SERVING AS ACTING CHAIR OF THIS
MIGHT. WE'D LIKE TO WELCOME THE
MEMBERS OF THE NATIONAL CANCER
ADVISORY BOARD, EX OFFICIO
MEMBERS, PRESIDENT MEMBERS AND
MOST ESPECIALLY A WARM WELCOME
TO DR. DOUGLAS LOWY, DOUG IS
GREAT TO HAVE YOU AT THE HELM.
MEMBERS OF THE PUBLIC WHO WISH
TO EXPRESS THEIR VIEWS REGARDING
ANY ITEMS DISCUSSED IN THIS
MEETING MAY DO SO BY WRITING
DR. PAULETTE GREY WITHIN TEN
DAYS AFTER THE MEETING. ANY
WRITTEN STATEMENTS OR QUESTIONS
SUBMITTED BY THE PUBLIC WILL
RECEIVE CAREFUL CONSIDERATION.
AS BOARD MEMBERS, I WANT TO
REMIND YOU THAT YOU MUST ABSENT
YOURSELVES VIRTUALLY WHENEVER
YOUR PARTICIPATION,
DELIBERATIONS ON A PARTICULAR
PRODUCT, PROGRAM OR OTHER
SPECIFIC MATTER WOULD CONSTITUTE
A CONFLICT OF INTEREST OR CREATE
THE APPEARANCE OF ONE. IT IS
INCUMBENT UPON YOU TO ADVISE THE
EXECUTIVE SECRETARY AND ABSTAIN
FROM ANY PARTICIPATION IN
DISCUSSION OR ACTION REGARDING
THAT MATTER. IN LIGHT OF THE
CURRENT POLICIES GOVERNING
CONFLICT OF INTEREST BASED ON
FINANCIAL HOLDINGS, SPECIAL
GOVERNMENT EMPLOYEES WHICH
INCLUDES ALL MEMBERS OF THIS
BOARD WE MUST DEPEND UPON YOU TO
VOLUNTARILY ABSENT YOURSELF
DURING ANY AND ALL DISCUSSIONS
OF MATTERS THAT COULD
CONCEIVABLY IMPACT THE STATUS OF
THOSE HOLDINGS WE TRUST YOUR
JUDGMENT IN THESE INSTANCES.
DURING ANY CLOSED SESSION, ANY
MATERIALS OR DISCUSSIONS OF A
CONFIDENTIAL NATURE DELIBERATED
ON TODAY ARE PRIVILEGED
INFORMATION AND ARE MADE
AVAILABLE TO YOU ON A NEED TO
KNOW BASIS. SUCH DELIBERATIONS
ARE PRIVATE AND THEIR CONTENT
SHOULD NOT BE DIVULGED. FUTURE
DATES WERE PROVIDED AND LISTED
IN OUR AGENDA. A QUORUM OF
BOARD MEMBERS IS REQUIRED FOR
EACH INSTANCE IN WHICH A VOTE
MAY OCCUR WHETHER IN OPEN OR
CLOSED SESSION DURING THIS
MEETING A MINIMUM OF NINE
APPOINTED MEMBERS MUST BE
PRESENT TO VOICE THEIR VOTES
SINCE WE CANNOT PREDICT THE TIME
NOR OCCURRENCE OF ANY MOTION
YOUR PRESENCE IN THE VIRTUAL
ROOM FOR ALL SEGMENTS IN THIS
MEETING IS A MUST. DR. GREY, DO
WE HAVE A QUORUM?
>> YES, WE DON'T -- DO.
>> THANK YOU. PLEASE MAKE SURE
YOU ARE RECOGNIZED BY ME,
DR. GRAY, DR. LOWY OR ANY
RESPECTIVE SPEAKER. WE WILL
BEGIN WITH THE DEPUTY DIRECTOR'S
REPORT. DR. LOWY, THE FLOOR IS
YOURS.
