10:18,120 IT'S NOT ENOUGH. 215 00:10:18,120 --> 00:10:19,840 WE'VE GOT A LOT MORE TO DO. 216 00:10:19,840 --> 00:10:22,160 AT THE OTHER THING I BELIEVE IS 217 00:10:22,160 --> 00:10:24,120 HAPPENED, IS THERE HAS BEEN A 218 00:10:24,120 --> 00:10:27,080 LONG-TERM SUSTAINED INVESTMENT 219 00:10:27,080 --> 00:10:30,920 IN SCIENCE, IN CANCER RESEARCH, 220 00:10:30,920 --> 00:10:32,880 AND THAT HAS PRODUCED SOME 221 00:10:32,880 --> 00:10:33,720 OPPORTUNITIES THAT WE HAVE TODAY 222 00:10:33,720 --> 00:10:36,080 THAT WE'VE NEVER HAD BEFORE. 223 00:10:36,080 --> 00:10:40,560 AND PART OF WHAT IS BEFORE US, 224 00:10:40,560 --> 00:10:43,720 REALLY FOR CTAC, I THINK 225 00:10:43,720 --> 00:10:46,160 CRITICALLY FOR CTAC IS HOW TO WE 226 00:10:46,160 --> 00:10:48,960 MAKE THE VERY BEST USE OF THOSE 227 00:10:48,960 --> 00:10:51,880 OPPORTUNITIES THAT ARE AHEAD. 228 00:10:51,880 --> 00:10:55,440 SO, I'LL ADMIT, THAT WHAT WE AIM 229 00:10:55,440 --> 00:11:04,400 TO AS SIRRATIONAL WE NEED TO BE 230 00:11:04,400 --> 00:11:07,000 BOLD AND GO FORWARD WITH WHAT WE 231 00:11:07,000 --> 00:11:17,440 KNOW PEOPLE NEED US TO DO. 232 00:11:21,160 --> 00:11:23,400 I WANT TO CONFIRM YOU CAN ALL 233 00:11:23,400 --> 00:11:25,120 STILL HEAR ME. 234 00:11:25,120 --> 00:11:25,720 GOOD. 235 00:11:25,720 --> 00:11:28,400 SORRY, MY VIDEO IS GOING OUT. 236 00:11:28,400 --> 00:11:29,960 IT GOES IN AND OUT A LITTLE BIT. 237 00:11:29,960 --> 00:11:34,400 SO FIRST OF ALL, YOU KNOW, WE 238 00:11:34,400 --> 00:11:35,960 MUST MODERNIZE CLINICAL TRIALS, 239 00:11:35,960 --> 00:11:38,040 I KNOW WE'VE BEEN SAYING THIS 240 00:11:38,040 --> 00:11:40,320 FOREVER, BUT IT IS MORE 241 00:11:40,320 --> 00:11:44,320 IMPERATIVE THAN EVER AND WE'VE 242 00:11:44,320 --> 00:11:49,360 SET A GOAL. 243 00:11:49,360 --> 00:11:51,160 WE CAN'T LEAVE IMPORTANT WORK ON 244 00:11:51,160 --> 00:11:56,520 THE TABLE BECAUSE WE LAR LACK TE 245 00:11:56,520 --> 00:11:56,800 BANDWIDTH. 246 00:11:56,800 --> 00:11:58,200 WE HAVE TO APPROACH AND DESIGN 247 00:11:58,200 --> 00:11:59,800 CONDUCT OF CLINICAL TRIALS AND 248 00:11:59,800 --> 00:12:01,760 REPORT OUR RESULTS. 249 00:12:01,760 --> 00:12:02,960 WE'VE LEARNED SOME THINGS FROM 250 00:12:02,960 --> 00:12:05,440 COVID BUT THERE'S A LOT MORE 251 00:12:05,440 --> 00:12:09,400 THAT WE CAN THINK ABOUT. 252 00:12:09,400 --> 00:12:13,280 INNOVATION, I THINK IT'S -- 253 00:12:13,280 --> 00:12:16,480 INNOVATION IN CLINICAL TRIALS IS 254 00:12:16,480 --> 00:12:16,920 ESSENTIAL. 255 00:12:16,920 --> 00:12:21,320 ON THAT NOTE, I REALLY LOOK 256 00:12:21,320 --> 00:12:22,480 FORWARD TO THE SESSION AT NOON 257 00:12:22,480 --> 00:12:24,560 TODAY, WHICH FOCUSES ON 258 00:12:24,560 --> 00:12:25,480 STREAMLINING CLINICAL TRIALS. 259 00:12:25,480 --> 00:12:27,800 I THINK THAT WILL BE VERY 260 00:12:27,800 --> 00:12:30,000 ILLUMINATING FOR US ALL AND A 261 00:12:30,000 --> 00:12:30,840 WONDERFUL PLACE TO START. 262 00:12:30,840 --> 00:12:32,680 I THINK ALL OF YOU HAVE THE 263 00:12:32,680 --> 00:12:33,920 KNOWLEDGE WE NEED TO ACHIEVE 264 00:12:33,920 --> 00:12:42,440 THESE KIND OF GOALS. 265 00:12:42,440 --> 00:12:43,720 THERE ARE RESOURCES TO MAKE THIS 266 00:12:43,720 --> 00:12:46,400 HAPPEN AND THAT'S WHY YOUR INPUT 267 00:12:46,400 --> 00:12:51,040 IS IMPORTANT. 268 00:12:51,040 --> 00:12:58,000 >>TO HELP REALIZE THAT GOAL. 269 00:12:58,000 --> 00:12:59,200 SOMEONE NEEDS TO MUTE. 270 00:12:59,200 --> 00:13:01,040 THERE YOU GO. 271 00:13:01,040 --> 00:13:02,600 I THINK ONE STEP WE'RE WORKING 272 00:13:02,600 --> 00:13:04,400 TOWARDS IS LAUNCHING A SURVEY 273 00:13:04,400 --> 00:13:05,840 AND EVALUATION OF THE 274 00:13:05,840 --> 00:13:07,640 REPRESENTATION OF UNDER 275 00:13:07,640 --> 00:13:08,480 REPRESENTED GROUPS AND WOMEN 276 00:13:08,480 --> 00:13:12,840 ACROSS NCI AND THE NCTN, THE NCI 277 00:13:12,840 --> 00:13:14,120 COMMUNITY ONCOLOGY RESEARCH 278 00:13:14,120 --> 00:13:18,160 PROGRAM AND THE NCI SCIENCE 279 00:13:18,160 --> 00:13:19,440 STEERING COMMITTEES. 280 00:13:19,440 --> 00:13:22,920 OF COURSE, WE EMBRACE DIVERSITY 281 00:13:22,920 --> 00:13:24,360 IN OUR WORKFORCE. 282 00:13:24,360 --> 00:13:26,920 WE EMBRACE DIVERSITY IN OUR 283 00:13:26,920 --> 00:13:27,240 LEADERSHIP. 284 00:13:27,240 --> 00:13:29,560 THIS IS THE BEST WAY TO SERVE 285 00:13:29,560 --> 00:13:33,200 OUR PATIENTS AND THE FIRST STEP 286 00:13:33,200 --> 00:13:37,160 IS MAKING SURE WE LOOK TO 287 00:13:37,160 --> 00:13:38,720 OURSELVES THAT WE'RE ADHERING TO 288 00:13:38,720 --> 00:13:40,280 THE STANDARDS WE WANT TO SEE. 289 00:13:40,280 --> 00:13:42,120 RIGHT NOW, WE DON'T HAVE A LOT 290 00:13:42,120 --> 00:13:44,040 OF INFORMATION ON LEADERSHIP 291 00:13:44,040 --> 00:13:45,640 REPRESENTATION AND THIS SURVEY 292 00:13:45,640 --> 00:13:48,080 WILL REALLY HELP US COLLECT THE 293 00:13:48,080 --> 00:13:49,440 DEMOGRAPHIC INFORMATION WE NODE 294 00:13:49,440 --> 00:13:50,520 TO BETTER UNDERSTAND AND MAKE 295 00:13:50,520 --> 00:13:57,160 ANY NEEDED IMPROVEMENTS. 296 00:13:57,160 --> 00:13:59,920 THE PLAN IS TO PILOT THE SURVEY 297 00:13:59,920 --> 00:14:03,960 IN NOVEMBER SO I URGE YOU TO 298 00:14:03,960 --> 00:14:04,960 PARTICIPATE IN THAT. 299 00:14:04,960 --> 00:14:06,760 ANOTHER STEP, IS THAT A WEEK 300 00:14:06,760 --> 00:14:09,280 FROM TODAY, NCI IS GOING TO HOST 301 00:14:09,280 --> 00:14:11,000 A SUMMIT ON INCREASING 302 00:14:11,000 --> 00:14:12,320 DIVERSITY, EQUITY AND INCLUSION 303 00:14:12,320 --> 00:14:16,440 IN EARLY PHASE CLINICAL TRIALS. 304 00:14:16,440 --> 00:14:18,480 THIS HAS BEEN RECOGNIZE AS AN 305 00:14:18,480 --> 00:14:19,240 ACUTE NEED. 306 00:14:19,240 --> 00:14:20,920 AS YOU KNOW, EARLY PHASE TRIALS 307 00:14:20,920 --> 00:14:24,280 CAN TAKE MORE RESOURCES AND BE 308 00:14:24,280 --> 00:14:25,760 MORE DIFFICULT BUT ARE SO 309 00:14:25,760 --> 00:14:27,240 IMPORTANT FOR PATIENTS WHO CAN 310 00:14:27,240 --> 00:14:29,200 CAN BENEFIT FROM THEM AND EQUITY 311 00:14:29,200 --> 00:14:33,200 AND ACCESS TO THESE RIALS IS A 312 00:14:33,200 --> 00:14:37,040 VERY IMPORTANT IMMEDIATE 313 00:14:37,040 --> 00:14:37,320 OBJECTIVE. 314 00:14:37,320 --> 00:14:39,640 THE INTENTION IS ALSO IN THIS 315 00:14:39,640 --> 00:14:43,800 INITIATIVE THAT INDUSTRY 316 00:14:43,800 --> 00:14:44,880 PARTICIPANTS WILL WORK TOGETHER 317 00:14:44,880 --> 00:14:46,000 TO STRUCTURE PARTNERSHIPS THAT 318 00:14:46,000 --> 00:14:47,600 WILL IMPROVE THE REPRESENTATION 319 00:14:47,600 --> 00:14:50,240 OF MEDICALLY UNDERSERVED 320 00:14:50,240 --> 00:14:51,960 PATIENTS IN NCI-FUNDED TRIALS. 321 00:14:51,960 --> 00:14:53,840 IF YOU WANT, YOU CAN STILL 322 00:14:53,840 --> 00:14:59,200 RIMMINREGISTERFOR THIS AND ATTE. 323 00:14:59,200 --> 00:15:00,520 OBVIOUSLY, WE NODE TO CONTINUE 324 00:15:00,520 --> 00:15:02,200 TO INVEST VERY HEAVILY IN BASIC 325 00:15:02,200 --> 00:15:04,520 AND TRANSLATIONAL RESEARCH TO 326 00:15:04,520 --> 00:15:06,120 MAKE SURE WE HAVE A STEADY 327 00:15:06,120 --> 00:15:07,800 STREAM OF NEW APPROACHES TO 328 00:15:07,800 --> 00:15:11,000 CANCER PREVENTION AND TREATMENT 329 00:15:11,000 --> 00:15:13,560 AND I ALSO AM VERY HAPPY THAT 330 00:15:13,560 --> 00:15:15,400 I'M SPEAKING TO A GROUP FOCUSED 331 00:15:15,400 --> 00:15:17,600 ON CLINICAL TRIALS AS WELL AS 332 00:15:17,600 --> 00:15:28,120 TRANSLATIONAL RESEARCH AND BAKE 333 00:15:28,800 --> 00:15:30,080 SCIENCES IS THE KNOWLEDGE ON 334 00:15:30,080 --> 00:15:31,480 WHICH TRANSLATIONAL SCIENCE 335 00:15:31,480 --> 00:15:33,920 WHERE IT STANDS, WE NEED THIS TO 336 00:15:33,920 --> 00:15:35,400 PROVIDE THE SOLUTIONS AND BUILD 337 00:15:35,400 --> 00:15:41,760 THE PIPELINE FOR TESTING THE 338 00:15:41,760 --> 00:15:43,560 BASS TICK REPORT YOU WILL HEAR 339 00:15:43,560 --> 00:15:46,600 ABOUT TODAY PRESIDES IN SIGHT 340 00:15:46,600 --> 00:15:50,760 WHY BASIC SIGNS SCIENCE IS SO 341 00:15:50,760 --> 00:15:51,800 IMPORTANT. 342 00:15:51,800 --> 00:15:57,880 NCI CAN BUILD RESOURCES FOR 343 00:15:57,880 --> 00:15:59,160 BASIC SIGNS FOR EXAMPLE IN 344 00:15:59,160 --> 00:16:03,280 ADVERTISE CEASES SUCH AS GASTRO 345 00:16:03,280 --> 00:16:05,120 AND GASTRIC THAT WE NEED TO 346 00:16:05,120 --> 00:16:07,080 BETTER UNDERSTAND. 347 00:16:07,080 --> 00:16:08,720 HOWEVER, AS WE MAKE THOSE 348 00:16:08,720 --> 00:16:10,040 DISCOVERIES, WE HAVE TO ALSO 349 00:16:10,040 --> 00:16:14,520 THINK ABOUT EQUITABLE DELIVERY 350 00:16:14,520 --> 00:16:16,160 OF EVIDENCE BASED CANCER 351 00:16:16,160 --> 00:16:17,320 PREVENTION AND TREATMENT AND 352 00:16:17,320 --> 00:16:19,000 IT'S VISITTAL THAT WE EXPAND OUR 353 00:16:19,000 --> 00:16:20,360 ACTIVITY AND OUR RESEARCH TO 354 00:16:20,360 --> 00:16:24,200 UNDERSTAND HOW TO OVERCOME 355 00:16:24,200 --> 00:16:26,600 FACTORS THAT CAUSE INEQUITY OUR 356 00:16:26,600 --> 00:16:28,640 CURRENT STANDARDS OF SCREENING 357 00:16:28,640 --> 00:16:32,080 DIAGNOSIS IN TREATMENT ARE 358 00:16:32,080 --> 00:16:34,800 AVAILABLE TO EVERYONE WHEN WE 359 00:16:34,800 --> 00:16:41,680 COLLECT SHARE DATA WE NEED TO DO 360 00:16:41,680 --> 00:16:43,440 IT IN A ETHICAL MANNER, OF 361 00:16:43,440 --> 00:16:45,040 COURSE IT'S THE UNDERPINNING OF 362 00:16:45,040 --> 00:16:46,720 WHAT WITH YOU ALL TO WITH YOU WE 363 00:16:46,720 --> 00:16:48,520 NEED TO INCLUDE EFFORTS TO 364 00:16:48,520 --> 00:16:50,360 INCREASE COLLECTION AND USE OF 365 00:16:50,360 --> 00:16:51,960 DATA PARTICULARLY FROM UNDER 366 00:16:51,960 --> 00:16:55,960 REPRESENTED POPULATIONS. 367 00:16:55,960 --> 00:16:57,520 RESEARCH, USING HEALTH DATA, 368 00:16:57,520 --> 00:17:01,080 MUST BE CONDUCTED WITH RESPECT 369 00:17:01,080 --> 00:17:03,040 TO THE WISHES OF THE PATIENT, 370 00:17:03,040 --> 00:17:05,200 INCLUDING HONORING BOTH PATIENT 371 00:17:05,200 --> 00:17:08,400 DESIRED RESTRICTIONS ON DATA USE 372 00:17:08,400 --> 00:17:11,960 OR ALSO ON A DESIRE ON THE PART 373 00:17:11,960 --> 00:17:14,720 OF PATIENTS TO HAVE THEIR DATA 374 00:17:14,720 --> 00:17:17,960 SHARED AS WIDELY AS POSSIBLE. 375 00:17:17,960 --> 00:17:19,760 I SEE THESE PRINCIPLES OF AN 376 00:17:19,760 --> 00:17:22,680 UNDERLYING PHILOSOPHY OF HOW NCI 377 00:17:22,680 --> 00:17:24,720 WILL APPROACH ITS SUPPORT OF ALL 378 00:17:24,720 --> 00:17:25,760 DATA INFRASTRUCTURE AND 379 00:17:25,760 --> 00:17:27,960 COLLABORATION WITH OUR PARTNERS 380 00:17:27,960 --> 00:17:31,120 TO SHARE. 381 00:17:31,120 --> 00:17:40,080 >>Tara: BROADLY AND WE ARE 382 00:17:40,080 --> 00:17:42,280 REALLY AT A TIME WHEN WE BEGIN 383 00:17:42,280 --> 00:17:45,240 TO TRULY HONOR, UNDERSTAND AND 384 00:17:45,240 --> 00:17:47,480 HONOR OUR PATIENTS' WISHES. 385 00:17:47,480 --> 00:17:49,000 WE HAVE TO INREESE THE DIVERSITY 386 00:17:49,000 --> 00:17:53,520 OF CANCER RESEARCH AND CARE 387 00:17:53,520 --> 00:17:54,920 WORKFORCE AND TO REFLECT THE 388 00:17:54,920 --> 00:17:56,160 COMMUNITIES WE SERVE. 389 00:17:56,160 --> 00:17:57,480 IT'S ESSENTIALLY ESSENTIAL TO 390 00:17:57,480 --> 00:17:59,680 BUILDING TRUST AND INCREASING 391 00:17:59,680 --> 00:18:05,480 UPTAKE OF PRE VEN TIVE BEHAVE 392 00:18:05,480 --> 00:18:07,600 YEARS AND EXPANDING CLINICAL 393 00:18:07,600 --> 00:18:09,120 TRAILS PARTICIPATION, AND 394 00:18:09,120 --> 00:18:10,720 IMPROVING THE OVER ALL QUALITY 395 00:18:10,720 --> 00:18:12,080 OF PATIENT CARE. 396 00:18:12,080 --> 00:18:13,920 A RESEARCH AREA THAT IS VERY 397 00:18:13,920 --> 00:18:17,440 IMPORTANT TO US AS WELL. 398 00:18:17,440 --> 00:18:19,160 OF COURSE, WE STILL NEED FUNDING 399 00:18:19,160 --> 00:18:22,200 TO ACHIEVE THE FULL POTENTIAL. 400 00:18:22,200 --> 00:18:25,120 FOR THE CANCER MOONSHOT, AND 401 00:18:25,120 --> 00:18:27,720 NCI'S WORK THAT EXTENDS BEYOND 402 00:18:27,720 --> 00:18:28,080 IT. 403 00:18:28,080 --> 00:18:30,160 IN SEPTEMBER, NCI SHARED ITS 404 00:18:30,160 --> 00:18:31,960 ANNUAL PLAN AND BUDGET PROPOSAL. 405 00:18:31,960 --> 00:18:33,760 I DON'T KNOW IF YOU SAW IT. 406 00:18:33,760 --> 00:18:35,920 IT EXPRESSED THE FUNDING NEEDED 407 00:18:35,920 --> 00:18:41,560 IN FISCAL YEAR 2024 TO BEGIN TO 408 00:18:41,560 --> 00:18:43,800 REALIZE, FULL USE OF THE 409 00:18:43,800 --> 00:18:45,880 OPPORTUNITIES BEFORE US. 410 00:18:45,880 --> 00:18:50,520 IT CAME OUT WITH A PRETTY BIG 411 00:18:50,520 --> 00:18:52,120 NUMBER. 412 00:18:52,120 --> 00:18:54,360 $10 BILLION FOR FUNDING TO THE 413 00:18:54,360 --> 00:18:59,120 NCI FOR OUR WORK. 414 00:18:59,120 --> 00:19:00,440 NCI HAS BEEN AT CANCER RESEARCH 415 00:19:00,440 --> 00:19:02,160 SINCE THE 1930s. 416 00:19:02,160 --> 00:19:06,400 THIS PROPOSAL WAS BASED ON NCI'S 417 00:19:06,400 --> 00:19:08,520 PROFESSIONAL JUDGMENT OF WHAT IT 418 00:19:08,520 --> 00:19:10,600 WILL TAKE TO BEST SUPPORT THE 419 00:19:10,600 --> 00:19:14,640 NATIONAL CANCER PROGRAMS TO 420 00:19:14,640 --> 00:19:18,840 ACHIEVE THE CURRENT PRESIDENT'S 421 00:19:18,840 --> 00:19:20,880 GOALS TO REDUCE CANCER MORTALITY 422 00:19:20,880 --> 00:19:22,920 BY 50% OVER THE NEXT 25 YEARS 423 00:19:22,920 --> 00:19:32,320 AND TO END CANCER AS WE KNOW IT. 424 00:19:32,320 --> 00:19:34,000 YOU WILL SEE A LINE ITEM 425 00:19:34,000 --> 00:19:37,440 SPECIFIC FOR MOONSHOT FUNDING. 426 00:19:37,440 --> 00:19:39,520 THAT'S BECAUSE THESE GOALS ARE 427 00:19:39,520 --> 00:19:41,480 INFUSED INTO TIVE PARTS OF THE 428 00:19:41,480 --> 00:19:44,880 ENTIRE FISCAL YEAR '24. 429 00:19:44,880 --> 00:19:47,720 WE TOO HAVE THIS FUNDING YET. 430 00:19:47,720 --> 00:19:53,120 IN FACT, EVEN FOR 2023, NCI IS 431 00:19:53,120 --> 00:19:53,840 OPERATING UNDER A CONTINUING 432 00:19:53,840 --> 00:19:55,920 RESOLUTION THAT RUNS THROUGH 433 00:19:55,920 --> 00:19:58,000 DECEMBER 16th AND THAT MEANS 434 00:19:58,000 --> 00:19:59,600 OUR CURRENT BUDGET WILL MIRROR 435 00:19:59,600 --> 00:20:04,240 THE FISCAL YEAR '22 BUDGET WHICH 436 00:20:04,240 --> 00:20:05,080 WAS $6.9 BILLION UNTIL CONGRESS 437 00:20:05,080 --> 00:20:07,960 CAN PASS A NEW BUDGET FOR FISCAL 438 00:20:07,960 --> 00:20:08,320 YEAR '23. 439 00:20:08,320 --> 00:20:12,560 IN A LITTLE BIT, M.K.HOLOHAN 440 00:20:12,560 --> 00:20:15,160 WILL TALK ABOUT THE BUDGETS OF 441 00:20:15,160 --> 00:20:16,520 CAPITOL HILL AND IN THE 442 00:20:16,520 --> 00:20:18,200 MEANTIME, NCI IS DOING ALL THAT 443 00:20:18,200 --> 00:20:20,040 IT CAN AND I'M SURE SO ARE YOU, 444 00:20:20,040 --> 00:20:24,760 WITH THE RESOURCES, LOOKING TO 445 00:20:24,760 --> 00:20:27,120 PARTNERS AND TO HELP REALIZE THE 446 00:20:27,120 --> 00:20:30,840 OPPORTUNITIES TO ADVANCE 447 00:20:30,840 --> 00:20:31,320 PROGRESS. 448 00:20:31,320 --> 00:20:34,720 HOW ABOUT ANOTHER NEW PARTNER, 449 00:20:34,720 --> 00:20:34,960 ARPA-H. 450 00:20:34,960 --> 00:20:37,240 I KNOW ALL OF US ARE WON TERRING 451 00:20:37,240 --> 00:20:39,720 WHAT THIS -- WHAT ARRIVAL OF 452 00:20:39,720 --> 00:20:44,360 THIS NEW AGENCY PANES FOR OUR 453 00:20:44,360 --> 00:20:44,560 WORK. 454 00:20:44,560 --> 00:20:47,680 I HAVE BEEN VERY GRATEFUL TO 455 00:20:47,680 --> 00:20:48,880 HAVE OPPORTUNITIES TO WORK WITH 456 00:20:48,880 --> 00:20:51,800 RENEE, THE NEW DIRECTOR OF 457 00:20:51,800 --> 00:20:52,000 ARPA-H. 458 00:20:52,000 --> 00:20:53,400 IT'S A BIG JOB. 459 00:20:53,400 --> 00:20:55,760 SETTING UP AN ENTIRE NEW AGENCY 460 00:20:55,760 --> 00:20:56,920 AND GETTING IT RUNNING AND I CAN 461 00:20:56,920 --> 00:20:59,600 TELL YOU, LOTS OF US ARE GIVING 462 00:20:59,600 --> 00:21:01,520 HER MANY GOOD IDEAS FOR HOW THAT 463 00:21:01,520 --> 00:21:07,480 AGENCY CAN HELP US. 464 00:21:07,480 --> 00:21:09,160 IT'S STILL TAKING SHAPE 465 00:21:09,160 --> 00:21:09,440 OBVIOUSLY. 466 00:21:09,440 --> 00:21:16,520 I CAN CAN GIVE YOU INSIGHTS INTO 467 00:21:16,520 --> 00:21:26,880 THE AND IT'S FOCUSED. 468 00:21:27,280 --> 00:21:29,240 NIMBLE VERY PROJECTOR' ENTERED 469 00:21:29,240 --> 00:21:31,240 AND ENGAGE PARTNERS FROM 470 00:21:31,240 --> 00:21:32,880 GOVERNMENT, ACADEMIA, INTUS 471 00:21:32,880 --> 00:21:36,080 TREMENDOUS AND FOUNDATIONS. 472 00:21:36,080 --> 00:21:38,920 AND MOST IMPORTANT, IT'S NOT 473 00:21:38,920 --> 00:21:41,600 INTENDED TO BE A NEW FUNDER OF 474 00:21:41,600 --> 00:21:44,320 WORK THAT IS BEST ACHIEVED IN AN 475 00:21:44,320 --> 00:21:47,840 ESTABLISHED ORGANIZATION, LIKE 476 00:21:47,840 --> 00:21:48,000 NCI. 477 00:21:48,000 --> 00:21:49,560 IT'S INTENDED TO BE ABLE TO 478 00:21:49,560 --> 00:21:51,960 ACHIEVE THINGS THAT ARE VERY 479 00:21:51,960 --> 00:21:56,400 DIFFICULT FOR ORGANIZATIONS LIKE 480 00:21:56,400 --> 00:21:57,400 NCI BUT REALLY ESSENTIAL TO MAKE 481 00:21:57,400 --> 00:22:01,360 PROGRESS IN HEALTHCARE. 482 00:22:01,360 --> 00:22:03,080 SO, WE ALREADY HAVE NCI AND 483 00:22:03,080 --> 00:22:05,520 OTHER INSTITUTES IN NIH CENTERS 484 00:22:05,520 --> 00:22:07,720 THAT ARE WELL EQUIPPED TO FUND 485 00:22:07,720 --> 00:22:09,040 RESEARCH VITAL FOR PROGRESS AND 486 00:22:09,040 --> 00:22:12,080 THIS WILL NOT REPRODUCE THAT. 487 00:22:12,080 --> 00:22:14,160 ARPA-H INTENDS TO FUND HIGH-RISK 488 00:22:14,160 --> 00:22:15,360 ACTIVITIES THAT REALLY TOO MAKE 489 00:22:15,360 --> 00:22:18,800 SENSE IN THESE OTHER AGENCIES. 490 00:22:18,800 --> 00:22:21,320 BECAUSE THEY'RE JUST OF A 491 00:22:21,320 --> 00:22:22,600 DIFFERENT NATURE. 492 00:22:22,600 --> 00:22:26,920 THINK OF NEW TOOLS TECHNOLOGIES 493 00:22:26,920 --> 00:22:30,360 THAT REALLY ENGAGE THAT ARE 494 00:22:30,360 --> 00:22:32,920 FOCUSED VERY MILESTONE DRIVEN 495 00:22:32,920 --> 00:22:34,880 AND IF ACHIEVED AND DEPLOYED, 496 00:22:34,880 --> 00:22:38,560 CAN REALLY HELP US ALL DELIVER 497 00:22:38,560 --> 00:22:40,120 CARE AND CONDUCT RESEARCH IN A 498 00:22:40,120 --> 00:22:42,960 MUCH MORE EFFECTIVE WAY. 499 00:22:42,960 --> 00:22:45,280 WE'RE VERY EXCITED ABOUT THE 500 00:22:45,280 --> 00:22:47,960 PROSPECT OF WORKING IN WAYS THAT 501 00:22:47,960 --> 00:22:50,560 COMPLIMENT WHAT ARPA-H ACHIEVES 502 00:22:50,560 --> 00:22:51,880 THEM BEG A GREAT PARTNER FOR 503 00:22:51,880 --> 00:22:54,560 WHAT WE DO ALREADY AND HELP 504 00:22:54,560 --> 00:22:56,920 PROVIDE SCIENTIFIC LEADERSHIP 505 00:22:56,920 --> 00:23:04,800 THAT WILL CREATE POTENTIAL FOR 506 00:23:04,800 --> 00:23:08,400 ARPA-H. 507 00:23:08,400 --> 00:23:12,200 ARPA-H IS FOLLOWING THE IT WAS 508 00:23:12,200 --> 00:23:18,360 PROJECT AGENCY O TARPA PLAYBOOK. 509 00:23:18,360 --> 00:23:20,560 THEY DON'T WANT TO SEE GRANT 510 00:23:20,560 --> 00:23:21,800 PROPOSALS WITH YEARS OF 511 00:23:21,800 --> 00:23:22,320 PRELIMINARY DATA. 512 00:23:22,320 --> 00:23:23,840 THAT'S NOT WHAT THEY'RE ABOUT. 513 00:23:23,840 --> 00:23:26,440 I'LL REFER YOU, YOU CAN CAN -- 514 00:23:26,440 --> 00:23:28,120 IT'S EASIER TO GOOGLE IT IF YOU 515 00:23:28,120 --> 00:23:30,680 WANT TO SEE HOW TO WRITE AN 516 00:23:30,680 --> 00:23:32,240 ARPA-H PROPOSAL. 517 00:23:32,240 --> 00:23:38,800 IT FOLLOWS THE HEIL MIRE CAT A 518 00:23:38,800 --> 00:23:39,400 KIDS UM. 519 00:23:39,400 --> 00:23:42,040 IT'S FOCUSED QUESTIONS THAT ASK 520 00:23:42,040 --> 00:23:44,880 YOU TO ARTICULATE IN A VERY 521 00:23:44,880 --> 00:23:48,560 SUCCINCT, JUST A FEW PAGES 522 00:23:48,560 --> 00:23:50,960 MANNER WHAT YOU WOULD LIKE TO 523 00:23:50,960 --> 00:23:55,800 ACHIEVE AND WHAT ARE THE CORE 524 00:23:55,800 --> 00:23:57,760 FEATURES TA DEFINE YOUR PROJECT. 525 00:23:57,760 --> 00:24:04,880 AS WE CONSIDER OUR WORK WITH 526 00:24:04,880 --> 00:24:05,960 PARTNERS, ANOTHER PEAL AND WITH 527 00:24:05,960 --> 00:24:07,880 OUR CLINICAL TRIAL AND PARTNERS 528 00:24:07,880 --> 00:24:09,600 AND YOU ALL KNOW THAT THIS IS 529 00:24:09,600 --> 00:24:19,560 VERY NEAR AND DEAR TO MY HEART. 530 00:24:19,560 --> 00:24:21,600 WE WOULDN'T BE ANYWHERE WITHOUT 531 00:24:21,600 --> 00:24:22,040 BASIC SCIENCE. 532 00:24:22,040 --> 00:24:24,080 THAT'S THE SEABED OF INNOVATION. 533 00:24:24,080 --> 00:24:25,880 HOWEVER, WE CAN'T BRING THAT 534 00:24:25,880 --> 00:24:29,920 BENEFIT TO PATIENTS UNTIL THEN 535 00:24:29,920 --> 00:24:32,520 TESTS IT IN WAYS THAT IT'S 536 00:24:32,520 --> 00:24:34,960 ADEQUATELY UNDERSTOOD TO SAFELY 537 00:24:34,960 --> 00:24:36,560 AND EFFECTIVELY USE IN REAL 538 00:24:36,560 --> 00:24:38,000 PATIENTS AND I KNOW ALL OF YOU 539 00:24:38,000 --> 00:24:41,200 HAVE TAKEN ON THAT CHALLENGE. 540 00:24:41,200 --> 00:24:42,800 CLINICAL TRIALS AND 541 00:24:42,800 --> 00:24:44,520 TRANSLATIONAL SCIENCE PLAY A 542 00:24:44,520 --> 00:24:48,080 CENTRAL ROLE IN CANCER RESEARCH. 543 00:24:48,080 --> 00:24:49,840 NOT JUST BECAUSE OF HOW IT 544 00:24:49,840 --> 00:24:50,840 CARRIES SCIENCE FORWARD TO 545 00:24:50,840 --> 00:24:53,040 DIRECT PATIENT BENEFITS, BUT 546 00:24:53,040 --> 00:24:56,000 THIS IS WHY IT'S ALSO THE 547 00:24:56,000 --> 00:24:56,960 TRANSLATIONAL COMMUNITY BECAUSE 548 00:24:56,960 --> 00:25:01,880 OF HOW IT POWERFULLY INFORMS 549 00:25:01,880 --> 00:25:03,040 BASIC SCIENCE AND OFFERS AN 550 00:25:03,040 --> 00:25:08,520 IMPORTANT GUIDE TO PUBLIC 551 00:25:08,520 --> 00:25:08,880 POLICY. 552 00:25:08,880 --> 00:25:10,800 I SEE IN THIS LIGHT THE 553 00:25:10,800 --> 00:25:12,400 ABSOLUTELY AND ESSENTIAL ROLE 554 00:25:12,400 --> 00:25:15,120 THAT THE NETWORK GROUPS PLAY IN 555 00:25:15,120 --> 00:25:17,800 THE MISSION OF THE NCI. 556 00:25:17,800 --> 00:25:19,840 AS A FORMER GROUP CHAIR, I'VE 557 00:25:19,840 --> 00:25:22,920 SEEN THE COMBINATION OF 558 00:25:22,920 --> 00:25:24,240 SCIENTIFIC EXCELLENCE, CARING 559 00:25:24,240 --> 00:25:29,240 FOR PATIENTS, INCREDIBLE 560 00:25:29,240 --> 00:25:30,680 VOLUNTEERISM, THE SPIRIT OF 561 00:25:30,680 --> 00:25:34,920 DOING WHATEVER IT TAKES WITH 562 00:25:34,920 --> 00:25:38,480 RESEARCH EMPOWERED BECAUSE IT'S 563 00:25:38,480 --> 00:25:39,440 BEING CONDUCTED BY THOSE WHO 564 00:25:39,440 --> 00:25:41,040 CARE ABOUT THE PATIENT SITTING 565 00:25:41,040 --> 00:25:43,560 IN FRONT OF THEM IN THE CLINIC. 566 00:25:43,560 --> 00:25:47,840 I REALLY SEE IT AS CRITICAL THAT 567 00:25:47,840 --> 00:25:49,560 NCI THE NETWORK GROUPS WORK 568 00:25:49,560 --> 00:25:52,480 TOGETHER CLOSER THAN EVER BEFORE 569 00:25:52,480 --> 00:25:55,840 TO DEVELOP SOLUTIONS THAT 570 00:25:55,840 --> 00:26:00,720 ADVANCE PROGRESS IN KEY AREAS. 571 00:26:00,720 --> 00:26:03,440 ABSOLUTELY CRITICAL PARTNERSHIP. 572 00:26:03,440 --> 00:26:05,040 TOGETHER, WE CAN LEVERAGE THE 573 00:26:05,040 --> 00:26:08,160 UNIQUE SKILLS AND RESOURCES OF 574 00:26:08,160 --> 00:26:09,520 ALL THE REQUIRED PARTNERS AND 575 00:26:09,520 --> 00:26:12,280 THERE ARE MANY, TO FULFILL THE 576 00:26:12,280 --> 00:26:14,120 REQUIREMENTS FOR EFFICIENT 577 00:26:14,120 --> 00:26:15,720 RESEARCH THAT ADDRESSED THE 578 00:26:15,720 --> 00:26:18,640 NEEDS OF ALL PATIENTS. 579 00:26:18,640 --> 00:26:23,160 WE CAN CAN ADOPT A POLICY OF 580 00:26:23,160 --> 00:26:25,560 DATA SHARING TO THE FULLEST 581 00:26:25,560 --> 00:26:27,600 EXTENT, ALLOWED BY ADHERENCE TO 582 00:26:27,600 --> 00:26:28,840 ETHICAL PRINCIPLES AND THE 583 00:26:28,840 --> 00:26:32,840 WISHES OF OUR PATIENTS. 584 00:26:32,840 --> 00:26:35,200 WE CAN DEVELOP AND IMPLEMENT AN 585 00:26:35,200 --> 00:26:38,680 APPROPRIATELY RESOURCED METHODS 586 00:26:38,680 --> 00:26:42,000 TO MAKE DATA SHARING A ROUTINE 587 00:26:42,000 --> 00:26:45,680 FEATURE OF ALL CANCER RESEARCH. 588 00:26:45,680 --> 00:26:52,160 WE LOCK WAY TOO MUCH KNOWLEDGE 589 00:26:52,160 --> 00:26:53,360 AWAY IF DATA SCIENCE. 590 00:26:53,360 --> 00:26:55,040 WE CAN ESTABLISH MUTUALLY 591 00:26:55,040 --> 00:26:57,200 BENEFICIAL COLLABORATIONS WITH 592 00:26:57,200 --> 00:27:02,840 BASIC SIGNS RESEARCH TO MAINTAIN 593 00:27:02,840 --> 00:27:04,280 A STEADY FLOW OF KNOWLEDGE FROM 594 00:27:04,280 --> 00:27:05,880 THE BENCH TO THE BEDSIDE AND 595 00:27:05,880 --> 00:27:09,200 BACK AGAIN, OH IT'S SUCH AN OLD 596 00:27:09,200 --> 00:27:09,560 PHRASE. 597 00:27:09,560 --> 00:27:11,400 BUT IT'S DIFFICULT TO DO AND 598 00:27:11,400 --> 00:27:13,160 IT'S ALWAYS BEEN CHALLENGING WE 599 00:27:13,160 --> 00:27:16,120 REALLY NEED TO REDOUBLE THOSE 600 00:27:16,120 --> 00:27:19,440 EFFORTS AND FIND THE RESOURCES 601 00:27:19,440 --> 00:27:23,080 AND THE ENGAGE COMMUNITIES THAT 602 00:27:23,080 --> 00:27:26,160 ALLOW US TO HAVE CLINICAL SIGNS 603 00:27:26,160 --> 00:27:29,400 INFORM OUR BASIC SCIENCE NEEDS 604 00:27:29,400 --> 00:27:31,640 AND VICE VERSA. 605 00:27:31,640 --> 00:27:34,120 FINALLY, I THINK THIS IS REALLY 606 00:27:34,120 --> 00:27:34,400 IMPORTANT. 607 00:27:34,400 --> 00:27:36,600 WE NEED TO ADDRESS THE NEEDS OF 608 00:27:36,600 --> 00:27:44,000 OUR CANCER CLINICAL RESEARCH 609 00:27:44,000 --> 00:27:44,280 WORKFORCE. 610 00:27:44,280 --> 00:27:46,200 BY ACHIEVING DIVERSITY AND ALL 611 00:27:46,200 --> 00:27:48,480 BY PROVIDING ADEQUATE SUPPORT SO 612 00:27:48,480 --> 00:27:52,400 OUR CLINICIANS AND RESEARCHERS 613 00:27:52,400 --> 00:27:55,880 AREN'T LOST TO BURNOUT. 614 00:27:55,880 --> 00:27:57,760 WE'VE ALL SEEN WAY TOO MUCH. 615 00:27:57,760 --> 00:28:01,080 WE NEED TO SUPPORT EDUCATION AND 616 00:28:01,080 --> 00:28:03,000 REIMBURSEMENT THAT MAKE IT 617 00:28:03,000 --> 00:28:06,680 POSSIBLE FOR THEM TO TO THEIR 618 00:28:06,680 --> 00:28:06,960 WORK. 619 00:28:06,960 --> 00:28:11,360 AND FINALLY, BY HIGHLY VALUING 620 00:28:11,360 --> 00:28:14,800 THE UNIQUE CONTRIBUTION OF 621 00:28:14,800 --> 00:28:17,680 CLINICIANS WHO SUPPORT THEIR 622 00:28:17,680 --> 00:28:20,880 PATIENTS BY CONDUCTING CLINICAL 623 00:28:20,880 --> 00:28:22,040 RESEARCH. 624 00:28:22,040 --> 00:28:24,200 CLINICIANS WHO TO THIS ON BEHALF 625 00:28:24,200 --> 00:28:26,760 OF THEIR PATIENTS AND EVERYONE 626 00:28:26,760 --> 00:28:29,320 ELSE HAVE A VERY SPECIAL PLACE 627 00:28:29,320 --> 00:28:32,040 IN OUR WORLD. 628 00:28:32,040 --> 00:28:33,400 AND VERY CERTAIN THAT THIS 629 00:28:33,400 --> 00:28:35,280 APPROACH WILL MAXIMIZE THE 630 00:28:35,280 --> 00:28:39,960 STRENGTH OF THE NETWORK GROUPS 631 00:28:39,960 --> 00:28:41,520 IN THEIR CENTRAL POSITION OF 632 00:28:41,520 --> 00:28:42,640 TRANSLATING EFFECTIVE KNOWLEDGE 633 00:28:42,640 --> 00:28:43,840 INTO BETTER CARE FOR PATIENTS 634 00:28:43,840 --> 00:28:45,880 AND LAYING THE FOUNDATION FOR 635 00:28:45,880 --> 00:28:47,720 CLINICAL RESEARCH IT LEADS TO 636 00:28:47,720 --> 00:28:50,080 BETTER CARE OVER ALL AND INFORMS 637 00:28:50,080 --> 00:28:53,000 PUBLIC POLICY. 638 00:28:53,000 --> 00:28:54,600 THIS PUTS NCI IN THE BEST 639 00:28:54,600 --> 00:28:56,800 POSSIBLE POSITION TO SUPPORT 640 00:28:56,800 --> 00:28:58,120 CRITICAL WORK FOR THE PEOPLE WHO 641 00:28:58,120 --> 00:29:00,040 ARE COUNTING ON US TO COME 642 00:29:00,040 --> 00:29:03,600 THROUGH FOR THEM. 643 00:29:03,600 --> 00:29:05,160 NAMELY, ALL PEOPLE LIVING WITH 644 00:29:05,160 --> 00:29:07,040 CANCER TODAY, AND THE REST WE 645 00:29:07,040 --> 00:29:08,480 HOPE WILL NEVER HAVE TO FACE 646 00:29:08,480 --> 00:29:10,320 THAT CHALLENGE. 647 00:29:10,320 --> 00:29:13,080 SO, NOW I HOPE TO HEAR FROM YOU 648 00:29:13,080 --> 00:29:14,800 AND I HAVE A FEW QUESTIONS FOR 649 00:29:14,800 --> 00:29:17,480 YOU, REALLY, THE MAIN ONE, WHAT 650 00:29:17,480 --> 00:29:19,840 DO YOU SEE? 651 00:29:19,840 --> 00:29:22,520 WHAT TO WE NEED TO TALK ABOUT? 652 00:29:22,520 --> 00:29:24,720 THE AREAS OF GREATEST 653 00:29:24,720 --> 00:29:28,680 OPPORTUNITY AND ALSO, YOUR 654 00:29:28,680 --> 00:29:31,240 GREATEST CONCERNS WITH RAR TO 655 00:29:31,240 --> 00:29:31,800 CLINICAL TRAILS ASK 656 00:29:31,800 --> 00:29:32,600 TRANSLATIONAL RESEARCH. 657 00:29:32,600 --> 00:29:34,880 I WOULD LIKE TO START A SERIOUS 658 00:29:34,880 --> 00:29:35,800 CONVERSATION, NOT ENDING TODAY 659 00:29:35,800 --> 00:29:39,120 BUT ON GOING FOR MY ENTIRE 660 00:29:39,120 --> 00:29:40,960 TENURE, ABOUT HOW WE CAN MAKE 661 00:29:40,960 --> 00:29:44,040 THE KIND OF PROGRESS THAT WE 662 00:29:44,040 --> 00:29:48,200 WANT AGAINST CANCER A REALITY 663 00:29:48,200 --> 00:29:49,200 FOR EVERYBODY. 664 00:29:49,200 --> 00:29:52,040 SO, WITH THAT, I'D LIKE TO TURN 665 00:29:52,040 --> 00:29:54,200 IT BECOME OVER TO NEIL AND HE 666 00:29:54,200 --> 00:29:58,880 CAN CAN HELP ME MODERATE SOME 667 00:29:58,880 --> 00:29:59,200 QUESTIONS. 668 00:29:59,200 --> 00:30:00,040 GREATEST OPPORTUNITIES AND 669 00:30:00,040 --> 00:30:03,720 GREATEST CHALLENGES. 670 00:30:03,720 --> 00:30:04,920 >>SOUNDS GREAT. 671 00:30:04,920 --> 00:30:15,400 SO Dr. BERTAGNOLLI, I AM 672 00:30:20,560 --> 00:30:22,040 EXCITED HOW YOU HIT THE GROUND 673 00:30:22,040 --> 00:30:23,440 AND RUNNING AND THE FOCUS AREAS 674 00:30:23,440 --> 00:30:26,840 YOU'VE PRESSED. 675 00:30:26,840 --> 00:30:27,320 EXPRESSED. 676 00:30:27,320 --> 00:30:28,720 I'VE LIKE TO OPEN IT UP TO THE 677 00:30:28,720 --> 00:30:31,680 COMMITTEE TO OFFER SUGGESTIONS, 678 00:30:31,680 --> 00:30:37,840 DISCUSSES TOPICS FOR MONICA. 679 00:30:37,840 --> 00:30:45,520 >>I SEE PATTY SPEARS HAS RAISED 680 00:30:45,520 --> 00:30:46,360 HER HAND. 681 00:30:46,360 --> 00:30:49,040 >>IT'S SO GOOD TO SEE YOU IN 682 00:30:49,040 --> 00:30:50,120 THIS ROLE. 683 00:30:50,120 --> 00:30:52,000 WE MISS YOU AT THE ALLIANCE FOR 684 00:30:52,000 --> 00:30:55,600 SURE BUT OF COURSE, I AGREE WITH 685 00:30:55,600 --> 00:30:56,640 EVERYTHING YOU HAVE SAID ABOUT 686 00:30:56,640 --> 00:30:58,000 YOUR GOALS AND OBJECTIVES 687 00:30:58,000 --> 00:30:59,440 BECAUSE I'VE BEEN HEARING THEM A 688 00:30:59,440 --> 00:31:01,000 LONG TIME AND I THINK YOU ARE ON 689 00:31:01,000 --> 00:31:01,240 TRACK. 690 00:31:01,240 --> 00:31:03,080 I THINK THAT YOU KNOW, ONE OF 691 00:31:03,080 --> 00:31:04,400 THE THINGS THAT I HAVE SEVERAL 692 00:31:04,400 --> 00:31:05,840 THINGS WRITTEN DOWN BUT YOU 693 00:31:05,840 --> 00:31:10,000 KNOW, A LOT OF IT AS PATIENTS IS 694 00:31:10,000 --> 00:31:12,120 ACCESS, ACCESS, ACCESS, ACCESS 695 00:31:12,120 --> 00:31:14,120 SO WHETHER IT'S ACCESS TO 696 00:31:14,120 --> 00:31:16,000 CLINICAL TRAILS OR ACCESS TO 697 00:31:16,000 --> 00:31:17,960 QUALITY CARE IN GENERAL FOR 698 00:31:17,960 --> 00:31:19,560 CANCER CARE, I THINK THAT'S 699 00:31:19,560 --> 00:31:22,280 REALLY WHERE IT IS I THINK THE 700 00:31:22,280 --> 00:31:24,400 OPPORTUNITY IS WHAT WE'VE SEEN 701 00:31:24,400 --> 00:31:27,360 HAPPEN WITH COVID, WHERE IT'S A 702 00:31:27,360 --> 00:31:30,840 LOT OF THE CLINICAL TRIALS HAS 703 00:31:30,840 --> 00:31:32,040 BEEN MORE PATIENT CENTERED 704 00:31:32,040 --> 00:31:33,760 RATHER THAN INSTITUTIONAL 705 00:31:33,760 --> 00:31:34,120 CENTERED. 706 00:31:34,120 --> 00:31:35,920 AND SO, KIND OF KEEPING SOME OF 707 00:31:35,920 --> 00:31:37,760 THOSE THINGS GOING, THAT ARE 708 00:31:37,760 --> 00:31:41,080 REALLY ADVANTAGEOUS FOR PATIENTS 709 00:31:41,080 --> 00:31:43,040 AND INCREASING THE PARTICIPATION 710 00:31:43,040 --> 00:31:44,600 AND TRIALS IN THE PARTICIPATION 711 00:31:44,600 --> 00:31:46,320 AND CARE AND JUST ACCESS TO CARE 712 00:31:46,320 --> 00:31:48,120 SO THE EQUITY AND CARE I THINK 713 00:31:48,120 --> 00:31:50,320 IS A REALLY HUGE, HUGE PART OF 714 00:31:50,320 --> 00:31:54,200 WHAT PATIENTS ARE LOOKING FOR. 715 00:31:54,200 --> 00:31:59,120 >>I ABSOLUTELY AGREE. 716 00:31:59,120 --> 00:32:00,920 YOU KNOW, COVID TAUGHT US A LOT 717 00:32:00,920 --> 00:32:02,760 BECAUSE IT PUT PRESSURE ON US TO 718 00:32:02,760 --> 00:32:04,600 THINK DIFFERENTLY, RIGHT. 719 00:32:04,600 --> 00:32:08,080 AND I DON'T THINK WE TRULY 720 00:32:08,080 --> 00:32:09,520 KNOW -- I DON'T THINK WE TRULY 721 00:32:09,520 --> 00:32:12,680 KNOW THE IMPLICATIONS OF WHAT 722 00:32:12,680 --> 00:32:13,440 THE CHANGES THAT ARE HAPPENING 723 00:32:13,440 --> 00:32:16,720 WITH COVID AND LIKE ANYTHING, 724 00:32:16,720 --> 00:32:18,680 THERE WERE SOME POSITIVE AND 725 00:32:18,680 --> 00:32:21,840 SOME NEGATIVE AND THAT IS WHY 726 00:32:21,840 --> 00:32:23,320 IT'S ABOUT RESEARCH, RIGHT. 727 00:32:23,320 --> 00:32:25,280 WE JUST DO MAKE ASSUMPTIONS WE 728 00:32:25,280 --> 00:32:26,880 DESIGN RESEARCH THAT REALLY 729 00:32:26,880 --> 00:32:28,160 TESTS AND UNDERSTANDS THE RISKS 730 00:32:28,160 --> 00:32:30,760 AND BENEFITS OF ANY APPROACH 731 00:32:30,760 --> 00:32:33,280 INCLUDING SOME OF THE NEW 732 00:32:33,280 --> 00:32:36,160 ACCESS-DRIVEN APPROACHES. 733 00:32:36,160 --> 00:32:39,440 I THINK NCI, I'M PROUD TO SAY, 734 00:32:39,440 --> 00:32:43,360 HAS AN INCREASING PORTFOLIO OF 735 00:32:43,360 --> 00:32:45,320 IMPLEMENTATION SCIENCE, AND 736 00:32:45,320 --> 00:32:47,160 REALLY DIRECTED TOWARD THE 737 00:32:47,160 --> 00:32:49,480 HEALTHCARE ENVIRONMENT AND HOW 738 00:32:49,480 --> 00:32:50,800 IT CAN BE BETTER. 739 00:32:50,800 --> 00:32:53,120 YOU KNOW, THAT IS ONLY GOING TO 740 00:32:53,120 --> 00:32:55,760 HELP CLINICAL TRAILS TO TO THAT 741 00:32:55,760 --> 00:32:58,200 AS WELL AND FINALLY, WE'VE BEEN 742 00:32:58,200 --> 00:33:00,920 SAYING THIS FOREVER, THE 743 00:33:00,920 --> 00:33:03,840 AVAILABILITY OF CLINICAL TRIALS 744 00:33:03,840 --> 00:33:06,440 PARTICIPATION IN CLINICAL 745 00:33:06,440 --> 00:33:11,400 RESEARCH IS A STANDARD OF CARE 746 00:33:11,400 --> 00:33:15,640 IMPERATIVE. 747 00:33:15,640 --> 00:33:17,000 THE LEARNING HEALTH SYSTEM IS 748 00:33:17,000 --> 00:33:18,280 WHAT WE ALL NEED. 749 00:33:18,280 --> 00:33:19,880 YOUR ADVOCACY AND ALL THE HARD 750 00:33:19,880 --> 00:33:20,080 WORK. 751 00:33:20,080 --> 00:33:24,320 >>WOVE GOT A LOT OF HANDS UP IN 752 00:33:24,320 --> 00:33:26,760 THE ROOM. 753 00:33:26,760 --> 00:33:28,080 RUBEN, YOU ARE UP NEXT. 754 00:33:28,080 --> 00:33:29,640 >>WELL, THANK YOU AND THANK YOU 755 00:33:29,640 --> 00:33:39,280 FOR THOSE WONDERFUL COMMENTS IN 756 00:33:39,280 --> 00:33:40,480 CLINICAL RESEARCH WHAT THAT 757 00:33:40,480 --> 00:33:42,520 OPPORTUNITY BRINGS, AS I BRAIN 758 00:33:42,520 --> 00:33:44,280 STORMED ALONG WITH MIKE WHO IS 759 00:33:44,280 --> 00:33:45,600 OUR SWAG P.I. AND AS WELL AS 760 00:33:45,600 --> 00:33:47,800 LEADS OUR CTO CORE CENTER, YOU 761 00:33:47,800 --> 00:33:50,200 KNOW, WHAT ARE SHOULD KEY 762 00:33:50,200 --> 00:34:00,720 TAKEAWAYS WE WANTED TO SHARE AND 763 00:34:17,360 --> 00:34:19,480 A FEW THINGS I WOULD HIGHLIGHT. 764 00:34:19,480 --> 00:34:22,720 ONE THE COMPLEXITY OF OUR TRIAL 765 00:34:22,720 --> 00:34:23,160 DESIGNS. 766 00:34:23,160 --> 00:34:24,480 DURING MY CAREER, THE 767 00:34:24,480 --> 00:34:25,880 COMPLEXITIES OF OUR TRIALS HAS 768 00:34:25,880 --> 00:34:27,880 EXPLODED TO WHERE WE NOW HAVE 769 00:34:27,880 --> 00:34:29,520 10-PAGE LONG INCLUSION CRY TER 770 00:34:29,520 --> 00:34:33,920 WHY FOR CLINICAL TRIALS THIS IS 771 00:34:33,920 --> 00:34:35,520 VERY COUNTER PRODUCTIVE ON MANY 772 00:34:35,520 --> 00:34:35,760 LEVELS. 773 00:34:35,760 --> 00:34:39,200 THE COMPLEXITY OF THE NUMBER OF 774 00:34:39,200 --> 00:34:40,720 COR LA TIVE STUDIES TUN AND I 775 00:34:40,720 --> 00:34:42,680 KNOW IN TERMS OF FEDERAL TRIALS 776 00:34:42,680 --> 00:34:44,200 AND YOU KNOW, OUR TEAM SAYS 777 00:34:44,200 --> 00:34:45,400 AGAIN, MANY OF THESE CAN CAN 778 00:34:45,400 --> 00:34:47,520 REALLY BE A TREMENDOUS BURDEN IN 779 00:34:47,520 --> 00:34:50,200 TERMS OF BEING ABLE TO IMPLEMENT 780 00:34:50,200 --> 00:34:52,000 THESE TRIALS AND TO USE 781 00:34:52,000 --> 00:34:53,560 TELEHEALTH AND TELE CONTENT BOTH 782 00:34:53,560 --> 00:34:55,920 FOR SCREENING AND CONSENTING AND 783 00:34:55,920 --> 00:35:00,600 IT'S A HUGE OPPORTUNITY AND 784 00:35:00,600 --> 00:35:02,480 WE'RE THE CENTER FOR SOUTH TEXAS 785 00:35:02,480 --> 00:35:03,920 AND IT'S THE SIZE OF 786 00:35:03,920 --> 00:35:04,400 PENNSYLVANIA. 787 00:35:04,400 --> 00:35:05,360 IT'S ENORMOUS. 788 00:35:05,360 --> 00:35:08,280 SO THOSE REMOTE PARTS ARE 789 00:35:08,280 --> 00:35:10,120 CRUCIAL AND THE LACK OF REALLY 790 00:35:10,120 --> 00:35:11,560 QUALIFIED COORDINATORS OXYGEN, 791 00:35:11,560 --> 00:35:13,280 AS WE THINK OUTSIDE THE BOX, AS 792 00:35:13,280 --> 00:35:17,600 INDIVIDUAL INSTITUTIONS AND YOU 793 00:35:17,600 --> 00:35:18,960 THINK HOW DO WE LEVERAGE ALL OF 794 00:35:18,960 --> 00:35:20,920 THESE OPPORTUNITIES TO CREATE A 795 00:35:20,920 --> 00:35:22,600 GREATER PIPELINE OF PEOPLE 796 00:35:22,600 --> 00:35:24,560 INTERESTED IN THESE SORT OF 797 00:35:24,560 --> 00:35:28,840 CAREERS AND THEY REALLY HELP TO 798 00:35:28,840 --> 00:35:34,280 SUPPORT OUR CLINICAL RESEARCH. 799 00:35:34,280 --> 00:35:38,200 IF WE CAN EXTEND WITHOUT REALLY 800 00:35:38,200 --> 00:35:39,440 THINKING ABOUT STRIPPING THEM 801 00:35:39,440 --> 00:35:40,720 DOWN TO THEIR MOST BASIC AND 802 00:35:40,720 --> 00:35:41,960 CRUCIAL ELEMENTS SO THEY'RE 803 00:35:41,960 --> 00:35:43,640 PORTABLE, ACCESSIBLE, AND THEY 804 00:35:43,640 --> 00:35:46,240 REALLY ARE ABLE TO BE ENROLLED 805 00:35:46,240 --> 00:35:48,160 BY THE DIVERSE SWATH OF PEOPLE 806 00:35:48,160 --> 00:35:51,000 THAT REALLY CONSTITUTE OUR 807 00:35:51,000 --> 00:35:57,640 COMMUNITY, YOU KNOW, WE WON'T BE 808 00:35:57,640 --> 00:35:59,480 SUCCESSFUL COMING UP WITH OUR 809 00:35:59,480 --> 00:36:00,680 STAFF AND CLINICAL INVESTIGATORS 810 00:36:00,680 --> 00:36:02,760 AND I THINK IT'S ANOTHER CRUCIAL 811 00:36:02,760 --> 00:36:04,440 PIECE AND I'VE SEEN SOME NEW 812 00:36:04,440 --> 00:36:05,960 ELEMENTS THAT I'VE BEEN INVOLVED 813 00:36:05,960 --> 00:36:11,840 WITH A REVIEW OF THE R50s FOR 814 00:36:11,840 --> 00:36:12,640 INDIVIDUALS TO BE INVOLVED IN 815 00:36:12,640 --> 00:36:14,600 TRIALS AND I THINK EFFORTS LIKE 816 00:36:14,600 --> 00:36:17,920 THAT, TO SUPPORT CLINICAL 817 00:36:17,920 --> 00:36:18,480 INVESTIGATORS AT "POLITICAL 818 00:36:18,480 --> 00:36:21,240 CONNEECONOMICINSTITUTIONS IS KE. 819 00:36:21,240 --> 00:36:24,120 A LOT ON YOUR PLATE BUT STAND BY 820 00:36:24,120 --> 00:36:25,960 READY TO ROLL UP OUR SLEEVES TO 821 00:36:25,960 --> 00:36:27,600 HELP IN ANYWAY THAT WE CAN. 822 00:36:27,600 --> 00:36:28,960 >>THAT'S WONDERFUL. 