1 00:00:06,421 --> 00:00:07,823 >> THANK YOU. 2 00:00:07,823 --> 00:00:08,590 WELCOME, EVERYBODY. 3 00:00:08,590 --> 00:00:10,726 I APPRECIATE YOU JOINING US 4 00:00:10,726 --> 00:00:11,326 TODAY. 5 00:00:11,326 --> 00:00:13,662 I WANT TO WELCOME YOU TO THE 6 00:00:13,662 --> 00:00:15,330 57th CTAC MEETING. 7 00:00:15,330 --> 00:00:19,434 WE WANT TO WELCOME DR. DESTINE 8 00:00:19,434 --> 00:00:23,405 SENIOR ADVISORY AND EXTERNAL 9 00:00:23,405 --> 00:00:25,474 STRATEGY AND ONCOLOGY IN PLACE 10 00:00:25,474 --> 00:00:26,775 OF DR. CASTER. 11 00:00:26,775 --> 00:00:30,512 I'D LIKE TO READ THE OPENING 12 00:00:30,512 --> 00:00:30,779 STATEMENT. 13 00:00:30,779 --> 00:00:33,515 AS COMMITTEE MEMBERS, I WANT TO 14 00:00:33,515 --> 00:00:36,084 REMIND YOU THAT WE MUST AB SENT 15 00:00:36,084 --> 00:00:37,886 YOURSELF DURING SPECIFIC 16 00:00:37,886 --> 00:00:38,854 DISCUSSIONS WHENEVER YOUR 17 00:00:38,854 --> 00:00:39,855 PARTICIPATION OR DELIBERATIONS 18 00:00:39,855 --> 00:00:43,358 ON A PRODUCT, PROGRAM OR OTHER 19 00:00:43,358 --> 00:00:46,528 MATTER WOULD CONSTITUTE A 20 00:00:46,528 --> 00:00:48,664 CONFLICT OF FROM OR CREATE THE 21 00:00:48,664 --> 00:00:51,333 APPEARANCE OF CONFLICT OF 22 00:00:51,333 --> 00:00:51,600 INTEREST. 23 00:00:51,600 --> 00:00:54,136 IT'S INCUMBENT ON YOU TO ADVISE 24 00:00:54,136 --> 00:00:55,337 THE EXECUTIVE SECRETARY FOR 25 00:00:55,337 --> 00:00:56,938 ACTIONS REGARDING THAT MATTER. 26 00:00:56,938 --> 00:00:59,341 IN LIGHT OF THE CURRENT POLICIES 27 00:00:59,341 --> 00:01:01,043 REGARDING CONFLICT OF INTEREST 28 00:01:01,043 --> 00:01:03,445 BASED ON FINANCIAL HOLDINGS OF 29 00:01:03,445 --> 00:01:04,813 SPECIAL GOVERNMENT EMPLOYEES 30 00:01:04,813 --> 00:01:06,915 INCLUDING ALL OF US ON THIS 31 00:01:06,915 --> 00:01:07,349 COMMITTEE. 32 00:01:07,349 --> 00:01:09,551 WE MUST DEPEND ON YOU TO 33 00:01:09,551 --> 00:01:10,619 VOLUNTARILY ABSENT YOURSELF 34 00:01:10,619 --> 00:01:12,154 DURING ANY AND ALL DISCUSSIONS 35 00:01:12,154 --> 00:01:18,160 OF MATTERS THAT COULD 36 00:01:18,160 --> 00:01:19,795 CONCEIVABLY IMPACT THE STATUS OF 37 00:01:19,795 --> 00:01:22,130 THOSE HOLDINGS AND TRUST YOUR 38 00:01:22,130 --> 00:01:24,132 JUDGMENT ON THESE INSTANCES. 39 00:01:24,132 --> 00:01:27,336 BY LAW A QUORUM IS REQUIRED FOR 40 00:01:27,336 --> 00:01:29,571 WHICH A VOTE OCCURS IN OPEN 41 00:01:29,571 --> 00:01:29,838 SESSION. 42 00:01:29,838 --> 00:01:31,940 DURING THIS MEETING A MINIMUM OF 43 00:01:31,940 --> 00:01:34,810 10 APPOINTED MEMBERS MUST BE 44 00:01:34,810 --> 00:01:35,877 PRESENT TO VOICE THEIR VOTES. 45 00:01:35,877 --> 00:01:39,348 NEW MEMBERS WHO ARE NOT CURRENT 46 00:01:39,348 --> 00:01:47,923 MEMBERS OF OTHER NCI BOARDS ARE 47 00:01:47,923 --> 00:01:49,224 NEED TO BE CLEARED OF HHS OFFICE 48 00:01:49,224 --> 00:01:50,959 AND HUMAN RESOURCES. 49 00:01:50,959 --> 00:01:53,328 NOW I'LL READ THE PUBLIC 50 00:01:53,328 --> 00:01:53,595 STATEMENT. 51 00:01:53,595 --> 00:01:57,132 MEMBERS OF THE PUBLIC WHO MAY 52 00:01:57,132 --> 00:02:00,102 WISH TO EXPRESS VIEWS REGARDING 53 00:02:00,102 --> 00:02:01,269 ITEMS DURING THE MEETING MAY 54 00:02:01,269 --> 00:02:06,141 WRITE THE EXECUTIVE SECRETARY, 55 00:02:06,141 --> 00:02:09,911 SHEILA PRINDIVILLE WITHIN 10 56 00:02:09,911 --> 00:02:12,581 DAYS AND WILL BE CAREFULLY 57 00:02:12,581 --> 00:02:14,049 CONSIDERED. 58 00:02:14,049 --> 00:02:14,549 THANK YOU. 59 00:02:14,549 --> 00:02:16,618 THIS MEETING IS BEING BROADCAST 60 00:02:16,618 --> 00:02:19,354 AND AVAILABLE TO THE PUBLIC AT 61 00:02:19,354 --> 00:02:22,758 THE NIH VIDEOCAST WEBSITE AND 62 00:02:22,758 --> 00:02:23,592 WILL BE ARCHIVED FOR VIEWING AT 63 00:02:23,592 --> 00:02:24,426 A LATER POINT IN TIME. 64 00:02:24,426 --> 00:02:27,329 I WANTED TO NOTE THAT THE FUTURE 65 00:02:27,329 --> 00:02:29,664 MEETING DATES WERE SENT OUT TO 66 00:02:29,664 --> 00:02:29,831 YOU. 67 00:02:29,831 --> 00:02:31,333 THERE WERE THREE NEW DATES ADDED 68 00:02:31,333 --> 00:02:34,536 FOR YOUR CALENDARS. 69 00:02:34,536 --> 00:02:37,672 AND THOSE WERE SENT OUT PRIOR TO 70 00:02:37,672 --> 00:02:37,973 THE MEETING. 71 00:02:37,973 --> 00:02:39,775 A FEW OTHER REMINDERS. 72 00:02:39,775 --> 00:02:41,243 PLEASE KEEP YOUR CAMERAS ON AT 73 00:02:41,243 --> 00:02:43,345 ALL TIMES TO ENSURE THE MEETING 74 00:02:43,345 --> 00:02:45,881 IS INTERACTIVE AS POSSIBLE. 75 00:02:45,881 --> 00:02:48,183 USE THE RAISE YOUR HAND FEATURE 76 00:02:48,183 --> 00:02:50,519 IN WEBEX TO ASK A QUESTION OR 77 00:02:50,519 --> 00:02:53,088 COMMENT AND WE'LL TRY TO MAKE 78 00:02:53,088 --> 00:02:55,056 SURE EVERYBODY GETS CALLED UPON 79 00:02:55,056 --> 00:02:58,360 AND REMAIN MUTED DURING THE 80 00:02:58,360 --> 00:03:00,128 WEBINAR UNLESS YOU'RE CALLED TO 81 00:03:00,128 --> 00:03:04,766 SPEAK OR ASKING A QUESTION AND 82 00:03:04,766 --> 00:03:06,301 THE RESPECTIVE PERSON WILL BE 83 00:03:06,301 --> 00:03:08,036 CALLED UPON. 84 00:03:08,036 --> 00:03:09,404 REMAIN PRESENT IN THE VIRTUAL 85 00:03:09,404 --> 00:03:11,039 ROOM FOR THE FULL DURATION OF 86 00:03:11,039 --> 00:03:11,673 THE MEETING. 87 00:03:11,673 --> 00:03:13,809 A QUORUM OF BOARD MEMBERS IS 88 00:03:13,809 --> 00:03:14,776 REQUIRED FOR ANY VOTE AND 89 00:03:14,776 --> 00:03:17,012 SEVERAL VOTES ARE EXPECTED 90 00:03:17,012 --> 00:03:17,646 DURING THIS BUSINESS MEETING. 91 00:03:17,646 --> 00:03:21,016 BECAUSE OF THE TIMING OF THEIR 92 00:03:21,016 --> 00:03:23,852 MOTIONS IT'S NOT PRE DETERMINED 93 00:03:23,852 --> 00:03:25,187 YOUR FULL ATTENDANCE IS 94 00:03:25,187 --> 00:03:26,121 REQUESTED DURING THE ENTIRE 95 00:03:26,121 --> 00:03:26,955 MEETING. 96 00:03:26,955 --> 00:03:27,622 ANY QUESTIONS ABOUT ANY OF THOSE 97 00:03:27,622 --> 00:03:32,360 STATEMENTS? 98 00:03:32,360 --> 00:03:32,694 ALL RIGHT. 99 00:03:32,694 --> 00:03:35,363 NOW I'M GOING TO TALK ABOUT A 100 00:03:35,363 --> 00:03:39,334 MOTION TO VOTE AND ACCEPT THE 101 00:03:39,334 --> 00:03:40,769 SUMMARY MEETING FROM NOVEMBER 6 102 00:03:40,769 --> 00:03:41,570 CTAC MEETING THE LAST ONE. 103 00:03:41,570 --> 00:03:43,338 IS THERE A MOTION TO ACCEPT THE 104 00:03:43,338 --> 00:03:45,574 SUMMARY? 105 00:03:45,574 --> 00:03:45,874 >> SO MOVED. 106 00:03:45,874 --> 00:03:51,446 >> A SECOND? 107 00:03:51,446 --> 00:03:54,216 OKAY. 108 00:03:54,216 --> 00:03:55,350 ANY DISCUSSION? 109 00:03:55,350 --> 00:03:58,386 BY SHOW OF HANDS, PLEASE SEE WHO 110 00:03:58,386 --> 00:04:08,063 WILL ACCEPT THE SUMMARY. 111 00:04:08,063 --> 00:04:09,731 ANYONE WHO DOES NOT ACCEPT THE 112 00:04:09,731 --> 00:04:13,835 SUMMARY OR ABSTENTIONS? 113 00:04:13,835 --> 00:04:15,470 OKAY THE SUMMARY PRASS. 114 00:04:15,470 --> 00:04:16,705 THANK YOU. 115 00:04:16,705 --> 00:04:18,573 -- PASSES. 116 00:04:18,573 --> 00:04:19,674 THANK YOU. 117 00:04:19,674 --> 00:04:23,378 ANY OTHER DISCUSSION ITEMS 118 00:04:23,378 --> 00:04:30,919 BRIEFLY? 119 00:04:30,919 --> 00:04:32,287 ALL RIGHT. 120 00:04:32,287 --> 00:04:36,258 THE NEXT ITEM IS DR. LOWY THE 121 00:04:36,258 --> 00:04:38,994 DEPUTY DIRECTOR OF NCI WITH 122 00:04:38,994 --> 00:04:40,662 BRIEF OPENING COMMENTS. 123 00:04:40,662 --> 00:04:40,962 THANK YOU. 124 00:04:40,962 --> 00:04:42,664 >> THANKS VERY MUCH. 125 00:04:42,664 --> 00:04:44,032 GOOD MORNING, EVERYONE. 126 00:04:44,032 --> 00:04:47,335 IT REALLY IS A PLEASURE FOR ME 127 00:04:47,335 --> 00:04:49,871 TO BE HERE. 128 00:04:49,871 --> 00:04:53,708 I'M GLAD CTAC IS CONVENING AT 129 00:04:53,708 --> 00:04:59,314 SUCH AN IMPORTANT TIME FOR THOSE 130 00:04:59,314 --> 00:05:01,383 WHO DO NOT KNOW I'VE BEEN 131 00:05:01,383 --> 00:05:05,220 SERVING AS THE ACTING DIRECTOR 132 00:05:05,220 --> 00:05:09,758 SINCE JANUARY 20th AND IT'S BEEN 133 00:05:09,758 --> 00:05:13,595 A TUMULTUOUS TIME. 134 00:05:13,595 --> 00:05:15,297 NOW MORE THAN EVER ADVISORY 135 00:05:15,297 --> 00:05:20,735 BOARDS LIKE YOURS PLAY A VIOLATE 136 00:05:20,735 --> 00:05:23,605 VITAL ROLE TO ENSURE WE REMAIN 137 00:05:23,605 --> 00:05:26,374 RESPONSIVE TO THE NEEDS AND 138 00:05:26,374 --> 00:05:28,810 PUBLIC AND RESEARCH COMMUNITY. 139 00:05:28,810 --> 00:05:31,346 IN FACT OUR NUMBER OF EXTRAMURAL 140 00:05:31,346 --> 00:05:33,982 COMMITTEES HAS GONE FROM FIVE TO 141 00:05:33,982 --> 00:05:35,083 TWO INCLUDING CTAC. 142 00:05:35,083 --> 00:05:40,722 THIS IS JUST ONE EXAMPLE OF MY 143 00:05:40,722 --> 00:05:41,222 POWER. 144 00:05:41,222 --> 00:05:43,358 A FEW MONTHS AGO NCI WAS ASKED 145 00:05:43,358 --> 00:05:46,595 TO JUSTIFY THE NEED FOR EACH 146 00:05:46,595 --> 00:05:50,265 COMMITTEE EXCEPT FOR NCAB AND WE 147 00:05:50,265 --> 00:05:53,368 WROTE WHAT I THOUGHT WERE 148 00:05:53,368 --> 00:05:57,739 SPIRITED DEFENSES OF THE FINLAC 149 00:05:57,739 --> 00:06:00,675 AND NCRA AND CTAC COMMITTEES. 150 00:06:00,675 --> 00:06:03,945 AND CTAC IS THE ONLY ONE OF 151 00:06:03,945 --> 00:06:11,686 THESE LEFT STANDING. 152 00:06:11,686 --> 00:06:13,922 I'M GOING TO DISCUSS SEVERAL 153 00:06:13,922 --> 00:06:15,824 TOPICS TODAY. 154 00:06:15,824 --> 00:06:19,294 UP FRONT FUNDING, NCAB WORKING 155 00:06:19,294 --> 00:06:21,229 GROUP, CHIEF SCIENCE ADVISORY, 156 00:06:21,229 --> 00:06:23,365 CANCER MORTALITY RATE TRENDS AND 157 00:06:23,365 --> 00:06:25,233 THE COMMITMENT OF NCI STAFF. 158 00:06:25,233 --> 00:06:28,036 BUT BEFORE I GET TO THOSE 159 00:06:28,036 --> 00:06:31,339 TOPICS, I WANT TO TELL YOU ABOUT 160 00:06:31,339 --> 00:06:34,242 A FEW IMPORTANT CHANGES WITH 161 00:06:34,242 --> 00:06:38,079 DIRECT IMPACT ON CTAC. 162 00:06:38,079 --> 00:06:42,517 FIRST, PAULETTE GRAY RETIRED AT 163 00:06:42,517 --> 00:06:46,154 THE END OF JUNE. 164 00:06:46,154 --> 00:06:56,865 AN ERA HAS END ED SHE DID SO MAY 165 00:06:59,401 --> 00:07:00,068 THINGS. 166 00:07:00,068 --> 00:07:02,804 DINAH SINGER HAS BECOME THE 167 00:07:02,804 --> 00:07:07,342 DIRECTOR OF THE DIVISION OF 168 00:07:07,342 --> 00:07:16,951 EXTRAMURAL ACTIVITIES AND SHAMLA 169 00:07:16,951 --> 00:07:19,387 IS THE ASSOCIATE DIRECTOR FOR 170 00:07:19,387 --> 00:07:21,222 SCIENTIFIC REVIEW AND POLICY. 171 00:07:21,222 --> 00:07:25,193 I'D LIKE TO DEAL WITH THE FIRST 172 00:07:25,193 --> 00:07:26,561 ISSUE IS THE UPFRONT FUNDING 173 00:07:26,561 --> 00:07:29,764 POLICY AND I HAVE THREE SLIDES 174 00:07:29,764 --> 00:07:32,734 ON IT. 175 00:07:32,734 --> 00:07:36,304 SO IN JUNE THE OFFICE OF 176 00:07:36,304 --> 00:07:38,440 MANAGEMENT AND BUDGET INFORMED 177 00:07:38,440 --> 00:07:40,275 NIH EACH INSTITUTE MUST USE UP 178 00:07:40,275 --> 00:07:43,778 FRONT FUNDING FOR AT LEAST 50% 179 00:07:43,778 --> 00:07:47,148 OF ITS REMAINING RPG FUNDS. 180 00:07:47,148 --> 00:07:50,118 NCI CAN CHOOSE WHICH AWARDS TO 181 00:07:50,118 --> 00:07:52,554 DESIGNATE FOR UP FRONT FUNDING 182 00:07:52,554 --> 00:07:56,157 PROVIDING THE TOTAL DOLLARS 183 00:07:56,157 --> 00:07:58,727 REWARDED ARE 50% OR MORE OF THE 184 00:07:58,727 --> 00:08:01,096 REMAINING RPG FUNDING. 185 00:08:01,096 --> 00:08:04,866 SO WHAT IS UP FRONT FUNDING? 186 00:08:04,866 --> 00:08:07,335 FUND FOR THE ENTIRE AWARD PERIOD 187 00:08:07,335 --> 00:08:10,572 WHICH IS USUALLY FIVE YEARS ARE 188 00:08:10,572 --> 00:08:13,007 OBLIGATED IN THE YEAR THE AWARD 189 00:08:13,007 --> 00:08:14,142 IS MADE. 190 00:08:14,142 --> 00:08:16,811 ALL THE FUNDS ARE MADE FROM THE 191 00:08:16,811 --> 00:08:18,980 YEAR OF THE AWARD. 192 00:08:18,980 --> 00:08:21,916 IT'S A SPECIAL CASE OF MULTIYEAR 193 00:08:21,916 --> 00:08:23,752 FUNDING WHICH REFERS TO 194 00:08:23,752 --> 00:08:25,053 OBLIGATING FUNDS FOR MORE THAN 195 00:08:25,053 --> 00:08:25,587 ONE YEAR. 196 00:08:25,587 --> 00:08:28,022 SOMETIMES A FIVE-YEAR AWARD WE 197 00:08:28,022 --> 00:08:29,991 MIGHT MAKE TWO OR THREE-YEAR 198 00:08:29,991 --> 00:08:34,362 AWARDS BUT NOW UP FRONT FUNDING 199 00:08:34,362 --> 00:08:37,799 IS ALL FIVE YEARS AND INSTEAD OF 200 00:08:37,799 --> 00:08:41,503 BEING LEFT UP TO NCI, THIS IS 201 00:08:41,503 --> 00:08:46,307 WHAT WE ARE REQUIRED TO DO. 202 00:08:46,307 --> 00:08:48,209 WE USUALLY HAVE JUST FUNDED ONE 203 00:08:48,209 --> 00:08:51,279 YEAR AND THEN FUNDED EACH OF THE 204 00:08:51,279 --> 00:08:54,816 SUBSEQUENT YEARS WITH YEAR BY 205 00:08:54,816 --> 00:08:56,785 YEAR FUNDING. 206 00:08:56,785 --> 00:08:58,586 I SHOULD POINT OUT THE LAST 207 00:08:58,586 --> 00:08:59,754 BULLET POINT 50% UP FRONT 208 00:08:59,754 --> 00:09:02,023 FUNDING IS INCLUDED IN THE 209 00:09:02,023 --> 00:09:03,658 PRESIDENT'S PROPOSED BUDGET FOR 210 00:09:03,658 --> 00:09:07,028 FY26 AND IT HAS BEEN SAID THAT 211 00:09:07,028 --> 00:09:09,764 100% OF UP FRONT RPG FUNDING 212 00:09:09,764 --> 00:09:11,399 WILL BE INCLUDED IN THE 213 00:09:11,399 --> 00:09:16,204 PRESIDENT'S PROPOSED BUDGET FOR 214 00:09:16,204 --> 00:09:18,773 FY27 ALTHOUGH THE BUDGET ITSELF 215 00:09:18,773 --> 00:09:27,916 IS NOT SET PUBLIC. 216 00:09:27,916 --> 00:09:29,884 THE NEXT IS A DIAGRAM I HAVE 217 00:09:29,884 --> 00:09:31,319 MADE TO EXPLAIN THE DIFFERENCES 218 00:09:31,319 --> 00:09:33,288 BETWEEN UM FRONT FUNDING AND 219 00:09:33,288 --> 00:09:43,665 YEAR BY YEAR FUNDING. 220 00:09:45,133 --> 00:09:46,568 AND UP FRONT FUNDING IN BROWN 221 00:09:46,568 --> 00:09:49,003 AND ON THE BOTTOM YEAR BY YEAR 222 00:09:49,003 --> 00:09:51,339 FUNDING IN GREEN. 223 00:09:51,339 --> 00:09:54,742 I'D LIKE YOU TO FOCUS FIRST ON 224 00:09:54,742 --> 00:09:58,680 YEAR ONE, WHICH I'VE OUTLINED 225 00:09:58,680 --> 00:10:04,185 WITH THE OPEN RECTANGLE. 226 00:10:04,185 --> 00:10:06,187 WITH YEAR BY YEAR FUNDING WHICH 227 00:10:06,187 --> 00:10:08,723 IS WHAT WE ARE USED TO DOING AS 228 00:10:08,723 --> 00:10:10,592 SHOWN IN THE GREEN, LET'S SAY WE 229 00:10:10,592 --> 00:10:15,330 HAD ENOUGH MONEY WE COULD FUND 230 00:10:15,330 --> 00:10:19,567 FIVE AWARDS FOR THAT YEAR. 231 00:10:19,567 --> 00:10:22,503 THAT'S WHAT DEPICTED BY THE FIVE 232 00:10:22,503 --> 00:10:24,973 GREEN RECTANGLES ON THE BOTTOM. 233 00:10:24,973 --> 00:10:27,208 BY CONTRAST WITH UP FRONT 234 00:10:27,208 --> 00:10:28,476 FUNDING IN YEAR ONE, YOU HAVE 235 00:10:28,476 --> 00:10:30,078 THE SAME AMOUNT OF MONEY BUT YOU 236 00:10:30,078 --> 00:10:36,050 NEED TO DEVOTE ALL OF IT TO ONE 237 00:10:36,050 --> 00:10:36,584 AWARD. 238 00:10:36,584 --> 00:10:38,419 THERE WOULD BE FIVE AWARDS BY 239 00:10:38,419 --> 00:10:41,122 YEAR BY YEAR FUNDING AND ONE 240 00:10:41,122 --> 00:10:43,291 AWARD WITH UP FRONT FUNDING. 241 00:10:43,291 --> 00:10:45,960 OF COURSE FROM THE PERSPECTIVE 242 00:10:45,960 --> 00:10:47,362 OF THE PEOPLE WHO GET THE UP 243 00:10:47,362 --> 00:10:50,365 FRONT FUNDING, THEY ARE CERTAIN 244 00:10:50,365 --> 00:10:55,103 OF HAVING THE MONEY THROUGHOUT 245 00:10:55,103 --> 00:10:56,371 THE FIVE YEARS. 246 00:10:56,371 --> 00:10:58,106 IN THE SECOND YEAR ASSUMING YOU 247 00:10:58,106 --> 00:11:00,909 HAD THE SAME AMOUNT OF MONEY YOU 248 00:11:00,909 --> 00:11:04,445 WOULD FUND ONE MORE AWARD WITH 249 00:11:04,445 --> 00:11:06,547 UP FRONT FUNDING AND THE SECOND 250 00:11:06,547 --> 00:11:10,084 YEAR WITH YEAR BY YEAR FUNDING. 251 00:11:10,084 --> 00:11:11,486 THAT GOES ON THROUGH YEAR FIVE. 252 00:11:11,486 --> 00:11:15,056 AND AT THE END OF YEAR FIVE, YOU 253 00:11:15,056 --> 00:11:18,927 HAVE SPENT THE SAME AMOUNT OF 254 00:11:18,927 --> 00:11:22,664 MONEY ON THE RESEARCH AND YOU 255 00:11:22,664 --> 00:11:27,368 NOW HAVE FIVE YEARS -- FIVE 256 00:11:27,368 --> 00:11:28,636 AWARDS YOU HAVE MADE BUT BECAUSE 257 00:11:28,636 --> 00:11:32,073 OF WHEN THE AWARDS WERE MADE, 258 00:11:32,073 --> 00:11:34,943 WITH YEAR BY YEAR FUNDING, THE 259 00:11:34,943 --> 00:11:40,982 FIVE YEARS OF THE FIVE AWARDS 260 00:11:40,982 --> 00:11:42,050 GIVE 25 RESEARCH YEARS OF 261 00:11:42,050 --> 00:11:42,450 FUNDING. 262 00:11:42,450 --> 00:11:44,152 ON THE OTHER HAND, IF YOU LOOK 263 00:11:44,152 --> 00:11:47,355 ABOVE AT THE UP FRONT FUNDING 264 00:11:47,355 --> 00:11:50,825 BECAUSE SO MUCH OF THE FUNDING 265 00:11:50,825 --> 00:11:53,895 ACTUALLY GOES INTO YEARS SIX 266 00:11:53,895 --> 00:11:56,798 THROUGH 10, YOU ONLY GET 15 267 00:11:56,798 --> 00:12:00,368 RESEARCH YEARS OF FUNDING. 268 00:12:00,368 --> 00:12:02,270 S BY THE TIME YOU GET TO THE 269 00:12:02,270 --> 00:12:04,839 SECOND FIVE YEAR IN THE 270 00:12:04,839 --> 00:12:06,507 HYPOTHETICAL EXAMPLE, BOTH GIVE 271 00:12:06,507 --> 00:12:08,142 25 RESEARCH YEARS OF FUNDING BUT 272 00:12:08,142 --> 00:12:12,780 IT TAKES A WHILE TO GET THERE. 273 00:12:12,780 --> 00:12:15,883 THE NEXT SLIDE SUMMARIZES WHAT I 274 00:12:15,883 --> 00:12:16,851 THINK WOULD HAPPEN. 275 00:12:16,851 --> 00:12:18,920 ONCE STEADY STATE IS ACHIEVED UP 276 00:12:18,920 --> 00:12:20,955 FRONT FUNDING AND YEAR BY YEAR 277 00:12:20,955 --> 00:12:21,723 FUNDING RESULT IN THE SIMILAR 278 00:12:21,723 --> 00:12:24,125 NUMBER OF AWARDS AND SIMILAR 279 00:12:24,125 --> 00:12:27,328 NUMBER OF RESEARCH YEARS 280 00:12:27,328 --> 00:12:27,628 CONDUCTED. 281 00:12:27,628 --> 00:12:29,530 FOR FIVE YEAR AWARDS IT WOULD 282 00:12:29,530 --> 00:12:32,133 TAKE FIVE YEARS OR MORE TO 283 00:12:32,133 --> 00:12:33,201 ACHIEVE STEADY STATE. 284 00:12:33,201 --> 00:12:36,371 THE SECOND BULLET EMPHASIZES 285 00:12:36,371 --> 00:12:37,672 DURING THE RAMP UP PERIOD THERE 286 00:12:37,672 --> 00:12:40,341 WOULD BE FEWER AWARDS INITIALLY 287 00:12:40,341 --> 00:12:42,377 WITH UP FRONT FUNDING. 288 00:12:42,377 --> 00:12:44,445 THE NUMBER OF RESEARCH YEARS 289 00:12:44,445 --> 00:12:47,348 CONDUCTED WOULD BE FEWER THAN 290 00:12:47,348 --> 00:12:49,751 WITH YEAR BY YEAR FUNDING DURING 291 00:12:49,751 --> 00:12:52,120 THE RAMP UP PERIOD AND IT IS 292 00:12:52,120 --> 00:12:53,755 REASONABLE TO SPECULATE THAT 293 00:12:53,755 --> 00:12:57,458 THERE WOULD BE SUBSTANTIAL LOSS 294 00:12:57,458 --> 00:13:00,695 OF PRINCIPLE INVESTIGATORS AND 295 00:13:00,695 --> 00:13:08,069 STAFF. 296 00:13:08,069 --> 00:13:11,005 I WANT TO TELL YOU NOW ABOUT A 297 00:13:11,005 --> 00:13:13,808 NEW NCAB WORKING GROUP. 298 00:13:13,808 --> 00:13:15,343 DURING THE MEETING THE BOARD 299 00:13:15,343 --> 00:13:19,347 APPROVED THE ESTABLISHMENT OF A 300 00:13:19,347 --> 00:13:21,282 NEW AD HOC RESEARCH GROUP ON 301 00:13:21,282 --> 00:13:22,750 CONCEPTS AND PROGRAMS. 302 00:13:22,750 --> 00:13:24,052 WE ENVISION THIS GROUP WILL TAKE 303 00:13:24,052 --> 00:13:27,355 ON MANY OF THE RESPONSIBILITIES 304 00:13:27,355 --> 00:13:30,725 PREVIOUSLY HANDLED BY THE NOW 305 00:13:30,725 --> 00:13:33,561 RETIRED BOARD OF SCIENTIFIC 306 00:13:33,561 --> 00:13:34,328 ADVISORS. 307 00:13:34,328 --> 00:13:36,531 A DIRECT RELEVANCE TO CTAC, WE 308 00:13:36,531 --> 00:13:38,433 INTEND FOR THE NEW WORKING GROUP 309 00:13:38,433 --> 00:13:42,737 TO BE MADE UP OF A BROAD RANGE 310 00:13:42,737 --> 00:13:45,773 OF CANCER RESEARCHERS AND 311 00:13:45,773 --> 00:13:46,374 ADVOCATES. 312 00:13:46,374 --> 00:13:49,577 THIS INCLUDES THE CURRENT 313 00:13:49,577 --> 00:13:53,481 MEMBERSHIP OF CTAC. 314 00:13:53,481 --> 00:13:57,118 THEN I'M PLEASED CTAC TODAY WILL 315 00:13:57,118 --> 00:14:00,888 BE CONSIDERING THE ESTABLISHMENT 316 00:14:00,888 --> 00:14:02,490 OF WORKING GROUPS ON STREAMLINE 317 00:14:02,490 --> 00:14:03,825 DATA COLLECTION AND ADVANCING 318 00:14:03,825 --> 00:14:05,893 INNOVATION AND STRENGTHENING THE 319 00:14:05,893 --> 00:14:08,629 ROLE OF PATIENT PERSPECTIVE IN 320 00:14:08,629 --> 00:14:09,030 CANCER RESEARCH. 321 00:14:09,030 --> 00:14:10,998 NEXT IS SLIDE. 322 00:14:10,998 --> 00:14:14,936 THE NEXT TOPIC IS THE CHIEF NEW 323 00:14:14,936 --> 00:14:19,073 POSITION OF CHIEF SCIENTIFIC 324 00:14:19,073 --> 00:14:19,307 ADVISER. 325 00:14:19,307 --> 00:14:25,146 DR. GEORGE SEV OF -- DR 326 00:14:25,146 --> 00:14:29,383 DR. SEGUNAS IS FROM EAST 327 00:14:29,383 --> 00:14:32,453 CAROLINA UNIVERSITY AND 328 00:14:32,453 --> 00:14:39,327 PRESIDENT DEN SL SHALLY 329 00:14:39,327 --> 00:14:42,263 APPOINTED -- PRESIDENTIALLY 330 00:14:42,263 --> 00:14:44,832 APPOINTED DIRECTOR AND WAS THE 331 00:14:44,832 --> 00:14:46,734 FORMER DIRECTOR OF HRSA DURING 332 00:14:46,734 --> 00:14:47,702 THE FIRST TRUMP ADMINISTRATION 333 00:14:47,702 --> 00:14:49,570 AS THE HEALTH RESOURCES AND 334 00:14:49,570 --> 00:14:50,805 SERVICES ADMINISTRATION. 