>> DR. LOWY: THANK YOU SO MUCH
FOR THE WONDERFUL INTRODUCTION
FOR ME BUT MORE IMPORTANTLY FOR
YOUR SETTING THE SCENE FOR THIS
REALLY IMPORTANT MEETING OF THE
NATIONAL CANCER ADVISORY BOARD.
I AM REALLY GLAD WE ARE ABLE TO
MEET TOGETHER TODAY. WE FIRST
PLAN TO GO OVER SEVERAL TOPICS
IN OPEN SESSION AND THEN FOR THE
NCAB TO PROVIDE SECOND LEVEL
REVIEW OF MANY GRANT
APPLICATIONS WITH THE HOPE THAT
THE MOST MERITORIOUS OF THEM CAN
BE FUNDED IN THE NEAR FUTURE.
ONE NOTE ABOUT INDIRECT COST
RATE. WE WILL CONTINUE TO USE
PREVIOUSLY NEGOTIATED AND
APPROVED RATES EXCEPT FOR AWARDS
UNDER WHICH FACILITIES AND
ADMINISTRATIVE COST OR FOA COSTS
ARE REIMBURSED AT A FIXED RATE I
ALSO JUST WANT EVERYONE TO KNOW
THAT OUR EARLY STAGE
INVESTIGATORS HAVE BEEN GRANTED
AUTOMATIC EXTENSIONS OF THEIR
ELIGIBILITY THAT MAY HAVE
RESULTED FROM DELAYS IN GRANT
APPLICATIONS, SUBMISSIONS, PEER
REVIEW, OR AWARD PROCESSING
BETWEEN THE BEGINNING OF JANUARY
AND THE END OF MAY. BEFORE
TURNING TO THE NEXT ORDER OF
BUSINESS, THE ANNUAL DELEGATION
OF AUTHORITY, I WOULD LIKE TO
REMIND ALL OF US THAT THE
ONGOING THREE DECADE DECREASE IN
CANCER MORTALITY RATES HAS
CONTINUED FOR 19, I'M SORRY, FOR
2023, THE MOST RECENT YEAR FOR
WHICH WE HAVE RELIABLE DATA.
PATIENTS, RESEARCHERS, OUR
ADVISORY COMMITTEES AND CONGRESS
SHOULD BE APPLAUDED FOR ENABLING
THIS PROGRESS. YOU CAN FIND THE
2023 DATA IN SEER EXPLORER WHICH
IS AVAILABLE TO EVERYONE. IN
THAT YEAR, THE ANNUAL MORTALITY
RATE DECREASE FOR BOTH SEXES
COMBINED WAS 1.5%. THANKFULLY,
THE 2023 MORTALITY RATES ARE
MORE THAN 1/3 LOWER THAN WHAT
THEY WERE IN 1992. WHAT THAT
MEANS FOR NOW IS AROUND 300,000
PEOPLE IN THE UNITED STATES THIS
YEAR WON'T DIE OF CANCER.
COMPARED WITH THE NUMBER WHO
WOULD HAVE DIED AT 1992 RATES.
OF COURSE THERE'LL ALSO BE SIX
THOUSAND PEOPLE WHO WILL DIE
FROM CANCER THIS YEAR. THIS
NUMBER AND THE PATIENTS,
FAMILIES AND FRIENDS PUTS IN
PERSPECTIVE THE IMPORTANCE AND
THE URGENCY FOR SUPPORTING AS
MUCH MERITORIOUS CANCER RESEARCH
AS POSSIBLE. THANKS SO MUCH FOR
YOUR PARTICIPATION. WE REALLY
LOOK FORWARD TO BEING ABLE TO
TRY TO MAKE MORE AWARDS IN THE
NEAR FUTURE COMPARED TO WHERE WE
HAVE BEEN.