823 00:36:28,960 --> 00:36:32,240 LET ME JUST RESPOND TO THIS ONE. 824 00:36:32,240 --> 00:36:33,240 WE'VE BEEN TALKING ABOUT THIS 825 00:36:33,240 --> 00:36:34,600 FOR A LONG TIME, RIGHT. 826 00:36:34,600 --> 00:36:38,240 I MEAN, AS LONG AS I WAS GROUP 827 00:36:38,240 --> 00:36:39,560 CHAIR WE'RE SAYING MANY OF THESE 828 00:36:39,560 --> 00:36:40,200 SAME THINGS. 829 00:36:40,200 --> 00:36:41,480 WE HAVE TO DO SOMETHING ABOUT 830 00:36:41,480 --> 00:36:41,680 IT. 831 00:36:41,680 --> 00:36:43,040 WE'VE GOT TO QUIT TALKING ABOUT 832 00:36:43,040 --> 00:36:44,320 IT AND WE HAVE GOT TO DO 833 00:36:44,320 --> 00:36:46,200 SOMETHING ABOUT IT AND I CAN CAN 834 00:36:46,200 --> 00:36:53,800 TELL YOU THAT ONE THING FOR 835 00:36:53,800 --> 00:37:02,800 SURE, WILL FIND A WAY THAT WE 836 00:37:02,800 --> 00:37:04,240 CAN PARTNER WITH THE CLINICAL 837 00:37:04,240 --> 00:37:07,520 TRIALS COMMUNITY AND PARTNER 838 00:37:07,520 --> 00:37:11,480 WITH THE ONES WOULD EX ON THESE 839 00:37:11,480 --> 00:37:13,280 STUDIES AND DESIGN THEM AND MAKE 840 00:37:13,280 --> 00:37:15,240 THEM HAPPEN AND PARTNER AS NEVER 841 00:37:15,240 --> 00:37:17,680 BEFORE AND SOLVE THESE PROBLEMS 842 00:37:17,680 --> 00:37:17,920 TOGETHER. 843 00:37:17,920 --> 00:37:20,120 WE HAVE TO SOLVE THIS TOGETHER 844 00:37:20,120 --> 00:37:21,520 AND OR NEITHER SIDE WILL DO IT 845 00:37:21,520 --> 00:37:23,760 BY OURSELVES WE NEED TO NULL 846 00:37:23,760 --> 00:37:24,920 OTHER PARTNERS THAT ARE GOING TO 847 00:37:24,920 --> 00:37:26,840 HELP US SOLVE THIS. 848 00:37:26,840 --> 00:37:29,520 MAYBE FDA, RIGHT, THERE ARE 849 00:37:29,520 --> 00:37:31,440 OTHER GOOD PARTNERS THAT CAN 850 00:37:31,440 --> 00:37:32,920 HELP US SOLVE SOME OF THOSE 851 00:37:32,920 --> 00:37:34,000 THINGS, WE'LL FIND, WE'RE 852 00:37:34,000 --> 00:37:44,480 WORKING ON A WAY THAT AT THE 853 00:37:53,880 --> 00:37:55,000 WILL REALLY HOLD OUR FEET TO THE 854 00:37:55,000 --> 00:38:01,920 FIRE AND MAKE SURE WE DO BETTER 855 00:38:01,920 --> 00:38:08,480 HERE I TOO SEE IT HAPPENING 856 00:38:08,480 --> 00:38:10,040 WITHOUT HARD WORK AND HAVING TO 857 00:38:10,040 --> 00:38:17,680 MAKE SOME CHOICES THAT YOU KNOW, 858 00:38:17,680 --> 00:38:20,880 MAYBE THERE'S CHOICES WE HAVEN'T 859 00:38:20,880 --> 00:38:22,400 MADE AND THEY'RE ADULT TO 860 00:38:22,400 --> 00:38:23,520 ACHIEVE SOME OF THIS AND WE'LL 861 00:38:23,520 --> 00:38:24,520 DO IT TOGETHER. 862 00:38:24,520 --> 00:38:26,960 >>SO UNFORTUNATELY, WE HAVE 863 00:38:26,960 --> 00:38:28,720 LOTS OF INTEREST AND ONLY A FEW 864 00:38:28,720 --> 00:38:34,760 MORE MINUTES SO I'M GO T IS 865 00:38:34,760 --> 00:38:37,080 EVERYONE TO SPEAK IN BULLET 866 00:38:37,080 --> 00:38:39,400 POINTS AND NOT PARAGRAPHS. 867 00:38:39,400 --> 00:38:45,120 I'M GOING TO START WITH MAYA. 868 00:38:45,120 --> 00:38:47,120 >>THANK YOU, I JUST WANT TO 869 00:38:47,120 --> 00:38:49,080 TAKE MY ONE LITTLE PARAGRAPH 870 00:38:49,080 --> 00:38:50,160 WHICH WAS I REALLY APPRECIATED 871 00:38:50,160 --> 00:38:51,640 THE SENTIMENT THAT YOU SAID 872 00:38:51,640 --> 00:38:53,560 ABOUT VOLUNTEERING AND OUR 873 00:38:53,560 --> 00:38:54,640 PASSION AND I THINK THAT 874 00:38:54,640 --> 00:39:01,240 REPRESENTS A LOT OF THE PEOPLE 875 00:39:01,240 --> 00:39:11,200 AND I'M THE CHIEF MEDICINE 876 00:39:11,200 --> 00:39:12,280 OFFICER OF FOUNDATION MEDICINE 877 00:39:12,280 --> 00:39:13,840 AND DATA SHARING IS A BIG PART 878 00:39:13,840 --> 00:39:17,040 OF WHAT WE ARE FOCUSED ON WITH 879 00:39:17,040 --> 00:39:20,480 OUR COLLABORATIONS WITH NCI AND 880 00:39:20,480 --> 00:39:22,560 OTHERS AND WE ANTICIPATE THAT 881 00:39:22,560 --> 00:39:24,760 THE ENVIRONMENT FOR DATA SHARING 882 00:39:24,760 --> 00:39:25,960 AND IS GOING TO BE A LITTLE BIT 883 00:39:25,960 --> 00:39:28,840 MORE CHALLENGING MORE RELATED TO 884 00:39:28,840 --> 00:39:35,880 SOCIAL MEDIA THAN TO MAYBE 885 00:39:35,880 --> 00:39:37,280 MEDICAL AND ONE OF YOUR GOALS OF 886 00:39:37,280 --> 00:39:38,520 LEARNING FROM THE EXPERIENCES OF 887 00:39:38,520 --> 00:39:43,120 EVERY PATIENT IS HINDERED BY OUR 888 00:39:43,120 --> 00:39:44,840 OWN LACK OF CLARITY AROUND 889 00:39:44,840 --> 00:39:46,560 CONSENT AND SECOND TARRY USE OF. 890 00:39:46,560 --> 00:39:47,600 >>Tara: AND HOW THAT CAN MOVE 891 00:39:47,600 --> 00:39:50,040 FORWARD AND I HOPE THAT IN YOUR 892 00:39:50,040 --> 00:39:51,240 ADMINISTRATION, WE CAN CONTINUE 893 00:39:51,240 --> 00:39:52,960 TO MAKE PROGRESS IN THIS RECORD. 894 00:39:52,960 --> 00:39:55,240 IT'S VERY NEAR AND DEAR TO BOTH 895 00:39:55,240 --> 00:39:56,280 NEIL AND MY HEARTS SO WE'RE ON 896 00:39:56,280 --> 00:39:57,480 THE SUBCOMMITTEES AND I KNOW 897 00:39:57,480 --> 00:39:59,200 THAT MANY OTHERS IN THIS GROUP, 898 00:39:59,200 --> 00:40:06,240 ADAM AS WELL, SO, WE HAVE SOME 899 00:40:06,240 --> 00:40:07,800 REGULATORY AND CONGRESSIONAL 900 00:40:07,800 --> 00:40:09,720 BATTLES AHEAD OF US THAT WE AS A 901 00:40:09,720 --> 00:40:12,160 COMMUNITY NEED TO STAY FOCUSED 902 00:40:12,160 --> 00:40:12,360 ON. 903 00:40:12,360 --> 00:40:12,800 >>RIGHT. 904 00:40:12,800 --> 00:40:15,440 WE DO, WE NEED TO PARTNER ON 905 00:40:15,440 --> 00:40:18,400 THIS AND OF COURSE, THIS IS A 906 00:40:18,400 --> 00:40:20,800 REALLY KEY FEATURE, NOT ONLY 907 00:40:20,800 --> 00:40:23,480 HERE IN THE BUDGET ASK IN THE 908 00:40:23,480 --> 00:40:25,200 MOONSHOT AND I WILL TAKE IT OFF 909 00:40:25,200 --> 00:40:27,000 LINE, YOU KNOW, I'M HAPPY TO 910 00:40:27,000 --> 00:40:28,080 PARTNER WITH YOU ON ALL OF THIS 911 00:40:28,080 --> 00:40:30,520 AND WE KNOW THAT FMI IS 912 00:40:30,520 --> 00:40:32,960 CURRENTLY WORKING WITH NCI AND 913 00:40:32,960 --> 00:40:34,160 SOME IMPORTANT THINGS AND WE'RE 914 00:40:34,160 --> 00:40:35,680 VERY GRATEFUL FOR THAT SO, YOU 915 00:40:35,680 --> 00:40:37,920 ARE RIGHT, AGAIN, WE HAVE TO DO 916 00:40:37,920 --> 00:40:43,960 WHAT OUR PATIENTS WANT US TO DO. 917 00:40:43,960 --> 00:40:45,360 WHAT OUR PATIENTS WANT IS WHAT 918 00:40:45,360 --> 00:40:47,200 WE HAVE TO DO SO WE GET TO WORK 919 00:40:47,200 --> 00:40:47,520 TOWARD THAT. 920 00:40:47,520 --> 00:40:49,000 >>THANK YOU. 921 00:40:49,000 --> 00:40:59,040 >>SETH LEARNER. 922 00:40:59,040 --> 00:41:00,240 I'M A YOU'RE LOGICAL CONNOLOGIST 923 00:41:00,240 --> 00:41:03,800 AND I CHAIR THE LOCAL BLADDER 924 00:41:03,800 --> 00:41:05,120 COMMITTEE, SO IT'S ONE OF THE 925 00:41:05,120 --> 00:41:06,840 PERSPECTIVES I HAVE BUT I ALSO 926 00:41:06,840 --> 00:41:08,520 CHAIRED THE BLADDER TASK FORCE 927 00:41:08,520 --> 00:41:10,840 MOST RECENTLY THE GU STEERING 928 00:41:10,840 --> 00:41:11,200 COMMITTEE. 929 00:41:11,200 --> 00:41:14,000 SO, AS ONE OF THE SURGEONS ON 930 00:41:14,000 --> 00:41:15,960 THIS COMMITTEE, PLEASE DON'T 931 00:41:15,960 --> 00:41:18,400 FORGET INNOVATION AND THE 932 00:41:18,400 --> 00:41:20,640 SURGERY AND SPECIFIC 933 00:41:20,640 --> 00:41:23,960 OPPORTUNITIES FOR SURGICAL 934 00:41:23,960 --> 00:41:26,760 TRIALS WITHIN THE NCTM. 935 00:41:26,760 --> 00:41:28,880 I JUST WANTED TO SHARE A THOUGHT 936 00:41:28,880 --> 00:41:30,720 ABOUT INNOVATION AND TRANSLATION 937 00:41:30,720 --> 00:41:33,200 AND I THINK THAT ONE OF THE 938 00:41:33,200 --> 00:41:34,640 OBSERVATIONS THAT I SUSPECT MANY 939 00:41:34,640 --> 00:41:37,080 OF US HAVE ARE THE CHALLENGES OF 940 00:41:37,080 --> 00:41:39,480 DOING SORT OF COMPLEX CLINICAL 941 00:41:39,480 --> 00:41:41,240 TRIALS WITHIN THE NCTN. 942 00:41:41,240 --> 00:41:43,720 I THINK BY HISTORY, WE TEND TO 943 00:41:43,720 --> 00:41:45,960 TO SEQUENTIAL TRIALS, BUILDING 944 00:41:45,960 --> 00:41:48,120 ON ONE TO THE NEXT AND I THINK 945 00:41:48,120 --> 00:41:52,400 THERE'S A VERY RICH OPPORTUNITY 946 00:41:52,400 --> 00:41:54,960 FOR USING EITHER MULTIPLE 947 00:41:54,960 --> 00:41:57,040 DISEASE STATES WITHIN AN ORGAN 948 00:41:57,040 --> 00:41:59,200 SITE CANCER MULTIPLE TREATMENTS 949 00:41:59,200 --> 00:42:02,280 I GUESS THE PODEL IS I SPY FOR 950 00:42:02,280 --> 00:42:05,080 INSTANCE AND REALLY INVESTING 951 00:42:05,080 --> 00:42:06,800 ENCOURAGING INFRASTRUCTURE TO BE 952 00:42:06,800 --> 00:42:08,720 ABLE TO DO THESE MORE COMPLEX 953 00:42:08,720 --> 00:42:10,080 TRIALS THAT I THINK ARE GOING TO 954 00:42:10,080 --> 00:42:12,520 TEND TO MOVE THE FIELD FORWARD 955 00:42:12,520 --> 00:42:14,280 MUCH QUICKER. 956 00:42:14,280 --> 00:42:15,960 I WOULD ALSO LIKE TO SEE AND I 957 00:42:15,960 --> 00:42:18,400 GUESS I JUST DID KNOW HAVING 958 00:42:18,400 --> 00:42:20,720 BEEN INVOLVED IN THE TCGA FOR A 959 00:42:20,720 --> 00:42:22,920 DECADE NOW CP TECH IS IF THERE 960 00:42:22,920 --> 00:42:25,080 ARE SPECIFIC OPPORTUNITIES TO 961 00:42:25,080 --> 00:42:27,000 FUND TRANSLATION OPPORTUNITIES 962 00:42:27,000 --> 00:42:28,480 INTO CLINICAL TRIALS FROM THOSE 963 00:42:28,480 --> 00:42:29,680 PROGRAMS AND AS YOU KNOW, IT'S 964 00:42:29,680 --> 00:42:32,000 JUST A MASSIVE INVESTMENT AND I 965 00:42:32,000 --> 00:42:33,800 THINK THAT THE BENEFIT OF THOSE 966 00:42:33,800 --> 00:42:37,280 TWO PROGRAMS IS JUST OFF THE 967 00:42:37,280 --> 00:42:41,280 CHART AND SKYROCKETING AND I 968 00:42:41,280 --> 00:42:43,040 THINK IN TERMS OF THE WORKFORCE 969 00:42:43,040 --> 00:42:44,840 YOU WILL HEAR THIS THEME OVER 970 00:42:44,840 --> 00:42:45,480 OVER AGAIN. 971 00:42:45,480 --> 00:42:47,480 I'VE BEEN SORT OF HARPING ON IT 972 00:42:47,480 --> 00:42:50,320 AND THAT THERE HAS TO BE A 973 00:42:50,320 --> 00:42:51,160 FINANCIAL INVESTMENT. 974 00:42:51,160 --> 00:42:52,960 WE'VE GOT TO BE ABLE TO 975 00:42:52,960 --> 00:42:57,520 COMPENSATE PEOPLE AT COMPETITIVE 976 00:42:57,520 --> 00:42:57,840 RATES. 977 00:42:57,840 --> 00:42:59,480 EVERY CANCER CENTER THAT I'VE 978 00:42:59,480 --> 00:43:02,360 HEARD FROM IS REALLY STRUGGLING 979 00:43:02,360 --> 00:43:04,200 WITH THIS RETENTION AND 980 00:43:04,200 --> 00:43:06,000 OBVIOUSLY THE DIVERSITY OF THE 981 00:43:06,000 --> 00:43:07,480 WORKFORCE IS VERY CRITICAL BUT 982 00:43:07,480 --> 00:43:09,680 JUST HAVING A WORKFORCE IS 983 00:43:09,680 --> 00:43:11,160 CRITICAL TO MEET YOUR OBJECTIVE 984 00:43:11,160 --> 00:43:12,480 WHICH WE'RE ALL THRILLED TO HAVE 985 00:43:12,480 --> 00:43:14,360 ABOUT IN DOUBLING THE CLINICAL 986 00:43:14,360 --> 00:43:15,840 TRIALS APPROVAL SO THANK YOU SO 987 00:43:15,840 --> 00:43:17,000 MUCH FOR EVERYTHING THAT YOU TO 988 00:43:17,000 --> 00:43:18,200 AND FOR SHARING YOUR TIME WITH 989 00:43:18,200 --> 00:43:22,920 US THIS MORNING. 990 00:43:22,920 --> 00:43:27,760 >>LET'S MOVE ON TO MICHAEL NAP. 991 00:43:27,760 --> 00:43:29,240 >>THANK YOU SO MUCH FOR REALLY 992 00:43:29,240 --> 00:43:31,920 BRINGING A LOT OF CONCRETE 993 00:43:31,920 --> 00:43:33,560 CONCEPTS TO THE OVER ALL VISION 994 00:43:33,560 --> 00:43:36,360 THAT YOU ARE PUTTING ON THE 995 00:43:36,360 --> 00:43:36,560 TABLE. 996 00:43:36,560 --> 00:43:38,200 I WANTED TO BRING THREE 997 00:43:38,200 --> 00:43:41,200 DIFFERENT TOPICS TOGETHER, 998 00:43:41,200 --> 00:43:42,920 NUMBER ONE, YOU HIGHLIGHTED 999 00:43:42,920 --> 00:43:44,760 REALLY THE PATIENT WISHES ON 1000 00:43:44,760 --> 00:43:45,960 THEIR PARTICIPATION AND THE DATA 1001 00:43:45,960 --> 00:43:49,440 AND I THINK WE COULDN'T GROW AGE 1002 00:43:49,440 --> 00:43:51,280 MORE AND IT NEEDS TO BE 1003 00:43:51,280 --> 00:43:52,600 REFLECTED BETTER AND IT'S GREAT 1004 00:43:52,600 --> 00:43:54,080 TO HEAR YOUR PASSION ON THIS. 1005 00:43:54,080 --> 00:43:55,520 THE SECOND, I THINK, WHAT YOU 1006 00:43:55,520 --> 00:43:56,920 ARE HEARING FROM ALL OF US IS 1007 00:43:56,920 --> 00:44:00,920 THE COMPLEXITY THAT IS BECOMING 1008 00:44:00,920 --> 00:44:04,280 MAJOR CHALLENGE AND THE THIRD, 1009 00:44:04,280 --> 00:44:06,200 IS THE OPPORTUNITY OF TYING REAL 1010 00:44:06,200 --> 00:44:07,680 WORLD DATA IN ADDITION TO 1011 00:44:07,680 --> 00:44:18,120 CLINICAL TRIALS TOGETHER. 1012 00:44:48,760 --> 00:44:58,360 >>REDUCTION ON COMPLEXITY. 1013 00:44:58,360 --> 00:45:00,680 >>THANK YOU, LET'S MOVE TO ADAM 1014 00:45:00,680 --> 00:45:02,240 DICKER AND MONICA, SPEAK UP IF 1015 00:45:02,240 --> 00:45:07,600 YOU WANT TO RESPOND TO ANY OF 1016 00:45:07,600 --> 00:45:15,800 THESE JUST INTERRUPT US. 1017 00:45:15,800 --> 00:45:18,000 I THINK THERE'S A TENSION 1018 00:45:18,000 --> 00:45:26,920 BETWEEN QUALITY OF THE PROCESS 1019 00:45:26,920 --> 00:45:28,720 IT DOESN'T ALWAYS WORK WELL 1020 00:45:28,720 --> 00:45:32,960 ACROSS SILOS SO IF THERE WAS AN 1021 00:45:32,960 --> 00:45:34,680 INCENTIVIZATION TO WORK ACROSS 1022 00:45:34,680 --> 00:45:36,480 SILOS AND MAINTAINING SOME RIG 1023 00:45:36,480 --> 00:45:39,040 OR AND QUALITY I THINK THAT 1024 00:45:39,040 --> 00:45:45,360 WOULD GO A LONG WAY TO REDUCING 1025 00:45:45,360 --> 00:45:47,200 THE ACTIVATION TO ACHIEVE MANY 1026 00:45:47,200 --> 00:45:50,600 OF THE VISIONS YOU TALKED ABOUT. 1027 00:45:50,600 --> 00:45:59,440 >>ADD MANY, COULD YOU SAY A ADT 1028 00:45:59,440 --> 00:46:00,160 WHAT SILOS? 1029 00:46:00,160 --> 00:46:02,240 >>WHETHER IT'S A DATA SILO FOR 1030 00:46:02,240 --> 00:46:05,680 CLINICAL TRIALS, I THINK THERE'S 1031 00:46:05,680 --> 00:46:08,680 CONCERN ABOUT -- RIGHTFULLY SO 1032 00:46:08,680 --> 00:46:11,800 IN TERMS OF THAT IF WE, YOU 1033 00:46:11,800 --> 00:46:15,400 KNOW, IF WE'RE NOT AS CAREFUL, 1034 00:46:15,400 --> 00:46:19,280 WE WON'T GET THE SAME QUALITY OF 1035 00:46:19,280 --> 00:46:21,840 INFORMATION ET CETERA. 1036 00:46:21,840 --> 00:46:23,920 IT'S A RISK OF TOWING MORE 1037 00:46:23,920 --> 00:46:25,160 CREATIVE APPROACHES AND COMES AT 1038 00:46:25,160 --> 00:46:28,200 A RISK OF INCREASING THE TIME 1039 00:46:28,200 --> 00:46:29,560 FOR APPROVAL, ET CETERA. 1040 00:46:29,560 --> 00:46:32,040 AND I THINK THAT'S A NORMAL 1041 00:46:32,040 --> 00:46:34,240 TENSION AND THE QUESTION IS, YOU 1042 00:46:34,240 --> 00:46:40,880 KNOW, IF THERE WAS AN NCI AND 1043 00:46:40,880 --> 00:46:43,560 BARRIERS TO REDUCE OBSTACLES AND 1044 00:46:43,560 --> 00:46:44,920 TO ACHIEVE SPEED, IT'S A 1045 00:46:44,920 --> 00:46:51,160 DIFFERENT PERSPECTIVE ON THAT WE 1046 00:46:51,160 --> 00:46:53,360 ALL VOLUNTEER ON COMMITTEES FOR 1047 00:46:53,360 --> 00:46:54,280 GRANTS AND OTHER TYPES OF, 1048 00:46:54,280 --> 00:46:57,120 ESPECIALLY RELATED TO CLINICAL 1049 00:46:57,120 --> 00:46:57,360 TRIALS. 1050 00:46:57,360 --> 00:46:57,680 >>THANK YOU. 1051 00:46:57,680 --> 00:46:59,320 ALL RIGHT, WE'RE GOING TO HAVE 1052 00:46:59,320 --> 00:47:01,920 TWO MORE COMMENTS AND WE'LL LET 1053 00:47:01,920 --> 00:47:05,240 MONICA CLOSE IT OUT. 1054 00:47:05,240 --> 00:47:05,720 CAROLINE MULLER MANY OF. 1055 00:47:05,720 --> 00:47:10,800 >>HI, THANK YOU. 1056 00:47:10,800 --> 00:47:12,120 I APPRECIATE EVERYBODY'S 1057 00:47:12,120 --> 00:47:12,480 COMMENTS. 1058 00:47:12,480 --> 00:47:18,520 I'M GOING TO TAKE ONE ADDITIONAL 1059 00:47:18,520 --> 00:47:20,680 LEAP AND JUST FOR ON TEXT, I'M A 1060 00:47:20,680 --> 00:47:24,120 ONCOLOGIST AND RUN UNDERSERVED 1061 00:47:24,120 --> 00:47:26,320 IN NEW MEXICO SO MY POINT IS THE 1062 00:47:26,320 --> 00:47:30,600 STAKEHOLDERS FOR CLINICAL TRIALS 1063 00:47:30,600 --> 00:47:33,200 ARE SO MANY DIFFERENT GROUPS 1064 00:47:33,200 --> 00:47:34,640 THAT GET PUSHED OUT BECAUSE THE 1065 00:47:34,640 --> 00:47:38,280 CULTURE OF CLINICAL TRIALS IS 1066 00:47:38,280 --> 00:47:38,920 NOT STRONG. 1067 00:47:38,920 --> 00:47:40,480 IT'S NOT A PRIORITY. 1068 00:47:40,480 --> 00:47:42,080 EVERYTHING ELSE PUSHES IT OUT. 1069 00:47:42,080 --> 00:47:44,680 SO I THINK ONE OF THE THINGS 1070 00:47:44,680 --> 00:47:46,120 THAT WOULD BE VERY IMPORTANT 1071 00:47:46,120 --> 00:47:47,680 MOVING FORWARD, AND BUILDING 1072 00:47:47,680 --> 00:47:50,120 THAT WORKFORCE AND BUILDING THE 1073 00:47:50,120 --> 00:47:51,200 COMMITMENTS AND OUR COMMUNITIES 1074 00:47:51,200 --> 00:47:56,120 AND OUR COMMUNITY ONCOLOGY 1075 00:47:56,120 --> 00:47:57,480 COMMITTEES IS TO STRENGTHEN 1076 00:47:57,480 --> 00:48:00,120 THETURE OF CLINICAL TRIALS, THE 1077 00:48:00,120 --> 00:48:01,400 IMPORTANCE, THE CAREER PATHS FOR 1078 00:48:01,400 --> 00:48:05,480 OUR STAFF, THE INTEGRATION OF 1079 00:48:05,480 --> 00:48:08,200 OUR APPs AND TAKE HOLDERS AND 1080 00:48:08,200 --> 00:48:09,600 OUR HOSPITALS TO REALLY 1081 00:48:09,600 --> 00:48:12,560 RECOGNIZE THAT IT HAS TO BE A 1082 00:48:12,560 --> 00:48:14,400 PRIORITY OVER BILLING REVENUES 1083 00:48:14,400 --> 00:48:15,960 AND OTHER THINGS GENERATED AND 1084 00:48:15,960 --> 00:48:17,920 I'M NOT QUITE SURE HOW TO DO 1085 00:48:17,920 --> 00:48:21,240 THAT BUT UNDERSTANDING THEM FOR 1086 00:48:21,240 --> 00:48:22,800 EACH COMMUNITY IS GOING TO BE 1087 00:48:22,800 --> 00:48:24,520 CRITICAL TO REALLY OVERCOMING 1088 00:48:24,520 --> 00:48:31,480 SOME OF THE BURDENS OF TOWING 1089 00:48:31,480 --> 00:48:34,040 THAT. 1090 00:48:34,040 --> 00:48:37,080 >>MONICA, FIRST OF ALL 1091 00:48:37,080 --> 00:48:38,400 CONGRATULATIONS I'M EXCITED AND 1092 00:48:38,400 --> 00:48:39,920 LOOKING FORWARD TO WORKING WITH 1093 00:48:39,920 --> 00:48:41,800 YOU AND I WILL BRING UP THIS 1094 00:48:41,800 --> 00:48:46,000 ISSUE ABOUT NCTN TRIALS. 1095 00:48:46,000 --> 00:48:48,560 WE ENROLL CLOSE TO 20,000 1096 00:48:48,560 --> 00:48:50,720 PATIENTS EVERY WEAR CONDUCT BIO 1097 00:48:50,720 --> 00:48:52,040 SAMPLES WITH ALL THE COMPLEXITY 1098 00:48:52,040 --> 00:48:54,480 THAT WAS MENTIONED EARLIER. 1099 00:48:54,480 --> 00:48:56,280 HOWEVER, WHEN IT COMES TO USING 1100 00:48:56,280 --> 00:48:58,760 THESE BIOSPECIMENS TO DO 1101 00:48:58,760 --> 00:49:00,520 BIOMARKER RESEARCH OR OTHER 1102 00:49:00,520 --> 00:49:01,600 TRANSLATIONAL WORK, I BELIEVE 1103 00:49:01,600 --> 00:49:03,920 THAT THERE'S AN OPPORTUNITY TO 1104 00:49:03,920 --> 00:49:06,520 IMPROVE THE PROCESS LOOKING AT 1105 00:49:06,520 --> 00:49:08,160 HOW QUICKLY CAN WE GET THESE 1106 00:49:08,160 --> 00:49:10,200 SAMPLES TO THE RESEARCHERS AND 1107 00:49:10,200 --> 00:49:11,560 LOWER THE BAR AND NOT PERFECT 1108 00:49:11,560 --> 00:49:15,480 PER BETHEN PEE OF GOOD. 1109 00:49:15,480 --> 00:49:18,160 SO I BELIEVE THAT THERE ARE 1110 00:49:18,160 --> 00:49:21,120 OPPORTUNITIES THERE ASK THAT'S 1111 00:49:21,120 --> 00:49:21,360 MY PLEA. 1112 00:49:21,360 --> 00:49:26,680 >>THANK YOU. 1113 00:49:26,680 --> 00:49:28,760 THE FLOOR IS YOURS. 1114 00:49:28,760 --> 00:49:33,320 SO, FIRST OF ALL, THANK YOU SO 1115 00:49:33,320 --> 00:49:33,840 MUCH. 1116 00:49:33,840 --> 00:49:34,880 AMAZING INSIGHTS. 1117 00:49:34,880 --> 00:49:36,840 I CAN REALLY VALIDATE EVERYTHING 1118 00:49:36,840 --> 00:49:38,760 THAT WAS SAID HERE TODAY. 1119 00:49:38,760 --> 00:49:40,480 AND I COULD TALK A LONG TIME. 1120 00:49:40,480 --> 00:49:42,720 SO I DON'T HAVE TIME. 1121 00:49:42,720 --> 00:49:45,440 LET ME JUST END WITH WHAT I 1122 00:49:45,440 --> 00:49:50,640 THINK IS ONE OF THE MOST KEYS TO 1123 00:49:50,640 --> 00:49:51,600 EVERYTHING WE'RE DOING AND THAT 1124 00:49:51,600 --> 00:49:54,560 WAS THE COMMENTS ABOUT CULTURE. 1125 00:49:54,560 --> 00:49:59,840 WHAT AN INCREDIBLE TREASURE WE 1126 00:49:59,840 --> 00:50:03,840 HAVE IN THE PEOPLE WHO ARE 1127 00:50:03,840 --> 00:50:06,280 DEVOTED TO CLINICAL AND 1128 00:50:06,280 --> 00:50:07,120 TRANSLATIONAL RESEARCH. 1129 00:50:07,120 --> 00:50:08,280 THE CULTURE IS THERE BECAUSE SO 1130 00:50:08,280 --> 00:50:12,320 MANY OF YOU LIVE IT ALL THE TIME 1131 00:50:12,320 --> 00:50:16,520 MANY OF NURTURING AND EXPAND 1132 00:50:16,520 --> 00:50:18,480 PARTICULAR AND NOT ITING VICTIM 1133 00:50:18,480 --> 00:50:24,480 OF BURNOUT AND IS A HUGE 1134 00:50:24,480 --> 00:50:25,040 PRIORITY. 1135 00:50:25,040 --> 00:50:25,320 IT'S GIVING. 1136 00:50:25,320 --> 00:50:26,680 EVERYONE TA DOES IT WORK DOESN'T 1137 00:50:26,680 --> 00:50:37,200 DO IT BECAUSE IT'S I'M LOOKING 1138 00:50:38,520 --> 00:50:40,760 TO HAVE YOU HELP ME EXPAND IT 1139 00:50:40,760 --> 00:50:42,720 OUT, IT'S OUR BIGGEST TREASURE, 1140 00:50:42,720 --> 00:50:42,920 FRANKLY. 1141 00:50:42,920 --> 00:50:43,640 >>THANK YOU. 1142 00:50:43,640 --> 00:50:44,360 >>GREAT. 1143 00:50:44,360 --> 00:50:45,560 THANK YOU. 1144 00:50:45,560 --> 00:50:51,160 THANK YOU, VERY MUCH. 1145 00:50:51,160 --> 00:50:52,400 YOU'VE GOT A SLIDE THAT YOU CAN 1146 00:50:52,400 --> 00:50:56,800 PROJECT AT THIS POINT. 1147 00:50:56,800 --> 00:50:58,520 >>WE'RE GOING TO MOVE ONTO THE 1148 00:50:58,520 --> 00:51:01,680 RECOGNITION OF A ROTATING MEMBER 1149 00:51:01,680 --> 00:51:04,760 AND WE'LL LEAVE THAT CAN YOU 1150 00:51:04,760 --> 00:51:08,720 BRING UP THE SLIDE. 1151 00:51:08,720 --> 00:51:10,480 >>OK. 1152 00:51:10,480 --> 00:51:11,800 SO, THANK YOU VERY MUCH. 1153 00:51:11,800 --> 00:51:14,240 SO, AS YOU KNOW, ANGIE DAVIS IS 1154 00:51:14,240 --> 00:51:16,560 ROTATING OFF CTAC AND WE REALLY 1155 00:51:16,560 --> 00:51:17,920 LIKE TO TAKE A MOMENT TO THANK 1156 00:51:17,920 --> 00:51:20,960 HER FOR HER DEDICATIONS AND HER 1157 00:51:20,960 --> 00:51:30,200 CONTRIBUTIONS TO CTAC. 1158 00:51:30,200 --> 00:51:32,000 I KNOW SHE'S BEEN A LEADER IN 1159 00:51:32,000 --> 00:51:33,600 THE CANCER RESEARCH COMMUNITY 1160 00:51:33,600 --> 00:51:37,800 AND FOR NCI AND SHE'S PROVIDED 1161 00:51:37,800 --> 00:51:39,400 SUBSTANTIAL SERVICES, NOT JUST 1162 00:51:39,400 --> 00:51:44,400 AS A CTAC MEMBER BUT A CHAIR OF 1163 00:51:44,400 --> 00:51:46,200 THE NATIONAL COUNCIL OF RESEARCH 1164 00:51:46,200 --> 00:51:46,480 ADVOCATES. 1165 00:51:46,480 --> 00:51:48,720 IT WAS A MEMBER OF CTAC 1166 00:51:48,720 --> 00:51:50,720 STRATEGIC PLANNING WORKSHOP 1167 00:51:50,720 --> 00:51:52,160 GROUP THAT PROVIDED IMPORTANT 1168 00:51:52,160 --> 00:51:54,440 RECOMMENDATIONS FOR MODERNIZING 1169 00:51:54,440 --> 00:51:57,280 NCI'S CLINICAL TRIALS SYSTEM. 1170 00:51:57,280 --> 00:52:00,000 SO, REALLY, THANK YOU SO MUCH 1171 00:52:00,000 --> 00:52:03,160 FOR YOUR SERVICE YOUR AMAZING 1172 00:52:03,160 --> 00:52:06,000 CONTRIBUTIONS AND WE REALLY HOPE 1173 00:52:06,000 --> 00:52:07,440 THIS ISN'T GOOD-BYE BUT WE LOOK 1174 00:52:07,440 --> 00:52:10,240 FORWARD TO WORKING WITH YOU IN 1175 00:52:10,240 --> 00:52:12,000 MANY WAYS, OTHER WAYS, IN THE 1176 00:52:12,000 --> 00:52:12,240 FUTURE. 1177 00:52:12,240 --> 00:52:16,080 THANK YOU SO MUCH. 1178 00:52:16,080 --> 00:52:17,520 >>>THANK YOU, ANGIE FOR 1179 00:52:17,520 --> 00:52:21,040 EVERYTHING THAT YOU DO EVERYDAY. 1180 00:52:21,040 --> 00:52:23,240 I'D LIKE TO MOVE ON TO THE NEXT 1181 00:52:23,240 --> 00:52:27,040 ITEM WHICH IS OUR LEGISLATIVE 1182 00:52:27,040 --> 00:52:27,280 UPDATE. 1183 00:52:27,280 --> 00:52:35,240 WE HAVE M.K.HOLOHAN TO GIVE HER 1184 00:52:35,240 --> 00:52:35,680 INSIGHTFUL REPORT. 1185 00:52:35,680 --> 00:52:37,440 YOU CAN CAN TELL US WHO IS 1186 00:52:37,440 --> 00:52:38,400 WINNING THE RACE THAT'S HAVEN'T 1187 00:52:38,400 --> 00:52:39,600 BEEN ANNOUNCED YET. 1188 00:52:39,600 --> 00:52:41,040 GIVE US THE INSIDE SCOOP. 1189 00:52:41,040 --> 00:52:42,240 WE'RE ALL EARS. 1190 00:52:42,240 --> 00:52:42,640 [LAUGHTER] 1191 00:52:42,640 --> 00:52:45,680 >>I WILL DO MY BEST. 1192 00:52:45,680 --> 00:52:48,240 THANK YOU, Dr. MEROPOL. 1193 00:52:48,240 --> 00:52:50,680 CAN CAN I HAVE THE SLIDES, 1194 00:52:50,680 --> 00:52:50,920 PLEASE. 1195 00:52:50,920 --> 00:52:52,120 THANK YOU FOR THE OPPORTUNITY TO 1196 00:52:52,120 --> 00:52:52,880 TALK WITH YOU TODAY AND I'M 1197 00:52:52,880 --> 00:52:56,520 GOING TO TRY TO BE QUICK. 1198 00:52:56,520 --> 00:53:04,520 Dr. BER -- SO, NEXT SLIDE, 1199 00:53:04,520 --> 00:53:05,000 PLEASE. 1200 00:53:05,000 --> 00:53:09,320 I'M GOING TO BRIEFLY COVER WHAT 1201 00:53:09,320 --> 00:53:11,120 WE KNOW ABOUT PRESIDENTIAL 1202 00:53:11,120 --> 00:53:12,680 APPOINTMENT WHAT WE KNOW ABOUT 1203 00:53:12,680 --> 00:53:14,240 THE ELECTIONS AND WE'RE GOING TO 1204 00:53:14,240 --> 00:53:17,080 TALK ABOUT APPROPRIATIONS FOR 1205 00:53:17,080 --> 00:53:20,360 FY23 AND 24 AND TOUCH ON THE 1206 00:53:20,360 --> 00:53:21,600 CANCER MOONSHOT AND ARPA-H AND 1207 00:53:21,600 --> 00:53:27,800 WHAT TO EXPECT FOR THE NAME DUCK 1208 00:53:27,800 --> 00:53:28,720 CONGRESS. 1209 00:53:28,720 --> 00:53:30,200 SO THE NIH DIRECTOR IS A 1210 00:53:30,200 --> 00:53:31,080 PRESIDENTIAL APPOINTMENT AND 1211 00:53:31,080 --> 00:53:32,480 EVERYONE KNOWS THAT AND THE NCI 1212 00:53:32,480 --> 00:53:34,160 IS THE ONLY INSTITUTE AT NIH 1213 00:53:34,160 --> 00:53:36,160 THAT ALSO HAS A PRESIDENTIAL 1214 00:53:36,160 --> 00:53:46,640 APPOINTEE AS THEIR DIRECTOR. 1215 00:53:54,400 --> 00:53:56,040 SO THAT VERY EXCITING. 1216 00:53:56,040 --> 00:53:57,520 PRESIDENT JOE BIDEN IS ALSO 1217 00:53:57,520 --> 00:53:58,320 NOMINATED THREE ACCOMPLISHED 1218 00:53:58,320 --> 00:53:59,640 CANCER RESEARCHERS TO SERVE ON 1219 00:53:59,640 --> 00:54:01,240 THE PRESIDENT'S CANCER PANEL 1220 00:54:01,240 --> 00:54:05,000 INCLUDING Dr. LIZ JAFFY WHO 1221 00:54:05,000 --> 00:54:07,560 WAS THE CHAIR OF THE NATIONAL 1222 00:54:07,560 --> 00:54:09,360 CANCER BOARD FOR NCI AND PLAYED 1223 00:54:09,360 --> 00:54:10,400 A LARGE LEADERSHIP ROLE IN THE 1224 00:54:10,400 --> 00:54:19,040 INITIAL CANCER MOON SHOOT AND IN 1225 00:54:19,040 --> 00:54:19,920 SEPTEMBER, PRESIDENT JOE BIDEN 1226 00:54:19,920 --> 00:54:22,240 FOR HEALTH IT'S EXPECTED TO TAKE 1227 00:54:22,240 --> 00:54:24,080 ON RESEARCH CHALLENGES AND 1228 00:54:24,080 --> 00:54:25,800 CONGRESS HAS MADE IF CLEAR THEY 1229 00:54:25,800 --> 00:54:27,360 EXPECT WORK IN THE AREAS OF 1230 00:54:27,360 --> 00:54:30,120 CANCER, DIABETES AND ALS AND 1231 00:54:30,120 --> 00:54:30,440 ALZHEIMER'S. 1232 00:54:30,440 --> 00:54:32,320 NEXT SLIDE, PLEASE. 1233 00:54:32,320 --> 00:54:35,000 SO, I REALLY THOUGHT THAT I WAS 1234 00:54:35,000 --> 00:54:37,360 GOING TO HAVE FANTASTIC INSIGHTS 1235 00:54:37,360 --> 00:54:38,760 AND I WOULD BE ABLE TO GIVE YOU 1236 00:54:38,760 --> 00:54:41,680 SOME REALLY DEFINITIVE 1237 00:54:41,680 --> 00:54:41,960 INFORMATION. 1238 00:54:41,960 --> 00:54:43,400 WHAT I CAN CAN TELL YOU RIGHT 1239 00:54:43,400 --> 00:54:44,320 NOW IN THE TIME WE'VE BEEN IN 1240 00:54:44,320 --> 00:54:47,000 THIS MEETING, THE SENATE NUMBERS 1241 00:54:47,000 --> 00:54:49,200 IS NOW 49-48. 1242 00:54:49,200 --> 00:54:50,800 RON JOHNSON IN WHICH IS CON SON 1243 00:54:50,800 --> 00:54:52,960 HAS HELD ON TO HIS SEAT, THEY 1244 00:54:52,960 --> 00:54:56,960 CALLED THAT JUST A FEW MINUTES 1245 00:54:56,960 --> 00:54:59,600 AGO AND THE SENATE MAY NOT BE 1246 00:54:59,600 --> 00:55:00,680 DECIDED UNTIL DECEMBER AND IT'S 1247 00:55:00,680 --> 00:55:02,280 LOOKING LIKELY. 1248 00:55:02,280 --> 00:55:04,920 IF THE DEMS HOLD ARIZONA IT'S 1249 00:55:04,920 --> 00:55:07,120 ABOUT 51-46 CURRENTLY AND THE 1250 00:55:07,120 --> 00:55:10,320 Rs FLIP NEVADA IT'S ABOUT 1251 00:55:10,320 --> 00:55:12,160 49-47 THEN GEORGIA WILL ONCE 1252 00:55:12,160 --> 00:55:13,200 AGAIN DECIDE CONTROL OF THE 1253 00:55:13,200 --> 00:55:14,760 SENATE AND THERE'S I THINK 1254 00:55:14,760 --> 00:55:16,520 EVERYONE KNOWS THIS BY NOW, YOU 1255 00:55:16,520 --> 00:55:20,440 NEED 50% PLUS ONE IN GEORGIA TO 1256 00:55:20,440 --> 00:55:21,800 WIN OUTRIGHT. 1257 00:55:21,800 --> 00:55:27,040 IT DOESN'T LOOK LIKE SENATOR 1258 00:55:27,040 --> 00:55:28,520 WORNAK WILL GET THERE SO WE MAY 1259 00:55:28,520 --> 00:55:29,920 NOT KNOW WHAT THE SITUATION IN 1260 00:55:29,920 --> 00:55:31,560 THE SENATE UNTIL THEN AND THE 1261 00:55:31,560 --> 00:55:35,960 HOUSE, RIGHT NOW, IS STILL 1262 00:55:35,960 --> 00:55:37,440 184-202. 1263 00:55:37,440 --> 00:55:40,000 184 DEMS TO 202 Rs. 1264 00:55:40,000 --> 00:55:45,280 THE DEMOCRATIC CAMPAIGN 1265 00:55:45,280 --> 00:55:47,480 CONGRESSIONAL CAMPAIGN COMMITTEE 1266 00:55:47,480 --> 00:55:53,000 CHAIRMAN, THE DCCCC, JOHN 1267 00:55:53,000 --> 00:55:54,840 PATRICK MALONEY CONCEDED THEIR 1268 00:55:54,840 --> 00:55:56,800 RACE AND THEY HAVEN'T LOST TO 1269 00:55:56,800 --> 00:55:58,600 THE OTHER SIDE SINCE 1980 SO 1270 00:55:58,600 --> 00:56:00,520 IT'S A BIGGY MOTIONAL LOSS RIGHT 1271 00:56:00,520 --> 00:56:02,120 THERE AND IT ALSO LOOKS LIKE 1272 00:56:02,120 --> 00:56:08,480 LAUREN BOBERT FROM COLORADO'S 1273 00:56:08,480 --> 00:56:09,560 THIRD DISTRICT, IT LOOKS LIKE 1274 00:56:09,560 --> 00:56:13,720 SHE LOST HER SEAT TO ADAM RICH. 1275 00:56:13,720 --> 00:56:16,520 WE CAN SAY THERE WAS NO RED 1276 00:56:16,520 --> 00:56:16,720 WAVE. 1277 00:56:16,720 --> 00:56:18,240 DEALS REALLY OUT PERFORMED 1278 00:56:18,240 --> 00:56:19,080 EXPECTATIONS AND HISTORY TELLS 1279 00:56:19,080 --> 00:56:20,680 US THAT THE PRESIDENT'S PARTY 1280 00:56:20,680 --> 00:56:25,720 LOSES SEATS IN MIDTERM ELECTIONS 1281 00:56:25,720 --> 00:56:27,000 AND IT SEEMS MUCH OF THE COUNTRY 1282 00:56:27,000 --> 00:56:28,360 IS READY TO MOVE ON TALKING 1283 00:56:28,360 --> 00:56:30,840 ABOUT THE RESULTS OF THE 2020 1284 00:56:30,840 --> 00:56:34,680 PRESIDENTIAL ELECTIONS. 1285 00:56:34,680 --> 00:56:36,520 THIS IS A BIT OF HISTORY. 1286 00:56:36,520 --> 00:56:39,360 THERE'S ONLY BEEN TWICE SINCE 1287 00:56:39,360 --> 00:56:41,080 THE MID-40S THAT THE PRESIDENT 1288 00:56:41,080 --> 00:56:44,080 PARTY HASN'T LOST SEATS IN THE 1289 00:56:44,080 --> 00:56:46,480 HOUSE IN MIDTERMS AND THE FIRST 1290 00:56:46,480 --> 00:56:48,200 EXCEPTION WAS IN BILL CLINTON'S 1291 00:56:48,200 --> 00:56:49,880 SECOND TERM AND THE SECOND WAS 1292 00:56:49,880 --> 00:56:52,240 IN GEORGE W. BUSH'S FIRST TERM 1293 00:56:52,240 --> 00:56:54,160 RIGHT AFTER 9/11. 1294 00:56:54,160 --> 00:56:54,960 WE ANTICIPATED DEMS LOSING SEATS 1295 00:56:54,960 --> 00:56:56,560 WHAT WE TOO KNOW IS HOW MANY 1296 00:56:56,560 --> 00:57:00,400 THEY WILL LOSE. 1297 00:57:00,400 --> 00:57:02,000 ONE THING THAT IS REALLY 1298 00:57:02,000 --> 00:57:03,400 IMPORTANT TO NOTE HERE AND MOST 1299 00:57:03,400 --> 00:57:05,800 OF THE POLITICAL PROGOSTICATOR 1300 00:57:05,800 --> 00:57:07,240 ARE SAYING THIS MORNING IT LOOKS 1301 00:57:07,240 --> 00:57:08,680 LIKE THE REPUBLICANS WILL TAKE 1302 00:57:08,680 --> 00:57:09,920 CONTROL OF THE HOUSE AND FLIP 1303 00:57:09,920 --> 00:57:16,880 THE MAJORITY. 1304 00:57:16,880 --> 00:57:18,120 THE EXPRESSIONS ELECTIONS MATTER 1305 00:57:18,120 --> 00:57:20,200 IS TRUE BUT MAJORITIES MATTER 1306 00:57:20,200 --> 00:57:20,440 ALSO. 1307 00:57:20,440 --> 00:57:22,280 HAVING A VERY SLIM MA COR TEE 1308 00:57:22,280 --> 00:57:24,760 MAKES IT VERY HARD FOR THE 1309 00:57:24,760 --> 00:57:35,240 LEADERS OF THAT PARTY IF KEVIN 1310 00:57:36,920 --> 00:57:38,440 McCARTHY WILL BE THE SPEAKER 1311 00:57:38,440 --> 00:57:40,120 HE WILL NAVIGATE THAT AS WELL 1312 00:57:40,120 --> 00:57:42,680 AND HE CAN BE VERY HAM STRUNG IF 1313 00:57:42,680 --> 00:57:45,040 THEY TOO HAVE ENOUGH VOTES TO 1314 00:57:45,040 --> 00:57:51,920 MOVE THINGS WITHOUT PLACATING 1315 00:57:51,920 --> 00:57:55,000 EVERYONE. 1316 00:57:55,000 --> 00:57:57,640 SO I WANTED TO TALK ABOUT HOW 1317 00:57:57,640 --> 00:57:59,640 NCI RECEIVES ITS FUNDING. 1318 00:57:59,640 --> 00:58:02,400 UNLIKE OTHER ICs AT THE NIH, 1319 00:58:02,400 --> 00:58:03,880 NCI HAS THE AUTHORITY AND THE 1320 00:58:03,880 --> 00:58:06,200 OBLIGATION, IT'S ACTUALLY IN OUR 1321 00:58:06,200 --> 00:58:07,400 STATUTE OF THE NATIONAL CANCER 1322 00:58:07,400 --> 00:58:11,040 ACT, TO PRESENT A PROFESSIONAL 1323 00:58:11,040 --> 00:58:12,400 BUDGET TO CONGRESS AND THE WHITE 1324 00:58:12,400 --> 00:58:13,280 HOUSE EACH YEAR. 1325 00:58:13,280 --> 00:58:14,800 YOU WILL HEAR THIS PREFERED TO 1326 00:58:14,800 --> 00:58:20,560 AREFERRED TOAS THE BY PASS. 1327 00:58:20,560 --> 00:58:22,160 IT'S REFERENCING THAT IT BY 1328 00:58:22,160 --> 00:58:24,080 PASSES THE TRADITIONAL BUDGET 1329 00:58:24,080 --> 00:58:27,040 PROCESS WHICH HAPPENS WITH EVERY 1330 00:58:27,040 --> 00:58:28,080 FEDERAL AGENCY AND MANAGEMENT 1331 00:58:28,080 --> 00:58:29,080 AND BUDGET. 1332 00:58:29,080 --> 00:58:31,360 THAT'S THE OFFICIAL PRESIDENT'S 1333 00:58:31,360 --> 00:58:32,360 BUDGET REQUEST AND NCI HAS THE 1334 00:58:32,360 --> 00:58:35,160 OPPORTUNITY TO IT THEIR OWN. 1335 00:58:35,160 --> 00:58:36,520 THIS PROVIDES AN OPPORTUNITY TO 1336 00:58:36,520 --> 00:58:39,280 PRESENT A PLAN FOR WHAT THE 1337 00:58:39,280 --> 00:58:40,000 INSTITUTES' LEADERSHIP BELIEVES 1338 00:58:40,000 --> 00:58:41,360 IS APPROPRIATE FOR THE SIZE AND 1339 00:58:41,360 --> 00:58:42,680 SCOPE OF INVESTMENT IN CANCER 1340 00:58:42,680 --> 00:58:44,240 RESEARCH AND TO TAKE ADVANTAGE 1341 00:58:44,240 --> 00:58:44,880 OF OPPORTUNITIES. 1342 00:58:44,880 --> 00:58:48,640 SO THE TIMING GETS A LITTLE BIT 1343 00:58:48,640 --> 00:58:49,320 CONFUSING. 1344 00:58:49,320 --> 00:58:51,960 SO, THE PIGGY BANK AT THE 1345 00:58:51,960 --> 00:58:53,520 FAR-LEFT BEFORE STEP ONE IS 1346 00:58:53,520 --> 00:58:57,280 SUPPOSED TO SHOW WE SUBMIT OUR 1347 00:58:57,280 --> 00:59:02,320 PROFESSIONAL JUDGE JUDGMENT BUDT 1348 00:59:02,320 --> 00:59:04,080 BEFORE TWO FISCAL YEARS EARLIER. 1349 00:59:04,080 --> 00:59:05,880 SO WE WERE WORKING ON THAT IN 1350 00:59:05,880 --> 00:59:08,640 FISCAL YEAR '22 AND WE SUBMITTED 1351 00:59:08,640 --> 00:59:10,600 IT AND RELEASED IT IN FISCAL 1352 00:59:10,600 --> 00:59:13,400 YEAR IN '22 SEPTEMBER 15th AND 1353 00:59:13,400 --> 00:59:15,400 FISCAL YEAR '23, CAN WE GO BACK 1354 00:59:15,400 --> 00:59:16,640 TO THAT SLIDE. 1355 00:59:16,640 --> 00:59:20,680 FISCAL YEAR '23, GANNON 1356 00:59:20,680 --> 00:59:22,880 OCTOBER 1st. 1357 00:59:22,880 --> 00:59:27,560 SO, WE SUBMITTED FOR OUR FY 1358 00:59:27,560 --> 00:59:29,120 '24 PROFESSIONAL BUDGET ON 1359 00:59:29,120 --> 00:59:32,080 SEPTEMBER 15th, 2022. 1360 00:59:32,080 --> 00:59:34,320 THEN WHAT THE BUDGET YEAR WE ARE 1361 00:59:34,320 --> 00:59:40,080 IN NOW, IT'S FY '23 AS WE ARE ON 1362 00:59:40,080 --> 00:59:43,040 A CONTINUING RESOLUTION THROUGH 1363 00:59:43,040 --> 00:59:44,360 DECEMBER 16th. 1364 00:59:44,360 --> 00:59:45,080 THEY HAVEN'T MADE A LOT OF 1365 00:59:45,080 --> 00:59:46,200 PROGRESS FROM THE PAST SEVERAL 1366 00:59:46,200 --> 00:59:48,400 MONTHS BECAUSE THE MIDTERMS 1367 00:59:48,400 --> 00:59:49,880 REALLY WERE, THE NEGOTIATIONS 1368 00:59:49,880 --> 00:59:51,840 WILL NOT BE BEGIN IN EARNEST 1369 00:59:51,840 --> 00:59:53,800 UNTIL CONGRESS COMES BACK 1370 00:59:53,800 --> 00:59:54,400 NOVEMBER 14th. 1371 00:59:54,400 --> 00:59:55,480 THE COMMITTEE CHAIRS AND THE 1372 00:59:55,480 --> 00:59:58,680 LEADERSHIP KNOWS THE HAND 1373 00:59:58,680 --> 00:59:59,280 THEY'RE DEALT SOME THEY'LL 1374 00:59:59,280 --> 01:00:01,320 DECIDE WHAT THEY'RE GOING TO DO 1375 01:00:01,320 --> 01:00:03,640 WITH FY '23 AND WILL THEY GET 1376 01:00:03,640 --> 01:00:05,320 CONSENSUS TO MOVE FORWARD WITH 1377 01:00:05,320 --> 01:00:05,680 THAT. 1378 01:00:05,680 --> 01:00:07,920 SO, WE'RE IN THE BETWEEN STEPS 2 1379 01:00:07,920 --> 01:00:10,240 AND 3 SO WE'VE HAD THE HEARINGS 1380 01:00:10,240 --> 01:00:13,600 ON THE FY23 BUDGET PROPOSAL AND 1381 01:00:13,600 --> 01:00:15,120 WE ARE WAITING TO SEE WHAT 1382 01:00:15,120 --> 01:00:19,480 CONGRESS DOES WITH THAT AND OUR 1383 01:00:19,480 --> 01:00:21,000 FY '24 PROFESSIONAL BUDGET 1384 01:00:21,000 --> 01:00:25,640 RELATES TO THE PRESIDENT'S FY 1385 01:00:25,640 --> 01:00:27,120 '24 REQUEST WHICH WILL GO TO 1386 01:00:27,120 --> 01:00:28,320 CONGRESS USUALLY IT'S THE SECOND 1387 01:00:28,320 --> 01:00:31,400 WEEK OF FEBRUARY. 1388 01:00:31,400 --> 01:00:33,720 SO OMB WORKS ACROSS THE FEDERAL 1389 01:00:33,720 --> 01:00:35,800 GOVERNMENT TO FORMULATE THAT 1390 01:00:35,800 --> 01:00:36,760 PRESIDENT'S BUDGET REQUEST. 1391 01:00:36,760 --> 01:00:38,200 THEY WORK WITH EVERY AGENCY AND 1392 01:00:38,200 --> 01:00:39,400 WE PARTICIPATE IN THAT PROCESS 1393 01:00:39,400 --> 01:00:41,640 AS WELL AS PART OF THE NIH. 1394 01:00:41,640 --> 01:00:45,560 AND NEXT SLIDE, PLEASE. 1395 01:00:45,560 --> 01:00:48,840 WE HAVE BEEN TALKING A BIT ABOUT 1396 01:00:48,840 --> 01:00:49,840 NCI PROFESSIONAL BUDGET BUDGET 1397 01:00:49,840 --> 01:00:51,080 THE PRESIDENT'S BUDGET REQUEST 1398 01:00:51,080 --> 01:00:52,560 AND IT'S IMPORTANT TO PUT THESE 1399 01:00:52,560 --> 01:00:53,640 IN CONTEXT. 1400 01:00:53,640 --> 01:00:55,240 THESE ARE JUST REQUESTS. 1401 01:00:55,240 --> 01:00:57,000 THE CONSTITUTION GIVES CONGRESS 1402 01:00:57,000 --> 01:00:58,600 THE POWER OF THE PURSE, THEY CAN 1403 01:00:58,600 --> 01:01:00,160 RAISE TAXES ORIGIN RATE MONEY 1404 01:01:00,160 --> 01:01:02,080 AND THEY CAN SPEND MONEY AND THE 1405 01:01:02,080 --> 01:01:04,920 EXECUTIVE BRANCH CAN'T DO THAT. 1406 01:01:04,920 --> 01:01:06,520 YOU OFTEN HEAR APPROPRIATORS 1407 01:01:06,520 --> 01:01:09,160 TAKE THIS SERIOUSLY AND YOU 1408 01:01:09,160 --> 01:01:12,240 OFTEN HEAR THEM QUOTING SLITLY 1409 01:01:12,240 --> 01:01:13,440 QUOTING FRANKLIN ROOSEVELT WHO 1410 01:01:13,440 --> 01:01:14,720 SAID IT'S THE DUTY OF THE 1411 01:01:14,720 --> 01:01:16,600 PRESIDENT TO PROPOSE AND IT'S A 1412 01:01:16,600 --> 01:01:18,040 PRIVILEGE OF CONGRESS TO 1413 01:01:18,040 --> 01:01:18,440 DISPOSE. 1414 01:01:18,440 --> 01:01:21,160 YOU OFTEN HEAR APPROPRIATORS SAY 1415 01:01:21,160 --> 01:01:23,320 THE PRESIDENT PROPOSES AND 1416 01:01:23,320 --> 01:01:24,320 CONGRESS DISPOSES. 1417 01:01:24,320 --> 01:01:26,200 THEY HAVE THE FINAL SAY ON WHAT 1418 01:01:26,200 --> 01:01:27,520 PROGRAMS, WHAT AGENCIES GET WHAT 1419 01:01:27,520 --> 01:01:28,840 LEVELS OF FUNDING. 