335 00:14:50,805 --> 00:14:54,308 AND BEFORE HE WENT TO EAST 336 00:14:54,308 --> 00:14:56,577 CAROLINA UNIVERSITY, HE DID 337 00:14:56,577 --> 00:15:00,281 SEVERAL YEARS OF POSTDOCTORAL 338 00:15:00,281 --> 00:15:09,457 FELLOWSHIP AT NIH, DR. SIGOUNAS 339 00:15:09,457 --> 00:15:10,625 HAS BEEN A REAL ASSET TALKING 340 00:15:10,625 --> 00:15:12,193 ABOUT WHAT NCI IS TRYING TO DO 341 00:15:12,193 --> 00:15:14,962 AND TRYING TO IMPROVE ON IT AND 342 00:15:14,962 --> 00:15:17,899 BEING A LIAISON FOR US WITH THE 343 00:15:17,899 --> 00:15:19,233 ADMINISTRATION. 344 00:15:19,233 --> 00:15:27,275 DEF 345 00:15:27,875 --> 00:15:31,279 >> I WANT TO TALK ABOUT CANCER 346 00:15:31,279 --> 00:15:32,213 MORTALITY TRENDS. 347 00:15:32,213 --> 00:15:35,149 THE GOOD NEWS IS SHOWN TO ME IN 348 00:15:35,149 --> 00:15:37,285 THE UPPER GRAPH BECAUSE WE NOW 349 00:15:37,285 --> 00:15:42,790 HAVE MORE THAN 30 YEARS OF 350 00:15:42,790 --> 00:15:44,425 PROGRESSIVELY DECREASING CANCER 351 00:15:44,425 --> 00:15:45,960 MORTALITY RATES IN THE UNITED 352 00:15:45,960 --> 00:15:47,528 STATES BOTH FOR MEN AS WELL AS 353 00:15:47,528 --> 00:15:55,903 FOR WOMEN. 354 00:15:55,903 --> 00:15:57,638 YOU THIS MEANS 300,000 AMERICANS 355 00:15:57,638 --> 00:16:00,274 WILL NOT DIE THIS YEAR FROM 356 00:16:00,274 --> 00:16:03,211 CANCER WHO WOULD HAVE DIED IN 357 00:16:03,211 --> 00:16:04,779 1990 MORTALITY RATES. 358 00:16:04,779 --> 00:16:05,613 THAT'S TERRIFIC. 359 00:16:05,613 --> 00:16:08,449 GONE DOWN BY MORE THAN 360 00:16:08,449 --> 00:16:08,716 ONE-THIRD. 361 00:16:08,716 --> 00:16:11,319 OF COURSE WE ARE ALL AWARE OF 362 00:16:11,319 --> 00:16:14,355 THE 600,000 PATIENTS WHO ARE 363 00:16:14,355 --> 00:16:18,392 GOING TO DIE OF CANCER DURING 364 00:16:18,392 --> 00:16:20,962 THIS YEAR WHICH REALLY 365 00:16:20,962 --> 00:16:21,862 EMPHASIZES THE URGENCY AND 366 00:16:21,862 --> 00:16:23,364 IMPORTANCE OF WHAT WE NEED TO 367 00:16:23,364 --> 00:16:26,901 DO. 368 00:16:26,901 --> 00:16:30,171 THE NEXT SLIDE SIMPLY DEPICTS 369 00:16:30,171 --> 00:16:32,006 FOR YOU DIFFERENT CANCER TYPES 370 00:16:32,006 --> 00:16:34,208 WITH THE BLUE BEING THE ONES 371 00:16:34,208 --> 00:16:36,444 WHERE WE'RE REDUCING MORTALITY 372 00:16:36,444 --> 00:16:38,379 RATES AND THE RED BEING ONES 373 00:16:38,379 --> 00:16:42,550 WHERE THE MORTALITY RATES ARE 374 00:16:42,550 --> 00:16:43,951 CONTINUING TO INCREASE. 375 00:16:43,951 --> 00:16:46,454 WHAT I HOPE YOU CAN APPRECIATE 376 00:16:46,454 --> 00:16:49,590 IS THERE ARE MANY MORE FORMS OF 377 00:16:49,590 --> 00:16:52,793 CANCER WHERE THE RATES OF 378 00:16:52,793 --> 00:16:54,562 MORTALITY ARE GOING DOWN. 379 00:16:54,562 --> 00:16:59,333 IF THIS HAD BEEN 15 YEARS AGO, 380 00:16:59,333 --> 00:17:02,336 FOR EXAMPLE, MELANOMA AND LUNG 381 00:17:02,336 --> 00:17:04,071 CANCER ARE CLOSE TO THE BOTTOM. 382 00:17:04,071 --> 00:17:07,074 THEY'RE HAVING THE GREATEST 383 00:17:07,074 --> 00:17:07,675 IMPROVEMENT WOULD NEVER HAVE 384 00:17:07,675 --> 00:17:11,345 BEEN THERE 15 YEARS AGO. 385 00:17:11,345 --> 00:17:14,915 SO IT'S A REALLY TESTIMONY TO 386 00:17:14,915 --> 00:17:16,717 THE ADVANCES OVER THE RELATIVELY 387 00:17:16,717 --> 00:17:17,151 RECENT PAST. 388 00:17:17,151 --> 00:17:19,954 BUT THE NEXT SLIDE SHOWS YOU 389 00:17:19,954 --> 00:17:23,391 THAT IN ADDITION TO THE 600,000 390 00:17:23,391 --> 00:17:26,494 PEOPLE THAT WE NEED TO BE VERY 391 00:17:26,494 --> 00:17:28,229 CONCERNED ABOUT THIS YEAR AND 392 00:17:28,229 --> 00:17:31,599 GOING FORWARD, THE ADVANCES IN 393 00:17:31,599 --> 00:17:35,336 CANCER RESEARCH HAVE NOT BEEN 394 00:17:35,336 --> 00:17:37,071 UNIFORM WITHOUT THE UNITED 395 00:17:37,071 --> 00:17:37,305 STATES. 396 00:17:37,305 --> 00:17:40,808 THE DARK RED STATES IN 397 00:17:40,808 --> 00:17:42,109 PARTICULAR REPRESENT THOSE 398 00:17:42,109 --> 00:17:45,713 STATES WITH THE HIGHEST CANCER 399 00:17:45,713 --> 00:17:51,319 MORTALITY RATES IN THE U.S. 400 00:17:51,319 --> 00:17:53,187 EVEN THOSE STATES HAVE HAD A 401 00:17:53,187 --> 00:17:59,960 DECREASE IN THE CANCER MORTALITY 402 00:17:59,960 --> 00:18:01,829 RATES AND THE SOME HAVE 403 00:18:01,829 --> 00:18:04,932 INCREASED SO THEY IN MOST OF 404 00:18:04,932 --> 00:18:07,335 THESE STATES THEY'RE 20% OR 405 00:18:07,335 --> 00:18:16,277 GREATER FOR THIS DISPARITY. 406 00:18:16,277 --> 00:18:18,045 THE LAST OF MY COMMENTS IS I 407 00:18:18,045 --> 00:18:21,382 JUST WANT TO REMIND ALL OF YOU 408 00:18:21,382 --> 00:18:25,753 PEOPLE LIKE SHEILA PRINDIVILLE 409 00:18:25,753 --> 00:18:29,857 AND JIM DORRSHELL AND OTHERS ARE 410 00:18:29,857 --> 00:18:30,124 COMMITTED. 411 00:18:30,124 --> 00:18:32,259 WE'RE EXTRAORDINARILY FORTUNATE 412 00:18:32,259 --> 00:18:35,930 THOUGH WE'VE HAD ABOUT A 10% 413 00:18:35,930 --> 00:18:39,333 REDUCTION IN NCI STAFF BETWEEN 414 00:18:39,333 --> 00:18:41,535 VOLUNTARY SEPARATIONS AND IN 415 00:18:41,535 --> 00:18:43,204 VOLUNTARY SEPARATIONS, THE 416 00:18:43,204 --> 00:18:46,140 PEOPLE WHO ARE HERE ARE TOTALLY 417 00:18:46,140 --> 00:18:48,676 COMMITTED TO OUR MISSION AND I 418 00:18:48,676 --> 00:18:52,246 JUST WANT TO ASSURE YOU, WE WILL 419 00:18:52,246 --> 00:18:55,649 BE DOING EVERYTHING WE CAN TO 420 00:18:55,649 --> 00:19:01,422 HELP YOU BE ABLE TO ADVANCES AND 421 00:19:01,422 --> 00:19:04,191 PROGRESS IN CANCER RESEARCH OUR 422 00:19:04,191 --> 00:19:05,593 PATIENTS DESERVE NO LESS. 423 00:19:05,593 --> 00:19:06,927 THE LAST SLIDE IS SIMPLY TO SAY 424 00:19:06,927 --> 00:19:08,095 THANK YOU AND I LOOK FORWARD TO 425 00:19:08,095 --> 00:19:15,636 YOUR QUESTIONS AND COMMENTS. 426 00:19:15,636 --> 00:19:17,338 >> THANK YOU SO MUCH. 427 00:19:17,338 --> 00:19:21,175 WE APPRECIATE THAT UPDATE ON 428 00:19:21,175 --> 00:19:21,475 INFORMATION. 429 00:19:21,475 --> 00:19:24,545 >> JULIE VOSE, I SHOULD HAVE 430 00:19:24,545 --> 00:19:25,780 INCLUDED YOU. 431 00:19:25,780 --> 00:19:26,180 APOLOGIES. 432 00:19:26,180 --> 00:19:27,681 IT TAKES ALL OF US. 433 00:19:27,681 --> 00:19:30,718 >> ABSOLUTELY. 434 00:19:30,718 --> 00:19:31,852 THANK YOU SO MUCH. 435 00:19:31,852 --> 00:19:37,858 SO ANY QUICK QUESTIONS FOR 436 00:19:37,858 --> 00:19:48,402 DR. LOWY BEFORE WE MOVE FORWARD? 437 00:19:54,275 --> 00:19:55,376 >> DOUG, I APPRECIATE ALL THE 438 00:19:55,376 --> 00:19:56,977 EFFORTS OF YOURSELVES AND THE 439 00:19:56,977 --> 00:19:58,546 FOLKS AT NCI DURING THIS 440 00:19:58,546 --> 00:19:59,346 CHALLENGING PERIOD. 441 00:19:59,346 --> 00:20:04,218 ONE QUESTION. 442 00:20:04,218 --> 00:20:07,087 IT'S A NOT LOST ON ME WITH ALL 443 00:20:07,087 --> 00:20:07,721 THE CHRONIC DISEASES HOW MANY 444 00:20:07,721 --> 00:20:09,323 MORE OF OUR CANCERS COULD BE 445 00:20:09,323 --> 00:20:12,359 THOUGHT OF IN THAT CATEGORY. 446 00:20:12,359 --> 00:20:13,828 WE CLEARLY HAVE THE PRIOR 447 00:20:13,828 --> 00:20:17,531 PARADIGM OF YOU HAD CANCER 448 00:20:17,531 --> 00:20:20,000 EITHER YOU WERE CAREER OR YOU 449 00:20:20,000 --> 00:20:23,304 ASPIRED FROM THE DISEASE. 450 00:20:23,304 --> 00:20:25,606 WE HAVE MANY EXAMPLES NOW OF 451 00:20:25,606 --> 00:20:26,574 PEOPLE WHO HAVE EXTENDED 452 00:20:26,574 --> 00:20:27,775 SURVIVAL WITHOUT A CURE OR LIVED 453 00:20:27,775 --> 00:20:31,345 WITH A CANCER IN A CHRONIC WAY. 454 00:20:31,345 --> 00:20:34,348 IS THAT AN ONGOING DISCUSSION 455 00:20:34,348 --> 00:20:37,685 JUST KEEPING THAT TOP OF MIND OF 456 00:20:37,685 --> 00:20:40,921 HOW CANCER FITS IN THE SPECTRUM 457 00:20:40,921 --> 00:20:42,923 OF CHRONIC DISEASE AS WELL AS 458 00:20:42,923 --> 00:20:45,292 HOW CHRONIC DISEASES ARE CLEARLY 459 00:20:45,292 --> 00:20:47,528 LINKED TO CANCER SUCH AS 460 00:20:47,528 --> 00:20:51,799 OBESITY, THE METABOLIC SYNDROME, 461 00:20:51,799 --> 00:20:52,066 ETCETERA. 462 00:20:52,066 --> 00:20:54,201 >> YES. 463 00:20:54,201 --> 00:21:02,743 I THINK IT IS WARREN TIBE ALSO 464 00:21:02,743 --> 00:21:04,845 ON, ANOTHER DIRECTOR HERE, WE 465 00:21:04,845 --> 00:21:06,046 TALKED WEEKS AGO WITH TWO PEOPLE 466 00:21:06,046 --> 00:21:10,117 REPRESENTING THE MAHA EFFORT, 467 00:21:10,117 --> 00:21:13,988 MAKE AMERICA HEALTHY AGAIN, 468 00:21:13,988 --> 00:21:23,430 ABOUT NCI WHAT WE'RE DOING AND 469 00:21:23,430 --> 00:21:24,198 CLEARLY UNDERSTAND. 470 00:21:24,198 --> 00:21:28,168 I THINK WE FIND OURSELVES IN 471 00:21:28,168 --> 00:21:31,138 GOOD NEWS, BAD NEWS. 472 00:21:31,138 --> 00:21:32,406 GOOD NEWS, MADE A LOT OF 473 00:21:32,406 --> 00:21:33,407 PROGRESS. 474 00:21:33,407 --> 00:21:41,415 BAD NEWS, AFTER PLACES TO GO. 475 00:21:41,415 --> 00:21:42,983 PATTY SPEARS. 476 00:21:42,983 --> 00:21:44,451 >> FIRST, THANK YOU SO MUCH FOR 477 00:21:44,451 --> 00:21:45,719 STEPPING UP TO THE PLATE. 478 00:21:45,719 --> 00:21:47,054 YOU'RE ALWAYS THERE TO TAKE 479 00:21:47,054 --> 00:21:50,024 CHARGE AND WE LOVE THAT. 480 00:21:50,024 --> 00:21:52,593 I REALLY APPRECIATE YOU GOING 481 00:21:52,593 --> 00:21:53,861 INTO WHAT THE UP FRONT FUNDING 482 00:21:53,861 --> 00:21:55,029 WAS AND APPRECIATE THE PICTURE 483 00:21:55,029 --> 00:21:57,398 BECAUSE IT WAS CLARIFYING FOR ME 484 00:21:57,398 --> 00:22:00,034 WHAT THAT MEANS AND THERE MIGHT 485 00:22:00,034 --> 00:22:02,503 BE THAT LULL WHEN THIS IS 486 00:22:02,503 --> 00:22:04,171 INSTITUTED. 487 00:22:04,171 --> 00:22:11,278 >> PATTY, IT IS NOT COPYRIGHTED. 488 00:22:11,278 --> 00:22:13,414 >> I LOVE A GOOD PICTURE AND IT 489 00:22:13,414 --> 00:22:14,048 WAS SO GOOD. 490 00:22:14,048 --> 00:22:19,353 IF YOU MARRY THAT WITH POTENTIAL 491 00:22:19,353 --> 00:22:23,090 CUTS IN FUNDING AND I'M WORRIED 492 00:22:23,090 --> 00:22:25,759 ABOUT DELAYS IN RESEARCH AND 493 00:22:25,759 --> 00:22:27,094 CLINICAL TRIALS AND LOSS OF OUR 494 00:22:27,094 --> 00:22:33,033 WORKFORCE, OUR RESEARCHERS AND 495 00:22:33,033 --> 00:22:38,739 THINGS. 496 00:22:38,739 --> 00:22:41,108 USE THIS AS THIS NEEDS TO BE 497 00:22:41,108 --> 00:22:43,344 USED IS WORRYING ME AS A PATIENT 498 00:22:43,344 --> 00:22:51,885 GOING FORWARD. 499 00:22:51,885 --> 00:22:53,320 >> TALKING WITH THE DIRECTORS 500 00:22:53,320 --> 00:22:57,391 FROM THE COOPERATIVE GROUPS, I 501 00:22:57,391 --> 00:22:59,693 GUESS ROB HAS HEARD THIS MORE 502 00:22:59,693 --> 00:23:00,494 THAN ONCE. 503 00:23:00,494 --> 00:23:04,398 WE ARE RESTRICTED IN TERMS OF 504 00:23:04,398 --> 00:23:14,908 WHAT WE CAN SAY WHATEVER YOU 505 00:23:21,115 --> 00:23:21,782 WANT. 506 00:23:21,782 --> 00:23:24,284 >> RAHM. 507 00:23:24,284 --> 00:23:26,020 >> THANK YOU ON BEHALF OF THE 508 00:23:26,020 --> 00:23:26,854 CANCER RESEARCH COMMUNITY AND 509 00:23:26,854 --> 00:23:28,355 NCI AND STAFF FOR WORKING HARD 510 00:23:28,355 --> 00:23:32,092 TO KEEP US MOVING FORWARD. 511 00:23:32,092 --> 00:23:33,427 OBVIOUSLY CHALLENGING TIMES. 512 00:23:33,427 --> 00:23:34,895 I WANT TO HEAR YOUR THOUGHTS ON 513 00:23:34,895 --> 00:23:38,132 HOW THIS UP FRONT FUNDING WOULD 514 00:23:38,132 --> 00:23:41,568 CHANGE THE FUNDING OF GRANTS. 515 00:23:41,568 --> 00:23:43,904 DO YOU SEE A BROAD EFFECT THAT'S 516 00:23:43,904 --> 00:23:46,173 DISTRIBUTED ACROSS ALL PROGRAMS 517 00:23:46,173 --> 00:23:47,141 OR DO YOU SEE PRIORITIZATION 518 00:23:47,141 --> 00:23:49,243 FROM PROGRAM TO THE OTHER AS TO 519 00:23:49,243 --> 00:23:50,110 HOW THIS WILL HIT THE RESEARCH 520 00:23:50,110 --> 00:23:58,385 PROGRAMS? 521 00:23:58,385 --> 00:23:59,753 >> THUS IS A GREAT QUESTION AND 522 00:23:59,753 --> 00:24:01,188 WE DON'T HAVE A FULL ANSWER YET. 523 00:24:01,188 --> 00:24:04,124 WE JUST STARTED WORKING WITH IT 524 00:24:04,124 --> 00:24:07,327 AND WRESTLING WITH IT. 525 00:24:07,327 --> 00:24:17,371 WHAT I SEE GOING FORWARD IN 526 00:24:17,371 --> 00:24:18,706 2027 WHEN THE ADMINISTRATION IS 527 00:24:18,706 --> 00:24:21,075 SAYING ALL RPG FUNDING IS GOING 528 00:24:21,075 --> 00:24:23,377 TO BE UP FRONT IS THAT WE'RE 529 00:24:23,377 --> 00:24:27,347 GOING TO BE LOOKING AT THE 530 00:24:27,347 --> 00:24:32,119 SECOND OR THIRD PERCENTILE FOR 531 00:24:32,119 --> 00:24:38,092 SUCCESS IF ALL WE DO IS GO BY 532 00:24:38,092 --> 00:24:39,026 PEER REVIEW. 533 00:24:39,026 --> 00:24:42,196 ONE THING WE DISCUSSED THIS 534 00:24:42,196 --> 00:24:45,666 MORNING WAS HOW IS THAT GOING TO 535 00:24:45,666 --> 00:24:48,335 SKEW THE CANCER RESEARCH 536 00:24:48,335 --> 00:24:48,569 EFFORTS? 537 00:24:48,569 --> 00:24:50,270 AND WHAT SHOULD WE BE DOING? 538 00:24:50,270 --> 00:24:53,741 WE ARE STILL REALLY THINKING 539 00:24:53,741 --> 00:25:01,648 ABOUT THAT. 540 00:25:01,648 --> 00:25:03,083 I'D LIKE DO ASK, WARREN DID YOU 541 00:25:03,083 --> 00:25:03,984 WANT TO ADD ANYTHING? 542 00:25:03,984 --> 00:25:06,487 >> I DON'T THINK I NEED TO, 543 00:25:06,487 --> 00:25:07,054 DOUG. 544 00:25:07,054 --> 00:25:11,358 THAT WAS A GREAT ANSWER. 545 00:25:11,358 --> 00:25:12,726 RAHM DID YOU HAVE SOMETHING ELSE 546 00:25:12,726 --> 00:25:14,027 YOU WERE CONCERNED ABOUT? 547 00:25:14,027 --> 00:25:17,431 >> NO, JUST WANTED TO SEE HOW 548 00:25:17,431 --> 00:25:19,366 THIS WOULD IMPACT WHEN 549 00:25:19,366 --> 00:25:23,370 IMPLEMENTED ACROSS PROGRAMS, 550 00:25:23,370 --> 00:25:33,580 THAT'S ALL. 551 00:25:34,481 --> 00:25:35,349 >> Dr. Lowy: SAY THE FIRST AND 552 00:25:35,349 --> 00:25:37,718 SECOND PERCENTILE ARE ALL PEOPLE 553 00:25:37,718 --> 00:25:40,854 DOING CLINICAL TRIALS OR SECOND 554 00:25:40,854 --> 00:25:41,922 PERCENTILE ARE ALL PEOPLE DOING 555 00:25:41,922 --> 00:25:44,491 BASIC RESEARCH. 556 00:25:44,491 --> 00:25:49,663 WE CAN'T HAVE THAT HAPPEN. 557 00:25:49,663 --> 00:25:50,798 AS IMPORTANT AS BASIC RESEARCH 558 00:25:50,798 --> 00:25:51,765 AND CLINICAL TRIALS RESEARCH IS, 559 00:25:51,765 --> 00:25:54,201 WE NEED TO TRY TO HAVE SOME KIND 560 00:25:54,201 --> 00:25:54,768 OF BALANCE. 561 00:25:54,768 --> 00:25:59,339 NOT EVERYONE WILL AGREE ON WHAT 562 00:25:59,339 --> 00:26:02,609 THAT WOULD BE. 563 00:26:02,609 --> 00:26:05,746 DR. AZAD. 564 00:26:05,746 --> 00:26:13,520 >> DR. AZAD: FRANKLY I WANT TO 565 00:26:13,520 --> 00:26:15,322 THANK ALL FOR ABOUT WHAT AS THE 566 00:26:15,322 --> 00:26:16,523 BEING IN CHALLENGING TIMES AND 567 00:26:16,523 --> 00:26:18,358 WE WANT TO FIGURE OUT WHAT WE 568 00:26:18,358 --> 00:26:20,427 CAN DO AND I KNOW THERE ARE 569 00:26:20,427 --> 00:26:21,962 CHALLENGES IN TERMS OF WHAT CAN 570 00:26:21,962 --> 00:26:26,266 BE ASKED OF US AS WELL BUT I 571 00:26:26,266 --> 00:26:28,669 DO -- I THINK WE'RE VERY READY 572 00:26:28,669 --> 00:26:29,336 TO BE ORGANIZED IN WHATEVER WAY 573 00:26:29,336 --> 00:26:30,504 WE CAN. 574 00:26:30,504 --> 00:26:33,874 I WANTED TO ASK A QUESTION 575 00:26:33,874 --> 00:26:36,410 FOLLOWING UP A LITTLE BIT ON THE 576 00:26:36,410 --> 00:26:38,212 CONCERN ABOUT HAVING THE FUNDING 577 00:26:38,212 --> 00:26:39,680 LINE HAS PARTICULAR 578 00:26:39,680 --> 00:26:42,549 RAMIFICATIONS FOR OUR YOUNG 579 00:26:42,549 --> 00:26:48,355 FOLKS AND FOR OUR EARLY CAREER 580 00:26:48,355 --> 00:26:49,122 INVESTIGATORS AND K GRANTS AND 581 00:26:49,122 --> 00:26:51,692 PART OF WHAT WE SHOULD BE 582 00:26:51,692 --> 00:26:52,793 ADVOCATING FOR IS CARVE OUTS FOR 583 00:26:52,793 --> 00:26:57,731 UP FRONT FUNDING TO HELP PROTECT 584 00:26:57,731 --> 00:26:59,333 THEM AND THEY'LL BE HIT THE 585 00:26:59,333 --> 00:27:00,934 HARDEST AND THE FUTURE OF OUR 586 00:27:00,934 --> 00:27:01,235 ENTERPRISE. 587 00:27:01,235 --> 00:27:05,405 CAN WE HELP WITH THAT? 588 00:27:05,405 --> 00:27:07,174 >> Dr. Lowy: DR. AZAD, FOR RIGHT 589 00:27:07,174 --> 00:27:14,348 NOW FY25, WE ARE TRYING TO AS IT 590 00:27:14,348 --> 00:27:18,819 WERE, THINK ABOUT FUNDING A 591 00:27:18,819 --> 00:27:20,454 LARGER PERCENTAGE OF EARLY STAGE 592 00:27:20,454 --> 00:27:23,023 INVESTIGATORS THAN WHEN WE HAVE 593 00:27:23,023 --> 00:27:26,059 BEEN FUNDING RECENTLY. 594 00:27:26,059 --> 00:27:31,231 BUT THE TOTAL NUMBER OF EARLY 595 00:27:31,231 --> 00:27:32,966 STAGE INVESTIGATORS WE'LL BE 596 00:27:32,966 --> 00:27:35,869 FUNDING WILL BE SMALLER THAN THE 597 00:27:35,869 --> 00:27:39,740 NUMBER WE HAVE BEEN. 598 00:27:39,740 --> 00:27:43,844 WHERE WE MIGHT END UP IN '26 OR 599 00:27:43,844 --> 00:27:47,180 '27 STILL REMAINS TO BE SEEN. 600 00:27:47,180 --> 00:27:49,082 WE'RE HAVING A LOT OF ONGOING 601 00:27:49,082 --> 00:27:51,184 DISCUSSIONS ABOUT IT. 602 00:27:51,184 --> 00:27:53,987 LET ME REASSURE YOU THAT WE'RE 603 00:27:53,987 --> 00:27:57,691 NOT JUST CONCERNED ABOUT EARLY 604 00:27:57,691 --> 00:27:59,326 STAGE INVESTIGATORS WE'RE 605 00:27:59,326 --> 00:28:00,594 CONCERNED ABOUT CANCER TRAINING. 606 00:28:00,594 --> 00:28:03,263 PEOPLE BEFORE THEY GET THERE. 607 00:28:03,263 --> 00:28:06,266 SO THESE ARE ISSUES WE CLEARLY 608 00:28:06,266 --> 00:28:14,341 ARE CONCERNED ABOUT. 609 00:28:14,341 --> 00:28:24,551 DR. WILDING. 610 00:28:26,186 --> 00:28:29,323 >> WHAT WILL WILL BE HAPPENING 611 00:28:29,323 --> 00:28:31,358 TO EVERYONE ELSE'S GRANT IN 612 00:28:31,358 --> 00:28:41,835 THEIR SECOND OR THIRD YEAR? 613 00:28:47,074 --> 00:28:48,275 >> Dr. Lowy: GREAT QUESTION. 614 00:28:48,275 --> 00:28:50,310 WE ANTICIPATE TO CONTINUE THE 615 00:28:50,310 --> 00:28:52,179 AWARDS AT A REASONABLE LEVEL I 616 00:28:52,179 --> 00:28:56,083 MEAN ABOUT 95% OF THE 617 00:28:56,083 --> 00:28:56,383 COMMITMENT. 618 00:28:56,383 --> 00:29:02,489 OUR DIFFICULTY REALLY IS THAT WE 619 00:29:02,489 --> 00:29:03,757 SUPPORT A TREMENDOUS AMOUNT OF 620 00:29:03,757 --> 00:29:07,461 RESEARCH OUTSIDE THE RPG POOL. 621 00:29:07,461 --> 00:29:09,863 I THINK WE'RE RELUCTANT TO TAKE 622 00:29:09,863 --> 00:29:12,599 A LOT OF MONEY AWAY FROM THAT 623 00:29:12,599 --> 00:29:13,700 BECAUSE WE'RE THEN 624 00:29:13,700 --> 00:29:14,735 DISADVANTAGING THOSE AREAS. 625 00:29:14,735 --> 00:29:19,339 IT IS A LOT EASIER TO ADD NEW 626 00:29:19,339 --> 00:29:23,176 MONEY THAN IT IS TO TAKE AWAY 627 00:29:23,176 --> 00:29:25,545 THE CURRENT LEVEL. 628 00:29:25,545 --> 00:29:26,613 I DON'T THINK I'M TELLING YOU 629 00:29:26,613 --> 00:29:31,485 ANYTHING YOU DON'T ALREADY KNOW. 630 00:29:31,485 --> 00:29:32,552 >> THANK YOU SO MUCH. 631 00:29:32,552 --> 00:29:34,454 I'M SORRY TO CUT THINGS OFF BUT 632 00:29:34,454 --> 00:29:38,425 WE NEED TO MOVE ON TO THE NEXT 633 00:29:38,425 --> 00:29:38,625 TOPIC. 634 00:29:38,625 --> 00:29:41,395 >> Dr. Lowy: THANKS EVERYONE. 635 00:29:41,395 --> 00:29:44,564 BEFORE I FINISH THOUGH, YOU ARE 636 00:29:44,564 --> 00:29:46,900 ABSOLUTELY -- YOU AND THE 637 00:29:46,900 --> 00:29:50,037 PATIENT ADVOCATES ARE THE BEST 638 00:29:50,037 --> 00:29:54,441 PEOPLE WE HAVE TO TALK ABOUT THE 639 00:29:54,441 --> 00:29:56,309 MIRACLE OF CANCER RESEARCH. 640 00:29:56,309 --> 00:29:59,346 THE PEOPLE THAT WE HAVE WHO 641 00:29:59,346 --> 00:30:00,514 SHOULD HAVE BEEN DEAD 10 YEARS 642 00:30:00,514 --> 00:30:04,785 AGO AND ARE STILL ALIVE AND 643 00:30:04,785 --> 00:30:07,354 WANTING TO GIVE EVERYONE THOSE 644 00:30:07,354 --> 00:30:09,022 OPPORTUNITIES FOR THE NEW 645 00:30:09,022 --> 00:30:11,324 RESEARCH TO TRY TO MAKE SURE 646 00:30:11,324 --> 00:30:15,095 THAT WE CONTINUE TO MAKE THE 647 00:30:15,095 --> 00:30:16,863 PROGRESS THAT OUR PATIENTS 648 00:30:16,863 --> 00:30:17,230 DESERVE. 649 00:30:17,230 --> 00:30:17,964 THANK YOU SO MUCH FOR WHAT 650 00:30:17,964 --> 00:30:18,799 YOU'RE DOING. 651 00:30:18,799 --> 00:30:20,567 >> THANK YOU. 652 00:30:20,567 --> 00:30:26,573 THANK YOU FOR EVERYTHING YOU DO. 653 00:30:26,573 --> 00:30:31,044 I THINK THE SLIDE YOU SHOWED IS 654 00:30:31,044 --> 00:30:31,344 HELPFUL. 655 00:30:31,344 --> 00:30:33,580 >> THEY'RE PUBLICALLY AVAILABLE 656 00:30:33,580 --> 00:30:36,616 AS FAR AS I'M CONCERNED. 657 00:30:36,616 --> 00:30:40,320 IF ANYBODY WANTS TO TALK WITH MK 658 00:30:40,320 --> 00:30:50,864 HAL HOOLIMAN IS IN THE PUBLIC 659 00:30:56,369 --> 00:30:59,306 AFFAIRS AND MAY BE ABLE TO HELP. 660 00:30:59,306 --> 00:31:03,977 >> NOW WE'LL MOVE TO THE NEXT 661 00:31:03,977 --> 00:31:13,153 TOPIC, DR. DOROSHOW WILL GIVE AN 662 00:31:13,153 --> 00:31:13,420 UPDATE. 663 00:31:13,420 --> 00:31:16,022 >> THANKS, EVERYBODY. 664 00:31:16,022 --> 00:31:19,192 I'LL BE BRIEF. 665 00:31:19,192 --> 00:31:22,896 IT'S GOING TO BE AN INTRODUCTION 666 00:31:22,896 --> 00:31:25,732 TO TODAY'S AGENDA. 667 00:31:25,732 --> 00:31:28,201 MANY HAVE PARTICIPATED IN OUR 668 00:31:28,201 --> 00:31:29,669 EFFORT TO DEVELOP A STRATEGIC 669 00:31:29,669 --> 00:31:31,338 PLAN FOR OUR CLINICAL TRIALS ON 670 00:31:31,338 --> 00:31:33,507 MORE FLEXIBLE TRIALS AND TRIALS 671 00:31:33,507 --> 00:31:36,977 THAT WE STREAMLINE THE PROCESS 672 00:31:36,977 --> 00:31:38,678 FOR TRIAL EXECUTION, DECREASE 673 00:31:38,678 --> 00:31:40,714 THE BURDEN AND FOCUS ON 674 00:31:40,714 --> 00:31:43,250 ESSENTIAL END POINTS AND 675 00:31:43,250 --> 00:31:44,618 INCREASE HOPEFULLY OUR 676 00:31:44,618 --> 00:31:47,220 EFFICIENCY FOR DATA COLLECTION. 