>> THANK YOU SO MUCH DOUG AND WE
APPRECIATE WHAT YOU AND THE TEAM
ARE DOING IN THESE EXTRAORDINARY
CIRCUMSTANCES AND MY PERSONAL
DEEP APPRECIATION FOR THE VERY
HARD WORK TO ACHIEVE THOSE GOALS
THAT YOU OUTLINED. WE HAVE
ABOUT NINE MINUTES OR SO FOR
QUESTIONS. AGAIN, I ASK NCAB
MEMBERS IF YOU HAVE A QUESTION
OR A COMMENT TO PLEASE RAISE
YOUR HAND TO BE IDENTIFIED. I
WILL CALL ON YOU FOR THE SAKE OF
EXPEDIENCY I ASK YOU KEEP YOUR
QUESTIONS AND COMMENTS AS BRIEF
AS POSSIBLE SO WE CAN HAVE AS
MUCH DISCUSSION AS POSSIBLE.
ISABE
ISABEL?
>> ISABEL: THANK YOU, CHRIS,
THANK YOU DR. LOWY, GOOD TO SEE
YOU THIS MORNING. ONE QUESTION,
WILL WE BE ABLE TO SEE THAT
REP
REPORT, A LINK TO THAT REPORT
AND PERHAPS A DEMOGRAPHIC
BREAKDOWN OF THE IMPROVEMENT
IN... IN THE AREA OF MORTALITY?
THAT IS, WE HAVE LESS DEATH IN A
DIFFERENT COMMUNITIES. SO THAT
WE CAN MEASURE IF WE'RE DOING
WELL. SNUG ISABEL, I'M NOT SURE
I UNDERSTOOD YOUR QUESTION.
>> ISABEL. LOOKING FOR A REPORT
WITH THE DATA SO WE CAN SEE HOW
OUR DIFFERENT DEMOGRAPHIC
BREAKDOWNS WE CAN SEE IF OUR
DIFFERENT COMMUNITIES ARE IN
FACT, ALSO, MORE SUCCESSFULLY
CONQUERING CANCER AND SURVIVING
RATHER THAN FACING SOME HIGHER
MORTALITY RATES.
>> YES, THE ANNUAL REVIEW ON
CANCER GIVES THOSE, GIVE THOSE
DATA THEY'RE ACTUALLY PUBLISHED
THIS YEAR IN CANCER A COUPLE OF
MONTHS AGO.
>> GREAT. THANK YOU VERY MUCH.
>> THANK YOU SO MUCH, DR. EM
MENS, PLEASE. DOCTOR, YOU'RE
MUTED. IF YOU WANT TO PUT YOUR
QUESTION IN THE CHAT, WE'LL
FOLLOW UP WITH YOU. THANK YOU.
ASHOW
>> I JUST WANT TO SAY THANK YOU
TO DR. LOWY AND ALL OF THE NCI
STAFF FOR THE AMAZING JOB YOU
GUYS ARE DOING THIS TRYING TIME
AND I HOPE YOU'RE ALL HANGING IN
THERE.
>> THANKS SO MUCH FOR YOUR
ENCOURAGEMENT AND SUPPORT. WE
LOOK AT THE MISSION OF THE NCI
AS A SACRED TRUST AND
RESPONSIBILITY AND IT REALLY
HELPS KEEP US CENTERED. IT IS
OUR NORTH STAR.
>> YOU WANT TO TRY AGAIN. I
THINK I SAW SOME VICTORY.
>> SORRY ABOUT THAT. APOLOGIES.
AGAIN, I WANT TO ECHO WHAT
EVERYONE HAS SAID ABOUT JUST
THAT AMAZING WORK THAT IS
HAPPENING TO KIND OF KEEP
EVERYTHING AFLOAT AND SO
APPRECIATIVE OF THAT. I KNOW
FOR MYSELF THAT WHEN THERE'S A
LOT OF CHANGES TO PROCESSES ALL
AT ONCE SOMETIMES IT MAKES ONE
CHANGE THE WAY BUSINESS IS DONE.