1420 01:01:28,840 --> 01:01:30,320 AND HOW LONG THEY HAVE TO SPEND 1421 01:01:30,320 --> 01:01:32,480 THAT MONEY AND WHAT THEY CAN 1422 01:01:32,480 --> 01:01:33,960 SPECIFY DELIVERABLES AND 1423 01:01:33,960 --> 01:01:35,080 REPORTING OUT BASED ON THE MONEY 1424 01:01:35,080 --> 01:01:37,560 THAT THEY'RE GIVING TO EXECUTIVE 1425 01:01:37,560 --> 01:01:40,360 BRANCHES AND AGENCIES. 1426 01:01:40,360 --> 01:01:42,600 NOW, WE WOULD EXPECT THAT THE 1427 01:01:42,600 --> 01:01:44,760 PRESIDENT'S PARTY WOULD STRIVE 1428 01:01:44,760 --> 01:01:46,720 TO THEREFORE FUNDING PRESSURE 1429 01:01:46,720 --> 01:01:56,560 REFLECTED ITHEIR FUNDING BUT ITE 1430 01:01:56,560 --> 01:01:59,040 50/50 SENATE AND ONE PARTY 1431 01:01:59,040 --> 01:02:00,720 CONTROLS ONE OF THE CHAMBERS. 1432 01:02:00,720 --> 01:02:01,680 APPROPRIATORS HAVE TO WORK 1433 01:02:01,680 --> 01:02:06,040 TOGETHER EACH YEAR TO DELIVER 1434 01:02:06,040 --> 01:02:12,680 FUNDING BILLS THEY MAY NOT 1435 01:02:12,680 --> 01:02:15,280 ADVANCE AMOUNT OF LEGISLATION. 1436 01:02:15,280 --> 01:02:17,960 APPROPRIATORS HAVE TO DO THEIR 1437 01:02:17,960 --> 01:02:18,200 WORK. 1438 01:02:18,200 --> 01:02:20,760 SO THE CULTURE IS DIFFERENT AND 1439 01:02:20,760 --> 01:02:23,200 FORTUNATELY, THEY ARE OFTEN LESS 1440 01:02:23,200 --> 01:02:24,760 PARTISAN AND MORE PRAGMATIC THAN 1441 01:02:24,760 --> 01:02:26,680 WE SEE SOMETIMES IN OTHER 1442 01:02:26,680 --> 01:02:29,360 COMMITTEES AND NIH AND NCI HAVE 1443 01:02:29,360 --> 01:02:31,040 BEEN FORTUNATE EVEN IN REALLY 1444 01:02:31,040 --> 01:02:32,040 BITTERLY PARTISAN TIMES THE 1445 01:02:32,040 --> 01:02:33,760 MEMBERS OF OUR SUBCOMMITTEE HAVE 1446 01:02:33,760 --> 01:02:36,320 MADE BIOMEDICAL RESEARCH AND NIH 1447 01:02:36,320 --> 01:02:38,520 AND NCI IN PARTICULAR, A 1448 01:02:38,520 --> 01:02:39,120 PRIORITY. 1449 01:02:39,120 --> 01:02:40,480 THERE'S A LOT OF CHAMPIONS OF 1450 01:02:40,480 --> 01:02:42,640 BIO MEDICAL RESEARCH RETIRING IN 1451 01:02:42,640 --> 01:02:44,080 SENATE APPROPRIATIONS SO WE ARE 1452 01:02:44,080 --> 01:02:45,480 VERY HOPEFUL THAT THIS CONTINUES 1453 01:02:45,480 --> 01:02:48,120 TO BE A PRIORITY. 1454 01:02:48,120 --> 01:02:50,080 THIS SLIDE SHOWS US HEARINGS 1455 01:02:50,080 --> 01:02:53,120 FROM THE FY23 BUDGET REQUEST 1456 01:02:53,120 --> 01:02:54,360 HEARINGS IN THE HOUSE AND 1457 01:02:54,360 --> 01:02:54,600 SENATE. 1458 01:02:54,600 --> 01:02:57,600 THE PICTURE, THESE HAPPENED 1459 01:02:57,600 --> 01:02:58,480 LATE. 1460 01:02:58,480 --> 01:02:59,640 TYPICALLY THEY WOULD BE MARCH OR 1461 01:02:59,640 --> 01:03:00,960 APRIL BUT THE BUDGET REQUEST 1462 01:03:00,960 --> 01:03:02,840 WASN'T RELEASED UNTIL 1463 01:03:02,840 --> 01:03:04,160 MARCH 29th SO THAT WAS A GOOD 1464 01:03:04,160 --> 01:03:05,800 FIVE OR SIX WEEKS AFTER IT WOULD 1465 01:03:05,800 --> 01:03:08,640 BE EXPECTED. 1466 01:03:08,640 --> 01:03:11,560 TO THE RIGHT YOU SEE Dr. LARRY 1467 01:03:11,560 --> 01:03:13,840 TABAK AND TONY FAUCI AT WHAT 1468 01:03:13,840 --> 01:03:15,640 TURNED OUT TO BE HIS LAST 1469 01:03:15,640 --> 01:03:16,760 APPROPRIATIONS HEARING IN THE 1470 01:03:16,760 --> 01:03:20,480 SENATE AND Dr. LOWY 1471 01:03:20,480 --> 01:03:21,080 REPRESENTED NCI AT THE HOUSE 1472 01:03:21,080 --> 01:03:22,960 HEARING AND THERE WERE A LOT OF 1473 01:03:22,960 --> 01:03:25,520 THOUGHTFUL COMMENTS FROM THE 1474 01:03:25,520 --> 01:03:27,120 LEADERSHIP THAT THEY'RE AWARE OF 1475 01:03:27,120 --> 01:03:30,320 THE RANKING MEMBERS VERY AWARE 1476 01:03:30,320 --> 01:03:32,920 OF VOLUME OF APPLICATIONS TO END 1477 01:03:32,920 --> 01:03:33,920 NCI AND THEY UNDERSTAND PAYLINE 1478 01:03:33,920 --> 01:03:35,640 AND SUCCESS RATES AND THEY'RE 1479 01:03:35,640 --> 01:03:37,000 EXCITED ABOUT THE OPPORTUNITIES 1480 01:03:37,000 --> 01:03:38,240 FOR PROGRESS. 1481 01:03:38,240 --> 01:03:40,000 I LIKE THIS PHOTO OF Dr. LOWY 1482 01:03:40,000 --> 01:03:41,080 TALKING WITH THEM AFTER THE 1483 01:03:41,080 --> 01:03:42,200 HEARING AND THERE'S TWO POINTS I 1484 01:03:42,200 --> 01:03:43,040 WANT TO MAKE. 1485 01:03:43,040 --> 01:03:43,880 THESE MEMBERS HAVE WORKED 1486 01:03:43,880 --> 01:03:45,000 TOGETHER FOR A LONG TIME AND 1487 01:03:45,000 --> 01:03:46,680 THEY HAVE PASSED THE GAVEL BACK 1488 01:03:46,680 --> 01:03:48,040 AND FOURTH AND THEY MAY BE DOING 1489 01:03:48,040 --> 01:03:49,920 THAT AGAIN SOON. 1490 01:03:49,920 --> 01:03:51,280 THEY HAVE JOINTLY SUSTAINED MANY 1491 01:03:51,280 --> 01:03:54,960 YEARS OF SUSTAINED FUNDING 1492 01:03:54,960 --> 01:03:55,440 INCREASES. 1493 01:03:55,440 --> 01:03:57,040 BOTH MEMBERS, AS I SAID, THEY'RE 1494 01:03:57,040 --> 01:03:58,960 REALLY EDUCATED AND INFORMATION 1495 01:03:58,960 --> 01:04:00,400 ABOUT A LOT OF SPECIFIC CANCER 1496 01:04:00,400 --> 01:04:01,840 ISSUES AND THOSE ARE POSITIVE 1497 01:04:01,840 --> 01:04:03,280 THINGS FOR US AND WE'RE LOOKING 1498 01:04:03,280 --> 01:04:05,840 FORWARD TO THEM GETTING TO KNOW 1499 01:04:05,840 --> 01:04:11,920 Dr. BERTGNOLLI. 1500 01:04:11,920 --> 01:04:13,760 ONE THEME IN THE HOUSE AND 1501 01:04:13,760 --> 01:04:15,440 SENATE HEARINGS, YOU KNOW, THERE 1502 01:04:15,440 --> 01:04:17,040 WAS RECENT ACTIVITY AMONG 1503 01:04:17,040 --> 01:04:19,840 CONGRESS ABOUT THE ARPA-H 1504 01:04:19,840 --> 01:04:20,080 PROPOSAL. 1505 01:04:20,080 --> 01:04:21,160 THERE WAS BIG NUMBERS REQUESTED 1506 01:04:21,160 --> 01:04:23,320 FOR THEM TO START THEIR BUDGET. 1507 01:04:23,320 --> 01:04:26,720 I THINK IT WAS 6.5 BILLION WAS 1508 01:04:26,720 --> 01:04:27,000 REQUESTED. 1509 01:04:27,000 --> 01:04:29,480 THE MEMBERS WERE REALLY CLEAR, 1510 01:04:29,480 --> 01:04:30,840 THEY WANT MORE DETAILS AND THEY 1511 01:04:30,840 --> 01:04:32,440 TO NOT WANT FUNDING FOR THE NEW 1512 01:04:32,440 --> 01:04:35,480 AGENCY TO COME AT EXPENSE OF THE 1513 01:04:35,480 --> 01:04:37,600 SUSTAINED INCREASES FOR NIH AND 1514 01:04:37,600 --> 01:04:38,280 NCI THAT THEY'VE WORKED TOGETHER 1515 01:04:38,280 --> 01:04:40,520 FOR MANY YEARS AND SO THEY MAY 1516 01:04:40,520 --> 01:04:41,920 MADE COMMENTS AND I THINK THAT 1517 01:04:41,920 --> 01:04:43,600 THIS AGENCY IS JUST GETTING KIND 1518 01:04:43,600 --> 01:04:46,680 OF OFF OF GROUND AND THEY'LL BE 1519 01:04:46,680 --> 01:04:48,480 MET WITH RECENT ACTIVITY BUT 1520 01:04:48,480 --> 01:04:49,680 THEY'RE UNDER A LOT OF PRESSURE 1521 01:04:49,680 --> 01:04:52,560 TO MOVE QUICKLY AND SO IT'S 1522 01:04:52,560 --> 01:04:54,240 REALLY HELPFUL TO KNOW AND IT'S 1523 01:04:54,240 --> 01:04:55,520 REALLY CONSTRUCTIVE THAT THEY'RE 1524 01:04:55,520 --> 01:04:58,280 WORKING CLOSELY WITH OTHER PARTS 1525 01:04:58,280 --> 01:05:00,560 OF FEDERAL RESEARCH SCIENTIFIC 1526 01:05:00,560 --> 01:05:01,280 AGENCIES. 1527 01:05:01,280 --> 01:05:05,280 AND I WANTED TO SEE THE NEXT 1528 01:05:05,280 --> 01:05:09,040 SLIDE, PLEASE. 1529 01:05:09,040 --> 01:05:11,560 THESE ARE THE NUMBERS PROPOSED 1530 01:05:11,560 --> 01:05:12,800 FOR FY23. 1531 01:05:12,800 --> 01:05:13,720 THE NUMBER NUMBERS SHOWED THE 1532 01:05:13,720 --> 01:05:19,240 HOUSE AND THE SENATE PROPOSED 1533 01:05:19,240 --> 01:05:20,480 INCREASES FOR FY23. 1534 01:05:20,480 --> 01:05:22,600 THESE ARE NOT BIPARTISAN 1535 01:05:22,600 --> 01:05:23,320 NEGOTIATIONED NUMBERS. 1536 01:05:23,320 --> 01:05:25,760 THE HOUSE DID HAVE THE VOTES TO 1537 01:05:25,760 --> 01:05:27,360 MOVE THEIR BILL THROUGH 1538 01:05:27,360 --> 01:05:30,160 COMMITTEES AND THEY DID NOT 1539 01:05:30,160 --> 01:05:31,240 ACTUALLY HAVE THE VOTES TO MOVE 1540 01:05:31,240 --> 01:05:32,840 IT TO A FLOOR VOTE. 1541 01:05:32,840 --> 01:05:34,280 BECAUSE THEY HAD A MAJORITY THEY 1542 01:05:34,280 --> 01:05:34,720 MOVED THIS. 1543 01:05:34,720 --> 01:05:37,440 THIS IS NOT REFLECTING THE 1544 01:05:37,440 --> 01:05:39,720 MINORITY'S VIEW POINTS. 1545 01:05:39,720 --> 01:05:41,320 THE 466 MILLION-DOLLAR INCREASE 1546 01:05:41,320 --> 01:05:42,600 FOR NCI, ALSO THE SENATE, THEY 1547 01:05:42,600 --> 01:05:43,600 DIDN'T ACTUALLY HAVE THE VOTES 1548 01:05:43,600 --> 01:05:45,080 TO GET THEIR BILLS OUT OF 1549 01:05:45,080 --> 01:05:46,640 COMMITTEE SO THE MAJORITY 1550 01:05:46,640 --> 01:05:47,560 DEMOCRATS POSTED THE BILLS AND 1551 01:05:47,560 --> 01:05:50,040 THEY POSTED A DRAFT, THAT'S 1552 01:05:50,040 --> 01:05:51,520 THEIR PREROGATIVE AND BOTH SIDES 1553 01:05:51,520 --> 01:05:59,120 HAVE DONE THIS AND YOU SEE THE 1554 01:05:59,120 --> 01:05:59,960 LOWER NUMBERS THERE. 1555 01:05:59,960 --> 01:06:01,520 THE TWO PARTIES HAVE NOT AGREED 1556 01:06:01,520 --> 01:06:03,120 ON THE TOP-LEVEL SPLIT OF 1557 01:06:03,120 --> 01:06:04,440 DEFENSE VERSUS NON DEFENSE. 1558 01:06:04,440 --> 01:06:13,560 SO A GOOD 6 O% 60% IS MANDATOR. 1559 01:06:13,560 --> 01:06:15,400 REST IS DISCRETIONARY AND 1560 01:06:15,400 --> 01:06:16,640 PAYMENT ON THE DEBT. 1561 01:06:16,640 --> 01:06:20,400 SO THEY NEED TO -- THIS IS A 1562 01:06:20,400 --> 01:06:21,440 PERENNIAL DISPUTE ABOUT WHAT IS 1563 01:06:21,440 --> 01:06:23,040 THE SPLIT GOING TO BE. 1564 01:06:23,040 --> 01:06:25,600 REPUBLICANS ALWAYS WANT PARITY 1565 01:06:25,600 --> 01:06:27,440 AND 50/50 AND DEMOCRATS TEND TO 1566 01:06:27,440 --> 01:06:29,000 HAVE A TIVE VIEWPOINT AND THEY 1567 01:06:29,000 --> 01:06:31,200 MEET SOMEWHERE IN THE MIDDLE AND 1568 01:06:31,200 --> 01:06:33,520 ELECTION YEAR OBVIOUS WILL HE 1569 01:06:33,520 --> 01:06:35,040 MAKE THIS A LITTLE BIT TOUGHER 1570 01:06:35,040 --> 01:06:37,080 AND THERE'S ALSO OTHER ISSUES 1571 01:06:37,080 --> 01:06:39,400 ABOUT IMMIGRATION, BORDER 1572 01:06:39,400 --> 01:06:41,840 SECURITY, ABORTION RIGHTS, THESE 1573 01:06:41,840 --> 01:06:43,800 THINGS HAVE MADE IT MORE 1574 01:06:43,800 --> 01:06:45,360 COMPLICATE SOD WE EXPECT WHEN 1575 01:06:45,360 --> 01:06:46,520 CONGRESS COMES BACK ON THE 1576 01:06:46,520 --> 01:06:51,840 14th:14th THEY WILL GET BACK DON 1577 01:06:51,840 --> 01:06:53,160 TO THE BRASS ABOUT 1578 01:06:53,160 --> 01:06:53,560 APPROPRIATIONS. 1579 01:06:53,560 --> 01:06:55,680 ONE THING I NEED TO SAY HERE IS 1580 01:06:55,680 --> 01:06:59,480 IT'S NOT -- THE CR RUNS THROUGH 1581 01:06:59,480 --> 01:07:00,000 DECEMBER 16th. 1582 01:07:00,000 --> 01:07:01,920 IT'S NOT IMPOSSIBLE, IT'S NOT 1583 01:07:01,920 --> 01:07:02,840 LIKELY AND I DON'T THINK IT WILL 1584 01:07:02,840 --> 01:07:04,560 HAPPEN BUT IT'S NOT IMPOSSIBLE 1585 01:07:04,560 --> 01:07:06,280 THAT THEY WILL BE UNABLE TO 1586 01:07:06,280 --> 01:07:13,760 AGREE ON AN OMNIBUS FUNDING AS 1587 01:07:13,760 --> 01:07:15,320 WELL MANY OF IF THE REPUBLICANS 1588 01:07:15,320 --> 01:07:17,600 TAKE THE HOUSE THEY CAN IS MORE 1589 01:07:17,600 --> 01:07:19,040 SAY ABOUT THE FINAL NUMBERS. 1590 01:07:19,040 --> 01:07:20,760 THERE'S A STRONG MOTEL VISION TO 1591 01:07:20,760 --> 01:07:22,800 GET IT DONE FOR THE RETIRING 1592 01:07:22,800 --> 01:07:23,920 MEMBERS. 1593 01:07:23,920 --> 01:07:25,560 SENIOR REPUBLICAN APPROPRIATORS 1594 01:07:25,560 --> 01:07:26,920 NOT ONLY BECAUSE THEY WANT TO 1595 01:07:26,920 --> 01:07:29,960 FINISH THE BILLS WITH THEIR 1596 01:07:29,960 --> 01:07:31,440 IMPRINT ON THEM AND THEY WANT TO 1597 01:07:31,440 --> 01:07:33,000 GET WHAT WE'RE CALLING COMMUNITY 1598 01:07:33,000 --> 01:07:36,040 FUNDING PROJECTS NOW AND THEY'RE 1599 01:07:36,040 --> 01:07:37,160 EARMARKS THAT HAVE BEEN BROUGHT 1600 01:07:37,160 --> 01:07:40,200 BACK FOR LAST FISCAL YEAR AND 1601 01:07:40,200 --> 01:07:41,520 THIS FISCAL YEAR AND THEY DO 1602 01:07:41,520 --> 01:07:43,240 KNOW IF THEY'LL BE MAINTAINED IN 1603 01:07:43,240 --> 01:07:44,680 THE FUTURE AND THEY MAY NOT BE 1604 01:07:44,680 --> 01:07:45,800 SO WE'LL SEE WHAT HAPPENS BUT 1605 01:07:45,800 --> 01:07:48,280 THERE'S A LOT OF MOMENTUM TO GET 1606 01:07:48,280 --> 01:07:49,320 THESE BILLS DONE. 1607 01:07:49,320 --> 01:07:51,040 ALSO, IF YOU ARE TAKING OVER THE 1608 01:07:51,040 --> 01:07:55,640 MAJORITY IN THE 118th CON 1609 01:07:55,640 --> 01:07:56,360 118th CONGRESS, LEADERSHIP 1610 01:07:56,360 --> 01:07:58,720 MIGHT FEEL LIKE THEY DO WANT TO 1611 01:07:58,720 --> 01:08:01,000 DEAL WITH FY '23 AND THEY WANT 1612 01:08:01,000 --> 01:08:06,560 TO DEAL WITH A CLEAN SATE. 1613 01:08:06,560 --> 01:08:06,920 CLEAN SLATE. 1614 01:08:06,920 --> 01:08:08,480 I JUST WANTED TO POINT OUT THAT 1615 01:08:08,480 --> 01:08:11,080 THE TIMING OF THIS, WE DON'T -- 1616 01:08:11,080 --> 01:08:12,520 WE HAVE ASKED, TIVE DIRECTORS 1617 01:08:12,520 --> 01:08:13,840 HAVE TAKEN DIFFERENT APPROACHES 1618 01:08:13,840 --> 01:08:15,000 OVER TIME. 1619 01:08:15,000 --> 01:08:17,040 SOME HAVE BEEN VERY BIG 1620 01:08:17,040 --> 01:08:20,080 ASPIRATIONAL BUDGETS AND SOME 1621 01:08:20,080 --> 01:08:22,120 MUCH MORE MODEST ASKS AND SO WE 1622 01:08:22,120 --> 01:08:24,120 HAVE SEEN IF YOU TRACK THE TWO 1623 01:08:24,120 --> 01:08:26,080 TOGETHER OVER TIME, THEY HAVE 1624 01:08:26,080 --> 01:08:28,480 BOTH GONE UP OVER TIME WHICH IS 1625 01:08:28,480 --> 01:08:31,920 ENCOURAGING BUT WE HAVE NOT 1626 01:08:31,920 --> 01:08:33,240 SEEN, USUALLY NOT PARITY FOR 1627 01:08:33,240 --> 01:08:34,720 WHAT WE REQUEST WE GET BUT THIS 1628 01:08:34,720 --> 01:08:37,120 IS REALLY IMPORTANT TOO IS IT 1629 01:08:37,120 --> 01:08:38,400 EXPLAINS THE VISION AND THAT IS 1630 01:08:38,400 --> 01:08:40,000 WHY WE HAVE THE AUTHORITY TO SAY 1631 01:08:40,000 --> 01:08:42,560 WHAT IS IT REALLY GOING TO TAKE 1632 01:08:42,560 --> 01:08:45,920 AND NCI WE'RE ASKING YOU 1633 01:08:45,920 --> 01:08:49,680 DIRECTLY. 1634 01:08:49,680 --> 01:08:59,760 AND. 1635 01:09:53,480 --> 01:09:55,520 >>THAT WOULD TINKER WITH THIS 1636 01:09:55,520 --> 01:09:57,120 AND THE ONE THAT PASSED THE 1637 01:09:57,120 --> 01:10:00,200 HOUSE WOULD PUT ARPA-H WITHIN 1638 01:10:00,200 --> 01:10:01,880 HHS BUT NOT INSIDE NIH AND THE 1639 01:10:01,880 --> 01:10:07,520 SENATE BILL WAS A LITTLE BIT 1640 01:10:07,520 --> 01:10:09,320 MORE NOT HIRING ANYONE NOT 1641 01:10:09,320 --> 01:10:10,640 WORKED FOR NIH IN THROW YEARS 1642 01:10:10,640 --> 01:10:12,720 AND THEY COULDN'T BE IN THE DC 1643 01:10:12,720 --> 01:10:12,920 AREA. 1644 01:10:12,920 --> 01:10:19,400 I DON'T KNOW THAT'S GOING TO 1645 01:10:19,400 --> 01:10:21,560 MOVE BUT IT WON'T HAVE AN AFFECT 1646 01:10:21,560 --> 01:10:22,840 HOW THIS ORGANIZATION WILL WORK. 1647 01:10:22,840 --> 01:10:25,040 WE'LL SEE WHERE THEY GET PASSED 1648 01:10:25,040 --> 01:10:27,480 IF THEY PASS AUTHORIZATION 1649 01:10:27,480 --> 01:10:28,840 LEGISLATIONMENT WE'LL SEE WHAT 1650 01:10:28,840 --> 01:10:31,280 HAPPENS WITH THAT. 1651 01:10:31,280 --> 01:10:32,600 THERE'S NOT A LOT OF TIME LEFT 1652 01:10:32,600 --> 01:10:35,040 WHEN CONGRESS COMES BACK. 1653 01:10:35,040 --> 01:10:36,480 THERE'S 17 LEGISLATIVE DAYS 1654 01:10:36,480 --> 01:10:40,400 WHERE BOTH THE HOUSE AND SENATE 1655 01:10:40,400 --> 01:10:42,840 ARE IN SESSION BEFORE THE CR 1656 01:10:42,840 --> 01:10:43,080 EXPIRES. 1657 01:10:43,080 --> 01:10:48,200 WE HAVE APPROPRIATIONS GETTING 1658 01:10:48,200 --> 01:10:49,320 DONE BEFORE THE CHRISTMAS 1659 01:10:49,320 --> 01:10:50,600 HOLIDAY IT'S THE NATURE OF THE 1660 01:10:50,600 --> 01:10:50,960 BEAST. 1661 01:10:50,960 --> 01:10:53,440 WHEN THEY COME BACK ON THE 1662 01:10:53,440 --> 01:10:54,600 14th, THE FIFTH OF REPUBLICANS 1663 01:10:54,600 --> 01:10:56,440 THE HOUSE REPUBLICAN ALSO HAVE 1664 01:10:56,440 --> 01:11:00,160 THEIR ORGANIZING ELECTIONS AND 1665 01:11:00,160 --> 01:11:01,840 FIGURE OUT WHO WILL BE IN CHARGE 1666 01:11:01,840 --> 01:11:03,200 NEXT CONGRESS. 1667 01:11:03,200 --> 01:11:04,240 THE DEMOCRATS WILL HOLD THEIRS 1668 01:11:04,240 --> 01:11:05,280 AFTER THANKSGIVING SO THAT WILL 1669 01:11:05,280 --> 01:11:08,600 TAKE TIM FROM THEM. 1670 01:11:08,600 --> 01:11:10,600 SO WHEN THEY COME BACK IN THE 1671 01:11:10,600 --> 01:11:11,480 LAME DUCK CONGRESS THERE ARE 1672 01:11:11,480 --> 01:11:13,000 THINGS THEY NEED TO DO THEY NODE 1673 01:11:13,000 --> 01:11:14,320 TO PASS APPROPRIATIONS. 1674 01:11:14,320 --> 01:11:16,560 THEY NEED TO PASS THE NATIONAL 1675 01:11:16,560 --> 01:11:17,400 DEFENSE AUTHORIZATION ACT AND 1676 01:11:17,400 --> 01:11:19,960 SOME OF THE OTHER MUST PASS 1677 01:11:19,960 --> 01:11:20,800 LEGISLATION ROW AUTHORIZATION 1678 01:11:20,800 --> 01:11:23,760 AND SBIR THOSE WERE TUN BEFORE 1679 01:11:23,760 --> 01:11:28,400 THEY LEFT FOR THE MID TERMS TO 1680 01:11:28,400 --> 01:11:28,640 CAMPAIGN. 1681 01:11:28,640 --> 01:11:30,400 WE'LL SEE WHAT HAPPENS IF THEY 1682 01:11:30,400 --> 01:11:36,040 TAKE ON TALK ABOUT A HEALTH 1683 01:11:36,040 --> 01:11:37,600 OMNIBUS BILL, IT MIGHT ADDRESS 1684 01:11:37,600 --> 01:11:39,560 MORE EXTENDING MEDICATION 1685 01:11:39,560 --> 01:11:40,760 TELEHEALTH COVERAGE AFTER THE 1686 01:11:40,760 --> 01:11:42,480 PUBLIC-HEALTH EMERGENCY EXPIRES 1687 01:11:42,480 --> 01:11:44,800 IN JANUARY AND MAYBE FDA 1688 01:11:44,800 --> 01:11:48,720 LEGISLATION TO TAKE ON LDTs. 1689 01:11:48,720 --> 01:11:50,120 THE ADMINISTRATION MAY TRY AGAIN 1690 01:11:50,120 --> 01:11:52,200 TO GET FUNDING FOR MORE PANDEMIC 1691 01:11:52,200 --> 01:11:53,320 PREPAREDNESS AND COVID AND 1692 01:11:53,320 --> 01:12:02,040 ADDITIONAL AID FOR UKRAINE, NOT 1693 01:12:02,040 --> 01:12:04,640 WANTING AND AID AND WE'LL SEE A 1694 01:12:04,640 --> 01:12:13,600 LOT OF IT AND OF THE MIDTERMS 1695 01:12:13,600 --> 01:12:17,280 AND WE'RE HAPPY TO HEAR FROM YOU 1696 01:12:17,280 --> 01:12:17,880 OR YOUR STAFF. 1697 01:12:17,880 --> 01:12:24,320 THANK YOU, VERY MUCH. 1698 01:12:24,320 --> 01:12:26,000 >>THANK YOU FOR ALL OF THESE 1699 01:12:26,000 --> 01:12:26,760 INSIGHTS AS ALWAYS. 1700 01:12:26,760 --> 01:12:27,960 WE DON'T HAVE TIME FOR 1701 01:12:27,960 --> 01:12:30,920 DISCUSSION TODAY AND WE'LL POV 1702 01:12:30,920 --> 01:12:31,120 ALONG. 1703 01:12:31,120 --> 01:12:36,200 THANK YOU FOR JOINING US. 1704 01:12:36,200 --> 01:12:37,800 AND WE'RE 10 OR 15 MINUTES 1705 01:12:37,800 --> 01:12:40,840 BEHIND IN THE SCHEDULE. 1706 01:12:40,840 --> 01:12:41,600 WE'LL RECOUPE A FEW MINUTES HERE 1707 01:12:41,600 --> 01:12:42,520 AND THERE THROUGH THE REST OF 1708 01:12:42,520 --> 01:12:43,240 THE DAY. 1709 01:12:43,240 --> 01:12:45,720 WE'LL MOVE ON TO OUR NEXT ITEM 1710 01:12:45,720 --> 01:12:48,040 WHICH IS STREAMLINING THE 1711 01:12:48,040 --> 01:12:50,600 CLINICAL TRIALS WORKING GROUP 1712 01:12:50,600 --> 01:12:53,400 WHICH IS COMING FORWARD WITH AN 1713 01:12:53,400 --> 01:12:55,600 INTERIM REPORT TODAY. 1714 01:12:55,600 --> 01:12:56,440 THERE WILL BE AN ACTION ITEM FOR 1715 01:12:56,440 --> 01:12:58,360 THE COMMITTEE FOLLOWING 1716 01:12:58,360 --> 01:13:01,200 PRESENTATIONS DISCUSSIONS. 1717 01:13:01,200 --> 01:13:04,760 WHICH WILL BE A MOTION VOTE TO 1718 01:13:04,760 --> 01:13:06,720 ACCEPT THE INTERIM REPORT AS 1719 01:13:06,720 --> 01:13:08,960 PROVIDED THROUGH THE COMMITTEE 1720 01:13:08,960 --> 01:13:09,200 MEMBERS. 1721 01:13:09,200 --> 01:13:12,840 I WANT TO KICK THIS OFF WITH 1722 01:13:12,840 --> 01:13:14,240 SOME HISTORICAL PERSPECTIVE ON 1723 01:13:14,240 --> 01:13:17,640 HOW WE GOT TO WHERE WE ARE AND 1724 01:13:17,640 --> 01:13:22,000 THAN I'LL TURN THIS OVER TO 1725 01:13:22,000 --> 01:13:25,640 INTEREST MANTREKAR WHO IS 1726 01:13:25,640 --> 01:13:28,480 CO-CHAIRING THIS WORKING GROUP 1727 01:13:28,480 --> 01:13:30,440 AND HE IS PROFESSOR OF BIAS 1728 01:13:30,440 --> 01:13:36,760 STATS AND ONCOLOGY AND SHE'S IN 1729 01:13:36,760 --> 01:13:47,320 THE DEPARTMENT OF -- ABOUT THREE 1730 01:14:04,520 --> 01:14:07,240 YEARS AGO, CTAC STOOD UP A 1731 01:14:07,240 --> 01:14:11,320 STRATEGIC PLANNING WORKING GROUP 1732 01:14:11,320 --> 01:14:14,400 WHICH WAS CHARGED WITH STATING A 1733 01:14:14,400 --> 01:14:16,200 VISION IF YOU WILL, FOR WHAT THE 1734 01:14:16,200 --> 01:14:21,080 CLINICAL TRIALS SYSTEM IN 2030 1735 01:14:21,080 --> 01:14:24,160 AND BEYOND AND TO MAKE 1736 01:14:24,160 --> 01:14:26,560 RECOMMENDATIONS TO THE NCI, 1737 01:14:26,560 --> 01:14:29,080 ABOUT WHAT ARE THE STEPS THAT 1738 01:14:29,080 --> 01:14:32,000 SHOULD BE TAKEN BY NCI TO HELP 1739 01:14:32,000 --> 01:14:41,240 US ACHIEVE THAT VISION. 1740 01:14:41,240 --> 01:14:48,640 IT CAME OUT IN NOVEMBER OF 2020 1741 01:14:48,640 --> 01:14:53,200 THAT STATED THE ENVISIONING OF A 1742 01:14:53,200 --> 01:14:55,680 MORE FLEXIBLE, FASTER, SIMPLER, 1743 01:14:55,680 --> 01:14:58,760 LESS EXPENSIVE AND HIGH-IMPACT 1744 01:14:58,760 --> 01:15:01,320 CLINICAL TRIALS SYSTEM THAT 1745 01:15:01,320 --> 01:15:03,560 WOULD SEAMLESSLY INTEGRATE 1746 01:15:03,560 --> 01:15:08,240 RESEARCH AND CLINICAL PRACTICE 1747 01:15:08,240 --> 01:15:15,720 AS INTEREST BERTAGNOLLI 1748 01:15:15,720 --> 01:15:16,880 REPORTED. 1749 01:15:16,880 --> 01:15:18,320 IT HAD THREE OPERATIONAL 1750 01:15:18,320 --> 01:15:19,640 INITIATIVES SPANNING EIGHT 1751 01:15:19,640 --> 01:15:22,080 THEMES, THOSE EIGHT THEMES ARE 1752 01:15:22,080 --> 01:15:26,880 LISTED HERE AN INCLUDE TRIAL 1753 01:15:26,880 --> 01:15:29,000 ACTIVITIES, PROMOTING ACCRUAL 1754 01:15:29,000 --> 01:15:31,440 AND ACCESS, NEW APPROACHES TO 1755 01:15:31,440 --> 01:15:35,000 DATA COLLECTION, PROs, FOR 1756 01:15:35,000 --> 01:15:38,240 CLINICAL TRIALS, AND OPERATIONAL 1757 01:15:38,240 --> 01:15:41,400 BURDEN, STATISTICAL 1758 01:15:41,400 --> 01:15:43,360 ENHANCEMENTS, AND WORKFORCE 1759 01:15:43,360 --> 01:15:48,800 OUTREACH AND TRAINING. 1760 01:15:48,800 --> 01:15:50,560 NEXT SLIDE, PLEASE. 1761 01:15:50,560 --> 01:15:55,800 SO THE NCA IN CONSIDERING THE 1762 01:15:55,800 --> 01:15:58,360 RECOMMENDATIONS OF THE STRATEGIC 1763 01:15:58,360 --> 01:16:01,400 PLANNING WORKING GROUP, 1764 01:16:01,400 --> 01:16:02,840 UNDERTOOK SIPS THAT TIME A 1765 01:16:02,840 --> 01:16:06,400 SERIES OF INITIATIVES RELATED TO 1766 01:16:06,400 --> 01:16:12,080 THE REPORT AND ONE OF THE THINGS 1767 01:16:12,080 --> 01:16:17,120 THAT WAS SET UP TO HELP THE NCI 1768 01:16:17,120 --> 01:16:18,360 FURTHER ADDRESS CERTAIN ASPECTS 1769 01:16:18,360 --> 01:16:20,880 OF THE STRATEGIC PLAN, WAS 1770 01:16:20,880 --> 01:16:22,720 ESTABLISHING A STREAMLINING 1771 01:16:22,720 --> 01:16:23,680 CLINICAL TRIALS WORKING GROUP 1772 01:16:23,680 --> 01:16:27,800 WHICH IS A SUB GROUP OF CTAC. 1773 01:16:27,800 --> 01:16:30,080 THIS WORKING GROUP WAS 1774 01:16:30,080 --> 01:16:33,680 ESTABLISHED IN JULY OF 2021 AND 1775 01:16:33,680 --> 01:16:35,560 IT WAS CHARGED WITH ADDRESSING 1776 01:16:35,560 --> 01:16:43,560 THE IMPLEMENTATION OF THREE MANY 1777 01:16:43,560 --> 01:16:47,680 OF RECOMMENDATIONS LISTED ON 1778 01:16:47,680 --> 01:16:57,880 THIS SLIDE. 1779 01:17:04,800 --> 01:17:06,760 AND THE THIRD TO ENGAGE HEALTH 1780 01:17:06,760 --> 01:17:08,200 RECORDS AND CLINICAL TRIAL 1781 01:17:08,200 --> 01:17:09,640 MANAGEMENT SYSTEM VENDORS TO 1782 01:17:09,640 --> 01:17:12,960 CREATE MECHANISMS FOR 1783 01:17:12,960 --> 01:17:16,160 INTEGRATING STUDY-SPECIFIC 1784 01:17:16,160 --> 01:17:17,720 DOCUMENTS INTO LOCAL 1785 01:17:17,720 --> 01:17:23,920 IMPLEMENTATIONS OF THEIR 1786 01:17:23,920 --> 01:17:24,160 PRODUCTS. 1787 01:17:24,160 --> 01:17:29,320 THE CLINICAL TRIALS WORKING 1788 01:17:29,320 --> 01:17:34,000 GROUP, MEMBERS ARE LISTED HERE 1789 01:17:34,000 --> 01:17:34,720 FOR REFERENCE. 1790 01:17:34,720 --> 01:17:37,240 MANY OF THESE FOLKS ARE ON THE 1791 01:17:37,240 --> 01:17:38,120 CALL TODAY. 1792 01:17:38,120 --> 01:17:41,560 AND NEXT SLIDE, PLEASE. 1793 01:17:41,560 --> 01:17:45,520 THE QUESTION ARISES WHY AN 1794 01:17:45,520 --> 01:17:47,000 INTERIM REPORT? 1795 01:17:47,000 --> 01:17:51,640 AND I GUESS TO STATE IT MOST 1796 01:17:51,640 --> 01:17:54,720 SUCCINCTLY, THERE'S URGENCY TO 1797 01:17:54,720 --> 01:17:57,000 MOVE FORWARD THE CLINICAL TRIALS 1798 01:17:57,000 --> 01:17:59,240 TO EVOLVE THE CLINICAL TRIAL 1799 01:17:59,240 --> 01:18:02,960 SYSTEM ON B BEHALF OF OUR PATIES 1800 01:18:02,960 --> 01:18:04,160 AND THERE ARE CURRENT STRESSES 1801 01:18:04,160 --> 01:18:06,880 ON THE SYSTEM AND THERE ARE 1802 01:18:06,880 --> 01:18:09,720 OPERATIONAL WORKFORCE ISSUES 1803 01:18:09,720 --> 01:18:12,560 THAT NEED TO BE ADDRESSED AND 1804 01:18:12,560 --> 01:18:18,600 THE STRATEGIC WAS ABLE TO 1805 01:18:18,600 --> 01:18:20,800 RAPIDLY COME TO CONSENSUS TASK 1806 01:18:20,800 --> 01:18:24,640 AND RELATED TO THE DATA 1807 01:18:24,640 --> 01:18:35,160 COLLECTION AND BURDEN AND THE 1808 01:18:39,520 --> 01:18:41,120 REPORT ALLOWS THE NCI TO 1809 01:18:41,120 --> 01:18:42,800 CONSIDER RECOMMENDATIONS NOW 1810 01:18:42,800 --> 01:18:45,520 RATHER THAN WAITING FOR THE 1811 01:18:45,520 --> 01:18:50,600 FINAL STREAMLINE AND CLINICAL 1812 01:18:50,600 --> 01:18:53,960 TRIALS AND REPORT AND THE WORK 1813 01:18:53,960 --> 01:19:00,640 OF THE SUBCOMMITTEE THAT WILL 1814 01:19:00,640 --> 01:19:03,680 CULMINATE TOO A REPORT TO NCI 1815 01:19:03,680 --> 01:19:05,160 WHEN THE DELIBERATIONS FOR ALL 1816 01:19:05,160 --> 01:19:07,360 THE TASKS ASSIGNED TO THE 1817 01:19:07,360 --> 01:19:15,160 WORKING GROUP ARE COMPLETED. 1818 01:19:15,160 --> 01:19:19,320 SO, THESE STRATEGIC CONTEXT FOR 1819 01:19:19,320 --> 01:19:23,200 THE LIMIT DATA COLLECTION ITEM 1820 01:19:23,200 --> 01:19:26,640 THE FOCUS OF THIS INTERIM 1821 01:19:26,640 --> 01:19:28,520 REPORT, IS THAT BECAUSE OF 1822 01:19:28,520 --> 01:19:31,240 ADVANCES IN SCIENCE AND 1823 01:19:31,240 --> 01:19:35,400 ASSOCIATED COMPLEXITY AND 1824 01:19:35,400 --> 01:19:39,360 RELATED TO STUDIES IN RARE 1825 01:19:39,360 --> 01:19:42,560 POPULATIONS AND AND THE 1826 01:19:42,560 --> 01:19:46,280 ASSOCIATIONED EXPENSE OF 1827 01:19:46,280 --> 01:19:47,600 CONDUCTING CLINICAL TRIALS WHICH 1828 01:19:47,600 --> 01:19:51,160 THREATENS THE CLINICAL TRIALS 1829 01:19:51,160 --> 01:19:51,960 ENTERPRISE. 1830 01:19:51,960 --> 01:19:53,640 WE LEARNED A LOT FROM THE 1831 01:19:53,640 --> 01:19:56,360 PANDEMIC AND WE EXPERIENCED LOTS 1832 01:19:56,360 --> 01:19:59,040 OF OPERATIONAL WORKFORCE 1833 01:19:59,040 --> 01:20:01,000 CHALLENGES THAT EXACERBATED 1834 01:20:01,000 --> 01:20:05,920 EXISTING PROBLEMS AND ALSO, 1835 01:20:05,920 --> 01:20:06,840 HIGHLIGHTED POTENTIAL 1836 01:20:06,840 --> 01:20:08,960 OPPORTUNITIES AND MECHANISMS TO 1837 01:20:08,960 --> 01:20:12,720 STREAMLINE TRIAL DESIGN AND 1838 01:20:12,720 --> 01:20:18,080 REDUCE THE BURDENS OF CLINICAL 1839 01:20:18,080 --> 01:20:24,480 TRIAL ARE URGENTLY NEEDED. 1840 01:20:24,480 --> 01:20:26,520 SO ONE STRATEGY RELATES TO WHAT 1841 01:20:26,520 --> 01:20:28,240 DATA ARE WE ACTUALLY COLLECTING 1842 01:20:28,240 --> 01:20:31,320 ON CLINICAL TRIALS TODAY AND 1843 01:20:31,320 --> 01:20:33,880 COULD WE ECONOMIZE ON THAT DATA 1844 01:20:33,880 --> 01:20:36,080 COLLECTION BURDEN IN A RATIONAL 1845 01:20:36,080 --> 01:20:38,080 WAY THAT DOESN'T ADVERSELY 1846 01:20:38,080 --> 01:20:39,960 EFFECT THE LEARNINGS FROM 1847 01:20:39,960 --> 01:20:45,720 STUDIES IN TERMS OF EFFICACY OF 1848 01:20:45,720 --> 01:20:49,200 NEW AGENTS AND POTENTIAL HARMS 1849 01:20:49,200 --> 01:20:50,760 OR SIDE EFFECTS OF TREATMENTS. 1850 01:20:50,760 --> 01:20:54,000 SO HOW FURTHER ADIEU, THE NEXT 1851 01:20:54,000 --> 01:20:58,280 SLIDE WILL ALLOW US TO 1852 01:20:58,280 --> 01:21:01,960 TRANSITION TO WHERE WE ARE 1853 01:21:01,960 --> 01:21:02,640 TODAY. 1854 01:21:02,640 --> 01:21:04,880 SO IF TERMS OF THESE 1855 01:21:04,880 --> 01:21:08,160 RECOMMENDATIONS, IN MID-JULY, 1856 01:21:08,160 --> 01:21:10,080 THE STREAMLINING AND CLINICAL 1857 01:21:10,080 --> 01:21:11,280 TRIALS WORKING GROUP HAD ITS 1858 01:21:11,280 --> 01:21:21,760 FIRST MEETING AND AFTER CASE 1859 01:21:23,960 --> 01:21:27,400 REPORT TOMORROW'S OF ENACTED AND 1860 01:21:27,400 --> 01:21:31,520 COMPLETED NCTN CLINICAL TRIALS 1861 01:21:31,520 --> 01:21:34,360 THE FRIENDSHIP DISCUSSED 1862 01:21:34,360 --> 01:21:36,440 POTENTIAL CANDIDATES LOW VOW IF 1863 01:21:36,440 --> 01:21:37,520 YOU WILL,. 1864 01:21:37,520 --> 01:21:40,360 >>Tara: ELEMENTS THAT COULD BE 1865 01:21:40,360 --> 01:21:47,640 CONSIDERED FOR ELIMINATION AND 1866 01:21:47,640 --> 01:21:50,040 AND CAME UP WITH CATEGORIES AND 1867 01:21:50,040 --> 01:21:51,720 WHERE REDUCTION AND DATA 1868 01:21:51,720 --> 01:21:58,280 COLLECTION MIGHT BE APPROPRIATE 1869 01:21:58,280 --> 01:22:07,320 AND THERE'S IN-PERSON MEETINGS 1870 01:22:07,320 --> 01:22:11,160 AS WELL AS LOTS OF ELECTRIC RON 1871 01:22:11,160 --> 01:22:12,680 I CAN COMMUNICATION THAT ALLOWED 1872 01:22:12,680 --> 01:22:17,600 US TO DRAFT AND REFINE 1873 01:22:17,600 --> 01:22:18,280 RECOMMENDATIONS TO BE CONSIDERED 1874 01:22:18,280 --> 01:22:24,640 BY CTAC AND ULTIMATE LOW TO BE E 1875 01:22:24,640 --> 01:22:26,160 PROVIDED TO THE NCI LEADERSHIP. 1876 01:22:26,160 --> 01:22:29,520 TODAY WE'RE READY TO PRESENT THE 1877 01:22:29,520 --> 01:22:32,480 INTERIM REPORT TO CTAC FOR 1878 01:22:32,480 --> 01:22:32,800 DISCUSSION. 1879 01:22:32,800 --> 01:22:36,800 AND I'M GOING TO TURN IT OVER 1880 01:22:36,800 --> 01:22:41,000 NOW TO PRESENT THE 1881 01:22:41,000 --> 01:22:41,360 RECOMMENDATIONS. 1882 01:22:41,360 --> 01:22:42,720 >>THANK YOU, NEIL. 1883 01:22:42,720 --> 01:22:49,480 I THINK NEXT SLIDE. 1884 01:22:49,480 --> 01:22:51,040 I THINK NEIL YOU IT A GREAT JOB 1885 01:22:51,040 --> 01:22:53,760 OF PROVIDING THE CONTEXT TO WHAT 1886 01:22:53,760 --> 01:22:56,320 WE DID SO I'M SURE EVERYBODY IS 1887 01:22:56,320 --> 01:23:00,480 EAGER TO KNOW WHAT OUR 1888 01:23:00,480 --> 01:23:02,760 RECOMMENDATIONS ARE. 1889 01:23:02,760 --> 01:23:05,560 WE'LL GET INTO THAT RIGHT AWAY. 1890 01:23:05,560 --> 01:23:08,640 SO THE RECOMMENDATION FROM THE 1891 01:23:08,640 --> 01:23:10,200 WORKING STREAMLINING LEGAL 1892 01:23:10,200 --> 01:23:11,400 TRIALS WORKING GROUP IS TO 1893 01:23:11,400 --> 01:23:13,800 ESTABLISH A SET OF STANDARD 1894 01:23:13,800 --> 01:23:16,320 PRACTICES FOR DATA COLLECTED IN 1895 01:23:16,320 --> 01:23:24,200 NCI PHASE 3 AND PHASE 2, 3 ADULT 1896 01:23:24,200 --> 01:23:24,880 TREATMENT TRIALS. 1897 01:23:24,880 --> 01:23:28,960 SO SPECIFICALLY, IN ORDER TO 1898 01:23:28,960 --> 01:23:32,560 REALIZE THIS RECOMMENDATION THE 1899 01:23:32,560 --> 01:23:33,960 WORKING GROUP PROPOSES THE SET 1900 01:23:33,960 --> 01:23:35,960 OF STANDARD PRACTICES THAT WE 1901 01:23:35,960 --> 01:23:37,640 WILL REVIEW IN THE NEXT FEW 1902 01:23:37,640 --> 01:23:40,200 SLIDES AND INTENDED TO COVER 1903 01:23:40,200 --> 01:23:41,760 TRIALS THAT ARE MEETING THE CRY 1904 01:23:41,760 --> 01:23:43,840 TER WHY LISTED ON THIS SLIDE. 1905 01:23:43,840 --> 01:23:48,800 SO, IT WILL BE APPLICABLE TO THE 1906 01:23:48,800 --> 01:23:52,280 NCI STUDIES PHASE 3, PHASE 2, 3 1907 01:23:52,280 --> 01:23:55,720 STUDIES FOCUSING ON TREATMENT 1908 01:23:55,720 --> 01:23:59,040 TRIALS IN THE ADULT POPULATION 1909 01:23:59,040 --> 01:24:01,080 AND EXAM WHICH COMPRISE OF 0% OF 1910 01:24:01,080 --> 01:24:07,960 THE NCTN TRAILS. 1911 01:24:07,960 --> 01:24:09,840 -- 40%. 1912 01:24:09,840 --> 01:24:11,520 THE FUTURE RECOMMENDATIONS ARE 1913 01:24:11,520 --> 01:24:13,840 HOW WE CAN EXTEND THESE 1914 01:24:13,840 --> 01:24:15,080 PRACTICES TO LATE PHASE IND 1915 01:24:15,080 --> 01:24:16,640 TRIALS AND PEDIATRIC TRIALS AND 1916 01:24:16,640 --> 01:24:18,080 THE WORKING GROUP RECOGNIZES 1917 01:24:18,080 --> 01:24:22,640 THAT EARLY PHASE TRIALS HAVE 1918 01:24:22,640 --> 01:24:23,840 DISTINCTIVE SIGN I HAVE I CAN 1919 01:24:23,840 --> 01:24:26,680 CHALLENGES SO THOSE WOULD 1920 01:24:26,680 --> 01:24:27,360 REQUIRE CAPITAL CONSIDERATION 1921 01:24:27,360 --> 01:24:33,800 FOR THOSE IN THE RECOMMENDATIONS 1922 01:24:33,800 --> 01:24:34,080 TODAY. 1923 01:24:34,080 --> 01:24:37,600 THE WORKING GROUP BELIEVES THESE 1924 01:24:37,600 --> 01:24:40,560 PROPOSED PRACTICES WILL BE IN 1925 01:24:40,560 --> 01:24:43,080 OUR -- CAN DEFINE A NEW NORMAL 1926 01:24:43,080 --> 01:24:44,440 FOR DATA COLLECTION SO THEY'LL 1927 01:24:44,440 --> 01:24:48,480 BE LESS BURDEN SOME AND THE 1928 01:24:48,480 --> 01:24:50,320 TRIAL ALS WILL BE MORE EFFICIENT 1929 01:24:50,320 --> 01:24:51,040 SUSTAINABLE THAN EVERYTHING 1930 01:24:51,040 --> 01:24:52,520 WE'VE DISCUSSED IN TERMS OF 1931 01:24:52,520 --> 01:24:54,640 WORKFORCE CHALLENGES. 1932 01:24:54,640 --> 01:24:56,200 THE WORKFORCE RECOGNIZES THAT 1933 01:24:56,200 --> 01:24:57,880 THESE PRACTICES ARE NOT INTENDED 1934 01:24:57,880 --> 01:25:01,360 TO BE APPLIED AT THE COST OF 1935 01:25:01,360 --> 01:25:05,680 COMPROMISING OF KEY STUDY 1936 01:25:05,680 --> 01:25:10,240 OBJECTS, HOWEVER, THEY CAN EVERY 1937 01:25:10,240 --> 01:25:12,720 PROPOSED AND WE MUST PROVIDE 1938 01:25:12,720 --> 01:25:19,120 JUSTIFICATION SPECIFIC TO THE 1939 01:25:19,120 --> 01:25:28,160 CLINICAL SO THE CATEGORY FALL IN 1940 01:25:28,160 --> 01:25:30,360 ADVERSE EVENTS, COLLECTION OF. 1941 01:25:30,360 --> 01:25:36,280 >>Tara: SURRODATA AND PHYSICALB 1942 01:25:36,280 --> 01:25:38,680 TESTS, IMAGING AND OTHER 1943 01:25:38,680 --> 01:25:40,320 ASSESSMENT PROCEDURES PATIENT 1944 01:25:40,320 --> 01:25:41,760 REPORTED OUTCOMES. 1945 01:25:41,760 --> 01:25:42,480 NEXT SLIGHT. 1946 01:25:42,480 --> 01:25:44,560 SO STARTING WITH ADVERSE EVENTS, 1947 01:25:44,560 --> 01:25:47,600 OUR PROPOSAL FROM THE 1948 01:25:47,600 --> 01:25:48,160 STREAMLINING CLINICAL TRIALS 1949 01:25:48,160 --> 01:25:51,560 WORKING GROUP IS TO COLLECT ONLY 1950 01:25:51,560 --> 01:25:52,360 ADVERSE EASTBOUND EVENTS OF 1951 01:25:52,360 --> 01:25:54,720 GRADE THREE AND HIGHER UNLESS 1952 01:25:54,720 --> 01:25:57,560 ASSESSMENT OF RELATED TO A 1953 01:25:57,560 --> 01:25:59,000 ADVERSE EVENT IS A STATED OBJECT 1954 01:25:59,000 --> 01:26:01,840 WITH A PRO SPECIFIED ANALYSIS 1955 01:26:01,840 --> 01:26:02,440 PLAN. 1956 01:26:02,440 --> 01:26:03,760 WE PROSE POSE FOR EACH ADVERSE 1957 01:26:03,760 --> 01:26:06,480 OFTEN WE COLLECT ONLY THE CTCA 1958 01:26:06,480 --> 01:26:11,120 TERM AND THE COMMON TOX SIT TEE 1959 01:26:11,120 --> 01:26:19,080 CRITERIA ADVERSE -- AND ADVERSEP 1960 01:26:19,080 --> 01:26:19,560 TIMES. 1961 01:26:19,560 --> 01:26:21,600 WE PROPOSE COLLECTION REGARDLESS 1962 01:26:21,600 --> 01:26:23,200 OF GRADE WHEN THEY ARE LIMITED 1963 01:26:23,200 --> 01:26:25,560 IT THOSE THAT RESULT IN A DOSE 1964 01:26:25,560 --> 01:26:26,320 MODIFICATION, TREATMENT 1965 01:26:26,320 --> 01:26:27,800 CONTINUATION OR NOT ADHERENCE. 1966 01:26:27,800 --> 01:26:31,920 AND WE DEFINE SOLICITED ADVERSE 1967 01:26:31,920 --> 01:26:33,360 EVENTS AS ACQUIRED TO BE 1968 01:26:33,360 --> 01:26:35,800 ASSESSED AND REPORTED ON A 1969 01:26:35,800 --> 01:26:37,160 REGULAR SCHEDULE AND ASSESSED ON 1970 01:26:37,160 --> 01:26:38,320 THE PATIENT WHETHER IT'S 1971 01:26:38,320 --> 01:26:43,480 PRESENTED OR ABSENT IN EVERY 1972 01:26:43,480 --> 01:26:43,920 CYCLE. 1973 01:26:43,920 --> 01:26:45,320 MOVING TO MEDICAL HISTORY 1974 01:26:45,320 --> 01:26:46,680 DEFINED AS EVENTS, MEDICAL 1975 01:26:46,680 --> 01:26:48,520 EVENTS ARE ON GOING CONDITIONS. 1976 01:26:48,520 --> 01:26:50,800 IDENTIFIED AT THE BASELINE AND 1977 01:26:50,800 --> 01:26:52,120 EITHER THROUGH A PATIENT REPORT 1978 01:26:52,120 --> 01:26:54,160 OR REVIEW OF THE PATIENT MEDICAL 1979 01:26:54,160 --> 01:26:55,720 REPORTS, OUR PROPOSAL IS TO 1980 01:26:55,720 --> 01:26:58,560 COLLECT ONLY THOSE MEDICAL 1981 01:26:58,560 --> 01:27:00,840 HISTORY ITEMS RELEVANT TO A 1982 01:27:00,840 --> 01:27:04,800 TRIAL EXCLUSION CRITERIA, NEXT 1983 01:27:04,800 --> 01:27:05,640 SLIDE. 1984 01:27:05,640 --> 01:27:08,320 IN TERMS OF MEDICATIONS, WE 1985 01:27:08,320 --> 01:27:10,160 PROPOSE THAT A BASELINE WE 1986 01:27:10,160 --> 01:27:13,200 COLLECT THOSE MEDICATIONS AND 1987 01:27:13,200 --> 01:27:14,800 THEIR USE REQUIRES MODIFICATIONS 1988 01:27:14,800 --> 01:27:17,600 OF THE STUDY TREATMENT FOR THE 1989 01:27:17,600 --> 01:27:18,680 PATIENT AND DURING THE TRIALS, 1990 01:27:18,680 --> 01:27:22,120 WE PROPOSE COLLECTION OF ONLY 1991 01:27:22,120 --> 01:27:23,960 CHANGES AND MEDICATIONS THAT 1992 01:27:23,960 --> 01:27:25,520 WILL COST MODIFICATION OR 1993 01:27:25,520 --> 01:27:28,200 DISCONTINUATION OF THE STUDY 1994 01:27:28,200 --> 01:27:31,240 TREATMENT. 1995 01:27:31,240 --> 01:27:34,160 NEXT SLIDE. 1996 01:27:34,160 --> 01:27:35,880 A PROPOSAL IS THOSE SHOULD BE 1997 01:27:35,880 --> 01:27:37,360 CONDUCTED ACCORDING TO STANDARD 1998 01:27:37,360 --> 01:27:41,200 OF CARE, AUGMENTED BY ANY TRIALS 1999 01:27:41,200 --> 01:27:42,600 SPECIFIC REQUIREMENTS AS THE 2000 01:27:42,600 --> 01:27:44,880 CASE MAY BE BUT ONLY THE 2001 01:27:44,880 --> 01:27:46,160 FOLLOWING EXAM FINDINGS SHOULD 2002 01:27:46,160 --> 01:27:47,760 BE COLLECTED. 2003 01:27:47,760 --> 01:27:51,080 FINDINGS THAT ARE 2004 01:27:51,080 --> 01:27:52,280 PROTOCOL-SPECIFIED END POINTS 2005 01:27:52,280 --> 01:27:55,200 ARE REQUIRED TO ACCESS 2006 01:27:55,200 --> 01:27:55,760 PROTOCOL-SPECIFIC FEED END 2007 01:27:55,760 --> 01:28:02,600 ONTPROTOCOL-SPECIFIED END POINTS 2008 01:28:02,600 --> 01:28:03,840 AND FINDINGS THAT RESULT IN 2009 01:28:03,840 --> 01:28:05,760 THOSE MODIFICATIONS OR TREATMENT 2010 01:28:05,760 --> 01:28:06,800 ADVERTISE CONTINUATION. 2011 01:28:06,800 --> 01:28:08,640 WE HAVE A CLARIFICATION ON 2012 01:28:08,640 --> 01:28:10,000 PHYSICAL EXAM FINDINGS 2013 01:28:10,000 --> 01:28:11,560 PERFORMANCE STATUS IS 2014 01:28:11,560 --> 01:28:12,800 CONSIDERING A PHYSICAL EXAM 2015 01:28:12,800 --> 01:28:14,120 FINDING AND SHOULD BE COLLECTED 2016 01:28:14,120 --> 01:28:19,680 IF IT PETES THE CRITERIA 2017 01:28:19,680 --> 01:28:29,120 SPECIFIED ABOVE. 