677 00:31:47,220 --> 00:31:50,657 AND THERE ARE A VARIETY OF 678 00:31:50,657 --> 00:31:50,891 THEMES. 679 00:31:50,891 --> 00:31:57,564 MANY OF WHICH WE ELEMENTS 680 00:31:57,564 --> 00:32:00,767 APPROACHES AND OPERATIONAL 681 00:32:00,767 --> 00:32:02,936 BURDENS AND WE'LL TELL YOU THE 682 00:32:02,936 --> 00:32:04,738 AGENDA TODAY IS REALLY AN 683 00:32:04,738 --> 00:32:04,971 UPDATE. 684 00:32:04,971 --> 00:32:09,075 WE'RE ABOUT FIVE YEARS IN AND WE 685 00:32:09,075 --> 00:32:11,344 MADE A LOT OF PROGRESS AND SOME 686 00:32:11,344 --> 00:32:12,746 OF THAT PROGRESS WILL BE 687 00:32:12,746 --> 00:32:13,713 FOCUSSED AROUND THE 688 00:32:13,713 --> 00:32:16,850 PRESENTATIONS FOR TODAY'S 689 00:32:16,850 --> 00:32:17,083 MEETING. 690 00:32:17,083 --> 00:32:20,754 WE'LL HAVE A PRESENTATION ON THE 691 00:32:20,754 --> 00:32:23,356 AUDIT PROCESS. 692 00:32:23,356 --> 00:32:29,663 WE'LL BE HEARING FROM MS. 693 00:32:29,663 --> 00:32:30,664 DENICOFF ABOUT THE PRIORITIES 694 00:32:30,664 --> 00:32:31,331 AND DATA COLLECTION. 695 00:32:31,331 --> 00:32:36,403 MANY PARTICIPATED IN THE EFFORT 696 00:32:36,403 --> 00:32:42,709 THAT'S TAKING ON STEAM AND HEAR 697 00:32:42,709 --> 00:32:45,212 FROM JEFF ALLEN ABOUT A PROJECT 698 00:32:45,212 --> 00:32:46,513 THEY'VE INITIATE AND WOULD LIKE 699 00:32:46,513 --> 00:32:47,714 TO HEAR DISCUSSION AFTER HE'S 700 00:32:47,714 --> 00:32:49,916 FINISHED ON WHAT WE SHOULD DO IN 701 00:32:49,916 --> 00:32:56,690 THAT SPACE OR WHETHER WE SHOULD 702 00:32:56,690 --> 00:32:59,025 WAIT UNTIL AFTER IT'S FINISHED 703 00:32:59,025 --> 00:32:59,793 ITS JOB. 704 00:32:59,793 --> 00:33:01,661 TO GIVE A BIRD'S-EYE VIEW OF THE 705 00:33:01,661 --> 00:33:01,895 AGENDA. 706 00:33:01,895 --> 00:33:03,330 IT'S ALL FOCUSSED ON TRYING TO 707 00:33:03,330 --> 00:33:05,398 GET AN UPDATE ON THE 708 00:33:05,398 --> 00:33:05,932 RECOMMENDATIONS FOR OUR 709 00:33:05,932 --> 00:33:07,567 STRATEGIC PLANNING, HOW TO MAKE 710 00:33:07,567 --> 00:33:08,735 CLINICAL TRIALS BETTER. 711 00:33:08,735 --> 00:33:17,210 SO THANK YOU SO MUCH. 712 00:33:17,210 --> 00:33:17,877 >> THANK YOU. 713 00:33:17,877 --> 00:33:19,346 ANY QUESTIONS FOR JIM BEFORE WE 714 00:33:19,346 --> 00:33:29,489 MOVE ON? 715 00:33:37,130 --> 00:33:40,600 SEEING NONE, WE'LL HAVE A 716 00:33:40,600 --> 00:33:45,705 DISCUSSION WITH JEFF ALLEN 717 00:33:45,705 --> 00:33:49,442 FRIENDS OF CANCER REASON AND 718 00:33:49,442 --> 00:33:50,443 TALKING ABOUT PRIVACY AND 719 00:33:50,443 --> 00:33:53,913 CONTROLS AND MAYBE IF WE CAN DO 720 00:33:53,913 --> 00:34:02,989 A PILOT AND WILL PRESENT WHAT 721 00:34:02,989 --> 00:34:05,158 THEY'VE DONE TO DATE. 722 00:34:05,158 --> 00:34:05,692 THANK YOU. 723 00:34:05,692 --> 00:34:07,494 >> THANK YOU, FOR THE CHANCE TO 724 00:34:07,494 --> 00:34:10,330 COME BRIEF THIS COMMITTEE ABOUT 725 00:34:10,330 --> 00:34:11,831 A PROJECT THAT WE ARE GETTING 726 00:34:11,831 --> 00:34:14,801 CLOSE TO GETTING UP AND RUNNING. 727 00:34:14,801 --> 00:34:16,603 I'M THRILLED TO BE ABLE TO SHARE 728 00:34:16,603 --> 00:34:18,271 UPDATES OF WHERE WE'VE COME AND 729 00:34:18,271 --> 00:34:19,806 WHERE WE THINK WE'RE GOING TO BE 730 00:34:19,806 --> 00:34:22,142 ABLE TO HEAD WITH THIS PROOF OF 731 00:34:22,142 --> 00:34:22,676 CONCEPT PILOT. 732 00:34:22,676 --> 00:34:25,812 AND VERY MUCH LOOK FORWARD TO 733 00:34:25,812 --> 00:34:27,580 THE IDEAS THE COMMITTEE MAY HAVE 734 00:34:27,580 --> 00:34:29,149 FOR US MOVING FORWARD. 735 00:34:29,149 --> 00:34:31,751 BY WAY OF BACKGROUND ON THE NEXT 736 00:34:31,751 --> 00:34:35,622 SLIDE, THIS EXTERNAL CONTROL ARM 737 00:34:35,622 --> 00:34:36,890 PILOT IS REALLY A CONTINUATION 738 00:34:36,890 --> 00:34:39,359 OF SOME WORK WE HAVE DONE OVER 739 00:34:39,359 --> 00:34:42,095 THE LAST SEVERAL YEARS AROUND 740 00:34:42,095 --> 00:34:44,297 THE POTENTIAL UTILIZATION OF 741 00:34:44,297 --> 00:34:46,666 REAL WORLD EFFORTS AS A TOOL IN 742 00:34:46,666 --> 00:34:47,000 RESEARCH. 743 00:34:47,000 --> 00:34:49,736 OF COURSE I THINK THIS IN LARN 744 00:34:49,736 --> 00:34:53,273 PART IS A TOPIC MOVING FORWARD 745 00:34:53,273 --> 00:34:55,342 QUICKLY DUE TO THE TECHNOLOGICAL 746 00:34:55,342 --> 00:34:58,111 ADVANCES AROUND DATA CAPTURE AND 747 00:34:58,111 --> 00:34:59,346 ED IMPLEMENTATION AND 748 00:34:59,346 --> 00:35:01,481 STANDARDIZATION OF ELECTRONIC 749 00:35:01,481 --> 00:35:02,349 HEALTH RECORDS AND RECOGNIZED IN 750 00:35:02,349 --> 00:35:03,316 THE LAST SEVERAL YEARS STARTING 751 00:35:03,316 --> 00:35:06,019 WITH THE COMMITMENT BETWEEN THE 752 00:35:06,019 --> 00:35:08,421 FDA AND THE BIO TECHNOLOGY 753 00:35:08,421 --> 00:35:10,690 INDUSTRY THROUGH A RECENT 754 00:35:10,690 --> 00:35:12,826 REAUTHORIZATION OF THE FDA USER 755 00:35:12,826 --> 00:35:14,527 FEES TO SUPPORT PROJECTS AND 756 00:35:14,527 --> 00:35:17,130 GUIDANCE DOCUMENTS AND MANY HAVE 757 00:35:17,130 --> 00:35:18,832 GOTTEN UNDERWAY AND MANY HAVE 758 00:35:18,832 --> 00:35:19,866 BEEN ISSUED IN THE LAST FEW 759 00:35:19,866 --> 00:35:20,133 YEARS. 760 00:35:20,133 --> 00:35:23,203 AT THE SAME TIME AS THAT WAS 761 00:35:23,203 --> 00:35:24,804 GETTING GOING WE THOUGHT IT 762 00:35:24,804 --> 00:35:27,340 WOULD BE HELPFUL RECOGNIZING THE 763 00:35:27,340 --> 00:35:31,344 TECHNOLOGY COMPANIES THAT ARE 764 00:35:31,344 --> 00:35:38,852 REALLY EXPONENTIALLY GROWING 765 00:35:38,852 --> 00:35:41,287 OPPOSED TO WAITING FOR OTHER 766 00:35:41,287 --> 00:35:44,190 PILOTS TO PLAY OUT GIVEN THE 767 00:35:44,190 --> 00:35:44,858 UNIQUE INFRASTRUCTURE AVAILABLE 768 00:35:44,858 --> 00:35:46,593 IN ONCOLOGY. 769 00:35:46,593 --> 00:35:48,762 TO GIVE A BRIEF SUMMARY OF REAL 770 00:35:48,762 --> 00:35:51,731 WORLD EVIDENCE PROJECTS THAT SET 771 00:35:51,731 --> 00:35:54,401 THE FOUNDATION FOR THE PROJECT. 772 00:35:54,401 --> 00:35:58,171 THE PAST PROJECTS DEPICTED IN 773 00:35:58,171 --> 00:35:59,339 THIS TRAJECTORY OF TIME, THE 774 00:35:59,339 --> 00:36:01,941 FIRST PILOT WAS A PARTNERSHIP 775 00:36:01,941 --> 00:36:04,711 WITH ABOUT SEVEN DIFFERENT DATA 776 00:36:04,711 --> 00:36:07,347 COMPANIES THAT HAVE DEVELOPED 777 00:36:07,347 --> 00:36:10,650 THEIR OWN INTERNAL RESEARCH 778 00:36:10,650 --> 00:36:14,120 DATABASES IN ORDER TO BEGIN TO 779 00:36:14,120 --> 00:36:16,990 BRING INFORMATION TO DEATH AND 780 00:36:16,990 --> 00:36:18,658 CURATE THE INFORMATION AND 781 00:36:18,658 --> 00:36:21,861 BETTER UNDERSTAND HOW IT CAN BE 782 00:36:21,861 --> 00:36:24,998 USED FOR BETTER RESEARCH IN 783 00:36:24,998 --> 00:36:26,032 CLINICAL PRACTICE AND WHEN WE 784 00:36:26,032 --> 00:36:28,368 CAN MOVE WITH THE DISPARATE DATA 785 00:36:28,368 --> 00:36:30,837 SOURCES TO ALIGN ON A COMMON 786 00:36:30,837 --> 00:36:32,238 PROTOCOL AND UNDERSTAND WHAT 787 00:36:32,238 --> 00:36:33,373 INFORMATION COULD BE EXTRACTED 788 00:36:33,373 --> 00:36:35,341 IN A UNIFORM WAY FROM DIFFERENT 789 00:36:35,341 --> 00:36:36,376 SOURCES OF DATA. 790 00:36:36,376 --> 00:36:38,878 IN THE SECOND PILOT BASED ON 791 00:36:38,878 --> 00:36:42,515 SOME OF THAT INITIAL EXTRACTION 792 00:36:42,515 --> 00:36:44,884 WE RECOGNIZED SOME TRADITIONAL 793 00:36:44,884 --> 00:36:46,753 MEASURES IN CLINICAL TRIALS ARE 794 00:36:46,753 --> 00:36:49,989 DIFFICULT TO EXTRACT FROM 795 00:36:49,989 --> 00:36:50,557 ELECTRONIC HEALTH RECORDS. 796 00:36:50,557 --> 00:36:52,859 THE DATA NEEDED TO BE DIFFERENT 797 00:36:52,859 --> 00:36:54,027 TO THINK ABOUT THE OBSERVATIONS 798 00:36:54,027 --> 00:36:55,328 THAT COULD BE MADE. 799 00:36:55,328 --> 00:36:59,165 IN THIS PILOT WE EXPLORED A 800 00:36:59,165 --> 00:37:01,634 PROXY END POINT LIKE TIME TO 801 00:37:01,634 --> 00:37:03,336 TREATMENT DISCONTINUATION AND 802 00:37:03,336 --> 00:37:06,072 TIME TO NEXT TREATMENT TO 803 00:37:06,072 --> 00:37:07,607 UNDERSTAND THE EXTENT WHICH THEY 804 00:37:07,607 --> 00:37:08,208 CORRELATE WITH MEASURES LIKE 805 00:37:08,208 --> 00:37:16,749 OVER ALL SURVIVAL. 806 00:37:16,749 --> 00:37:18,818 CERTAINLY THERE WERE CHALLENGES 807 00:37:18,818 --> 00:37:21,354 ON DATA AND SUBSEQUENT THERAPY. 808 00:37:21,354 --> 00:37:23,289 THE THIRD PILOT CALLED REAL 809 00:37:23,289 --> 00:37:24,858 WORLD RESPONSE WAS WORKING WITH 810 00:37:24,858 --> 00:37:26,893 THE DATA CURATORS TO UNDERSTAND 811 00:37:26,893 --> 00:37:33,967 THE EXTEND A, IMAGES WERE 812 00:37:33,967 --> 00:37:36,069 AVAILABLE OR RESPONSE RATES FROM 813 00:37:36,069 --> 00:37:37,670 REAL WORLD DATA. 814 00:37:37,670 --> 00:37:40,707 WE SAW IN MOST CASES IT WAS NOT 815 00:37:40,707 --> 00:37:42,141 SCHEDULED SAME AS CLINICAL 816 00:37:42,141 --> 00:37:44,878 TRIALS AND MOST DATA SOURCES IT 817 00:37:44,878 --> 00:37:46,946 WASN'T EVEN AVAILABLE BUT WERE 818 00:37:46,946 --> 00:37:47,914 ABLE TO EXTRACT FROM CLINICAL 819 00:37:47,914 --> 00:37:50,783 NOTES FROM THE CLINICIANS TO BE 820 00:37:50,783 --> 00:37:55,088 ABLE TO ESTIMATE RESPONSE IN A 821 00:37:55,088 --> 00:37:56,890 CONSISTENT WAY ACROSS DATA SETS 822 00:37:56,890 --> 00:38:01,094 BY IMPLEMENTING A PROTOCOL 823 00:38:01,094 --> 00:38:02,562 SHOWING CONSISTENCY IN RESPONSE 824 00:38:02,562 --> 00:38:06,866 RATES FOR THOSE TREATED IN 825 00:38:06,866 --> 00:38:08,902 CHEMOTHERAPY IN THIS PILOT 826 00:38:08,902 --> 00:38:11,337 SETTING THE STAGE TO NOT JUST 827 00:38:11,337 --> 00:38:13,439 WHAT THE INDEPENDENT DATA SETS 828 00:38:13,439 --> 00:38:15,909 CAN DO AS THEIR OWN RESEARCH 829 00:38:15,909 --> 00:38:17,043 DATA TOOLS BUT AUGMENT CLINICAL 830 00:38:17,043 --> 00:38:17,277 TRIALS. 831 00:38:17,277 --> 00:38:20,380 THIS IS HOW WE ARRIVED AT THE 832 00:38:20,380 --> 00:38:21,347 EXTERNAL CONTROL ARM PROJECT 833 00:38:21,347 --> 00:38:22,215 THAT I'LL WALK THROUGH A LITTLE 834 00:38:22,215 --> 00:38:23,283 BIT TODAY. 835 00:38:23,283 --> 00:38:25,818 ON THE NEXT SLIDE I WON'T SPEND 836 00:38:25,818 --> 00:38:27,153 A LOT OF TIME ON THIS PARTICULAR 837 00:38:27,153 --> 00:38:30,490 BACKGROUND BUT I THINK THE 838 00:38:30,490 --> 00:38:32,959 CHALLENGES HERE ARE PRETTY WELL 839 00:38:32,959 --> 00:38:33,760 CHARACTERIZED. 840 00:38:33,760 --> 00:38:37,363 A RANDOMIZED CONTROL ARM CAN BE 841 00:38:37,363 --> 00:38:39,332 DIFFICULT IN CERTAIN 842 00:38:39,332 --> 00:38:40,333 CIRCUMSTANCES TO IMPLEMENT 843 00:38:40,333 --> 00:38:42,435 BECAUSE OF THE RARITY OF THE 844 00:38:42,435 --> 00:38:42,869 CONDITION. 845 00:38:42,869 --> 00:38:45,972 IT MAY JUST BE VERY DIFFICULT TO 846 00:38:45,972 --> 00:38:48,341 HAVE ENOUGH PATIENTS IN ORDER TO 847 00:38:48,341 --> 00:38:50,443 SUFFICIENTLY RANDOMIZE THE TRIAL 848 00:38:50,443 --> 00:38:52,211 IN A SUFFICIENT TIME FRAME AND 849 00:38:52,211 --> 00:38:53,179 MADE ETHICAL CONSIDERATIONS IN 850 00:38:53,179 --> 00:38:54,914 TERMS OF THE AVAILABILITY OF 851 00:38:54,914 --> 00:38:58,985 THERAPY OF HAVING TO RANDOMIZE 852 00:38:58,985 --> 00:39:04,691 TO A LESS EFFICACIOUS THERAPY OR 853 00:39:04,691 --> 00:39:06,759 KNOWN THERAPY AVAILABLE. 854 00:39:06,759 --> 00:39:08,161 THE IDEA OF USING THE EXTERNAL 855 00:39:08,161 --> 00:39:09,596 CONTROL ARM IS TO BRING IN DATA 856 00:39:09,596 --> 00:39:13,566 FROM AN EXTERNAL SOURCE, REAL 857 00:39:13,566 --> 00:39:15,068 WORLD DATA USING PATIENT 858 00:39:15,068 --> 00:39:18,771 RECORDS, INSURANCE CLAIMS, 859 00:39:18,771 --> 00:39:20,239 PROSPECTIVE DISEASE REGISTRIES 860 00:39:20,239 --> 00:39:22,442 OR CONSTRUCT A VIRTUAL CONTROL 861 00:39:22,442 --> 00:39:25,178 GROUP IN ORDER TO PROVIDE 862 00:39:25,178 --> 00:39:26,746 ADDITIONAL CONTEXT TO 863 00:39:26,746 --> 00:39:28,948 INTERVENTIONAL SINGLE ARM STUDY. 864 00:39:28,948 --> 00:39:31,284 NOW, THE IDEA ISN'T NEW. 865 00:39:31,284 --> 00:39:34,153 CERTAINLY OTHER RESEARCHERS HAVE 866 00:39:34,153 --> 00:39:36,255 DEVELOPED PROTOTYPES FOR 867 00:39:36,255 --> 00:39:38,257 BUILDING THE EXTERNAL CONTROL 868 00:39:38,257 --> 00:39:40,727 ARM IN THE PAST. 869 00:39:40,727 --> 00:39:42,895 BUT WHAT WE'RE HOPING IS TO 870 00:39:42,895 --> 00:39:44,564 DETERMINE OPTIMAL 871 00:39:44,564 --> 00:39:46,833 CHARACTERISTICS OR THE CRITERIA 872 00:39:46,833 --> 00:39:48,234 NECESSARY FOR SOURCES DATA IN 873 00:39:48,234 --> 00:39:50,570 ORDER TO HELP IMPROVE THE 874 00:39:50,570 --> 00:39:51,904 CONFIDENCE AND ACCEPTANCE OF 875 00:39:51,904 --> 00:39:53,272 THEIR USE IN CONTROL. 876 00:39:53,272 --> 00:39:55,441 THE UNIQUE ASPECT OF WHAT WE ARE 877 00:39:55,441 --> 00:39:58,478 TRYING TO BUILD IS BUILD 878 00:39:58,478 --> 00:40:01,581 EXTERNAL CONTROL ARMS TO 879 00:40:01,581 --> 00:40:03,016 UNDERSTAND THE CHARACTERISTIC OF 880 00:40:03,016 --> 00:40:04,884 THE DATA OF DIFFERENT SOURCES 881 00:40:04,884 --> 00:40:06,119 AND UNDERSTAND THE EXTENT TO 882 00:40:06,119 --> 00:40:08,287 WHICH WE CAN REPLICATE TO 883 00:40:08,287 --> 00:40:10,323 IMPROVE THE CONFIDENCE. 884 00:40:10,323 --> 00:40:11,491 SO IN THE NEXT SLIDE, I'VE LAID 885 00:40:11,491 --> 00:40:15,161 OUT SOME OF OUR OVER ALL 886 00:40:15,161 --> 00:40:15,728 OBJECTIVES FOR THIS PROJECT. 887 00:40:15,728 --> 00:40:18,097 THE FIRST GOAL IS TO CONSTRUCT 888 00:40:18,097 --> 00:40:21,067 AN ECA USING PATIENT-LEVEL DATA 889 00:40:21,067 --> 00:40:23,002 FROM DIFFERENT DATA SOURCES THAT 890 00:40:23,002 --> 00:40:25,772 LEVERAGING THE KNOWN PROGNOSTIC 891 00:40:25,772 --> 00:40:27,573 AND DEMOCRATIC CHARACTERISTICS 892 00:40:27,573 --> 00:40:28,808 FROM A CLINICAL TRIAL ARE ABLE 893 00:40:28,808 --> 00:40:30,176 TO MATCH AT A PATIENT LEVEL TO 894 00:40:30,176 --> 00:40:32,345 THE CONTROL ARM OF A RANDOMIZED 895 00:40:32,345 --> 00:40:34,247 CONTROL ARM TRIAL OR THE TARGET 896 00:40:34,247 --> 00:40:34,914 TRIAL. 897 00:40:34,914 --> 00:40:35,948 AND THROUGH THIS WE HOPE TO 898 00:40:35,948 --> 00:40:42,555 ESTABLISH A METHODOLOGY OF A 899 00:40:42,555 --> 00:40:44,691 PROCESS THAT MIGHT BE ABLE TO BE 900 00:40:44,691 --> 00:40:45,892 IMPLEMENTED MORE READILY IN THE 901 00:40:45,892 --> 00:40:50,329 FUTURE TO AUGMENT EXISTING OR 902 00:40:50,329 --> 00:40:51,330 UPCOMING RANDOMIZED CLINICAL 903 00:40:51,330 --> 00:40:52,165 TRIALS. 904 00:40:52,165 --> 00:40:54,600 WE RECOGNIZE THE FDA HAS ISSUED 905 00:40:54,600 --> 00:40:56,202 GUIDANCE DOCUMENTS ON EXTERNAL 906 00:40:56,202 --> 00:40:59,338 CONTROL ARMS IN 2023 TO HELP LAY 907 00:40:59,338 --> 00:41:00,306 OUT CONSIDERATIONS FOR THE 908 00:41:00,306 --> 00:41:02,975 RESEARCH COMMUNITY ABOUT THE 909 00:41:02,975 --> 00:41:05,511 SOURCES OF DATA AND METHODOLOGY 910 00:41:05,511 --> 00:41:12,218 APPLIED BUT THUS FAR HAS BEEN 911 00:41:12,218 --> 00:41:12,752 SELDO 912 00:41:12,752 --> 00:41:18,157 SELDOMLY IMPLEMENTED AND WE HOPE 913 00:41:18,157 --> 00:41:19,325 THE PROJECT PILOT WILL HELP 914 00:41:19,325 --> 00:41:21,227 RAISE THE DATA QUALITY OF THE 915 00:41:21,227 --> 00:41:24,797 DATA SOURCED AND ULTIMATELY 916 00:41:24,797 --> 00:41:26,199 PROVIDE ADDITIONAL GUIDANCE AS 917 00:41:26,199 --> 00:41:28,201 TO HOW THESE TOOLS COULD BE 918 00:41:28,201 --> 00:41:28,801 USED. 919 00:41:28,801 --> 00:41:32,839 SO WE HOPE FROM A REGULATORY 920 00:41:32,839 --> 00:41:35,141 STANDPOINT WE'LL BE ABLE TO 921 00:41:35,141 --> 00:41:35,708 ESTABLISH CRITERIA WHETHER 922 00:41:35,708 --> 00:41:39,212 DIFFERENT DATA SOURCES THAT MAY 923 00:41:39,212 --> 00:41:41,214 BE E.H.R. DERIVED REAL WORLD 924 00:41:41,214 --> 00:41:45,685 DATA OR PILOT CONTROL AND HAVE 925 00:41:45,685 --> 00:41:46,953 DATA FROM BOTH SOURCES AND 926 00:41:46,953 --> 00:41:48,221 UNDERSTAND WHETHER THEY'RE FIT 927 00:41:48,221 --> 00:41:50,623 FOR PURPOSE FOR DEVELOPING AN 928 00:41:50,623 --> 00:41:50,857 ECA. 929 00:41:50,857 --> 00:41:53,926 WE HOPE WE'LL BE ABLE TO 930 00:41:53,926 --> 00:41:55,995 IDENTIFY CHARACTERISTICS OF THE 931 00:41:55,995 --> 00:41:59,332 DATA SOURCE THAT MAKE IT MORE 932 00:41:59,332 --> 00:42:03,236 ACCEPTABLE IN ORDER TO BE ABLE 933 00:42:03,236 --> 00:42:05,071 TO REPLICATE THE ELIGIBILITY AND 934 00:42:05,071 --> 00:42:07,273 THE TIMING MEASURES INCLUDED IN 935 00:42:07,273 --> 00:42:11,344 A RANDOMIZED CLINICAL TRIAL TO 936 00:42:11,344 --> 00:42:18,417 MAKE THE ECA MORE FEASIBLE AND 937 00:42:18,417 --> 00:42:20,086 METHODOLOGIES TO INFORM BEST 938 00:42:20,086 --> 00:42:21,187 PRACTICES IN THE FUTURE. 939 00:42:21,187 --> 00:42:22,855 IN THE NEXT SLIDE THE SITUATION 940 00:42:22,855 --> 00:42:23,890 WE WERE LOOKING FOR IN ORDER TO 941 00:42:23,890 --> 00:42:30,129 TRY AND IDENTIFY A TARGET TRIAL 942 00:42:30,129 --> 00:42:32,398 TO REPLICATE WE SELECTED A 943 00:42:32,398 --> 00:42:34,801 CONTROL EXAMPLE WHERE VARIOUS 944 00:42:34,801 --> 00:42:37,937 FACTORS WERE SIMILAR TO A 945 00:42:37,937 --> 00:42:39,272 SCENARIO WHERE AN EXTERNAL 946 00:42:39,272 --> 00:42:42,441 CONTROL ARM MAY BE ACCEPTABLE 947 00:42:42,441 --> 00:42:44,944 AND WANTED TO HAVE A PATIENT 948 00:42:44,944 --> 00:42:46,813 POPULATION OR AREA WHERE IT WAS 949 00:42:46,813 --> 00:42:50,449 RELATIVELY SMALL ENOUGH AN ECA 950 00:42:50,449 --> 00:42:54,887 COULD BE THOUGHT ABOUT AS A 951 00:42:54,887 --> 00:42:58,558 COMPONENT OF CLINICAL RESEARCH 952 00:42:58,558 --> 00:43:05,364 BUT STILL FEASIBLE A CLINICAL 953 00:43:05,364 --> 00:43:06,933 TRIAL COULD BE REPLICATED. 954 00:43:06,933 --> 00:43:10,369 WE LOOKED AT METASTATIC CANCER 955 00:43:10,369 --> 00:43:13,105 WITH THE UNMET NEED IT PRESENTS. 956 00:43:13,105 --> 00:43:15,308 IMPORTANTLY IN THIS CASE THE 957 00:43:15,308 --> 00:43:17,009 STANDARD OF CARE HAS REMAINED 958 00:43:17,009 --> 00:43:19,312 RELATIVELY UNCHANGED OVER TIME. 959 00:43:19,312 --> 00:43:21,981 THE MAJORITY OF THE DATA 960 00:43:21,981 --> 00:43:24,317 INCLUDED IN THIS IS 961 00:43:24,317 --> 00:43:25,751 RETROSPECTIVE TO DATA FROM 962 00:43:25,751 --> 00:43:27,286 ELECTRONIC HEALTH RECORDS. 963 00:43:27,286 --> 00:43:31,090 WE NEEDED SOMETHING THAT HAD NOT 964 00:43:31,090 --> 00:43:32,425 BEEN RAPIDLY EVOLVING IN ORDER 965 00:43:32,425 --> 00:43:33,559 TO USE HISTORIC DATA FOR THIS 966 00:43:33,559 --> 00:43:37,230 USE. 967 00:43:37,230 --> 00:43:39,432 WE CHOSE THE RESOLVE TRIAL AS 968 00:43:39,432 --> 00:43:41,200 THE TARGET TRIAL. 969 00:43:41,200 --> 00:43:42,902 WE'VE OBTAINED THE DATA AND IT 970 00:43:42,902 --> 00:43:44,670 WAS A TRIAL THAT EVALUATED THE 971 00:43:44,670 --> 00:43:53,279 SAFETY AND EFFICACY OF IBRUTNIB 972 00:43:53,279 --> 00:43:58,784 AND NAB-PACLITAXEL AND IT'S THE 973 00:43:58,784 --> 00:44:03,322 CONTROL ARM TO REPLICATE FOR 974 00:44:03,322 --> 00:44:06,959 THIS PARTICULAR PILOT PROJECT. 975 00:44:06,959 --> 00:44:10,596 AND TO UNDERSTAND WHETHER OUR 976 00:44:10,596 --> 00:44:14,333 DATA SOURCES HAVE THE CAPABILITY 977 00:44:14,333 --> 00:44:18,638 TO CONSTRUCT THE ECA WE ASKED 978 00:44:18,638 --> 00:44:21,941 EACH POTENTIAL DATA PARTNER TO 979 00:44:21,941 --> 00:44:23,376 ISOLATE THE PATIENT IN THEIR 980 00:44:23,376 --> 00:44:26,579 BASE AND PULLED THE DATA FROM 981 00:44:26,579 --> 00:44:27,413 IMPLEMENTING A COMMON PROTOCOL 982 00:44:27,413 --> 00:44:33,352 TO APPLY TO THEIR DATA AND 983 00:44:33,352 --> 00:44:34,887 UNDERSTAND THE NUMBERS AND 984 00:44:34,887 --> 00:44:36,789 AVAILABLE PATIENT DATA FROM A 985 00:44:36,789 --> 00:44:38,224 FEASIBILITY STANDPOINT TO FIT 986 00:44:38,224 --> 00:44:40,092 THE CRITERIA OF THE TARGET TRIAL 987 00:44:40,092 --> 00:44:41,160 CONTROL ARM. 988 00:44:41,160 --> 00:44:44,697 ON THE NEXT SLIDE THIS BRIEFLY 989 00:44:44,697 --> 00:44:46,866 DESCRIBES THE NUMBERS WE 990 00:44:46,866 --> 00:44:48,301 OBSERVED FROM SIX DIFFERENT DATA 991 00:44:48,301 --> 00:44:51,337 SETS THAT HAVE SUBMITTED THEIR 992 00:44:51,337 --> 00:44:52,605 DATA THUS FAR. 993 00:44:52,605 --> 00:44:55,875 AS YOU CAN SEE FIVE ARE BEING 994 00:44:55,875 --> 00:45:00,980 UTILIZED ON REAL WORLD DATA FROM 995 00:45:00,980 --> 00:45:04,550 ELECTRONIC HEALTH RECORDS THEY 996 00:45:04,550 --> 00:45:07,386 CURATED FOR RESEARCH PURPOSES 997 00:45:07,386 --> 00:45:09,822 AND ONE LEVERAGING PRIOR 998 00:45:09,822 --> 00:45:12,558 CLINICAL TRIAL DATA THEY ASKED 999 00:45:12,558 --> 00:45:14,293 OF THEIR SYSTEM OVER THE LAST 1000 00:45:14,293 --> 00:45:14,493 YEARS. 