I WAS JUST CURIOUS IF YOU CAN
SAY A LITTLE BIT ABOUT THE,
THERE'S SO MUCH COMING AT YOU,
SO MANY CHANGES AND BUDGETARY
ISSUES. HOW ARE YOU MANAGING
KIND OF THE LEADERSHIP OF
DECISION-MAKING? HAS THAT
CHANGED? DO YOU STILL HAVE FULL
REPRESENTATION IN YOUR ACTION
TEAM FROM ALL OF THE AREAS THAT
NCI REPRESENTS? I WONDER IF YOU
CAN SAY A LITTLE BIT ABOUT THAT
STRUCTURE THAT YOU'RE USING
GOING FORWARD. NOW IS WE TRY TO
DO A LOT OF DECISION-MAKING BY
CONSENSUS. WHEN... BUT THERE
ARE SOECERTAIN TIMES WHEN I NEEO
BE MAKING THE DECISION.
HOPEFULLY WE'LL BE DOING A
USEFUL EXERCISE FOR TRYING TO
PRIORITIZE WHAT IS MOST
IMPORTANT AMONG OUR CANCER
RESEARCH AND REALLY MAKING USE
OF THE INCREDIBLE LEADERSHIP
THAT WE HAVEMOST IMPORTANT AMON
RESEARCH AND REALLY MAKING USE
OF THE INCREDIBLE LEADERSHIP
THAT WE HAVE THAT SPANS THE NCI
AND THEN WE ALSO HAVE WHAT WE
CALL THE DEPUTIES AND THAT GROUP
HAS CONTINUED TO BE THERE AND I
JUST WANT TO TELL YOU ABOUT TWO
NEW APPOINTMENTS BECAUSE THEY,
WHAT HAPPENED WAS WITH THE LOSS
OF OUR DIRECTOR, YOU KNOW, AKEEM
HAD A WEALTH OF CLINICAL
EXPERIENCE BUT WE FELT WE NEEDED
DEPUTIES WHO HAVE THAT KIND OF
CLINICAL EXPERIENCE. THE
DOCTORS BOTH HAVE THAT. THEY
ARE NOT OFFICIALLY DEPUTIES.
THEY'RE SPECIAL ADVISORS BUT
THEY FUNCTION IN THAT WAY. LET
ME TURN TO NCI IN GENERAL. WE
HAVE LOST MANY COLLEAGUES, BOTH
THROUGH VOLUNTARY RETIREMENT AS
WELL AS INVOLUNTARY SEPARATION.
WHAT REALLY MATTERS FOR THE NCI
IS THAT EVERYBODY PLAYS A
CRITICAL ROLE AND THE NCI
DIRECTOR'S OFFICE, WE HAVE A
PHOTOGRAPH OF A STONE BRIDGE.
AND IT ASKS THE QUESTION, WHICH
STONE HOLDS UP THE BRIDGE? AND
THE ANSWER IS ALL OF THEM. SO
WE HAVE A CHALLENGE WITHIN THE
NCI OF HAVING LOST A LOT OF
COLLEAGUES AS I SAY FOR VARIOUS
REASONS. AND NEEDING TO
CONTINUE TO PRESS FORWARD. BUT
WE ARE DOING THAT TO THE BEST OF
OUR APPRECIATES AND WE HAVE
TERRIFIC PEOPLE WHO REMAIN HERE.
THANKS SO MUCH FOR YOUR
QUESTION.
>> PANEEZ: THE ACTING CHAIR
RECOGNIZES THE CHAIR, DOCTOR.