2018 01:28:29,120 --> 01:28:31,440 IN TERMS OF LAB TESTS, WE 2019 01:28:31,440 --> 01:28:32,280 PROPOSE THOSE SHOULD BE 2020 01:28:32,280 --> 01:28:33,600 CONDUCTED ACCORDING TO STANDARD 2021 01:28:33,600 --> 01:28:34,360 OF CARE. 2022 01:28:34,360 --> 01:28:36,720 AGAIN, AUGMENTED BY NEED BID ANY 2023 01:28:36,720 --> 01:28:38,080 TRIAL SPECIFIC REQUIREMENTS 2024 01:28:38,080 --> 01:28:39,440 HOWEVER WE PROPOSE ONLY THOSE 2025 01:28:39,440 --> 01:28:42,000 TEST RESULTS TO BE COLLECTED 2026 01:28:42,000 --> 01:28:44,920 THAT ARE ASSOCIATED WITH 2027 01:28:44,920 --> 01:28:46,240 PROPERTY-SPECIFIC END POINTS AND 2028 01:28:46,240 --> 01:28:49,240 REQUIRED TO ASSESS 2029 01:28:49,240 --> 01:28:50,240 PROTOCOL-SPECIFIED END POINTS OR 2030 01:28:50,240 --> 01:28:51,760 THOSE THAT RESULT IN THOSE 2031 01:28:51,760 --> 01:29:02,240 MODIFICATIONS OR TREATMENTS. 2032 01:29:05,480 --> 01:29:08,680 WE WILL LIMIT IMAGING TO THOSE 2033 01:29:08,680 --> 01:29:11,760 THAT REQUIRE TO MET 2034 01:29:11,760 --> 01:29:12,560 PROTOCOL-SPECIFIED OBJECTIVES 2035 01:29:12,560 --> 01:29:13,920 AND MODIFICATION AND ASSESSMENT 2036 01:29:13,920 --> 01:29:15,760 OF CLINICAL OUTCOMES AND SO ON 2037 01:29:15,760 --> 01:29:17,960 AND THE COST OF ANY IMAGING OR 2038 01:29:17,960 --> 01:29:19,680 OTHER ASSESSMENT PROCEDURES, 2039 01:29:19,680 --> 01:29:22,520 THAT IS NOT COVERED BY INSURANCE 2040 01:29:22,520 --> 01:29:26,920 MUST BE COVERED BY THE RESEARCH 2041 01:29:26,920 --> 01:29:27,240 STUDY. 2042 01:29:27,240 --> 01:29:30,200 IN TERMS OF PATIENT REPORTED 2043 01:29:30,200 --> 01:29:32,240 OUTCOMES, PATIENT REPORTED DATA, 2044 01:29:32,240 --> 01:29:35,720 THE PROPOSAL IS TO NOT REQUIRE 2045 01:29:35,720 --> 01:29:38,560 COLLECTION OF PATIENT 2046 01:29:38,560 --> 01:29:39,760 MEDICATIONS DIARIES UNLESS THE 2047 01:29:39,760 --> 01:29:45,560 PROTOCOL THEDEFINES HOW IT WILLD 2048 01:29:45,560 --> 01:29:49,400 TO ADDRESS THE TRIAL SPECIFIED 2049 01:29:49,400 --> 01:29:49,800 OBJECTS. 2050 01:29:49,800 --> 01:29:52,120 FOR PROs THEY MUST CLEARLY 2051 01:29:52,120 --> 01:29:53,880 ADDRESS HOW THOSE PRO 2052 01:29:53,880 --> 01:29:56,000 INSTRUMENTS WILL BE CHOSEN AND 2053 01:29:56,000 --> 01:29:59,080 HOW THE DATA COLLECTION SCHEDULE 2054 01:29:59,080 --> 01:30:01,240 WILL BE INCLUDED IN THE 2055 01:30:01,240 --> 01:30:02,560 PROTOCOLS, SO THAT WE CONTINUE 2056 01:30:02,560 --> 01:30:04,720 TO ACHIEVE THE SCIENTIFIC 2057 01:30:04,720 --> 01:30:06,720 OBJECTIVE MINIMIZING PATIENT 2058 01:30:06,720 --> 01:30:06,960 BURDEN. 2059 01:30:06,960 --> 01:30:09,600 OUR CLARIFICATIONS ON THE PRO 2060 01:30:09,600 --> 01:30:11,520 INSTRUMENTS INCLUDE COMPLETE 2061 01:30:11,520 --> 01:30:12,360 INSTRUMENTS, SELECTED WE SEE 2062 01:30:12,360 --> 01:30:14,520 FROM AN INSTRUMENT AND READING 2063 01:30:14,520 --> 01:30:16,200 SCALE AS APPROPRIATE WHATEVER IS 2064 01:30:16,200 --> 01:30:18,520 IMPORTANT FOR THE TRIAL 2065 01:30:18,520 --> 01:30:20,000 SCIENTIFIC OBJECTIVES IN TERMS 2066 01:30:20,000 --> 01:30:22,600 OF DATA COLLECTION SCHEDULE WE 2067 01:30:22,600 --> 01:30:23,800 HAVE TIMING WHEN THESE ARE 2068 01:30:23,800 --> 01:30:25,000 COLLECTED THE FREQUENCY OF 2069 01:30:25,000 --> 01:30:26,360 COLLECTION AND THE DURATION OF 2070 01:30:26,360 --> 01:30:29,760 FOLLOW-UP AND ENSURING THESE ARE 2071 01:30:29,760 --> 01:30:30,440 COORDINATED WITH OTHER 2072 01:30:30,440 --> 01:30:39,080 ACTIVITIES ON THE TRIAL. 2073 01:30:39,080 --> 01:30:41,360 SO, IN CONCLUSION, I THINK IT'S 2074 01:30:41,360 --> 01:30:46,000 CLEAR IF YOU HAVE SEEN THE SAME 2075 01:30:46,000 --> 01:30:49,040 PRAISE REPEATED OVER OVER AGAIN 2076 01:30:49,040 --> 01:30:50,720 AND SPECIFIED OBJECTS OUR 2077 01:30:50,720 --> 01:30:53,280 DEFINING THEME FROM THIS 2078 01:30:53,280 --> 01:30:55,280 STREAMLINING TRIALS WORKING 2079 01:30:55,280 --> 01:30:56,600 GROUP IS TO RECOMMEND COLLECTION 2080 01:30:56,600 --> 01:30:58,640 OF DATA THAT ARE ABSOLUTELY 2081 01:30:58,640 --> 01:31:00,160 NECESSARY TO ADDRESS TRIAL 2082 01:31:00,160 --> 01:31:01,840 OBJECTIVES AND THEY HAVE CLEARLY 2083 01:31:01,840 --> 01:31:04,160 DEFINED ANALYSIS PLANS. 2084 01:31:04,160 --> 01:31:05,840 SO, WE BELIEVE THAT THE 2085 01:31:05,840 --> 01:31:06,880 IMPLEMENTATION OF THESE 2086 01:31:06,880 --> 01:31:09,960 PRACTICES FOR DATA COLLECTION 2087 01:31:09,960 --> 01:31:13,120 AND PHASE 3 AND 2, 3 ABOUT THE 2088 01:31:13,120 --> 01:31:14,520 TREATMENT TRAILS WILL REDUCE 2089 01:31:14,520 --> 01:31:15,280 OPERATIONAL PUSHED AND I KNOW 2090 01:31:15,280 --> 01:31:19,560 IT'S EXPECTED TO BUT COMING FROM 2091 01:31:19,560 --> 01:31:21,360 AN NETWORK I KNOW THIS WILL 2092 01:31:21,360 --> 01:31:22,360 REDUCE OPERATIONAL BURDEN AND 2093 01:31:22,360 --> 01:31:24,240 THAT IT WOULD PROVIDE IMPORTANT 2094 01:31:24,240 --> 01:31:26,200 INSIGHTS THAT WILL CONTINUE TO 2095 01:31:26,200 --> 01:31:27,400 INFORMATION DEVELOPMENTAL DATA 2096 01:31:27,400 --> 01:31:29,120 COLLECTION STANDARDS FOR OTHER 2097 01:31:29,120 --> 01:31:30,800 TYPE OF TRIALS THAT WE DIDN'T 2098 01:31:30,800 --> 01:31:33,120 ADDRESS RIGHT HERE AND WE ALSO 2099 01:31:33,120 --> 01:31:34,120 UNDERSTAND AND RECOGNIZE THAT A 2100 01:31:34,120 --> 01:31:38,040 LOT OF THESE RECOMMENDATIONS 2101 01:31:38,040 --> 01:31:39,000 WILL REQUIRE STAKEHOLDER 2102 01:31:39,000 --> 01:31:40,440 ENGAGEMENTS SO WE HOPE TO 2103 01:31:40,440 --> 01:31:42,000 CONTINUE TO WORK WITH OUR 2104 01:31:42,000 --> 01:31:45,440 STAKEHOLDERS SO THAT WE CAN 2105 01:31:45,440 --> 01:31:46,640 SUCCESSFULLY IMPLEMENT SOME OF 2106 01:31:46,640 --> 01:31:57,040 THESE PROPOSE STANDARDS. 2107 01:31:57,520 --> 01:31:59,840 >>THANK YOU SO MUCH. 2108 01:31:59,840 --> 01:32:02,000 BEFORE I OPEN THIS UP TO 2109 01:32:02,000 --> 01:32:05,280 DISCUSSION, I WANT TO HIGHLIGHT 2110 01:32:05,280 --> 01:32:07,160 SOME BESTS THAT ARE PRESENT ON 2111 01:32:07,160 --> 01:32:09,080 THE CALL WHO WILL BE ABLE TO 2112 01:32:09,080 --> 01:32:11,800 ADDRESS CERTAIN ASPECTS OF THIS 2113 01:32:11,800 --> 01:32:19,040 WORK STREAM AND AS HAVE 2114 01:32:19,040 --> 01:32:20,160 PERSPECTIVE. 2115 01:32:20,160 --> 01:32:26,040 THE FIRST IS ORIN GRAD. 2116 01:32:26,040 --> 01:32:29,760 JUDY WITH THE SCIENCE AND 2117 01:32:29,760 --> 01:32:31,160 TECHNOLOGY POLICY INSTITUTE AND 2118 01:32:31,160 --> 01:32:33,480 MARK FROM THE FDA WHO 2119 01:32:33,480 --> 01:32:36,160 PARTICIPATED IN SOME OF THESE 2120 01:32:36,160 --> 01:32:36,760 DISCUSSIONS. 2121 01:32:36,760 --> 01:32:39,240 SO, WITHOUT FURTHER ADIEU, LET'S 2122 01:32:39,240 --> 01:32:42,200 OPEN IT UP TO DISCUSSION. 2123 01:32:42,200 --> 01:32:51,200 PLEASE RAISE YOUR HANDS AND 2124 01:32:51,200 --> 01:32:55,960 WE'LL GO FROM THERE. 2125 01:32:55,960 --> 01:32:56,440 I SEE RUBEN. 2126 01:32:56,440 --> 01:33:00,320 >>LET ME KNOW WHAT IS GOING ON. 2127 01:33:00,320 --> 01:33:03,800 >>SO, I THINK THIS VERY MUCH IS 2128 01:33:03,800 --> 01:33:08,040 ALIGNED WITH THE ADVERT DISPARIE 2129 01:33:08,040 --> 01:33:09,120 DISCUSSED BEFORE TRYING TO MAKE 2130 01:33:09,120 --> 01:33:10,000 THINGS EASIER. 2131 01:33:10,000 --> 01:33:11,920 IT'S A SET OF RECOMMENDATIONS 2132 01:33:11,920 --> 01:33:13,640 AND CERTAINLY I VOW THAT THIS 2133 01:33:13,640 --> 01:33:16,320 PROBABLY WILL BE AN ITERATIVE 2134 01:33:16,320 --> 01:33:18,200 PROCESS IF IT'S CONTINUAL TO 2135 01:33:18,200 --> 01:33:19,600 VALUE WAIT OTHER OPPORTUNITIES 2136 01:33:19,600 --> 01:33:21,160 FOR STREAMLINING. 2137 01:33:21,160 --> 01:33:23,120 WITHOUT QUESTION, I THINK THESE 2138 01:33:23,120 --> 01:33:24,800 ARE PRETTY IMPACTFUL. 2139 01:33:24,800 --> 01:33:26,320 THERE'S A LOT OF WORK THAT GOES 2140 01:33:26,320 --> 01:33:29,040 INTO EACH OF THESE WITH HISTORY 2141 01:33:29,040 --> 01:33:31,480 MEDS, ADVERSE EVENTS AT A 2142 01:33:31,480 --> 01:33:32,800 VARIETY OF THESE THINGS SO IT'S 2143 01:33:32,800 --> 01:33:34,000 A GREAT PLACE TO BEGIN BUT 2144 01:33:34,000 --> 01:33:36,160 CERTAINLY WITH A GOAL OF 2145 01:33:36,160 --> 01:33:38,000 REASSESSING IT AFTER A PERIOD OF 2146 01:33:38,000 --> 01:33:40,200 TIME AND DRILLING DOWN INTO 2147 01:33:40,200 --> 01:33:44,880 FURTHER AREAS IN AN ITERATIVE 2148 01:33:44,880 --> 01:33:45,040 WAY. 2149 01:33:45,040 --> 01:33:49,040 >>THANK YOU. 2150 01:33:49,040 --> 01:33:49,400 PATTY SPEARS. 2151 01:33:49,400 --> 01:33:51,360 >>HI, THAT WAS A NICE 2152 01:33:51,360 --> 01:33:51,680 PRESENTATION. 2153 01:33:51,680 --> 01:33:54,360 I LIKE THE IDEA OF KIND OF ABOUT 2154 01:33:54,360 --> 01:33:55,440 THING THAT THREAT WITH THE 2155 01:33:55,440 --> 01:33:57,080 BENEFIT TYPE OF THING. 2156 01:33:57,080 --> 01:33:58,640 AND GETTING THE BEST DATA AS WE 2157 01:33:58,640 --> 01:34:00,360 CAN BUT ALSO, YOU KNOW, YOU 2158 01:34:00,360 --> 01:34:01,720 MENTIONED STAKEHOLDER ENGAGEMENT 2159 01:34:01,720 --> 01:34:03,320 AND TO ININCLUDED SOME PATIENTS 2160 01:34:03,320 --> 01:34:04,880 IN THERE AS WELL SO WE DO FORGET 2161 01:34:04,880 --> 01:34:07,560 THE PATIENT BENEFIT INFORMATION 2162 01:34:07,560 --> 01:34:09,560 AND KIND OF PLAYING ON THAT TOO, 2163 01:34:09,560 --> 01:34:13,320 YOU MENTIONED KEY OBJECTIVES. 2164 01:34:13,320 --> 01:34:15,600 TUESDAY THAT INCLUDE PRIMARY, 2165 01:34:15,600 --> 01:34:17,400 SECONDARY OBJECTIVE, 2166 01:34:17,400 --> 01:34:19,000 EXPLORATORY, WHERE DID THOSE 2167 01:34:19,000 --> 01:34:21,560 EXPLORATORY COME IN IN THERE? 2168 01:34:21,560 --> 01:34:23,040 >>YOU WANT TO TAKE THAT? 2169 01:34:23,040 --> 01:34:25,640 >>YEAH, THANK YOU, PATTY. 2170 01:34:25,640 --> 01:34:28,880 IT'S GO AHEAD TO SEE YOU AGAIN. 2171 01:34:28,880 --> 01:34:31,800 I THINK A LOT OF WHAT WE WERE 2172 01:34:31,800 --> 01:34:33,920 FOCUSING ON WERE PRIMARY AND 2173 01:34:33,920 --> 01:34:35,320 SECONDARY OBJECTIVES, ESPECIALLY 2174 01:34:35,320 --> 01:34:37,280 WHEN YOU THINK OF YOU KNOW, LA 2175 01:34:37,280 --> 01:34:39,840 OR TORI ASSESSMENTS AND IMAGING 2176 01:34:39,840 --> 01:34:41,880 AND ADVERSE EVENTS BUT THERE 2177 01:34:41,880 --> 01:34:44,240 COULD BE EXPLORATORY OBJECTS BUT 2178 01:34:44,240 --> 01:34:51,400 I THINK THE WHOLE IDEA BEHIND 2179 01:34:51,400 --> 01:34:53,360 THE WORKING GROUP WAS WE DON'T 2180 01:34:53,360 --> 01:34:54,840 PUT ANYTHING FOR DATA COLLECTION 2181 01:34:54,840 --> 01:34:57,400 UNLESS WE HAVE A CLEARLY 2182 01:34:57,400 --> 01:34:59,200 SPECIFIED UNDERSTANDING OF HOW 2183 01:34:59,200 --> 01:34:59,400 THOSE. 2184 01:34:59,400 --> 01:35:03,880 >>Tara: WDATA WILL BE UTILIZEDS 2185 01:35:03,880 --> 01:35:05,680 FOR VARIOUS REASONS YOUR NOT 2186 01:35:05,680 --> 01:35:08,320 COLLECTING IT ON EVERY PATIENT 2187 01:35:08,320 --> 01:35:11,040 OR ON SEVERAL PATIENCE OR IT'S A 2188 01:35:11,040 --> 01:35:12,200 DIFFERENT QUESTION YOU WANT TO 2189 01:35:12,200 --> 01:35:14,040 ASK, AS LONG AS YOU HAVE A CLEAR 2190 01:35:14,040 --> 01:35:15,520 PLAN OF I'M GOING TO COLLECT A 2191 01:35:15,520 --> 01:35:18,960 AND I'M GOING TO USE THIS AND 2192 01:35:18,960 --> 01:35:20,760 ANALYZE AND UTILITY OF 2193 01:35:20,760 --> 01:35:22,960 COLLECTING A, I THINK THAT'S 2194 01:35:22,960 --> 01:35:24,080 VALID. 2195 01:35:24,080 --> 01:35:26,760 BUT YEAH, IN GENERAL, WE WERE 2196 01:35:26,760 --> 01:35:29,240 PRIMARILY FOCUSED ON CLEARLY 2197 01:35:29,240 --> 01:35:31,920 DEFINED PRIMARY AND SECONDARY 2198 01:35:31,920 --> 01:35:33,280 OBJECTIVES BUT THEY'RE TOTALLY 2199 01:35:33,280 --> 01:35:34,800 INCLUDED AS WELL IF YOU CAN 2200 01:35:34,800 --> 01:35:40,960 DEFINE THEM CORRECTLY. 2201 01:35:40,960 --> 01:35:46,040 >>ANY OTHER COMMENTS? 2202 01:35:46,040 --> 01:35:46,400 NANCY DAVIDSON. 2203 01:35:46,400 --> 01:35:47,600 >>BEAUTIFUL PRESENTATION. 2204 01:35:47,600 --> 01:35:51,320 I'VE BEEN WATCHING THIS OFF AND 2205 01:35:51,320 --> 01:35:52,920 ON FOR A NUMBER OF YEARS BUT 2206 01:35:52,920 --> 01:35:54,480 GETTING WHAT WE NEED AND NOT 2207 01:35:54,480 --> 01:35:55,920 DOING THE THINGS WE DON'T NEED. 2208 01:35:55,920 --> 01:35:57,640 DID YOU MAKE AN EFFORT TO THINK 2209 01:35:57,640 --> 01:35:59,040 ABOUT WHAT WOULD HAPPEN IF YOU 2210 01:35:59,040 --> 01:36:02,440 APPLIED THIS TO AN NCTN TRIAL OR 2211 01:36:02,440 --> 01:36:03,080 TWO? 2212 01:36:03,080 --> 01:36:04,880 IF YOU TOOK WHAT WE DID FOR THAT 2213 01:36:04,880 --> 01:36:06,240 TRIAL AND YOU TOOK WHAT WE MIGHT 2214 01:36:06,240 --> 01:36:08,760 HAVE DONE IF WE USED THESE 2215 01:36:08,760 --> 01:36:11,360 GUIDELINES, WE WOULD HAVE MISSED 2216 01:36:11,360 --> 01:36:11,760 ANYTHING BIG? 2217 01:36:11,760 --> 01:36:14,520 WE WOULD HAVE MISSED CONCERNS, 2218 01:36:14,520 --> 01:36:15,760 TOXICITY CONCERNS OR THINGS LIKE 2219 01:36:15,760 --> 01:36:18,600 THAT BECAUSE WE USED THESE 2220 01:36:18,600 --> 01:36:19,200 GUIDELINES? 2221 01:36:19,200 --> 01:36:24,160 IS IT POSSIBLE TO BOTTLE THAT? 2222 01:36:24,160 --> 01:36:26,440 >>THAT'S AN EXCELLENT QUESTION, 2223 01:36:26,440 --> 01:36:26,800 NANCY. 2224 01:36:26,800 --> 01:36:29,400 HAVE WE DONE THAT IN THESE 2225 01:36:29,400 --> 01:36:32,960 AREAS, PROBABLY NOT, BECAUSE 2226 01:36:32,960 --> 01:36:35,640 IT'S NOT VERY EASY TO IDENTIFY 2227 01:36:35,640 --> 01:36:39,040 STUDIES THAT YOU KNOW COLLECTED 2228 01:36:39,040 --> 01:36:42,080 ON MEDS AND THOSE ARE THE 2229 01:36:42,080 --> 01:36:44,160 EASIEST ONCE, WE NEVER UTILIZE 2230 01:36:44,160 --> 01:36:45,840 CON MEDS SO IT'S A WAY THAT 2231 01:36:45,840 --> 01:36:47,720 THERE WAS NOT A LOT OF VALUE FOR 2232 01:36:47,720 --> 01:36:50,160 THIS DATA COLLECTED. 2233 01:36:50,160 --> 01:36:52,800 IT'S KIND OF HARD TO TO THAT IN 2234 01:36:52,800 --> 01:36:54,640 A SYSTEMATIC WAY BUT THIS IS A 2235 01:36:54,640 --> 01:36:55,360 GREAT IDEA. 2236 01:36:55,360 --> 01:36:56,600 ONE OF THE THINGS THAT OTHERS 2237 01:36:56,600 --> 01:36:59,160 DID WAS TO GO THROUGH OUR CASE 2238 01:36:59,160 --> 01:37:02,400 REPORT FORUMS ACROSS A NUMBER OF 2239 01:37:02,400 --> 01:37:04,480 LARGE TRIALS AND THAT'S HOW WE 2240 01:37:04,480 --> 01:37:06,160 LANDED ON THESE PARTICULAR 2241 01:37:06,160 --> 01:37:07,720 CATEGORIES BECAUSE IT WAS VERY 2242 01:37:07,720 --> 01:37:09,440 INCONSISTENTLY COLLECTED AND IT 2243 01:37:09,440 --> 01:37:12,560 WASN'T STANDARD ACROSS TRIALS, 2244 01:37:12,560 --> 01:37:15,280 IT WAS NOT SYSTEMATIC AND 2245 01:37:15,280 --> 01:37:15,640 STANDARDIZED. 2246 01:37:15,640 --> 01:37:16,880 I'LL PUT IT THAT WAY. 2247 01:37:16,880 --> 01:37:18,040 THAT'S WHAT BROUGHT US TOGETHER 2248 01:37:18,040 --> 01:37:20,480 TO THINK THROUGH THESE SPECIFIC 2249 01:37:20,480 --> 01:37:22,240 DATA ELEMENTS AND SAY OK, WHY 2250 01:37:22,240 --> 01:37:23,840 ARE WE COLLECTING IT AND SOME 2251 01:37:23,840 --> 01:37:25,560 TRAILS NOT ON ALL TRIALS? 2252 01:37:25,560 --> 01:37:28,000 WHY DO WE COLLECT IT IN SUDDEN 2253 01:37:28,000 --> 01:37:29,600 WAYS AND TRIALS AND NOT 2254 01:37:29,600 --> 01:37:30,840 COMPREHENSIVE OTHERWISE SO WE 2255 01:37:30,840 --> 01:37:32,480 KIND OF, THAT'S WHERE WE LANDED 2256 01:37:32,480 --> 01:37:34,840 AND THE SECOND ONE I WILL SAY IS 2257 01:37:34,840 --> 01:37:37,120 IN TERMS OF HAVING TRIED TO SEE 2258 01:37:37,120 --> 01:37:38,480 IF WE DIDN'T COLLECT THIS WHAT 2259 01:37:38,480 --> 01:37:40,720 WOULD HAVE HAPPENED? 2260 01:37:40,720 --> 01:37:42,920 I DON'T THINK WE'VE DONE THAT 2261 01:37:42,920 --> 01:37:43,120 EXAM. 2262 01:37:43,120 --> 01:37:46,480 WE ARE, I WILL PUT A PLUG IN FOR 2263 01:37:46,480 --> 01:37:48,240 AN ALLIANCE DRIVE COMING UP. 2264 01:37:48,240 --> 01:37:53,120 WHERE WE ARE ATTEMPTING TO NOT 2265 01:37:53,120 --> 01:37:55,320 COLLECT ATTRIBUTION ON THAT 2266 01:37:55,320 --> 01:37:56,800 STUDY BECAUSE IT'S ON APPROVED 2267 01:37:56,800 --> 01:37:58,920 AGENTS AND RANDOMIZED STUDY AND 2268 01:37:58,920 --> 01:38:01,960 WE GOT IT FROM THE NCI AND STUDY 2269 01:38:01,960 --> 01:38:04,400 TEAM TO SAY OK WE ONLY COLLECT 2270 01:38:04,400 --> 01:38:06,640 WHAT THE STUDY TEAM IS REPORTING 2271 01:38:06,640 --> 01:38:09,440 WE CAN FIGURE OUT YOU KNOW, WHAT 2272 01:38:09,440 --> 01:38:11,400 JUST BY SUBTRACTING THE RATES OF 2273 01:38:11,400 --> 01:38:12,880 ADVERSE EVENTS WE WOULD BE ABLE 2274 01:38:12,880 --> 01:38:14,480 TO FIGURE OUT THE TREATMENT. 2275 01:38:14,480 --> 01:38:16,000 SO WE'RE MAKING SOME PROGRESS 2276 01:38:16,000 --> 01:38:17,560 WHILE WE ARE WORKING ON THIS BUT 2277 01:38:17,560 --> 01:38:19,360 YEAH, YOURS IS A GREAT QUESTION 2278 01:38:19,360 --> 01:38:20,600 AND WE SHOULD TAKE IT BACK TO 2279 01:38:20,600 --> 01:38:22,040 THE WORKING GROUP TO SEE IF 2280 01:38:22,040 --> 01:38:26,200 THERE'S A WAY TO ADDRESS THAT. 2281 01:38:26,200 --> 01:38:28,920 >>I WOULD JUST UNDERSCORE 2282 01:38:28,920 --> 01:38:31,400 EXACTLY WHAT YOU SAID AND THAT 2283 01:38:31,400 --> 01:38:37,080 IS THAT THE PROCESS THAT LED TO 2284 01:38:37,080 --> 01:38:41,240 THIS CATEGORIES, BASICALLY ASKED 2285 01:38:41,240 --> 01:38:45,080 THE GROUP TO PRESSURE TEST WHAT 2286 01:38:45,080 --> 01:38:45,680 IF. 2287 01:38:45,680 --> 01:38:50,240 WHAT IF WE ELIMINATED THIS. 2288 01:38:50,240 --> 01:38:51,680 WAS THERE -- WITH THESE DATA 2289 01:38:51,680 --> 01:38:54,280 THAT WERE COLLECTED ANALYZED IN 2290 01:38:54,280 --> 01:38:57,080 ANYWAY AT ALL? 2291 01:38:57,080 --> 01:39:02,280 AND WE FOUND THAT A LOT WERE 2292 01:39:02,280 --> 01:39:02,720 NOT. 2293 01:39:02,720 --> 01:39:08,640 ALSO, THE RELIABILITY OF CERTAIN 2294 01:39:08,640 --> 01:39:09,600 PARAMETERS WAS LOW. 2295 01:39:09,600 --> 01:39:12,520 SO FOR EXAMPLE, ATTRIBUTION, THE 2296 01:39:12,520 --> 01:39:15,720 COMMITTEE HIGHLIGHTED THAT WORK 2297 01:39:15,720 --> 01:39:19,480 HAD BEEN DONE TO SHOW 2298 01:39:19,480 --> 01:39:21,080 INCONSISTENCY AND ATTRIBUTIONS 2299 01:39:21,080 --> 01:39:24,560 FROM EVALUATOR TO EVALUATOR 2300 01:39:24,560 --> 01:39:29,160 WHICH LED US TO CONCLUDE THAT 2301 01:39:29,160 --> 01:39:32,520 ATTRIBUTION IS REALLY NOT USEFUL 2302 01:39:32,520 --> 01:39:34,480 AND AT LEAST THAT'S OUR 2303 01:39:34,480 --> 01:39:36,080 HYPOTHESIS FOR WHY IT FOUND ITS 2304 01:39:36,080 --> 01:39:37,920 WAY INTO THE RECOMMENDATIONS. 2305 01:39:37,920 --> 01:39:39,200 >>THANK YOU, VERY MUCH. 2306 01:39:39,200 --> 01:39:41,880 REALLY WONDERFUL WORKING GROUP 2307 01:39:41,880 --> 01:39:44,640 RESULTS, SO THANK YOU TO NEIL 2308 01:39:44,640 --> 01:39:50,560 AND THE TEAM. 2309 01:39:50,560 --> 01:39:52,800 >>THANK YOU. 2310 01:39:52,800 --> 01:39:54,800 >>MARK -- 2311 01:39:54,800 --> 01:39:56,440 >>HI, CAN CAN YOU HEAR ME? 2312 01:39:56,440 --> 01:39:59,080 >>YEP. 2313 01:39:59,080 --> 01:40:00,120 >>GREAT. 2314 01:40:00,120 --> 01:40:01,080 >>Rachelle: , SO I WAS 2315 01:40:01,080 --> 01:40:03,160 FORTUNATE TO BE ABLE TO 2316 01:40:03,160 --> 01:40:04,480 PARTICIPATE AND I THINK WHICH 2317 01:40:04,480 --> 01:40:06,840 BACK WHEN THE ORIGINAL 2318 01:40:06,840 --> 01:40:08,320 RECOMMENDATIONS WERE COMING 2319 01:40:08,320 --> 01:40:12,520 ABOUT FOR THE 2030 2320 01:40:12,520 --> 01:40:15,640 RECOMMENDATIONS AND I WAS ABLE O 2321 01:40:15,640 --> 01:40:18,560 SIT IN MEETINGS US BECAUSE OF 2322 01:40:18,560 --> 01:40:19,080 EXEMPT MEANING THEY'RE NOT 2323 01:40:19,080 --> 01:40:21,000 TRIALS THAT WOULD BE INTENDED TO 2324 01:40:21,000 --> 01:40:22,440 SUPPORT A NEW INDICATION OR 2325 01:40:22,440 --> 01:40:24,120 MEANINGFUL CHANGES TO THE 2326 01:40:24,120 --> 01:40:25,800 LABELING, YOU HAVE A MUCH TIVE 2327 01:40:25,800 --> 01:40:27,560 CONSIDERATIONS FROM THE FTA 2328 01:40:27,560 --> 01:40:29,240 PERSPECTIVE AND WE HAVE 2329 01:40:29,240 --> 01:40:31,720 ABSOLUTELY HAPPY TO PARTICIPATE 2330 01:40:31,720 --> 01:40:34,040 IN A MORE, I GUESS, INTEGRATED 2331 01:40:34,040 --> 01:40:36,680 AND LONGITUDINAL WAY, WHEN YOU 2332 01:40:36,680 --> 01:40:38,400 START THINKING ABOUT THE 2333 01:40:38,400 --> 01:40:42,320 TRANSLATION TO IND STUDIES 2334 01:40:42,320 --> 01:40:43,920 CONDUCTED HERE AND ONE OF THE 2335 01:40:43,920 --> 01:40:46,480 THINGS THAT WE'RE CERTAINLY 2336 01:40:46,480 --> 01:40:49,040 THINKING ABOUT IS SITUATIONS IN 2337 01:40:49,040 --> 01:40:52,680 GENERAL WHERE COLLECTION OF 2338 01:40:52,680 --> 01:40:55,800 LIMITED DATA WOULD BE A 2339 01:40:55,800 --> 01:40:57,880 INTERESTED VERY SPECIFIC SCIENCE 2340 01:40:57,880 --> 01:40:59,840 QUESTIONS AND I JUST WANTED TO 2341 01:40:59,840 --> 01:41:02,480 HIGHLIGHT EVEN IN THE INDA 2342 01:41:02,480 --> 01:41:03,640 EXEMPT, WE'RE TALKING ABOUT 2343 01:41:03,640 --> 01:41:05,000 MARKET OF PRODUCTS SO THERE'S A 2344 01:41:05,000 --> 01:41:07,440 DIFFERENCE BETWEEN COLLECTION OF 2345 01:41:07,440 --> 01:41:08,520 SAFETY INFORMATION AND THE 2346 01:41:08,520 --> 01:41:10,360 REPORTING REQUIREMENTS, OF 2347 01:41:10,360 --> 01:41:11,800 COURSE, FOR MARKETED PRODUCTS 2348 01:41:11,800 --> 01:41:13,880 BUT NO I JUST WANTED TO SAY THAT 2349 01:41:13,880 --> 01:41:16,320 WE'RE HAPPY TO, AS THIS MOVES 2350 01:41:16,320 --> 01:41:17,680 FORWARD AND THINKING ABOUT WAYS 2351 01:41:17,680 --> 01:41:19,880 TO LIMIT DATA COLLECTION AND IN 2352 01:41:19,880 --> 01:41:22,560 THE IND AND YOU KNOW, SPACE AND 2353 01:41:22,560 --> 01:41:26,360 I'M HAPPY TO PROVIDE ADDITIONAL 2354 01:41:26,360 --> 01:41:26,640 INPUT. 2355 01:41:26,640 --> 01:41:28,600 >>YES, THANK YOU SO MUCH FOR 2356 01:41:28,600 --> 01:41:33,840 YOUR INPUT TO DATE AND YOUR 2357 01:41:33,840 --> 01:41:37,160 WILLINGNESS TO JUMP IN AS THIS 2358 01:41:37,160 --> 01:41:37,760 NOT FOLDS FURTHER. 2359 01:41:37,760 --> 01:41:40,080 YOU KNOW, TO THE POINTS THAT YOU 2360 01:41:40,080 --> 01:41:41,920 MADE AND THAT PATTY MADE 2361 01:41:41,920 --> 01:41:43,880 REGARDING CO STAKEHOLDERS, 2362 01:41:43,880 --> 01:41:46,480 THERE'S A RECOGNITION THAT WE 2363 01:41:46,480 --> 01:41:47,800 NOW NEED TO BROADEN OUT THE 2364 01:41:47,800 --> 01:41:49,320 LAYERS OF THE ONION IN TERMS OF 2365 01:41:49,320 --> 01:41:54,360 WHO IS WEIGHING IN AND TO BUILD 2366 01:41:54,360 --> 01:41:59,800 FURTHER CONSENSUS SO THAT IF THE 2367 01:41:59,800 --> 01:42:01,800 NCI CHOSES TO PURSUE A SET THE 2368 01:42:01,800 --> 01:42:06,200 STANDARD PRACTICES, THAT WE HAVE 2369 01:42:06,200 --> 01:42:10,520 STAKEHOLDER BUY IN SUCH THAT WE 2370 01:42:10,520 --> 01:42:12,840 HAVE ROBUST IMPLEMENTATION. 2371 01:42:12,840 --> 01:42:15,440 AT THIS FOR ALL COMMENTS. 2372 01:42:15,440 --> 01:42:19,280 WITH THAT, I WOULD LIKE TO MOVE 2373 01:42:19,280 --> 01:42:22,320 ON TO CONSIDERATION OF ACCEPTING 2374 01:42:22,320 --> 01:42:24,960 THE INTERIM REPORT. 2375 01:42:24,960 --> 01:42:29,320 SO, I WOULD LIKE A COMING TO MOO 2376 01:42:29,320 --> 01:42:30,760 ACCEPT THE INTERIM REPORT. 2377 01:42:30,760 --> 01:42:31,640 >>SO MOVED. 2378 01:42:31,640 --> 01:42:32,760 >>IS THERE A SECOND. 2379 01:42:32,760 --> 01:42:33,720 >>SECOND. 2380 01:42:33,720 --> 01:42:41,240 >>WOULD ANYONE LIKE ANY FURTHER 2381 01:42:41,240 --> 01:42:43,640 DISCUSSION? 2382 01:42:43,640 --> 01:42:46,160 OK, NOW BY A SHOW OF HANDS, I'M 2383 01:42:46,160 --> 01:42:49,000 ASKING IF ANYONE TUESDAY NOT 2384 01:42:49,000 --> 01:42:50,480 ACCEPT THE INTERIM REPORT. 2385 01:42:50,480 --> 01:43:00,240 SO LOOKING FOR THE NAYs. 2386 01:43:00,240 --> 01:43:04,200 BY SHOW OF HANDS, ANY AB 2387 01:43:04,200 --> 01:43:11,120 ABSTENTIONS. 2388 01:43:11,120 --> 01:43:13,600 OK, WE WILL THEREFORE CONSIDER 2389 01:43:13,600 --> 01:43:20,560 THE INTERIM REPORT ACCEPTED. 2390 01:43:20,560 --> 01:43:20,720 OK. 2391 01:43:20,720 --> 01:43:25,240 THANK YOU, EVERYBODY, FOR GOOD 2392 01:43:25,240 --> 01:43:26,440 DISCUSSION THERE AND WE HAVE ONE 2393 01:43:26,440 --> 01:43:30,520 MORE A AGAIN TA ITEM, 5 BEFORE 2394 01:43:30,520 --> 01:43:32,560 TAKING A QUICK BREAK. 2395 01:43:32,560 --> 01:43:38,840 AND THIS IS LEVERAGING THE NCTN 2396 01:43:38,840 --> 01:43:39,320 NCORP CLINICAL TRAILS 2397 01:43:39,320 --> 01:43:43,200 POPULATIONS FOR OBSERVATIONAL 2398 01:43:43,200 --> 01:43:45,680 CANCER SURVIVER SHIP RESEARCH 2399 01:43:45,680 --> 01:43:46,920 AND THIS PRESENTATION AND 2400 01:43:46,920 --> 01:43:49,840 DISCUSSION WILL BE LED BY Dr. 2401 01:43:49,840 --> 01:43:54,120 LISA GALLICCHIO FROM RESEARCH 2402 01:43:54,120 --> 01:43:56,080 PROGRAM AND IN THE DIVISION OF 2403 01:43:56,080 --> 01:43:57,920 CANCER CONTROL AND POPULATION 2404 01:43:57,920 --> 01:44:03,440 SCIENCES, WHICH IS THE TCRPS AT 2405 01:44:03,440 --> 01:44:03,720 THE NCI. 2406 01:44:03,720 --> 01:44:05,960 SO, LISA, IT'S ALL YOURS. 2407 01:44:05,960 --> 01:44:06,800 >>ALL RIGHT. 2408 01:44:06,800 --> 01:44:11,320 THANK YOU, INTEREST MEROPOL. 2409 01:44:11,320 --> 01:44:12,440 THIS WILL BE A INTERESTING 2410 01:44:12,440 --> 01:44:14,360 DISCUSSION IN LIGHT OF THE 2411 01:44:14,360 --> 01:44:17,920 PREVIOUS PRESENTATION ASK 2412 01:44:17,920 --> 01:44:18,200 DISCUSSION. 2413 01:44:18,200 --> 01:44:21,040 I AM PRESENTING THE FINDINGS 2414 01:44:21,040 --> 01:44:23,200 FROM OUR REQUEST FOR INFORMATION 2415 01:44:23,200 --> 01:44:25,800 ON LEVERAGING NCTN AND CLINICAL 2416 01:44:25,800 --> 01:44:27,000 TRIAL POPULATIONS FOR 2417 01:44:27,000 --> 01:44:29,200 OBSERVATIONAL CANCER SURVIVOR 2418 01:44:29,200 --> 01:44:38,960 SHIP RESEARCH. 2419 01:44:38,960 --> 01:44:42,360 THIS IS BEEN A THREE-DIVISION. 2420 01:44:42,360 --> 01:44:48,760 STAFF AT DCCPS AND DCP TCTD HAVE 2421 01:44:48,760 --> 01:44:49,840 BEEN INVOLVED AND SOME ARE ON 2422 01:44:49,840 --> 01:44:53,160 THE CALL TODAY. 2423 01:44:53,160 --> 01:44:55,960 HERE IS THE TIMELINE FOR OUR 2424 01:44:55,960 --> 01:44:58,040 REQUEST FOR INFORMATION WORK. 2425 01:44:58,040 --> 01:45:00,240 THIS REQUEST FOR INFORMATION WAS 2426 01:45:00,240 --> 01:45:03,240 DEVELOPED IN RESPONSE TO A 2019 2427 01:45:03,240 --> 01:45:05,280 NATIONAL CANCER ADVISORY BOARD 2428 01:45:05,280 --> 01:45:07,760 WORKING GROUP REPORT 2429 01:45:07,760 --> 01:45:10,960 RECOMMENDATION TO LEVERAGE NCTN 2430 01:45:10,960 --> 01:45:15,600 AND NCORP FOR CANCER SURVIVE OR 2431 01:45:15,600 --> 01:45:16,960 SHIP CO SHORTS STUDIES. 2432 01:45:16,960 --> 01:45:23,800 THIS WAS PUBLISHED IN THE NIH 2433 01:45:23,800 --> 01:45:34,280 GUIDE -- TO NOTE, WE HAD ONE 2434 01:45:37,360 --> 01:45:40,880 RESPONSE THAT WAS SUBMITTED FROM 2435 01:45:40,880 --> 01:45:44,920 THE RESEARCH BASE ECOG-ACRIN 2436 01:45:44,920 --> 01:45:48,720 FROM MULTIPLE INVESTIGATORS. 2437 01:45:48,720 --> 01:45:51,160 NEXT SLIDE. 2438 01:45:51,160 --> 01:45:52,840 WHAT THE RFI ASKED OF THE 2439 01:45:52,840 --> 01:45:55,280 COMMUNITY WAS WHAT RESEARCH GAPS 2440 01:45:55,280 --> 01:45:58,080 IN CANCER SURVIVE OR SHIP COULD 2441 01:45:58,080 --> 01:46:08,680 BE ADDRESSED BY LEVERAGING AS WL 2442 01:46:14,840 --> 01:46:17,360 AS THE AREA ON THE CANCER 2443 01:46:17,360 --> 01:46:18,200 SURVIVORSHIP WHERE WE BELIEVE 2444 01:46:18,200 --> 01:46:19,680 THERE'S THE GREAT OF THE 2445 01:46:19,680 --> 01:46:21,520 OPPORTUNITY TO FILL RESEARCH 2446 01:46:21,520 --> 01:46:26,840 GAPS AND LEVERAGE NCTN AND ENCOR 2447 01:46:26,840 --> 01:46:27,480 POPULATIONS. 2448 01:46:27,480 --> 01:46:30,440 AS THIS GROUP KNOWS, NCTN 2449 01:46:30,440 --> 01:46:31,920 SUPPORTS TREATMENT TRIALS WITH 2450 01:46:31,920 --> 01:46:41,600 ADVERTISE SEIZEDISEASE END PONTH 2451 01:46:41,600 --> 01:46:43,440 STUDIES AS WELL AS END-OF-LIFE 2452 01:46:43,440 --> 01:46:45,280 STUDIES TREATMENT-RELATED 2453 01:46:45,280 --> 01:46:49,480 ADVERSE EVENTS RESEARCH. 2454 01:46:49,480 --> 01:46:52,960 NCTN AND NCORP HAVE INITIAL 2455 01:46:52,960 --> 01:46:54,200 TREATMENT FOCUSED STUDIES SO 2456 01:46:54,200 --> 01:46:56,760 WITHIN THE FIRST FIVE YEARS OF 2457 01:46:56,760 --> 01:46:59,760 DIAGNOSIS FOR A PATIENT ALTHOUGH 2458 01:46:59,760 --> 01:47:01,000 THEIR FOLLOW-UP FOR THESE TRIALS 2459 01:47:01,000 --> 01:47:02,680 CAN BE LONGER. 2460 01:47:02,680 --> 01:47:05,600 WE SEE THAT THERE COULD BE AN 2461 01:47:05,600 --> 01:47:06,920 OPPORTUNITY TO LEVERAGE THESE 2462 01:47:06,920 --> 01:47:08,760 TRIAL POPULATIONS TO FILL SOME 2463 01:47:08,760 --> 01:47:12,200 GAPS IN THIS LONGER-TERM 2464 01:47:12,200 --> 01:47:14,120 SURVIVORSHIP PERIOD OR FIVE 2465 01:47:14,120 --> 01:47:22,520 YEARS POST DYING KNO DIAGNOSIS . 2466 01:47:22,520 --> 01:47:28,440 WHAT DID WE ASK? 2467 01:47:28,440 --> 01:47:29,640 FIRST SPECIFIC RESEARCH 2468 01:47:29,640 --> 01:47:31,560 QUESTIONS OR EVIDENCE GAPS IN 2469 01:47:31,560 --> 01:47:33,760 CANCER SURVIVORSHIP THAT CAN BE 2470 01:47:33,760 --> 01:47:39,560 ADDRESSED UTILIZING EXITING NCTN 2471 01:47:39,560 --> 01:47:41,360 ENCORE POPULATIONS AND SECOND, 2472 01:47:41,360 --> 01:47:43,040 TO CONDUCT OBSERVATIONAL 2473 01:47:43,040 --> 01:47:47,440 RESEARCH STUDIES UTILIZING THE 2474 01:47:47,440 --> 01:47:47,800 POPULATIONS. 2475 01:47:47,800 --> 01:47:50,280 THIRD, STRATEGIES TO USE 2476 01:47:50,280 --> 01:47:51,480 EXISTING INFRASTRUCTURE TO 2477 01:47:51,480 --> 01:47:53,920 SUPPORT LONG-TERM CANCER 2478 01:47:53,920 --> 01:47:56,440 SURVIVORSHIP STUDIES AND 2479 01:47:56,440 --> 01:47:57,320 FINALLY, INFRASTRUCTURE THAT 2480 01:47:57,320 --> 01:47:59,400 MIGHT BE NEEDED TO FACILITATE 2481 01:47:59,400 --> 01:48:02,080 LONG-TERM CANCER SURVIVORSHIP 2482 01:48:02,080 --> 01:48:02,440 STUDIES. 2483 01:48:02,440 --> 01:48:05,160 SO ON THE NEXT FOUR SLIDES, I'LL 2484 01:48:05,160 --> 01:48:06,800 SUMMARIZE SOME OF THE RESPONSES 2485 01:48:06,800 --> 01:48:11,640 TO THESE FOUR BULLET POINTS. 2486 01:48:11,640 --> 01:48:14,520 NEXT SLIDE, SO FIRST WITH 2487 01:48:14,520 --> 01:48:17,760 RESPECT TO RESEARCH QUESTIONS. 2488 01:48:17,760 --> 01:48:24,040 THE OVERWHELMING RESPONSE TO 2489 01:48:24,040 --> 01:48:26,360 THIS BULLET POINT WAS THESE 2490 01:48:26,360 --> 01:48:27,960 POPULATIONS CAN CAN BE LEVERAGED 2491 01:48:27,960 --> 01:48:29,640 TO FILL GAPS WITH OUTCOMES 2492 01:48:29,640 --> 01:48:30,880 ASSOCIATED WITH NEW OR 2493 01:48:30,880 --> 01:48:32,920 COMBINATION ANTI CANCER 2494 01:48:32,920 --> 01:48:34,960 THERAPIES INCLUDING AMINO 2495 01:48:34,960 --> 01:48:37,360 THERAPIES AND TARGETED THEORIES. 2496 01:48:37,360 --> 01:48:38,800 THERE WERE A NUMBER OF OUTCOMES 2497 01:48:38,800 --> 01:48:42,480 THAT WERE MENTIONED RELATED TO 2498 01:48:42,480 --> 01:48:43,360 THIS TOPIC. 2499 01:48:43,360 --> 01:48:49,560 AND SOME OF THEM ARE LISTED 2500 01:48:49,560 --> 01:48:50,160 HERE. 2501 01:48:50,160 --> 01:48:50,400 SECOND. 2502 01:48:50,400 --> 01:48:51,480 SOMETHING MENTIONED WAS 2503 01:48:51,480 --> 01:48:53,560 LONG-TERM SURVIVORSHIP OUTCOMES 2504 01:48:53,560 --> 01:48:58,400 AMONG INDIVIDUALS DIAGNOSED WITH 2505 01:48:58,400 --> 01:48:59,280 RARE CANCERS. 2506 01:48:59,280 --> 01:49:01,120 WHICH HEARD THE ROLE OF SOCIAL 2507 01:49:01,120 --> 01:49:04,080 DETERMINANTS ON LONG-TERM 2508 01:49:04,080 --> 01:49:05,120 SURVIVORSHIP AS WELL AS 2509 01:49:05,120 --> 01:49:08,240 TECHNOLOGY BASED STRATEGIES FOR 2510 01:49:08,240 --> 01:49:11,760 MANAGEMENT OF LONGER TERMS AND 2511 01:49:11,760 --> 01:49:15,120 CANCER TREATMENT WERE ALSO AREAS 2512 01:49:15,120 --> 01:49:16,200 THE COMMUNITY THOUGHT THESE 2513 01:49:16,200 --> 01:49:17,800 TRIAL POPULATIONS COULD BE 2514 01:49:17,800 --> 01:49:21,960 LEVERAGED TO FILL GAPS. 2515 01:49:21,960 --> 01:49:23,320 NEXT SLIDE. 2516 01:49:23,320 --> 01:49:25,360 THE SECOND BULLET POINT WAS 2517 01:49:25,360 --> 01:49:27,680 GENERAL METHODOLOGIES THAT CAN 2518 01:49:27,680 --> 01:49:30,560 BE UTILIZED TO ANSWER THESE 2519 01:49:30,560 --> 01:49:33,280 RESEARCH QUESTIONS WITH THESE 2520 01:49:33,280 --> 01:49:33,760 POPULATIONS. 2521 01:49:33,760 --> 01:49:36,320 FIRST, AND MENTIONED IN MULTIPLE 2522 01:49:36,320 --> 01:49:37,840 RESPONSES, WAS ESTABLISHING A 2523 01:49:37,840 --> 01:49:40,160 CLINICAL TRIAL SURVIVORSHIP 2524 01:49:40,160 --> 01:49:41,640 REGISTRY THAT ENCLOUDS ALL 2525 01:49:41,640 --> 01:49:45,040 PATIENTS ENROLLED IN NCTN 2526 01:49:45,040 --> 01:49:47,360 TREATMENT TRAILS AND NCORP 2527 01:49:47,360 --> 01:49:49,480 STUDIES FOR LONG-TERM CANCER 2528 01:49:49,480 --> 01:49:51,320 SURVIVORSHIP FOLLOW-UP STUDIES. 2529 01:49:51,320 --> 01:49:53,520 SECOND AND NOT SURPRISING, 2530 01:49:53,520 --> 01:49:55,000 CONDUCTING SURVEYS STUDIES FOR 2531 01:49:55,000 --> 01:49:59,800 LONGER TERM FOLLOW-UP DATA. 2532 01:49:59,800 --> 01:50:00,880 THIRD AND SOMETHING THAT SOME OF 2533 01:50:00,880 --> 01:50:02,680 THE RESEARCH BASIS AND 2534 01:50:02,680 --> 01:50:03,560 CO-OPERATIVE GROUPS HAVE BEEN 2535 01:50:03,560 --> 01:50:07,920 SUCCESSFUL IN DOING IS LINKING 2536 01:50:07,920 --> 01:50:09,560 CLINICAL TRIALS DID HE DO TO 2537 01:50:09,560 --> 01:50:12,000 MEDICARE, MEDICAID AND OTHER 2538 01:50:12,000 --> 01:50:12,240 CLAIMS. 2539 01:50:12,240 --> 01:50:14,760 FOURTH METHODS FOR DATA 2540 01:50:14,760 --> 01:50:16,560 COLLECTION SUCH AS THE EASY PRO 2541 01:50:16,560 --> 01:50:19,520 AND FINALLY, SOMETHING HAPPENS 2542 01:50:19,520 --> 01:50:21,800 MENTIONED BY ONE RESPOND AROUND, 2543 01:50:21,800 --> 01:50:23,160 SPECIFICALLY RELATED TO 2544 01:50:23,160 --> 01:50:24,480 HEALTHCARE DELIVER RE RESEARCH 2545 01:50:24,480 --> 01:50:26,320 WAS TO ESTABLISH A NETWORK OF 2546 01:50:26,320 --> 01:50:31,480 PRIMARY CARE PRACTICES WITHIN 2547 01:50:31,480 --> 01:50:35,760 NCORP FOR LARGE-SCALE STUDIES OF 2548 01:50:35,760 --> 01:50:37,360 SURVIVORSHIP CARE. 2549 01:50:37,360 --> 01:50:40,040 NEXT WERE THE BARRIERS THAT THE 2550 01:50:40,040 --> 01:50:41,720 COMMUNITY SAW IN CONDUCTING 2551 01:50:41,720 --> 01:50:43,920 LONG-TERM SURVIVORSHIP STUDIES 2552 01:50:43,920 --> 01:50:47,480 AND NCTN AND NCORP. 2553 01:50:47,480 --> 01:50:50,640 THIS WAS MENTIONED ON 99% OF THE 2554 01:50:50,640 --> 01:50:51,880 RESPONSES WAS THAT CLINICAL 2555 01:50:51,880 --> 01:50:54,080 TRIAL PATIENTS ARE NOT CONSENTED 2556 01:50:54,080 --> 01:50:56,000 FOR ANCILLARY OR FOLLOW-UP 2557 01:50:56,000 --> 01:50:59,920 STUDIES, A LOT OF THE TIMES. 2558 01:50:59,920 --> 01:51:00,640 NOT THINK A CENTRAL MECHANISM 2559 01:51:00,640 --> 01:51:02,520 AND TO BE IN LONGER TERM 2560 01:51:02,520 --> 01:51:04,560 FOLLOW-UP STUDIES OR ANCILLARY 2561 01:51:04,560 --> 01:51:06,240 STUDIES, THEY NEED TO BE 2562 01:51:06,240 --> 01:51:07,840 RECONSENTED AND THAT CAN CAN BE 2563 01:51:07,840 --> 01:51:08,800 PROBLEMATIC BECAUSE IT CAN BE 2564 01:51:08,800 --> 01:51:12,400 DIFFICULT TO RELOCATE TRIAL 2565 01:51:12,400 --> 01:51:14,640 PARTICIPANTS FOR RECONSENT OR 2566 01:51:14,640 --> 01:51:15,520 FOLLOW-UP. 2567 01:51:15,520 --> 01:51:17,720 SECOND, IT'S SOMETIMES DIFFICULT 2568 01:51:17,720 --> 01:51:22,160 TO GET COMMUNITY SITES TO OPEN 2569 01:51:22,160 --> 01:51:28,720 ANCILLARY STUD S AN SIL AR STUDY 2570 01:51:28,720 --> 01:51:29,880 BE INFORMATION WITHOUT RECONTACT 2571 01:51:29,880 --> 01:51:32,680 TO ENABLE STRONG LINKAGES AND 2572 01:51:32,680 --> 01:51:34,120 ONE RESPONDENT MENTIONED IT CAN 2573 01:51:34,120 --> 01:51:36,440 BE EXPENSIVE TO COLLECT 2574 01:51:36,440 --> 01:51:40,760 EPIDEMIOLOGIC DATA IN CLINICAL 2575 01:51:40,760 --> 01:51:41,120 TRIALS. 2576 01:51:41,120 --> 01:51:44,080 AND FINALLY, STRATEGIES TO 2577 01:51:44,080 --> 01:51:48,720 UTILIZE EXISTING NCTN AND NCORP 2578 01:51:48,720 --> 01:51:49,560 INFRASTRUCTURE FOR LONG-TERM 2579 01:51:49,560 --> 01:51:53,640 CANCER SURVIVORSHIP STUDIES. 2580 01:51:53,640 --> 01:51:55,200 ONE RESPONSE WAS THE ROUTINE 2581 01:51:55,200 --> 01:51:56,640 COLLECTION OF PATIENT CONSENT 2582 01:51:56,640 --> 01:51:57,960 FOR SURVIVORSHIP STUDIES AT THE 2583 01:51:57,960 --> 01:52:00,040 TIME OF CLINICAL TRIALS 2584 01:52:00,040 --> 01:52:07,040 ENROLLMENT AND RELATED TO THIS 2585 01:52:07,040 --> 01:52:10,040 IS DOCUMENT THIS INFORMATION 2586 01:52:10,040 --> 01:52:13,040 CENTRALLY WITH PATIENT CONTACT 2587 01:52:13,040 --> 01:52:14,480 INFORMATION AND AND A SMALL 2588 01:52:14,480 --> 01:52:19,080 NUMBER OF PATIENTS DEMOGRAPHIC 2589 01:52:19,080 --> 01:52:20,040 CHARACTERISTICS. 2590 01:52:20,040 --> 01:52:20,760 NEXT SLIDE. 2591 01:52:20,760 --> 01:52:22,480 SO, ONE COMMON THEME THAT I 2592 01:52:22,480 --> 01:52:24,680 MENTIONED ON ONE OF MY PREVIOUS 2593 01:52:24,680 --> 01:52:26,480 SLIDES, THROUGHOUT SOME OF THE 2594 01:52:26,480 --> 01:52:28,440 RESPONSES, WAS THIS IDEA OF THE 2595 01:52:28,440 --> 01:52:30,360 CLINICAL TRAILS SURVIVORSHIP 2596 01:52:30,360 --> 01:52:32,400 REGISTRY TO FACILITATE THESE 2597 01:52:32,400 --> 01:52:35,080 LONG-TERM CANCER SURVIVORSHIP 2598 01:52:35,080 --> 01:52:35,440 STUDIES. 2599 01:52:35,440 --> 01:52:37,600 THIS IS NOT A NEW IDEA. 2600 01:52:37,600 --> 01:52:40,080 IT WAS MENTIONED IN A MANUSCRIPT 2601 01:52:40,080 --> 01:52:43,760 PUBLISHED BY PATTY GANTZ IN 2602 01:52:43,760 --> 01:52:44,000 2009. 2603 01:52:44,000 --> 01:52:46,880 HERE IS ONE OF THE QUOTE FROM 2604 01:52:46,880 --> 01:52:50,120 ONE OF THE RESPONSE TO THE RFI 2605 01:52:50,120 --> 01:52:51,760 ABOUT WHAT THIS RESPONDENT 2606 01:52:51,760 --> 01:52:55,000 THOUGHT A CLINICAL TRIAL 2607 01:52:55,000 --> 01:52:55,640 REGISTRY WOULD ENTAIL. 2608 01:52:55,640 --> 01:52:56,840 WHAT IS NEEDED IS THE 2609 01:52:56,840 --> 01:52:58,760 ESTABLISHMENT OF A CLINICAL 2610 01:52:58,760 --> 01:53:02,960 TRIAL SURVIVORSHIP REGISTRY WITH 2611 01:53:02,960 --> 01:53:05,800 PARTICIPANTS ACROSS NCORP TRIALS 2612 01:53:05,800 --> 01:53:06,920 THROUGH ROUTINE COLLECTION OF 2613 01:53:06,920 --> 01:53:14,400 PATIENT CONSENT, AND COLLECTING 2614 01:53:14,400 --> 01:53:14,880 PATIENTS AGREEMENT TO BE 2615 01:53:14,880 --> 01:53:15,520 CONTACTED FOR FUTURE RESEARCH 2616 01:53:15,520 --> 01:53:16,600 AND PATIENT CONTACT INFORMATION 2617 01:53:16,600 --> 01:53:18,760 TO ALLOW INVESTIGATORS TO FEES 2618 01:53:18,760 --> 01:53:21,240 BLEE COLLECT DATA FROM LONG-TERM 2619 01:53:21,240 --> 01:53:22,240 COHORTS. 