1001 00:45:14,493 --> 00:45:17,296 THE RANGE AND ELIGIBLE PATIENTS 1002 00:45:17,296 --> 00:45:18,564 THAT FIT THE CRITERIA OF THE 1003 00:45:18,564 --> 00:45:20,499 TYPE OF CANCER AND CONTROL ARM 1004 00:45:20,499 --> 00:45:22,868 TREATMENT THAT WE'RE LOOKING AT 1005 00:45:22,868 --> 00:45:25,338 RANGE FROM 39 TO OVER 2600 1006 00:45:25,338 --> 00:45:27,006 PATIENTS IN DIFFERENT DATA SETS 1007 00:45:27,006 --> 00:45:30,109 AND A MEDIAN ACROSS THE GROUPS 1008 00:45:30,109 --> 00:45:31,277 OF 326. 1009 00:45:31,277 --> 00:45:33,879 IN ORDER TO CONSTRUCT THE 1010 00:45:33,879 --> 00:45:38,417 EXTERNAL CONTROL ARM WE HAVE A 1011 00:45:38,417 --> 00:45:39,318 STATISTICAL ADVISORY GROUP THAT 1012 00:45:39,318 --> 00:45:42,488 HAS HELPED US PREPARE THE 1013 00:45:42,488 --> 00:45:44,223 STATISTICAL ANALYSIS PLAN FOR 1014 00:45:44,223 --> 00:45:46,959 THE PROJECT AND I WON'T GET OVER 1015 00:45:46,959 --> 00:45:50,429 MY STATISTICAL SKIS HERE EXCEPT 1016 00:45:50,429 --> 00:45:51,897 TO SAY THE MINIMUM DESIRABLE 1017 00:45:51,897 --> 00:45:55,067 NUMBER IS 171 PATIENTS FOR EACH 1018 00:45:55,067 --> 00:45:57,470 IS 80% OF THE TOTAL CONTROL ARM 1019 00:45:57,470 --> 00:46:01,707 IN ORDER TO BE ABLE TO DO 1020 00:46:01,707 --> 00:46:03,309 SUFFICIENT MATCHING BY 1021 00:46:03,309 --> 00:46:05,211 PROPENSITY SCORES BASED ON THE 1022 00:46:05,211 --> 00:46:06,579 CRITERIA OF THE TRIAL IN ORDER 1023 00:46:06,579 --> 00:46:08,614 TO BE ABLE TO RUN THE ANALYSIS. 1024 00:46:08,614 --> 00:46:10,149 IF IT'S LESS THAN THAT WE HAVE 1025 00:46:10,149 --> 00:46:12,518 COME UP WITH A PLAN FOR THOSE 1026 00:46:12,518 --> 00:46:15,454 WHO MAY HAVE FEWER DATAED TO 1027 00:46:15,454 --> 00:46:17,456 COMPARE THE DIFFERENCES IN THE 1028 00:46:17,456 --> 00:46:18,724 OUTCOMES FROM EACH OF THE 1029 00:46:18,724 --> 00:46:21,560 DIFFERENT ECAs COMPARED TO THE 1030 00:46:21,560 --> 00:46:23,195 TARGET TRIAL. 1031 00:46:23,195 --> 00:46:25,097 SO, ON THE NEXT SLIDE, AS THE 1032 00:46:25,097 --> 00:46:26,932 NEXT STEP TO ISOLATING THE 1033 00:46:26,932 --> 00:46:28,467 PATIENT POPULATION TREATED 1034 00:46:28,467 --> 00:46:31,370 SIMILAR TO THE RESOLVE TRIAL, WE 1035 00:46:31,370 --> 00:46:37,309 AIM TO ALIGN TO THE INCLUSION 1036 00:46:37,309 --> 00:46:44,016 AND EXCLUSION CRITERIA AND THE 1037 00:46:44,016 --> 00:46:47,319 EXCLUSION IS ON THE LEFT FROM 1038 00:46:47,319 --> 00:46:50,956 THE RESOLVE TRIAL AND THE 1039 00:46:50,956 --> 00:46:51,757 CORRESPONDING NUMBERS FOR THE 1040 00:46:51,757 --> 00:46:54,560 DATA SETS SUBMITTED THUS FAR ARE 1041 00:46:54,560 --> 00:46:59,365 DISPLAYED AAS S -- AS THE 1042 00:46:59,365 --> 00:47:01,133 INCLUSION AND EXCLUSION. 1043 00:47:01,133 --> 00:47:03,135 THIS APPLIES TO THE MISSINGNESS 1044 00:47:03,135 --> 00:47:04,136 OF DATA. 1045 00:47:04,136 --> 00:47:09,475 IN SUMMARY YOU CAN SEE THAT AS 1046 00:47:09,475 --> 00:47:10,943 MORE EXCLUSIONARY CRITERIA ARE 1047 00:47:10,943 --> 00:47:13,579 APPLIED THE NUMBER OF PATIENTS 1048 00:47:13,579 --> 00:47:15,314 AVAILABLE TO FIT TO CORRESPOND 1049 00:47:15,314 --> 00:47:17,416 WITH THE TARGET TRIAL FOR EXACT 1050 00:47:17,416 --> 00:47:19,318 MATCHING GOES DOWN. 1051 00:47:19,318 --> 00:47:21,220 THE GOOD NEWS IS THAT FROM EACH 1052 00:47:21,220 --> 00:47:22,922 OF THE SIX DIFFERENT DATA 1053 00:47:22,922 --> 00:47:26,092 PARTNERS LISTED HERE ONLY TWO OF 1054 00:47:26,092 --> 00:47:29,462 THEM HAVE THE DESIRED 171 1055 00:47:29,462 --> 00:47:31,330 NECESSARY IN ORDER TO DO THE 1056 00:47:31,330 --> 00:47:33,199 DIRECT PROPENSITY SCORE 1057 00:47:33,199 --> 00:47:33,466 MATCHING. 1058 00:47:33,466 --> 00:47:36,569 SO FOR THOSE TWO THAT HAVE UNDER 1059 00:47:36,569 --> 00:47:38,304 171, WE ARE STILL IN THE PROCESS 1060 00:47:38,304 --> 00:47:40,106 OF EXPLORING THE OPTIMAL 1061 00:47:40,106 --> 00:47:41,740 APPROACH OF RUNNING THE ANALYSES 1062 00:47:41,740 --> 00:47:44,143 AND STILL BE ABLE TO LEVERAGE 1063 00:47:44,143 --> 00:47:45,511 THE DATA BY WEIGHTING SOME OF 1064 00:47:45,511 --> 00:47:51,317 THE DATA THERE OR PERHAPS LO 1065 00:47:51,317 --> 00:47:54,520 LOOSENING THE DATA SET FOR WHICH 1066 00:47:54,520 --> 00:47:56,322 THEY OBSERVED A SIGNIFICANT 1067 00:47:56,322 --> 00:47:59,325 AMOUNT OF ATTRITION. 1068 00:47:59,325 --> 00:48:00,860 THOUGH WE KNOW WE'VE INTRODUCED 1069 00:48:00,860 --> 00:48:03,362 VARIABILITY WE THINK IT WILL 1070 00:48:03,362 --> 00:48:05,397 HELP UNDERSTAND WHETHER THE 1071 00:48:05,397 --> 00:48:07,700 EXTENT OF MISSING THE DATA 1072 00:48:07,700 --> 00:48:09,401 ACCEPTABLE TO ACCURATELY 1073 00:48:09,401 --> 00:48:11,570 CONSTRUCT AN ECA OR THE CRITERIA 1074 00:48:11,570 --> 00:48:14,373 NEEDED FOR SOURCE DATA TO BE 1075 00:48:14,373 --> 00:48:15,474 ULTIMATELY FIT FOR PURPOSE TO BE 1076 00:48:15,474 --> 00:48:19,044 AN ECA BY OBSERVING THAT 1077 00:48:19,044 --> 00:48:20,946 VARIABILITY BETWEEN DATA SOURCES 1078 00:48:20,946 --> 00:48:22,214 THAT HAVE DIFFERENT 1079 00:48:22,214 --> 00:48:22,948 CHARACTERISTICS OF DATA 1080 00:48:22,948 --> 00:48:23,315 AVAILABLE. 1081 00:48:23,315 --> 00:48:25,484 SO ON THE NEXT SLIDE IS AN 1082 00:48:25,484 --> 00:48:28,721 UPDATE OF WHERE WE ARE. 1083 00:48:28,721 --> 00:48:33,459 WE HAVE -- BEFORE I GET TO THE 1084 00:48:33,459 --> 00:48:35,194 UPDATE OF WHERE WE ARE, THIS IS 1085 00:48:35,194 --> 00:48:36,328 THE SUMMARY OF ANALYSES WE'LL BE 1086 00:48:36,328 --> 00:48:39,698 DOING AS WE CONSTRUCT THIS. 1087 00:48:39,698 --> 00:48:41,734 THIS IS HOPEFULLY WHAT THE TOTAL 1088 00:48:41,734 --> 00:48:43,836 PROJECT WILL BEGIN TO LOOK LIKE. 1089 00:48:43,836 --> 00:48:47,339 THE TOP BOXES ARE REPRESENTING 1090 00:48:47,339 --> 00:48:49,608 THE CLINICAL TRIAL SOURCE DATA. 1091 00:48:49,608 --> 00:48:53,412 THE DATA WE'LL BE USING CASE 1092 00:48:53,412 --> 00:48:56,682 REPORT FORMS FROM HISTORIC 1093 00:48:56,682 --> 00:48:58,984 CLINICAL TRIALS TO REPLICATE 1094 00:48:58,984 --> 00:49:02,121 THEIR ECA. 1095 00:49:02,121 --> 00:49:04,456 WE OBSERVE THERE'LL BE LESS 1096 00:49:04,456 --> 00:49:06,158 MISSING AND MORE THAN AN EHR 1097 00:49:06,158 --> 00:49:09,962 SOURCE WOULD HAVE AND FOR THOSE 1098 00:49:09,962 --> 00:49:14,133 ADDITIONAL FIVE EHR SOURCE ECAs 1099 00:49:14,133 --> 00:49:16,769 WE'LL BE CONSTRUCTING AN 1100 00:49:16,769 --> 00:49:17,603 INDIVIDUAL CONTROL ARM WHERE 1101 00:49:17,603 --> 00:49:21,473 EACH DATA PARTNER WILL HAVE 1102 00:49:21,473 --> 00:49:24,076 PROPENSITY SCORE MATCHING TO 1103 00:49:24,076 --> 00:49:26,178 MATCH THE PATIENTS IN THE 1104 00:49:26,178 --> 00:49:28,781 RESOLVE TRIAL AND IN THE 1105 00:49:28,781 --> 00:49:29,848 ANALYSES RECONSTRUCTING AND 1106 00:49:29,848 --> 00:49:34,853 LOOKING AT THE KM CURVES AND 1107 00:49:34,853 --> 00:49:37,356 HAZARD RATIO FOR THE TARGET 1108 00:49:37,356 --> 00:49:39,225 CONTROL AND COMPARING THE SIX 1109 00:49:39,225 --> 00:49:41,560 DIFFERENT CONTROL ARMS IN THE 1110 00:49:41,560 --> 00:49:43,329 PILOT WE HOPE WE'LL BE ABLE TO 1111 00:49:43,329 --> 00:49:45,698 OBSERVE THE AVAILABILITY FROM 1112 00:49:45,698 --> 00:49:48,234 DIFFERENT SOURCE DATA WHETHER 1113 00:49:48,234 --> 00:49:54,306 THE E.H.R.s OR CLINICAL TRIAL OR 1114 00:49:54,306 --> 00:49:56,342 DIFFERENT ALIGNMENT TO THE 1115 00:49:56,342 --> 00:49:57,476 ELIGIBILITY CRITERIA OF THE 1116 00:49:57,476 --> 00:50:03,482 ORIGINAL TRIAL. 1117 00:50:03,482 --> 00:50:05,718 THIS JUST GIVES A SUMMARY OF 1118 00:50:05,718 --> 00:50:06,719 WHERE WE ARE. 1119 00:50:06,719 --> 00:50:08,520 SO WE HAVE COMPLETE THE SCOPING. 1120 00:50:08,520 --> 00:50:13,459 WE KNOW THE NUMBER OF DATA 1121 00:50:13,459 --> 00:50:15,327 SOURCES THAT WILL BE ABLE TO 1122 00:50:15,327 --> 00:50:19,231 PARTICIPATE AND THE BROAD 1123 00:50:19,231 --> 00:50:20,966 WORKING GROUP AND THE 1124 00:50:20,966 --> 00:50:23,168 STATISTICAL WORKING GROUP HAS 1125 00:50:23,168 --> 00:50:27,172 COMPLETE THE PILOT DESIGN. 1126 00:50:27,172 --> 00:50:29,742 WE'VE IDENTIFIED THE STUDY 1127 00:50:29,742 --> 00:50:33,312 POPULATION WITH THE INCLUSION 1128 00:50:33,312 --> 00:50:34,480 AND EXCLUSION CRITERIA AND 1129 00:50:34,480 --> 00:50:36,615 CONTRACTING FOR THE DATA FROM 1130 00:50:36,615 --> 00:50:38,050 THE TARGET TRIAL IN ORDER TO GET 1131 00:50:38,050 --> 00:50:40,653 THE STUDY UP AND RUNNING AND OUR 1132 00:50:40,653 --> 00:50:42,554 PLAN IS FOR THE DURATION OF THIS 1133 00:50:42,554 --> 00:50:44,523 YEAR BE ABLE TO OVER THE NEXT 1134 00:50:44,523 --> 00:50:50,162 SEVERAL MONTHS CONDUCT THE 1135 00:50:50,162 --> 00:50:54,066 STATISTICAL ANALYSIS TO APPLY 1136 00:50:54,066 --> 00:50:56,035 THE COMMON PROTOCOL TO DATA AND 1137 00:50:56,035 --> 00:50:57,503 THEN TAKE THE POPULATIONS THEY 1138 00:50:57,503 --> 00:50:58,704 ARE CONSTRUCT AND COMPARE THE 1139 00:50:58,704 --> 00:51:00,706 OUTCOMES TO THAT OF THE TARGET 1140 00:51:00,706 --> 00:51:02,441 TRIAL AND DIFFERENT PARTICIPANTS 1141 00:51:02,441 --> 00:51:05,010 IN THE PILOT PROJECT AND OUR 1142 00:51:05,010 --> 00:51:06,879 INTENTION IS TO REPORT THE 1143 00:51:06,879 --> 00:51:08,881 FINDINGS FROM THIS IN THE FIRST 1144 00:51:08,881 --> 00:51:10,082 PORTION OF 2026. 1145 00:51:10,082 --> 00:51:12,685 IN THE FINAL SLIDE I WANT TO 1146 00:51:12,685 --> 00:51:16,388 THANK EVERYONE WHO HAS HELPED 1147 00:51:16,388 --> 00:51:18,857 PROVIDE EXPERTISE AND GUIDANCE 1148 00:51:18,857 --> 00:51:20,259 FOR THIS PROJECT OVER THE LAST 1149 00:51:20,259 --> 00:51:24,563 YEAR OR SO TRYING TO CONSTRUCT 1150 00:51:24,563 --> 00:51:35,107 IT AND IN PARTICULAR THOSE WHO 1151 00:51:36,442 --> 00:51:38,310 HAVE THE INTENTION OF RUNNING 1152 00:51:38,310 --> 00:51:39,845 THE ANALYSIS IN THE COMING 1153 00:51:39,845 --> 00:51:40,079 MONTHS. 1154 00:51:40,079 --> 00:51:40,479 I'LL STOP THERE. 1155 00:51:40,479 --> 00:51:43,148 THANK YOU FOR THE OPPORTUNITY TO 1156 00:51:43,148 --> 00:51:44,750 SHARE SOME OF THE EARLY WORK AND 1157 00:51:44,750 --> 00:51:47,753 LOOK FORWARD TO SHARING RESULTS 1158 00:51:47,753 --> 00:51:51,190 HOPEFULLY SOON BUT IF YOU HAVE 1159 00:51:51,190 --> 00:51:56,195 QUESTIONS OR IDEAS THE COMMITTEE 1160 00:51:56,195 --> 00:51:57,596 HAS TODAY. 1161 00:51:57,596 --> 00:51:59,064 >> THANK YOU, THAT'S VERY 1162 00:51:59,064 --> 00:51:59,298 AWESOME. 1163 00:51:59,298 --> 00:52:03,335 WE HAVE TIME FOR A FEW 1164 00:52:03,335 --> 00:52:12,978 QUESTIONS. 1165 00:52:12,978 --> 00:52:16,949 >> THANK YOU AND YOUR 1166 00:52:16,949 --> 00:52:17,783 PRESENTATION CLEARLY LAID OUT 1167 00:52:17,783 --> 00:52:21,453 HOW YOU SELECT THE CONTROL GROUP 1168 00:52:21,453 --> 00:52:25,224 FROM USING BASELINE ELIGIBILITY, 1169 00:52:25,224 --> 00:52:26,592 EXCLUSION CRITERIA SO THAT'S 1170 00:52:26,592 --> 00:52:26,792 GREAT. 1171 00:52:26,792 --> 00:52:30,162 MY QUESTION IS HOW DO YOU 1172 00:52:30,162 --> 00:52:31,296 CONTROL FOR WHAT HAPPENS BEYOND 1173 00:52:31,296 --> 00:52:33,999 THAT DURING THE COURSE OF 1174 00:52:33,999 --> 00:52:34,266 TREATMENT. 1175 00:52:34,266 --> 00:52:35,768 FOR INSTANCE, IF I'M TREATING A 1176 00:52:35,768 --> 00:52:37,136 PATIENT IN A SITUATION I HAVE 1177 00:52:37,136 --> 00:52:39,438 THE LUXURY OF IF THE PATIENT 1178 00:52:39,438 --> 00:52:42,207 MEETS RADIATION, I CAN DO A DOSE 1179 00:52:42,207 --> 00:52:44,810 AND GO BACK TO THE SAME 1180 00:52:44,810 --> 00:52:46,545 TREATMENT BUT AS THE CLINICAL 1181 00:52:46,545 --> 00:52:47,446 TRIAL DOES NOT HAVE THOSE -- 1182 00:52:47,446 --> 00:52:49,615 LIKE THE PATIENT WANTS TO GO ON 1183 00:52:49,615 --> 00:52:51,316 VACATION FOR THREE WEEKS. 1184 00:52:51,316 --> 00:52:53,685 I CAN DELAY TREATMENT FOR THREE 1185 00:52:53,685 --> 00:52:55,854 WEEKS, NO PROB. 1186 00:52:55,854 --> 00:52:57,122 HOW DO YOU CONTROL FOR WHAT 1187 00:52:57,122 --> 00:52:59,324 HAPPENS DURING THE COURSE OF 1188 00:52:59,324 --> 00:53:08,367 TREATMENT SO THE COHORT MATCHES 1189 00:53:08,367 --> 00:53:09,768 AS CLOSE AS POSSIBLE? 1190 00:53:09,768 --> 00:53:15,207 >> THERE'S A NUMBER OF DATA 1191 00:53:15,207 --> 00:53:16,475 SOURCES BASED ON CLINICAL 1192 00:53:16,475 --> 00:53:16,742 PRACTICE. 1193 00:53:16,742 --> 00:53:20,746 SOME DISCUSSIONS WE HAD AT FDA 1194 00:53:20,746 --> 00:53:25,484 AS WELL AND RECOGNIZE A 1195 00:53:25,484 --> 00:53:26,585 PROSPECTIVE REGISTRY COLLECTION 1196 00:53:26,585 --> 00:53:28,187 OF DATA FROM CLINICAL PRACTICE 1197 00:53:28,187 --> 00:53:32,558 WOULD BE BETTER OFF THAN A 1198 00:53:32,558 --> 00:53:33,692 RETROSPECTIVE REAL WORLD DATA 1199 00:53:33,692 --> 00:53:35,794 SET BUT FROM OUR VANTAGE POINT 1200 00:53:35,794 --> 00:53:37,663 WE THOUGHT WHILE THAT MAY BE THE 1201 00:53:37,663 --> 00:53:39,331 CASE, LET'S PRESSURE TEST IT AND 1202 00:53:39,331 --> 00:53:42,367 SEE HOW DIVERGENT THE DIFFERENT 1203 00:53:42,367 --> 00:53:43,635 DATA SOURCES ARE. 1204 00:53:43,635 --> 00:53:45,270 HOW SIMILAR THE PATIENT 1205 00:53:45,270 --> 00:53:48,407 POPULATIONS CAN BE BY TRYING TO 1206 00:53:48,407 --> 00:53:51,543 SET UP CRITERIA AND MAYBE WE 1207 00:53:51,543 --> 00:53:54,213 WILL FIND THE REAL WORLD DATA IN 1208 00:53:54,213 --> 00:53:56,782 ITS CURRENT FORM IS NOT 1209 00:53:56,782 --> 00:54:02,120 SUFFICIENT TO REPLICATE A 1210 00:54:02,120 --> 00:54:03,322 CLINICAL CONTROL ARM OF THE 1211 00:54:03,322 --> 00:54:05,424 TRIAL BUT MAYBE IN THIS SCENARIO 1212 00:54:05,424 --> 00:54:07,960 WHERE THERE ARE FEW TREATMENT 1213 00:54:07,960 --> 00:54:09,628 OPTIONS WHERE UNFORTUNATELY THE 1214 00:54:09,628 --> 00:54:11,330 OUTCOMES ARE RELATIVELY SHORT 1215 00:54:11,330 --> 00:54:14,132 HERE THAT MAYBE SOME OF THE 1216 00:54:14,132 --> 00:54:15,267 VARIABILITY THAT CAN BE 1217 00:54:15,267 --> 00:54:16,835 INTRODUCED IN OTHER SETTINGS MAY 1218 00:54:16,835 --> 00:54:19,805 NOT BE IN THIS PLACE AND THIS 1219 00:54:19,805 --> 00:54:23,075 COULD BE ANOTHER INDICATOR AS TO 1220 00:54:23,075 --> 00:54:27,646 WHEN AN ECA MAY BE APPROPRIATE 1221 00:54:27,646 --> 00:54:27,880 TO USE. 1222 00:54:27,880 --> 00:54:32,484 >> I THINK IT'S A GOOD THING TO 1223 00:54:32,484 --> 00:54:39,625 HAVE A REAL WORLD EC A AND IT'S 1224 00:54:39,625 --> 00:54:41,360 ALMOST A DIFFERENT KIND OF 1225 00:54:41,360 --> 00:54:43,328 CONTROL NO SO MANICURED, IF YOU 1226 00:54:43,328 --> 00:54:53,438 WILL. 1227 00:55:26,004 --> 00:55:27,673 >> WE WANT TO MAKE SURE THEY'RE 1228 00:55:27,673 --> 00:55:29,908 VETTED FOR THAT OR PERHAPS IF 1229 00:55:29,908 --> 00:55:32,744 YOU HAVE BIG DATA SETS YOU CAN 1230 00:55:32,744 --> 00:55:35,314 HAVE MORE HYPOTHESIS DRIVEN 1231 00:55:35,314 --> 00:55:37,049 QUESTIONS ON GENERATING 1232 00:55:37,049 --> 00:55:38,050 POPULATION SPECIFIC EXTERNAL 1233 00:55:38,050 --> 00:55:40,285 CONTROLS AND LOOKING AT 1234 00:55:40,285 --> 00:55:41,320 DIFFERENCES THAT MAY BE VALUABLE 1235 00:55:41,320 --> 00:55:44,089 THAT WE DON'T HAVE AN 1236 00:55:44,089 --> 00:55:47,359 OPPORTUNITY TO DO AS WE DESIGN 1237 00:55:47,359 --> 00:55:48,727 THE RANDOMIZATION. 1238 00:55:48,727 --> 00:55:51,330 >> THAT'S AN IMPORTANT POINT. 1239 00:55:51,330 --> 00:55:54,266 I DON'T WANT TO GET AHEAD OF OUR 1240 00:55:54,266 --> 00:55:55,834 DATA PARTNERS AND CAUSE 1241 00:55:55,834 --> 00:55:57,069 ADDITIONAL WORK BUT THE DATA 1242 00:55:57,069 --> 00:55:59,805 THEY'LL BE ISOLATING WILL BE A 1243 00:55:59,805 --> 00:56:02,908 1:1 PATIENT MATCH FOR THOSE IN 1244 00:56:02,908 --> 00:56:04,543 THE TRIAL. 1245 00:56:04,543 --> 00:56:06,778 SO, BY DESIGN IT WILL HOPEFULLY 1246 00:56:06,778 --> 00:56:08,413 LOOK SIMILAR TO THAT COHORT FOR 1247 00:56:08,413 --> 00:56:09,748 THE TRIAL BUT WHAT WOULD BE 1248 00:56:09,748 --> 00:56:11,416 INTERESTING TO YOUR POINT WOULD 1249 00:56:11,416 --> 00:56:15,320 BE COULD WE ALSO TAKE THE SAME 1250 00:56:15,320 --> 00:56:16,588 DATA SET AND EVALUATE THE 1251 00:56:16,588 --> 00:56:19,324 PATIENTS PART OF THE ECA VERSUS 1252 00:56:19,324 --> 00:56:22,094 THOSE THAT WEREN'T ASSUMING 1253 00:56:22,094 --> 00:56:24,162 PERHAPS THEY CLEARLY HAVE 1254 00:56:24,162 --> 00:56:26,131 DIFFERENT CHARACTERISTICS THAT 1255 00:56:26,131 --> 00:56:27,199 DIDN'T ALLOW THEM TO BE A DIRECT 1256 00:56:27,199 --> 00:56:31,203 MATCH TO THOSE IN THE TRIAL AND 1257 00:56:31,203 --> 00:56:33,772 UNDERSTAND WHETHER THERE ARE 1258 00:56:33,772 --> 00:56:34,439 SIGNIFICANT DIFFERENCES IN THE 1259 00:56:34,439 --> 00:56:36,775 OBSERVATIONS BETWEEN THAT 1260 00:56:36,775 --> 00:56:37,776 CLINICAL TRIAL POPULATION AND 1261 00:56:37,776 --> 00:56:40,245 THE ACTUAL REAL WORLD POPULATION 1262 00:56:40,245 --> 00:56:43,315 THAT WE SEE IN THE TREATMENT. 1263 00:56:43,315 --> 00:56:44,049 IT'S A GREAT IDEA. 1264 00:56:44,049 --> 00:56:48,353 >> PATTY, I THINK YOU'RE NEXT. 1265 00:56:48,353 --> 00:56:50,255 >> I THINK THIS IS A GREAT 1266 00:56:50,255 --> 00:56:50,489 PROJECT. 1267 00:56:50,489 --> 00:56:52,457 I THINK THIS IS REALLY NEEDED. 1268 00:56:52,457 --> 00:56:54,226 IT COMES UP ALL THE TIME IN ALL 1269 00:56:54,226 --> 00:56:54,760 DIFFERENT AREAS. 1270 00:56:54,760 --> 00:56:57,429 I THINK IT'S REALLY ABOUT 1271 00:56:57,429 --> 00:56:59,331 BUILDING THAT CONFIDENCE SO THAT 1272 00:56:59,331 --> 00:57:01,099 PEOPLE WILL ACTUALLY USE THE 1273 00:57:01,099 --> 00:57:03,335 EXTERNAL CONTROL ARMS AND THIS 1274 00:57:03,335 --> 00:57:06,338 IS A GREAT PILOT BECAUSE IT IS A 1275 00:57:06,338 --> 00:57:08,073 CANCER STANDARD TREATMENT THAT 1276 00:57:08,073 --> 00:57:09,775 HASN'T CHANGED AND SOME OF THE 1277 00:57:09,775 --> 00:57:11,743 AREAS TREATMENT IS CHANGING SO 1278 00:57:11,743 --> 00:57:13,045 RAPIDLY IT'S GOING TO BE REALLY 1279 00:57:13,045 --> 00:57:15,013 HARD BUT I THINK WE CAN TALK 1280 00:57:15,013 --> 00:57:16,915 ABOUT THAT WHEN IT'S NEEDED. 1281 00:57:16,915 --> 00:57:18,283 THE QUESTION I HAD IS WHEN 1282 00:57:18,283 --> 00:57:22,921 YOU'RE DOING THE COMPARISON, HOW 1283 00:57:22,921 --> 00:57:25,757 CLOSE DO YOU NEED TO BE TO BE 1284 00:57:25,757 --> 00:57:26,058 SUCCESSFUL. 1285 00:57:26,058 --> 00:57:27,759 WHAT IS SUCCESS GOING TO BE 1286 00:57:27,759 --> 00:57:31,329 DRAWN BY TO BUILD THE CONFIDENT 1287 00:57:31,329 --> 00:57:35,634 YOU'RE NOT LOSING ANYTHING -- 1288 00:57:35,634 --> 00:57:38,303 >> THAT'S A GREAT QUESTION. 1289 00:57:38,303 --> 00:57:42,007 SO WE HAVEN'T REALLY QUITE YET 1290 00:57:42,007 --> 00:57:45,744 DETERMINED HOW IMPORTANT IS C 1291 00:57:45,744 --> 00:57:48,513 CONCORDANT ENOUGH. 1292 00:57:48,513 --> 00:57:51,683 I SUPPOSE IT WILL BE IN THE EYE 1293 00:57:51,683 --> 00:57:55,787 OF THIS BEHOLDER AND WE'LL USE 1294 00:57:55,787 --> 00:58:01,093 WHAT WE CAN TO INFORM THE 1295 00:58:01,093 --> 00:58:02,227 METHODOLOGY. 1296 00:58:02,227 --> 00:58:06,064 WOULDN'T IT BE GREAT IF THE ECAs 1297 00:58:06,064 --> 00:58:09,534 WERE CLOSE TO THE TARGET AND THE 1298 00:58:09,534 --> 00:58:13,905 THING ABOUT THE PILOT IS A 1299 00:58:13,905 --> 00:58:15,207 LOW-RISK PILOT. 1300 00:58:15,207 --> 00:58:17,709 WE'RE NOT ADJUDICATING A PAST 1301 00:58:17,709 --> 00:58:18,076 CLINICAL TRIAL. 1302 00:58:18,076 --> 00:58:21,213 WE'RE TRYING TO SEE CAN IT WORK? 1303 00:58:21,213 --> 00:58:23,582 WE HAVE SIX OR SEVEN DATA 1304 00:58:23,582 --> 00:58:26,718 SOURCES FROM DIFFERENT PLACES 1305 00:58:26,718 --> 00:58:29,888 AND HAVE DIFFERENT DEMOGRAPHICS 1306 00:58:29,888 --> 00:58:31,356 WE'RE TRYING TO IMPLEMENT A 1307 00:58:31,356 --> 00:58:34,126 COMMON PROTOCOL JUST TO SEE WILL 1308 00:58:34,126 --> 00:58:35,026 IT WORK. 1309 00:58:35,026 --> 00:58:36,394 IT'S NOT QUITE AS EXCITING AS 1310 00:58:36,394 --> 00:58:39,998 USING AN ECA I SUPPOSE, BUT IT'S 1311 00:58:39,998 --> 00:58:43,335 A STEPPING STONE TO THINK ABOUT 1312 00:58:43,335 --> 00:58:45,203 THE RIGHT METHODOLOGY AND 1313 00:58:45,203 --> 00:58:46,805 THEY'RE APPROPRIATELY FIT FOR 1314 00:58:46,805 --> 00:58:50,442 PURPOSE FOR THE USE. 1315 00:58:50,442 --> 00:58:57,749 IF THEY ARE, GREAT, IF NOT WHAT 1316 00:58:57,749 --> 00:58:59,651 CAN THEY DO TO GET THERE IN THE 1317 00:58:59,651 --> 00:59:00,185 NEAR FUTURE. 1318 00:59:00,185 --> 00:59:02,487 >> ADAM, YOU'RE NEXT. 1319 00:59:02,487 --> 00:59:04,956 >> THAT WAS FANTASTIC. 1320 00:59:04,956 --> 00:59:09,427 I HOPE WE CAN SHAVE YEARS OFF 1321 00:59:09,427 --> 00:59:10,929 GETTING A GREATER NUMBER OF 1322 00:59:10,929 --> 00:59:13,064 ORPHAN DISEASES TO APPROVAL. 1323 00:59:13,064 --> 00:59:15,400 HOW DOES CONTROL ARM OF THE 1324 00:59:15,400 --> 00:59:18,103 STUFF IN THE DATA SPHERE, CAN 1325 00:59:18,103 --> 00:59:19,604 YOU USE IT IN THE GLOBAL EFFORT 1326 00:59:19,604 --> 00:59:25,277 OF YOURS? 