>> THANKS, CHRIS. GOOD MORNING,
DOUG, THANKS FOR STAYING THE
COURSE DURING THESE DIFFICULT
TIMES OVER THIS TIME OF CHANGE
AND SO I GUESS FROM MY
PERSPECTIVE, YOU KNOW, MANY OF
US HAVE SEEN THAT THE CURRENT
DRAFT BUDGET COMING OUT OF THE
WHITE HOUSE. AND IT'S
UNPRECEDENTED, RIGHT? SO I
GUESS IF WE'RE EVEN CLOSE TO
THAT, EVEN IF CONGRESS EXPANDS
IT SOME I DON'T KNOW IF WE'LL
GET TO THE LEVELS WE REALLY
NEED. I KNOW YOU'RE GOING TO
HAVE TO ALL MAKE SOME CHOICES
EXTERNALLY. YOU HAVE SOME
EXTRAMURAL FUNDING AND A
BEAUTIFUL INTRAMURAL PROGRAM SO
WHAT DOES THAT DECISION TRY AND
PRIORITIZATION LOOK LIKE FROM
YOUR STANDPOINT IN HOW YOU WOULD
BALANCE US SPENDING EXTRAMURALLY
AND INTRAMURALLY? ? SNOU I DON'T
MEAN TO WAFFLE BUT THIS IS ONE
OF THE IMPORTANT QUESTIONS THAT
THE LEADERSHIP GROUP I TALKED
ABOUT 30 PEOPLE AT NCI ARE
TRYING TO WORK THROUGH AND WE
ALSO ANTICIPATE TALKING WITH
EXTRAMURAL COLLEAGUES BECAUSE
ULTIMATELY THE VAST MAJORITY OF
OUR FUNDING GOES TO YOU. AND WE
WOULD LIKE TO BE CLEAR THAT WHAT
WE ARE TRYING TO DO TO HELP YOU
ACTUALLY WORKS IN THAT
DIRECTION. SNARP THANKS, DOUG,
WE'RE HAPPY TO HELP AND THEY
HOPE WE GET AN OPPORTUNITY TO
PLAY A ROLE IN THOSE
DISCUSSIONS. THANK YOU.
>> DR. FRIESE: I THINK WE HAVE
ONE MORE QUESTION PLEASE,
APOLOGIES. GO AHEAD WITH YOUR
QUESTION. SORRY. YOU CAN
UNMUTE. OKAY, MAYBE IF YOU PUT
YOUR QUESTION IN THE CHAT WE CAN
GET TO IT DURING THE COURSE OF
THE MEETING. THANK YOU SO MUCH.
OUR NEXT TOPIC WILL BE ANNUAL
DELEGATION OF AUTHORITY. AND
DR. SRINIVAS OFFICE OF REVIEW
AND COORDINATION IS PRESENTING.
>> THANK YOU FOR THE OPPORTUNITY
I HOPE YOU ALL CAN HEAR ME. SO
THIS IS THE DELEGATIONS OF
AUTHORITY OF NCA BEFORE 2025.
DELEGATION A, THE NCA BEING DULY
CONSULTED HERE BY THE DIRECTOR
OF NATIONAL CANCER INSTITUTE
PERMISSION TO UPDATE AS STATED
IN SECTION 413B 5 OF THE PUBLIC
HEALTH SERVICE ACT AND IN
ACCORDANCE WITH THE SECTION IF
109 OF TITLE 5 UNITED STATES
CODE BUT WITHOUT REGARD TO THE
LIMITATION IN SUBSECTION ON A
PERIOD OF SERVICE THE SERVICES
OF NOT MORE THAN 151 SPECIAL
EXPERTSES OR CONSULTANT WHO IS
HAVE SCIENTIFIC OR PROFESSIONAL
QUALIFICATION TO ASSIST IN
ACCOMPLISHING THE MISSION OF THE
INSTITUTE.