2620 01:53:22,240 --> 01:53:23,200 IMPLEMENTING A MECHANISM THAT 2621 01:53:23,200 --> 01:53:24,640 WILL ALLOW INVESTIGATORS DIRECT 2622 01:53:24,640 --> 01:53:26,920 ACCESS TO SURVIVE OR COHORTS 2623 01:53:26,920 --> 01:53:28,640 THROUGH CONTACTING POTENTIAL 2624 01:53:28,640 --> 01:53:30,120 PARTICIPANTS DIRECTLY AND 2625 01:53:30,120 --> 01:53:31,240 ASSUMING APPROPRIATE APPROVALS 2626 01:53:31,240 --> 01:53:33,120 WILL GREATLY MAXIMIZE 2627 01:53:33,120 --> 01:53:34,760 FEASIBILITY FOR SURVIVORSHIP 2628 01:53:34,760 --> 01:53:38,400 COHORT RESEARCH. 2629 01:53:38,400 --> 01:53:39,240 NEXT SLIDE. 2630 01:53:39,240 --> 01:53:41,560 HERE, I JUST, WE JUST PUT THIS 2631 01:53:41,560 --> 01:53:42,960 INTO FIGURE FORM. 2632 01:53:42,960 --> 01:53:45,000 THE CONCEPTUAL MODEL OF THIS 2633 01:53:45,000 --> 01:53:47,080 CLINICAL TRIAL SURVIVORSHIP 2634 01:53:47,080 --> 01:53:48,000 REGISTRY. 2635 01:53:48,000 --> 01:53:50,880 AGAIN, UPON CONSENT INTO THE 2636 01:53:50,880 --> 01:53:53,560 NCTN OR NCORP STUDY THE PATIENT 2637 01:53:53,560 --> 01:53:56,400 WOULD BE RECONTACTED IF HE OR 2638 01:53:56,400 --> 01:53:58,360 SHE CONSENTED TO RECONTACT, HIS 2639 01:53:58,360 --> 01:53:59,840 OR HER NAME, CONTACT 2640 01:53:59,840 --> 01:54:01,520 INFORMATION, AND CLINICAL TRIALS 2641 01:54:01,520 --> 01:54:04,600 INFORMATION WOULD BE PUT INTO A 2642 01:54:04,600 --> 01:54:05,720 REGISTRY. 2643 01:54:05,720 --> 01:54:07,200 DEMOGRAPHIC OR HEALTH 2644 01:54:07,200 --> 01:54:08,320 CHARACTERISTICS ARE OTHER 2645 01:54:08,320 --> 01:54:12,360 INFORMATION COULD BE COLLECTED 2646 01:54:12,360 --> 01:54:13,720 FOR THE PURVIEW OF THE CLINICAL 2647 01:54:13,720 --> 01:54:15,400 TRIALS SURVIVORSHIP REGISTRY 2648 01:54:15,400 --> 01:54:17,200 GOVERNING COMMITTEE. 2649 01:54:17,200 --> 01:54:19,320 DURING THE TIME THAT THE 2650 01:54:19,320 --> 01:54:20,640 PARTICIPANT IS PARTICIPATING IN 2651 01:54:20,640 --> 01:54:25,200 THE NCTN AND NCORP STUDY HIS OR 2652 01:54:25,200 --> 01:54:26,280 HER DATA WOULD BE UPDATED 2653 01:54:26,280 --> 01:54:28,240 THROUGH THE PARTICIPATE IN THOSE 2654 01:54:28,240 --> 01:54:28,600 STUDIES. 2655 01:54:28,600 --> 01:54:30,160 AFTER THE PARTICIPATION IN THOSE 2656 01:54:30,160 --> 01:54:31,480 STUDIES ENDED, FOLLOWING UP 2657 01:54:31,480 --> 01:54:33,200 THROUGH THE REGISTRY COULD 2658 01:54:33,200 --> 01:54:37,480 CONTINUE FOR A PERIOD OF TIME. 2659 01:54:37,480 --> 01:54:39,680 THROUGHOUT THE PARTICIPANT'S 2660 01:54:39,680 --> 01:54:42,520 PARTATION AND THE REGISTER TEE, 2661 01:54:42,520 --> 01:54:48,560 HE OR SHE O SHE COULD BE CONTACR 2662 01:54:48,560 --> 01:54:49,640 FURTHER STUDIES. 2663 01:54:49,640 --> 01:54:53,200 AFTER WE HAD SOME INTERNAL 2664 01:54:53,200 --> 01:54:54,200 DISCUSSIONS AT NCI, WE REACHED 2665 01:54:54,200 --> 01:54:56,760 OUT TO SURVIVORSHIP 2666 01:54:56,760 --> 01:55:00,320 INVESTIGATORS AT THE NCORP 2667 01:55:00,320 --> 01:55:05,080 RESEARCH BASES. 2668 01:55:05,080 --> 01:55:07,600 ENCLOUDED WAS WE TALKED TO HER 2669 01:55:07,600 --> 01:55:09,240 ABOUT THE CHILDREN'S ONCOLOGY 2670 01:55:09,240 --> 01:55:11,320 GROUP AND THE UMBRELLA PROTOCOLS 2671 01:55:11,320 --> 01:55:13,600 WHICH IS ONE MODEL OF CLINICAL 2672 01:55:13,600 --> 01:55:16,800 TRIALS SURVIVORSHIP REGISTRY. 2673 01:55:16,800 --> 01:55:19,040 BUT HERE I SUMMARIZED SORT OF 2674 01:55:19,040 --> 01:55:21,760 THE MAIN TAKEAWAY POINTS FROM 2675 01:55:21,760 --> 01:55:25,520 OUR CONVERSATIONS WITH THESE 2676 01:55:25,520 --> 01:55:26,400 SURVIVORSHIP INVESTIGATORS ABOUT 2677 01:55:26,400 --> 01:55:29,320 THE CLINICAL TRIAL SURVIVORSHIP 2678 01:55:29,320 --> 01:55:30,800 REGISTRY IDEA AND FIRST, IT 2679 01:55:30,800 --> 01:55:31,880 SEEMS THAT THERE WAS A HIGH 2680 01:55:31,880 --> 01:55:34,160 LEVEL OF ENTHUSIASM BY THE 2681 01:55:34,160 --> 01:55:41,320 SURVIVORSHIP INVESTIGATORS. 2682 01:55:41,320 --> 01:55:44,840 IT'S DISCUSSED BY ALL ENCORE 2683 01:55:44,840 --> 01:55:46,720 RESEARCH BASIS AND THIRD, MOST 2684 01:55:46,720 --> 01:55:50,440 OF THE INVESTIGATORS THAT WE 2685 01:55:50,440 --> 01:55:53,680 TALKED TO RECOGNIZE A NEED TO BE 2686 01:55:53,680 --> 01:55:55,400 CLINICAL TRIAL POPULATIONS FOR 2687 01:55:55,400 --> 01:55:57,560 IN CONCLUDED INTO THE REGISTRY 2688 01:55:57,560 --> 01:55:59,240 AND FOURTH MENTIONED BEFORE 2689 01:55:59,240 --> 01:56:00,000 THERE'S SOME EXISTING 2690 01:56:00,000 --> 01:56:01,720 INFRASTRUCTURE THAT COULD BE 2691 01:56:01,720 --> 01:56:04,920 UTILIZED FOR THIS REGISTER ARE 2692 01:56:04,920 --> 01:56:05,760 TREE AND FIFTH. 2693 01:56:05,760 --> 01:56:08,520 THE INVESTIGATORS THOUGHT THAT 2694 01:56:08,520 --> 01:56:09,880 PATIENTS WOULD BE WILLING TO 2695 01:56:09,880 --> 01:56:11,840 CONTENT TO BE IN A REGISTRY AND 2696 01:56:11,840 --> 01:56:14,480 THE PATIENT ENGAGEMENT AND 2697 01:56:14,480 --> 01:56:17,120 INVOLVEMENT OF PATIENT ADVOCATES 2698 01:56:17,120 --> 01:56:17,720 IS KEY. 2699 01:56:17,720 --> 01:56:19,560 WE ALSO DISCUSSED A NUMBER OF 2700 01:56:19,560 --> 01:56:21,760 KEY CONSIDERATIONS SUCH AS THE 2701 01:56:21,760 --> 01:56:24,840 PROJECTION OF PERSONAL HEALTH 2702 01:56:24,840 --> 01:56:26,320 INFORMATION, AS WELL AS THE NEED 2703 01:56:26,320 --> 01:56:28,480 TO PREVENT COLLECTION BY AS WITH 2704 01:56:28,480 --> 01:56:33,320 INTO THE REGISTRY. 2705 01:56:33,320 --> 01:56:33,880 OF COURSE. 2706 01:56:33,880 --> 01:56:36,080 THE PRIMARY BARRIER ACKNOWLEDGED 2707 01:56:36,080 --> 01:56:38,920 THROUGHOUT ALL OF OUR 2708 01:56:38,920 --> 01:56:39,760 DISCUSSIONS IS THE FUNDS TO 2709 01:56:39,760 --> 01:56:42,320 BUILD AND SUPPORT RECONTACT OF 2710 01:56:42,320 --> 01:56:48,400 PATIENTS ONCE IN THE REGISTRY. 2711 01:56:48,400 --> 01:56:51,520 SO IN SUMMARY, THIS REQUEST FOR 2712 01:56:51,520 --> 01:56:53,080 INFORMATION IDENTIFIED GAPS IN 2713 01:56:53,080 --> 01:56:55,760 RESEARCH PERTAINING TO CANCER 2714 01:56:55,760 --> 01:56:58,360 SURVIVORSHIP THAT CAN BE LEDGED 2715 01:56:58,360 --> 01:57:01,240 BY LEVERAGING NCTN CLINICAL 2716 01:57:01,240 --> 01:57:03,080 TRIAL ASK NCORP STUDY 2717 01:57:03,080 --> 01:57:08,240 POPULATIONS INCLUDING IN THESE 2718 01:57:08,240 --> 01:57:12,280 GAS NEW TREATMENTS AND TREATMENT 2719 01:57:12,280 --> 01:57:16,080 REGIMENT AND OUTCOMES AMONG 2720 01:57:16,080 --> 01:57:18,320 INDIVIDUALS WITH RARE CANCEL AND 2721 01:57:18,320 --> 01:57:21,800 SECOND BUILDING A CLINICAL TRIAL 2722 01:57:21,800 --> 01:57:22,600 REGISTRY COULD ALLOW 2723 01:57:22,600 --> 01:57:23,920 INVESTIGATORS TO EFFICIENTLY 2724 01:57:23,920 --> 01:57:26,680 LEVERAGE NCTN CLINICAL TRIALS 2725 01:57:26,680 --> 01:57:28,440 AND STUDY POPULATION FORCE 2726 01:57:28,440 --> 01:57:33,440 CANCER SURVIVORSHIP RESEARCH. 2727 01:57:33,440 --> 01:57:35,160 NEXT BEFORE I END, I WANT TO 2728 01:57:35,160 --> 01:57:36,240 ACKNOWLEDGE THERE ARE MANY GAPS 2729 01:57:36,240 --> 01:57:45,640 IN KNOWLEDGE REGARDING THE 2730 01:57:45,640 --> 01:57:47,960 PATIENT POPULATIONS ELIGIBLE FOR 2731 01:57:47,960 --> 01:57:50,680 THE REGISTRY AND PATIENT 2732 01:57:50,680 --> 01:57:52,360 WILLINGNESS TO THE WORKLOAD BY 2733 01:57:52,360 --> 01:57:54,200 THE END CORE AND COOPERATIVE 2734 01:57:54,200 --> 01:57:57,080 GROUPS TO CONSENT AND COLLECT 2735 01:57:57,080 --> 01:57:59,680 DATA GIVEN THE CURRENT WORKLOAD 2736 01:57:59,680 --> 01:58:02,480 ALREADY AND A RESEARCH BASE 2737 01:58:02,480 --> 01:58:04,360 ABILITY TO CONDUCT FOLLOW-UP AND 2738 01:58:04,360 --> 01:58:05,400 FOR HOW LONG. 2739 01:58:05,400 --> 01:58:05,600 OTHER. 2740 01:58:05,600 --> 01:58:06,400 >>Tara: TO BE COLLECTED AND I 2741 01:58:06,400 --> 01:58:09,600 THINK WE JUST HEARD IN THE 2742 01:58:09,600 --> 01:58:13,000 PREVIOUS PRESENTATION ABOUT 2743 01:58:13,000 --> 01:58:14,200 LIMITING DATA COLLECTION SO IT'S 2744 01:58:14,200 --> 01:58:15,720 A CONSIDERATION, AND OF COURSE, 2745 01:58:15,720 --> 01:58:18,120 THE BIG GAP IN KNOWLEDGE IS THE 2746 01:58:18,120 --> 01:58:20,480 PROJECTED EFFORT AND COST FOR 2747 01:58:20,480 --> 01:58:22,280 BUILDING AND MANAGING A REGISTRY 2748 01:58:22,280 --> 01:58:32,240 AND CONDUCTING FOLLOW-UP. 2749 01:58:32,240 --> 01:58:34,160 THANK YOU FOR THE WITH FOR 2750 01:58:34,160 --> 01:58:37,960 INFORMATION AND I HAVE A COUPLE 2751 01:58:37,960 --> 01:58:39,200 DISCUSSIONS POINTS HERE THAT WE 2752 01:58:39,200 --> 01:58:42,000 CAN DISCUSS IN THE NEXT SEVERAL 2753 01:58:42,000 --> 01:58:42,400 MINUTES. 2754 01:58:42,400 --> 01:58:45,960 OTHER ADDITIONAL GAPS IN CANCER 2755 01:58:45,960 --> 01:58:46,800 SURVIVORSHIP KNOWLEDGE NOT 2756 01:58:46,800 --> 01:58:47,880 MENTIONED IN THIS PRESENTATION 2757 01:58:47,880 --> 01:58:52,520 TA YOU THINK THE STUDY 2758 01:58:52,520 --> 01:58:53,800 POPULATIONS CAN CAN BE LEVERAGED 2759 01:58:53,800 --> 01:58:54,480 TO ADDRESS. 2760 01:58:54,480 --> 01:58:56,800 WHAT DO YOU THINK OF THIS 2761 01:58:56,800 --> 01:58:58,880 CLINICAL TRIAL REGISTER 2762 01:58:58,880 --> 01:58:59,600 TREMENDOUS CONCEPTUAL MODEL AND 2763 01:58:59,600 --> 01:59:01,200 WHAT ARE THE PROS AND CONS OF 2764 01:59:01,200 --> 01:59:04,960 VERYING A CLINICAL TRIAL 2765 01:59:04,960 --> 01:59:05,560 SURVIVORSHIP REGISTER TREE FOR 2766 01:59:05,560 --> 01:59:07,640 OBSERVATIONAL CANCER 2767 01:59:07,640 --> 01:59:10,760 SURVIVORSHIP RESEARCH. 2768 01:59:10,760 --> 01:59:13,160 THANK YOU. 2769 01:59:13,160 --> 01:59:17,200 >>THANK YOU SO MUCH FOR THIS 2770 01:59:17,200 --> 01:59:17,560 PRESENTATION. 2771 01:59:17,560 --> 01:59:21,800 A LOT TO CHEW ON HERE AND 2772 01:59:21,800 --> 01:59:23,760 APPARENTLY A SUBSTANTIAL 2773 01:59:23,760 --> 01:59:24,240 OPPORTUNITY. 2774 01:59:24,240 --> 01:59:31,600 SO, I'D LIKE TO OPEN THIS UP TO 2775 01:59:31,600 --> 01:59:42,160 MEMBERS OF CTAC FOR DISCUSSION. 2776 01:59:42,440 --> 01:59:44,240 VICTOR SANTANA. 2777 01:59:44,240 --> 01:59:45,360 >>THANK YOU, NEIL. 2778 01:59:45,360 --> 01:59:46,760 THANK YOU, LISA. 2779 01:59:46,760 --> 01:59:48,960 I'M A PEDIATRIC ONCOLOGIST SAYS 2780 01:59:48,960 --> 01:59:50,680 YOU KNOW FROM MY NAME AND WHERE 2781 01:59:50,680 --> 01:59:51,760 I'M AFFILIATED WITH. 2782 01:59:51,760 --> 01:59:53,960 AS I WAS LISTENING TO THIS, THIS 2783 01:59:53,960 --> 01:59:56,240 IS REALLY IMPORTANT BUT THERE 2784 01:59:56,240 --> 01:59:59,920 WERE TWO ISSUES THAT YOU CAN 2785 01:59:59,920 --> 02:00:01,280 DIDN'T MENTION THAT YOU MAY WANT 2786 02:00:01,280 --> 02:00:03,240 TO CONSIDER AS THIS GETS 2787 02:00:03,240 --> 02:00:04,440 DEVELOPED FURTHER. 2788 02:00:04,440 --> 02:00:06,120 ONE IS THE BIDIRECTIONAL TEE OF 2789 02:00:06,120 --> 02:00:07,360 THE REGISTRY, RIGHT. 2790 02:00:07,360 --> 02:00:10,160 RIGHT NOW THE WAY YOUR 2791 02:00:10,160 --> 02:00:12,400 CONCEPTUALIZING ALL THE 2792 02:00:12,400 --> 02:00:14,120 INFORMATION IS FLOWING FROM A 2793 02:00:14,120 --> 02:00:16,160 PRIMARY GROUP OR A PRIMARY 2794 02:00:16,160 --> 02:00:19,120 NUMBER OF CLINICAL TRAILS INTO A 2795 02:00:19,120 --> 02:00:21,720 REGISTRY AND THEN SOME OF THAT 2796 02:00:21,720 --> 02:00:23,000 BASIC INFORMATION ON PATIENTS 2797 02:00:23,000 --> 02:00:24,880 WILL LEAD TO IDENTIFICATION OF 2798 02:00:24,880 --> 02:00:26,720 PATIENTS OR POPULATIONS THAT MAY 2799 02:00:26,720 --> 02:00:28,800 BE ELIGIBLE FOR OBSERVATIONAL 2800 02:00:28,800 --> 02:00:30,160 STUDIES OR OTHER TYPES OF 2801 02:00:30,160 --> 02:00:31,680 STUDIES BUT WHAT YOU LEARN FROM 2802 02:00:31,680 --> 02:00:33,880 THOSE STUDIES, HOW IS THAT. 2803 02:00:33,880 --> 02:00:38,600 >>Tara: DATAFEEDING BACK INTO Y 2804 02:00:38,600 --> 02:00:40,280 STUDIES THAT MAY HAVE IMPORTANT 2805 02:00:40,280 --> 02:00:42,600 INFORMATION FOR THEM, RIGHT. 2806 02:00:42,600 --> 02:00:44,720 FOR EXAMPLE, LONG-TERM ADVERSE 2807 02:00:44,720 --> 02:00:46,160 EVENTS FOR THINGS LIKE THAT WERE 2808 02:00:46,160 --> 02:00:47,880 NOT COLLECTED AS PART OF THE 2809 02:00:47,880 --> 02:00:52,960 PRIMARY OUTCOMES OF THE PRIMARY 2810 02:00:52,960 --> 02:00:54,800 STUDIES, IT'S MORE OF A PROCESS 2811 02:00:54,800 --> 02:00:56,880 ISSUE RATHER THAN A CONCEPTUAL 2812 02:00:56,880 --> 02:00:58,200 ISSUE BUT IT'S GOING TO BE 2813 02:00:58,200 --> 02:01:00,560 REALLY IMPORTANT TOO SO THAT 2814 02:01:00,560 --> 02:01:03,840 THERE'S VALUE FROM THE OTHER END 2815 02:01:03,840 --> 02:01:06,800 NOT JUST THE REGISTER TREE. 2816 02:01:06,800 --> 02:01:08,560 YOU THINK ABOUT RESEARCH IN THIS 2817 02:01:08,560 --> 02:01:09,560 AREA AND I KNOW IT'S NOT THE 2818 02:01:09,560 --> 02:01:11,480 PURPOSE OR THE PRESENTATION 2819 02:01:11,480 --> 02:01:14,720 TODAY AND WE CAN CAN TALK MORE 2820 02:01:14,720 --> 02:01:16,280 ABOUT THAT BUT THE THING WE FACE 2821 02:01:16,280 --> 02:01:19,480 IN PEDIATRICS IS THE TRANSITION 2822 02:01:19,480 --> 02:01:21,160 OF CARE FROM CHILDREN WHEN THEY 2823 02:01:21,160 --> 02:01:23,000 BECOME YOUNG ADULTS AND THEN HOW 2824 02:01:23,000 --> 02:01:24,960 THAT TRANSITION OF CARE AND 2825 02:01:24,960 --> 02:01:25,840 SURVIVORSHIP OCCURS OUTSIDE OF 2826 02:01:25,840 --> 02:01:29,680 THE PRIMARY PEDIATRIC CENTER. 2827 02:01:29,680 --> 02:01:31,320 THINKING OF THAT AS A POTENTIAL 2828 02:01:31,320 --> 02:01:33,720 WAY TO BUILD A REGISTRY THAT 2829 02:01:33,720 --> 02:01:35,520 ALSO REFLECTS THAT TRANSITION OF 2830 02:01:35,520 --> 02:01:37,080 CARE AND ALL THE ISSUES THAT ARE 2831 02:01:37,080 --> 02:01:39,280 ASSOCIATED WITH THAT AND SHE MAY 2832 02:01:39,280 --> 02:01:40,800 HAVE COMMENTS ABOUT THAT BUT 2833 02:01:40,800 --> 02:01:42,840 THOSE ARE MY TWO OBSERVATIONS, 2834 02:01:42,840 --> 02:01:44,160 IT'S A FANTASTIC IDEA. 2835 02:01:44,160 --> 02:01:46,120 THESE ARE MORE JUST PROCESS 2836 02:01:46,120 --> 02:01:47,080 ISSUES, THANK YOU FOR ALLOWING 2837 02:01:47,080 --> 02:01:52,440 ME TO COMMENT. 2838 02:01:52,440 --> 02:01:54,960 >>THANK YOU, GREAT COMMENTS. 2839 02:01:54,960 --> 02:01:56,080 >>DO I HAVE PERMISSION? 2840 02:01:56,080 --> 02:01:58,360 >>YOU CERTAINLY DO, THANK YOU 2841 02:01:58,360 --> 02:01:59,960 FOR STEPPING FORWARD. 2842 02:01:59,960 --> 02:02:02,520 >>HI, LISA, THANK YOU FOR 2843 02:02:02,520 --> 02:02:03,200 PRESENTING THIS. 2844 02:02:03,200 --> 02:02:05,400 AS YOU WERE PRESENTING IT, I WAS 2845 02:02:05,400 --> 02:02:07,360 THINKING THAT THIS IS ALREADY, 2846 02:02:07,360 --> 02:02:10,880 WORE DOING THIS IN PEDIATRICS SO 2847 02:02:10,880 --> 02:02:12,240 WHAT WE ARE DOING, AND I'M 2848 02:02:12,240 --> 02:02:15,280 LEADING THE EFFORT, IS THAT AT 2849 02:02:15,280 --> 02:02:17,600 THE TIME WHEN A CHILD GETS DONE 2850 02:02:17,600 --> 02:02:20,120 WITH THEIR TREATMENT, THEY'RE 2851 02:02:20,120 --> 02:02:23,040 ENROLLED WITHIN SIX MONTHS ON A 2852 02:02:23,040 --> 02:02:24,920 LONG-TERM FOLLOW-UP CENTER. 2853 02:02:24,920 --> 02:02:29,040 AND WE THEN FOLLOW THEM FOR LIFE 2854 02:02:29,040 --> 02:02:30,600 BY ANNUALLY CONTACTING THEM TO 2855 02:02:30,600 --> 02:02:33,880 MAKE SURE THAT WE ARE STAYING 2856 02:02:33,880 --> 02:02:40,160 UP-TO-DATE ON THEIR CONTACT 2857 02:02:40,160 --> 02:02:43,880 INFORMATION WE ASK THEM FOR A 2858 02:02:43,880 --> 02:02:45,640 BRIEF SURVEY USING PROMISE 2859 02:02:45,640 --> 02:02:45,880 MEASURES. 2860 02:02:45,880 --> 02:02:47,920 THIS IS FOR LIFE. 2861 02:02:47,920 --> 02:02:49,760 ALL CHILDREN. 2862 02:02:49,760 --> 02:02:52,280 AND VICTOR BROUGHT NOT THE ISSUE 2863 02:02:52,280 --> 02:02:54,040 ABOUT WHAT HAPPENS WHEN THEY 2864 02:02:54,040 --> 02:02:56,400 RAGE THE AGE OF MAJORITY AND SO 2865 02:02:56,400 --> 02:02:59,320 WE RECONSENT THE PATIENT AT THAT 2866 02:02:59,320 --> 02:03:04,520 TIME WHEN THEY TURN 18 SO THE 2867 02:03:04,520 --> 02:03:05,640 BATON PASSES OFF FROM THE 2868 02:03:05,640 --> 02:03:07,080 PARENTS TO THE PATIENT THEM 2869 02:03:07,080 --> 02:03:09,200 SELLS TO THE SURVIVE OR 2870 02:03:09,200 --> 02:03:11,200 THEMSELVES AND I WANTED TO BRING 2871 02:03:11,200 --> 02:03:13,120 UP A DIFFERENT ISSUE, SO THIS IS 2872 02:03:13,120 --> 02:03:15,840 SOMETHING THAT WE DO ANYWAY. 2873 02:03:15,840 --> 02:03:20,840 WE ALSO AT THE TIME OF DIAGNO 2874 02:03:20,840 --> 02:03:22,240 DIAGNOSIS, OBTAIN THE COCK 2875 02:03:22,240 --> 02:03:23,640 INFORMATION AS WELL AS CONSENT 2876 02:03:23,640 --> 02:03:26,120 FOR FUTURE CONTACT. 2877 02:03:26,120 --> 02:03:29,280 BUT, THE LONG-TERM FOLLOW-UP 2878 02:03:29,280 --> 02:03:29,840 CENTER BRIDGES THAT EFFORT 2879 02:03:29,840 --> 02:03:31,560 BECAUSE YOU CAN CAN OBTAIN THAT 2880 02:03:31,560 --> 02:03:33,480 CONTACT INFORMATION BUT THE 2881 02:03:33,480 --> 02:03:34,800 UNITED STATES POPULATION IS SO 2882 02:03:34,800 --> 02:03:40,560 MOBILE, RIGHT, AND ESPECIALLY AT 2883 02:03:40,560 --> 02:03:42,560 LEAST IN OUR POPULATION, THEY 2884 02:03:42,560 --> 02:03:44,040 POV FROM PLACE TO PLACE AND THE 2885 02:03:44,040 --> 02:03:45,000 CONTACT GETS LOST FAST. 2886 02:03:45,000 --> 02:03:47,000 THAT'S WHY THE LONG-TERM 2887 02:03:47,000 --> 02:03:48,320 FOLLOW-UP CENTER MAINTAINS THE 2888 02:03:48,320 --> 02:03:50,160 REGISTRY AND DEVELOPS THE 2889 02:03:50,160 --> 02:03:51,720 INFRASTRUCTURE FOR DOING ANY 2890 02:03:51,720 --> 02:03:52,920 SURVIVORSHIP WORK THAT WE MIGHT 2891 02:03:52,920 --> 02:03:55,400 WANT TO DO WITH THESE PATIENTS. 2892 02:03:55,400 --> 02:03:56,880 COMING BACK TO THE QUESTION OF, 2893 02:03:56,880 --> 02:03:59,480 IS THIS POPULATION GOING TO BE 2894 02:03:59,480 --> 02:04:00,480 THE ADULT POPULATION, IS IT 2895 02:04:00,480 --> 02:04:04,720 GOING TO BE REPRESENTATIVE OF 2896 02:04:04,720 --> 02:04:05,920 SURVIVORSHIP AND THE GENERAL 2897 02:04:05,920 --> 02:04:08,520 CANCER POPULATION, AND THAT IS 2898 02:04:08,520 --> 02:04:09,960 SOMETHING THAT ONE SHOULD PAUSE 2899 02:04:09,960 --> 02:04:11,800 AND GIVE SOME THOUGHT TO IS THAT 2900 02:04:11,800 --> 02:04:13,560 LESS THAN 10% OF THE PATIENTS 2901 02:04:13,560 --> 02:04:15,560 ARE BEING PLACED ARE MUCH LESS 2902 02:04:15,560 --> 02:04:19,880 THAN 10% ARE BEING PLACED ON 2903 02:04:19,880 --> 02:04:25,840 CLINICAL TRIALS SO DOES THAT 2904 02:04:25,840 --> 02:04:28,920 REPRESENT WHAT IS GOING ON IN 2905 02:04:28,920 --> 02:04:32,240 TERMS OF OUTCOMES IN THE GENERAL 2906 02:04:32,240 --> 02:04:33,200 POPULATION AND THAT'S ALL I HAVE 2907 02:04:33,200 --> 02:04:33,760 TO SAY. 2908 02:04:33,760 --> 02:04:36,160 >>THANK YOU. 2909 02:04:36,160 --> 02:04:38,720 ALONG THOSE LINES. 2910 02:04:38,720 --> 02:04:41,120 I WOULD LOVE TO HEAR LISA 2911 02:04:41,120 --> 02:04:43,360 WHETHER THIS QUESTION CAME UP 2912 02:04:43,360 --> 02:04:49,400 ABOUT INCLUDING INDIVIDUALS IN 2913 02:04:49,400 --> 02:04:51,840 THE REGISTRY WHO HAD NOT TAKEN 2914 02:04:51,840 --> 02:04:54,320 PART IN A PUBLIC AND ENROLLED 2915 02:04:54,320 --> 02:04:59,400 AFTER A STANDARD OF CARE REAL 2916 02:04:59,400 --> 02:04:59,680 WORLD AND. 2917 02:04:59,680 --> 02:05:04,760 >>IT DIDN'T COME UP AND THAT IS 2918 02:05:04,760 --> 02:05:06,640 A GOOD POINT. 2919 02:05:06,640 --> 02:05:09,320 HOW DO YOU EGGMENT THE 2920 02:05:09,320 --> 02:05:11,200 POPULATION THAT IN CLINICAL 2921 02:05:11,200 --> 02:05:14,280 TRIALS WITH PERHAPS MORE REAL 2922 02:05:14,280 --> 02:05:15,640 WORLD PARTICIPANTS TO GET A 2923 02:05:15,640 --> 02:05:16,960 BETTER REPRESENTATION OF THE 2924 02:05:16,960 --> 02:05:23,760 SURVIVE OR POPULATION. 2925 02:05:23,760 --> 02:05:25,320 >>ONE OTHER COMMENT I WOULD 2926 02:05:25,320 --> 02:05:29,600 MAKE AND HEARING ALL OF YOUR 2927 02:05:29,600 --> 02:05:31,640 PRESENTATIONS, AND I WAS STRUCK 2928 02:05:31,640 --> 02:05:34,640 BY THE COMMENT ABOUT HOW 2929 02:05:34,640 --> 02:05:37,800 EXTENSIVE SUCH A SYSTEM COULD BE 2930 02:05:37,800 --> 02:05:41,840 AND I WONDER WHETHER THERE ARE 2931 02:05:41,840 --> 02:05:43,080 PUBLIC PUBLIC PRIVILEGE AT 2932 02:05:43,080 --> 02:05:44,920 PARTNERSHIP AROUND SPECIFIC 2933 02:05:44,920 --> 02:05:49,560 RESEARCH QUESTIONS AND THAT CAN 2934 02:05:49,560 --> 02:05:51,600 HELP SUPPORT SUCH AN ENTERPRISE. 2935 02:05:51,600 --> 02:05:53,160 >>WE HAVEN'T GOTTEN THAT PAR 2936 02:05:53,160 --> 02:05:57,360 BUT IT'S A GOOD POINT. 2937 02:05:57,360 --> 02:05:58,720 >>I WOULD LIKE TO TALK YOU 2938 02:05:58,720 --> 02:06:00,400 ABOUT THE LONG-TERM FOLLOW-UP 2939 02:06:00,400 --> 02:06:01,640 CENTER WE HAVE AND IN THE 2940 02:06:01,640 --> 02:06:04,040 PEDIATRIC POPULATION WE FUNDED 2941 02:06:04,040 --> 02:06:04,240 IT. 2942 02:06:04,240 --> 02:06:06,840 >>>>IT'S CLEAR THAT COG IS 2943 02:06:06,840 --> 02:06:09,160 YOUR GROUP IS WAY AHEAD OF THE 2944 02:06:09,160 --> 02:06:12,320 OTHER GROUPS IN TERMS OF LOOKING 2945 02:06:12,320 --> 02:06:16,000 AT THESE POPULATIONS FOR LONGER 2946 02:06:16,000 --> 02:06:16,960 TERM SURVIVE OR STUDIES AND 2947 02:06:16,960 --> 02:06:17,680 LEVERAGING THEM. 2948 02:06:17,680 --> 02:06:27,680 >>IF WE CAN LEARN, WE CAN TAKE 2949 02:06:27,680 --> 02:06:30,400 WHAT HAS WORKED. 2950 02:06:30,400 --> 02:06:33,280 >>PATTY SPEARS, YOU HAVE YOUR 2951 02:06:33,280 --> 02:06:33,520 HAND UP. 2952 02:06:33,520 --> 02:06:35,560 >>I'M A SURVIVOR AND I THINK 2953 02:06:35,560 --> 02:06:38,040 THIS IS A GREAT IDEA. 2954 02:06:38,040 --> 02:06:39,560 BEYOND 10 YEARS, I LIKE HOW THEY 2955 02:06:39,560 --> 02:06:42,080 DO THE LIFETIME OF THE PEDIATRIC 2956 02:06:42,080 --> 02:06:43,480 PATIENTS THAT WOULD BE REALLY 2957 02:06:43,480 --> 02:06:52,720 HELPFUL AS WELL BUT TOO, I THINK 2958 02:06:52,720 --> 02:06:54,400 LISTENING TO THE SURVIVORSHIP 2959 02:06:54,400 --> 02:06:55,960 POPULATION IS THE OFFICE OF 2960 02:06:55,960 --> 02:06:58,760 CANCER SURVIVORSHIP AT THE NCI 2961 02:06:58,760 --> 02:07:01,160 REALLY HAS BEEN REALLY COGNIZANT 2962 02:07:01,160 --> 02:07:02,800 OF REALLY RECOGNIZING THOSE 2963 02:07:02,800 --> 02:07:05,000 PATIENTS THAT ARE ALSO LIVING 2964 02:07:05,000 --> 02:07:06,680 WITH METASTATIC DISEASE AND 2965 02:07:06,680 --> 02:07:08,000 ADVANCE DISEASE AND IT'S A 2966 02:07:08,000 --> 02:07:09,360 POPULATION THAT'S REALLY MISSING 2967 02:07:09,360 --> 02:07:10,200 FROM THIS. 2968 02:07:10,200 --> 02:07:13,160 I THINK THAT WE HAVE A LOT OF 2969 02:07:13,160 --> 02:07:14,480 LONG-TERM SURVIVE OR IN THAT 2970 02:07:14,480 --> 02:07:16,600 FIVE TO GREATER THAN 10 YEAR 2971 02:07:16,600 --> 02:07:18,680 RANGE NOW AND THAT POPULATION 2972 02:07:18,680 --> 02:07:20,240 NOW THAT THE OUTCOMES AND 2973 02:07:20,240 --> 02:07:21,320 QUESTIONS MIGHT BE DIFFERENT BUT 2974 02:07:21,320 --> 02:07:23,120 I THINK IT WOULD BE REALLY 2975 02:07:23,120 --> 02:07:24,600 HELPFUL TO ACTUALLY PUT THEM IN 2976 02:07:24,600 --> 02:07:26,640 THE CATEGORY THAT THEY 2977 02:07:26,640 --> 02:07:28,600 ACKNOWLEDGE THEY'RE ALSO SURVIVE 2978 02:07:28,600 --> 02:07:30,040 OR IN THERE BECAUSE IT'S A REAL 2979 02:07:30,040 --> 02:07:32,960 BIG PUSH OF THE OFFICE OF CANCER 2980 02:07:32,960 --> 02:07:34,320 SURVIVORSHIP AND IT WOULD BE 2981 02:07:34,320 --> 02:07:37,880 MORE INCLUSIVE OF A -- OTHERWISE 2982 02:07:37,880 --> 02:07:39,200 YOU REALLY NEED TO CHANGE THE 2983 02:07:39,200 --> 02:07:41,520 NAME TO A LONG-TERM EARLY STAGE 2984 02:07:41,520 --> 02:07:44,040 CANCER SURVIVORSHIP PROGRAM TO 2985 02:07:44,040 --> 02:07:46,720 REALLY BE CLEAR OF WHAT YOU ARE 2986 02:07:46,720 --> 02:07:47,280 LOOKING AT. 2987 02:07:47,280 --> 02:07:48,680 I WOULD JUST KEEP THAT IF MIND 2988 02:07:48,680 --> 02:07:49,560 AS YOU GO FORWARD. 2989 02:07:49,560 --> 02:07:50,360 >>THANK YOU. 2990 02:07:50,360 --> 02:07:53,040 AND WE DEFINITELY DO NOT MEAN TO 2991 02:07:53,040 --> 02:07:54,360 EXCLUDE THEM FROM OUR 2992 02:07:54,360 --> 02:07:55,520 DEFINITION, WE ACKNOWLEDGE THAT 2993 02:07:55,520 --> 02:07:59,720 THEY ARE PART OF THE CANCER 2994 02:07:59,720 --> 02:08:02,960 SURVIVORSHIP COMMUNITY. 2995 02:08:02,960 --> 02:08:07,080 >>SO, I REALLY LIKE THIS 2996 02:08:07,080 --> 02:08:08,400 DESPITE THE FACT WE JUST 2997 02:08:08,400 --> 02:08:11,000 FINISHED THE TALK ABOUT BURDEN 2998 02:08:11,000 --> 02:08:11,680 OF DATA. 2999 02:08:11,680 --> 02:08:13,200 I DO THINK THAT THERE ARE 3000 02:08:13,200 --> 02:08:14,600 SEVERAL WAYS IN WHICH THIS CAN 3001 02:08:14,600 --> 02:08:17,320 BE UTILIZED, EVEN HOW OUR 3002 02:08:17,320 --> 02:08:19,360 CURRENT TRIAL INFRASTRUCTURE IS 3003 02:08:19,360 --> 02:08:20,880 BUILT WHERE SOME TRIALS FOLLOW 3004 02:08:20,880 --> 02:08:29,240 OUR PATIENT FOR 10 YEARS AND 10D 3005 02:08:29,240 --> 02:08:30,560 SOME FOR FIVE YEARS AND FOLLOW 3006 02:08:30,560 --> 02:08:31,760 THE PATIENTS INTO THE SORT OF 3007 02:08:31,760 --> 02:08:33,240 REGISTRY OR A DATABASE WHERE YOU 3008 02:08:33,240 --> 02:08:34,920 DON'T PUT THE BURDEN ON 3009 02:08:34,920 --> 02:08:35,920 INDIVIDUAL TRIALS AT THAT POINT 3010 02:08:35,920 --> 02:08:37,120 AND YOU MINIMIZE THE DATA 3011 02:08:37,120 --> 02:08:39,440 COLLECTION AND THEN YOU MOVE 3012 02:08:39,440 --> 02:08:41,280 THEM TO THE SORT OF REGISTRY 3013 02:08:41,280 --> 02:08:43,080 HOWEVER WE ENVISION THAT 3014 02:08:43,080 --> 02:08:45,880 REGISTER WOULD BE STRUCTURED AND 3015 02:08:45,880 --> 02:08:47,720 IT WOULD DEFINITELY ACTUAL LIE 3016 02:08:47,720 --> 02:08:49,960 TIE IN WELL WITH WHAT WE JUST 3017 02:08:49,960 --> 02:08:50,240 PRESENTED. 3018 02:08:50,240 --> 02:08:52,560 IF WE TRY TO STAND THIS UP AS AN 3019 02:08:52,560 --> 02:08:53,520 INDEPENDENT REGISTRY AND 3020 02:08:53,520 --> 02:08:55,520 CONTINUE COLLECTION HERE AND 3021 02:08:55,520 --> 02:08:56,960 THEN IT'S NOT GREAT. 3022 02:08:56,960 --> 02:08:59,080 WE HAVE TO THINK ABOUT HOW WE 3023 02:08:59,080 --> 02:09:00,600 CAN PARTNER WITH WHAT WE JUST 3024 02:09:00,600 --> 02:09:02,120 HEARD AND THE NEWS IS REGISTRY 3025 02:09:02,120 --> 02:09:04,160 TO REALLY UTILIZE HOW WE COLLECT 3026 02:09:04,160 --> 02:09:06,320 DATA ON ALL CLINICAL TRIALS 3027 02:09:06,320 --> 02:09:07,320 BEYOND A CERTAIN POINT AND DO WE 3028 02:09:07,320 --> 02:09:09,000 HAVE TO COLLECT ALL THAT 3029 02:09:09,000 --> 02:09:10,240 INFORMATION ON INDIVIDUAL 3030 02:09:10,240 --> 02:09:11,320 CLINICAL TRIALS SO CAN CAN WE 3031 02:09:11,320 --> 02:09:14,240 USE THIS REGISTRY TO MINIMIZE 3032 02:09:14,240 --> 02:09:15,920 DATA COLLECTION AND LEVERAGE A 3033 02:09:15,920 --> 02:09:17,520 LOT MORE INFORMATION ON THESE 3034 02:09:17,520 --> 02:09:19,080 PATIENTS FOR LONGER TERM SO 3035 02:09:19,080 --> 02:09:21,200 YEAH, SO I REALLY LIKED THIS 3036 02:09:21,200 --> 02:09:22,920 IDEA BUT I THINK THERE'S A LOT 3037 02:09:22,920 --> 02:09:24,840 TO THINK THROUGH. 3038 02:09:24,840 --> 02:09:26,240 >>I LOVE THAT COMMENT. 3039 02:09:26,240 --> 02:09:29,120 THE PARTNERING WITH INSTEAD OF 3040 02:09:29,120 --> 02:09:33,680 ONE WAY OR THE OTHER WAY. 3041 02:09:33,680 --> 02:09:35,560 THANK YOU. 3042 02:09:35,560 --> 02:09:40,480 >>LEASE A. I'L 3043 02:09:40,480 --> 02:09:42,640 >>LISA, WHAT ARE THE NEXT 3044 02:09:42,640 --> 02:09:43,120 STEPS? 3045 02:09:43,120 --> 02:09:44,160 >>WE'RE JUST COLLECTING 3046 02:09:44,160 --> 02:09:46,000 INFORMATION AND DISCUSSING THIS 3047 02:09:46,000 --> 02:09:47,480 INTERNALLY AMONGST THE 3048 02:09:47,480 --> 02:09:47,760 DIVISIONS. 3049 02:09:47,760 --> 02:09:50,320 IT'S VERY COMPLICATED AND IT'S 3050 02:09:50,320 --> 02:09:51,960 MADE EVEN MORE COMPLICATED BY 3051 02:09:51,960 --> 02:09:53,640 THE FACT AS YOU SAID IN THE LAST 3052 02:09:53,640 --> 02:09:56,200 PRESENTATION, CLINICAL TRIALS, 3053 02:09:56,200 --> 02:09:58,280 IT'S SUCH A COMPLEX SYSTEM AND 3054 02:09:58,280 --> 02:10:02,720 THE WORKLOAD IS IMMENSE ALREADY. 3055 02:10:02,720 --> 02:10:04,440 SO, I REALLY LIKE THE LAST 3056 02:10:04,440 --> 02:10:05,760 COMMENT ABOUT PARTNERING AND 3057 02:10:05,760 --> 02:10:07,720 FIGURING OUT HOW TO DO THIS 3058 02:10:07,720 --> 02:10:09,160 WITHIN THE STRUCTURE OF ABOUT 3059 02:10:09,160 --> 02:10:10,120 WHAT IS THERE BECAUSE I THINK IT 3060 02:10:10,120 --> 02:10:12,720 CAN CAN BE DONE, YOU HAVE TO 3061 02:10:12,720 --> 02:10:16,080 FIGURE OUT HOW TO DO IT. 3062 02:10:16,080 --> 02:10:19,080 >>THANK YOU SO MUCH. 3063 02:10:19,080 --> 02:10:22,480 WE'RE NOW GOING TO TAKE A BREAK, 3064 02:10:22,480 --> 02:10:25,280 EVERYBODY DESERVES TO STRETCH 3065 02:10:25,280 --> 02:10:26,000 THEIR LEGS. 3066 02:10:26,000 --> 02:10:29,240 IT IS 1:10 AND EASTERN TIME AND 3067 02:10:29,240 --> 02:10:35,000 WE'LL RECONVENE IN 15 MINUTES. 3068 02:10:35,000 --> 02:10:39,080 AT 1:25 EASTERN. 3069 02:10:39,080 --> 02:10:40,320 SEE YOU ALL BACK THEN. 3070 02:10:40,320 --> 02:10:42,640 >>WELCOME BACK, 3071 02:10:42,640 --> 02:10:44,920 EVERYBODY. 3072 02:10:44,920 --> 02:10:46,920 WE ARE ABOUT TO EMBARK ON AGENDA 3073 02:10:46,920 --> 02:10:48,240 ITEM 6. 3074 02:10:48,240 --> 02:10:50,120 WHICH IS AN INFORMATIONAL ITEM 3075 02:10:50,120 --> 02:10:53,080 WITH AN OPPORTUNITY FOR 3076 02:10:53,080 --> 02:10:55,120 DISCUSSION AFTERWARDS. 3077 02:10:55,120 --> 02:10:59,080 THIS IS CANCER SCREENING TRIALS 3078 02:10:59,080 --> 02:10:59,800 WORKING GROUP. 3079 02:10:59,800 --> 02:11:03,320 WITH AN UP TATE ON 3080 02:11:03,320 --> 02:11:06,800 IMPLEMENTATION OF THEIR 3081 02:11:06,800 --> 02:11:08,480 RECOMMENDATIONS. 3082 02:11:08,480 --> 02:11:12,240 THIS PRESENTATION WILL BE CO LED 3083 02:11:12,240 --> 02:11:16,360 BY Dr. McCASKILL-STEVENS AND 3084 02:11:16,360 --> 02:11:19,800 RESEARCH GROUP AT THE NCI Ms. 3085 02:11:19,800 --> 02:11:24,840 LINDA PARRECO, A NURSE 3086 02:11:24,840 --> 02:11:32,200 CONSULTANT IN THE TA VISION OF R 3087 02:11:32,200 --> 02:11:32,600 PREVENTION AT NCI. 3088 02:11:32,600 --> 02:11:33,360 >>THANK YOU, NEIL. 3089 02:11:33,360 --> 02:11:35,360 GOOD AFTERNOON, EVERYONE. 3090 02:11:35,360 --> 02:11:38,680 I'M PRESENTING ON THE NCI'S 3091 02:11:38,680 --> 02:11:39,280 IMPLEMENTATION OF 3092 02:11:39,280 --> 02:11:40,640 RECOMMENDATIONS FROM THE WORKING 3093 02:11:40,640 --> 02:11:42,080 GROUP AND I'M GOING TO TALK 3094 02:11:42,080 --> 02:11:48,840 ABOUT PART 1. 3095 02:11:48,840 --> 02:11:49,040 TMIST. 3096 02:11:49,040 --> 02:11:51,240 A BIT OF BACKGROUND ABOUT THE 3097 02:11:51,240 --> 02:11:51,920 WORKING WORK. 3098 02:11:51,920 --> 02:11:53,320 IT WAS ESTABLISHED IN NOVEMBER 3099 02:11:53,320 --> 02:11:54,720 OF 2020 MANY OF THE PURPOSE OF 3100 02:11:54,720 --> 02:11:58,440 THE WORKING GROUP WAS TO ADVISE 3101 02:11:58,440 --> 02:12:00,760 THE NCI DIRECTOR AS WELL AS CT 3102 02:12:00,760 --> 02:12:03,560 AC ON THE REAL WORLD IMPACT ON 3103 02:12:03,560 --> 02:12:03,760 COVID. 3104 02:12:03,760 --> 02:12:06,240 THE ON GOING TRIAL AND THE 3105 02:12:06,240 --> 02:12:07,600 LARGEST AT THE TIME WAS FOCUSED 3106 02:12:07,600 --> 02:12:11,560 TO BE FOCUSED ON THE IMAGING 3107 02:12:11,560 --> 02:12:13,160 TRIAL OR TMIST. 3108 02:12:13,160 --> 02:12:14,640 THERE WERE THREE VIRTUAL WORKING 3109 02:12:14,640 --> 02:12:18,080 GROUP MEETINGS BETWEEN 3110 02:12:18,080 --> 02:12:21,880 DECEMBER 2020 AND FEBRUARY OF 21 3111 02:12:21,880 --> 02:12:22,120 TATE. 3112 02:12:22,120 --> 02:12:23,800 THERE WERE 12 MEMBERS ON THE 3113 02:12:23,800 --> 02:12:25,120 COMMITTEE THAT EXPERTISE AND 3114 02:12:25,120 --> 02:12:29,960 BREAST CANCER IN BREAST CANCER 3115 02:12:29,960 --> 02:12:32,000 CLINICAL TRIALS AND OTHER EXTRA 3116 02:12:32,000 --> 02:12:34,120 SCREENING EXPERTISE IN THIS 3117 02:12:34,120 --> 02:12:34,400 AREA. 3118 02:12:34,400 --> 02:12:35,800 THERE ARE TWO SETS OF 3119 02:12:35,800 --> 02:12:36,920 RECOMMENDATIONS AS I MENTIONED. 3120 02:12:36,920 --> 02:12:40,480 I'M GOING TO DO THE TMIST AND 3121 02:12:40,480 --> 02:12:42,920 LINDA WILL PRESENT ON DCP'S 3122 02:12:42,920 --> 02:12:44,240 CANCER SCREENING TRIALS IF 3123 02:12:44,240 --> 02:12:44,440 GENERAL. 3124 02:12:44,440 --> 02:12:50,080 ON BEHALF OF THE TRANS DCP 3125 02:12:50,080 --> 02:12:52,200 CLINAL TRIALS WORKING GROUP. 3126 02:12:52,200 --> 02:12:54,880 SO, JUST A BIT OF BACKGROUND ON 3127 02:12:54,880 --> 02:12:55,200 TMIST. 3128 02:12:55,200 --> 02:12:57,320 THE PRIMARY OBJECTIVE OF THIS 3129 02:12:57,320 --> 02:12:59,720 STUDY WAS TO DETERMINE WHETHER 3130 02:12:59,720 --> 02:13:01,760 THE CUMULATIVE RATE OF ADVANCE 3131 02:13:01,760 --> 02:13:03,360 CANCERS IN BREAST CANCER IN 3132 02:13:03,360 --> 02:13:07,040 WOMEN UNDERGOING SCREENING WITH 3133 02:13:07,040 --> 02:13:09,920 DIGITAL MAMMOGRAPHY AND TOM OWE 3134 02:13:09,920 --> 02:13:11,800 SYNTHESIS IS REDUCED WITH 3135 02:13:11,800 --> 02:13:13,600 GENERAL MAMMOGRAPHY ALONE. 3136 02:13:13,600 --> 02:13:16,120 JUST AS A BIT OF INFORMATION, 3137 02:13:16,120 --> 02:13:18,240 PARTICIPANTS MET THEIR PRIMARY 3138 02:13:18,240 --> 02:13:20,680 IMPORT AT THE ADVANCED CANCER AT 3139 02:13:20,680 --> 02:13:25,320 ANY TIME DURING THE PERIOD OF 3140 02:13:25,320 --> 02:13:26,680 4.5 YEARS. 3141 02:13:26,680 --> 02:13:28,120 SO AFTER ACTIVE SCREENING TO THE 3142 02:13:28,120 --> 02:13:30,480 LAST SCREENING ROUND, PRE 3143 02:13:30,480 --> 02:13:32,240 MENOPAUSAL WOMAN WERE RANDOMIZED 3144 02:13:32,240 --> 02:13:35,120 TO ANNUAL SCREENING, POST 3145 02:13:35,120 --> 02:13:36,560 MENOPAUSAL WOMAN TO BY ANNUAL 3146 02:13:36,560 --> 02:13:40,160 SCREENING UNLESS ME MET THE 3147 02:13:40,160 --> 02:13:42,600 CRITERIA FOR INCREASED RISK. 3148 02:13:42,600 --> 02:13:45,200 A SAMPLE SIZE OF 64,000 3149 02:13:45,200 --> 02:13:46,960 PARTICIPANTS WITH COMPLETE DATA 3150 02:13:46,960 --> 02:13:49,160 IN HARMS PROVIDED A 90% POWER TO 3151 02:13:49,160 --> 02:13:51,240 DETECT A RELATIVE REDUCTION OF 3152 02:13:51,240 --> 02:13:53,840 20% AND AFTER THE ADJUSTMENT, 3153 02:13:53,840 --> 02:13:56,720 THE SAMPLE SIZE IT WAS 164,000 3154 02:13:56,720 --> 02:14:00,440 AND IT HAD INCLUDED IN IT A BUY 3155 02:14:00,440 --> 02:14:01,920 REPOSITORY FOR WHICH BIOPSIES 3156 02:14:01,920 --> 02:14:04,520 THAT WERE SUBMITTED WERE TO BE 3157 02:14:04,520 --> 02:14:05,760 MOLECULAR CHARACTERIZED, THERE 3158 02:14:05,760 --> 02:14:07,760 WAS TISSUE OF BLOOD AND BUCKLE 3159 02:14:07,760 --> 02:14:08,360 CELLS AS WELL. 3160 02:14:08,360 --> 02:14:09,960 I HAVE LISTED AT THE BOTTOM OF 3161 02:14:09,960 --> 02:14:11,160 THE SLIDE THE DEFINITION OF 3162 02:14:11,160 --> 02:14:12,720 ADVANCE BREAST CANCER 3163 02:14:12,720 --> 02:14:15,400 ESSENTIALLY WAS DIS STAND 3164 02:14:15,400 --> 02:14:17,440 DISEASE, SMALLER TUMORS THAT ARE 3165 02:14:17,440 --> 02:14:20,120 VERY HIGH-RISK AND ANY INVASIVE 3166 02:14:20,120 --> 02:14:21,800 CANCER THAT WAS GREATER THAN TWO 3167 02:14:21,800 --> 02:14:23,840 CENTIMETERS UNLESS IT MET THE 3168 02:14:23,840 --> 02:14:28,640 CRITERIA FOR A GOOD PROGNOSIS OF 3169 02:14:28,640 --> 02:14:29,240 SUBTYPE. 3170 02:14:29,240 --> 02:14:31,680 SO, THE OVERARCHING 3171 02:14:31,680 --> 02:14:32,840 RECOMMENDATION FOR TMIST FROM 3172 02:14:32,840 --> 02:14:35,640 THE WORKING GROUP WAS THE TMIST 3173 02:14:35,640 --> 02:14:36,720 SHOULD CONTINUE WITH 3174 02:14:36,720 --> 02:14:39,080 MODIFICATIONS HELPING TO 3175 02:14:39,080 --> 02:14:40,640 EXPEDITE TO BE COMPLETED MORE 3176 02:14:40,640 --> 02:14:42,440 QUICKLY AND TO ANSWER THE 3177 02:14:42,440 --> 02:14:43,640 PRIMARY QUESTION IN MAXIMIZING 3178 02:14:43,640 --> 02:14:45,200 THE LIKELIHOOD THAT THE 3179 02:14:45,200 --> 02:14:46,680 INSTITUTE IN QUESTION WOULD 3180 02:14:46,680 --> 02:14:47,400 RESULT IN INFORMED INFORMATION 3181 02:14:47,400 --> 02:14:50,080 FOR THE PATIENT AND TO ENHANCE 3182 02:14:50,080 --> 02:14:56,400 SCREENING RESEARCH. 3183 02:14:56,400 --> 02:14:58,640 SO, IN DECEMBER OF 2021, THERE 3184 02:14:58,640 --> 02:15:00,200 WAS AN AMENDMENT AFTER 3185 02:15:00,200 --> 02:15:01,120 SIGNIFICANT DISCUSSIONS ABOUT 3186 02:15:01,120 --> 02:15:03,840 THE RECOMMENDATIONS AND HERE ARE 3187 02:15:03,840 --> 02:15:07,000 THE CHARACTERISTICS OF THE 3188 02:15:07,000 --> 02:15:08,200 DESIRED MODIFICATIONS. 3189 02:15:08,200 --> 02:15:09,400 PARTICIPANTS WOULD REACH THE 3190 02:15:09,400 --> 02:15:10,520 PRIMARY END POINT AT THE 3191 02:15:10,520 --> 02:15:12,120 CURRENTS OF ADVANCE BREAST 3192 02:15:12,120 --> 02:15:14,160 CANCER AT ANY TIME UP TO SEVEN 3193 02:15:14,160 --> 02:15:16,760 YEARS FROM RANDOMIZATION. 3194 02:15:16,760 --> 02:15:18,080 TIME TO INVENT AND IT WAS 3195 02:15:18,080 --> 02:15:21,200 POWERED AT 85% CONTINUE OF THE 3196 02:15:21,200 --> 02:15:23,200 20 PER PRODUCTION IN ADVANCE 3197 02:15:23,200 --> 02:15:27,840 CANCER AT 4.5 YEARS OF 3198 02:15:27,840 --> 02:15:28,360 RANDOMIZATION. 3199 02:15:28,360 --> 02:15:32,240 AFTER FOLLOW-UP LOSS, ACROSS 3200 02:15:32,240 --> 02:15:34,280 OFFERS THE SAMPLE SIZE GOING 3201 02:15:34,280 --> 02:15:43,280 INTO THE CONTINUED TRIAL WAS 3202 02:15:43,280 --> 02:15:47,760 128,905. 3203 02:15:47,760 --> 02:15:49,640 THERE WERE NO CHANGES WITH THE 3204 02:15:49,640 --> 02:15:51,240 BIO REPOSITORY. 3205 02:15:51,240 --> 02:15:53,280 IT WAS CITED TO BE A SIGNIFICANT 3206 02:15:53,280 --> 02:15:58,480 RESOURCE MOVING FORWARD. 3207 02:15:58,480 --> 02:16:00,080 SO, ONE OF THE RECOMMENDATIONS 3208 02:16:00,080 --> 02:16:01,960 WAS TO ESTABLISH A REALISTIC 3209 02:16:01,960 --> 02:16:06,320 TIME FOR OVER ALL MINORITY 3210 02:16:06,320 --> 02:16:08,040 ACCRUAL AND CRY TER WHY FOR 3211 02:16:08,040 --> 02:16:11,480 TERMINATION AND THE STUDY GOES. 3212 02:16:11,480 --> 02:16:13,760 SO THE PROTOCOL TRIAL DESIGN 3213 02:16:13,760 --> 02:16:14,840 MODIFICATIONS, AS THEY ARE NOW, 3214 02:16:14,840 --> 02:16:18,720 ARE EXPECTED TO END THE TRIAL IN 3215 02:16:18,720 --> 02:16:20,400 2024, EARLY 2025. 