1327 00:59:25,277 --> 00:59:27,579 >> IT'S A GOOD QUESTION. 1328 00:59:27,579 --> 00:59:31,950 WE HAVE BEEN WORKING WITH 1329 00:59:31,950 --> 00:59:34,352 PROJECT DATA SPHERE ON A 1330 00:59:34,352 --> 00:59:35,020 SLIGHTLY DIFFERENT PROJECT 1331 00:59:35,020 --> 00:59:39,324 AROUND THE IMAGING DATA THEY 1332 00:59:39,324 --> 00:59:39,758 HAVE. 1333 00:59:39,758 --> 00:59:43,762 MY UNDERSTANDING IS THAT AT 1334 00:59:43,762 --> 00:59:44,429 LEAST FOR THE THERAPEUTIC AREA 1335 00:59:44,429 --> 00:59:46,131 WE SELECTED FOR THE PILOT THEY 1336 00:59:46,131 --> 00:59:48,366 DON'T HAVE THE DATA THAT COULD 1337 00:59:48,366 --> 00:59:53,205 BE DRAWN FROM IN ORDER TO 1338 00:59:53,205 --> 00:59:54,372 SUFFICIENTLY MATCH IN THE 1339 00:59:54,372 --> 00:59:55,307 METASTATIC SETTING AND THE 1340 00:59:55,307 --> 00:59:58,877 REASON WE DID THAT I THINK WE 1341 00:59:58,877 --> 01:00:09,421 DID HAVE THOUGHT THAT IT MAY BE 1342 01:00:19,497 --> 01:00:21,733 GOOD METHODOLOGY BUT NOT GOOD 1343 01:00:21,733 --> 01:00:24,236 FOR MATCHING FOR A MORE LIMITED 1344 01:00:24,236 --> 01:00:26,404 DATA SOURCE AND WHY WE CHOSE THE 1345 01:00:26,404 --> 01:00:28,607 SCENARIO WE DID. 1346 01:00:28,607 --> 01:00:32,244 I'D LIKE TO THINK IF WE OR OTHER 1347 01:00:32,244 --> 01:00:36,214 PILOTS ARE ACCESSIBLE IT'S FOR 1348 01:00:36,214 --> 01:00:39,017 SHARING OF DATA THAT WOULD MAKE 1349 01:00:39,017 --> 01:00:40,819 THIS MORE READILY AVAILABLE 1350 01:00:40,819 --> 01:00:42,554 BECAUSE WE WOULDN'T WANT TO DO 1351 01:00:42,554 --> 01:00:45,090 THIS SEVEN TIMES OVER FOR ONE 1352 01:00:45,090 --> 01:00:45,257 ECA. 1353 01:00:45,257 --> 01:00:48,393 YOU'D LIKE ONE MAYBE TWO TO 1354 01:00:48,393 --> 01:00:50,996 VERIFY BUT A FIT FOR PURPOSE 1355 01:00:50,996 --> 01:00:51,897 RELIABLE DATA SET YOU COULD 1356 01:00:51,897 --> 01:00:55,333 LEVERAGE IN ORDER TO AUGMENT THE 1357 01:00:55,333 --> 01:00:58,236 CLINICAL TRIAL. 1358 01:00:58,236 --> 01:00:59,037 >> KEN AND THEN WE'LL HAVE TO 1359 01:00:59,037 --> 01:01:06,578 MOVE ON. 1360 01:01:06,578 --> 01:01:17,022 KEN I THINK YOU'RE MUTED. 1361 01:01:23,061 --> 01:01:29,334 >> I WANT TO SAY JEFF, I STUDY 1362 01:01:29,334 --> 01:01:30,602 RARE DISEASES MYELOFIBROSIS AND 1363 01:01:30,602 --> 01:01:32,370 THIS IS A CRUCIAL NEED. 1364 01:01:32,370 --> 01:01:33,672 WE'RE IN A POSITION WHERE WE HAD 1365 01:01:33,672 --> 01:01:37,742 A DECADE OF REALLY ONE ONLY 1366 01:01:37,742 --> 01:01:40,178 APPROVED DRUG AND THEN THE PHASE 1367 01:01:40,178 --> 01:01:41,947 III TRIALS THAT ARE TRYING TO 1368 01:01:41,947 --> 01:01:43,481 COMPARE AGAINST THE DRUG 1369 01:01:43,481 --> 01:01:47,018 STRUGGLED BECAUSE IT'S SUCH A 1370 01:01:47,018 --> 01:01:49,854 WIDELY AVAILABLE STANDARD. 1371 01:01:49,854 --> 01:01:52,724 HAVING ACCESS TO REAL WORLD DATA 1372 01:01:52,724 --> 01:01:55,327 WHETHER IT'S A GLOBE OF DATA 1373 01:01:55,327 --> 01:01:58,463 REGARDING THE POPULATION ALREADY 1374 01:01:58,463 --> 01:01:58,697 EXISTS. 1375 01:01:58,697 --> 01:02:01,533 I THINK AS WE TRY TO WEAVE IN 1376 01:02:01,533 --> 01:02:03,868 THE INFORMATION IN TERMS OF 1377 01:02:03,868 --> 01:02:07,339 LONGER FOLLOW-UP SURVIVAL AND 1378 01:02:07,339 --> 01:02:17,816 OTHER THINGS IT COMPLICATED 1379 01:02:21,786 --> 01:02:23,221 HAVING CONTROL ARMS AND THESE 1380 01:02:23,221 --> 01:02:24,522 REAL WORLD EVIDENCE CONTROL ARMS 1381 01:02:24,522 --> 01:02:27,892 WILL BE KEY FOR SOME OF THESE 1382 01:02:27,892 --> 01:02:38,303 WHERE IT'S VERY UNAC -- 1383 01:02:39,971 --> 01:02:41,139 [INDISCERNIBLE] TO BE ON THE 1384 01:02:41,139 --> 01:02:42,140 CONTROL ARM. 1385 01:02:42,140 --> 01:02:45,910 >> ONE THING OF INTEREST TOO IS 1386 01:02:45,910 --> 01:02:46,745 WE HAVEN'T DETERMINED IF IT'S 1387 01:02:46,745 --> 01:02:54,552 GOING TO BE PART OF OUR ANALYSIS 1388 01:02:54,552 --> 01:02:57,989 MAYBE AS A STEPPING ZONE A 1389 01:02:57,989 --> 01:03:01,960 RANDOMIZATION EXTREME WHERE A 1390 01:03:01,960 --> 01:03:04,229 COMPONENT MAY BE 1391 01:03:04,229 --> 01:03:06,097 CONTEMPORANEOUSLY CONTROLLED AND 1392 01:03:06,097 --> 01:03:08,333 HALF ARE FROM A REAL WORLD DATA 1393 01:03:08,333 --> 01:03:09,667 SOURCE TO AUGMENT THE CLINICAL 1394 01:03:09,667 --> 01:03:11,336 TRIAL TO YOUR POINT MOST 1395 01:03:11,336 --> 01:03:14,506 PATIENTS LOOKING TO ENROLL IN A 1396 01:03:14,506 --> 01:03:16,741 CLINICAL STUDY ARE OFTEN TIMES 1397 01:03:16,741 --> 01:03:19,310 DOING SO FOR POTENTIAL ACCESS TO 1398 01:03:19,310 --> 01:03:22,414 THE INTERVENTIONAL ARM OR 1399 01:03:22,414 --> 01:03:23,081 EXPERIMENTAL ARM. 1400 01:03:23,081 --> 01:03:24,315 HOW CAN WE RECOGNIZE THAT AND 1401 01:03:24,315 --> 01:03:26,017 TRY TO MAKE THE STUDIES A LITTLE 1402 01:03:26,017 --> 01:03:31,322 BIT MORE FEASIBLE TO PARTICIPATE 1403 01:03:31,322 --> 01:03:41,399 IN. 1404 01:03:56,915 --> 01:04:00,585 >> WHEN WE TALK ABOUT EXTERNAL 1405 01:04:00,585 --> 01:04:03,221 CONTROL ARMS EVERYONE THINKS OF 1406 01:04:03,221 --> 01:04:03,822 REGULATORY APPROVAL PURPOSES 1407 01:04:03,822 --> 01:04:07,192 WHICH IS GREAT BUT AS I THINK OF 1408 01:04:07,192 --> 01:04:11,329 THE PRESENT, THIS COULD BE A 1409 01:04:11,329 --> 01:04:13,565 FANTASTIC RESOURCE FOR TRIAL 1410 01:04:13,565 --> 01:04:16,835 PLANNING TO TRY TO REDUCE THE 1411 01:04:16,835 --> 01:04:20,171 FAILURE RATE OF OUR PHASE III 1412 01:04:20,171 --> 01:04:20,472 TRIALS. 1413 01:04:20,472 --> 01:04:31,015 THE SECOND IS THAT IN PLANNING 1414 01:04:31,316 --> 01:04:33,952 POSTAPPROVAL ACTIVITIES AND TRY 1415 01:04:33,952 --> 01:04:38,756 TO EXTRAPOLATE A DRUG INTO AN 1416 01:04:38,756 --> 01:04:49,100 EFFECTIVE TREATMENT. 1417 01:04:49,501 --> 01:04:49,834 >> THANKS SO MUCH. 1418 01:04:49,834 --> 01:04:52,504 SO AS WE TALKED ABOUT BEFORE, WE 1419 01:04:52,504 --> 01:04:55,306 WERE PLANNING ON KIND OF DOING 1420 01:04:55,306 --> 01:04:57,942 THE SAME SORT OF ACTIVITY BUT 1421 01:04:57,942 --> 01:04:59,310 GIVEN THE FACT THAT FRIENDS OF 1422 01:04:59,310 --> 01:05:03,314 CANCER RESEARCH ARE WELL INTO 1423 01:05:03,314 --> 01:05:07,418 THAT SHOULD WE DELAY THE 1424 01:05:07,418 --> 01:05:09,954 ACTIVITY UNTIL WE CAN POST 1425 01:05:09,954 --> 01:05:13,358 RESULTS WHICH WOULD BE PRUDENT 1426 01:05:13,358 --> 01:05:14,425 FROM THIS STANDPOINT. 1427 01:05:14,425 --> 01:05:18,963 BUT ANY DISCUSSION OB -- ON 1428 01:05:18,963 --> 01:05:27,305 THAT? 1429 01:05:27,305 --> 01:05:27,939 >> AGREED. 1430 01:05:27,939 --> 01:05:29,841 >> WE CAN TALK ABOUT THAT LATER. 1431 01:05:29,841 --> 01:05:30,942 THANK YOU SO MUCH. 1432 01:05:30,942 --> 01:05:31,709 WE APPRECIATE THE PRESENTATION 1433 01:05:31,709 --> 01:05:33,945 AND AWESOME WORK. 1434 01:05:33,945 --> 01:05:36,214 THANK YOU. 1435 01:05:36,214 --> 01:05:37,315 ALL RIGHT. 1436 01:05:37,315 --> 01:05:41,519 MOVING ON TO THE SECTION HERE ON 1437 01:05:41,519 --> 01:05:43,354 STREAMLINING CLINICAL TRIAL 1438 01:05:43,354 --> 01:05:46,224 IMPLEMENTATION IN OUR UPDATE. 1439 01:05:46,224 --> 01:05:51,095 DR. JIM DOROSHOW WILL NOW GIVE 1440 01:05:51,095 --> 01:05:59,938 AN UPDATE ON THAT. 1441 01:05:59,938 --> 01:06:02,040 >> WE GOT SPECIFIC 1442 01:06:02,040 --> 01:06:02,574 RECOMMENDATIONS FROM OUR 1443 01:06:02,574 --> 01:06:04,676 PLANNING GROUP AND WHEN WE 1444 01:06:04,676 --> 01:06:06,477 REVIEWED THESE WAS COULD WE 1445 01:06:06,477 --> 01:06:08,346 REDESIGN THE AUDIT PROCESS 1446 01:06:08,346 --> 01:06:09,547 BECAUSE IT'S CLEARLY A BURDEN 1447 01:06:09,547 --> 01:06:12,784 EVERYONE ON THE CALL HAS BEEN 1448 01:06:12,784 --> 01:06:17,555 THROUGH THIS AND WE KNOW WHAT 1449 01:06:17,555 --> 01:06:20,992 TIME IT TAKES AND KNOW IT REALLY 1450 01:06:20,992 --> 01:06:30,034 IS A DIFFICULT ISSUE AND SO 1451 01:06:30,034 --> 01:06:32,170 BASICALLY WE THOUGHT A PAST 1452 01:06:32,170 --> 01:06:34,072 ANALYSIS OF PAST RESULTS WOULD 1453 01:06:34,072 --> 01:06:36,641 BE THE FIRST STEP AND I THE 1454 01:06:36,641 --> 01:06:39,310 RECOMMENDATION WAS ON PROCESS OF 1455 01:06:39,310 --> 01:06:42,480 DOING AUDIT TO SEE THERE'S 1456 01:06:42,480 --> 01:06:44,382 SOMETHING WE CAN DO TO REDUCE 1457 01:06:44,382 --> 01:06:45,850 THE BURDEN. 1458 01:06:45,850 --> 01:06:48,086 IT MAY NOT COME AS A SURPRISE TO 1459 01:06:48,086 --> 01:06:51,022 EVERYONE THERE'S LIMITED PUBLIC 1460 01:06:51,022 --> 01:06:51,856 DATA IN THIS SPEAR. 1461 01:06:51,856 --> 01:06:53,458 VERY FEW PUBLICATIONS BECAUSE 1462 01:06:53,458 --> 01:06:56,794 COMPANIES DO THEIR AUDITS FOR 1463 01:06:56,794 --> 01:06:58,196 REGULATORY PURPOSES AND THEIR 1464 01:06:58,196 --> 01:07:01,132 CONFIDENT SLAL INFORMATION. 1465 01:07:01,132 --> 01:07:02,667 -- CONFIDENTIAL INFORMATION AND 1466 01:07:02,667 --> 01:07:03,835 THEY'RE NOT AVAILABLE TO THE 1467 01:07:03,835 --> 01:07:04,068 PUBLIC. 1468 01:07:04,068 --> 01:07:06,204 WE DECIDED TO HAVE TWO APPROACH. 1469 01:07:06,204 --> 01:07:11,342 ONE, LOOK AT THE DATABASE OF 1470 01:07:11,342 --> 01:07:14,078 DEFICIENCY REPORTS THAT EXIST IN 1471 01:07:14,078 --> 01:07:16,281 THE CTMB MONITORING BRANCH AND 1472 01:07:16,281 --> 01:07:18,483 GO RIGHT TO THE SOURCE IN TERMS 1473 01:07:18,483 --> 01:07:21,185 OF THE UA AND REGULATORY STAFF 1474 01:07:21,185 --> 01:07:23,388 OF THE COOPERATIVE GROUPS TO SEE 1475 01:07:23,388 --> 01:07:25,423 IF THEY HAD IDEAS HOW THE 1476 01:07:25,423 --> 01:07:26,858 PROFESSION COULD BE IMPROVED IN 1477 01:07:26,858 --> 01:07:37,201 THE AREA WE OVERSEE. 1478 01:07:43,141 --> 01:07:46,077 THIS FOCUSSED ON DEFICIENCY 1479 01:07:46,077 --> 01:07:54,185 REPORTS FOR THREE YEARS, '22, 1480 01:07:54,185 --> 01:07:59,791 '23 AND '24 AND CTMB AND TRIALS. 1481 01:07:59,791 --> 01:08:03,361 NOW, FOR THOSE WHO DON'T 1482 01:08:03,361 --> 01:08:05,697 REMEMBER BECAUSE IF IF YOU 1483 01:08:05,697 --> 01:08:07,699 HAVEN'T HAD THE PLEASURE OF 1484 01:08:07,699 --> 01:08:10,068 UNDERGOING ONE OF THESE AUDITS 1485 01:08:10,068 --> 01:08:11,336 RECENTLY THEY'RE FOCUSSED ON 1486 01:08:11,336 --> 01:08:14,739 THREE BROAD CATEGORIES. 1487 01:08:14,739 --> 01:08:17,175 REVIEW OF THE CASES, PHARMACY 1488 01:08:17,175 --> 01:08:18,609 REVIEW, WHAT YOU'VE DONE WITH 1489 01:08:18,609 --> 01:08:21,412 YOUR IV DRUGS AND REGULATORY 1490 01:08:21,412 --> 01:08:21,646 REVIEW. 1491 01:08:21,646 --> 01:08:24,849 ONE THING THAT MAY NOT BE 1492 01:08:24,849 --> 01:08:26,818 SOMETHING YOU ALL REMEMBER VERY 1493 01:08:26,818 --> 01:08:28,786 CLEARLY IS THESE DEFICIENCIES 1494 01:08:28,786 --> 01:08:30,455 ARE CLASSIFIED UNDER A WIDE 1495 01:08:30,455 --> 01:08:32,990 VARIETY OF CAT GEGOCATEGORIES. 1496 01:08:32,990 --> 01:08:39,197 IT'S A VERY COMPLEX BUSINESS. 1497 01:08:39,197 --> 01:08:41,366 THE OTHER THING IS THE DATA ARE 1498 01:08:41,366 --> 01:08:42,166 NOT COLLECTIVE FOR THE PURPOSE 1499 01:08:42,166 --> 01:08:44,569 OF UNDERSTAND THIG AUDIT 1500 01:08:44,569 --> 01:08:45,103 PROCESS. 1501 01:08:45,103 --> 01:08:48,606 I'LL GIVE YOU MY CONCLUSION NOW 1502 01:08:48,606 --> 01:08:59,117 TO SAY THAT THE PROCESS WORKS 1503 01:09:02,453 --> 01:09:04,021 WELL AND IN TERMS OF AGGREGATE 1504 01:09:04,021 --> 01:09:05,423 DATA IT'S VERY DIFFICULT BECAUSE 1505 01:09:05,423 --> 01:09:08,626 THERE'S SO MANY DIFFERENT WAYS 1506 01:09:08,626 --> 01:09:14,999 THE DATA ARE CLASSIFIED ARD THE 1507 01:09:14,999 --> 01:09:18,603 RULES SAY DEFICIENCIES CAN BE 1508 01:09:18,603 --> 01:09:25,476 SINGLE OR IN MULTIPLE ERRORS AND 1509 01:09:25,476 --> 01:09:26,244 THE MOST IMPORTANT INFORMATION 1510 01:09:26,244 --> 01:09:29,180 WE COLLECT WERE A SINGLE SITE OR 1511 01:09:29,180 --> 01:09:32,150 ONE OR TWO TRIALS IS ALL LOCATED 1512 01:09:32,150 --> 01:09:34,118 IN THE UNSTRUCTURED DATA 1513 01:09:34,118 --> 01:09:40,057 COMMENTS FIELD. 1514 01:09:40,057 --> 01:09:42,260 TO GIVE AN UNDERSTANDING OF THE 1515 01:09:42,260 --> 01:09:47,365 TABLE BELOW ARE EXAMPLES OF DATA 1516 01:09:47,365 --> 01:09:49,534 IN OPEN END DEFICIENCY DATA 1517 01:09:49,534 --> 01:09:51,836 FIELD AND RUN AN INCREDIBLE 1518 01:09:51,836 --> 01:09:56,908 GAMUT FROM THINGS COUNTED AS 1519 01:09:56,908 --> 01:10:00,011 DEFICIENCIES AND THE PATIENT ZIP 1520 01:10:00,011 --> 01:10:08,085 CODE AND IF THE TREATMENT WAS 1521 01:10:08,085 --> 01:10:13,424 REPORTED INCORRECTLY IS CRITICAL 1522 01:10:13,424 --> 01:10:19,330 OR WERE NOT APPROPRIATE HI 1523 01:10:19,330 --> 01:10:27,205 CATEGORIZED. 1524 01:10:27,205 --> 01:10:28,039 THERE'S A WIDE VARIETY OF 1525 01:10:28,039 --> 01:10:31,209 INFORMATION THAT CAN'T BE 1526 01:10:31,209 --> 01:10:33,945 QUANTITATED IN THE AGGREGATED 1527 01:10:33,945 --> 01:10:35,279 AND IF YOU'RE SITTING WITH AN 1528 01:10:35,279 --> 01:10:37,849 AUDITOR AS I HAVE AND GOING OVER 1529 01:10:37,849 --> 01:10:39,350 A TRIAL AND PATIENTS MANY ISSUES 1530 01:10:39,350 --> 01:10:41,352 ARE VERY IMPORTANT AND THEY ARE 1531 01:10:41,352 --> 01:10:42,787 CONTRIBUTE TO THE WAY TRIALS ARE 1532 01:10:42,787 --> 01:10:45,289 CONDUCTED AND HOW WELL THEY'RE 1533 01:10:45,289 --> 01:10:51,362 CONDUCTED AT PARTICULAR SITES. 1534 01:10:51,362 --> 01:10:54,432 SO BASICALLY THE HIGH-LEVEL DATA 1535 01:10:54,432 --> 01:10:56,033 IS NOT GIVEN US A LOT OF HELP IN 1536 01:10:56,033 --> 01:10:58,035 UNDERSTANDING HOW TO BASICALLY 1537 01:10:58,035 --> 01:10:59,337 IMPROVE THE BURDEN. 1538 01:10:59,337 --> 01:11:03,341 ONE THING WE DID FIND OUT IS 1539 01:11:03,341 --> 01:11:06,010 THAT MAYBE THIS IS OBVIOUS TO 1540 01:11:06,010 --> 01:11:09,680 LEARN, MAYBE NOT, BUT IND-EXEMPT 1541 01:11:09,680 --> 01:11:13,751 STUDIES HAVE FEWER EFFICIENCIES 1542 01:11:13,751 --> 01:11:17,054 THAN IMD TRIALS. 1543 01:11:17,054 --> 01:11:17,889 WHAT'S THE REASON? 1544 01:11:17,889 --> 01:11:21,292 IS IT BECAUSE THE COMPLEXITY OF 1545 01:11:21,292 --> 01:11:31,836 THE TRIALS OR MORE COMPLEX AND 1546 01:11:35,406 --> 01:11:35,940 UNDER SCRUTINY. 1547 01:11:35,940 --> 01:11:39,343 WHAT'S DIFFICULT GOING FROM THE 1548 01:11:39,343 --> 01:11:43,814 DATA FROM THE DATA IS TO 1549 01:11:43,814 --> 01:11:46,384 DETERMINE THE RECOMMENDATION 1550 01:11:46,384 --> 01:11:52,857 FROM THE PLANNING GROUP WOULD 1551 01:11:52,857 --> 01:11:55,893 REQUIRE REVIEW TO GET MORE 1552 01:11:55,893 --> 01:11:57,395 SPECIFIC DATA RELATED TO PROCESS 1553 01:11:57,395 --> 01:12:05,570 AND HOW TO REDUCE THE BURDEN. 1554 01:12:05,570 --> 01:12:08,839 WE HAVE FRUITFUL DISCUSSIONS 1555 01:12:08,839 --> 01:12:10,374 WITH OUR STAFF. 1556 01:12:10,374 --> 01:12:12,009 THEY'RE THE PEOPLE THAT DEAL 1557 01:12:12,009 --> 01:12:20,051 WITH THE NCI AUDITS. 1558 01:12:20,051 --> 01:12:22,186 THESE WERE OPEN ENDED QUESTIONS 1559 01:12:22,186 --> 01:12:24,188 AND GIVE THE RECOMMENDATIONS THE 1560 01:12:24,188 --> 01:12:27,525 GROUP OF INDIVIDUALS CAME UP 1561 01:12:27,525 --> 01:12:30,428 WITH. 1562 01:12:30,428 --> 01:12:34,231 SO ONE THING IMPORTANT TO POINT 1563 01:12:34,231 --> 01:12:44,675 OUT AS WE ALL THINK ABOUT 1564 01:12:46,310 --> 01:12:48,879 AUDITS, IT'S SOMETIMES DIFFICULT 1565 01:12:48,879 --> 01:12:55,519 TO PARS OUT THE NCTN AUDITS THAN 1566 01:12:55,519 --> 01:13:00,424 THE INDUSTRY AUDITS AND THEY'RE 1567 01:13:00,424 --> 01:13:04,462 MORE PAINFUL THAN THE NCTN 1568 01:13:04,462 --> 01:13:07,131 AUDITS AND IF YOU'RE IN A GROUP 1569 01:13:07,131 --> 01:13:08,165 AND PREPARING FOR THESE THINGS 1570 01:13:08,165 --> 01:13:09,834 IT'S HARDER FOR THE STAFF TO 1571 01:13:09,834 --> 01:13:12,937 KEEP ALL THE DETAILS IN TERMS OF 1572 01:13:12,937 --> 01:13:16,273 WHAT WAS INDUSTRY-RELATED BURDEN 1573 01:13:16,273 --> 01:13:21,312 TO NCTN-BURDEN CLEAR. 1574 01:13:21,312 --> 01:13:23,247 THE PREPARATION FOR THE AUDITS 1575 01:13:23,247 --> 01:13:25,616 IS A SIGNIFICANT BURDEN AND 1576 01:13:25,616 --> 01:13:27,351 TAKES DAYS AND DAYS. 1577 01:13:27,351 --> 01:13:32,390 I'LL SHARE IN MY PREVIOUS EMPLOY 1578 01:13:32,390 --> 01:13:35,359 WE HAD A CONFERENCE ROOM 1579 01:13:35,359 --> 01:13:36,961 DEDICATED AUDITS BECAUSE WE HAD 1580 01:13:36,961 --> 01:13:38,663 SO MANY COMING SO OFTEN. 1581 01:13:38,663 --> 01:13:42,433 ALSO WHAT WE GOT FROM THE GROUP 1582 01:13:42,433 --> 01:13:51,275 STAFF WAS THAT THERE'S A LOT 1583 01:13:51,275 --> 01:13:52,910 VARIABILITY IN LESSER VERSUS 1584 01:13:52,910 --> 01:13:54,679 MAJOR IN TERMS OF DEFICIENCY. 1585 01:13:54,679 --> 01:13:57,281 THE SYSTEM IS BURDENSOME AND 1586 01:13:57,281 --> 01:13:59,383 TRAINING IS DIFFICULT BECAUSE 1587 01:13:59,383 --> 01:14:00,284 IT'S CRITICALLY IMPORTANT A LOT 1588 01:14:00,284 --> 01:14:02,820 OF REALLY EXPERIENCES PEOPLE 1589 01:14:02,820 --> 01:14:04,722 WERE LOST DURING THE PANDEMIC. 1590 01:14:04,722 --> 01:14:06,057 WE HAVE TO HAVE THE KIND OF 1591 01:14:06,057 --> 01:14:07,358 STAFF TO RESPOND TO THE 1592 01:14:07,358 --> 01:14:10,394 PREPARATION AND THE AUDIT 1593 01:14:10,394 --> 01:14:20,671 CONDUCT ITSELF. 1594 01:14:34,385 --> 01:14:37,088 WE CAN'T HAVE ACTIVITIES THAT 1595 01:14:37,088 --> 01:14:39,356 INVOLVE SURGERY AND RADIATION 1596 01:14:39,356 --> 01:14:44,395 AND SO THERE HAS TO BE SOME 1597 01:14:44,395 --> 01:14:45,730 FLEXIBILITY HOW IT WOULD OCCUR 1598 01:14:45,730 --> 01:14:47,098 BUT THERE WAS ENTHUSIASM IN HOW 1599 01:14:47,098 --> 01:14:47,832 TO DO SO. 1600 01:14:47,832 --> 01:14:51,769 SO WHAT ARE WE GOING TO DO? 1601 01:14:51,769 --> 01:14:54,004 I THINK WE HAVE TO CONTINUE TO 1602 01:14:54,004 --> 01:14:56,240 EXPLORE WAYS TO STREAMLINE THE 1603 01:14:56,240 --> 01:14:56,474 PROCESS. 1604 01:14:56,474 --> 01:14:57,942 SO THE FIRST THING THAT IS 1605 01:14:57,942 --> 01:15:00,177 OBVIOUS IS THE MORE WE CAN DO TO 1606 01:15:00,177 --> 01:15:02,813 DECREASE THE AMOUNT OF DATA THAT 1607 01:15:02,813 --> 01:15:03,481 WE COLLECT, THE LESS THE BURDEN 1608 01:15:03,481 --> 01:15:06,550 FOR THE AUDIT. 1609 01:15:06,550 --> 01:15:09,687 SO THAT REALLY PUTS US AT 1610 01:15:09,687 --> 01:15:10,988 GREATER PARITY AT OUR EFFORTS TO 1611 01:15:10,988 --> 01:15:12,356 STREAMLINE THE DATA COLLECTION. 1612 01:15:12,356 --> 01:15:16,360 THIS HAS BEEN THE HOLY GRAIL IN 1613 01:15:16,360 --> 01:15:18,129 TERMS OF DIRECT TRANSMISSION 1614 01:15:18,129 --> 01:15:21,465 FROM EHRs TO DATABASES. 1615 01:15:21,465 --> 01:15:23,768 A VERY HEAVY LIFT. 1616 01:15:23,768 --> 01:15:26,270 A VERY HEAVY LIFT GOING ON FOR 1617 01:15:26,270 --> 01:15:26,604 DECADES. 1618 01:15:26,604 --> 01:15:28,205 I WOULD LOVE TO BE ABLE TO DO 1619 01:15:28,205 --> 01:15:28,806 THAT. 1620 01:15:28,806 --> 01:15:31,342 IT COULD DECREASE THE ERRORS I'M 1621 01:15:31,342 --> 01:15:41,452 SURE. 1622 01:15:43,654 --> 01:15:46,157 THE MONITORING GROUP WOULD LOVE 1623 01:15:46,157 --> 01:15:48,793 FEEDBACK AND ONE THING THEY'RE 1624 01:15:48,793 --> 01:15:50,261 DOING IN THE AUDITING GUIDELINES 1625 01:15:50,261 --> 01:15:52,129 IS TO HAVE A SEPARATE CATEGORY 1626 01:15:52,129 --> 01:15:55,833 OR DEFICIENCIES RELATED TO 1627 01:15:55,833 --> 01:15:57,868 STUDIES. 1628 01:15:57,868 --> 01:16:03,340 15 YEARS AGO WE DID FEWER 1629 01:16:03,340 --> 01:16:07,344 CORRELATIVE STUDIES NOW THERE'S 1630 01:16:07,344 --> 01:16:12,817 MORE AND MISSING A BLOOD DRAW 1631 01:16:12,817 --> 01:16:16,453 FOR A CTNA TEST IS NOT IN THE 1632 01:16:16,453 --> 01:16:18,823 SAME CATEGORY AS NOT APPROPRIATE 1633 01:16:18,823 --> 01:16:20,858 FOR CATEGORIZING AEs OR 1634 01:16:20,858 --> 01:16:22,293 REGULATORY DEFICIENCIES. 1635 01:16:22,293 --> 01:16:23,994 HAVING THEM AS A SEPARATE 1636 01:16:23,994 --> 01:16:25,429 CATEGORY IS VERY IMPORTANT AND I 1637 01:16:25,429 --> 01:16:27,164 THINK WILL DECREASE THE AMOUNT 1638 01:16:27,164 --> 01:16:29,133 OF INFORMATION WE NEED TO 1639 01:16:29,133 --> 01:16:31,335 RESPOND TO NOT THAT IT'S NOT 1640 01:16:31,335 --> 01:16:32,837 IMPORTANT TO GET THE DATA 1641 01:16:32,837 --> 01:16:34,672 COLLECTED AND SAMPLES COLLECTED 1642 01:16:34,672 --> 01:16:37,908 BUT HAVE TO BE VIEWED AS AN 1643 01:16:37,908 --> 01:16:39,243 APPROPRIATE FOR WHAT THE STUDY 1644 01:16:39,243 --> 01:16:42,613 IS GOING TO BE SET OUT TO DO AND 1645 01:16:42,613 --> 01:16:43,380 WHAT THE QUALITY INSURANCE 1646 01:16:43,380 --> 01:16:53,691 ISSUES REALLY ARE. 1647 01:17:03,667 --> 01:17:06,136 AND I THINK ANYTHING WE CAN DO 1648 01:17:06,136 --> 01:17:10,107 TO WORK WITH THE GROUPS TO 1649 01:17:10,107 --> 01:17:11,141 FURTHER HARMONIZE THE PROCESS 1650 01:17:11,141 --> 01:17:13,577 ACROSS THE GROUPS AND AUDITORS 1651 01:17:13,577 --> 01:17:14,745 WE'D LOVE TO BE ABLE TO DO 1652 01:17:14,745 --> 01:17:16,480 WHEREVER THAT'S POSSIBLE. 