DELEGATION B, THE NCAB BEING
DULY CONSULTED BY THE DELEGATE
TO THE DIRECTOR NCI PERMISSION
TO ACCESS AUTHORITY AS STATED IN
14B 7 OF THE PUBLIC HEALTH
SERVICE ACT TO APPOINT ONE OR
MORE ADVISORY COMMITTEES
COMPOSED OF SUCH PRIVATE
CITIZENS AND OFFICIALS OR
FEDERALS STATED IN LOCAL
GOVERNMENT TO ADVISE THE
DIRECTOR WITH RESPECT TO THE THE
DIRECTOR'S FUNCTIONS. STATEMENT
OF UNDERSTANDING WITH NATIONAL
CANCER INSTITUTE, STAFF ON
OPERATING PRINCIPLES IN
EXTRAMURAL AWARDS. OPERATIONS
OF THE NCAB WILL BE CONDUCTED BY
THE NCI IN ACCORDANCE WITH
MANAGEMENT, INTERVIEW
PROCEDURES, SET FORTH IN THE NIH
MANUAL ISSUANCE 4513
SPECIFICALLY CONCURRENCE OF THE
NCAB WITH RECOMMENDATIONS OF
INITIAL REVIEW GROUPS WILL BE
REQUIRED EXCEPT FOR TRAINING
PLANS, FELLOWSHIPS AND OTHER
GRANT APPLICATIONS ARE NOT
PROPOSALS TO CONDUCT OR RESEARCH
AND ARE NOT SUBJECT TO REVIEW
AND APPROVAL AND WITHOUT OTHER
CONSTANTS MAY BE AWARDED WE
THOUGHT PRESENTATION TO THE NCAB
FOR CONCURRENCE. THAT IS EXCEPT
FOR ROOT OR NATIONAL SERVICE
AWARDS. APPLICATIONS OVER THE
20TH PERCENTILE WILL NOT HAVE
SOME OF THESE STATEMENTS
PRESENTED TO THE NCAB UNLESS THE
INSTITUTE IS CONSIDERING THE
AWARD FOR SUCH AN APPLICATION OR
OTHER SPECIAL CONSIDERATIONS IS
REQUESTED OR OTHER POLICY OR FOR
SPECIAL CONSIDERATION BY AN
APPOINTED MEMBER OF THE BOARD.
FOR APPLICATIONS ASSIGNED THAT
ARE NOT PERCENTILE THE CUTOFF
WILL BE AN IMPACT SCORE OF 50
MORE ALL MECHANISMS EXCEPT FOR R
4
41-44 AWARDS. ALL OTHER
APPLICATIONS LISTINGS AND SOME
OF THESE OTHER STATEMENTS
PRESENTED FOR PURPOSE OF
CONCURRENCE WILL BE CONSIDERED
ON BLOCK BY THE MEMBERS OF THE
BOARD. IN THE CASE OF EXPEDITED
CONCURRENTS, FOR R 01 AND R 21
APPLICATIONS EXCLUDING THOSE
FROM FOREIGN ORGANIZATIONS, WITH
PERCENTILE SCORES THAT FALL
WITHIN PAY LINES FOR THAT
MECHANISM THAT HAVE NO CONSTANTS
NOTED THAT WILL REPRESENT AN
ADMINISTRATIVE BARTER AWARD
EXAMPLE WILL BE HUMAN SUBJECTS,
ANIMAL WELFARE, BIOHAZARDS OR
INCLUSION OF WOMEN INDIVIDUALS
ACROSS THE LIFE SPAN AND
APPROPRIATE MINORITY
DISTRIBUTION, A PROCESS OF
EXPEDITED CONCURRENTS WILL BE
USED WHEREBY THE REVIEW
APPLICATIONS IS DELEGATED BY THE
CHAIR SPECIFICALLY DESIGNATED
MEMBERS OF THE BOARD ACTING ON
BEHALF OF THE BOARD AS A WHOLE.