3216 02:16:20,400 --> 02:16:20,720 THE. 3217 02:16:20,720 --> 02:16:28,760 >>Tara: SFURTHER RECOMMENDATIOY 3218 02:16:28,760 --> 02:16:34,000 AND HE HAVE EFFICACY AND 50% A 3219 02:16:34,000 --> 02:16:35,840 PERSON YEAR FOLLOW-UP DATA IS IN 3220 02:16:35,840 --> 02:16:37,440 HAND MANY OF THE CONDITIONAL 3221 02:16:37,440 --> 02:16:39,840 POWER FOR FUTILITY ANALYSIS IS 3222 02:16:39,840 --> 02:16:41,880 25% SUCH THAT IF THE CONDITIONAL 3223 02:16:41,880 --> 02:16:43,920 POWER IS LOWER THAN THAT, AT THE 3224 02:16:43,920 --> 02:16:46,440 TIME THE TIME OF ANALYSIS THE 3225 02:16:46,440 --> 02:16:47,160 RECOMMENDATION WOULD BE TO STOP 3226 02:16:47,160 --> 02:16:47,640 THE TRIAL. 3227 02:16:47,640 --> 02:16:50,320 OVER ALL RECRUITMENT AND 3228 02:16:50,320 --> 02:16:52,280 ENROLLMENT ARE MONITORED IN MANY 3229 02:16:52,280 --> 02:16:54,720 WAYS AT MANY TIMES POINTS WITHIN 3230 02:16:54,720 --> 02:16:57,320 AN END CORE WE HAVE MONTH LOO 3231 02:16:57,320 --> 02:16:58,520 DISSEMINATION AND MORE OFTEN 3232 02:16:58,520 --> 02:17:00,560 THAN NOT MORE FREQUENTLY 3233 02:17:00,560 --> 02:17:01,800 DEPENDING UPON REQUEST FROM 3234 02:17:01,800 --> 02:17:05,600 CONGRESS OR OTHER MEDIA, THE 3235 02:17:05,600 --> 02:17:07,920 COMMITTEE MEETS MONTHLY AS DOES 3236 02:17:07,920 --> 02:17:10,240 A COMMITTEE THAT'S LED BY THE 3237 02:17:10,240 --> 02:17:12,240 PROJECT DIRECTOR WITH THE 3238 02:17:12,240 --> 02:17:14,600 TECHNICAL WITH IT AND THAT IS 3239 02:17:14,600 --> 02:17:16,080 MONTH LOO AND BY ANNUALLY 3240 02:17:16,080 --> 02:17:18,720 THERE'S A DESIGNATED DATA SAFETY 3241 02:17:18,720 --> 02:17:19,960 MONITOR MEETING FORAY 3242 02:17:19,960 --> 02:17:20,680 ACHIEVEMENT. 3243 02:17:20,680 --> 02:17:23,040 MINORITY ENROLLMENT IN ADDITION 3244 02:17:23,040 --> 02:17:25,120 TO A NETWORK WITH A TARGET WITH 3245 02:17:25,120 --> 02:17:27,200 SPECIFIC POPULATIONS AND 3246 02:17:27,200 --> 02:17:30,000 ENROLLMENT AND IS MONITORED BY 3247 02:17:30,000 --> 02:17:32,120 PARTICIPATING SITE AND TO 3248 02:17:32,120 --> 02:17:33,360 INCENTIVIZE THOSE WHO NEED 3249 02:17:33,360 --> 02:17:34,320 ADDITIONAL HELP OR SOME OF THE 3250 02:17:34,320 --> 02:17:35,920 TOOLS THAT WE HAVE IF HOUSE AND 3251 02:17:35,920 --> 02:17:37,360 WE SHARE BEST PRACTICES AND 3252 02:17:37,360 --> 02:17:39,800 SUPPORT NEW INITIATIVES IN SIGHT 3253 02:17:39,800 --> 02:17:42,640 FOR EXAMPLE, VIRTUAL NURSE IN 3254 02:17:42,640 --> 02:17:44,920 LOUISIANA THAT HAS DONE 3255 02:17:44,920 --> 02:17:46,640 TREMENDOUS JOB IN REACHING OUT 3256 02:17:46,640 --> 02:17:50,960 THROUGHOUT THE STATE FO FOR 3257 02:17:50,960 --> 02:17:56,680 ENHANCING AND ENGAGING THE HBC 3258 02:17:56,680 --> 02:17:58,160 AND OPENING SITES THAT HAVE NOT 3259 02:17:58,160 --> 02:18:00,800 HAD ACCESS OR PARTICIPATING 3260 02:18:00,800 --> 02:18:01,360 IMAGING GROUPING THAT HAVE 3261 02:18:01,360 --> 02:18:02,280 PARTICIPATED IN CLINICAL TRIALS 3262 02:18:02,280 --> 02:18:07,480 SUCH AS IN MISSISSIPPI. 3263 02:18:07,480 --> 02:18:09,320 ANOTHER CONSIDERATION WAS THE 3264 02:18:09,320 --> 02:18:13,240 INCORPORATING AND TO THE ADVANCE 3265 02:18:13,240 --> 02:18:15,760 DEFINITION OF BREAST CANCER WAS 3266 02:18:15,760 --> 02:18:17,280 GENOMIC INFORMATION INTO THE 3267 02:18:17,280 --> 02:18:27,800 DEFINITION AND THE STUDY TEAMS 3268 02:18:36,200 --> 02:18:38,800 THIS TOOK PLACE WHEN WE WERE AT 3269 02:18:38,800 --> 02:18:39,400 41,000 INDIVIDUALS. 3270 02:18:39,400 --> 02:18:40,520 SO, ANOTHER RECOMMENDATION WAS 3271 02:18:40,520 --> 02:18:42,440 TO NOT SURE THAT THE. 3272 02:18:42,440 --> 02:18:45,800 >>Tara: COLLECTION FOR THE 3273 02:18:45,800 --> 02:18:47,760 SECONDARY ENDPOINTS WERE INCLUDE 3274 02:18:47,760 --> 02:18:50,800 AND HAD STATISTICAL PLANS. 3275 02:18:50,800 --> 02:18:52,240 THE PROTOCOL AMENDMENT WAS DONE 3276 02:18:52,240 --> 02:18:54,160 IN THE YEAR HAS BEEN AMENDED 3277 02:18:54,160 --> 02:18:56,760 WITH FULL ANALYSIS PLANS FOR ALL 3278 02:18:56,760 --> 02:18:59,120 OF THE STEADY AIMS. 3279 02:18:59,120 --> 02:19:01,840 I SHARE WITH YOU THAT I WON'T GO 3280 02:19:01,840 --> 02:19:03,440 THROUGH ALL THE SECONDARY 3281 02:19:03,440 --> 02:19:05,640 ENDPOINTS BUT THEY HAVE IMAGING 3282 02:19:05,640 --> 02:19:07,320 ASSESSMENT, LONG-TERM FOLLOW-UP, 3283 02:19:07,320 --> 02:19:13,280 BIOLOGY AND MEDICAL PHYSICS. 3284 02:19:13,280 --> 02:19:15,840 WE'VE BEEN HAVING ON GOING WITH 3285 02:19:15,840 --> 02:19:17,400 WHAT WAS REFERENCED IN THE 3286 02:19:17,400 --> 02:19:17,800 REPORT. 3287 02:19:17,800 --> 02:19:19,200 THERE ARE RANDOMIZED TRIALS IN 3288 02:19:19,200 --> 02:19:21,440 THE U.K., GERMANY AND NORWAY AND 3289 02:19:21,440 --> 02:19:23,360 THE LAST TWO FROM GERMANY AND 3290 02:19:23,360 --> 02:19:25,040 NORWAY HAVE ALREADY BEEN 3291 02:19:25,040 --> 02:19:26,040 PUBLISHED AND WE HAVE SCHEDULED 3292 02:19:26,040 --> 02:19:28,440 A MEETING TO MEET THE NEXT 3293 02:19:28,440 --> 02:19:30,240 COUPLE OF WEEKS WITH THE U.K. 3294 02:19:30,240 --> 02:19:31,600 TRIAL WHICH IS STILL ON GOING 3295 02:19:31,600 --> 02:19:32,880 TRIAL AND WE HAVE A COMMITMENT 3296 02:19:32,880 --> 02:19:34,480 FROM ALL OF THEM TO SHARE DATA 3297 02:19:34,480 --> 02:19:36,520 AND THINK ABOUT WAYS IN WHICH WE 3298 02:19:36,520 --> 02:19:38,640 MIGHT COLLABORATE ON SECONDARY 3299 02:19:38,640 --> 02:19:39,120 IMPORTS. 3300 02:19:39,120 --> 02:19:42,920 NEXT SLIDE, PLEASE. 3301 02:19:42,920 --> 02:19:45,040 SHOWN HERE IS THE ENROLLMENT 3302 02:19:45,040 --> 02:19:46,640 FROM THE INCEPTION OF THE TRIAL. 3303 02:19:46,640 --> 02:19:51,680 I'VE HIGHLIGHTED THE TIME OF 3304 02:19:51,680 --> 02:19:56,360 PEOPLE -- CIRCLE ONE IS THE LAST 3305 02:19:56,360 --> 02:19:59,000 TIME WE PRESENTED AT ABOUT 3306 02:19:59,000 --> 02:19:59,880 41,000 IN MARCH. 3307 02:19:59,880 --> 02:20:01,920 AND WHERE WE ARE NOW. 3308 02:20:01,920 --> 02:20:05,640 AS OF TODAY, THERE IS 78,186 3309 02:20:05,640 --> 02:20:09,400 PARTICIPANTS IN THE TRIAL WITH 3310 02:20:09,400 --> 02:20:13,000 124 SITES WITH ABOUT 12 SITES IN 3311 02:20:13,000 --> 02:20:15,960 LINE TO OPEN THEIR TRIAL IN A 3312 02:20:15,960 --> 02:20:19,520 COUPLE OF WEEKS. 3313 02:20:19,520 --> 02:20:21,320 AND WE SEE VALLEYS AND PEAKS. 3314 02:20:21,320 --> 02:20:23,160 SOME ARE CHARACTERIZED BY 3315 02:20:23,160 --> 02:20:24,800 VARIABILITY WE SEE IN SCREENING 3316 02:20:24,800 --> 02:20:28,680 IN GENERAL AND AROUND THE 3317 02:20:28,680 --> 02:20:33,680 HOLIDAYS AND WE HAVE POST COVID 3318 02:20:33,680 --> 02:20:34,040 EFFECTS WITH. 3319 02:20:34,040 --> 02:20:40,120 >>Saphia: ING STAFFING.WE'RE CE 3320 02:20:40,120 --> 02:20:41,320 CONFIDENT WITH THE NEW 3321 02:20:41,320 --> 02:20:41,960 ONBOARDING AND THE CONTINUED 3322 02:20:41,960 --> 02:20:43,680 INTEREST IN THE TRIAL COMING ON 3323 02:20:43,680 --> 02:20:46,120 AS NEW SITES THAT THIS WILL 3324 02:20:46,120 --> 02:20:47,120 CONTINUE. 3325 02:20:47,120 --> 02:20:49,320 NEXT SLIDE. 3326 02:20:49,320 --> 02:20:53,200 SHOWN HERE ARE THE DEMOGRAPHICS 3327 02:20:53,200 --> 02:20:54,400 OF THE PARTICIPANTS. 3328 02:20:54,400 --> 02:20:56,480 AS YOU CAN SEE, WE HAVE 3329 02:20:56,480 --> 02:20:57,960 CATEGORIZED THAT BY U.S., 3330 02:20:57,960 --> 02:20:59,280 CANADA, WHICH WAS THE LEAD 3331 02:20:59,280 --> 02:21:03,600 ORGANIZATION FOR THE 3,000 LEAD 3332 02:21:03,600 --> 02:21:04,640 IN STUDY. 3333 02:21:04,640 --> 02:21:08,440 THE INTERNATIONAL PARTICIPATION 3334 02:21:08,440 --> 02:21:08,680 AS WELL. 3335 02:21:08,680 --> 02:21:11,120 THERE WAS AN INTEREST IN THE 3336 02:21:11,120 --> 02:21:11,520 MINORITY ACCRUAL. 3337 02:21:11,520 --> 02:21:13,760 WE WERE AT 20% WHEN WE WERE LAST 3338 02:21:13,760 --> 02:21:15,320 AND 21% NOW SO WE'VE HAD 3339 02:21:15,320 --> 02:21:16,440 STRATEGIES IN PLACE TO SUSTAIN 3340 02:21:16,440 --> 02:21:21,080 AND HOPEFULLY INCREASE OUR 3341 02:21:21,080 --> 02:21:26,520 MEMBERS AND OF COURSE WE'LL HAVE 3342 02:21:26,520 --> 02:21:28,600 DATA FROM SOUTH AMERICA FOR 3343 02:21:28,600 --> 02:21:30,320 THOSE WHO PRESENT THEMSELVES AS 3344 02:21:30,320 --> 02:21:33,080 A REPORT THEMSELVES AS BEING 3345 02:21:33,080 --> 02:21:34,040 HISPANIC AND GIVE US AN 3346 02:21:34,040 --> 02:21:35,640 OPPORTUNITY TO LOOK AT THE 3347 02:21:35,640 --> 02:21:36,840 MOLECULAR DIFFERENCES MANY OF 3348 02:21:36,840 --> 02:21:38,440 THESE POPULATIONS THAT ACTUALLY 3349 02:21:38,440 --> 02:21:47,560 EMIGRATE INTO THE STATES. 3350 02:21:47,560 --> 02:21:49,320 I'M SHOWING THE RESULTS OF THE 3351 02:21:49,320 --> 02:21:50,800 BY REPOSITORY FUNDED BY THE 3352 02:21:50,800 --> 02:21:53,760 BREAST CANCER STAMP SO THIS THE 3353 02:21:53,760 --> 02:21:55,600 TOP CORNER IS WHAT HAPPENED IN 3354 02:21:55,600 --> 02:21:57,240 MARCH AT THE LAST PRESENTATION 3355 02:21:57,240 --> 02:22:00,360 AND WHERE WE ARE NOW SO, WHAT WE 3356 02:22:00,360 --> 02:22:02,680 SHOW IS FOR BLACK AND AFRICAN 3357 02:22:02,680 --> 02:22:04,960 AMERICAN WHICH WAS A SUBGROUP OF 3358 02:22:04,960 --> 02:22:11,840 INTEREST, IN THE MEETING IS THAT 3359 02:22:11,840 --> 02:22:16,960 THE THERE'S BEEN A LITTLE 3360 02:22:16,960 --> 02:22:22,360 DECREASE AND TO COLLECT THE 3361 02:22:22,360 --> 02:22:25,120 BUCKLE SPECIMENS DURING THE 3362 02:22:25,120 --> 02:22:27,720 COVID AND THERE WAS AN AMENDMENT 3363 02:22:27,720 --> 02:22:30,920 MADE TO THE TRIAL WHICH CHANGED 3364 02:22:30,920 --> 02:22:36,200 FROM BEING ABLE TO CONSENT AND 3365 02:22:36,200 --> 02:22:37,920 COLLECT SPECIMENS ANY TIME 3366 02:22:37,920 --> 02:22:40,960 DURING THE ROUNDS AND NOW, OR 3367 02:22:40,960 --> 02:22:42,640 BLOOD THE SPECIMENS HAVE TO BE 3368 02:22:42,640 --> 02:22:50,280 COLLECTED THAT T2 SO FOR THE 3369 02:22:50,280 --> 02:22:59,680 BUCKLE AT T3 IS WE IT WAS FUNDED 3370 02:22:59,680 --> 02:23:03,360 AND COMMON FOUNDATION GRANT TO 3371 02:23:03,360 --> 02:23:05,320 ENHANCE AND TO HOPEFULLY CHANGE 3372 02:23:05,320 --> 02:23:10,960 THE CULTURE WITH MORE TO 3373 02:23:10,960 --> 02:23:11,800 INCREASE MORE FOR AFRICAN 3374 02:23:11,800 --> 02:23:13,520 AMERICAN WOMEN AND FOR OUR BY 3375 02:23:13,520 --> 02:23:20,080 OWE SPECIMEN COLLECTION. 3376 02:23:20,080 --> 02:23:21,760 SO, IN SUMMARY, I'D LIKE TO 3377 02:23:21,760 --> 02:23:22,960 SHARE WITH YOU SOME OTHER 3378 02:23:22,960 --> 02:23:25,480 MODIFICATIONS WHICH WE THINK IT 3379 02:23:25,480 --> 02:23:27,520 WILL CONTRIBUTE TO ENHANCING AND 3380 02:23:27,520 --> 02:23:28,760 SUSTAINING THE INTEREST IN THE 3381 02:23:28,760 --> 02:23:29,840 TRIAL CONTRIBUTING TO THE 3382 02:23:29,840 --> 02:23:31,760 SCIENCE OF SCREENING. 3383 02:23:31,760 --> 02:23:34,000 ONE IS THAT ON THE SITE LEVEL, 3384 02:23:34,000 --> 02:23:37,040 WE HAVE REDUCED SOME OF THE 3385 02:23:37,040 --> 02:23:39,520 QUALITY FREQUENCY OF QC 3386 02:23:39,520 --> 02:23:39,760 REPORTING. 3387 02:23:39,760 --> 02:23:42,080 WE WILL STILL REQUIRE THAT THE 3388 02:23:42,080 --> 02:23:44,640 SITES COMPLY WITH THE 3389 02:23:44,640 --> 02:23:46,960 MAMMOGRAPHY AND THE FDA AND WE 3390 02:23:46,960 --> 02:23:49,880 HAVE A CATEGORY OF SITES THAT 3391 02:23:49,880 --> 02:23:56,160 HAVE GREAT PERFORMANCE AND WE'LL 3392 02:23:56,160 --> 02:24:00,080 HAVE A LESS FREQUENT COLLECTIONS 3393 02:24:00,080 --> 02:24:06,400 OF DATA WE HAD SOME WORK AROUNDS 3394 02:24:06,400 --> 02:24:07,880 INITIALLY SO WE HOPE THIS 3395 02:24:07,880 --> 02:24:10,880 MODIFICATIONS FOR NON ONCOLOGY 3396 02:24:10,880 --> 02:24:12,560 DISCIPLINES WILL HELP AND ALLOW 3397 02:24:12,560 --> 02:24:14,160 OTHER SITES TO CONTINUE TO COME 3398 02:24:14,160 --> 02:24:19,280 IN AND WE NEED TO WORK WITH OUR 3399 02:24:19,280 --> 02:24:22,240 COMMUNICATIONS PEOPLE TO HELP US 3400 02:24:22,240 --> 02:24:24,440 PROMOTE SPANISH PARTICIPATION IN 3401 02:24:24,440 --> 02:24:26,200 THE TRIAL AND THE BIO SPECIMENS 3402 02:24:26,200 --> 02:24:28,480 AS WELL AND WE HAD BEEN ABLE TO 3403 02:24:28,480 --> 02:24:29,360 INCENTIVIZE THOSE SITES THAT 3404 02:24:29,360 --> 02:24:31,600 HAVE BEEN EXTREMELY HIGH ACCRUE 3405 02:24:31,600 --> 02:24:34,040 ALS AND OVER TIME, AS THE WOMEN 3406 02:24:34,040 --> 02:24:35,600 RETURN FOR THEIR SUBSEQUENT 3407 02:24:35,600 --> 02:24:37,440 ROUNDS, IT'S SIGNIFICANTLY 3408 02:24:37,440 --> 02:24:40,680 CAUSING A BURDEN ON THE SITES SO 3409 02:24:40,680 --> 02:24:49,200 WE HAVE INSEN TA VO INCENTIVIZEE 3410 02:24:49,200 --> 02:24:51,840 HAVE BEEN AT LEAST OVER A 3411 02:24:51,840 --> 02:24:54,000 HANDFUL OF SCIENTIFIC INTEREST 3412 02:24:54,000 --> 02:24:57,080 IN THE UTILIZING THE TMIST 3413 02:24:57,080 --> 02:25:00,440 DATABASE OR INCORPORATING THOSE 3414 02:25:00,440 --> 02:25:00,920 INTO IT. 3415 02:25:00,920 --> 02:25:02,120 AND THE INTEREST OF TIME I'M 3416 02:25:02,120 --> 02:25:03,560 JUST GOING TO MENTION THROW OF 3417 02:25:03,560 --> 02:25:05,120 THOSE, ONE OF THEM IS A 3418 02:25:05,120 --> 02:25:09,800 COLLABORATION WITH ALL OF US AND 3419 02:25:09,800 --> 02:25:13,320 TMIST DESIGNED FOR PRECISION 3420 02:25:13,320 --> 02:25:15,560 SCREENING FOR ADVANCES CANCER, 3421 02:25:15,560 --> 02:25:16,440 IMAGE FAIL YOUR AND FALSE 3422 02:25:16,440 --> 02:25:18,520 POSITIVE AND ANOTHER EXAMPLE IS 3423 02:25:18,520 --> 02:25:21,400 COMPARING MRIs WHERE VERSUS 3424 02:25:21,400 --> 02:25:22,000 CONDITIONAL DYING THIS IS TICK 3425 02:25:22,000 --> 02:25:23,960 IMAGING AND THOSE PATIENTS WHO 3426 02:25:23,960 --> 02:25:26,520 ARE PRESENTING FOR DIAGNOSTIC 3427 02:25:26,520 --> 02:25:29,040 RISK IMAGING AND FINALLY, THE 3428 02:25:29,040 --> 02:25:30,520 DEVELOPMENT OF PROGNOSTIC 3429 02:25:30,520 --> 02:25:33,480 THERAPY USING A TOOL WITH THE 3430 02:25:33,480 --> 02:25:34,880 DATABASE AND SO ON THAT, I'M 3431 02:25:34,880 --> 02:25:38,080 GOING TO END AND TURNED THE 3432 02:25:38,080 --> 02:25:41,280 PODIUM OVER TO LINDA. 3433 02:25:41,280 --> 02:25:45,520 >>THANK YOU. 3434 02:25:45,520 --> 02:25:47,560 I'M LINDA AND I'M A NURSE 3435 02:25:47,560 --> 02:25:50,520 CONSULTANT IN THE DIVISION OF 3436 02:25:50,520 --> 02:25:52,480 CANCER PREVENTION I'LL HAVE AN 3437 02:25:52,480 --> 02:25:55,400 UPDATE ON DCPC PROGRESS IN THE 3438 02:25:55,400 --> 02:26:02,240 OVERARCHING RECOMMENDATIONS. 3439 02:26:02,240 --> 02:26:05,000 THE WORKING GROUP SHE HAD 3440 02:26:05,000 --> 02:26:06,160 OVERARCHING RECOMMENDATIONS THAT 3441 02:26:06,160 --> 02:26:08,120 ENCOURAGED OUR DIVISION, DCP, TO 3442 02:26:08,120 --> 02:26:10,600 LOOK AT OUR ENTIRE SCREENING 3443 02:26:10,600 --> 02:26:11,800 PORTFOLIO AND ENSURE WE HAVE A 3444 02:26:11,800 --> 02:26:14,480 PLAN FOR MONITORING OVER ALL 3445 02:26:14,480 --> 02:26:15,600 ACCRUAL AS WELL AS ACCRUAL OF 3446 02:26:15,600 --> 02:26:17,560 DAY VERSE POPULATIONS ON TO OUR 3447 02:26:17,560 --> 02:26:19,400 SCREENING TRIALS. 3448 02:26:19,400 --> 02:26:21,840 AND ALSO, RECOMMENDED THAT WE 3449 02:26:21,840 --> 02:26:24,160 HAVE EARLY TERMINATION CRITERIA 3450 02:26:24,160 --> 02:26:25,760 DEFINED AND APPLIED BEFORE 3451 02:26:25,760 --> 02:26:28,320 SCREENING STUDIES ARE LAUNCHED 3452 02:26:28,320 --> 02:26:29,400 ESPECIALLY LARGE STUDIES. 3453 02:26:29,400 --> 02:26:33,680 NEXT SLIDE, PLEASE. 3454 02:26:33,680 --> 02:26:35,520 SO, FIRST I'LL REVIEW 3455 02:26:35,520 --> 02:26:36,520 ORGANIZATIONAL STRUCTURES THAT 3456 02:26:36,520 --> 02:26:38,040 WE USED FOR THIS EFFORT ON THE 3457 02:26:38,040 --> 02:26:40,240 LEFT AND YOU WILL SEE THE MEMBER 3458 02:26:40,240 --> 02:26:42,800 OF OUR TRANS DCP CLINICAL TRIALS 3459 02:26:42,800 --> 02:26:44,720 WORKING GROUP WHICH I'LL REFER 3460 02:26:44,720 --> 02:26:46,440 TO AS CTWG. 3461 02:26:46,440 --> 02:26:48,480 MY COLLEAGUE AND I WERE ASKED TO 3462 02:26:48,480 --> 02:26:49,680 CO-CHAIR THIS GROUP AND IT 3463 02:26:49,680 --> 02:26:55,800 STARTED IN EARLY 2021. 3464 02:26:55,800 --> 02:26:58,160 THE GROUP HAS THE DIRECTOR AND 3465 02:26:58,160 --> 02:27:01,400 THE DIVISIONS CLINICAL TRIAL 3466 02:27:01,400 --> 02:27:02,320 LEADERSHIP INDIVIDUALS. 3467 02:27:02,320 --> 02:27:12,840 AND THE ROLE OF THIS GROUP IS TO 3468 02:27:22,120 --> 02:27:27,560 OOHED ROXs GROUP WE COINED THE 3469 02:27:27,560 --> 02:27:28,720 TEAM STRIKE TEAM BECAUSE WE 3470 02:27:28,720 --> 02:27:30,160 THOUGHT IT WOULD BE FAST AND IT 3471 02:27:30,160 --> 02:27:34,240 WASN'T AS FAST AS WE EXPECTED IT 3472 02:27:34,240 --> 02:27:36,200 TO BE AND YOU SEE THE MEMBERSHIP 3473 02:27:36,200 --> 02:27:37,000 OF THE STRIKE TEAM SO THE 3474 02:27:37,000 --> 02:27:40,040 MEMBERS INCLUDED REPRESENTATIVES 3475 02:27:40,040 --> 02:27:42,160 FROM THE THREE AREAS WITHIN THE 3476 02:27:42,160 --> 02:27:43,880 TA VISION THAT HAVE SCREENING 3477 02:27:43,880 --> 02:27:46,840 TRIALS IN THEIR PORTFOLIO SO 3478 02:27:46,840 --> 02:27:50,280 SPECIFICALLY, THE NCORP AND 3479 02:27:50,280 --> 02:27:55,640 CECILIA LEE AND THE SECOND AREA 3480 02:27:55,640 --> 02:28:06,120 OUR HPV STUDIES AND FROM THE 3481 02:28:13,520 --> 02:28:14,400 PROTOCOL INFORMATION OFFICE. 3482 02:28:14,400 --> 02:28:17,720 THE CHARGE WAS TO ASSESS DCP'S 3483 02:28:17,720 --> 02:28:20,000 CURRENT AND PLAN SCREENING 3484 02:28:20,000 --> 02:28:20,600 PROTOCOLS AGAINST THE 3485 02:28:20,600 --> 02:28:22,080 RECOMMENDATIONS AND THE METHODS 3486 02:28:22,080 --> 02:28:25,240 ATTITUDES BY THE TEAM WERE TO 3487 02:28:25,240 --> 02:28:28,440 IDENTIFY AND REVIEW ALL THE 3488 02:28:28,440 --> 02:28:29,920 RELEVANT PROGRAM MATERIALS FOR A 3489 02:28:29,920 --> 02:28:32,800 PORTFOLIO REVIEW AND ASSESS THE 3490 02:28:32,800 --> 02:28:34,120 IT THOSE STUDENTS BY PROGRAM 3491 02:28:34,120 --> 02:28:36,080 STAFF TO MONITOR ACCRUAL BOTH 3492 02:28:36,080 --> 02:28:38,760 OVER ALL MINORITY ACCRUAL. 3493 02:28:38,760 --> 02:28:41,600 NEXT SLIDE, PLEASE. 3494 02:28:41,600 --> 02:28:43,440 THE STRIKE TEAM PRODUCED TWO 3495 02:28:43,440 --> 02:28:45,360 DOCUMENTS BOTH OF WHICH WERE 3496 02:28:45,360 --> 02:28:47,200 DISTRIBUTED TO THE CTAC MEMBERS 3497 02:28:47,200 --> 02:28:48,920 AND THE FIRST IS OUR REPORT 3498 02:28:48,920 --> 02:28:51,480 WHICH RESPONDS TO THE 3499 02:28:51,480 --> 02:28:52,680 RECOMMENDATIONS AND INCLUDES THE 3500 02:28:52,680 --> 02:28:54,160 METHODS AND DESCRIBES THE 3501 02:28:54,160 --> 02:28:55,640 FINDINGS, ANALYSIS AND OUR 3502 02:28:55,640 --> 02:28:56,960 RECOMMENDATIONS AND THAT WAS 3503 02:28:56,960 --> 02:28:59,160 ACCEPTED BY DCP LEADERSHIP IN 3504 02:28:59,160 --> 02:29:00,920 APRIL AND THE STRIKE TEAM WAS IN 3505 02:29:00,920 --> 02:29:03,440 TASK WITH IMPLEMENTING THE 3506 02:29:03,440 --> 02:29:04,200 RECOMMENDATIONS FROM THE REPORT 3507 02:29:04,200 --> 02:29:06,640 WHICH I'LL FOCUS ON TODAY. 3508 02:29:06,640 --> 02:29:08,480 NEXT SLIDE, PLEASE. 3509 02:29:08,480 --> 02:29:11,160 SO BASED ON THE STRIKE TEAM 3510 02:29:11,160 --> 02:29:12,880 FINDINGS, IN DISCUSSION WITH OUR 3511 02:29:12,880 --> 02:29:13,600 LEARNING CLINICAL TRIALS WORKING 3512 02:29:13,600 --> 02:29:15,480 GROUP INCLUDING DCP LEADERSHIP, 3513 02:29:15,480 --> 02:29:18,000 A SET OF NEW DCP SCREENING TRIAL 3514 02:29:18,000 --> 02:29:20,080 REQUIRE MANIES WAS DEVELOPED. 3515 02:29:20,080 --> 02:29:22,240 THE COMPLETE LIST OF THESE 3516 02:29:22,240 --> 02:29:24,440 REQUIREMENTS IS AVAILABLE IN THE 3517 02:29:24,440 --> 02:29:25,200 IMPLEMENTATION PLAN AND THIS 3518 02:29:25,200 --> 02:29:29,200 SLIDE IS A SAMPLE OF THOSE 3519 02:29:29,200 --> 02:29:30,040 REQUIREMENTS. 3520 02:29:30,040 --> 02:29:33,200 THEY PERTAIN TO ALL FUTURE TCP 3521 02:29:33,200 --> 02:29:34,080 SPONSORED SCREENING TILES AND 3522 02:29:34,080 --> 02:29:35,240 THEY MUST BE ADDRESSED IN THE 3523 02:29:35,240 --> 02:29:45,760 PROTOCOL AND THE GOAL OF THESE 3524 02:29:49,400 --> 02:29:52,160 THEY'RE HAVING PLANNING BUILDING 3525 02:29:52,160 --> 02:29:53,320 ON BASIC GOOD CLINICAL TRIALS 3526 02:29:53,320 --> 02:29:54,400 PRINCIPLES AND SO THESE 3527 02:29:54,400 --> 02:29:56,000 REQUIREMENTS WILL ENSURE THAT 3528 02:29:56,000 --> 02:29:57,680 ACROSS THE DIVISION, WE'RE 3529 02:29:57,680 --> 02:29:59,800 TAKING A SYSTEM AT TRICK 3530 02:29:59,800 --> 02:30:06,280 APPROACH TO OUR SCREENING 3531 02:30:06,280 --> 02:30:11,880 PORTFOLIO. 3532 02:30:11,880 --> 02:30:13,320 A WORKING GROUP WILL PLAY A 3533 02:30:13,320 --> 02:30:15,280 FUNCTION IN THIS IMPLEMENTATION 3534 02:30:15,280 --> 02:30:16,600 PROCESS. 3535 02:30:16,600 --> 02:30:19,760 THE FIRST PHASE ENSURES ALL THE 3536 02:30:19,760 --> 02:30:23,360 RELEVANT PROGRAM DOCUMENTS IN 3537 02:30:23,360 --> 02:30:25,240 THE AREAS ARE REVIEWED, ASSESSED 3538 02:30:25,240 --> 02:30:27,400 AND REVISED TO COMPLY WITH THE 3539 02:30:27,400 --> 02:30:29,640 NEW SCREENING TRIAL 3540 02:30:29,640 --> 02:30:29,960 REQUIREMENTS. 3541 02:30:29,960 --> 02:30:33,560 THE EXPECTED OUT SOME OF THIS 3542 02:30:33,560 --> 02:30:36,120 PHASE IS DCP WILL COMMUNICATE 3543 02:30:36,120 --> 02:30:38,760 THESE AND TO THEIR GROUPS AND 3544 02:30:38,760 --> 02:30:39,680 THE SCREENING PROTOCOLS ADDRESS 3545 02:30:39,680 --> 02:30:42,000 THESE REQUIREMENT AND DCP'S 3546 02:30:42,000 --> 02:30:43,320 INTERNAL SCIENTIFIC REVIEW 3547 02:30:43,320 --> 02:30:45,280 PROCESS REVIEWS THOSE PROTOCOLS 3548 02:30:45,280 --> 02:30:46,960 AND INSURES THAT THESE 3549 02:30:46,960 --> 02:30:48,160 REQUIREMENTS HAVE BEEN 3550 02:30:48,160 --> 02:30:52,680 SATISFACTORY ADDRESSED. 3551 02:30:52,680 --> 02:30:55,280 THE SECOND FACE IS WE WILL 3552 02:30:55,280 --> 02:30:56,400 INITIATIVE, WE'LL IPSOS-REID 3553 02:30:56,400 --> 02:30:57,560 TAUGHT A NEW WORK FLOW THAT 3554 02:30:57,560 --> 02:31:00,280 ROUTES THE PROTOCOLS TO THE 3555 02:31:00,280 --> 02:31:01,640 DIRECTOR FOR REVIEWING ALLOWING 3556 02:31:01,640 --> 02:31:03,200 THEM TO HAVE REVIEW AT THE 3557 02:31:03,200 --> 02:31:13,720 APPROPRIATE POINT TO BE ABLE TO 3558 02:31:20,320 --> 02:31:21,080 AND SIGNIFICANT AMENDMENT WOULD 3559 02:31:21,080 --> 02:31:22,920 BE DEFINED AS A CHANGE IN 3560 02:31:22,920 --> 02:31:25,000 DESIGN, STUDY ENDPOINTS OR 3561 02:31:25,000 --> 02:31:25,600 SAMPLE SIZE. 3562 02:31:25,600 --> 02:31:28,040 AND THE THIRD PHASE IS TCP 3563 02:31:28,040 --> 02:31:31,440 MONITORING AND THIS IS PERFORMED 3564 02:31:31,440 --> 02:31:33,560 BY THE DCP CLINICAL TRAILS 3565 02:31:33,560 --> 02:31:35,720 WORKING GROUP AND AT QUARTERLY 3566 02:31:35,720 --> 02:31:37,440 MEETINGS, A DESIGNEE FROM EACH 3567 02:31:37,440 --> 02:31:38,760 AREA WILL PRESENT THE SCREENING 3568 02:31:38,760 --> 02:31:40,840 TRIALS IN THE PORTFOLIO AND THE 3569 02:31:40,840 --> 02:31:43,280 PURPOSE OF THIS STEP IS NOT TO 3570 02:31:43,280 --> 02:31:44,760 REPLICATE OR REPLACE ALL THE 3571 02:31:44,760 --> 02:31:46,240 CURRENT ON GOING MONITORING 3572 02:31:46,240 --> 02:31:48,160 ACTIVITIES BUT IT'S TO PROVIDE A 3573 02:31:48,160 --> 02:31:49,920 STRUCTURE AND A PROCESS WITHIN 3574 02:31:49,920 --> 02:31:52,080 OUR DIVISION TO SYSTEMATICALLY 3575 02:31:52,080 --> 02:31:54,600 ASSESS AND STUDY PROGRESS AND TO 3576 02:31:54,600 --> 02:31:56,080 ENSURE THAT IF MORNING LETTERS 3577 02:31:56,080 --> 02:31:57,880 NEED TO BE ISSUED, THAT'S BEEN 3578 02:31:57,880 --> 02:32:00,160 DONE AND IF THERE'S CORRECTIVE 3579 02:32:00,160 --> 02:32:01,160 ACTION PLANS IN PLACE, TO SUN 3580 02:32:01,160 --> 02:32:11,640 TIM ATTICLY REVIEW PROGRESS WE 3581 02:32:12,640 --> 02:32:14,040 WILL LOOK BROADLY AT CHANGES IN 3582 02:32:14,040 --> 02:32:15,680 SCIENCE OR TECHNOLOGY LANDSCAPE 3583 02:32:15,680 --> 02:32:16,840 THAT MAY HAVE IMPACT ON THE 3584 02:32:16,840 --> 02:32:19,000 TRIAL AND IT GIVES PEOPLE IN THE 3585 02:32:19,000 --> 02:32:20,200 DIVISION LEADERSHIP IN THE TA 3586 02:32:20,200 --> 02:32:21,440 VISION THE OPPORTUNITY TO LOOK 3587 02:32:21,440 --> 02:32:22,760 ACROSS THE DIVISION AT THE 3588 02:32:22,760 --> 02:32:24,360 ENTIRE SCREENING PORTFOLIO AND 3589 02:32:24,360 --> 02:32:26,480 TO DISCUSS CHALLENGE TO LOOK AT 3590 02:32:26,480 --> 02:32:28,280 OPPORTUNITIES AND TO HAVE A LOT 3591 02:32:28,280 --> 02:32:31,680 MORE COMMUNICATION AND A 3592 02:32:31,680 --> 02:32:32,440 SYSTEMATIC APPROACH. 3593 02:32:32,440 --> 02:32:33,560 WE'RE DEVELOPING AN EVALUATION 3594 02:32:33,560 --> 02:32:40,840 PLAN THAT WILL LAUNCH IN EARLY 3595 02:32:40,840 --> 02:32:42,120 2023. 3596 02:32:42,120 --> 02:32:43,840 DEVELOPING NEW CANCER SCREENING 3597 02:32:43,840 --> 02:32:45,440 TRIALS WITH THE ASSISTANCE OF 3598 02:32:45,440 --> 02:32:51,280 KEVIN DoD FROM OUR BUY BRANCH, 3599 02:32:51,280 --> 02:32:52,840 THERE WAS ON GOING AND PAST 3600 02:32:52,840 --> 02:32:54,280 SCREENING PROTOCOLS AND THE PAST 3601 02:32:54,280 --> 02:32:56,880 LARGE PREVENTION TRIALS. 3602 02:32:56,880 --> 02:33:01,640 12 TRIALS WERE EVALUATED FOR 3603 02:33:01,640 --> 02:33:02,240 ACCRUAL. 3604 02:33:02,240 --> 02:33:03,360 OBVIOUSLY THAT IS AN 3605 02:33:03,360 --> 02:33:05,160 INSUFFICIENT NUMBER TO BE ABLE 3606 02:33:05,160 --> 02:33:10,760 TO ESTABLISH A DEFINITIVE SET OF 3607 02:33:10,760 --> 02:33:11,600 STOPPING RULES HOWEVER IT SERVES 3608 02:33:11,600 --> 02:33:16,640 AS A USEFUL TOOL TO DEVELOP 3609 02:33:16,640 --> 02:33:18,280 PRELIMINARY AND IMPLEMENTED NOW 3610 02:33:18,280 --> 02:33:23,480 AND REFINED OVER TIME AS 3611 02:33:23,480 --> 02:33:25,120 ADDITIONAL DATA IT IS AT 3612 02:33:25,120 --> 02:33:25,560 AVAILABLE. 3613 02:33:25,560 --> 02:33:29,400 IT'S ACHIEVING A PERCENTAGE OF 3614 02:33:29,400 --> 02:33:30,400 EXPECTED ACCRUAL AND AN 3615 02:33:30,400 --> 02:33:31,720 IDENTIFIED POINT IN THE 3616 02:33:31,720 --> 02:33:38,680 TIMEFRAME FORAY CRUEL. 3617 02:33:38,680 --> 02:33:41,480 WE HAVE FIVE EVALUATION WE'RE 3618 02:33:41,480 --> 02:33:43,200 CALLING THEM BREAK POINTS AND SO 3619 02:33:43,200 --> 02:33:47,120 IF WE LOOK AT THE FIRST BREAK 3620 02:33:47,120 --> 02:33:48,640 POINT, THIS IS AT 25% OF THE 3621 02:33:48,640 --> 02:33:50,400 TIME OF THE EXPECTED ACCRUAL 3622 02:33:50,400 --> 02:33:51,840 PERIOD OF THE PROTOCOL SO THE 3623 02:33:51,840 --> 02:33:54,040 PROTOCOL NEEDS TO DEFINE THE 3624 02:33:54,040 --> 02:33:57,240 EXPECTED ACCRUAL PER IDEA AT 25% 3625 02:33:57,240 --> 02:34:01,800 AND ELAPSED AND 10% HAS TO BE 3626 02:34:01,800 --> 02:34:02,360 COMPLETED. 3627 02:34:02,360 --> 02:34:03,600 THIS CHECKPOINT ACKNOWLEDGES 3628 02:34:03,600 --> 02:34:06,280 START UP TIME AND ISSUES AND 3629 02:34:06,280 --> 02:34:10,120 WHEN HALF OF THE TIME OF THE 3630 02:34:10,120 --> 02:34:12,280 EXPECTED ACCRUAL PER IDEA HAS 3631 02:34:12,280 --> 02:34:14,160 ELAPSED WE WILL SEE 25% OF THE 3632 02:34:14,160 --> 02:34:15,560 ACCRUAL BEING COMPLETE AND THE 3633 02:34:15,560 --> 02:34:18,600 THIRD CHECKPOINT IS 75% OF THE' 3634 02:34:18,600 --> 02:34:19,920 CLAPSED TIME HALF SHOULD BE 3635 02:34:19,920 --> 02:34:21,520 COMPLETE AND ADDITIONAL 3636 02:34:21,520 --> 02:34:23,720 CHECKPOINT AT 8 A% OF TIME TO 3637 02:34:23,720 --> 02:34:26,680 ENSURE THAT 65% OF ACCRUAL IS 3638 02:34:26,680 --> 02:34:29,520 COMPLETE AND AT 100% TIME, IF 3639 02:34:29,520 --> 02:34:31,280 90% OF ACCRUAL HAS BEEN ACHIEVED 3640 02:34:31,280 --> 02:34:32,560 WE WILL CONSIDER THAT SUCCESSFUL 3641 02:34:32,560 --> 02:34:34,320 AND EXPECT SUCCESSFUL COMPLETION 3642 02:34:34,320 --> 02:34:38,160 OF THE TRIAL. 3643 02:34:38,160 --> 02:34:40,120 SO, IMPLEMENTING THE STOPPING 3644 02:34:40,120 --> 02:34:41,160 RULES, THIS WILL BE DONE WITH 3645 02:34:41,160 --> 02:34:42,880 THE OVERSIGHT OF OUR CLINICAL 3646 02:34:42,880 --> 02:34:44,360 TRAILS WORKING GROUP LOOKING AT 3647 02:34:44,360 --> 02:34:45,920 THE STUDIES AT EACH OF THE 3648 02:34:45,920 --> 02:34:46,840 QUARTERLY MEETINGS. 3649 02:34:46,840 --> 02:34:49,600 SO THE ACTUAL ACCRUAL VERSUS THE 3650 02:34:49,600 --> 02:34:50,320 EXPECTED ACCRUAL WILL BE 3651 02:34:50,320 --> 02:34:51,520 ASSESSED FOR EACH BREAK POINT 3652 02:34:51,520 --> 02:34:53,800 AND IF THE BREAK POINT IS MET OR 3653 02:34:53,800 --> 02:34:54,800 EXCEEDED, THE STUDY WILL 3654 02:34:54,800 --> 02:34:56,360 CONTINUE AND BE ASSESSED AGAIN 3655 02:34:56,360 --> 02:34:57,440 AT THE NEXT BREAK POINT. 3656 02:34:57,440 --> 02:34:59,880 THE TRIAL IS NOT MEETING ITS 3657 02:34:59,880 --> 02:35:00,840 EXPECTED ACCRUAL AT THE BREAK 3658 02:35:00,840 --> 02:35:02,800 POINT DCP ISSUES A WARNING 3659 02:35:02,800 --> 02:35:04,480 LETTER, REQUESTS A CORRECTIVE 3660 02:35:04,480 --> 02:35:05,360 ACTION PLAN. 3661 02:35:05,360 --> 02:35:09,400 IF THE TRIAL IS ABLE TO IMPROVE 3662 02:35:09,400 --> 02:35:11,320 IT CONTINUES AND IT'S MONITORED 3663 02:35:11,320 --> 02:35:13,080 CLOSELY ON THE OTHER HAND IF THE 3664 02:35:13,080 --> 02:35:14,320 TRIAL ACCRUAL DOES NOT MEET THE 3665 02:35:14,320 --> 02:35:16,680 BREAK POINT, IT WILL BE 3666 02:35:16,680 --> 02:35:18,360 TERMINATED FOR IN ABILITY TO 3667 02:35:18,360 --> 02:35:18,600 ACCRUE. 3668 02:35:18,600 --> 02:35:21,560 NEXT SLIDE, PLEASE. 3669 02:35:21,560 --> 02:35:23,240 SO GOING FORWARD, SOME THINGS 3670 02:35:23,240 --> 02:35:24,360 THAT WILL BE HAPPENING RELATED 3671 02:35:24,360 --> 02:35:27,600 IT OUR SCREENING PORTFOLIO IN 3672 02:35:27,600 --> 02:35:29,160 2023. 3673 02:35:29,160 --> 02:35:31,360 FIRST, THIS IN EARLY 2023, THERE 3674 02:35:31,360 --> 02:35:35,880 WOULD BE A SIMPLIFIED NCI 3675 02:35:35,880 --> 02:35:38,080 REGISTRATION PROCESS FOR THOSE 3676 02:35:38,080 --> 02:35:39,280 PARTICIPATING IN SCREENING 3677 02:35:39,280 --> 02:35:39,560 PROTOCOLS. 3678 02:35:39,560 --> 02:35:41,320 THIS IS PASS DIFFICULTY IN BAR 3679 02:35:41,320 --> 02:35:42,200 WE ARE AND WE'RE LOOKING FORWARD 3680 02:35:42,200 --> 02:35:51,080 TO OVERCOMING THAT. 3681 02:35:51,080 --> 02:35:55,160 THIS IS AN R34 AND U34 GRAB 3682 02:35:55,160 --> 02:35:56,000 PROGRAM THAT PROVIDES FUNDING 3683 02:35:56,000 --> 02:36:04,600 FOR FEASIBILITY ASSESSMENTS THE 3684 02:36:04,600 --> 02:36:06,240 CANCER SCREENING RESEARCH 3685 02:36:06,240 --> 02:36:07,440 NETWORK THAT WILL BE CONDUCTING 3686 02:36:07,440 --> 02:36:14,080 CANCER SCREENING TRIALS WILL BE 3687 02:36:14,080 --> 02:36:15,160 SPLIT UP AND THERE WILL BE 3688 02:36:15,160 --> 02:36:16,240 SCREENING RULES AND THE 3689 02:36:16,240 --> 02:36:17,440 SCREENING REQUIREMENTS AND THE 3690 02:36:17,440 --> 02:36:18,520 STOPPING RULES FROM THE VERY 3691 02:36:18,520 --> 02:36:20,320 BEGINNING IN THE MEANTIME, WE'LL 3692 02:36:20,320 --> 02:36:21,840 CONTINUE THE FULL IMPLEMENTATION 3693 02:36:21,840 --> 02:36:28,640 OF THESE SCREENING REQUIREMENT 3694 02:36:28,640 --> 02:36:32,560 WE LOOKED AT OUR SYSTEMS 3695 02:36:32,560 --> 02:36:35,720 DEVELOPING REQUIREMENT THIS IS 3696 02:36:35,720 --> 02:36:44,280 THE PROCESS SO IN CLOSING, I'D 3697 02:36:44,280 --> 02:36:45,640 LIKE TO ACKNOWLEDGE THE MEMBERS 3698 02:36:45,640 --> 02:36:47,720 OF THE STRIKE TEAM AND THE DCP 3699 02:36:47,720 --> 02:36:48,800 CLINICAL TRIALS WORKING GROUP 3700 02:36:48,800 --> 02:36:52,040 AND I KNOW MY DCP COLLEAGUES 3701 02:36:52,040 --> 02:36:53,920 JOINED WITH ME IN THANKING 3702 02:36:53,920 --> 02:36:55,120 INTEREST DAVIDSON AND THE TRIALS 3703 02:36:55,120 --> 02:36:56,120 WORKING GROUP FOR THEIR 3704 02:36:56,120 --> 02:36:59,720 THOUGHTFUL WORK AND THEIR 3705 02:36:59,720 --> 02:37:02,800 RECOMMENDATIONS. 3706 02:37:02,800 --> 02:37:08,560 >>THANK YOU SO MUCH, DOCTOR. 3707 02:37:08,560 --> 02:37:13,240 GREAT PRESENTATION AND A LOT OF 3708 02:37:13,240 --> 02:37:13,480 PROGRESS. 3709 02:37:13,480 --> 02:37:19,760 AYED LIKE TO OPEN UP THE 3710 02:37:19,760 --> 02:37:21,360 DISCUSSION, WE HAVE ABOUT 10 3711 02:37:21,360 --> 02:37:22,760 MINUTES, I'D LIKE TO ASK Dr. 3712 02:37:22,760 --> 02:37:26,120 DAVIDSON, NANCY, YOU WERE CHAIR 3713 02:37:26,120 --> 02:37:28,480 OF THE CANCER SCREENING TRIALS 3714 02:37:28,480 --> 02:37:30,160 WORKING GROUP AND I'M WONDERING 3715 02:37:30,160 --> 02:37:34,440 IF YOU HAVE ANY INITIATION OR 3716 02:37:34,440 --> 02:37:34,880 INITIATING COMMENTS? 3717 02:37:34,880 --> 02:37:37,240 >>THANK YOU, NEIL. 3718 02:37:37,240 --> 02:37:39,320 YOU REMINDED ME THAT WAS OUR 3719 02:37:39,320 --> 02:37:41,280 HOLIDAY PROJECT AND THE 13 OF US 3720 02:37:41,280 --> 02:37:43,120 IN THE FIRST WINTER OF THE 3721 02:37:43,120 --> 02:37:44,440 PANDEMIC BECAUSE WE STARTED JUST 3722 02:37:44,440 --> 02:37:46,440 ABOUT TWO YEARS AGO NOW. 3723 02:37:46,440 --> 02:37:48,760 AND WE DID TAKE UP TWO TOPICS AS 3724 02:37:48,760 --> 02:37:50,600 YOU PUT IT OUT. 3725 02:37:50,600 --> 02:37:54,320 THE FIRST HAD TO DO WITH A TMIST 3726 02:37:54,320 --> 02:37:56,080 TRIAL AND I'M GLAD TO SEE THE 3727 02:37:56,080 --> 02:37:58,000 TMIST INVESTIGATORS WERE ABLE TO 3728 02:37:58,000 --> 02:38:00,080 REVISE THE TRIAL IN A WAY THAT 3729 02:38:00,080 --> 02:38:01,600 IT SEEMS TO GO GOING REALLY 3730 02:38:01,600 --> 02:38:02,960 SMOOTHLY, AS BEST AS I CAN CAN 3731 02:38:02,960 --> 02:38:03,440 TELL. 3732 02:38:03,440 --> 02:38:04,920 IT LOOKS LIKE ONE OF OUR BIG 3733 02:38:04,920 --> 02:38:06,240 ISSUES WHICH WAS TO MAKE SURE 3734 02:38:06,240 --> 02:38:11,200 THAT THEY REALLY RAMPED UP THEIR 3735 02:38:11,200 --> 02:38:12,680 SPECIMEN COLLECTION AND THEY 3736 02:38:12,680 --> 02:38:14,240 WERE ABLE TO THINK ABOUT DIVERSE 3737 02:38:14,240 --> 02:38:16,320 POPULATIONS AND THOSE WERE 3738 02:38:16,320 --> 02:38:18,160 STRENGTHENS OF THE TRAIL. 3739 02:38:18,160 --> 02:38:20,200 I PRAY THEY WILL MAINTAIN THE 3740 02:38:20,200 --> 02:38:21,120 ACCRUAL THEY'VE BEEN SEEING AND 3741 02:38:21,120 --> 02:38:22,880 THEY WILL BE ABLE TO FINISH 3742 02:38:22,880 --> 02:38:24,280 ACCRUAL, HOPEFULLY EARLIER THAN 3743 02:38:24,280 --> 02:38:26,480 THE END OF 2024 AND IT'S PARTLY 3744 02:38:26,480 --> 02:38:28,200 BECAUSE AS WE KNOW THIS IS A 3745 02:38:28,200 --> 02:38:29,880 TECHNOLOGY WHICH IS WIDELY 3746 02:38:29,880 --> 02:38:31,840 AVAILABLE IN THE COMMUNITY AND I 3747 02:38:31,840 --> 02:38:33,640 THINK THE LONGER WE GO AND THE 3748 02:38:33,640 --> 02:38:37,400 MORE IT PENETRATES, IT MAKING 3749 02:38:37,400 --> 02:38:39,440 THE FINAL END POINT MAY BE LESS 3750 02:38:39,440 --> 02:38:41,200 MEANINGFUL BECAUSE OF WHAT HAS 3751 02:38:41,200 --> 02:38:42,000 TRANSPIRED WITH FROM. 3752 02:38:42,000 --> 02:38:46,000 THE SECOND GOES BACK TO I 3753 02:38:46,000 --> 02:38:49,640 APPOINT THAT MAYBE ONE OF THE 3754 02:38:49,640 --> 02:38:51,200 FEW POSITIVES THAT CAME OUT OF 3755 02:38:51,200 --> 02:38:52,800 COVID WAS THE NEED TO LOOK AT 3756 02:38:52,800 --> 02:38:54,040 THESE LARGE TRIALS AND REALIZE 3757 02:38:54,040 --> 02:38:56,680 WE NEEDED TO BRING MORE RIGGER 3758 02:38:56,680 --> 02:38:58,760 HOW WE MONITOR THESE LARGE 3759 02:38:58,760 --> 02:39:00,480 PREVENTION TRIALS SO I'M REALLY 3760 02:39:00,480 --> 02:39:03,120 IMPRESSED BY WHAT THE CTWG IN 3761 02:39:03,120 --> 02:39:07,360 THE STRIKE TEAM OF PROPOSED 3762 02:39:07,360 --> 02:39:09,320 PROCESS LOOKS REALLY GOOD TO ME 3763 02:39:09,320 --> 02:39:10,560 AND I HAVE TO BELIEVE THIS IS 3764 02:39:10,560 --> 02:39:12,480 MORE IMPORTANT BECAUSE AS I 3765 02:39:12,480 --> 02:39:13,520 UNDERSTAND, THE PRESIDENT'S 3766 02:39:13,520 --> 02:39:16,640 GOALS AND YOU KNOW THE NEXT 3767 02:39:16,640 --> 02:39:17,880 MOONSHOT AND OUR GOAL OF 3768 02:39:17,880 --> 02:39:20,080 REDUCING CANCER MORTALITY BY A 3769 02:39:20,080 --> 02:39:23,520 SUBSTANTIAL AMOUNT, THESE ARE 3770 02:39:23,520 --> 02:39:24,960 EARLY TRIALS WILL BE REALLY 3771 02:39:24,960 --> 02:39:25,240 IMPORTANT. 3772 02:39:25,240 --> 02:39:26,680 SO I'M GLAD WE HAVE A FRAMEWORK 3773 02:39:26,680 --> 02:39:27,840 TO BRING THEM INTO PLACE. 3774 02:39:27,840 --> 02:39:29,080 THANK YOU SO MUCH FOR ALL THAT 3775 02:39:29,080 --> 02:39:30,960 HARD WORK AND THANK YOU FOR THE 3776 02:39:30,960 --> 02:39:31,240 FEEDBACK. 3777 02:39:31,240 --> 02:39:34,720 I AM HOPING WE CAN GET THIS TO 3778 02:39:34,720 --> 02:39:35,960 THOSE 13 PEOPLE WHO DID SPEND 3779 02:39:35,960 --> 02:39:37,480 THEIR HOLIDAY SEASON WITH ME SO 3780 02:39:37,480 --> 02:39:40,160 THEY CAN SEE WHAT TRANSPIRED. 3781 02:39:40,160 --> 02:39:40,480 THANK YOU. 3782 02:39:40,480 --> 02:39:42,800 >>THANK YOU, NANCY. 3783 02:39:42,800 --> 02:39:45,920 WHILE FOLKS ARE THINKING OF 3784 02:39:45,920 --> 02:39:47,520 QUESTIONS, ONE THING THAT KIM TO 3785 02:39:47,520 --> 02:39:49,360 MIND FOR ME WAS, WE HAVE A 3786 02:39:49,360 --> 02:39:52,680 PRETTY LENGTHY EXPERIENCE NOW 3787 02:39:52,680 --> 02:39:55,400 THROUGH THE NCTN CANCER 3788 02:39:55,400 --> 02:39:57,320 TREATMENT STUDIES WITH REGARDS 3789 02:39:57,320 --> 02:40:00,880 TO EARLY STOPPING FORAY CRUEL, 3790 02:40:00,880 --> 02:40:02,680 IT'S BEEN GOING ON MORE THAN A 3791 02:40:02,680 --> 02:40:06,000 DECADE NOW AND I WONDER IF 3792 02:40:06,000 --> 02:40:12,240 LEARNLEARNINGS HAVE INFORMED ONE 3793 02:40:12,240 --> 02:40:15,960 PERSPECTIVE OF HOW YOU'VE 3794 02:40:15,960 --> 02:40:17,880 DECIDED TO UPON TER THE 3795 02:40:17,880 --> 02:40:18,640 PREVENTION STUDIES? 3796 02:40:18,640 --> 02:40:21,680 >>THANK YOU FOR THAT. 3797 02:40:21,680 --> 02:40:24,280 NON PREVENTION, SORRY. 3798 02:40:24,280 --> 02:40:27,000 >>I HAVE. 3799 02:40:27,000 --> 02:40:28,880 TRP'S DEPUTY DIRECTOR ON THE 3800 02:40:28,880 --> 02:40:31,360 CALL WITH ME TODAY AND WHO IS 3801 02:40:31,360 --> 02:40:33,240 HERE TO FIELD DIFFICULT 3802 02:40:33,240 --> 02:40:33,480 QUESTIONS. 3803 02:40:33,480 --> 02:40:38,640 >>THANK YOU, LY LINDA. 