1653 01:17:16,480 --> 01:17:19,350 I THINK SOME OF THE CALL WOULD 1654 01:17:19,350 --> 01:17:22,686 LOVE THE NOTION OF DEVELOPING 1655 01:17:22,686 --> 01:17:24,188 LIKE FOR THE CENTRAL IRB AND 1656 01:17:24,188 --> 01:17:27,791 OTHER SERVICES TO HAVE A 1657 01:17:27,791 --> 01:17:31,762 CENTRALIZED PROCESS TO DO ALL 1658 01:17:31,762 --> 01:17:42,239 THE AUDITING WOULD BE GREAT. 1659 01:17:43,407 --> 01:17:47,344 IT ONLY MAKES IT DIFFICULT TO 1660 01:17:47,344 --> 01:17:48,846 DIFFICULT IN THE CURRENT 1661 01:17:48,846 --> 01:17:49,713 ADMINISTRATION THOUGH IT WOULD 1662 01:17:49,713 --> 01:17:51,282 BE SOMETHING I'D LOVE TO 1663 01:17:51,282 --> 01:17:51,548 ENTERTAIN. 1664 01:17:51,548 --> 01:17:56,387 I'D LIKE TO THANK ALL THE FOLKS 1665 01:17:56,387 --> 01:17:58,489 WHO HELPED INITIATE THE 1666 01:17:58,489 --> 01:18:02,893 RECOMMENDATIONS AND THE STAFF 1667 01:18:02,893 --> 01:18:07,264 AND CTAC MEMBERS AND CCCT AND 1668 01:18:07,264 --> 01:18:11,335 ALL WHO PLAYED A CRITICAL ROLE 1669 01:18:11,335 --> 01:18:12,303 IN PUTTING THE INFORMATION 1670 01:18:12,303 --> 01:18:16,473 TOGETHER FOR THE ANALYSIS. 1671 01:18:16,473 --> 01:18:18,208 HAPPY TO TAKE QUESTIONS. 1672 01:18:18,208 --> 01:18:20,177 >> I KNOW IT'S A LOT OF WORK FOR 1673 01:18:20,177 --> 01:18:22,479 EVERYBODY BUT IMPORTANT WORK. 1674 01:18:22,479 --> 01:18:32,890 QUESTIONS FROM ANYBODY? 1675 01:18:40,197 --> 01:18:42,533 >> IT'S TWO SIDES OF THE COIN IN 1676 01:18:42,533 --> 01:18:45,970 THE STRUCTURE IT'S ACTUALLY A 1677 01:18:45,970 --> 01:18:51,075 LEARNING PROCESS AND A HEAVILY 1678 01:18:51,075 --> 01:18:53,811 VOLUNTEERED PROCESS. 1679 01:18:53,811 --> 01:18:58,515 WHEN WE PUT TOGETHER AN AUDIT 1680 01:18:58,515 --> 01:18:59,783 GROUP OR TEAM YOU'RE EDUCATING 1681 01:18:59,783 --> 01:19:01,952 PEOPLE HOW TO MAKE THEIR SITE 1682 01:19:01,952 --> 01:19:02,186 BETTER. 1683 01:19:02,186 --> 01:19:06,023 THEN THEY DO AUDIT AND THAT 1684 01:19:06,023 --> 01:19:07,925 DOESN'T COST THE NCI ANYTHING. 1685 01:19:07,925 --> 01:19:09,660 THAT'S VOLUNTEER HOURS. 1686 01:19:09,660 --> 01:19:10,694 I DON'T KNOW WHERE ON THE ONE 1687 01:19:10,694 --> 01:19:12,363 HAND I WOULD LOVE TO SAY I DON'T 1688 01:19:12,363 --> 01:19:15,366 HAVE TO WORRY ABOUT THE AUDIT 1689 01:19:15,366 --> 01:19:17,201 PROCESS ANYMORE AS A COOPERATE 1690 01:19:17,201 --> 01:19:20,037 GROUP AND THERE'S A CENTRALIZED 1691 01:19:20,037 --> 01:19:20,904 PROCESS FOR IT. 1692 01:19:20,904 --> 01:19:24,341 ON THE OTHER HAND I THINK IT 1693 01:19:24,341 --> 01:19:26,543 HELPS THE COOPERATIVE GROUPS 1694 01:19:26,543 --> 01:19:29,613 TRAIN THE NEXT GENERATION AND 1695 01:19:29,613 --> 01:19:40,024 HAVE HIGH QUALITY DATA. 1696 01:19:41,859 --> 01:19:43,360 ALSO OPPOSED TO THE MORE 1697 01:19:43,360 --> 01:19:45,429 CHALLENGING AUDITS FROM FDA OR 1698 01:19:45,429 --> 01:19:47,331 INDUSTRY, THE COOPERATIVE GROUPS 1699 01:19:47,331 --> 01:19:51,335 IS TRULY AN AUDIT TO TRY TO HELP 1700 01:19:51,335 --> 01:19:53,203 PEOPLE IMPROVE THEIR PROCESSES 1701 01:19:53,203 --> 01:20:02,413 AND ALWAYS VIEWED AS A POSITIVE 1702 01:20:02,413 --> 01:20:03,380 THOUGH THERE'S CHALLENGES 1703 01:20:03,380 --> 01:20:04,681 GETTING IT TOGETHER ON THE 1704 01:20:04,681 --> 01:20:05,215 INVESTIGATOR END. 1705 01:20:05,215 --> 01:20:06,884 YES, IT'S A BURDEN BUT I THINK 1706 01:20:06,884 --> 01:20:10,554 WE HAVE TO LOOK AT THE BIG 1707 01:20:10,554 --> 01:20:10,954 PICTURES AS WELL. 1708 01:20:10,954 --> 01:20:21,131 >> GREAT. 1709 01:20:26,170 --> 01:20:29,940 SO WE DON'T NEED TO TAKE A LOT 1710 01:20:29,940 --> 01:20:32,142 OF BIG LEEMZ LEAPS FORWARD -- 1711 01:20:33,877 --> 01:20:37,714 BIG LEAPS FORWARD BUT I WAS 1712 01:20:37,714 --> 01:20:40,751 STRUCK FROM COMMENTS FROM THE QA 1713 01:20:40,751 --> 01:20:41,752 TEAMS WHERE THEY THOUGHT CHANGES 1714 01:20:41,752 --> 01:20:44,955 COULD HELP THE PROCESS. 1715 01:20:44,955 --> 01:20:46,623 ONE THAT -- TWO STRUCK ME IN THE 1716 01:20:46,623 --> 01:20:46,990 SLIDE. 1717 01:20:46,990 --> 01:20:49,860 ONE WAS THE TRAINING. 1718 01:20:49,860 --> 01:20:56,767 SO ONE IS TO HARMONIZE THE AUDIT 1719 01:20:56,767 --> 01:20:59,336 MANUAL BUT IT'S NOT THE AUDIT 1720 01:20:59,336 --> 01:20:59,803 MANUAL ITSELF. 1721 01:20:59,803 --> 01:21:01,105 IT'S THE TRAINING THAT GOES HOW 1722 01:21:01,105 --> 01:21:03,173 TO USE THE AUDIT MANUAL. 1723 01:21:03,173 --> 01:21:06,043 SO MAYBE SOME EFFORT OF GETTING 1724 01:21:06,043 --> 01:21:08,512 THE GROUPS TOGETHER TO COME 1725 01:21:08,512 --> 01:21:10,614 TOGETHER TO DEVELOP A TRAINING 1726 01:21:10,614 --> 01:21:14,151 PROGRAM THAT'S HARMONIZED MAY BE 1727 01:21:14,151 --> 01:21:18,388 A SMALL STEP THAT COULD MOVE US 1728 01:21:18,388 --> 01:21:21,091 IN THE RIGHT DIRECTION INSTEAD 1729 01:21:21,091 --> 01:21:22,126 OF CENTRALIZING EVERYTHING 1730 01:21:22,126 --> 01:21:24,328 GETTING THE GROUPS TO COME UP 1731 01:21:24,328 --> 01:21:25,395 WITH A COMMON TRAINING PROGRAM 1732 01:21:25,395 --> 01:21:26,330 THAT APPLIES TO EVERYBODY. 1733 01:21:26,330 --> 01:21:28,265 THAT COULD BE A SMALL STEP THAT 1734 01:21:28,265 --> 01:21:30,033 POTENTIALLY COULD HAVE A BIG 1735 01:21:30,033 --> 01:21:30,267 IMPACT. 1736 01:21:30,267 --> 01:21:31,902 THE OTHER ONE THAT STRUCK ME WAS 1737 01:21:31,902 --> 01:21:39,343 THE ISSUE OF AUDIT INFORMATION 1738 01:21:39,343 --> 01:21:40,511 SYSTEM. 1739 01:21:40,511 --> 01:21:41,879 THERE MAY BE EFFORTS THERE TOO 1740 01:21:41,879 --> 01:21:45,582 TO ALLEVIATE THE BURDEN BY 1741 01:21:45,582 --> 01:21:49,820 MAKING THAT SYSTEM MORE USER 1742 01:21:49,820 --> 01:21:51,255 FRIENDLY, LESS BURDENSOME IN 1743 01:21:51,255 --> 01:21:52,489 TERMS OF DETAILS. 1744 01:21:52,489 --> 01:21:54,725 THERE MAY BE TWO SMALL STEPS 1745 01:21:54,725 --> 01:21:56,693 THAT INCREDIBLY COULD GET US 1746 01:21:56,693 --> 01:22:00,697 WHERE WE WANT WITHOUT HAVING TO 1747 01:22:00,697 --> 01:22:01,532 CENTRALIZE EVERYTHING. 1748 01:22:01,532 --> 01:22:04,434 JUST SOME SUGGESTIONS. 1749 01:22:04,434 --> 01:22:14,077 >> THANK YOU. 1750 01:22:14,077 --> 01:22:16,413 >> YOU HAVE PROVEN IT'S 1751 01:22:16,413 --> 01:22:17,648 DISPARATE AND HARD TO AGGREGATE 1752 01:22:17,648 --> 01:22:19,750 AND BUILD A BETTER MORE 1753 01:22:19,750 --> 01:22:22,686 SIMPLIFIED SYSTEM AND TELL THEM 1754 01:22:22,686 --> 01:22:24,688 WHAT TO DO. 1755 01:22:24,688 --> 01:22:27,925 DON'T COLLECT BAD ZIP CODES. 1756 01:22:27,925 --> 01:22:30,160 WHO CARES IT WOULD LEAD TO LESS 1757 01:22:30,160 --> 01:22:31,195 RESOURCES. 1758 01:22:31,195 --> 01:22:34,698 COULD WE PILOT AT 10 SITES A 1759 01:22:34,698 --> 01:22:36,600 SIMPLER AUDITING SYSTEM AND 1760 01:22:36,600 --> 01:22:39,570 ENSURE IT'S STILL SAFE? 1761 01:22:39,570 --> 01:22:41,205 >> CHUCK, I THINK THAT'S 1762 01:22:41,205 --> 01:22:44,841 SOMETHING THE GROUPS WANT TO DO, 1763 01:22:44,841 --> 01:22:46,677 WE NEED TO START THINKING ABOUT 1764 01:22:46,677 --> 01:22:56,753 IT. 1765 01:23:02,559 --> 01:23:03,060 >> CAROLINE. 1766 01:23:03,060 --> 01:23:06,630 >> I AGREE IN A BALANCED WAY 1767 01:23:06,630 --> 01:23:07,965 WITH WHAT ROBERT SAID. 1768 01:23:07,965 --> 01:23:10,701 WE TAKE THEM AS EDUCATIONAL 1769 01:23:10,701 --> 01:23:14,605 OPPORTUNITIES BUT WE HAVE TO 1770 01:23:14,605 --> 01:23:18,475 REMEMBER WHY WE'RE DOING AUDITS 1771 01:23:18,475 --> 01:23:21,678 FOR INTEGRITY OF THE TRIAL AND 1772 01:23:21,678 --> 01:23:22,713 NOT PATIENT SAFETY. 1773 01:23:22,713 --> 01:23:28,285 EVERYBODY WANTS TO DO ATTENTION 1774 01:23:28,285 --> 01:23:32,356 TO DETAIL BUT WE'RE HUMAN AND 1775 01:23:32,356 --> 01:23:34,825 THE OTHER ASPECT OF ALL OF THE 1776 01:23:34,825 --> 01:23:38,295 AUDITING PREP IS WE PUT CAP IN 1777 01:23:38,295 --> 01:23:40,731 PLACE TO ADDRESS THE ISSUES THAT 1778 01:23:40,731 --> 01:23:42,933 WE DISCOVER BUT IF WE DON'T HAVE 1779 01:23:42,933 --> 01:23:44,835 THE AVAILABILITY TO MONITOR 1780 01:23:44,835 --> 01:23:46,570 BECAUSE WE'RE ALWAYS IN AUDIT 1781 01:23:46,570 --> 01:23:49,940 PROCESS, WE DON'T KNOW WE'RE 1782 01:23:49,940 --> 01:23:50,841 SUCCESSFULLY ADAPTING OUR CAP 1783 01:23:50,841 --> 01:23:52,009 AND EVERYTHING LIKE THAT. 1784 01:23:52,009 --> 01:24:02,586 IT'S A BALANCE OF THE BURDEN AND 1785 01:24:05,589 --> 01:24:07,057 WHEN THE AUDITORS PULL CHARTS 1786 01:24:07,057 --> 01:24:09,326 FROM THREE YEARS AGO AND WE 1787 01:24:09,326 --> 01:24:11,495 DISCOVERED THE PROBLEMS AND MADE 1788 01:24:11,495 --> 01:24:13,730 A CAP BUT THE NEXT AUDIT IS 1789 01:24:13,730 --> 01:24:15,332 STILL SEEING THE BACK TIMING 1790 01:24:15,332 --> 01:24:19,102 THEN WE'RE JUST REHASHING THE 1791 01:24:19,102 --> 01:24:20,203 SAME THING. 1792 01:24:20,203 --> 01:24:22,839 THERE'S GOT TO BE A BALANCE WITH 1793 01:24:22,839 --> 01:24:33,050 ALL OF THAT. 1794 01:24:33,984 --> 01:24:38,021 >> ABOUT POINT, EVERYBODY, MADE. 1795 01:24:38,021 --> 01:24:38,989 TWO COMMENTS. 1796 01:24:38,989 --> 01:24:40,824 FIRST, I AGREE THERE'S AN 1797 01:24:40,824 --> 01:24:42,359 EDUCATIONAL COMPONENT TO ALL 1798 01:24:42,359 --> 01:24:43,727 THIS GIVEN THE PANDEMIC AND 1799 01:24:43,727 --> 01:24:44,494 ANTICIPATED LOSS OF STAFF AND SO 1800 01:24:44,494 --> 01:24:55,005 ON BUT I AGREE WITH CARE LINE 1801 01:24:56,807 --> 01:24:58,408 THAT WE CAN'T LOSE SIGHT OF 1802 01:24:58,408 --> 01:24:58,642 THAT. 1803 01:24:58,642 --> 01:25:02,012 FALLING ON THAT I WONDER IF 1804 01:25:02,012 --> 01:25:12,122 THERE'S A WAY TO HAVE THE DATA 1805 01:25:12,122 --> 01:25:14,691 ELEMENTS AUDITED FOR INSTANCE 1806 01:25:14,691 --> 01:25:22,733 THE ZIP CODE IS NOT ON ITS FACE 1807 01:25:22,733 --> 01:25:30,407 WOULD AFFECT PATIENT SAFETY AND 1808 01:25:30,407 --> 01:25:32,876 COULD THOSE BE PRIORITIZED IN A 1809 01:25:32,876 --> 01:25:33,977 RISK-BASED APPROACH. 1810 01:25:33,977 --> 01:25:36,780 THAT'S THE FIRST COMMENT. 1811 01:25:36,780 --> 01:25:47,324 THE SECOND IS THAT THE PROCESS 1812 01:25:51,428 --> 01:25:56,066 IS ONEROUS AND IT'S THE 1813 01:25:56,066 --> 01:26:02,539 FOLLOW-UP THAT TAKES PLACE IS 1814 01:26:02,539 --> 01:26:04,808 OFTEN MORE ONEROUS AND THE 1815 01:26:04,808 --> 01:26:06,476 AUDITOR COMES AND THE UNSPOKEN 1816 01:26:06,476 --> 01:26:08,678 THREAT IS WE'RE GOING TO PUT YOU 1817 01:26:08,678 --> 01:26:11,948 ON ENROLLMENT HOLD OR SOMETHING 1818 01:26:11,948 --> 01:26:22,192 BECAUSE WE DISCOVERED SOME MAJOR 1819 01:26:22,192 --> 01:26:23,393 THING AND EVERYBODY GETS 1820 01:26:23,393 --> 01:26:23,627 NERVOUS. 1821 01:26:23,627 --> 01:26:33,170 FOR THE NCI IS THERE A WAY THE 1822 01:26:33,170 --> 01:26:34,805 CONSEQUENCES COULD NOT BE MADE 1823 01:26:34,805 --> 01:26:38,942 LESS MEANINGFUL BUT MADE MORE 1824 01:26:38,942 --> 01:26:46,149 TRANSPARENT SO IS THE SITES HAVE 1825 01:26:46,149 --> 01:26:48,218 LESS FEAR OF THE CONSEQUENCES OR 1826 01:26:48,218 --> 01:26:51,054 HAVE MORE INPUT OR CONTROL TO 1827 01:26:51,054 --> 01:26:51,988 HOW THEY'RE MANAGED. 1828 01:26:51,988 --> 01:26:54,324 THAT MAY HELP ALLEVIATE THE 1829 01:26:54,324 --> 01:26:56,226 ANXIETY AROUND THE ACTUAL AUDIT 1830 01:26:56,226 --> 01:26:58,829 PROCESS ITSELF WHICH THEN FEEDS 1831 01:26:58,829 --> 01:27:02,232 INTO HOW MUCH TIME PEOPLE PUT 1832 01:27:02,232 --> 01:27:04,801 INTO PREPARING FOR IT. 1833 01:27:04,801 --> 01:27:14,578 THOSE ARE TWO COMMENTS. 1834 01:27:14,578 --> 01:27:20,550 >> THERE'S A LOT OF VARIABILITY 1835 01:27:20,550 --> 01:27:21,952 AND HARMONIZE SITES WOULD BE 1836 01:27:21,952 --> 01:27:22,819 HELPFUL. 1837 01:27:22,819 --> 01:27:30,660 WE NEED TO MOVE ON AND ANDREA 1838 01:27:30,660 --> 01:27:36,867 DENICOFF WILL TALK ABOUT THE 1839 01:27:36,867 --> 01:27:37,334 SITES MORE. 1840 01:27:37,334 --> 01:27:38,702 >> THANK YOU FOR THE OPPORTUNITY 1841 01:27:38,702 --> 01:27:47,410 TO SHARE THIS WORK WITH YOU. 1842 01:27:47,410 --> 01:27:54,651 THIS IS DECENTRALIZED CLINICAL 1843 01:27:54,651 --> 01:27:56,653 TRIAL ELEMENTS AND DESCRIBE HOW 1844 01:27:56,653 --> 01:27:58,121 WE'RE IMPLEMENTING IT. 1845 01:27:58,121 --> 01:28:02,325 AS MANY ARE AWARE, MANY 1846 01:28:02,325 --> 01:28:04,561 DECENTRALIZED ELEMENTS WITHIN A 1847 01:28:04,561 --> 01:28:05,762 TRIAL WERE FOUND TO BE EXTREMELY 1848 01:28:05,762 --> 01:28:08,298 BENEFICIAL TO PATIENTS DURING 1849 01:28:08,298 --> 01:28:10,834 THE COVID-19 PANDEMIC AND AS WE 1850 01:28:10,834 --> 01:28:14,604 WERE COMING OUT OF THE PANDEMIC 1851 01:28:14,604 --> 01:28:16,239 EVERYONE REACHED OUT TO US AND 1852 01:28:16,239 --> 01:28:18,275 SAID WE WANT TO CONTINUE MANY OF 1853 01:28:18,275 --> 01:28:19,676 THESE DECENTRALIZED ACTIVITIES 1854 01:28:19,676 --> 01:28:30,353 AS THEY'RE HELPFUL TO PATIENTS 1855 01:28:32,656 --> 01:28:36,059 AND THE WAS CREATING GUIDANCE ON 1856 01:28:36,059 --> 01:28:38,628 ACTIVITIES AND IN PARALLEL THE 1857 01:28:38,628 --> 01:28:41,731 RESEARCH BASES REALLY WANTED TO 1858 01:28:41,731 --> 01:28:45,435 WORK TOGETHER WITH CTAC AND DCP 1859 01:28:45,435 --> 01:28:55,979 TO SEE IF WE CAN CREATE COMMONLY 1860 01:28:55,979 --> 01:29:01,651 USED LANGUAGE SO ALL COULD 1861 01:29:01,651 --> 01:29:07,624 UNDERSTAND WITHIN THE TRIAL. 1862 01:29:07,624 --> 01:29:10,794 WHAT THE CTAC RESEARCH BASES 1863 01:29:10,794 --> 01:29:13,496 THOUGHT WOULD BE HELPFUL WAS TO 1864 01:29:13,496 --> 01:29:17,000 CREATE A CHECKLIST TO HELP 1865 01:29:17,000 --> 01:29:19,669 PROTOCOL AUTHORIZE AND STUDY 1866 01:29:19,669 --> 01:29:25,709 TEAMS TO LOOK AT WHAT COULD BE 1867 01:29:25,709 --> 01:29:33,817 DECENTRALIZED AND -- THE DCT, 1868 01:29:33,817 --> 01:29:34,884 COULD CREATE LANGUAGE TO BE USED 1869 01:29:34,884 --> 01:29:45,395 ACROSS THE PROTOCOLS SO SITES 1870 01:29:46,429 --> 01:29:49,766 AND HAVE A BETTER UNDERSTANDING. 1871 01:29:49,766 --> 01:29:57,440 THAT'S WHAT OUR NCTN/NCORP TEAM 1872 01:29:57,440 --> 01:30:05,615 DID CIRCULATING SOME LANGUAGE. 1873 01:30:05,615 --> 01:30:07,651 FOR THOSE COMMONLY DE SEN IZED 1874 01:30:07,651 --> 01:30:10,887 AND TO HAVE THE OPPORTUNITY FOR 1875 01:30:10,887 --> 01:30:15,725 THE WORK WOULD BE REMOTE CONSENT 1876 01:30:15,725 --> 01:30:18,128 AND NOT A REGISTERED 1877 01:30:18,128 --> 01:30:19,329 INVESTIGATOR. 1878 01:30:19,329 --> 01:30:22,565 TELEHEALTH VISITS WITH STUDY 1879 01:30:22,565 --> 01:30:27,337 TEAM FORMING LOCAL LABS, AND 1880 01:30:27,337 --> 01:30:30,507 SINCE THE START OF THE PANDEMIC 1881 01:30:30,507 --> 01:30:34,144 WE WERE SHIPPING AGENTS DIRECTLY 1882 01:30:34,144 --> 01:30:40,083 TO PARTICIPANTS AND WHERE 1883 01:30:40,083 --> 01:30:42,085 POSSIBLE TREATMENTS FOR 1884 01:30:42,085 --> 01:30:43,353 INVESTIGATIONAL THERAPIES FOR A 1885 01:30:43,353 --> 01:30:44,921 TRIAL AND IF POSSIBLE RADIATION 1886 01:30:44,921 --> 01:30:47,457 THERAPY DONE MORE CLOSE TO A 1887 01:30:47,457 --> 01:30:52,562 PATIENT'S HOME. 1888 01:30:52,562 --> 01:30:55,899 AT THE BOTTOM IS DIFFERENT 1889 01:30:55,899 --> 01:30:57,367 SCENARIOS FOR SCENARIOS IN THE 1890 01:30:57,367 --> 01:31:00,503 CHECKLIST WE HEARD BACK FROM ALL 1891 01:31:00,503 --> 01:31:04,507 THE GROUPS THAT IS HELPFUL TO 1892 01:31:04,507 --> 01:31:07,343 PROMPT STUDY TEAMS FOR 1893 01:31:07,343 --> 01:31:08,378 ACTIVITIES THAT COULD BE 1894 01:31:08,378 --> 01:31:18,888 DECENTRALIZED WITHIN A TRIAL. 1895 01:31:19,756 --> 01:31:22,592 WE HAVE ONE TRIAL CURRENTLY 1896 01:31:22,592 --> 01:31:28,331 ACTIVE, A PHASE III STUDY FOR 1897 01:31:28,331 --> 01:31:30,567 PATIENTS WITH METASTATIC 1898 01:31:30,567 --> 01:31:34,170 PROSTATE CANCER AND IT'S AN 1899 01:31:34,170 --> 01:31:37,273 IND-EXEMPT TRIAL SO IT HAS 1900 01:31:37,273 --> 01:31:41,945 SEVERAL COMMERCIAL AGENTS AND 1901 01:31:41,945 --> 01:31:42,679 ONE INCLUDES THE ADMINISTRATION 1902 01:31:42,679 --> 01:31:44,114 OF COMMERCIAL AGENTS COULD BE 1903 01:31:44,114 --> 01:31:54,791 DONE BY A LOCAL ONCOLOGIST AND 1904 01:31:54,791 --> 01:31:57,727 ELEMENTS WITH THE STUDY TEAM 1905 01:31:57,727 --> 01:31:59,062 SUCH AS THOSE IN ASSESSING 1906 01:31:59,062 --> 01:32:02,432 ADVERSE EVENTS AND CAN HAVE 1907 01:32:02,432 --> 01:32:06,736 THEIR LOCAL LAB TESTS AND IN 1908 01:32:06,736 --> 01:32:13,977 PARTICULAR IS FOR 1909 01:32:13,977 --> 01:32:15,345 PROGRESSION-FREE SURVIVAL AND IN 1910 01:32:15,345 --> 01:32:17,046 THIS CASE THE PATIENT COULD NOT 1911 01:32:17,046 --> 01:32:19,149 HAVE IMAGING STUDIES DONE 1912 01:32:19,149 --> 01:32:19,382 LOCALLY. 1913 01:32:19,382 --> 01:32:23,052 THEY NEED TO COME TO THE TRIAL 1914 01:32:23,052 --> 01:32:25,555 SITE BECAUSE OF THE END POINT 1915 01:32:25,555 --> 01:32:28,858 AND DEPENDING ON THE TRIAL 1916 01:32:28,858 --> 01:32:29,993 CENTRALIZED ACTIVITIES WORK 1917 01:32:29,993 --> 01:32:30,693 BETTER THAN OTHERS DEPENDING ON 1918 01:32:30,693 --> 01:32:37,767 THE DESIGN OF THE TRIAL. 1919 01:32:37,767 --> 01:32:40,670 >> ONE OF THE ISSUES WAS THE 1920 01:32:40,670 --> 01:32:42,639 DEBATE BETWEEN THE RESPONSIBLE 1921 01:32:42,639 --> 01:32:44,741 INVESTIGATOR AND LOCAL HEALTH 1922 01:32:44,741 --> 01:32:47,076 CARE PROVIDER OR NON-REGISTERED 1923 01:32:47,076 --> 01:32:56,219 INVESTIGATOR. 1924 01:32:56,219 --> 01:32:58,121 THROUGH DISCUSSION WITH THE 1925 01:32:58,121 --> 01:32:59,355 GROUPS AND CENTRALIZED IRB 1926 01:32:59,355 --> 01:33:01,357 DISCUSSED THE OVERSIGHT BY THE 1927 01:33:01,357 --> 01:33:03,660 RESPONSIBLE INVESTIGATOR OR THE 1928 01:33:03,660 --> 01:33:05,061 ENROLLING SITE INVESTIGATOR 1929 01:33:05,061 --> 01:33:11,100 WOULD HAVE TO HAVE AN AGREEMENT 1930 01:33:11,100 --> 01:33:15,338 WITH THAT OF THE LOCAL 1931 01:33:15,338 --> 01:33:18,241 ONCOLOGIST PROVIDER WITH THE 1932 01:33:18,241 --> 01:33:19,242 STANDARD OF CARE WITH COMMERCIAL 1933 01:33:19,242 --> 01:33:20,844 AGENTS BECAUSE WE NEED TO HAVE 1934 01:33:20,844 --> 01:33:24,981 THE DATA RECORD AS PART OF THE 1935 01:33:24,981 --> 01:33:30,587 TRIAL SO THAT FOR STUDIES UNDER 1936 01:33:30,587 --> 01:33:33,790 THE NCIB PART OF THE INSTITUTION 1937 01:33:33,790 --> 01:33:36,693 WORK SHEET FOR THE NCIB THEY 1938 01:33:36,693 --> 01:33:42,031 PRODUCED IT THEY DO EVERY YEAR 1939 01:33:42,031 --> 01:33:43,333 THEY HAD TO INCLUDE THE 1940 01:33:43,333 --> 01:33:44,200 AGREEMENT WITH THE LOCAL HEALTH 1941 01:33:44,200 --> 01:33:45,802 CARE PROVIDERS BECAUSE MANY 1942 01:33:45,802 --> 01:33:47,337 SITES USE THE SAME LOCAL HEALTH 1943 01:33:47,337 --> 01:33:54,811 CARE PROVIDERS WITHIN THEIR SITE 1944 01:33:54,811 --> 01:33:57,714 AND THIS SHOULD BE PART OF THE 1945 01:33:57,714 --> 01:34:00,550 APPROACH FOR CAPTURING STUDY 1946 01:34:00,550 --> 01:34:00,783 RECORDS. 1947 01:34:00,783 --> 01:34:02,652 WE CLEARED THE WAY FOR THIS TO 1948 01:34:02,652 --> 01:34:05,922 MAKE IT POSSIBLE FOR THIS TO 1949 01:34:05,922 --> 01:34:13,630 HAPPEN WITH THE AGREEMENT. 1950 01:34:13,630 --> 01:34:17,467 SOME OF THE TRIAL ELEMENTS NOT 1951 01:34:17,467 --> 01:34:19,335 DECENTRALIZED IN THE TRIALS FOR 1952 01:34:19,335 --> 01:34:23,139 THE INVESTIGATIONAL AGENTS 1953 01:34:23,139 --> 01:34:25,475 DELIVERED VIA IV HAS THE 1954 01:34:25,475 --> 01:34:28,144 POTENTIAL FOR IT BUT WOULD NEED 1955 01:34:28,144 --> 01:34:32,282 FDA REVIEW AND APPROVAL. 1956 01:34:32,282 --> 01:34:36,185 THE CURRENT FDA GUIDANCE I SITED 1957 01:34:36,185 --> 01:34:39,422 ON THE EARLIER SLIDE HAS A 1958 01:34:39,422 --> 01:34:41,157 STATEMENT THAT TALKS ABOUT 1959 01:34:41,157 --> 01:34:43,426 TRIALS WHERE ALL ACTIVITIES 1960 01:34:43,426 --> 01:34:46,796 WHERE DECENTRALIZED MAY BE 1961 01:34:46,796 --> 01:34:48,431 APPROPRIATE FOR INVESTIGATIONAL 1962 01:34:48,431 --> 01:34:51,334 PRODUCTS WITH WELL CHARACTERIZED 1963 01:34:51,334 --> 01:34:55,071 SAFETY PROFILES AND DO NOT 1964 01:34:55,071 --> 01:34:55,605 REQUIRE ADMINISTRATION OR 1965 01:34:55,605 --> 01:34:57,006 MEDICAL ASSESSMENTS. 1966 01:34:57,006 --> 01:34:58,441 IT'S STILL POTENTIAL OPTION JUST 1967 01:34:58,441 --> 01:35:02,211 FOR THE FDA REVIEW AND APPROVAL 1968 01:35:02,211 --> 01:35:03,346 AND CERTAINLY WORTH CONSIDERING 1969 01:35:03,346 --> 01:35:13,389 IN SOME TRIALS. 1970 01:35:13,389 --> 01:35:15,325 THAT'S IT FOR THE DECENTRALIZED 1971 01:35:15,325 --> 01:35:16,559 TRIAL ACTIVITIES. 1972 01:35:16,559 --> 01:35:17,393 SHOULD WE DO COMMENTS OR 1973 01:35:17,393 --> 01:35:19,195 QUESTIONS NOW OR GO ON TO THE 1974 01:35:19,195 --> 01:35:19,462 NEXT -- 1975 01:35:19,462 --> 01:35:21,397 >> GO AHEAD AND DO THE NEXT 1976 01:35:21,397 --> 01:35:23,399 TOPIC AND THEN TAKE THEM ALL AT 1977 01:35:23,399 --> 01:35:23,599 ONCE. 1978 01:35:23,599 --> 01:35:27,337 >> OKAY. 1979 01:35:27,337 --> 01:35:30,373 SOUNDS GREAT. 