THE REVIEWERS WILL CONSIST OF
THE CHAIR, SUBCOMMITTEE ON
SPECIAL ACTIONS AND THREE
ADDITIONAL MEMBERS AS APPOINTED
BY THE CHAIR IN NCAB IN CASES OF
EMERGENT NEED AS DETERMINED BY
THE DIRECTOR OF NCI WITH THE
CONCURRENCE OF THE CHAIR,
EXPEDITED CONCURRENCE MAY BE
UTILIZED BY SINGLE CASE
COMPETITIVE APPLICATIONS WHEN
TIME IS OF ESSENCE IN ISSUING
THE AWARD THE EXECUTIVE
SECRETARY WILL ALERT THE BOARD
MEMBERS WITH THE RESPONSIBILITY
FOR EXPEDITED CONCURRENCE WITH
THE REVIEW OUTCOMES FOR ELIGIBLE
APPLICATIONS THAT ARE AVAILABLE
ON THE ELECTRONIC PORTION OF THE
ELECTRONIC COUNCIL BOOK THE
EXECUTIVE SECRETARY WILL PROVIDE
THE FOLLOWING INFORMATION TO THE
MEMBERS, APPLICATION NUMBER,
NAME OF THE PI, PROJECT TITLE,
AND PERCENTILE AND ALL IMPACT
SCORE. ELECTRONIC CONCURRENCE
BY THE MINIMUM OF TWO MEMBERS
WITH NO AWARDS FOR NON-CON
CURVES WITHIN SEVEN DAYS OF
NOTIFICATION OF POSTING IS
REQUIRED FOR APROVEN ANY MEMBER
MAY BRING AN APPLICATION TO FULL
BOARD CONSIDERATION WITHOUT THE
NEED FOR JUSTIFICATION. ANY
SINGLE BOARD FOR NON-CON CURVES
WITHIN THAT ALLOTTED TIME PERIOD
WILL RESULT IN THAT APPLICATION
FOR REGULAR CONSIDERATION TO THE
BOARD UNDER ITS STANDARD
PROCEDURES FOR ANY NON-EXPEDITED
APPLICATION. MEMBERS NOT ACTING
UPON AN APPLICATION WITHIN THE
ALLOTTED TIME PERIOD AFTER
POSTING WILL BE CONSIDERED TO
HAVE ABSTAINED FROM VOTE ON THAT
APPLICATION. EXPEDITED LISTINGS
LACK ENOUGH WORDS FOR FINAL
ACTION WILL BE PRESENTED TO THE
FULL NCAB ADDED TO THE MEETING.
A FULL NCAB WILL BE PROVIDED
WITH A LIST OF ALL APPLICATIONS,
ELIGIBLE FOR EXPEDITED
CONCURRENCE AS WELL AS THE
OUTCOME OF THE VOTE BY THE
DELEGATED MEMBERS ON THOSE
APPLICATIONS. A REPORT OF THE
EXPEDITED RECOMMENDATIONS WILL
BE POSTED ELECTRONICALLY FOR
EACH MEETING WHERE APPLICATIONS
ARE REVIEWED A BOARD MAY
CONSIDER THE PARAMETERS FOR
EXPEDITED ELIGIBILITY AT ANY
TIME BUT NO LESS THAN ONCE PER
YEAR. ADMINISTRATIVE
ADJUSTMENTS THE NCAB BEING NEWLY
CONSULTED HEREBY DELEGATES TO
THE DIRECTOR OF THE NATIONAL
CANCER INSTITUTE. PERMISSION TO
ALLOW STAFF TO NEGOTIATE
APPROPRIATE ADJUSTMENTS IN THE
DOLLARS OR OTHER GRANTS OR
COOPERATIVE AGREEMENT AWARDS
RECOMMENDED BY THE BOARD. THESE
GUIDELINES HAVE BEEN DEVELOPED
TO MAINTAIN THE SMOOTH EFFECT
ANDIVE OPERATION THAT HAS
CHARACTERIZED THE DEBUT OF GRANT
APPLICATIONS OF THE BOARD AND
THE ADMINISTRATION OF GRANTS BY
THE INSTITUTE. STAFF OF THE NC
ANALYZES AND REVIEWS ALL
APPLICATIONS THAT IS
NON-COMPETING NON CONTINUATION
APPLICATIONS. THE NEW
SUPPLEMENT COMPETING
APPLICATIONS BEFORE ISSUING
GRANT AWARD. STAFF WILL
NEGOTIATE APPROPRIATE
ADJUSTMENTS WHEN APPLICABLE FOR
CHANGES AS THE BASE USED FOR THE
FACILITIES AND ADMINISTRATIVE
COSTS AND ON LEGISLATIVE IMPOSE
SALARY OR OTHER LIMITS ON THE
COSTS, ET CETERA. ALSO STAFF
WILL MAKE ADJUSTMENTS TO
RECONCILE INCONSISTENCIES
BETWEEN THE RECOMMENDED BUDGET
AND AIMS AND ACTIVITIES.