3804 02:40:38,640 --> 02:40:40,200 WE'VE SPENT TIME, 10 YEARS AGO 3805 02:40:40,200 --> 02:40:42,400 WE WENT BACK AND LOOKED AT THE 3806 02:40:42,400 --> 02:40:44,120 CANCER CONTROLS TRIALS TO LOOK 3807 02:40:44,120 --> 02:40:45,720 AT EARLY STOPPING RULES AND WHAT 3808 02:40:45,720 --> 02:40:48,880 WE DID DO IS WHEN WE APPLIED THE 3809 02:40:48,880 --> 02:40:50,200 RULES TO THE CANCER CONTROL 3810 02:40:50,200 --> 02:40:53,040 STUDIES THEY DIDN'T FIT AND SO 3811 02:40:53,040 --> 02:40:56,240 WE DEVELOPED AN INDEPENDENT SET 3812 02:40:56,240 --> 02:40:57,840 OF STOPPING RULES WHICH HAS 3813 02:40:57,840 --> 02:40:59,560 SERVED ACTUALLY PRETTY WELL. 3814 02:40:59,560 --> 02:41:04,080 KEVIN DoD, OUR STATISTICIANS 3815 02:41:04,080 --> 02:41:05,640 HELPED DEVELOP THOSE RULES SO 3816 02:41:05,640 --> 02:41:07,480 WHEN LINDA AND Dr. CASTLE 3817 02:41:07,480 --> 02:41:09,680 DECIDED WE WOULD START DOWN THIS 3818 02:41:09,680 --> 02:41:10,800 ROAD, THAT IS WHY. 3819 02:41:10,800 --> 02:41:12,880 WE WENT BACK TO OUR LARGE 3820 02:41:12,880 --> 02:41:14,320 PREVENTION TRIALS AND OUR 3821 02:41:14,320 --> 02:41:16,240 PREVIOUS SCREENING TRIALS TO 3822 02:41:16,240 --> 02:41:19,200 REALLY LOOK AT BOTH THE ACCRUAL, 3823 02:41:19,200 --> 02:41:20,440 THE ACCRUAL RATES AS WELL AS THE 3824 02:41:20,440 --> 02:41:22,760 TIME AND THAT IS HOW WE 3825 02:41:22,760 --> 02:41:25,240 DEVELOPED OR ACTUALLY HOW KEVIN 3826 02:41:25,240 --> 02:41:27,800 DEVELOPED THE NEW STOPPING RULES 3827 02:41:27,800 --> 02:41:29,360 BECAUSE THEY SEEM TO BE 3828 02:41:29,360 --> 02:41:30,560 CONSISTENT WITH THE DATA THAT 3829 02:41:30,560 --> 02:41:32,160 WE'VE GENERATED. 3830 02:41:32,160 --> 02:41:34,320 MIND YOU, OVER TIME, AS WE 3831 02:41:34,320 --> 02:41:35,800 LAUNCH OTHER SCREENING TRIALS, 3832 02:41:35,800 --> 02:41:39,120 WE WILL RE-EVALUATE THEM AND 3833 02:41:39,120 --> 02:41:41,320 EXPLORE THEIR UTILITY AND 3834 02:41:41,320 --> 02:41:42,560 POTENTIALLY MODIFY THEM. 3835 02:41:42,560 --> 02:41:44,760 >>THANK YOU, LORI. 3836 02:41:44,760 --> 02:41:53,200 WE'VE GOT SOME HANDS UP. 3837 02:41:53,200 --> 02:41:54,720 >>FIRST OF ALL, I WANT TO 3838 02:41:54,720 --> 02:41:57,200 RECOGNIZE THE FANTASTIC WORK AND 3839 02:41:57,200 --> 02:41:58,240 THE DECISION ON TMIST MANY OF 3840 02:41:58,240 --> 02:42:00,960 IT'S SUPPOSE AN IMPORTANT TRIAL 3841 02:42:00,960 --> 02:42:02,400 AND I THINK THAT GUIDANCE HAS 3842 02:42:02,400 --> 02:42:08,520 BEEN INVALUABLE. 3843 02:42:08,520 --> 02:42:10,640 SO POSITIVE ASPECTS. 3844 02:42:10,640 --> 02:42:11,480 ONE THING I WANT TO HEAR A 3845 02:42:11,480 --> 02:42:15,400 LITTLE BIT MORE ABOUT, IT'S 3846 02:42:15,400 --> 02:42:18,160 FANTASTIC TO ENVISION THE CANCER 3847 02:42:18,160 --> 02:42:19,360 SCREENING NETWORK. 3848 02:42:19,360 --> 02:42:21,920 MY CONCERN IS HOW WILL THIS BE 3849 02:42:21,920 --> 02:42:23,640 INTEGRATED INTO THE OTHER 3850 02:42:23,640 --> 02:42:24,720 NETWORK STRUCTURES SO THAT WE 3851 02:42:24,720 --> 02:42:34,560 HAVE THE SINNER GEEZ SI SYNERGYE 3852 02:42:34,560 --> 02:42:36,800 PURPOSE OF SIMPLIFICATION AND 3853 02:42:36,800 --> 02:42:40,000 MAKING THINGS LESS COMPLEX. 3854 02:42:40,000 --> 02:42:42,360 >>THANK YOU, I'M HAPPY TO TAKE 3855 02:42:42,360 --> 02:42:43,440 THAT QUESTION AS WELL BECAUSE 3856 02:42:43,440 --> 02:42:46,480 I'M LEADING THAT EFFORT. 3857 02:42:46,480 --> 02:42:48,160 SO, THE CANCER SCREENING 3858 02:42:48,160 --> 02:42:50,680 RESEARCH NETWORK WILL USE THE 3859 02:42:50,680 --> 02:42:53,040 ENTIRE BACK END INFRASTRUCTURE 3860 02:42:53,040 --> 02:42:56,920 THAT NCTN AND NCORP USE. 3861 02:42:56,920 --> 02:42:58,520 THEY'LL USE THE REGISTRATION 3862 02:42:58,520 --> 02:43:01,720 PROCESS AND THE CENTRAL IRB AND 3863 02:43:01,720 --> 02:43:03,560 WE WILL, THE SCREENING NETWORK 3864 02:43:03,560 --> 02:43:06,240 WILL ALSO USE THE STEERING 3865 02:43:06,240 --> 02:43:07,520 COMMITTEE REVIEWS FOR CONCEPTS 3866 02:43:07,520 --> 02:43:09,960 AND SO MUCH OF THE PROCESS WILL 3867 02:43:09,960 --> 02:43:12,120 LOOK VERY SIMILAR AND HOWEVER, 3868 02:43:12,120 --> 02:43:16,360 BECAUSE THERE HAVE BEEN UNIQUE 3869 02:43:16,360 --> 02:43:26,840 CHALLENGE THIS IS RUNNING TA 3870 02:43:39,600 --> 02:43:42,480 BEING SAID, WE FULLY ENVISION 3871 02:43:42,480 --> 02:43:44,280 THAT THERE MAY BE CERTAIN 3872 02:43:44,280 --> 02:43:46,480 POPULATIONS THAT POTENTIALLY 3873 02:43:46,480 --> 02:43:48,080 OVERLAP OR THERE MAY BE A LAND 3874 02:43:48,080 --> 02:43:52,240 OFF AND YOU COULD SEE A STUDY IN 3875 02:43:52,240 --> 02:43:53,040 ASYMPTOMATIC INDIVIDUALS WHICH 3876 02:43:53,040 --> 02:43:56,280 WOULD BE PARTICULARLY SUCCESSFUL 3877 02:43:56,280 --> 02:43:58,400 IN A CANCER SCREENING RESEARCH 3878 02:43:58,400 --> 02:44:00,560 NETWORK BUT SAY A POPULATION OF 3879 02:44:00,560 --> 02:44:01,880 CANCER PATIENTS THAT ARE 3880 02:44:01,880 --> 02:44:05,840 LONG-TERM SURVIVORS MIGHT BE 3881 02:44:05,840 --> 02:44:09,280 BETTER EVALUATE INSIDE NCORP OR 3882 02:44:09,280 --> 02:44:10,160 NCTN MANY OF THERE'S AN 3883 02:44:10,160 --> 02:44:11,720 OPPORTUNITY NOW WITH THESE 3884 02:44:11,720 --> 02:44:13,280 INCREDIBLE TECHNOLOGIES TO 3885 02:44:13,280 --> 02:44:14,760 IDENTIFY EARLIER STAGE DISEASE 3886 02:44:14,760 --> 02:44:17,960 THAT WOULD BE RIPE FOR 3887 02:44:17,960 --> 02:44:18,920 PARTICIPANTS INTERESTED IN 3888 02:44:18,920 --> 02:44:20,480 CANCER PREVENTION AND 3889 02:44:20,480 --> 02:44:22,600 INTERCEPTION STUDIES SO WE 3890 02:44:22,600 --> 02:44:27,080 REALLY SEE THIS AS ANOTHER ARM 3891 02:44:27,080 --> 02:44:29,680 OF OUR RESEARCH TO EXTEND ALL OF 3892 02:44:29,680 --> 02:44:35,240 THE SUCCESS THAT WE'VE HAD IN 3893 02:44:35,240 --> 02:44:45,600 CLINICAL TRIALS TO NON 3894 02:44:52,800 --> 02:44:53,000 ONCOLOGIST. 3895 02:44:53,000 --> 02:44:54,920 >>THAT WAS A GREAT PRESENTATION 3896 02:44:54,920 --> 02:44:56,240 AND SCREENING TRIALS ARE SO 3897 02:44:56,240 --> 02:44:58,560 DIFFERENT SO PUTTING PARAMETERS 3898 02:44:58,560 --> 02:44:59,280 ON THERE. 3899 02:44:59,280 --> 02:45:00,920 I HAVE ONE COMMENT AND A 3900 02:45:00,920 --> 02:45:02,160 QUESTION ABOUT IT. 3901 02:45:02,160 --> 02:45:04,200 SO, I HEARD SOMETHING AT THE A 3902 02:45:04,200 --> 02:45:05,120 BIANCE MEETING THAT WAS JUST 3903 02:45:05,120 --> 02:45:07,480 KIND OF AN EYE OPENING 3904 02:45:07,480 --> 02:45:08,680 EXPERIENCE WHERE THEY MAPPED OUT 3905 02:45:08,680 --> 02:45:11,000 IN THE U.S. MAP YOU KNOW THE 3906 02:45:11,000 --> 02:45:12,440 HIGHEST INCIDENTS FROM MORTALITY 3907 02:45:12,440 --> 02:45:14,120 I THINK THEY WERE LOOKING AT OF 3908 02:45:14,120 --> 02:45:16,240 LUNG CANCER AND THEY MAPPED OUT 3909 02:45:16,240 --> 02:45:17,800 WHERE WE OPENED THE SCREENING 3910 02:45:17,800 --> 02:45:20,960 TRAILS AND THEY DID NOT OVERLAP. 3911 02:45:20,960 --> 02:45:23,000 SO, I'M WONDERING IF FOR SOME OF 3912 02:45:23,000 --> 02:45:25,840 THESE TRIALS, IF YOU ACTUALLY 3913 02:45:25,840 --> 02:45:29,760 MAP OUT THE INCIDENTS MORTALITY 3914 02:45:29,760 --> 02:45:31,800 AND THIS IS OUR CHANCE, I THINK 3915 02:45:31,800 --> 02:45:33,760 OF SCREENING TRIALS IS THAT 3916 02:45:33,760 --> 02:45:35,320 OPPORTUNITY TO REALLY GET OUT OF 3917 02:45:35,320 --> 02:45:37,880 THE NCTN NETWORKS AND REALLY GO 3918 02:45:37,880 --> 02:45:38,880 TO THE COMMUNITY BECAUSE THAT'S 3919 02:45:38,880 --> 02:45:41,200 WHERE YOU WANT IT TO BE MOST 3920 02:45:41,200 --> 02:45:42,320 SUCCESSFUL AND IF YOU ARE 3921 02:45:42,320 --> 02:45:46,360 LOOKING INTO ANY OF THOSE IDEAS 3922 02:45:46,360 --> 02:45:49,440 AS WELL MATCHING. 3923 02:45:49,440 --> 02:45:51,960 >>WE HAVE ALL KINDS OF 3924 02:45:51,960 --> 02:45:53,280 OPPORTUNITIES WITH A BRAND NEW 3925 02:45:53,280 --> 02:45:56,360 NETWORK TO EXPLORE, INNOVATIVE 3926 02:45:56,360 --> 02:46:00,160 WAYS OF COMMUNICATING, OF 3927 02:46:00,160 --> 02:46:01,120 REACHING OUT. 3928 02:46:01,120 --> 02:46:03,040 THE NOTICE OF INTENT TO PUBLISH 3929 02:46:03,040 --> 02:46:11,520 IS CURRENT LELY ON OUR WEBSITE. 3930 02:46:11,520 --> 02:46:13,000 IN ADDITION, THERE WILL BE 3931 02:46:13,000 --> 02:46:14,800 DIFFERENT REQUIREMENTS FOR THE 3932 02:46:14,800 --> 02:46:20,200 COR TCOORDINATING CENTER AND THE 3933 02:46:20,200 --> 02:46:22,120 STATISTICAL CENTER. 3934 02:46:22,120 --> 02:46:23,960 THEY'LL BE FAMILIAR BUT LOOK 3935 02:46:23,960 --> 02:46:24,200 DIFFERENT. 3936 02:46:24,200 --> 02:46:25,160 THE EXPERIENCE WE'VE HAD WITH 3937 02:46:25,160 --> 02:46:28,120 THE SCREENING TRIALS HAS ALSO 3938 02:46:28,120 --> 02:46:30,880 LED US TO THE DEVELOPMENT OF THE 3939 02:46:30,880 --> 02:46:35,440 NEW PILOT AND FEASIBILITY 3940 02:46:35,440 --> 02:46:39,640 MECHANISM, THE U-34, R-34 WAS 3941 02:46:39,640 --> 02:46:41,800 NOT USED BY NCI AT ALL BUT 3942 02:46:41,800 --> 02:46:42,480 THROUGH THE EXPERIENCE OF A 3943 02:46:42,480 --> 02:46:44,600 COUPLE OF THE CANCER CONTROL 3944 02:46:44,600 --> 02:46:46,520 STUDIES AND OTHER INSTITUTES 3945 02:46:46,520 --> 02:46:48,760 WE'VE IMPLEMENTED IT NOW AND 3946 02:46:48,760 --> 02:46:55,840 WE'VE HAD SOME REALLY ROBUST 3947 02:46:55,840 --> 02:46:59,600 RESPONSES TO MECHANISMS SO WE'RE 3948 02:46:59,600 --> 02:47:01,480 SEEING IDEAS IN THIS FACE FOR 3949 02:47:01,480 --> 02:47:02,920 WHAT WE'VE LEARNED FROM COVID 3950 02:47:02,920 --> 02:47:08,480 PUT INTO PLACE. 3951 02:47:08,480 --> 02:47:09,640 >>CAROLYN. 3952 02:47:09,640 --> 02:47:11,520 I JUST WANT TO SAY, YOU KNOW, 3953 02:47:11,520 --> 02:47:12,720 THE SCREENING TRIALS ARE 3954 02:47:12,720 --> 02:47:14,800 CRITICAL AND I WANT TO PIGGYBACK 3955 02:47:14,800 --> 02:47:19,840 ON WHAT LORI SAID IS THAT WHEN 3956 02:47:19,840 --> 02:47:21,800 WE DO THESE TRIALS, OUR 3957 02:47:21,800 --> 02:47:23,480 COMMITMENT IN THE TRIALS OF 3958 02:47:23,480 --> 02:47:27,000 ONCOLOGY WE'RE ALL VERY MUCH 3959 02:47:27,000 --> 02:47:30,960 PASSIONATE ABOUT DOING THAT BUT 3960 02:47:30,960 --> 02:47:33,560 WHEN WE GO OUTSIDE TO THE 3961 02:47:33,560 --> 02:47:37,680 COMMUNITY AND NON CONIOLOGY AND 3962 02:47:37,680 --> 02:47:42,080 RADIOLOGY FIRST GREETING FOR JOY 3963 02:47:42,080 --> 02:47:43,800 AND 008 ALL THESE TYPE OF TRIALS 3964 02:47:43,800 --> 02:47:46,120 IT TAKES QUITE A BIT OF TIME TO 3965 02:47:46,120 --> 02:47:48,200 ENGAGE THE STAKEHOLDERS AND TO 3966 02:47:48,200 --> 02:47:50,200 GET BUY IN AND TO DEVELOP WORK 3967 02:47:50,200 --> 02:47:54,600 FLOW PROCESSES AND WHAT WE TO 3968 02:47:54,600 --> 02:47:59,040 WELL IS WE HEAR WHAT WORKS AT 3969 02:47:59,040 --> 02:48:00,360 OTHER CENTERS AND WE CHANGE THE 3970 02:48:00,360 --> 02:48:02,480 GAME TO GET THIS ALL TO WORK SO 3971 02:48:02,480 --> 02:48:06,680 I JUST WANT TO MAKE A SUGGESTION 3972 02:48:06,680 --> 02:48:10,680 AS THE EVALUATION IN THOSE FOUR 3973 02:48:10,680 --> 02:48:12,520 STEPS IN FEASIBILITY AND 3974 02:48:12,520 --> 02:48:15,000 STOPPING OF SCREENING TRIALS 3975 02:48:15,000 --> 02:48:18,400 THAT WE KIND OF ALSO VALUE WAIT 3976 02:48:18,400 --> 02:48:22,360 WHAT IT TAKES TO GET THAT 3977 02:48:22,360 --> 02:48:24,280 STARTED BECAUSE WE CAN PUT A LOT 3978 02:48:24,280 --> 02:48:27,680 OF EFFORT GETTING THE WORKFLOWS 3979 02:48:27,680 --> 02:48:28,960 DONE AND THIS COULD HAPPEN IN 3980 02:48:28,960 --> 02:48:31,040 ALL OF THESE SITES AND THE TRIAL 3981 02:48:31,040 --> 02:48:34,360 GETS PULLED BACK POSSIBLY SO, 3982 02:48:34,360 --> 02:48:36,400 THAT IS JUST KIND OF A CRITICAL 3983 02:48:36,400 --> 02:48:40,200 ISSUE WITH GETTING THESE 3984 02:48:40,200 --> 02:48:40,440 STARTED. 3985 02:48:40,440 --> 02:48:42,000 >>THANK YOU. 3986 02:48:42,000 --> 02:48:44,360 I'LL GIVE YOU THE LAST WORD 3987 02:48:44,360 --> 02:48:44,560 HERE. 3988 02:48:44,560 --> 02:48:46,920 >>I THINK THERE ARE TWO THINGS 3989 02:48:46,920 --> 02:48:48,520 THAT WE NEED TO KEEP IN MIND 3990 02:48:48,520 --> 02:48:50,000 THAT THERE ARE STILL SO MANY 3991 02:48:50,000 --> 02:48:51,040 PARTS OF THE COUNTRY WHERE 3992 02:48:51,040 --> 02:48:52,520 THEY'RE JUST NOTTEN GAGED IN 3993 02:48:52,520 --> 02:48:55,440 RESEARCH SO I THINK WE NEED TO 3994 02:48:55,440 --> 02:48:58,280 FOCUS TIME ON TRYING TO CHANGE 3995 02:48:58,280 --> 02:49:00,240 THE CULTURE PEOPLE WHO ARE 3996 02:49:00,240 --> 02:49:01,800 GRAINED AND NOT EXPERIENCING 3997 02:49:01,800 --> 02:49:02,680 CLINICAL TRIALS AND IT'S NOT 3998 02:49:02,680 --> 02:49:13,120 GOING TO HAPPEN OVERNIGHT. 3999 02:49:15,920 --> 02:49:17,040 NOR TO THEY HAVE ACCESS. 4000 02:49:17,040 --> 02:49:18,680 THE MONEY WILL BE LIMITED BUT WE 4001 02:49:18,680 --> 02:49:20,600 CAN'T FORGET ABOUT SMALLER PLACE 4002 02:49:20,600 --> 02:49:23,520 AND SOME ARE FANTASTIC IN 4003 02:49:23,520 --> 02:49:25,520 ENROLLING AND OTHER AREAS WHERE 4004 02:49:25,520 --> 02:49:26,960 WE LOVE TO HAVE GETTING INTO 4005 02:49:26,960 --> 02:49:29,240 THEM SO THEY CAN HAVE ACCESS THE 4006 02:49:29,240 --> 02:49:30,720 SAME ACCESS AS OTHER PLAYERS 4007 02:49:30,720 --> 02:49:37,840 THAT TO WELL THROUGHOUT THE 4008 02:49:37,840 --> 02:49:38,880 COUNTRY. 4009 02:49:38,880 --> 02:49:41,160 MOVING ON TO THE NEXT IDEA WHICH 4010 02:49:41,160 --> 02:49:46,360 IS A PRESENTATION AND DISCUSSION 4011 02:49:46,360 --> 02:49:48,560 OF THE GASTRIC CANCERS WORKING 4012 02:49:48,560 --> 02:49:51,000 GROUP REPORT WHICH THE MEMBERS 4013 02:49:51,000 --> 02:49:52,840 HAVE HAD THE OPPORTUNITY TO 4014 02:49:52,840 --> 02:49:55,920 REVIEW AND THIS SESSION WILL BE 4015 02:49:55,920 --> 02:50:00,080 LED BY INTEREST KAREN GOODMAN 4016 02:50:00,080 --> 02:50:03,080 THE PROFESSOR AND DEPARTMENT OF 4017 02:50:03,080 --> 02:50:07,360 RADIATION ONCOLOGY AT THE ICON 4018 02:50:07,360 --> 02:50:14,120 SCHOOL OF MEDICINE AND Dr. 4019 02:50:14,120 --> 02:50:17,760 NEIL RUSTGI. 4020 02:50:17,760 --> 02:50:20,080 SO, I DON'T KNOW WHO WILL GO 4021 02:50:20,080 --> 02:50:24,320 FIRST AND TAKE IT AWAY KAREN AND 4022 02:50:24,320 --> 02:50:26,400 A KNEEL >>THANK YOU SO MUCH, 4023 02:50:26,400 --> 02:50:28,840 EVERYBODY. 4024 02:50:28,840 --> 02:50:30,680 Dr. GOODMAN IS AWAY AT A 4025 02:50:30,680 --> 02:50:32,080 MEETING WHICH REQUIRED HER 4026 02:50:32,080 --> 02:50:34,680 MANDATORY ATTENDANCE SO I WILL 4027 02:50:34,680 --> 02:50:36,040 PRESENT ON OUR COLLECTIVE BEHALF 4028 02:50:36,040 --> 02:50:38,840 AND MOST IMPORTANTLY, I WANT TO 4029 02:50:38,840 --> 02:50:40,280 AGO KNOWLEDGE THE DIFFERENT 4030 02:50:40,280 --> 02:50:42,480 WORKING GROUPS THAT ARE LIVED TO 4031 02:50:42,480 --> 02:50:44,400 WHEN THE NCI STAFF BECAUSE 4032 02:50:44,400 --> 02:50:45,480 WITHOUT THEIR EFFORT THIS REPORT 4033 02:50:45,480 --> 02:50:50,760 WOULD NOT HAVE BEEN POSSIBLE I 4034 02:50:50,760 --> 02:50:52,160 WILL PROMPT THE TEAM TO ADVANCE 4035 02:50:52,160 --> 02:50:53,640 THE SLIDESMENT NEXT SLIDE. 4036 02:50:53,640 --> 02:50:57,720 SO OUR OVERVIEW IS BRIEF. 4037 02:50:57,720 --> 02:51:00,800 THE EPIDEMIOLOGY RECOGNIZING 4038 02:51:00,800 --> 02:51:02,480 THAT TOPIC ALONE FOR CANCER 4039 02:51:02,480 --> 02:51:06,160 COULD BE EXTENDED FOR A LONG 4040 02:51:06,160 --> 02:51:08,600 PERIOD OF TIME AND WE'LL TALK 4041 02:51:08,600 --> 02:51:10,680 ABOUT THE WORKING GROUP BACK 4042 02:51:10,680 --> 02:51:13,120 GROUND AND THE PROCESS AND THAT 4043 02:51:13,120 --> 02:51:15,960 LED TO THIS REPORT WITH A SERIES 4044 02:51:15,960 --> 02:51:21,200 OF RECOMMENDATIONS THAT I'LL 4045 02:51:21,200 --> 02:51:28,120 ELABORATE UPON AND THE SPECIFIC 4046 02:51:28,120 --> 02:51:28,320 RACE? 4047 02:51:28,320 --> 02:51:30,520 THE NEXT 25 MINUTES AND I WILL 4048 02:51:30,520 --> 02:51:34,080 RECOMMEND YOUR QUESTIONS AND 4049 02:51:34,080 --> 02:51:36,920 COMMENTS. 4050 02:51:36,920 --> 02:51:43,480 SO, GASTRIC CANCER AND ACCOUNTS 4051 02:51:43,480 --> 02:51:46,360 FOR GASTRIC ACCOUNTS FOR MOST 4052 02:51:46,360 --> 02:51:49,720 GAS TICK CANCER. 4053 02:51:49,720 --> 02:51:50,000 95%. 4054 02:51:50,000 --> 02:51:54,040 THE REMAINING IS HODGKINS 4055 02:51:54,040 --> 02:51:56,840 LYMPHOMA OR NON HODGKINS 4056 02:51:56,840 --> 02:51:57,120 LYMPHOMA. 4057 02:51:57,120 --> 02:52:01,120 IN THE UNITED STATES AS OF 2022, 4058 02:52:01,120 --> 02:52:03,160 IT'S ESTIMATED THERE WILL BE 4059 02:52:03,160 --> 02:52:11,520 26,000 NEW CASES TRIGGERING 4060 02:52:11,520 --> 02:52:12,160 11,100 DEATHS. 4061 02:52:12,160 --> 02:52:13,400 100 YEARS IN THE UNITED STATES, 4062 02:52:13,400 --> 02:52:16,920 IT WAS THE MOST COMMON CANCER IN 4063 02:52:16,920 --> 02:52:18,640 THE UNITED STATES AND IF YOU 4064 02:52:18,640 --> 02:52:20,200 LOOK INTERNATIONALLY, IT REALLY 4065 02:52:20,200 --> 02:52:23,640 IS A GLOBAL PROBLEM. 4066 02:52:23,640 --> 02:52:28,440 THERE ARE OVER 1 MILLION CASES 4067 02:52:28,440 --> 02:52:30,520 EVERY YEAR AND NOT 80,000 DEATHS 4068 02:52:30,520 --> 02:52:33,480 SO IT'S THE FIFTH MOST COMMON 4069 02:52:33,480 --> 02:52:37,160 CANCER WORLDWIDE AND THE THIRD 4070 02:52:37,160 --> 02:52:39,200 LEADING CAUSE OF CANCER RELATED 4071 02:52:39,200 --> 02:52:40,640 MORTALITY WORLDWIDE. 4072 02:52:40,640 --> 02:52:45,360 WHILE THE PER PONDERANCE ARE 4073 02:52:45,360 --> 02:52:47,320 SPORADIC IN NATURE, 10% OR LESS 4074 02:52:47,320 --> 02:52:53,240 ARE MER HE HEREDITARY IN NATURD 4075 02:52:53,240 --> 02:52:59,120 THERE'S A DISORDER CALLED GERM 4076 02:52:59,120 --> 02:53:05,400 LINE MUTATIONS AND BUT FOR THE 4077 02:53:05,400 --> 02:53:08,360 SPORADIC SUPPOSE TYPE, DIFFUSED, 4078 02:53:08,360 --> 02:53:12,000 IT'S ASSOCIATED WITH INFECTION 4079 02:53:12,000 --> 02:53:16,840 WITH HPYLORI, AN ORGANISM IN 4080 02:53:16,840 --> 02:53:17,680 2 BILLION INDIVIDUALS IN THE 4081 02:53:17,680 --> 02:53:18,960 UNITED STATES AND THE WORLD 4082 02:53:18,960 --> 02:53:21,240 HEALTH ORGANIZATION, CLASSIFIED 4083 02:53:21,240 --> 02:53:25,680 IT AS A CLASS 1 CARCINOGEN AND 4084 02:53:25,680 --> 02:53:27,320 DIETARY FACTORS SUCH AS 4085 02:53:27,320 --> 02:53:31,520 NUTRITIONAL DEFICIENCIES, LOW 4086 02:53:31,520 --> 02:53:32,880 FRUIT, CIGARETTE SMOKING, ANEMIA 4087 02:53:32,880 --> 02:53:38,280 WHICH LEADS TO ABLATION OF ACID 4088 02:53:38,280 --> 02:53:39,960 PRODUCING CELLS ARE OTHER RISK 4089 02:53:39,960 --> 02:53:42,920 FACTORS AND THEY OFTEN ACT IN 4090 02:53:42,920 --> 02:53:43,600 COMBINATION. 4091 02:53:43,600 --> 02:53:48,080 SO, WHILE CLASSICALLY, IT WAS 4092 02:53:48,080 --> 02:53:53,480 SUB TYPED INTO TWO INTESTINAL 4093 02:53:53,480 --> 02:53:54,240 TYPE. 4094 02:53:54,240 --> 02:53:56,400 GENOMIC SEQUENCES, TRANSRIPTOME 4095 02:53:56,400 --> 02:53:59,880 I CAN PROFILING HAS LEFT TO A 4096 02:53:59,880 --> 02:54:02,080 MOLECULAR SUB CLASSIFICATION TO 4097 02:54:02,080 --> 02:54:12,680 FOUR SUBTYPES LISTED AND IT REMS 4098 02:54:23,560 --> 02:54:27,240 LOW AT ABOUT 30% AND THE 4099 02:54:27,240 --> 02:54:31,360 DIFFUSED SUBTYPE IS DECREASING 4100 02:54:31,360 --> 02:54:34,040 IN YOUNG CAUCASIAN FEMALES. 4101 02:54:34,040 --> 02:54:38,800 THERE ARE TWO MAJOR SUBTYPES. 4102 02:54:38,800 --> 02:54:43,080 IF YOU AGGREGATE IT, SIMILAR TO 4103 02:54:43,080 --> 02:54:44,920 GAS TICK CANCER, ABOUT 20,000 4104 02:54:44,920 --> 02:54:47,200 NEW CASES ANNUALLY IN THE UNITED 4105 02:54:47,200 --> 02:54:49,600 STATES AND 11,000 DEATHS BUT 4106 02:54:49,600 --> 02:54:51,000 GLOBALLY SPEAKING, THE NUMBERS 4107 02:54:51,000 --> 02:54:56,240 ARE STAGGERING. 4108 02:54:56,240 --> 02:54:58,640 OVER 600,000 CASES WORLDWIDE, 4109 02:54:58,640 --> 02:55:01,200 PROJECTED TO BE 1 MILLION BY THE 4110 02:55:01,200 --> 02:55:03,760 YEAR 2040 AND 540,000 DEATHS 4111 02:55:03,760 --> 02:55:10,040 RELATED TO E.S.O. PHAGEAL 4112 02:55:10,040 --> 02:55:14,360 CANCER, SO CAME US CELL CANCER 4113 02:55:14,360 --> 02:55:16,240 IS ASSOCIATED WITH CIGARETTE 4114 02:55:16,240 --> 02:55:26,600 SMOKING ASK ALCOHOL. 4115 02:55:32,000 --> 02:55:34,960 ADDEN OWE CARCINOMA INCREASING 4116 02:55:34,960 --> 02:55:37,160 IN THE, S. AND WESTERN EUROPE 4117 02:55:37,160 --> 02:55:39,480 WITH CENTRAL ADD POS TEE AND 4118 02:55:39,480 --> 02:55:44,320 CHRONIC ACID REFLUX MORE COMMON 4119 02:55:44,320 --> 02:55:46,040 IN THE JUNCTION AND IT'S PRE 4120 02:55:46,040 --> 02:55:49,760 CURSE SER THE WELL DEFINED 4121 02:55:49,760 --> 02:55:52,000 PATHOLOGIC ENTITY CALLED 4122 02:55:52,000 --> 02:55:56,800 BARRETT'S H H H ESOPHAGEUS. 4123 02:55:56,800 --> 02:56:07,320 GLOBALLY ESCC IS MORE COMMON AND 4124 02:56:09,360 --> 02:56:13,800 THIS IS IN A SETTING OR AGE 4125 02:56:13,800 --> 02:56:17,040 HAVEN'T SO WITH THIS PREAMBLE 4126 02:56:17,040 --> 02:56:20,120 AND THE RECOGNITION THAT GASTRIC 4127 02:56:20,120 --> 02:56:23,120 AND HE IS SOF FEAL CANCER ARE 4128 02:56:23,120 --> 02:56:33,800 LETHAL AND FORCE SURVIVAL, SURVR 4129 02:56:38,640 --> 02:56:43,480 SHIPS OF THESE CANCERS SO, THE 4130 02:56:43,480 --> 02:56:45,760 NCI FORMED OUR WORKING GROUP TO 4131 02:56:45,760 --> 02:56:48,080 HELP IDENTIFY STRATEGIES THAT 4132 02:56:48,080 --> 02:56:51,120 ARE IMPACTFUL IN THE CONTEXT OF 4133 02:56:51,120 --> 02:56:52,600 TRANSLATIONAL RESEARCH TO 4134 02:56:52,600 --> 02:56:55,120 ADVANCE PREVENTION, DIAGNOSIS, 4135 02:56:55,120 --> 02:56:57,160 EARLY DETECTION AND TREATMENT OF 4136 02:56:57,160 --> 02:57:02,280 THESE UPPER G.I. CANCERS. 4137 02:57:02,280 --> 02:57:07,200 SO, MY CO-CHAIR IS Dr. GOODMAN 4138 02:57:07,200 --> 02:57:10,520 AND A GROUP OF WORKING MEMBERS 4139 02:57:10,520 --> 02:57:14,920 AND A LOT OF HELP FROM THE NCI 4140 02:57:14,920 --> 02:57:15,920 COLLEAGUES AND STAFF. 4141 02:57:15,920 --> 02:57:17,480 IT WOULD NOT HAVE BEEN POSSIBLE 4142 02:57:17,480 --> 02:57:20,880 WITHOUT THIS COLLECTIVE SPIRIT 4143 02:57:20,880 --> 02:57:23,320 AND COLLECTIVE EFFORT. 4144 02:57:23,320 --> 02:57:27,120 OUR MISSION WAS TO SURVEY THE 4145 02:57:27,120 --> 02:57:29,440 SCIENTIFIC HORIZONS IN A 4146 02:57:29,440 --> 02:57:31,160 HOLISTIC FASHION, VERY BROADLY 4147 02:57:31,160 --> 02:57:36,040 SPEAKING TO IDENTIFY WHAT IS 4148 02:57:36,040 --> 02:57:37,640 KNOWN AND AT THE SAME TIME TO 4149 02:57:37,640 --> 02:57:39,000 IDENTIFY GAPS. 4150 02:57:39,000 --> 02:57:42,200 AND TO TAKE THE POWER OF 4151 02:57:42,200 --> 02:57:44,600 TRANSLATIONAL RESEARCH TO FILL 4152 02:57:44,600 --> 02:57:45,360 THESE GAPS. 4153 02:57:45,360 --> 02:57:52,440 AND TO A REPLY NEW TECHNOLOGIES 4154 02:57:52,440 --> 02:57:59,520 TO FOR THE TRANSLATIONAL 4155 02:57:59,520 --> 02:58:03,240 RESEARCH AND ESCR AND 4156 02:58:03,240 --> 02:58:05,160 RECOGNIZING LYMPHOMA AND SOME 4157 02:58:05,160 --> 02:58:08,880 OTHER UPPER BI CANCERS ARE 4158 02:58:08,880 --> 02:58:12,800 UNCOMMON SO WE DIDN'T FOCUS TOO 4159 02:58:12,800 --> 02:58:20,200 MUCH ON THOSE SUBTYPES. 4160 02:58:20,200 --> 02:58:22,280 WE MET A YEAR AGO AND WE WERE 4161 02:58:22,280 --> 02:58:26,000 CHARGED BY Dr. SHARPLESS, WE 4162 02:58:26,000 --> 02:58:29,280 HAD A AN EXTENSIVE REVIEW OF THE 4163 02:58:29,280 --> 02:58:33,320 EXISTING NCI BRANT PORTFOLIO FOR 4164 02:58:33,320 --> 02:58:35,400 UPPER GI CANCERS AND THE 4165 02:58:35,400 --> 02:58:40,160 PORTFOLIO FOR UPPER GI CANCERS 4166 02:58:40,160 --> 02:58:41,600 AND WE THEN MET WITH THE WORKING 4167 02:58:41,600 --> 02:58:46,680 GROUP AND WE DIVIDED THEM INTO 4168 02:58:46,680 --> 02:58:51,360 SUPPOSE GROUPS AND MEETINGS 4169 02:58:51,360 --> 02:58:53,280 THERE WAS A FOLLOW-UP MEETING IN 4170 02:58:53,280 --> 02:58:55,640 JUNE AND BASED UPON DISCUSSIONS, 4171 02:58:55,640 --> 02:58:57,800 REPORT BACK, RECOMMENDATIONS, 4172 02:58:57,800 --> 02:59:02,120 AND MODIFICATIONS OF THOSE 4173 02:59:02,120 --> 02:59:03,440 RECOMMENDATIONS WE WENT THROUGH 4174 02:59:03,440 --> 02:59:06,440 SEVERAL ITERATIONS OF A REPORT 4175 02:59:06,440 --> 02:59:08,000 AND THAT CULMINATED IN THE 4176 02:59:08,000 --> 02:59:09,920 REPORT THAT IS IN YOUR HANDS AND 4177 02:59:09,920 --> 02:59:15,880 THAT I'M SUMMARIZING IN THIS 4178 02:59:15,880 --> 02:59:16,280 PRESENTATION. 4179 02:59:16,280 --> 02:59:19,800 SO THE SUB GROUPS WERE FOUR IN 4180 02:59:19,800 --> 02:59:20,200 NUMBER. 4181 02:59:20,200 --> 02:59:23,080 THE FIRST RELATED TO OMICS. 4182 02:59:23,080 --> 02:59:27,480 FUNCTIONAL GENOMICS, 4183 02:59:27,480 --> 02:59:28,680 TRANSCRIPTOMIC, METABOLOMICS, 4184 02:59:28,680 --> 02:59:32,120 LED BY INTEREST SANDY MARCOWITS 4185 02:59:32,120 --> 02:59:32,960 AT CASE WESTERN. 4186 02:59:32,960 --> 02:59:34,680 THE SECOND GROUP, THE MODEL 4187 02:59:34,680 --> 02:59:40,120 SYSTEMS WHAT DO I MEAN BY THAT? 4188 02:59:40,120 --> 02:59:42,360 IT'S MOUSE TO HUMAN. 4189 02:59:42,360 --> 02:59:49,960 MOUSE MODEL, GENETIC, NON 4190 02:59:49,960 --> 02:59:59,800 GENETIC, HUMAN TISSUE AND AIM AG 4191 02:59:59,800 --> 03:00:04,440 FROM MOUSE TO HUMAN THIS WAS LED 4192 03:00:04,440 --> 03:00:09,440 AT VANDER. 4193 03:00:09,440 --> 03:00:12,200 COUNTRIES WHERE UPPER G.I. 4194 03:00:12,200 --> 03:00:16,360 CANCER ARE ENDEMIC AND HIGH-RISK 4195 03:00:16,360 --> 03:00:17,200 IN THE UNITED STATES. 4196 03:00:17,200 --> 03:00:20,880 LED BY MARCIA CRUZ-KOREA THE 4197 03:00:20,880 --> 03:00:21,960 EXECUTIVE OF THE CANCER CENTER 4198 03:00:21,960 --> 03:00:23,800 AT THE UNIVERSITY OF PUERTO RICO 4199 03:00:23,800 --> 03:00:28,080 AND THEN, FINISHING IN PARALLEL 4200 03:00:28,080 --> 03:00:31,240 TREATMENT, MOLECULAR COREL TIVE 4201 03:00:31,240 --> 03:00:33,200 STUDIES AND ENABLING 4202 03:00:33,200 --> 03:00:35,240 TECHNOLOGIES SUCH AS RADIO OMICS 4203 03:00:35,240 --> 03:00:37,760 AND IMPORTANT COM UPON ANT OF 4204 03:00:37,760 --> 03:00:46,480 THIS BY OWE BANKING LET BY Dr. 4205 03:00:46,480 --> 03:00:46,680 IKBAL. 4206 03:00:46,680 --> 03:00:48,520 I HAVE THE FOUR WORKING GROUPS 4207 03:00:48,520 --> 03:00:55,560 AND HOPE THAT IT MAKES SENSE TO 4208 03:00:55,560 --> 03:00:58,400 YOU. 4209 03:00:58,400 --> 03:01:01,320 WE WANTED TO GET A GOOD SENSE, A 4210 03:01:01,320 --> 03:01:03,280 DEEP SENSE OF THE CURRENT 4211 03:01:03,280 --> 03:01:06,120 LANDSCAPE AND EVALUATE AVAILABLE 4212 03:01:06,120 --> 03:01:08,200 TARGETED AND IMMUNO THERAPEUTIC 4213 03:01:08,200 --> 03:01:10,040 DRUGS THAT HAVE HAD MODEST 4214 03:01:10,040 --> 03:01:12,960 IMPACT SO FAR IN TREATMENT OF 4215 03:01:12,960 --> 03:01:14,680 UPPER G.I. CANCERS. 4216 03:01:14,680 --> 03:01:16,920 WE WANTED TO ALSO ASSESS THE 4217 03:01:16,920 --> 03:01:18,920 COST AND INVASIVENESS OF 4218 03:01:18,920 --> 03:01:21,480 EXISTING ASSESSMENT MODALITIES 4219 03:01:21,480 --> 03:01:23,320 WHICH REALLY ARE NOT ABLE TO BE 4220 03:01:23,320 --> 03:01:25,600 A PLAYED TO THE AVERAGE RISK 4221 03:01:25,600 --> 03:01:28,040 GENERAL POPULATION AND MOST 4222 03:01:28,040 --> 03:01:30,160 COUNTRIES, SOME COUNTRIES, YES 4223 03:01:30,160 --> 03:01:31,320 BUT THERE'S RE SOURCE 4224 03:01:31,320 --> 03:01:32,560 RESTRICTION IN THOSE COUNTRIES 4225 03:01:32,560 --> 03:01:35,240 AND WHAT IS OUR PROGRESS ON 4226 03:01:35,240 --> 03:01:36,840 PREVENTION? 4227 03:01:36,840 --> 03:01:43,880 ESPECIALLY FOR H PYLORI 4228 03:01:43,880 --> 03:01:44,360 INFECTION? 4229 03:01:44,360 --> 03:01:47,160 OUR WORKING GROUP CONCLUDED, 4230 03:01:47,160 --> 03:01:49,880 THIS IS NOW AGAIN, FROM AN 4231 03:01:49,880 --> 03:01:51,240 OVERARCHING VIEWPOINT, THAT WE 4232 03:01:51,240 --> 03:01:53,400 SHOULD FOCUS ON BUILDING A MORE 4233 03:01:53,400 --> 03:01:56,720 ROBUST PIPELINE OF TRANSLATIONAL 4234 03:01:56,720 --> 03:01:57,080 OPPORTUNITIES. 4235 03:01:57,080 --> 03:01:59,360 SO SOMEWHAT MORE TARGETED IN 4236 03:01:59,360 --> 03:02:00,960 NATURE AND WE SHOULD ADDRESS 4237 03:02:00,960 --> 03:02:08,360 BOTH ENABLING RESOURCES, 4238 03:02:08,360 --> 03:02:09,480 INFRASTRUCTURE, IN FLOWERS AND 4239 03:02:09,480 --> 03:02:11,880 GOALS THAT ARE ACHIEVABLE AND SO 4240 03:02:11,880 --> 03:02:13,240 THAT INVOLVES STRENGTHENING OUR 4241 03:02:13,240 --> 03:02:17,480 KEY ENABLING RESOURCES AND TOOLS 4242 03:02:17,480 --> 03:02:20,280 AND TO IDENTIFY NEW BIOMARKERS 4243 03:02:20,280 --> 03:02:21,080 AND THEY ARE PEWS I CAN TARGETS 4244 03:02:21,080 --> 03:02:22,960 AND INTERVENTIONS BOTH INVASIVE 4245 03:02:22,960 --> 03:02:27,320 AND NON-INVASIVE APPLY THIS TO 4246 03:02:27,320 --> 03:02:28,560 APPROPRIATE POPULATIONS WITH 4247 03:02:28,560 --> 03:02:31,800 SUFFICIENT PROMISE TO JUSTIFY 4248 03:02:31,800 --> 03:02:35,560 THESE FOCUS TRANSLATIONAL 4249 03:02:35,560 --> 03:02:37,680 EFFORTS. 4250 03:02:37,680 --> 03:02:40,600 SO, WE WISH TO BUILD 4251 03:02:40,600 --> 03:02:42,120 REPOSITORIES OF WELL 4252 03:02:42,120 --> 03:02:43,280 CHARACTERIZED BY OWE SPECIMENS 4253 03:02:43,280 --> 03:02:49,440 AND MODEL SYSTEMS THAT WOULD 4254 03:02:49,440 --> 03:02:50,440 REALLY UNIFY INVESTIGATORS 4255 03:02:50,440 --> 03:02:52,560 CLINICAL ACROSS THE COUNTRY AND 4256 03:02:52,560 --> 03:02:59,320 HOPEFULLY GLOBALLY EVENTUALLY 4257 03:02:59,320 --> 03:03:00,920 ACROSS DIVERSE POPULATIONS. 4258 03:03:00,920 --> 03:03:02,160 WE FURTHER DEVELOP THESE TOOLS 4259 03:03:02,160 --> 03:03:04,960 AND OR ANALYTIC TOOLS 4260 03:03:04,960 --> 03:03:06,880 COMPUTATIONAL METHODS TO 4261 03:03:06,880 --> 03:03:08,920 CHARACTERIZE THE UNDERLYING THE 4262 03:03:08,920 --> 03:03:09,920 PATHO PHYSICAL LOGIC PROCESSES 4263 03:03:09,920 --> 03:03:11,960 AND WE SEEK TO IDENTIFY 4264 03:03:11,960 --> 03:03:14,640 ACTIONABLE MARGARET AND TARGETS 4265 03:03:14,640 --> 03:03:16,760 AND DEVELOP CLINICAL ASSESSMENT 4266 03:03:16,760 --> 03:03:21,600 TOOLS AND INTERVENTIONS AND FROM 4267 03:03:21,600 --> 03:03:25,480 PREVENTION AND SCREENING AND 4268 03:03:25,480 --> 03:03:25,840 SURVEILLANCE. 4269 03:03:25,840 --> 03:03:28,600 SPECIFIC RECOMMENDATIONS, BY A 4270 03:03:28,600 --> 03:03:31,320 SPECIMEN REPOSITORY AND RESEARCH 4271 03:03:31,320 --> 03:03:32,920 TOOLS WHICH LAYS THE FOUNDATION 4272 03:03:32,920 --> 03:03:35,720 FOR CURRENT AND FUTURE RESEARCH 4273 03:03:35,720 --> 03:03:37,160 DIRECTIONS, FOR IN SIGHTS INTO 4274 03:03:37,160 --> 03:03:39,440 UNDERLYING MECHANISMS AND 4275 03:03:39,440 --> 03:03:41,400 APPLICATIONS TO PREVENTION AND 4276 03:03:41,400 --> 03:03:44,280 TREATMENT. 4277 03:03:44,280 --> 03:03:46,960 NEXT SLIDE, NEXT SLIDE. 4278 03:03:46,960 --> 03:03:51,800 SO WHAT TO WE MEAN BY 4279 03:03:51,800 --> 03:03:54,480 BIOSPECIMEN REPOSITORY. 4280 03:03:54,480 --> 03:03:55,680 BIOSPECIMENS WOULD DEFINE 4281 03:03:55,680 --> 03:03:57,520 DISEASE RELATED CHARACTERISTICS 4282 03:03:57,520 --> 03:03:59,280 ARE CRITICAL ENABLING RESOURCES 4283 03:03:59,280 --> 03:04:01,240 FOR THE RESEARCH NEDDED TO 4284 03:04:01,240 --> 03:04:03,400 IDENTIFY BIOMARKERS FOR RISK 4285 03:04:03,400 --> 03:04:05,600 RATIFICATION AND NEW TARGETS FOR 4286 03:04:05,600 --> 03:04:07,400 THERAPEUTIC INTERVENTIONS BOTH 4287 03:04:07,400 --> 03:04:09,600 CONVENTIONAL THERAPEUTICS AND 4288 03:04:09,600 --> 03:04:13,640 REAPPLICATION OF CONVENTION AS 4289 03:04:13,640 --> 03:04:15,480 WELL AS IF YOU THERAPEUTICS AND 4290 03:04:15,480 --> 03:04:22,240 IT'S REALLY IMPORTANT TO HAVE 4291 03:04:22,240 --> 03:04:25,240 EXISTING GENERAL BIO 4292 03:04:25,240 --> 03:04:29,480 REPOSITORIES TO BE ABLE TO APPLY 4293 03:04:29,480 --> 03:04:39,480 TO GASTRO H GAS CANCER AND WE WO 4294 03:04:39,480 --> 03:04:42,880 MAKE THESE BIOSPECIMEN 4295 03:04:42,880 --> 03:04:44,720 REPOSITORIES AVAILABLE TO 4296 03:04:44,720 --> 03:04:46,000 RESEARCHERS THAT HAVE BEEN 4297 03:04:46,000 --> 03:04:47,240 LIMITED THUS FAR SO THAT THEY 4298 03:04:47,240 --> 03:04:50,240 CAN GENERATE NEW HYPOTHESIS AND 4299 03:04:50,240 --> 03:04:52,240 AS WELL AS TO VALIDATION 4300 03:04:52,240 --> 03:04:55,280 STUDIES. 4301 03:04:55,280 --> 03:04:57,080 NEXT SLIDE. 4302 03:04:57,080 --> 03:04:59,160 HIGH-LEVEL RECOMMENDATIONS, SO, 4303 03:04:59,160 --> 03:05:02,320 THEY'LL BE ABBREVIATED BY A 4304 03:05:02,320 --> 03:05:10,880 SPECIMEN BR/123 CONSECUTIVELY. 4305 03:05:10,880 --> 03:05:21,400 BC THEY ARE ONLY GOOD WITH WHAT 4306 03:05:23,160 --> 03:05:24,920 IS GOING ON AND THE QUALITY OF 4307 03:05:24,920 --> 03:05:26,400 THE SPECIMENS AS WELL AS THE 4308 03:05:26,400 --> 03:05:29,400 CLINICAL ANNOTATION AND BR2, 4309 03:05:29,400 --> 03:05:30,520 IDENTIFYING AN INITIAL SET OF 4310 03:05:30,520 --> 03:05:32,760 HIGH PRIORITY BIAS SPECIMENS TO 4311 03:05:32,760 --> 03:05:34,960 BE MADE AVAILABLE THROUGH A 4312 03:05:34,960 --> 03:05:36,640 CENTRALIZED NATIONAL REPOSITORY 4313 03:05:36,640 --> 03:05:39,480 THAT IS THEN ACCESSIBLE FOR 4314 03:05:39,480 --> 03:05:40,720 MERITORIOUS PROPOSALS. 4315 03:05:40,720 --> 03:05:47,760 THESE TWO ARE INTER RELATED. 4316 03:05:47,760 --> 03:05:48,120 BR-1. 4317 03:05:48,120 --> 03:05:49,120 SUB RECOMMENDATION THAT'S 4318 03:05:49,120 --> 03:05:50,560 SUPPORT THE BROADER 4319 03:05:50,560 --> 03:05:51,120 RECOMMENDATIONS. 4320 03:05:51,120 --> 03:05:52,160 COLLECT SPECIMENS FROM 4321 03:05:52,160 --> 03:05:53,960 OBSERVATIONAL AND INTERVENTIONAL 4322 03:05:53,960 --> 03:05:56,920 STUDY COHORTS AND BR-2 CREATE 4323 03:05:56,920 --> 03:05:58,120 OBSERVATIONAL AND INTERVENTIONAL 4324 03:05:58,120 --> 03:06:00,080 STUDY COHORTS THAT ENABLE 4325 03:06:00,080 --> 03:06:01,560 EFFICIENT COLLECTION OF 4326 03:06:01,560 --> 03:06:05,600 SPECIMENS AND BR-S3. 4327 03:06:05,600 --> 03:06:06,600 STANDARDS FOR COLLECTION WE HAVE 4328 03:06:06,600 --> 03:06:09,640 A TENDENCY TO HAVE A DESIRED TO 4329 03:06:09,640 --> 03:06:11,600 MAKE COLLECTIONS BUT THE 4330 03:06:11,600 --> 03:06:14,400 PROTOCOLS FOR COLLECTIONS ARE 4331 03:06:14,400 --> 03:06:15,960 DISPARATE IN NATURE SO WE SEEK 4332 03:06:15,960 --> 03:06:17,840 TO HAVE STANDARDIZED PROTOCOLS 4333 03:06:17,840 --> 03:06:20,720 SO THE TISSUES, THE BLOODS, THE 4334 03:06:20,720 --> 03:06:23,520 BODY FLUIDS THAT ARE OBTAINED 4335 03:06:23,520 --> 03:06:26,080 ARE UNIFORM AND STANDARDIZED IN 4336 03:06:26,080 --> 03:06:28,400 NATURE SO THE MOLECULAR ANALYSIS 4337 03:06:28,400 --> 03:06:31,440 IS ROBUST AND THE COMPUTATIONAL 4338 03:06:31,440 --> 03:06:38,440 ANALYTICS IS ROBUST AS WELL. 4339 03:06:38,440 --> 03:06:40,160 RESEARCH TOOLS. 4340 03:06:40,160 --> 03:06:44,760 WE TALKED ABOUT SWELLED ON ABOUL 4341 03:06:44,760 --> 03:06:47,240 SYSTEMS, PRECLINICAL TO 4342 03:06:47,240 --> 03:06:50,080 CLINICAL, LABORATORY ANALYTIC 4343 03:06:50,080 --> 03:06:54,440 METHODS, PROFILING, DNA AND RNA, 4344 03:06:54,440 --> 03:06:59,240 AND THE COMPUTATIONAL PLATFORMS. 4345 03:06:59,240 --> 03:07:01,920 THESE NEED TO BE DONE IN A 4346 03:07:01,920 --> 03:07:03,160 COMBINATION FASHION TO GENERATE 4347 03:07:03,160 --> 03:07:06,920 NEW INSIGHTS AND FACILITATE THE 4348 03:07:06,920 --> 03:07:08,400 EYE TEN INDICATION OF BIO 4349 03:07:08,400 --> 03:07:11,800 MARKERS AND THERAPEUTIC TARGETS. 4350 03:07:11,800 --> 03:07:13,040 EACH APPROACH REQUIRES FURTHER 4351 03:07:13,040 --> 03:07:18,040 DEVELOPMENT TO ACHIEVE ITS FULL 4352 03:07:18,040 --> 03:07:18,280 POTENTIAL. 4353 03:07:18,280 --> 03:07:18,920 THE BEGINS THAT WILL BE ACCUSED 4354 03:07:18,920 --> 03:07:20,560 IN EACH OF THESE DOMAINS CAN 4355 03:07:20,560 --> 03:07:22,760 EASILY THEN BE EXTENDED ALSO TO 4356 03:07:22,760 --> 03:07:24,720 OTHER CANCERS AS WELL, USING 4357 03:07:24,720 --> 03:07:33,120 UPPER GI CANCERS AS THE INITIATE 4358 03:07:33,120 --> 03:07:33,720 OR. 4359 03:07:33,720 --> 03:07:34,440 RESEARCH TOOLS. 4360 03:07:34,440 --> 03:07:36,520 HIGH LEVEL RECOMMENDATIONS, 4361 03:07:36,520 --> 03:07:37,960 RT-1, DEVELOP AND REFINERY 4362 03:07:37,960 --> 03:07:39,640 SEARCH TOOLS FOR OUR A LOT TO 4363 03:07:39,640 --> 03:07:42,120 DERIVE INSIGHTS INTO THE BIOLOGY 4364 03:07:42,120 --> 03:07:44,640 OF UPPER GI CANCERS AND SUB 4365 03:07:44,640 --> 03:07:45,800 RECOMMENDATIONS ARE RELATED 4366 03:07:45,800 --> 03:07:53,400 INFORM WHAT IS LISTED HERE. 4367 03:07:53,400 --> 03:07:56,240 RT-MS1, MS FOR MODEL SIS TOLLS. 4368 03:07:56,240 --> 03:08:00,680 WE WANT TO EMPHASIS THAT THERE 4369 03:08:00,680 --> 03:08:02,720 ARE EXISTING, ESTABLISHED, 4370 03:08:02,720 --> 03:08:05,720 PUBLISHED PRECLINICAL ANIMAL 4371 03:08:05,720 --> 03:08:10,320 MODELS, GENETIC ASK NON GENETIC 4372 03:08:10,320 --> 03:08:20,120 THAT COPY A GREAT JOB IN 4373 03:08:20,120 --> 03:08:21,600 RECAPITULATING GI CANCER AND WE 4374 03:08:21,600 --> 03:08:28,640 WANT TO AUGU AUGMENT THESE AND E 4375 03:08:28,640 --> 03:08:30,160 CARE OF DIFFERENT DRIVERS IN 4376 03:08:30,160 --> 03:08:35,920 UPPER G.I. CANCERS. 4377 03:08:35,920 --> 03:08:44,240 RT-MS2 IS TO MATH MAT TICK 4378 03:08:44,240 --> 03:08:46,440 MODELERS AND ORGANIC CHEMIST SO 4379 03:08:46,440 --> 03:08:48,600 DEVELOP MODEL SYSTEMS THAT 4380 03:08:48,600 --> 03:08:51,040 REFLECT THE HETERO AGAIN A TEE 4381 03:08:51,040 --> 03:08:53,720 OF UPPER G.I. CANCERS THAT HAVE 4382 03:08:53,720 --> 03:08:56,200 TAKEN BEYOND OUR EXISTING ANIMAL 4383 03:08:56,200 --> 03:08:58,400 MODELS. 4384 03:08:58,400 --> 03:09:00,680 RT-M3 IS TO EMPLOY OUR BIOEN 4385 03:09:00,680 --> 03:09:10,360 GUINEARS CHEENGINEER FOR CULTURO 4386 03:09:10,360 --> 03:09:12,520 REPLICATE AND DISTRIBUTE MODEL 4387 03:09:12,520 --> 03:09:12,760 SYSTEMS. 4388 03:09:12,760 --> 03:09:16,680 AN EXAMPLE OF THAT, NOT THE ONLY 4389 03:09:16,680 --> 03:09:19,640 EXAMPLE, THREE DIMENSIONAL 4390 03:09:19,640 --> 03:09:20,960 ORGANOIDS WHICH CAN HAVE A LOT 4391 03:09:20,960 --> 03:09:23,000 OF VARIABILITY AND IT'S NOT 4392 03:09:23,000 --> 03:09:26,760 WITHOUT EXPENSE SO A SYNTHETIC 4393 03:09:26,760 --> 03:09:28,200 PHYSICAL GEL CALLED HYDRO GEL IS 4394 03:09:28,200 --> 03:09:29,880 BEING USED MORE AND MORE WHICH 4395 03:09:29,880 --> 03:09:35,280 CAN BE FABRICATED MUCH MORE SEEM 4396 03:09:35,280 --> 03:09:36,680 LESLEY AND MUCH MORE COST 4397 03:09:36,680 --> 03:09:38,600 EFFECTIVE SO YOU CAN TAKE YOUR 4398 03:09:38,600 --> 03:09:40,680 PRE CANCER OR CANCER CELLS AND 4399 03:09:40,680 --> 03:09:46,720 PUT THEM ON HYDRO GEL AND 4400 03:09:46,720 --> 03:09:50,000 RECAPITULATE THE TUMOR AND DO CO 4401 03:09:50,000 --> 03:09:54,720 CULTURE WITH IMMUNE CELLS AND AS 4402 03:09:54,720 --> 03:09:57,120 WELL AS FIBRO BLAST AND WE WANT 4403 03:09:57,120 --> 03:09:58,840 THESE METHODS FOR THESE MODEL 4404 03:09:58,840 --> 03:10:03,000 SYSTEMS IN MS4. 4405 03:10:03,000 --> 03:10:04,720 SOME RECOMMENDATIONS ON 4406 03:10:04,720 --> 03:10:08,280 LABORATORY AN ANALYTIC. 4407 03:10:08,280 --> 03:10:10,080 THIS IS AM-1. 