1980 01:35:30,373 --> 01:35:34,944 THE NEXT TOPIC IS TE 1981 01:35:34,944 --> 01:35:36,346 STREAMLINING OF DATA COLLECTION 1982 01:35:36,346 --> 01:35:38,281 OR IMD EXEMPT TRIALS AND I'M 1983 01:35:38,281 --> 01:35:42,285 PRESENTING THIS ON BEHALF OF MY 1984 01:35:42,285 --> 01:35:50,126 CO-CHAIR OF THE STREAMLINE 1985 01:35:50,126 --> 01:35:52,795 IMPLEMENTATION COMMITTEE AND I'M 1986 01:35:52,795 --> 01:35:55,465 PRESENTING ON WE HALF OF BOTH OF 1987 01:35:55,465 --> 01:36:05,641 US TODAY. 1988 01:36:08,845 --> 01:36:11,014 WE UNDERSTAND THE TERRIFIC AND 1989 01:36:11,014 --> 01:36:15,351 GREAT NEED TO STREAMLINE OUR 1990 01:36:15,351 --> 01:36:18,287 CLINICAL TRIALS DATA AND THE 1991 01:36:18,287 --> 01:36:18,921 CLINICAL TRIALS WORKING GROUP 1992 01:36:18,921 --> 01:36:22,392 CAME UP WITH THE IDEA OF COMING 1993 01:36:22,392 --> 01:36:24,193 UP WITH STANDARD PRACTICES FOR 1994 01:36:24,193 --> 01:36:26,262 STREAMLINING DATA AND REDUCE THE 1995 01:36:26,262 --> 01:36:29,065 OPERATIONAL BURDEN OF THE TRIALS 1996 01:36:29,065 --> 01:36:29,465 AND THE INITIAL 1997 01:36:29,465 --> 01:36:37,140 [NO AUDIO] 1998 01:36:37,140 --> 01:36:41,744 AND WERE IND-EXEMPT AND WHEN WE 1999 01:36:41,744 --> 01:36:46,215 LOOKED AT THE PORTFOLIO TO 2000 01:36:46,215 --> 01:36:51,854 REPRESENT ABOUT 30%-35% OF OUR 2001 01:36:51,854 --> 01:36:54,424 TRIALS SO IT WOULD BE A GOOD 2002 01:36:54,424 --> 01:36:55,458 PROPORTION TO HAVE REDUCED DATA 2003 01:36:55,458 --> 01:37:04,700 TRIALS FOR THE SITES. 2004 01:37:04,700 --> 01:37:06,502 I THINK EVERYONE CAN AGREE THE 2005 01:37:06,502 --> 01:37:09,505 BIGGEST BURDEN IS COLLECTING 2006 01:37:09,505 --> 01:37:11,107 ADVERSE EVENT DATA. 2007 01:37:11,107 --> 01:37:13,943 THE STREAMLINING STANDARD 2008 01:37:13,943 --> 01:37:16,946 PRACTICE FOR THIS DATA ELEMENT 2009 01:37:16,946 --> 01:37:20,216 WOULD BE THAT FOR THESE IND 2010 01:37:20,216 --> 01:37:21,451 EXEMPT TRIALS WOULD ONLY COLLECT 2011 01:37:21,451 --> 01:37:24,387 GRADE 3 ADVERSE EVENTS OR HIGHER 2012 01:37:24,387 --> 01:37:25,955 UNLESS THERE'S SOME SPECIFIC 2013 01:37:25,955 --> 01:37:29,125 STATED OBJECTIVE WHY YOU NEED TO 2014 01:37:29,125 --> 01:37:31,794 COLLECT A LOWER GRADE AE IN 2015 01:37:31,794 --> 01:37:34,931 ADDITION TO ONLY COLLECTING 2016 01:37:34,931 --> 01:37:38,601 GRADE 3 OR HIGHER, THE ELEMENTS 2017 01:37:38,601 --> 01:37:42,004 WOULD NOT HAVE THE ATTRIBUTION 2018 01:37:42,004 --> 01:37:47,310 OF DATA COLLECTED AND WOULD 2019 01:37:47,310 --> 01:37:49,579 SIMPLIFY AND STREAMLINE THIS 2020 01:37:49,579 --> 01:37:53,282 MORE AND ADVERSE DATA HAS BEEN 2021 01:37:53,282 --> 01:37:55,751 RESEARCHED IN THE PAST AND 2022 01:37:55,751 --> 01:38:00,289 THINGS LIKE AE ATTRIBUTION HAVE 2023 01:38:00,289 --> 01:38:05,294 NOT BEEN USED IN MOST 2024 01:38:05,294 --> 01:38:12,301 PUBLICATIONS WHEN DESCRIBING THE 2025 01:38:12,301 --> 01:38:13,136 ADVERSE EVENTS FOR DATA USED IN 2026 01:38:13,136 --> 01:38:21,043 THE STUDY. 2027 01:38:21,043 --> 01:38:23,412 SO THE OTHER DATA CATEGORIES 2028 01:38:23,412 --> 01:38:25,481 WERE ALSO LOOKED AT TO BE 2029 01:38:25,481 --> 01:38:28,751 STREAMLINED AS PART OF THE 2030 01:38:28,751 --> 01:38:30,219 STANDARD PRACTICES AND THE DATA 2031 01:38:30,219 --> 01:38:33,389 IN THE CATEGORIES SHOULD ONLY BE 2032 01:38:33,389 --> 01:38:35,758 SUBMITTED IF THERE'S SOME 2033 01:38:35,758 --> 01:38:38,761 SPECIFIC NEED FOR END POINT 2034 01:38:38,761 --> 01:38:42,365 DATA, STRATIFICATION FACTORS, IF 2035 01:38:42,365 --> 01:38:44,100 IT'S A PATIENT CHARACTERISTIC 2036 01:38:44,100 --> 01:38:46,235 NEEDED TO DESCRIBE THE PATIENT 2037 01:38:46,235 --> 01:38:50,406 POPULATION OR PUBLICATION FOR 2038 01:38:50,406 --> 01:38:51,340 DETERMINING ELIGIBILITY OF 2039 01:38:51,340 --> 01:38:51,774 TREATMENT. 2040 01:38:51,774 --> 01:38:53,910 SO THIS IS SOMETHING THAT EACH 2041 01:38:53,910 --> 01:38:56,245 OF GROUPS HAD TO DO INDIVIDUALLY 2042 01:38:56,245 --> 01:39:00,049 BECAUSE EACH GROUP HAS THEIR OWN 2043 01:39:00,049 --> 01:39:01,717 CASE REPORT FORM THEY UTILIZED. 2044 01:39:01,717 --> 01:39:03,920 SO EACH GROUP REALLY HAD TO DO A 2045 01:39:03,920 --> 01:39:06,422 LOT OF WORK IN STREAMLINING 2046 01:39:06,422 --> 01:39:11,327 THESE ELEMENTS FOR IND-EXEMPT 2047 01:39:11,327 --> 01:39:15,131 STUDIES. 2048 01:39:15,131 --> 01:39:19,068 SO THE STREAMLINE DATA PRACTICES 2049 01:39:19,068 --> 01:39:22,838 WERE IMPLEMENTED WE STARTED 2050 01:39:22,838 --> 01:39:25,241 IMPLEMENTING THEM JANUARY 1, 2051 01:39:25,241 --> 01:39:25,441 2025. 2052 01:39:25,441 --> 01:39:30,213 AND THE ENTIRE GROUP DECIDED THE 2053 01:39:30,213 --> 01:39:31,347 STANDARD PRACTICE WOULD FIRST 2054 01:39:31,347 --> 01:39:35,318 HAVE TO REQUIRE AN APPROVAL 2055 01:39:35,318 --> 01:39:45,828 WITHIN THEIR OWN GROUP FIRST. 2056 01:39:50,967 --> 01:39:52,301 AND REQUIRE APPROVAL AND IF THAT 2057 01:39:52,301 --> 01:39:56,138 WAS APPROVED THEN SUBMITTED TO 2058 01:39:56,138 --> 01:39:58,274 CTAC AND THEN CTAC DURING 2059 01:39:58,274 --> 01:39:59,809 PROTOCOL REVIEW COULD DECIDE IF 2060 01:39:59,809 --> 01:40:03,045 THERE WAS A COMPELLING REASON TO 2061 01:40:03,045 --> 01:40:06,415 HAVE THE EXPANDED DATA 2062 01:40:06,415 --> 01:40:11,320 COLLECTION NEEDED OR WAS IT 2063 01:40:11,320 --> 01:40:11,854 JUSTIFIED FOR SCIENTIFIC 2064 01:40:11,854 --> 01:40:22,031 RATIONALE. 2065 01:40:56,232 --> 01:40:57,967 AND WORKING WITH THE CHAIRS OF 2066 01:40:57,967 --> 01:40:59,368 THIS COMMITTEE WE WERE MEETING 2067 01:40:59,368 --> 01:41:02,405 QUARTERLY TO SEE HOW THE 2068 01:41:02,405 --> 01:41:03,606 IMPLEMENTATION IS GOING. 2069 01:41:03,606 --> 01:41:07,109 WE'RE -- THE GROUP ITSELF ARE 2070 01:41:07,109 --> 01:41:08,010 REALLY A TERRIFIC GROUP. 2071 01:41:08,010 --> 01:41:11,080 THEY'RE WORKING TOGETHER TO 2072 01:41:11,080 --> 01:41:13,449 SHARE SITE STAFF EDUCATION. 2073 01:41:13,449 --> 01:41:17,119 WORKING WITH EDUCATING THEIR 2074 01:41:17,119 --> 01:41:27,530 INVESTIGATOR COMMUNITY. 2075 01:41:39,342 --> 01:41:41,243 AND GROUPS WERE TALKING ABOUT 2076 01:41:41,243 --> 01:41:42,478 HARMONIZING IN A MORE STREAMLINE 2077 01:41:42,478 --> 01:41:44,480 FASHION THE REPORTING CRITERIA 2078 01:41:44,480 --> 01:41:47,350 AND MAYBE HAVING AN FAQ DOCUMENT 2079 01:41:47,350 --> 01:41:49,652 TO CAPTURE LESSONS LEARNED TO 2080 01:41:49,652 --> 01:41:52,121 SHARE WITH EACH OTHER BECAUSE WE 2081 01:41:52,121 --> 01:41:53,456 HAD GROUPS HAVE A FEW STUDIES 2082 01:41:53,456 --> 01:41:55,891 AND ONE OR TWO GROUPS THAT 2083 01:41:55,891 --> 01:41:59,462 HAVEN'T HAD AN IND EXEMPT STUDY 2084 01:41:59,462 --> 01:42:01,497 SO FAR. 2085 01:42:01,497 --> 01:42:05,134 SO HERE'S WHERE WE ARE TO DATE 2086 01:42:05,134 --> 01:42:06,569 SO FAR. 2087 01:42:06,569 --> 01:42:11,340 WE'VE ALREADY ACTIVATED NINE 2088 01:42:11,340 --> 01:42:18,647 PHASE III TRIALS WITH STREAMLINE 2089 01:42:18,647 --> 01:42:20,349 ACTIVATION AND THREE UNDER 2090 01:42:20,349 --> 01:42:24,053 REVIEW AND WE HAVEN'T HAD A 2091 01:42:24,053 --> 01:42:25,287 SINGLE GROUP REQUEST AN 2092 01:42:25,287 --> 01:42:28,457 EXCEPTION FROM THE STREAMLINE 2093 01:42:28,457 --> 01:42:29,458 DATA COLLECTION FOR THE TRIALS 2094 01:42:29,458 --> 01:42:33,596 SO FAR SO I HAVE TO REALLY SING 2095 01:42:33,596 --> 01:42:34,997 THE PRAISES OF ALL THE GROUPS TO 2096 01:42:34,997 --> 01:42:35,898 EMBRACE THIS. 2097 01:42:35,898 --> 01:42:40,603 I THINK ON MY NEXT SLIDE I LIST 2098 01:42:40,603 --> 01:42:41,303 WHOSE PART OF THE TEAM. 2099 01:42:41,303 --> 01:42:41,837 NOT YET. 2100 01:42:41,837 --> 01:42:43,005 IT'S COMING. 2101 01:42:43,005 --> 01:42:43,773 SO NEXT STEPS. 2102 01:42:43,773 --> 01:42:47,243 WHAT ARE WITH DOING NEXT? 2103 01:42:47,243 --> 01:42:57,653 SO AROUND WE HAD GROUPS 2104 01:43:04,160 --> 01:43:06,929 INTERESTED IN DOING THE NCOR 2105 01:43:06,929 --> 01:43:09,865 STUDIES AND WANT TO EXPLORE IS 2106 01:43:09,865 --> 01:43:19,341 THERE AA WAY TO REDUCE -- -- 2107 01:43:19,341 --> 01:43:29,885 THERE'S A WAY TO REDUCE ISSUES 2108 01:43:33,556 --> 01:43:35,324 AND NEED A SPECIALIZED THOUGHT 2109 01:43:35,324 --> 01:43:45,835 ABOUT THOSE SPECIFIC ELEMENTS. 2110 01:43:46,335 --> 01:43:52,208 AND FUTURE CONSIDERATIONS FOR 2111 01:43:52,208 --> 01:43:52,408 CTAC. 2112 01:43:52,408 --> 01:43:54,276 HIND STUDIES ARE FEASIBLE TO USE 2113 01:43:54,276 --> 01:43:59,114 THE DATA COLLECTION STANDARDS. 2114 01:43:59,114 --> 01:44:00,282 AND WHILE WE'RE DOING THIS IN 2115 01:44:00,282 --> 01:44:07,523 ABOUT 30% OF OUR TRIALS, AND 2116 01:44:07,523 --> 01:44:10,893 DATA COLLECTION BURDEN SO THERE 2117 01:44:10,893 --> 01:44:12,094 ARE WAYS WE CAN STREAMLINE 2118 01:44:12,094 --> 01:44:22,238 COLLECTION IN IND STUDIES. 2119 01:44:22,238 --> 01:44:26,041 AND LOOK AT A PARTNERSHIP AND 2120 01:44:26,041 --> 01:44:29,545 MORE OF THAT EXAMPLE ROLLOUT FOR 2121 01:44:29,545 --> 01:44:32,248 OTHER IND TRIALS. 2122 01:44:32,248 --> 01:44:35,251 AND SHOULD CTAC CONSIDER FORMING 2123 01:44:35,251 --> 01:44:37,386 THE WORKING GROUP AND CONSIDER 2124 01:44:37,386 --> 01:44:39,321 STRATEGIES FOR ELIMINATING DATA 2125 01:44:39,321 --> 01:44:41,524 COLLECTION FOR IND STUDIES 2126 01:44:41,524 --> 01:44:43,325 WITHIN ALL THE APPROPRIATE 2127 01:44:43,325 --> 01:44:53,502 CONTEXTS. 2128 01:45:09,618 --> 01:45:12,988 AND I THINK THE FEEDBACK WE'RE 2129 01:45:12,988 --> 01:45:16,725 GETTING ON OUR QUARTERLY CALLSES 2130 01:45:16,725 --> 01:45:17,960 ELEMENT AT LEAST THE GROUPS THAT 2131 01:45:17,960 --> 01:45:18,961 SUCCESSFULLY LAUNCHED THE TRIALS 2132 01:45:18,961 --> 01:45:22,565 OUT THERE IS THAT WHEN THEY 2133 01:45:22,565 --> 01:45:23,666 BROUGHT THIS BACK TO THE 2134 01:45:23,666 --> 01:45:27,336 PROTOCOL WRITING TEAM AND THEIR 2135 01:45:27,336 --> 01:45:29,505 DATA DEVELOPMENT TEAM IS THAT 2136 01:45:29,505 --> 01:45:31,040 THEY'RE EMBRACING THIS. 2137 01:45:31,040 --> 01:45:33,242 SOME OF THIS THERE'S A QUESTION 2138 01:45:33,242 --> 01:45:35,277 ABOUT CAN I STILL ASK THIS 2139 01:45:35,277 --> 01:45:36,245 QUESTION AND THIS QUESTION BUT 2140 01:45:36,245 --> 01:45:40,115 WE'RE REALLY TRYING TO MAKE IT 2141 01:45:40,115 --> 01:45:45,120 SO THAT THE DATA ELEMENTS IN A 2142 01:45:45,120 --> 01:45:46,722 TRIAL HAVE A SCIENTIFIC MERIT TO 2143 01:45:46,722 --> 01:45:48,390 THEM ASKING THEM AND NOT THAT WE 2144 01:45:48,390 --> 01:45:53,696 MIGHT DO THIS AND THAT AND THIS 2145 01:45:53,696 --> 01:45:58,467 PHASE III IND-EXEMPT TRIAL WE 2146 01:45:58,467 --> 01:45:59,702 LIKE TO FOCUS ON THE COMPELLING 2147 01:45:59,702 --> 01:46:03,372 SCIENCE AND I'LL STOP THERE AND 2148 01:46:03,372 --> 01:46:13,716 TAKE ANY QUESTIONS. 2149 01:46:15,417 --> 01:46:20,823 >> DO YOU HAVE QUESTIONS? 2150 01:46:20,823 --> 01:46:31,333 >> AND OFTEN A CLINICAL SITE 2151 01:46:52,254 --> 01:46:54,289 DOESN'T HAVE RESOURCES TO HELP 2152 01:46:54,289 --> 01:46:56,392 ADDRESS THE PATIENT'S NEEDS 2153 01:46:56,392 --> 01:46:59,561 WHEREAS THEY MIGHT HAVE THEM AT 2154 01:46:59,561 --> 01:47:03,932 HOME AND THAT RELIEVES THE 2155 01:47:03,932 --> 01:47:08,504 SUPPORT PERSON OF THE BURDEN FOR 2156 01:47:08,504 --> 01:47:11,874 THE HOSPITAL AND SO I THINK 2157 01:47:11,874 --> 01:47:16,278 THAT'S REALLY COOL ADVANTAGE FOR 2158 01:47:16,278 --> 01:47:19,348 REMOTE CONSENT AND ENCOURAGE 2159 01:47:19,348 --> 01:47:20,649 THEM TO USE THAT. 2160 01:47:20,649 --> 01:47:23,385 >> GREAT POINT. 2161 01:47:23,385 --> 01:47:24,820 I TOTALLY AGREE. 2162 01:47:24,820 --> 01:47:27,322 >> THANK YOU SO MUCH. 2163 01:47:27,322 --> 01:47:27,890 PATTY? 2164 01:47:27,890 --> 01:47:32,161 >> HI, ANDREA. 2165 01:47:32,161 --> 01:47:35,330 BOTH OF THESE TOPICS ARE VERY 2166 01:47:35,330 --> 01:47:42,671 IMPORTANT TO ME AS YOU KNOW. 2167 01:47:42,671 --> 01:47:46,642 THAT WILL DECREASE DEVIATIONS AS 2168 01:47:46,642 --> 01:47:57,186 WELL AS THE AUDIT PROCESS AND IT 2169 01:48:27,015 --> 01:48:28,984 SAYS DECENTRALIZED IN THE STUDY 2170 01:48:28,984 --> 01:48:30,552 AND TITLE BUT THEN YOU DON'T 2171 01:48:30,552 --> 01:48:33,655 READ IT ANYWHERE AND NOW WE'RE 2172 01:48:33,655 --> 01:48:37,059 MOVING TO THE AND CONSENT FORM 2173 01:48:37,059 --> 01:48:37,693 LANGUAGE AS WELL. 2174 01:48:37,693 --> 01:48:40,529 >> YOU KNOW, WE TALKED ABOUT 2175 01:48:40,529 --> 01:48:42,731 THAT AND PEOPLE DIDN'T THINK IT 2176 01:48:42,731 --> 01:48:47,302 NEEDED TO BE IN THE CONSENT FORM 2177 01:48:47,302 --> 01:48:48,871 BECAUSE THE CONSENT DOESN'T GET 2178 01:48:48,871 --> 01:48:51,073 DOWN TO THE GRANULAR OF WHERE 2179 01:48:51,073 --> 01:48:51,640 THE ACTUAL ACTIVITIES TAKE 2180 01:48:51,640 --> 01:48:57,112 PLACE. 2181 01:48:57,112 --> 01:48:59,782 AND SOME SITES ARE MORE AMENABLE 2182 01:48:59,782 --> 01:49:02,718 TO DOING THEM THAN OTHERS AND 2183 01:49:02,718 --> 01:49:13,195 THOSE ARE NATIONAL CONSENT. 2184 01:49:20,435 --> 01:49:29,178 AND LOOK AT THE CENTRALIZED 2185 01:49:29,178 --> 01:49:31,346 TRIALS AND SOME CALL IT 2186 01:49:31,346 --> 01:49:32,214 DECENTRALIZED ACTIVITIES AND 2187 01:49:32,214 --> 01:49:39,121 SOME CALL IT CONTINUITY OF CARE. 2188 01:49:39,121 --> 01:49:39,688 IT'S IN THE APPENDIX. 2189 01:49:39,688 --> 01:49:49,932 >> THANK YOU. 2190 01:49:54,803 --> 01:49:56,271 >> AND LOOK AT THE LOCAL 2191 01:49:56,271 --> 01:49:59,675 PROCESSES AND REPORTING OF AEs. 2192 01:49:59,675 --> 01:50:02,411 I THINK MANY OF US ARE STILL 2193 01:50:02,411 --> 01:50:06,048 STUCK IN THIS MODE OF HAVING TO 2194 01:50:06,048 --> 01:50:07,850 CONTINUE TO ATTRIBUTE FOR EVERY 2195 01:50:07,850 --> 01:50:09,985 SINGLE THING THAT OCCURS TO A 2196 01:50:09,985 --> 01:50:14,189 PATIENT ON AN NCTN TRIAL AND I 2197 01:50:14,189 --> 01:50:16,458 WOULD JUST ENCOURAGE US TO 2198 01:50:16,458 --> 01:50:18,227 FIGURE OUT HOW WE GET THAT 2199 01:50:18,227 --> 01:50:21,463 MESSAGE TO THE CANCER CENTERS 2200 01:50:21,463 --> 01:50:29,471 AND HELP THEM GET UP TO SPEED 2201 01:50:29,471 --> 01:50:33,175 WITH THIS INITIATIVE. 2202 01:50:33,175 --> 01:50:35,077 WE WERE A TEST CASE WITH 2312 2203 01:50:35,077 --> 01:50:36,879 AND I'M EXCITED TO BE ABLE TO DO 2204 01:50:36,879 --> 01:50:37,079 THIS. 2205 01:50:37,079 --> 01:50:39,781 HOW DO WE KNOW IF IT'S WORKING? 2206 01:50:39,781 --> 01:50:42,451 ARE THERE -- IS THERE A PROCESS 2207 01:50:42,451 --> 01:50:44,553 IN PLACE TO SAY OKAY, THIS IS 2208 01:50:44,553 --> 01:50:47,723 WORKING, THIS ISN'T WORKING? 2209 01:50:47,723 --> 01:50:48,323 SOME SUBJECTIVE EVALUATION? 2210 01:50:48,323 --> 01:50:52,060 HAVE YOU THOUGHT ABOUT THAT? 2211 01:50:52,060 --> 01:50:53,262 I'M SURE YOU'VE THOUGHT ABOUT 2212 01:50:53,262 --> 01:50:53,462 THAT. 2213 01:50:53,462 --> 01:50:54,796 >> WE HAVE THOUGHT ABOUT IT. 2214 01:50:54,796 --> 01:50:58,500 WE DIDN'T WANT TO ADD ANOTHER 2215 01:50:58,500 --> 01:51:00,402 BURDEN TO THE SITES OF MORE DATA 2216 01:51:00,402 --> 01:51:01,737 BEING COLLECTED BUT THOUGHT WE'D 2217 01:51:01,737 --> 01:51:08,977 DO IT MORE BY GOING TO THE NCTN 2218 01:51:08,977 --> 01:51:09,978 GROUP MEETINGS AND HAVING DIRECT 2219 01:51:09,978 --> 01:51:12,147 DIALOGUE WITH THE SITES. 2220 01:51:12,147 --> 01:51:17,286 THEY ALL HAVE SITE OPERATION 2221 01:51:17,286 --> 01:51:19,922 COMMITTEES AND WE PRESENTED THE 2222 01:51:19,922 --> 01:51:20,122 TOPIC. 2223 01:51:20,122 --> 01:51:22,591 WE'LL HAVE TO DO -- WE DIDN'T 2224 01:51:22,591 --> 01:51:24,726 FEEL THERE WAS A NEED FOR FORMAL 2225 01:51:24,726 --> 01:51:29,498 DATA COLLECTION IN TERMS OF THE 2226 01:51:29,498 --> 01:51:39,908 DECENTRALIZED ACTIVITY. 2227 01:52:01,496 --> 01:52:04,433 >> WE NEED TO MOVE THE LIMITED 2228 01:52:04,433 --> 01:52:06,301 DATA TO THE IND STUDIES. 2229 01:52:06,301 --> 01:52:07,636 THAT WAS ALL THE GOAL. 2230 01:52:07,636 --> 01:52:09,137 I THINK WE'VE SHOWN THE PROCESS 2231 01:52:09,137 --> 01:52:09,338 WORKS. 2232 01:52:09,338 --> 01:52:12,607 WE NEED TO TAKE THE NEXT STEP. 2233 01:52:12,607 --> 01:52:15,210 I'M NOT SAYING REGISTRY STUDIES 2234 01:52:15,210 --> 01:52:17,212 AT THIS POINT BUT CERTAINLY IND 2235 01:52:17,212 --> 01:52:18,714 STUDIES THAT AND WOULD BE REALLY 2236 01:52:18,714 --> 01:52:19,448 HELPFUL WITH THE AUDITING 2237 01:52:19,448 --> 01:52:23,251 BURDEN. 2238 01:52:23,251 --> 01:52:26,621 >> IT WOULD HELP EVERYTHING. 2239 01:52:26,621 --> 01:52:28,924 >> JACK. 2240 01:52:28,924 --> 01:52:31,126 >> THOUGH THIS IS A NO-BRAINER 2241 01:52:31,126 --> 01:52:34,796 IT TAKES A SURPRISING AMOUNT OF 2242 01:52:34,796 --> 01:52:36,231 EDUCATION OF YOUR MEMBERS OF 2243 01:52:36,231 --> 01:52:38,066 YOUR NETWORK OR CANCER CENTER 2244 01:52:38,066 --> 01:52:39,067 NETWORK OR GROUP NETWORK. 2245 01:52:39,067 --> 01:52:40,469 I CAN'T TELL YOU HOW MANY TIMES 2246 01:52:40,469 --> 01:52:42,004 PEOPLE COME BACK LATER AND SAY I 2247 01:52:42,004 --> 01:52:47,876 WAS GOING TO DO A PAPER ON THE 2248 01:52:47,876 --> 01:52:49,945 EFFECT OF SMOKING WITH THIS 2249 01:52:49,945 --> 01:52:52,247 DRUG. 2250 01:52:52,247 --> 01:52:54,349 YOU'RE NOT GOING TO BE DOING 2251 01:52:54,349 --> 01:52:55,550 THIS IS REQUIRED. 2252 01:52:55,550 --> 01:52:56,985 >> ALL RIGHT. 2253 01:52:56,985 --> 01:52:58,820 >> THANK YOU SO MUCH. 2254 01:52:58,820 --> 01:53:02,958 GREAT TO SEE ALMOST A DOZEN 2255 01:53:02,958 --> 01:53:05,727 TRIALS ON THEIR OWN WITH NEW 2256 01:53:05,727 --> 01:53:06,061 REQUIREMENTS. 2257 01:53:06,061 --> 01:53:09,598 MY COMMENT RELATES TO THE 2258 01:53:09,598 --> 01:53:11,666 DECENTRALIZED TRIAL ELEMENTS. 2259 01:53:11,666 --> 01:53:15,437 YOU'VE HAD A GREAT LIST AND EACH 2260 01:53:15,437 --> 01:53:16,938 WILL MAKE A DIFFERENCE. 2261 01:53:16,938 --> 01:53:19,107 THE ONE I WANTED TO ASK MORE 2262 01:53:19,107 --> 01:53:22,110 ABOUT IS THE ADMINISTRATION OF 2263 01:53:22,110 --> 01:53:24,579 COMMERCIAL PRODUCTS BY A LOCAL 2264 01:53:24,579 --> 01:53:26,214 HCP. 2265 01:53:26,214 --> 01:53:30,218 YOU DESCRIBED SOME REQUIREMENTS 2266 01:53:30,218 --> 01:53:32,087 AND UNDERSTAND WHAT NEEDS TO 2267 01:53:32,087 --> 01:53:33,321 HAPPEN FOR ME TO BE COMFORTABLE 2268 01:53:33,321 --> 01:53:36,758 WITH THE LOCAL PHYSICIAN NOT 2269 01:53:36,758 --> 01:53:38,593 PART OF MY HEALTH SYSTEM 2270 01:53:38,593 --> 01:53:39,127 ADMINISTER THE DRUG. 2271 01:53:39,127 --> 01:53:42,230 IF THE PROCESS IS NOT SIMPLE 2272 01:53:42,230 --> 01:53:42,998 ENOUGH INVESTIGATORS MAY SHY 2273 01:53:42,998 --> 01:53:44,699 AWAY FROM USING THAT MECHANISM. 2274 01:53:44,699 --> 01:53:48,236 JUST WANTED TO HEAR YOUR 2275 01:53:48,236 --> 01:53:50,272 THOUGHTS AND MAKE IT AS SIMPLE 2276 01:53:50,272 --> 01:53:51,206 AS POSSIBLE. 2277 01:53:51,206 --> 01:53:55,010 >> YEAH, IT COULD BE AS SIMPLE 2278 01:53:55,010 --> 01:53:59,314 AS THE AGREEMENT COULD BE BACK 2279 01:53:59,314 --> 01:54:00,248 AND FORTH DOCUMENTATION. 2280 01:54:00,248 --> 01:54:02,584 THIS PATIENT IS ON THIS CLINICAL 2281 01:54:02,584 --> 01:54:03,351 TRIAL. 2282 01:54:03,351 --> 01:54:06,288 THIS IS THE -- IF THERE IS A 2283 01:54:06,288 --> 01:54:09,424 SPECIFIED IT DEPENDING ON THE 2284 01:54:09,424 --> 01:54:09,958 TRIAL. 2285 01:54:09,958 --> 01:54:12,561 SOME TRIALS JUST SAY DON'T 2286 01:54:12,561 --> 01:54:15,130 SPECIFY THE DETAILS OF THE 2287 01:54:15,130 --> 01:54:17,766 STANDARD OF CARE ARM IT COULD BE 2288 01:54:17,766 --> 01:54:20,068 PHYSICIANS CHOICE. 2289 01:54:20,068 --> 01:54:23,939 WHATEVER THE PATIENT AND THE 2290 01:54:23,939 --> 01:54:24,606 RESPONSIBLE INVESTIGATOR AT SITE 2291 01:54:24,606 --> 01:54:27,242 HAVE DETERMINED, YOU MAKE THE 2292 01:54:27,242 --> 01:54:30,245 CONNECTION WITH THE LOCAL HEALTH 2293 01:54:30,245 --> 01:54:32,747 CARE PROVIDER AND HAVE IT HAVE A 2294 01:54:32,747 --> 01:54:34,116 DOCUMENT LIKE SOMETHING LIKE 2295 01:54:34,116 --> 01:54:35,917 WITH E-MAIL AND YOUR SITE NEEDS 2296 01:54:35,917 --> 01:54:40,922 TO HAVE AS PART OF ITS ANNUAL 2297 01:54:40,922 --> 01:54:42,824 SIGNATORY WORK SHEET WITH THE 2298 01:54:42,824 --> 01:54:45,127 IRB YOU HAVE RELATIONSHIPS WITH 2299 01:54:45,127 --> 01:54:47,329 LOCAL ONCOLOGISTS TO PROVIDE 2300 01:54:47,329 --> 01:54:49,197 STANDARD OF CARE COMMERCIAL 2301 01:54:49,197 --> 01:54:49,431 AGENTS. 2302 01:54:49,431 --> 01:54:51,333 SO IT REALLY DOESN'T HAVE TO 2303 01:54:51,333 --> 01:54:53,368 BE -- WHEN I WAS IN PRACTICE WE 2304 01:54:53,368 --> 01:54:55,270 DID THIS A LOT AND IT WASN'T A 2305 01:54:55,270 --> 01:54:59,508 BIG DEAL AND WAS TERRIFIC FOR 2306 01:54:59,508 --> 01:54:59,774 PATIENTS. 2307 01:54:59,774 --> 01:55:06,314 SO SO, HOPEFULLY THAT DOESN'T 2308 01:55:06,314 --> 01:55:07,682 SOUND TOO BURDENSOME. 2309 01:55:07,682 --> 01:55:08,450 >> ALL RIGHT. 2310 01:55:08,450 --> 01:55:11,219 ANY OTHER QUESTIONS FOR ANDREA? 2311 01:55:11,219 --> 01:55:14,656 IF NOT THANKS SO MUCH. 2312 01:55:14,656 --> 01:55:25,066 WE APPRECIATE THE WORK. 2313 01:55:45,086 --> 01:55:45,353 >> ALL RIGHT. 2314 01:55:45,353 --> 01:55:47,322 WE'RE GOING TO MOVE ON TO THE 2315 01:55:47,322 --> 01:55:51,326 LAST PART THE NEW BUSINESS PART 2316 01:55:51,326 --> 01:55:57,599 AND TURN IT OVER TO SHEILA. 2317 01:55:57,599 --> 01:55:57,966 >> TERRIFIC. 2318 01:55:57,966 --> 01:56:01,303 CAN WE BRING UP THE SLIDES? 2319 01:56:01,303 --> 01:56:02,204 GOOD AFTERNOON, EVERYONE. 2320 01:56:02,204 --> 01:56:05,106 AND SO GLAD WE WERE ABLE TO 2321 01:56:05,106 --> 01:56:07,342 CONVENE TODAY. 2322 01:56:07,342 --> 01:56:11,079 AS YOU ALL KNOW, CTAC PLAYS AN 2323 01:56:11,079 --> 01:56:12,681 IMPORTANT ROLE IN SHARING THAT 2324 01:56:12,681 --> 01:56:15,350 NCI REMAINS RESPONSIVE TO THE 2325 01:56:15,350 --> 01:56:18,687 NEEDS OF PATIENTS AS WELL AS THE 2326 01:56:18,687 --> 01:56:24,426 RESEARCH COMMUNITY. 2327 01:56:24,426 --> 01:56:25,827 THE WORKING GROUPS ARE FORMED 2328 01:56:25,827 --> 01:56:29,264 PERIODICALLY UNDER THE AUSPICES 2329 01:56:29,264 --> 01:56:32,000 OF CTAC TO LOOK AT TOPICS AND 2330 01:56:32,000 --> 01:56:34,869 CHALLENGES FACING THE CLINICAL 2331 01:56:34,869 --> 01:56:39,341 TRIALS OPERATION IN RESEARCH. 2332 01:56:39,341 --> 01:56:42,477 AND TO COME BACK AND PROVIDE 2333 01:56:42,477 --> 01:56:53,021 RECOMMENDATION TO CTAC AND NCI. 2334 01:56:59,361 --> 01:56:59,961 ZA TODAY WE'D LIKE TO CONSIDER 2335 01:56:59,961 --> 01:57:02,097 THE FORMATION OF THREE WORKING 2336 01:57:02,097 --> 01:57:06,134 GROUPS TO HELP US MOVE FORWARD. 2337 01:57:06,134 --> 01:57:09,704 PARTICULARLY CONTINUE WORKING 2338 01:57:09,704 --> 01:57:11,339 DISCUSSION DURING THE CHALLENGES 2339 01:57:11,339 --> 01:57:17,078 TIMES. 2340 01:57:17,078 --> 01:57:19,848 AND THE PERSPECTIVES IN CANCER 2341 01:57:19,848 --> 01:57:20,915 RESEARCH AND CLINICAL TRIAL 2342 01:57:20,915 --> 01:57:21,583 INNOVATIONS WORKING GROUP. 2343 01:57:21,583 --> 01:57:23,852 THE FIRST I DON'T THINK I NEED 2344 01:57:23,852 --> 01:57:26,154 TO SAY TOO MUCH MORE. 2345 01:57:26,154 --> 01:57:29,424 ANDREA HAS SPOKEN TO YOU ABOUT 2346 01:57:29,424 --> 01:57:33,995 THE NEED CTAC ALWAYS ENVISIONED 2347 01:57:33,995 --> 01:57:35,697 INCORPORATING AND STREAMLINING 2348 01:57:35,697 --> 01:57:36,498 IND-EXEMPT TRIALS. 2349 01:57:36,498 --> 01:57:38,266 THE PURPOSE OF THE STREAMLINING 2350 01:57:38,266 --> 01:57:39,234 DATA COLLECTION IN CLINICAL 2351 01:57:39,234 --> 01:57:40,835 TRIALS WORKING GROUP WOULD BE 2352 01:57:40,835 --> 01:57:42,537 LIKE VERSION 2. 2353 01:57:42,537 --> 01:57:46,074 THE PURPOSE IS TO ADVISE CTAC 2354 01:57:46,074 --> 01:57:48,476 AND THE NCI DIRECTOR ON 2355 01:57:48,476 --> 01:57:50,278 ADDITIONAL STRATEGIES FOR 2356 01:57:50,278 --> 01:57:52,180 LIMITING DATA COLLECTION AND NCI 2357 01:57:52,180 --> 01:57:52,714 CLINICAL TRIALS. 2358 01:57:52,714 --> 01:57:56,351 AND THESE STRATEGIES MAY INCLUDE 2359 01:57:56,351 --> 01:58:01,022 DEVELOPING PRACTICES FOR IND 2360 01:58:01,022 --> 01:58:02,524 TRIAL IN THE RIGHT CLINICAL 2361 01:58:02,524 --> 01:58:03,992 SCIENTIFIC AND REGULATORY 2362 01:58:03,992 --> 01:58:04,225 CONTEXT. 2363 01:58:04,225 --> 01:58:07,329 SO THE MEMBERSHIP WILL INCLUDE 2364 01:58:07,329 --> 01:58:10,532 REPRESENTS FROM CTAC AND OTHER 2365 01:58:10,532 --> 01:58:12,901 INDIVIDUALS WITH RELEVANT 2366 01:58:12,901 --> 01:58:13,168 EXPERTISE. 2367 01:58:13,168 --> 01:58:15,103 IT'S A CRITICAL INITIATIVE TO 2368 01:58:15,103 --> 01:58:17,405 HAVE FDA COLLEAGUES 2369 01:58:17,405 --> 01:58:20,675 PARTICIPATING IN AS WELL AS WE 2370 01:58:20,675 --> 01:58:21,743 CONSIDER IND STUDIES. 2371 01:58:21,743 --> 01:58:23,345 THAT'S IT FOR THE WORKING GROUP. 2372 01:58:23,345 --> 01:58:25,580 SO WHAT WE NEED TO DO 2373 01:58:25,580 --> 01:58:26,481 PROCEDURALLY IS PAUSE AFTER EACH 2374 01:58:26,481 --> 01:58:28,249 OF THESE TOPICS AND TAKE A VOTE 2375 01:58:28,249 --> 01:58:30,852 FOR EACH MUCH THE WORKING 2376 01:58:30,852 --> 01:58:32,520 GROUPS, OKAY. 2377 01:58:32,520 --> 01:58:35,323 I WILL FINISH AND HAVE 2378 01:58:35,323 --> 01:58:36,691 DISCUSSION AND THEN TALK ABOUT 2379 01:58:36,691 --> 01:58:39,327 THE OTHER TWO GROUPS. 2380 01:58:39,327 --> 01:58:41,496 >> OKAY. 2381 01:58:41,496 --> 01:58:42,797 ANY DISCUSSION OR QUESTIONS 2382 01:58:42,797 --> 01:58:53,007 ABOUT THIS? 2383 01:58:57,312 --> 01:59:00,248 >> IT I THINK SINCE IT'S AN IND 2384 01:59:00,248 --> 01:59:02,050 IS ONE OF THE PROCESSES HERE ON 2385 01:59:02,050 --> 01:59:06,588 THAT WORKING GROUP SHOULD BE 2386 01:59:06,588 --> 01:59:07,055 SOME FORM OF INDUSTRY 2387 01:59:07,055 --> 01:59:15,730 REPRESENTATION. 2388 01:59:15,730 --> 01:59:21,002 >> WE'LL TAKE A VOTE ON THIS. 2389 01:59:21,002 --> 01:59:24,038 ANYONE OPPOSED TO HAVING THIS 2390 01:59:24,038 --> 01:59:24,639 STREAMLINING DATA COLLECTION 2391 01:59:24,639 --> 01:59:32,547 WORKING GROUP? 2392 01:59:32,547 --> 01:59:35,383 SEEING NONE, I BELIEVE IT 2393 01:59:35,383 --> 01:59:35,617 PASSES. 2394 01:59:35,617 --> 01:59:35,884 THANK YOU. 2395 01:59:35,884 --> 01:59:36,618 >> OKAY. 2396 01:59:36,618 --> 01:59:36,918 THANK YOU. 2397 01:59:36,918 --> 01:59:46,594 CAN WE MOVE TO THE NEXT SLIDE? 2398 01:59:46,594 --> 01:59:49,063 SECOND IS A WORKING GROUP 2399 01:59:49,063 --> 01:59:50,598 FOCUSSED ON PATIENT PERSPECTIVES 2400 01:59:50,598 --> 01:59:52,567 ON CANCER RESEARCH. 2401 01:59:52,567 --> 01:59:55,370 WE HEARD FROM DR. LOWY EARLIER 2402 01:59:55,370 --> 01:59:58,973 NOW MORE THAN EVER IT'S 2403 01:59:58,973 --> 02:00:00,542 IMPORTANT TO HAVE A VENUE TO 2404 02:00:00,542 --> 02:00:01,443 INFORM OUR RESEARCH EFFORTS. 2405 02:00:01,443 --> 02:00:04,612 THE PURPOSE OF THIS WORKING 2406 02:00:04,612 --> 02:00:07,348 GROUP WOULD BE TO PROVIDE THE 2407 02:00:07,348 --> 02:00:08,149 COLLECTIVE PATIENT PERSPECTIVE 2408 02:00:08,149 --> 02:00:11,319 ON CLINICAL AND TRANSLATIONAL 2409 02:00:11,319 --> 02:00:16,825 RESEARCH INITIATIVES TO ADVISE 2410 02:00:16,825 --> 02:00:19,861 CTAC AND ACTIVITIES THAT FOSTER 2411 02:00:19,861 --> 02:00:20,929 MEANINGFUL ENGAGEMENT BETWEEN 2412 02:00:20,929 --> 02:00:23,898 NCI AND THE PATIENT COMMUNITY, 2413 02:00:23,898 --> 02:00:25,300 PARTICULARLY IN AREAS OF 2414 02:00:25,300 --> 02:00:25,767 EMERGING RESEARCH. 2415 02:00:25,767 --> 02:00:27,135 AND THEN OF COURSE WE WANT TO 2416 02:00:27,135 --> 02:00:30,438 MAKE SURE WE'RE ABLE TO PROVIDE 2417 02:00:30,438 --> 02:00:31,706 PATIENT-CENTERED INPUT TO INFORM 2418 02:00:31,706 --> 02:00:32,340 OUR RESEARCH PROGRAMS. 2419 02:00:32,340 --> 02:00:38,313 SO MEMBERSHIP FOR THIS GROUP 2420 02:00:38,313 --> 02:00:38,913 WOULD INCLUDE REPRESENTATIVES 2421 02:00:38,913 --> 02:00:39,714 FROM CTAC. 2422 02:00:39,714 --> 02:00:41,783 WE HAVE ONE PATIENT ADVOCATE. 2423 02:00:41,783 --> 02:00:44,486 WE HAVE A SLOT FOR ANOTHER AND 2424 02:00:44,486 --> 02:00:47,021 ENVISION THE CTAC ADVOCATES 2425 02:00:47,021 --> 02:00:49,357 WOULD BE ON THE GROUP AS WELL AS 2426 02:00:49,357 --> 02:00:51,326 OTHERS FROM THE CANCER COMMUNITY 2427 02:00:51,326 --> 02:00:57,765 WITH RELEVANT EXPERTISE. 2428 02:00:57,765 --> 02:00:59,901 I DON'T KNOW IF THERE'S ANY 2429 02:00:59,901 --> 02:01:01,336 OTHER COMMENTS FROM CTAC 2430 02:01:01,336 --> 02:01:01,569 MEMBERS. 2431 02:01:01,569 --> 02:01:02,370 YOU CAN OPEN IT UP. 2432 02:01:02,370 --> 02:01:08,877 >> ANY DISCUSSION OR COMMENTS? 2433 02:01:08,877 --> 02:01:12,013 >> THIS IS A WONDERFUL IDEA. 2434 02:01:12,013 --> 02:01:12,647 ONE QUESTION. 2435 02:01:12,647 --> 02:01:17,385 IS THE SCOPE FOR THIS GROUP 2436 02:01:17,385 --> 02:01:20,121 REALLY PATIENT ADVISORY GROUP 2437 02:01:20,121 --> 02:01:21,623 INPUT ON THE BROADER RESEARCH 2438 02:01:21,623 --> 02:01:24,425 INITIATIVES OR DOES IT INCLUDE 2439 02:01:24,425 --> 02:01:26,027 WITHIN SCOPE HOW WE FACTOR IN 2440 02:01:26,027 --> 02:01:27,095 THE PATIENT VOICE IN TERMS OF 2441 02:01:27,095 --> 02:01:31,032 THE DESIGN OR CONDUCT OF 2442 02:01:31,032 --> 02:01:31,733 INDIVIDUAL TRIALS? 2443 02:01:31,733 --> 02:01:33,268 >> IT'S AN OPPORTUNITY FOR THE 2444 02:01:33,268 --> 02:01:35,336 PATIENT COMMUNITY TO HEAR ABOUT 2445 02:01:35,336 --> 02:01:39,340 OUR RESEARCH ACTIVITIES AND 2446 02:01:39,340 --> 02:01:42,310 PROVIDE INPUT BACK TO US AS WELL 2447 02:01:42,310 --> 02:01:45,947 AS NEW THINGS ALONG THE LINES OF 2448 02:01:45,947 --> 02:01:49,250 WHAT THE PATIENT COMMUNITY VIEWS 2449 02:01:49,250 --> 02:01:53,888 AS THE NEED FOR US TO BE AWARE 2450 02:01:53,888 --> 02:01:54,856 OF NCI'S RESEARCH PROGRAMS. 2451 02:01:54,856 --> 02:02:00,795 I DON'T KNOW IF PATTY OR VINCENT 2452 02:02:00,795 --> 02:02:02,130 FROM OUR ADVOCACY RESEARCH 2453 02:02:02,130 --> 02:02:04,899 OFFICE ANY ADDITIONAL COMMENTS 2454 02:02:04,899 --> 02:02:08,636 YOU WANT TO MAKE TO RUBEN'S 2455 02:02:08,636 --> 02:02:09,070 QUESTION. 2456 02:02:09,070 --> 02:02:19,013 >> I THINK FOR ME IT'S REALLY BY 2457 02:02:19,013 --> 02:02:23,384 DIRECTIONAL. 2458 02:02:23,384 --> 02:02:25,553 DURING THE TIMES OF REAL 2459 02:02:25,553 --> 02:02:26,387 UNCERTAINTY AND WHAT'S GOING ON 2460 02:02:26,387 --> 02:02:29,791 I THINK IT'S REALLY IMPORTANT TO 2461 02:02:29,791 --> 02:02:36,764 HAVE SOMETHING LIKE THIS AND 2462 02:02:36,764 --> 02:02:40,268 LOOK AT CLINICAL TRIALS AND 2463 02:02:40,268 --> 02:02:50,712 THERE'S SO MANY PROGRAMS. 2464 02:02:54,215 --> 02:02:54,782 THERE'S A LOT OF ORGANIZATION 2465 02:02:54,782 --> 02:02:55,383 WITHIN CTAC WOULD BE NICE TO 2466 02:02:55,383 --> 02:03:03,358 HAVE. 2467 02:03:03,358 --> 02:03:09,998 AND IT'S ABOUT THE ATMOSPHERE 2468 02:03:09,998 --> 02:03:10,698 AND THERE'S PATIENT TRUST AND 2469 02:03:10,698 --> 02:03:12,734 THE MORE WE CAN HAVE AT THE 2470 02:03:12,734 --> 02:03:13,801 VOICE AND EVERYTHING DONE AT NCI 2471 02:03:13,801 --> 02:03:15,036 THE BETTER IT'S GOING TO BE 2472 02:03:15,036 --> 02:03:16,971 PERCEIVED BY THE COMMUNITY AND 2473 02:03:16,971 --> 02:03:20,508 THE PUBLIC IN IN STILLING MORE 2474 02:03:20,508 --> 02:03:22,310 TRUST. 2475 02:03:22,310 --> 02:03:23,444 I THINK IT'S IMPORTANT AND THE 2476 02:03:23,444 --> 02:03:33,788 TIMING IS IMPORTANT. 2477 02:03:36,290 --> 02:03:38,726 >> I WANTED TO MAKE SURE IT'S 2478 02:03:38,726 --> 02:03:39,394 CONSIDERED BROADLY NOT JUST 2479 02:03:39,394 --> 02:03:41,462 UNDER THERAPY BUT SURVIVORS, 2480 02:03:41,462 --> 02:03:43,164 COMMUNITY MEMBERS, INDIVIDUALS 2481 02:03:43,164 --> 02:03:44,565 INVOLVED IN PREVENTION AND 2482 02:03:44,565 --> 02:03:45,600 SCREENING TRIALS PARTICULARLY AS 2483 02:03:45,600 --> 02:03:47,335 MORE OF THOSE ARE BROUGHT 2484 02:03:47,335 --> 02:03:50,605 FORWARD I THINK IS REALLY 2485 02:03:50,605 --> 02:03:51,339 IMPORTANT. 2486 02:03:51,339 --> 02:03:53,508 JUST SIMPLY UNDER LINING WHAT 2487 02:03:53,508 --> 02:03:55,343 SHE STATED NEEDS TO BE BROADLY 2488 02:03:55,343 --> 02:03:55,610 INCLUSIVE. 2489 02:03:55,610 --> 02:04:01,382 THANK YOU. 2490 02:04:01,382 --> 02:04:03,017 >> ALL RIGHT. 2491 02:04:03,017 --> 02:04:06,921 ANY OTHER COMMENTS FOR THIS 2492 02:04:06,921 --> 02:04:07,221 PERSPECTIVE? 2493 02:04:07,221 --> 02:04:08,456 ALL RIGHT. 2494 02:04:08,456 --> 02:04:11,325 ANYBODY OPPOSED TO THIS AS AN 2495 02:04:11,325 --> 02:04:15,563 INITIATIVE? 2496 02:04:15,563 --> 02:04:19,333 HEARING NONE, THAT PASSES. 2497 02:04:19,333 --> 02:04:24,772 THANK YOU. 2498 02:04:24,772 --> 02:04:27,141 MOVING ON TO THE NEXT ONE? 2499 02:04:27,141 --> 02:04:27,608 >> WE NEED TO VOTE. 2500 02:04:27,608 --> 02:04:33,781 OKAY. 2501 02:04:33,781 --> 02:04:39,187 ALL RIGHT. 2502 02:04:39,187 --> 02:04:41,155 ANYONE IN FAVOR OF THE 2503 02:04:41,155 --> 02:04:42,657 INITIATIVE, PLEASE RAISE YOUR 2504 02:04:42,657 --> 02:04:42,857 HAND. 2505 02:04:42,857 --> 02:04:43,324 ALL RIGHT. 2506 02:04:43,324 --> 02:04:46,961 ANYONE OPPOSED? 2507 02:04:46,961 --> 02:04:47,395 I BELIEVE IT PASSES. 2508 02:04:47,395 --> 02:04:49,797 THANK YOU. 2509 02:04:49,797 --> 02:04:50,531 >> THANK YOU. 2510 02:04:50,531 --> 02:04:52,834 WE CAN MOVE TO THE NEXT SLIDE. 2511 02:04:52,834 --> 02:04:57,438 THE FINAL ONE WE WOULD GROUP IS 2512 02:04:57,438 --> 02:04:59,173 THE CLINICAL TRIAL INNOVATION 2513 02:04:59,173 --> 02:05:00,875 WORKING GROUP. 2514 02:05:00,875 --> 02:05:05,546 AS MANY RECALL NCI FORMS A 2515 02:05:05,546 --> 02:05:06,914 CLINICAL TRIALS INNOVATION UNIT 2516 02:05:06,914 --> 02:05:08,783 FOR OPERATIONAL EFFICIENCIES FOR 2517 02:05:08,783 --> 02:05:13,054 HIGH PRIORITY RESEARCH NEEDS IN 2518 02:05:13,054 --> 02:05:13,488 2023. 2519 02:05:13,488 --> 02:05:16,591 CTAC HEARD ABOUT THIS SO I'M 2520 02:05:16,591 --> 02:05:18,326 HOPEFUL SOME RECALL THAT ABOUT 2521 02:05:18,326 --> 02:05:21,796 THE INITIATIVE EARLY ON BUT 2522 02:05:21,796 --> 02:05:25,833 SINCE THAT TIME THEY LAUNCHED A 2523 02:05:25,833 --> 02:05:27,869 HIGHLY PRAGMATIC TRIAL KNOWN AS 2524 02:05:27,869 --> 02:05:31,305 A PROSPECT LAUNCHED BY ALLIANCE 2525 02:05:31,305 --> 02:05:35,076 AND THAT IS AIMING TO 2526 02:05:35,076 --> 02:05:37,845 RE-EVALUATE THE ROLE OF 2527 02:05:37,845 --> 02:05:39,947 IMMUNOTHERAPY WITH PATIENTS WITH 2528 02:05:39,947 --> 02:05:42,850 NON-SMALL CELL LUNG CANCER. 2529 02:05:42,850 --> 02:05:44,418 IN THE PRESENT ENVIRONMENT NCI 2530 02:05:44,418 --> 02:05:47,155 WOULD LIKE TO BRING IT UNDER THE 2531 02:05:47,155 --> 02:05:52,260 AUSPICES OF CTAC BY FORMING A 2532 02:05:52,260 --> 02:05:54,896 WORKING GROUP FOR RESEARCH 2533 02:05:54,896 --> 02:05:56,597 OPPORTUNITIES AND TO BUILD ON 2534 02:05:56,597 --> 02:05:59,133 THE PROGRESS ON THE WORK WITH 2535 02:05:59,133 --> 02:06:03,337 THE COMMUNITY PARTICULARLY THE 2536 02:06:03,337 --> 02:06:05,373 GROUP CHAIR LEADERSHIP AND FDA 2537 02:06:05,373 --> 02:06:07,208 ONCOLOGY OF EXCELLENCE AND NCI. 2538 02:06:07,208 --> 02:06:09,577 IT'S BEEN A GOOD FORUM AND WE 2539 02:06:09,577 --> 02:06:11,279 ALSO WOULD LIKE TO LOOK AT THE 2540 02:06:11,279 --> 02:06:14,448 PROGRESS OF THE WORK THIS GROUP 2541 02:06:14,448 --> 02:06:17,151 HAS ALREADY BEGUN. 2542 02:06:17,151 --> 02:06:19,320 THE PURPOSE IS TO ADVISE CTAC 2543 02:06:19,320 --> 02:06:21,255 AND THE NCI DIRECTOR 2544 02:06:21,255 --> 02:06:24,158 TRANSFORMATIVE APPROACHES TO 2545 02:06:24,158 --> 02:06:25,459 CLINICAL TRIALS DRAWING ON THE 2546 02:06:25,459 --> 02:06:32,266 WORK OF THE CLINICAL TRIALS 2547 02:06:32,266 --> 02:06:33,601 INNOVATION UNIT AND STRATEGIES 2548 02:06:33,601 --> 02:06:34,235 THAT MAY BE DISCUSSED AND HAVE 2549 02:06:34,235 --> 02:06:36,571 FURTHER DISCUSSION INCLUDING 2550 02:06:36,571 --> 02:06:37,738 ADVANCING PRAGMATIC TRIALS AND 2551 02:06:37,738 --> 02:06:41,976 REAL WORLD DATA AND MEMBERSHIP 2552 02:06:41,976 --> 02:06:44,111 INCLUDE REPRESENTATIVES FROM 2553 02:06:44,111 --> 02:06:47,348 CTAC AND OTHER INDIVIDUALS WITH 2554 02:06:47,348 --> 02:06:50,251 RELEVANT EXPERTISE INCLUDING THE 2555 02:06:50,251 --> 02:06:51,485 NCTN LEADERSHIP AND 2556 02:06:51,485 --> 02:06:56,524 REPRESENTATIVES NCI AND THANK 2557 02:06:56,524 --> 02:07:00,862 YOU I'LL TURN IT BACK TO YOU. 2558 02:07:00,862 --> 02:07:01,562 >> ANYBODY WITH DISCUSSION OR 2559 02:07:01,562 --> 02:07:12,006 QUESTIONS ABOUT THE TOPIC? 2560 02:07:12,907 --> 02:07:15,243 >> OKAY. 2561 02:07:15,243 --> 02:07:15,443 ERNIE. 2562 02:07:15,443 --> 02:07:19,347 >> THE RECENT ANNOUNCEMENT 2563 02:07:19,347 --> 02:07:21,482 REGARDING USE OF AGENTS IN 2564 02:07:21,482 --> 02:07:23,384 ANIMAL MODELS AND THINGS IS 2565 02:07:23,384 --> 02:07:29,690 CAUSING OUR CENTER TO RE-EXAMINE 2566 02:07:29,690 --> 02:07:33,194 WHAT THE INNOVATIONS WOULD BE 2567 02:07:33,194 --> 02:07:36,330 AND I'M ADVOCATING FOR 2568 02:07:36,330 --> 02:07:38,132 INNOVATION IN CLINICAL TRIALS IN 2569 02:07:38,132 --> 02:07:40,434 WAYS THAT MAY OVERCOME OTHER 2570 02:07:40,434 --> 02:07:43,337 CHALLENGES THAT FACE NCI. 2571 02:07:43,337 --> 02:07:44,972 THANKS. 2572 02:07:44,972 --> 02:07:46,040 >> THANK YOU. 2573 02:07:46,040 --> 02:07:47,842 ANY OTHER COMMENTS OR DISCUSSION 2574 02:07:47,842 --> 02:07:52,546 POINTS? 2575 02:07:52,546 --> 02:07:52,813 ALL RIGHT. 2576 02:07:52,813 --> 02:07:55,182 WE NEED TO VOTE THEN. 2577 02:07:55,182 --> 02:07:56,217 EVERYONE IN FAVOR OF THIS 2578 02:07:56,217 --> 02:07:56,817 INITIATIVE PLEASE RAISE YOUR 2579 02:07:56,817 --> 02:08:02,657 HAND. 2580 02:08:02,657 --> 02:08:04,292 ANYONE OPPOSED? 2581 02:08:04,292 --> 02:08:07,328 ALL RIGHT. 2582 02:08:07,328 --> 02:08:07,662 MOTION PASSES. 2583 02:08:07,662 --> 02:08:11,265 THANK YOU VERY MUCH. 2584 02:08:11,265 --> 02:08:13,301 ALL RIGHT. 2585 02:08:13,301 --> 02:08:15,169 ANY OTHER ITEMS TO BE DISCUSSED 2586 02:08:15,169 --> 02:08:21,542 TODAY? 2587 02:08:21,542 --> 02:08:23,611 >> I HAD A QUESTION QUESTION FOR 2588 02:08:23,611 --> 02:08:26,580 SHEILA, WITH THE THREE 2589 02:08:26,580 --> 02:08:29,283 INITIATIVES PROCESS FOR 2590 02:08:29,283 --> 02:08:31,752 IDENTIFIED APPROPRIATE PEOPLE ON 2591 02:08:31,752 --> 02:08:33,788 CTAC AND EXPERTISE THAT MAY NOT 2592 02:08:33,788 --> 02:08:34,789 BE PART OF CTAC? 2593 02:08:34,789 --> 02:08:37,792 >> YES. 2594 02:08:37,792 --> 02:08:43,264 DEPENDING ON THE PARTICULAR 2595 02:08:43,264 --> 02:08:44,932 NEEDS OF THE GROUP THERE WILL BE 2596 02:08:44,932 --> 02:08:46,500 CTAC MEMBERS AND INDIVIDUALS 2597 02:08:46,500 --> 02:08:49,003 PLUS THE BROAD COMMUNITY WITH 2598 02:08:49,003 --> 02:08:51,172 THE APPROPRIATE EXPERTISE 2599 02:08:51,172 --> 02:08:55,042 IDENTIFIED TO PARTICIPATE. 2600 02:08:55,042 --> 02:08:55,476 IT WILL BE MRICHLD. 2601 02:08:55,476 --> 02:08:57,144 CLEARLY WE THESE TO BRING IN 2602 02:08:57,144 --> 02:08:59,146 ADDITIONAL EXPERTISE AND THIS IS 2603 02:08:59,146 --> 02:09:00,614 ONE OF THE THINGS THAT MAKES 2604 02:09:00,614 --> 02:09:03,284 THIS MECHANISM VALUABLE AND 2605 02:09:03,284 --> 02:09:04,719 ALLOWS US TO BRING IN EXPERTISE 2606 02:09:04,719 --> 02:09:08,022 TO ADVISE ON THINGS AND THEN 2607 02:09:08,022 --> 02:09:11,325 REPORT BACK TO CTAC ON WHAT WE 2608 02:09:11,325 --> 02:09:15,830 LEARN. 2609 02:09:15,830 --> 02:09:17,465 >> ALL RIGHT. 2610 02:09:17,465 --> 02:09:19,333 ANY OTHER DISCUSSION POINTS? 2611 02:09:19,333 --> 02:09:22,169 SHEILA, ANYTHING FROM YOU? 2612 02:09:22,169 --> 02:09:23,704 >> NO, OTHER THAN TO SAY THANK 2613 02:09:23,704 --> 02:09:24,271 YOU ALL VERY MUCH. 2614 02:09:24,271 --> 02:09:26,474 I KNOW IT'S BEEN A CHALLENGING 2615 02:09:26,474 --> 02:09:27,008 TIME. 2616 02:09:27,008 --> 02:09:30,511 MANY HAVE EXTENDED YOUR STAY ON 2617 02:09:30,511 --> 02:09:34,515 CTAC AND I GREATLY PATIENT THAT 2618 02:09:34,515 --> 02:09:37,785 AND WE'RE TRYING TO MOVE FORWARD 2619 02:09:37,785 --> 02:09:42,823 WITH POPULATING THE COMMITTEE. 2620 02:09:42,823 --> 02:09:45,092 WE HOPE TO HAVE A MEETING IN 2621 02:09:45,092 --> 02:09:46,494 PERSON AND RECOGNIZING MAYBE 2622 02:09:46,494 --> 02:09:47,895 ONCE A CAREER RATHER THAN ALL 2623 02:09:47,895 --> 02:09:52,066 VIRTUALLY IS VERY VALUABLE. 2624 02:09:52,066 --> 02:10:00,274 OUR NEXT MEETING IS NOVEMBER 19. 2625 02:10:00,274 --> 02:10:01,842 >> NOVEMBER 19 IS THE NEXT 2626 02:10:01,842 --> 02:10:04,045 MEETING AND I APPRECIATE 2627 02:10:04,045 --> 02:10:05,279 EVERYONE'S HELP WITH THE TOPICS 2628 02:10:05,279 --> 02:10:07,314 AND THEY'RE VERY IMPORTANT TO 2629 02:10:07,314 --> 02:10:09,216 OUR PATIENTS AS WELL AS OUR US. 2630 02:10:09,216 --> 02:10:12,053 THANK YOU FOR ALL YOUR TIME AND 2631 02:10:12,053 --> 02:10:12,286 EFFORT. 2632 02:10:12,286 --> 02:10:16,490 AND THEY DO GIVE YOU NEW MEETING 2633 02:10:16,490 --> 02:10:18,292 DATES IN THE INFORMATION SENT 2634 02:10:18,292 --> 02:10:20,561 OUT SO PUT THAT ON YOUR CALENDAR 2635 02:10:20,561 --> 02:10:22,329 FOR THE FUTURE AND THANKS 2636 02:10:22,329 --> 02:10:22,596 EVERYBODY. 2637 02:10:22,596 --> 02:10:23,164 WE'LL END THE MEETING THEN. 2638 02:10:23,164 --> 02:10:23,431 THANK YOU. 2639 02:10:23,431 --> 02:10:23,497