4408 03:10:10,080 --> 03:10:11,960 DEVELOP AND REFINE BIOLOGICAL 4409 03:10:11,960 --> 03:10:13,680 AND CHEMICAL AND PHYSICAL 4410 03:10:13,680 --> 03:10:16,120 ANALYTIC METHODS SO THIS IS 4411 03:10:16,120 --> 03:10:18,560 TAKING STOCK OF ALL OMICS 4412 03:10:18,560 --> 03:10:20,160 SCHOOLS ABOUT THEM AROUND US AND 4413 03:10:20,160 --> 03:10:22,080 WITH US AND APPLY THEM IN A 4414 03:10:22,080 --> 03:10:23,960 THOUGHTFUL AND RATIONAL WAY INTO 4415 03:10:23,960 --> 03:10:27,520 THE ANNAL SEES OF THE MODEL 4416 03:10:27,520 --> 03:10:32,320 SYSTEM AND BY OW BIOSPECIMENS. 4417 03:10:32,320 --> 03:10:33,920 THE THIRD DOMAIN IS 4418 03:10:33,920 --> 03:10:35,360 COMPUTATIONAL METHODS SO THIS IS 4419 03:10:35,360 --> 03:10:38,080 SUB RECOMMENDATIONS CM1 AND WE 4420 03:10:38,080 --> 03:10:41,280 WANT TO BRING IN OTHER 4421 03:10:41,280 --> 03:10:43,080 DISCIPLINES TO DEVELOP AND 4422 03:10:43,080 --> 03:10:44,520 VALIDATE MACHINE LEARNING 4423 03:10:44,520 --> 03:10:46,240 APPROACHES FOR ASSESSING 4424 03:10:46,240 --> 03:10:48,800 PATTERNS WITHIN A CROSS THESE 4425 03:10:48,800 --> 03:10:50,400 DIFFERENT OMICS AND OTHER DATA 4426 03:10:50,400 --> 03:10:54,680 TYPES TO INSURE IN VALIDATE IN 4427 03:10:54,680 --> 03:10:56,840 VIVO INTERVENTIONAL TARGETS FROM 4428 03:10:56,840 --> 03:11:01,600 PREVENTION TO TREATMENT OF UPPER 4429 03:11:01,600 --> 03:11:04,600 G.I. CANCERS. 4430 03:11:04,600 --> 03:11:06,040 I'LL SWITCH DIRECTIONS AND YOUR 4431 03:11:06,040 --> 03:11:08,960 ATTENTION TO FUTURE RESEARCH 4432 03:11:08,960 --> 03:11:10,680 DIRECTIONS. 4433 03:11:10,680 --> 03:11:11,440 NEXT SLIDE. 4434 03:11:11,440 --> 03:11:14,720 SO THE GOAL IS TO HARVEST OUR 4435 03:11:14,720 --> 03:11:18,360 MANY ON GOING ADVANCES IN UPPER 4436 03:11:18,360 --> 03:11:20,320 G.I. CANCER AND RESEARCH METHODS 4437 03:11:20,320 --> 03:11:22,360 BY APPLYING THEM TO BIOLOGICAL 4438 03:11:22,360 --> 03:11:24,560 QUESTIONS THAT ARE EVEN MORE 4439 03:11:24,560 --> 03:11:26,720 TARGETED AND PRIORITIZED FOR 4440 03:11:26,720 --> 03:11:29,120 THESE CANCERS IN ORDER TO BUILD 4441 03:11:29,120 --> 03:11:32,920 AND EXPAND A ROBUST PIPELINE OF 4442 03:11:32,920 --> 03:11:34,040 TRANSLATIONAL OPPORTUNITIES. 4443 03:11:34,040 --> 03:11:36,600 THERE WAS AN RFA ISSUED BY THE 4444 03:11:36,600 --> 03:11:40,240 NCI IN CALENDER YEAR 2021 AWARDS 4445 03:11:40,240 --> 03:11:43,720 WERE MADE IN CALENDER YEAR 2022 4446 03:11:43,720 --> 03:11:46,280 TO SIX TIVE WORKING GROUPS WITH 4447 03:11:46,280 --> 03:11:49,640 MULTI P.I.-RO1s AND A 4448 03:11:49,640 --> 03:11:50,680 COORDINATING CENTER. 4449 03:11:50,680 --> 03:11:57,120 SO WE SEEK TO TAKE ADVANTAGE OF 4450 03:11:57,120 --> 03:12:05,880 THE PROWESS AND WHAT WE ARE 4451 03:12:05,880 --> 03:12:06,880 ARTICULATING NOW. 4452 03:12:06,880 --> 03:12:08,840 SO, HIGH-LEVEL RECOMMENDATIONS 4453 03:12:08,840 --> 03:12:11,880 FOR BIOLOGICAL INSIGHTS APPLY 4454 03:12:11,880 --> 03:12:14,320 OMICS AND OTHER EMERGING 4455 03:12:14,320 --> 03:12:15,800 ANALYTICAL TOOLS AND 4456 03:12:15,800 --> 03:12:17,280 COMPUTATIONAL METHODS TO 4457 03:12:17,280 --> 03:12:20,200 CHARACTERIZE UPPER G.I. CANCERS 4458 03:12:20,200 --> 03:12:24,280 WITH EVEN GREATER PRECISION AND 4459 03:12:24,280 --> 03:12:25,600 IDENTIFYING ACTIONABLE 4460 03:12:25,600 --> 03:12:27,440 BIOMARKERS AND APPLICABLE 4461 03:12:27,440 --> 03:12:34,200 THERAPEUTIC TARGETS AND NEXT 4462 03:12:34,200 --> 03:12:44,320 SLIDE. 4463 03:13:04,560 --> 03:13:07,200 ACCESSING TISSUE AND PRE 4464 03:13:07,200 --> 03:13:10,680 TREATMENT, POST TREATMENT, AS 4465 03:13:10,680 --> 03:13:21,160 WELL AS AND YOU KNOW, CAN WE 4466 03:13:36,440 --> 03:13:38,920 APPLY THIS TO STANDARD OF CARE 4467 03:13:38,920 --> 03:13:42,360 APPROACHES AND CAN CAN WE 4468 03:13:42,360 --> 03:13:43,800 OVERCOME OUR MECHANISMS OF 4469 03:13:43,800 --> 03:13:46,240 RESISTANCE WHETHER IT'S DINOVO 4470 03:13:46,240 --> 03:13:48,200 OR ACQUIRED THROUGH OUR 4471 03:13:48,200 --> 03:13:55,360 KNOWLEDGE OF THE EXCEPTIONAL 4472 03:13:55,360 --> 03:13:57,720 RESPONDERS. 4473 03:13:57,720 --> 03:13:58,000 TREATMENT. 4474 03:13:58,000 --> 03:13:59,960 SURGICAL IS POTENTIALLY CURE 4475 03:13:59,960 --> 03:14:01,760 TIVE FOR THE SMALL SUBSET OF 4476 03:14:01,760 --> 03:14:03,600 PATIENTS WITH LOCALIZED 4477 03:14:03,600 --> 03:14:06,160 ADVERTISE SEIZE WHETHER IT'S 4478 03:14:06,160 --> 03:14:07,880 CANCER, OR GASTRIC CANCER OFTEN 4479 03:14:07,880 --> 03:14:10,520 IN THOSE INSTANCES PATIENTS WILL 4480 03:14:10,520 --> 03:14:14,400 STILL GET CHEMO RADIATION OR 4481 03:14:14,400 --> 03:14:17,240 IMMUNOTHERAPY AS A PRELUDE TO 4482 03:14:17,240 --> 03:14:18,120 SURGICAL RE SECTION. 4483 03:14:18,120 --> 03:14:20,920 NONE OF LESS, THE NEW APPROACHES 4484 03:14:20,920 --> 03:14:23,720 HAVE LIMITED SURVIVAL. 4485 03:14:23,720 --> 03:14:28,640 WITH THE MODEST EXCEPTION OF 4486 03:14:28,640 --> 03:14:34,080 TREATING HER2-POSITIVE TUMORS 4487 03:14:34,080 --> 03:14:35,560 TARGETED AS WELL AS THERAPY FOR 4488 03:14:35,560 --> 03:14:38,360 METASTATIC ESCC MORE THAN EAC 4489 03:14:38,360 --> 03:14:39,600 TARGETED THERAPIES HAVE BEEN 4490 03:14:39,600 --> 03:14:41,440 SOMEWHAT LIMITED IF NOT 4491 03:14:41,440 --> 03:14:42,640 DISAPPOINTING TO DATE. 4492 03:14:42,640 --> 03:14:44,680 AS I MENTIONED, IMMUNO 4493 03:14:44,680 --> 03:14:47,280 THERAPIES, IN THE NEW SETTING IN 4494 03:14:47,280 --> 03:14:49,480 THE ARE SHOWING PROMISE BUT 4495 03:14:49,480 --> 03:14:51,440 THESE TUMORS ARE FUNDAMENTALLY 4496 03:14:51,440 --> 03:14:53,720 IMMUNE LOGICALLY COLD, 4497 03:14:53,720 --> 03:14:57,000 REMINISCENT OF PANCREATIC 4498 03:14:57,000 --> 03:15:04,000 CARCINOMA WITH A VERY ROBUST AND 4499 03:15:04,000 --> 03:15:06,920 STROM MA SO WE NEED TO IDENTIFY 4500 03:15:06,920 --> 03:15:08,400 ADDITIONAL TARGETS IMMUNE 4501 03:15:08,400 --> 03:15:10,120 TARGETS THAT ARE ON IMMUNE CELLS 4502 03:15:10,120 --> 03:15:14,200 AND TARGETS THAT ARE ON FIBER 4503 03:15:14,200 --> 03:15:18,440 BLAST AND TAKE A APPROACH BASED 4504 03:15:18,440 --> 03:15:25,840 ON OUR HIGH LEVEL AND TREATMENT 4505 03:15:25,840 --> 03:15:36,240 RESEARCH AND NEXT SLIDE. 4506 03:15:38,440 --> 03:15:41,080 DEVELOP IMPROVE METHODS FOR PRE 4507 03:15:41,080 --> 03:15:42,880 TICKETING AND RESPONSE IN 4508 03:15:42,880 --> 03:15:44,600 RESISTANCE AND THIS CAN BE DONE 4509 03:15:44,600 --> 03:15:47,760 THROUGH NON-INVASIVE APPROACHES, 4510 03:15:47,760 --> 03:15:50,800 INVASIVE APPROACHES SUCH AS 4511 03:15:50,800 --> 03:15:52,760 ENDOSCOPY AND TISSUE-DERIVED 4512 03:15:52,760 --> 03:15:56,160 PLATFORM SUCH AS ORGANOIDS AND 4513 03:15:56,160 --> 03:16:02,000 SURROGATE MARKERS OF AND 4514 03:16:02,000 --> 03:16:04,040 RESPONSE FOR RESISTANCE AND 4515 03:16:04,040 --> 03:16:06,360 THOSE THAT RESPOND WHO MIGHT 4516 03:16:06,360 --> 03:16:09,040 HAVE THAT MIGHT ACQUIRE 4517 03:16:09,040 --> 03:16:09,440 RESISTANCE. 4518 03:16:09,440 --> 03:16:11,000 I THINK THIS IS DOABLE GIVEN THE 4519 03:16:11,000 --> 03:16:16,760 AN OWE TOPIC LOCATION OF THESE 4520 03:16:16,760 --> 03:16:17,760 CANCERS. 4521 03:16:17,760 --> 03:16:19,440 T-S3 IMPROVE TREATMENTS AND ONE 4522 03:16:19,440 --> 03:16:22,360 CAN'T EMPHASIS THAT ENOUGH. 4523 03:16:22,360 --> 03:16:25,080 AND THIS IS GOING TO BE IN 4524 03:16:25,080 --> 03:16:26,760 NATURE AND TAKING ADVANTAGE OF 4525 03:16:26,760 --> 03:16:29,040 THE ADVANCES MADE IN 4526 03:16:29,040 --> 03:16:31,120 IMMUNOTHERAPY AND TARGETED 4527 03:16:31,120 --> 03:16:38,120 THERAPY OF RECEPTORS KINASE AND 4528 03:16:38,120 --> 03:16:40,200 CELL BASED THERAPIES POSSIBLY 4529 03:16:40,200 --> 03:16:42,520 BUT IT'S BEEN DIFFICULT WITH 4530 03:16:42,520 --> 03:16:44,360 SOLID MALIGNANCY SO WE'LL SEE 4531 03:16:44,360 --> 03:16:46,920 ABOUT THAT AND T-S4, DEVELOPING 4532 03:16:46,920 --> 03:16:49,360 METHODS FOR IMAGE GUIDED 4533 03:16:49,360 --> 03:16:52,080 TREATMENT THROUGH ENDOSCAPY AS 4534 03:16:52,080 --> 03:16:55,720 WELL AS RADIOLOGY AND T-S5 4535 03:16:55,720 --> 03:16:57,160 DEVELOP NEW APPROACHES FOR 4536 03:16:57,160 --> 03:16:59,960 PREVENTING OR MITIGATING ADVERSE 4537 03:16:59,960 --> 03:17:00,840 EFFECTS ASSOCIATED WITH 4538 03:17:00,840 --> 03:17:07,360 TREATMENT OR TREATMENT. 4539 03:17:07,360 --> 03:17:08,960 PREVENTION FROM A GLOBAL 4540 03:17:08,960 --> 03:17:10,040 VIEWPOINT MAKES THE MOST SENSE 4541 03:17:10,040 --> 03:17:11,880 FOR THE REGIONS I MENTIONED AT 4542 03:17:11,880 --> 03:17:16,840 THE OUTSET WITH A ORGANISM AND 4543 03:17:16,840 --> 03:17:17,640 INFECTING 2 BILLION PEOPLE YET 4544 03:17:17,640 --> 03:17:19,760 IT'S LESS THAN 1% OF THOSE 4545 03:17:19,760 --> 03:17:21,280 2 BILLION PEOPLE THAT WILL 4546 03:17:21,280 --> 03:17:24,520 DEVELOP CARCINOMA IN ASSOCIATION 4547 03:17:24,520 --> 03:17:28,760 WITH H PYLORI THINKING OF GERM 4548 03:17:28,760 --> 03:17:30,520 LINE POLY MOTHISM AND AS WELL AS 4549 03:17:30,520 --> 03:17:33,120 CO FACTORS THAT ARE INTER 4550 03:17:33,120 --> 03:17:37,040 PLAYING WITH H PYLORI INFECTION 4551 03:17:37,040 --> 03:17:39,520 SO IT'S A DIFFICULT CHALLENGE 4552 03:17:39,520 --> 03:17:41,600 FOR POPULATION SCALE PROGRAMS 4553 03:17:41,600 --> 03:17:46,160 EVEN IF COUNTRIES IN WHICH H. 4554 03:17:46,160 --> 03:17:48,840 PYLORI IS ENDEMIC AND THE 4555 03:17:48,840 --> 03:17:52,760 COMPLEXITY OF H. PIE LORI ARE A 4556 03:17:52,760 --> 03:17:54,440 BROAD BASED APPROACH THAT ARE 4557 03:17:54,440 --> 03:17:58,200 CURRENTLY AVAILABLE ANTIBIOTIC 4558 03:17:58,200 --> 03:18:00,760 REGIMENTS AND A VACCINE REGIMENT 4559 03:18:00,760 --> 03:18:11,280 AND VACCINES HAVE BEEN THEY'RE 4560 03:18:12,000 --> 03:18:18,840 RELATED FOR NON H. PYLORI 4561 03:18:18,840 --> 03:18:19,520 CANCER. 4562 03:18:19,520 --> 03:18:19,880 P-1. 4563 03:18:19,880 --> 03:18:21,840 TRANSLATE THE EMERGING 4564 03:18:21,840 --> 03:18:24,440 BIOLOGICAL INSIGHTS INTO 4565 03:18:24,440 --> 03:18:26,080 PRACTICAL TOOLS AND STRATEGIES 4566 03:18:26,080 --> 03:18:27,920 FOR SCREENING, SURVEILLANCE, 4567 03:18:27,920 --> 03:18:30,480 EARLY DETECTION, AND RISK 4568 03:18:30,480 --> 03:18:36,920 STRATIFICATION AND NEXT SLIDE. 4569 03:18:36,920 --> 03:18:38,640 P-S1 DEVELOP SENSITIVE TOOLS FOR 4570 03:18:38,640 --> 03:18:39,840 SCREENING AND EARLY DETECTION 4571 03:18:39,840 --> 03:18:42,400 AND THIS COULD AGAIN BE 4572 03:18:42,400 --> 03:18:43,840 NON-INVASIVE ESPECIALLY IN 4573 03:18:43,840 --> 03:18:45,960 COUNTRIES THAT ARE UNDER 4574 03:18:45,960 --> 03:18:48,160 RESOURCED AS WELL AS INVASIVE IN 4575 03:18:48,160 --> 03:18:50,000 DEVELOPED COUNTRIES AND 4576 03:18:50,000 --> 03:18:51,440 DEVELOPED MORE SENSITIVE AND 4577 03:18:51,440 --> 03:18:53,880 ACCURATE ASSESSMENT TOOLS AND 4578 03:18:53,880 --> 03:18:56,840 DEVELOP MORE SENSITIVE AND 4579 03:18:56,840 --> 03:18:59,280 ACCURATE ASSESSMENT TOOLS FOR 4580 03:18:59,280 --> 03:19:02,720 DISEASE SURVEILLANCE. 4581 03:19:02,720 --> 03:19:06,280 NEXT SLIDE. 4582 03:19:06,280 --> 03:19:08,960 P-S4, NOVEL PREVENTATIVE 4583 03:19:08,960 --> 03:19:09,920 INTERVENTIONS AND ASPIRIN IS 4584 03:19:09,920 --> 03:19:15,040 EFFECTIVE AS CHEMO PREVENTION 4585 03:19:15,040 --> 03:19:20,240 FOR CARCINOMA BUT WE NEED MORE. 4586 03:19:20,240 --> 03:19:21,920 SUPPLY STATE OF THE ART 4587 03:19:21,920 --> 03:19:22,680 TECHNOLOGIES GO BEYOND THAT TO 4588 03:19:22,680 --> 03:19:27,240 THE NEXT GENERATION OF VACCINES 4589 03:19:27,240 --> 03:19:29,240 AND PERHAPS THINGS THAT ARE MRNA 4590 03:19:29,240 --> 03:19:32,080 BASED TO ADVANCE THE DEVELOPMENT 4591 03:19:32,080 --> 03:19:34,560 OF H. PYLORI VACCINES AND 4592 03:19:34,560 --> 03:19:37,640 DEVELOP ANTIBODY STEWARDSHIP AND 4593 03:19:37,640 --> 03:19:38,600 ERADICATION BECAUSE THERE'S A 4594 03:19:38,600 --> 03:19:41,600 AMOUNT OF ANTIBIOTIC RESISTANCE 4595 03:19:41,600 --> 03:19:42,600 IN THROUGH OUT THE WORLD AND LET 4596 03:19:42,600 --> 03:19:44,960 ALONE THE UNITED STATES SO 4597 03:19:44,960 --> 03:19:47,400 PEOPLE HAVE REOCCURRING H PYLORI 4598 03:19:47,400 --> 03:19:49,720 INFECTION WHICH IS CULTIVATED IN 4599 03:19:49,720 --> 03:19:53,240 CLOSE QUARTERS AND IS BY ORAL 4600 03:19:53,240 --> 03:19:57,920 FECAL TRANSMISSION. 4601 03:19:57,920 --> 03:19:59,200 CONCLUSIONS, THE 'EM TOMMY 4602 03:19:59,200 --> 03:20:00,800 LOGICAL AND CLINICAL REALITIES 4603 03:20:00,800 --> 03:20:04,480 THAT AR STAGGERING IN NATURE AND 4604 03:20:04,480 --> 03:20:06,280 NEED TO BE ACKNOWLEDGED IN THE 4605 03:20:06,280 --> 03:20:08,880 UNITED STATES OF UPPER G.I. 4606 03:20:08,880 --> 03:20:14,200 CANCERS DEFY A COMPELLING NEED 4607 03:20:14,200 --> 03:20:15,400 FOR FURTHER FOCUS AND 4608 03:20:15,400 --> 03:20:17,320 SUBSTANTIAL ADVANCES IN 4609 03:20:17,320 --> 03:20:22,360 PREVENTION AND DETECTION AND 4610 03:20:22,360 --> 03:20:24,440 SCREENING, SURVEILLANCE AND 4611 03:20:24,440 --> 03:20:24,720 TREATMENT. 4612 03:20:24,720 --> 03:20:26,120 WE'RE REVIEWING TWO DECADES OF 4613 03:20:26,120 --> 03:20:28,320 PROGRESS AND I WANT TO ALSO 4614 03:20:28,320 --> 03:20:30,200 EMPHASIZE PROGRESS HAS BEEN 4615 03:20:30,200 --> 03:20:30,600 MADE. 4616 03:20:30,600 --> 03:20:32,360 THE WORKING GROUP CONCLUDED A 4617 03:20:32,360 --> 03:20:34,200 CONCERTED AND SUSTAINED EFFORT 4618 03:20:34,200 --> 03:20:37,160 IS NEEDED TO BUILD A MORE 4619 03:20:37,160 --> 03:20:39,960 ASPIRATIONAL ROBUST PIPELINE OF 4620 03:20:39,960 --> 03:20:40,640 TRANSLATIONAL OPPORTUNITIES INTO 4621 03:20:40,640 --> 03:20:45,560 THE REMAINING PART OF THIS 4622 03:20:45,560 --> 03:20:45,800 DECADE. 4623 03:20:45,800 --> 03:20:47,360 NO WONDER INTERVENTION OR 4624 03:20:47,360 --> 03:20:50,080 PRIORITY WILL SERVE AS A 4625 03:20:50,080 --> 03:20:50,560 PANACEA. 4626 03:20:50,560 --> 03:20:54,560 IT REQUIRES A MULTI-DISCIPLINARY 4627 03:20:54,560 --> 03:20:57,240 INTER INSTITUTIONAL AND 4628 03:20:57,240 --> 03:21:00,240 COLLABORATIONAL AT THE NCI 4629 03:21:00,240 --> 03:21:00,840 MULTI-PRONGED APPROACH. 4630 03:21:00,840 --> 03:21:02,400 THAT'S WHY THE WORKING GROUP, 4631 03:21:02,400 --> 03:21:03,880 THROUGH ITS WORKING SUPPOSE 4632 03:21:03,880 --> 03:21:07,440 GROUPS RECOMMEND A BROAD BASED 4633 03:21:07,440 --> 03:21:10,200 APPROACH CRITICAL TO THIS IS A 4634 03:21:10,200 --> 03:21:12,480 CENTRALIZED NATIONAL BIOSPECIMEN 4635 03:21:12,480 --> 03:21:13,760 REPOSITORY AND THERE WAS MUCH, 4636 03:21:13,760 --> 03:21:16,320 MUCH EMPHASIS ON THIS AND MUCH 4637 03:21:16,320 --> 03:21:17,680 ENTHUSIASM FOR THIS AND WE THINK 4638 03:21:17,680 --> 03:21:19,120 THAT IT WILL BE TRANSFORMATIVE 4639 03:21:19,120 --> 03:21:21,160 IN NATURE TO DO THIS. 4640 03:21:21,160 --> 03:21:24,040 AND IT REQUIRES COLLABORATIONS 4641 03:21:24,040 --> 03:21:25,640 BETWEEN A PRIVATE AND PUBLIC 4642 03:21:25,640 --> 03:21:29,160 ENTITIES AND FEDERAL AGENCIES, 4643 03:21:29,160 --> 03:21:30,880 INDUSTRY AND PHILANTHROPY WHICH 4644 03:21:30,880 --> 03:21:41,400 IS EMERGING IN THE FIELD AND I 4645 03:21:46,680 --> 03:21:47,640 WELCOME YOUR COMMENTS AND 4646 03:21:47,640 --> 03:21:47,880 QUESTIONS. 4647 03:21:47,880 --> 03:21:50,960 I WANT TO REEMPHASIZE THE HARD 4648 03:21:50,960 --> 03:21:52,480 WORK OF INTEREST GOODMAN, 4649 03:21:52,480 --> 03:21:54,240 EVERYONE IN THE WORKING GROUP 4650 03:21:54,240 --> 03:21:56,040 AND OUR NCI COLLEAGUES THAT 4651 03:21:56,040 --> 03:21:58,760 WOULD NOT HAVE BEEN POSSIBLE 4652 03:21:58,760 --> 03:21:59,000 OTHERWISE. 4653 03:21:59,000 --> 03:22:01,560 >>THANK YOU SO MUCH. 4654 03:22:01,560 --> 03:22:04,280 THE THOROUGHNESS OF THE EFFORT 4655 03:22:04,280 --> 03:22:07,200 BY THE WORKING GROUP IS 4656 03:22:07,200 --> 03:22:09,200 REFLECTED IN YOUR PRESENTATION 4657 03:22:09,200 --> 03:22:12,640 AS WELL AS IN THE WORLD ITSELF. 4658 03:22:12,640 --> 03:22:15,840 WE WILL HAVE COMMENTS, 4659 03:22:15,840 --> 03:22:17,560 DISCUSSION, WHICH WILL BE 4660 03:22:17,560 --> 03:22:20,120 FOLLOWED BY COMMITTEE VOTE ON 4661 03:22:20,120 --> 03:22:22,240 THE APPROVAL OF THE REPORT 4662 03:22:22,240 --> 03:22:28,400 BEFORE WE CLOSE. 4663 03:22:28,400 --> 03:22:31,320 TO START US OFF, KAREN GOODMAN 4664 03:22:31,320 --> 03:22:33,960 JOINED BY PHONE AND I WOULD LOVE 4665 03:22:33,960 --> 03:22:34,880 TO GIVE HER. 4666 03:22:34,880 --> 03:22:37,720 I THINK THIS IS HOT OFF THE 4667 03:22:37,720 --> 03:22:37,920 PRESS. 4668 03:22:37,920 --> 03:22:39,760 >>IT'S IMPORTANT THAT Dr. 4669 03:22:39,760 --> 03:22:40,600 GOODMAN SPEAK UP AS WELL. 4670 03:22:40,600 --> 03:22:44,560 >>SO, KAREN, IT'S ALL YOURS. 4671 03:22:44,560 --> 03:22:46,040 >>HI, THANK YOU, CAN CAN YOU 4672 03:22:46,040 --> 03:22:46,760 HEAR ME? 4673 03:22:46,760 --> 03:22:47,680 >>YES. 4674 03:22:47,680 --> 03:22:48,840 >>OK, GREAT. 4675 03:22:48,840 --> 03:22:51,840 I'M GOING TO TRY TO GET MY VIDEO 4676 03:22:51,840 --> 03:22:54,280 ON, I'M HAVING ISSUES WITH THE 4677 03:22:54,280 --> 03:22:56,680 CONNECTION HERE AND I'M IN 4678 03:22:56,680 --> 03:23:00,120 ISRAEL AT A DINNER FOR OUR 4679 03:23:00,120 --> 03:23:01,440 EXTERNAL ADVISORY BOARD MEETING 4680 03:23:01,440 --> 03:23:02,640 AND THERE WERE ISSUES WITH 4681 03:23:02,640 --> 03:23:04,280 GETTING ON-LINE. 4682 03:23:04,280 --> 03:23:06,800 I JUST WANT TO THANK YOU, NEIL, 4683 03:23:06,800 --> 03:23:08,480 FABULOUS JOB OF PRESENTING WHAT 4684 03:23:08,480 --> 03:23:09,800 THE GROUP HAS REALLY PUT 4685 03:23:09,800 --> 03:23:12,160 TOGETHER OVER THESE LAST NINE 4686 03:23:12,160 --> 03:23:13,480 MONTHS OR SO. 4687 03:23:13,480 --> 03:23:17,120 I THINK THIS WAS A CHALLENGING 4688 03:23:17,120 --> 03:23:17,320 TOPIC. 4689 03:23:17,320 --> 03:23:19,960 WE HAD REALIZED IN GOING INTO 4690 03:23:19,960 --> 03:23:21,520 THIS THAT THERE WAS STILL A LOT 4691 03:23:21,520 --> 03:23:23,200 OF FUNDAMENTAL DATA AND 4692 03:23:23,200 --> 03:23:26,000 INFORMATION THAT WE NEEDED TO 4693 03:23:26,000 --> 03:23:29,800 ACQUIRE BEFORE WE COULD TACKLE 4694 03:23:29,800 --> 03:23:31,360 SOME OF THE QUESTIONS RELATED TO 4695 03:23:31,360 --> 03:23:35,720 WHAT ARE THE BEST OPTIONS FOR 4696 03:23:35,720 --> 03:23:39,080 PREVENTION, AND TREATMENTS, 4697 03:23:39,080 --> 03:23:40,640 OPTIMAL TREATMENT REGIMENTS FOR 4698 03:23:40,640 --> 03:23:42,560 THESE PATIENTS AND IT GOES BACK 4699 03:23:42,560 --> 03:23:47,360 TO A NEED FOR HAVING THE OPTIONS 4700 03:23:47,360 --> 03:23:49,640 TO HAVE PRECLINICAL DATA AND 4701 03:23:49,640 --> 03:23:52,600 CLINICAL DATA BASED ON HAVING 4702 03:23:52,600 --> 03:23:54,760 MORE ROBUST BIOSPECIMEN 4703 03:23:54,760 --> 03:23:58,440 REPOSITORIES TO REALLY 4704 03:23:58,440 --> 03:24:02,360 UNDERSTAND OUR TRANSITION FROM 4705 03:24:02,360 --> 03:24:03,720 NORMAL TO ADVERTISE PLASIA SO 4706 03:24:03,720 --> 03:24:07,000 CANCER AND UNDERSTANDING THE 4707 03:24:07,000 --> 03:24:09,120 EFFECT OF TREATMENT, 4708 03:24:09,120 --> 03:24:10,920 UNDERSTANDING THE BASELINE 4709 03:24:10,920 --> 03:24:13,280 TISSUE AND CANCER TISSUE AND 4710 03:24:13,280 --> 03:24:14,960 POST TREATMENT SO I THINK THIS 4711 03:24:14,960 --> 03:24:16,720 IS REALLY BEEN AN OPPORTUNITY 4712 03:24:16,720 --> 03:24:21,360 FOR US TO EX TOGETHER WITH A LOT 4713 03:24:21,360 --> 03:24:22,960 OF DIFFERENT SPECIALITIES AND 4714 03:24:22,960 --> 03:24:25,280 BACKGROUNDS TO REALLY PUT 4715 03:24:25,280 --> 03:24:28,000 FORWARD A REPRESENTATION I 4716 03:24:28,000 --> 03:24:29,200 REALLY HAVE TO THANK NEIL. 4717 03:24:29,200 --> 03:24:35,960 HE HAS BEEN WONDERFUL TO WORK 4718 03:24:35,960 --> 03:24:36,200 WITH. 4719 03:24:36,200 --> 03:24:37,880 WE HOPE PRIORITIZING THE NEED 4720 03:24:37,880 --> 03:24:39,720 HAVING CENTRALIZED RE SOURCE TO 4721 03:24:39,720 --> 03:24:41,560 BRING TOGETHER BIOSPECIMENS 4722 03:24:41,560 --> 03:24:42,880 WHETHER IT'S THROUGH OUR 4723 03:24:42,880 --> 03:24:45,080 CLINICAL TRIALS NETWORK AND OR 4724 03:24:45,080 --> 03:24:55,600 FROM OBSERVATIONAL STUDIES WE 4725 03:24:56,840 --> 03:25:00,840 HAVE BIO MARKERS AND TREATMENT 4726 03:25:00,840 --> 03:25:01,160 STRATEGIES. 4727 03:25:01,160 --> 03:25:03,160 >>CERTAINLY IT'S NOT YOU NECK 4728 03:25:03,160 --> 03:25:04,440 TO THESE ON STILLATION OF 4729 03:25:04,440 --> 03:25:07,360 CANCERS TO GO FROM NORMAL TO PRE 4730 03:25:07,360 --> 03:25:08,240 CANCER TO CANCER. 4731 03:25:08,240 --> 03:25:13,680 BUT WHAT IS DISTINCTIVE IS THE 4732 03:25:13,680 --> 03:25:14,800 ACCESSIBILITY TO TISSUES AT TIVE 4733 03:25:14,800 --> 03:25:16,680 STAGES, NORMAL PRE CANCER TO 4734 03:25:16,680 --> 03:25:18,120 CANCER SO THE MORE WE LEARN 4735 03:25:18,120 --> 03:25:19,960 ABOUT PRE CANCER, THE MORE IT 4736 03:25:19,960 --> 03:25:22,160 WILL HELP US INFORM ABOUT 4737 03:25:22,160 --> 03:25:25,080 PREVENTION AND INTERVENTION FOR 4738 03:25:25,080 --> 03:25:25,800 CANCER. 4739 03:25:25,800 --> 03:25:28,120 SO, BY BUILDING A CENTRALIZED 4740 03:25:28,120 --> 03:25:30,040 BIO REPOSITORY WE REALLY WANTED 4741 03:25:30,040 --> 03:25:34,040 TO INCLUDE PRE CANCER TISSUES AS 4742 03:25:34,040 --> 03:25:34,240 WELL. 4743 03:25:34,240 --> 03:25:35,480 >>THANK YOU. 4744 03:25:35,480 --> 03:25:37,520 I'D LIKE TO CALL ON NANCY 4745 03:25:37,520 --> 03:25:41,240 DAVIDSON WHO IS A MEMBER OF CTAR 4746 03:25:41,240 --> 03:25:43,280 AND ALSO CO-CHAIRS THE CTAC 4747 03:25:43,280 --> 03:25:45,720 TRANSLATIONAL RESEARCH STRATEGY 4748 03:25:45,720 --> 03:25:49,320 COMMITTEE, TRSS IS THE ACRONYM. 4749 03:25:49,320 --> 03:25:50,720 DO YOU HAVE ANY COMMENTS THAT 4750 03:25:50,720 --> 03:25:53,640 YOU WOULD LIKE TO MAKE ON BEHALF 4751 03:25:53,640 --> 03:25:54,600 OF THE TRSS. 4752 03:25:54,600 --> 03:25:57,680 >>THANK YOU SO MUCH. 4753 03:25:57,680 --> 03:25:58,800 FANTASTIC REPORT. 4754 03:25:58,800 --> 03:26:00,240 VERY COMPREHENSIVE. 4755 03:26:00,240 --> 03:26:03,160 THE MEMBERS OF THE TRSS AND 4756 03:26:03,160 --> 03:26:06,240 KEVIN SHANNON, DAVID AND MYSELF 4757 03:26:06,240 --> 03:26:08,320 ALL HAD A CHANCE TO REVIEW THIS 4758 03:26:08,320 --> 03:26:09,800 IN ADVANCE AND I THINK WE WERE 4759 03:26:09,800 --> 03:26:12,480 REALLY IMPRESSED BY THE 4760 03:26:12,480 --> 03:26:13,560 COMPREHENSIVE NATURE OF YOUR 4761 03:26:13,560 --> 03:26:15,000 ANALYSIS AND THE ONE THING WE 4762 03:26:15,000 --> 03:26:16,600 HOPED FOR WAS PRIORITIZATION AND 4763 03:26:16,600 --> 03:26:18,800 I HEARD THAT FROM YOU TODAY. 4764 03:26:18,800 --> 03:26:22,680 I BELIEVE I HEARD A REAL, REAL 4765 03:26:22,680 --> 03:26:24,720 MAJOR GOAL OF TRYING TO 4766 03:26:24,720 --> 03:26:26,560 PRIORITIZE TISSUE ACQUISITION 4767 03:26:26,560 --> 03:26:28,360 AND SPECIMEN ACQUISITION AS THE 4768 03:26:28,360 --> 03:26:29,560 FIRST STEP IN ALL OF THIS. 4769 03:26:29,560 --> 03:26:31,160 THANK YOU AND WE APPRECIATE IT. 4770 03:26:31,160 --> 03:26:33,600 >>AND THEN, HAVING THE 4771 03:26:33,600 --> 03:26:35,280 APPROPRIATE MODEL SYSTEMS TO BE 4772 03:26:35,280 --> 03:26:41,640 ABLE TO DO THE WORK WE WALKED A 4773 03:26:41,640 --> 03:26:45,600 FINE LINE BETWEEN BEING TOO 4774 03:26:45,600 --> 03:26:47,280 BROAD AND TOO SPOKE AND IT CAN 4775 03:26:47,280 --> 03:26:49,360 CAN APPLY TO ANY CANCER SO WE 4776 03:26:49,360 --> 03:26:52,240 DIDN'T WANT TO BE SO RESTRICTIVE 4777 03:26:52,240 --> 03:26:54,320 AND PRECLUDE HYPOTHESIS-DRIVEN 4778 03:26:54,320 --> 03:26:56,120 RESEARCH BUT THEN ESTABLISH AN 4779 03:26:56,120 --> 03:26:58,000 INFRASTRUCTURE THAT WOULD 4780 03:26:58,000 --> 03:26:59,560 APPLY -- ALLOW PEOPLE TO TAKE 4781 03:26:59,560 --> 03:27:03,120 DIFFERENT APPROACHES, NOVEL 4782 03:27:03,120 --> 03:27:05,040 APPROACHES TO THE ISSUES AT HAND 4783 03:27:05,040 --> 03:27:06,600 AND WE'RE GRATEFUL FOR THE 4784 03:27:06,600 --> 03:27:09,200 COMMENTS THAT WE RECEIVED FROM 4785 03:27:09,200 --> 03:27:11,040 THEM IN ADVANCE AND DID DISCUSS 4786 03:27:11,040 --> 03:27:18,240 THEM IN GREAT DETAIL AS WELL. 4787 03:27:18,240 --> 03:27:20,760 >>I I SEE ERNIE TALKS. 4788 03:27:20,760 --> 03:27:22,720 THE ONLY CTAC MEMBER THAT 4789 03:27:22,720 --> 03:27:27,920 PARTICIPATED IN THIS GROUP. 4790 03:27:27,920 --> 03:27:31,640 ERNIE, YOUR PERSPECTIVE IS 4791 03:27:31,640 --> 03:27:32,440 WELCOME. 4792 03:27:32,440 --> 03:27:33,640 >>YOU ARE ON MUTE. 4793 03:27:33,640 --> 03:27:37,120 WE CAN'T HEAR YOU. 4794 03:27:37,120 --> 03:27:47,640 >>THIS WAS A VERY JUST AS WE'VE 4795 03:28:07,120 --> 03:28:08,960 HEARD, A VERY COMPREHENSIVE 4796 03:28:08,960 --> 03:28:10,680 EFFORT TO TOOK AT THE PROGRESS 4797 03:28:10,680 --> 03:28:11,800 THAT'S MADE BUT THE REMAINING 4798 03:28:11,800 --> 03:28:15,360 GAPS AND OPPORTUNITIES THAT 4799 03:28:15,360 --> 03:28:16,680 EXIST AND WE WERE HOPING TO 4800 03:28:16,680 --> 03:28:20,240 PRIORITIZE EVEN MORE THAN YOU 4801 03:28:20,240 --> 03:28:29,160 HEARD AND IT'S A VERY LONG LIST. 4802 03:28:29,160 --> 03:28:30,760 PART OF THE CHALLENGE HERE IS 4803 03:28:30,760 --> 03:28:32,080 THAT WE'RE WORKING ACROSS THE 4804 03:28:32,080 --> 03:28:35,520 FULL SPECTRUM OF ADVERTISE SEIZE 4805 03:28:35,520 --> 03:28:36,760 AND AS WELL AS NOT ACROSS ONE 4806 03:28:36,760 --> 03:28:40,800 DISEASE BUT AT LEAST TWO 4807 03:28:40,800 --> 03:28:42,360 DISEASES OR SIX DISEASES 4808 03:28:42,360 --> 03:28:44,440 CONSIDERING MOLECULARLY AND NEIL 4809 03:28:44,440 --> 03:28:45,600 HIGHLIGHTED AT THE BEGINNING AND 4810 03:28:45,600 --> 03:28:47,320 IT'S PART OF THE CHALLENGE, I 4811 03:28:47,320 --> 03:28:49,720 THINK, IN TRYING TO PRIORITIZE. 4812 03:28:49,720 --> 03:28:51,680 IN OUR WORKING GROUP, IT WAS 4813 03:28:51,680 --> 03:28:53,200 FOCUSED ON PREVENTION, EARLY 4814 03:28:53,200 --> 03:28:55,120 TEXT AND SCREENING, OUR SUB 4815 03:28:55,120 --> 03:28:57,280 GROUP THAT IS, WE TALKED ABOUT 4816 03:28:57,280 --> 03:28:59,480 IS THERE ANYWAY TO TRY TO 4817 03:28:59,480 --> 03:29:01,080 PRIORITIZE ACROSS THOSE SIX 4818 03:29:01,080 --> 03:29:03,280 DISEASES AS WE WERE CONSIDERING 4819 03:29:03,280 --> 03:29:05,680 THEM FROM THE PERSPECTIVE. 4820 03:29:05,680 --> 03:29:08,880 WE DIDN'T A ARRIVE SATISFYING 4821 03:29:08,880 --> 03:29:12,320 CONCLUSIONS TO THAT AND THERE 4822 03:29:12,320 --> 03:29:14,280 WERE ARGUMENTS THAT PERHAPS WE 4823 03:29:14,280 --> 03:29:15,560 SHOULD CONCENTRATE ON THE 4824 03:29:15,560 --> 03:29:18,760 DISEASES THAT ARE MOST PREVALENT 4825 03:29:18,760 --> 03:29:20,080 IN BURDENSOME TO THE AMERICAN 4826 03:29:20,080 --> 03:29:22,360 POPULATION BUT THE OTHER HAND, 4827 03:29:22,360 --> 03:29:23,600 NCI PLAYS A IMPORTANT ROLE AS AN 4828 03:29:23,600 --> 03:29:25,880 INTERNATIONAL CATALYST IN TRYING 4829 03:29:25,880 --> 03:29:28,600 TO RESOLVE INEQUITIES AND AS 4830 03:29:28,600 --> 03:29:31,080 THEY RELATE TO CANCER GLOBALLY 4831 03:29:31,080 --> 03:29:34,120 AND SO AGAIN, WE DECIDED TO BACK 4832 03:29:34,120 --> 03:29:36,480 AWAY FROM THAT PRIORITIZATION. 4833 03:29:36,480 --> 03:29:39,520 AT LEAST TWO AREAS THAT I WOULD 4834 03:29:39,520 --> 03:29:42,120 HIGHLIGHT THAT PROBABLY DESERVE 4835 03:29:42,120 --> 03:29:48,080 SOME PRIORITIZATION WOULD BE 4836 03:29:48,080 --> 03:29:49,160 GENETICALLY BASED CANCER BECAUSE 4837 03:29:49,160 --> 03:29:51,600 IT'S THE GROUP THAT'S IN 4838 03:29:51,600 --> 03:29:54,800 GREATEST POTENTIAL IMMEDIATE 4839 03:29:54,800 --> 03:29:56,000 NEEDS AND THEREFORE MAY BE 4840 03:29:56,000 --> 03:30:00,320 WILLING TO UNDERGO THE SORTS OF 4841 03:30:00,320 --> 03:30:02,000 ANALYSIS PARTICIPATE IN A LEVEL 4842 03:30:02,000 --> 03:30:03,440 THAT WOULD PROVIDE THE MOST 4843 03:30:03,440 --> 03:30:05,680 INSIGHTS AND THE SECOND ONE WE 4844 03:30:05,680 --> 03:30:08,480 THOUGHT OF AT LEAST WAS IN ONE 4845 03:30:08,480 --> 03:30:10,160 OF THOSE DISEASES THAT IS STILL 4846 03:30:10,160 --> 03:30:18,960 ON THE RISE AND IN TERMS OF 4847 03:30:18,960 --> 03:30:20,400 MORBIDITY MORTALITY AND WE DO 4848 03:30:20,400 --> 03:30:21,080 HAVE SOLUTIONS. 4849 03:30:21,080 --> 03:30:23,120 I WANT TO CONSIDER NCI FOR 4850 03:30:23,120 --> 03:30:25,400 TAKING THE LEADERSHIP TO CONVENE 4851 03:30:25,400 --> 03:30:28,360 US AND IN PARTICULAR KAREN AND 4852 03:30:28,360 --> 03:30:30,360 NEIL FOR THEIR LEADERSHIP OF THE 4853 03:30:30,360 --> 03:30:30,600 EFFORT. 4854 03:30:30,600 --> 03:30:32,640 I KNOW FROM MY PAST EXPERIENCE 4855 03:30:32,640 --> 03:30:35,960 IT'S DIFFICULT TO TO AND THEY IT 4856 03:30:35,960 --> 03:30:36,360 A MARVELOUS JOB. 4857 03:30:36,360 --> 03:30:41,000 I'M END THERE AND THANK YOU. 4858 03:30:41,000 --> 03:30:45,520 >>THANK YOU, ERNIE. 4859 03:30:45,520 --> 03:30:48,120 I SEE RUBEN'S HANDS EXTENDED. 4860 03:30:48,120 --> 03:30:49,520 RUBEN, YOU ARE UP. 4861 03:30:49,520 --> 03:30:52,040 >>WONDERFUL. 4862 03:30:52,040 --> 03:30:56,720 I JUST APPLAUD THIS ENDEAVOR. 4863 03:30:56,720 --> 03:30:59,400 I THINK NCI IS SUCH A UNIQUE 4864 03:30:59,400 --> 03:31:02,400 ABILITY TO CONVENE. 4865 03:31:02,400 --> 03:31:04,960 BOTH KIND OF CONTINUOUS SPECTRUM 4866 03:31:04,960 --> 03:31:10,360 ACROSS THE GI TRACT AS YOU TAKE 4867 03:31:10,360 --> 03:31:11,560 THIS AS WELL AS FORGING 4868 03:31:11,560 --> 03:31:12,920 COLLABORATIONS ACROSS 4869 03:31:12,920 --> 03:31:13,400 INSTITUTIONS. 4870 03:31:13,400 --> 03:31:14,600 I'VE BEEN INVOLVED WITH A 4871 03:31:14,600 --> 03:31:16,280 PARALLEL EFFORT ON A SMALLER 4872 03:31:16,280 --> 03:31:18,920 SCALE THAT WAS CONVENED BY THE 4873 03:31:18,920 --> 03:31:20,960 LEUKEMIA SOCIETY AS IT RELATED 4874 03:31:20,960 --> 03:31:26,640 TO ACUTE LEUKEMIA TRYING TO 4875 03:31:26,640 --> 03:31:30,720 CONVENE STAKEHOLDERS FROM A 4876 03:31:30,720 --> 03:31:32,760 AROUND THE COMMUNITY WITH 4877 03:31:32,760 --> 03:31:35,920 MOLECULAR DATA TIED TO A 4878 03:31:35,920 --> 03:31:36,880 THERAPEUTIC PIECE. 4879 03:31:36,880 --> 03:31:39,200 THIS DEEP DIVE IN A TIME OR BOTH 4880 03:31:39,200 --> 03:31:40,400 LOOK SUCCESSFUL BUT ALWAYS 4881 03:31:40,400 --> 03:31:41,640 RAISES THE QUESTIONS ARE THERE 4882 03:31:41,640 --> 03:31:43,920 OTHER AREAS THAT ARE A SIMILAR 4883 03:31:43,920 --> 03:31:48,440 METHODOLOGY CAN BE APPLIED TO. 4884 03:31:48,440 --> 03:31:50,720 >>THANK YOU. 4885 03:31:50,720 --> 03:31:52,800 DOES ANYBODY ELSE ON CTAC HAVE 4886 03:31:52,800 --> 03:31:53,800 ANY COMMENTS THAT THEY WOULD 4887 03:31:53,800 --> 03:31:57,280 LIKE TO OFFER? 4888 03:31:57,280 --> 03:32:07,800 >>WROTE SEE ANY HANDS EXTENDED. 4889 03:32:09,480 --> 03:32:14,840 I'LL THEREFORE MOVE TOWARDS 4890 03:32:14,840 --> 03:32:15,920 APPROVAL OF THE REPORT. 4891 03:32:15,920 --> 03:32:18,080 TO I HAVE A MOTION TO ACCEPT THE 4892 03:32:18,080 --> 03:32:18,320 REPORT? 4893 03:32:18,320 --> 03:32:20,160 >>SO MOVED. 4894 03:32:20,160 --> 03:32:23,880 >>AND IS THERE A SECOND. 4895 03:32:23,880 --> 03:32:25,320 >>SECOND. 4896 03:32:25,320 --> 03:32:28,320 >>THANK YOU. 4897 03:32:28,320 --> 03:32:29,040 ANY DISCUSSION? 4898 03:32:29,040 --> 03:32:35,240 ANY FURTHER DISCUSSION? 4899 03:32:35,240 --> 03:32:37,400 IF NOT, I WOULD LIKE TO ASK FOR 4900 03:32:37,400 --> 03:32:41,120 A SHOW OF HANDS IF ANYONE DOES 4901 03:32:41,120 --> 03:32:43,040 NOT ACCEPT THE REPORT. 4902 03:32:43,040 --> 03:32:50,160 THESE ARE THE NAY VOTES. 4903 03:32:50,160 --> 03:32:55,800 AND ARE THERE ANY ABSTENTIONS? 4904 03:32:55,800 --> 03:32:59,120 SHOW OF HANDS. 4905 03:32:59,120 --> 03:32:59,480 OK. 4906 03:32:59,480 --> 03:33:02,080 I THINK WE CAN THEN GO AHEAD AND 4907 03:33:02,080 --> 03:33:05,960 ACCEPT THIS REPORT FROM THE 4908 03:33:05,960 --> 03:33:06,840 CANCER WORKING GROUP. 4909 03:33:06,840 --> 03:33:11,000 THANK YOU SO MUCH. 4910 03:33:11,000 --> 03:33:15,080 WE ARE ALMOST AT THE END OF OUR 4911 03:33:15,080 --> 03:33:15,360 MARATHON. 4912 03:33:15,360 --> 03:33:19,160 I WANT TO TAKE THIS MOMENT TO 4913 03:33:19,160 --> 03:33:20,240 THANK EVERYBODY FOR STICKING 4914 03:33:20,240 --> 03:33:24,200 WITH US TODAY AND FOR ALL THE 4915 03:33:24,200 --> 03:33:25,120 EXCELLENT DISCUSSION THAT WE 4916 03:33:25,120 --> 03:33:25,280 HAD. 4917 03:33:25,280 --> 03:33:28,080 I WOULD LIKE TO GIVE A SPECIAL 4918 03:33:28,080 --> 03:33:34,760 SHOUT OUT TO SHEL SHELIA FOR MAG 4919 03:33:34,760 --> 03:33:36,560 THIS HAPPEN IN SO MANY WAYS AT 4920 03:33:36,560 --> 03:33:40,280 NCI AND SO THANK YOU FOR THE 4921 03:33:40,280 --> 03:33:42,840 EXCELLENT WORK IN OUR NATION'S 4922 03:33:42,840 --> 03:33:43,120 CAPITOL. 4923 03:33:43,120 --> 03:33:46,160 AND I NOW LIKE TO TURN IT OVER 4924 03:33:46,160 --> 03:33:56,600 TO Dr. PRINDIVILLE FOR ANY 4925 03:33:58,720 --> 03:34:01,800 FINAL REMARKS. 4926 03:34:01,800 --> 03:34:05,280 >>YOU ARE MUTED. 4927 03:34:05,280 --> 03:34:06,800 >>SORRY. 4928 03:34:06,800 --> 03:34:10,080 I JUST HAVE TWO SLIDES THAT I 4929 03:34:10,080 --> 03:34:11,600 WANT TO CALL YOUR ATTENTION TO 4930 03:34:11,600 --> 03:34:15,880 TIGER WOODS THINYOUR MEETING MA. 4931 03:34:15,880 --> 03:34:17,120 I WANT TO MAKE SURE YOU ARE 4932 03:34:17,120 --> 03:34:19,040 AWARE OF THESE PROGRAMS. 4933 03:34:19,040 --> 03:34:21,240 ONE OF THEM, IF YOU GO TO THE 4934 03:34:21,240 --> 03:34:21,840 NEXT SLIDE. 4935 03:34:21,840 --> 03:34:26,240 ONE OF THEM IS THE PROGRAM THAT 4936 03:34:26,240 --> 03:34:28,200 RUBEN MENTIONED, JUST REMIND YOU 4937 03:34:28,200 --> 03:34:30,760 ALL THAT NCI HAS CREATED THIS 4938 03:34:30,760 --> 03:34:33,480 NEW AWARD IT'S CALLED THE R50 4939 03:34:33,480 --> 03:34:34,880 AWARD AND WE'VE TALKED ABOUT IT 4940 03:34:34,880 --> 03:34:36,920 BEFORE SO ARE CALL FAMILIAR WITH 4941 03:34:36,920 --> 03:34:38,400 IT AND I DO WANT TO NOTE THERE 4942 03:34:38,400 --> 03:34:40,440 ARE ACTUALLY IS AN OPEN FUNDING 4943 03:34:40,440 --> 03:34:41,760 ANNOUNCEMENT ON THE STREET SO 4944 03:34:41,760 --> 03:34:43,880 THESE SLIDES ARE IN YOUR NEW 4945 03:34:43,880 --> 03:34:45,120 BUSINESS SECTION. 4946 03:34:45,120 --> 03:34:48,360 YOU CAN GO TO THE PAR. 4947 03:34:48,360 --> 03:34:51,160 MOST IMPORTANTLY THE NEXT AWARD 4948 03:34:51,160 --> 03:34:52,880 ACCEPTANCE CYCLE IS 4949 03:34:52,880 --> 03:34:53,360 FEBRUARY 7th. 4950 03:34:53,360 --> 03:34:56,120 I WANT TO CALL THAT ALL TO YOUR 4951 03:34:56,120 --> 03:34:56,400 ATTENTION. 4952 03:34:56,400 --> 03:35:05,280 AND THEN, THE NEXT -- THIS IS 4953 03:35:05,280 --> 03:35:07,000 THE NCI SUMMIT THAT'S COMING UP 4954 03:35:07,000 --> 03:35:09,080 NEXT WEEK FOCUSING ON INCREASING 4955 03:35:09,080 --> 03:35:11,160 DIVERSITY AND EQUITY AND 4956 03:35:11,160 --> 03:35:13,120 INCLUSION FOCUSING ON 4957 03:35:13,120 --> 03:35:14,520 EARLY-PHASE CLINICAL TRIALS SO 4958 03:35:14,520 --> 03:35:17,720 WE HOPE TO HAVE A BROADEN 4959 03:35:17,720 --> 03:35:19,640 GAGEMENT WITH OUR PHARMACEUTICAL 4960 03:35:19,640 --> 03:35:22,960 PARTNERS AND OTHERS AND FOLKS 4961 03:35:22,960 --> 03:35:24,960 ARE TALLLY VIRTUAL FOLKS ARE 4962 03:35:24,960 --> 03:35:26,800 ACTUALLY ABLE TO REGISTER AND 4963 03:35:26,800 --> 03:35:28,760 WATCH THIS SO THE LINK TO THAT 4964 03:35:28,760 --> 03:35:31,000 REGISTRATION IS AT THE BOTTOM OF 4965 03:35:31,000 --> 03:35:32,720 THE SLIDE. 4966 03:35:32,720 --> 03:35:34,920 AND THEN, AGAIN, THESE LINKS ARE 4967 03:35:34,920 --> 03:35:37,600 ALSO IN THE MATERIALS SO YOU CAN 4968 03:35:37,600 --> 03:35:39,080 SIGN UP FOR THIS IF YOU WOULD 4969 03:35:39,080 --> 03:35:40,880 LIKE TO ATTEND AND THEN FINAL 4970 03:35:40,880 --> 03:35:43,960 SLIDE IS JUST REMINDING YOU OF 4971 03:35:43,960 --> 03:35:46,960 OUR FUTURE MEETI MEETI MEETINGSE 4972 03:35:46,960 --> 03:35:48,560 ACTUALLY SET THROUGH 2024 SO 4973 03:35:48,560 --> 03:35:50,320 PLEASE NOTE YOUR CALENDARS. 4974 03:35:50,320 --> 03:35:54,440 SO, NEAL, THAT'S ALL OTHER THAN 4975 03:35:54,440 --> 03:35:55,760 THANKS TO THE GREAT TEAM THAT I 4976 03:35:55,760 --> 03:35:57,800 HAVE SUPPORTING ME HERE AND AS 4977 03:35:57,800 --> 03:36:02,200 YOU ALL KNOW FROM INTERACTING 4978 03:36:02,200 --> 03:36:04,280 WITH TAWNI, IRIS AND ASHLEY VERY 4979 03:36:04,280 --> 03:36:06,440 MUCH IN THE LAST SEVERAL WEEKS 4980 03:36:06,440 --> 03:36:10,560 GETTING READY FOR THIS. 4981 03:36:10,560 --> 03:36:13,480 SO THANK YOU. 4982 03:36:13,480 --> 03:36:16,640 WILL WE BE IN-PERSON AT OUR NEXT 4983 03:36:16,640 --> 03:36:16,880 MEETING? 4984 03:36:16,880 --> 03:36:22,000 >>WELL, OK, SO, TWO COMMENTS ON 4985 03:36:22,000 --> 03:36:22,200 THAT. 4986 03:36:22,200 --> 03:36:23,720 SO, NUMBER ONE, TRADITIONALLY 4987 03:36:23,720 --> 03:36:25,680 WE'LL ACTUALLY ALWAYS MET 4988 03:36:25,680 --> 03:36:28,240 VIRTUALLY IN THE WINTER WHEN WE 4989 03:36:28,240 --> 03:36:29,680 MEET IN MARCH BECAUSE WE'VE HAD 4990 03:36:29,680 --> 03:36:31,600 A LOT OF CHALLENGES GETTING 4991 03:36:31,600 --> 03:36:34,080 PEOPLE HERE WITH SNOW STORMS. 4992 03:36:34,080 --> 03:36:36,280 WE CAN BEGIN TO HAVE IN-PERSON 4993 03:36:36,280 --> 03:36:38,000 MEETINGS BUT, IT'S HARD SO THE 4994 03:36:38,000 --> 03:36:39,480 QUESTION IS WHETHER WE DO IT IN 4995 03:36:39,480 --> 03:36:42,040 NEAR OR WE DO IT IN THE SUMMER 4996 03:36:42,040 --> 03:36:43,240 WHEN WE'RE MORE LIKELY TO HAVE 4997 03:36:43,240 --> 03:36:44,840 NO CHALLENGES GETTING PEOPLE 4998 03:36:44,840 --> 03:36:45,040 HERE. 4999 03:36:45,040 --> 03:36:49,600 WE'RE WORKING ON DOING THAT AND 5000 03:36:49,600 --> 03:36:51,880 WE HOPE THAT MEMBERS WILL COME. 5001 03:36:51,880 --> 03:36:54,320 I THINK A LOT OF THIS WILL -- 5002 03:36:54,320 --> 03:36:57,520 WE'RE STILL IN THIS VIRTUAL 5003 03:36:57,520 --> 03:36:58,440 HYBRID WORLD AS WELL. 5004 03:36:58,440 --> 03:37:00,400 WE ARE AIMING FOR THAT. 5005 03:37:00,400 --> 03:37:01,280 >>GOOD. 5006 03:37:01,280 --> 03:37:02,400 THANK YOU FOR THE VOTE OF ON TA 5007 03:37:02,400 --> 03:37:03,720 MITCH. 5008 03:37:03,720 --> 03:37:04,000 OPTIMISM. 5009 03:37:04,000 --> 03:37:05,960 >>THANK YOU, EVERYBODY. 5010 03:37:05,960 --> 03:37:06,840 ENJOY THE REST OF THE DAY. 5011 03:37:06,840 --> 00:00:00,000 >>THANK YOU, BYE-BYE.