ADMINISTRATIVE REQUESTS FOR
INCREASE IN DIRECT COSTS WHICH
ARE RESULT OF MARKED EXPANSION
OR SIGNIFICANT CHANGE IN
SCIENTIFIC CONTENT OF THE
PROGRAM, AFTER FORMAL PEER
REVIEW WILL BE REFERRED TO THE
BOARD FOR ADVICE AND
RECOMMENDATION. THE DIRECTOR OF
NCI WILL DETERMINE WHETHER THE
SCOPE AND URGENCY ARE SUFFICIENT
TO WARRANT CONSULTATION WITH THE
BOARD BY MAIL OR TELEPHONE
INSTEAD OF DELAYING ACTIONS
UNTIL THE NEXT BOARD MEETING OR
THE MUTUAL AGREEMENT WITH THE
DIRECTOR, THE CHAIR MAY ACT ON
BEHALF OF THE BOARD AS A WHOLE.
ACTIONS NOT REQUIRING BOARD
REVIEW AND CHANGE OF
INSTITUTION, CHANGE OF PRINCIPLE
INVESTIGATOR, PHASE OUT OF
SUPPORT OR ADDITIONAL SUPPORT
EITHER TO MEET THE INCREASED
COST OF MAINTAINING THE LEVEL OF
RESEARCH PREVIOUSLY RECOMMENDED
OR TO ACCOMMODATE ACTIVITIES,
JUDGED BY STAFF TO BE WITHIN THE
SCOPE OF THE PREVIOUSLY REVIEWED
RESEARCH NEED NOT BE REPORTED TO
THE BOARD. THE BOARD WILL BE
PROVIDE WITH NOTICE OF GENERAL
SOLICITATIONS FOR ADMINISTRATIVE
SUPPLEMENTS IF THEY APPLY TO THE
APPLICATIONS. IN ADDITION, NCI
STAFF MAY RESTORE REQUESTED TIME
AND SUPPORT WHICH ARE DELETED BY
THE INITIAL REVIEW GROUP WHEN
THE PI HAS PROVIDED
JUSTIFICATION IN AN APPEAL
LETTER THE RESTORE RATION IS IN
THE BEST INTEREST. AS
CIRCUMSTANCES REQUIRED, BASED ON
PROGRAMMATIC CONSIDERATION, THE
DIRECTOR OF NCI AFTER
CONSULTATION WITH NCI CHAIR MAY
MAKE EXCEPTION TO THESE
GUIDELINES REGARDING THE SPECIAL
COUNCIL REVIEW OF PIS WITH
GREATER THAN TWO MILLION DOLLARS
TOTAL COST IN THE RPG AWARDS IN
AN EFFORT TO CONTINUE
RESPONSIBLE STEWARDSHIP OF
PUBLIC FUNDS AND TO SUPPORT
RESEARCH, NIH HAS INSTITUTED A
POLICY OF SPECIAL CONSIDERATE
REVIEW FOR SCR OF APPLICATION OF
WELL-FUNDED INVESTIGATORS
PENDING GRANTS GOING TO THE
BOARD FROM PIS THAT HAVE MORE
THAN TWO ADMINISTER MILLION OR
MORE IN TOTAL COST FROM ACTIVE
RESEARCH PROJECT GRANTSES OR
RPGS MUST BE GIVEN ADDITIONAL
CONSIDERATION IT IS IMPORTANT TO
RECOGNIZE THAT THIS IS A
THRESHOLD ONLY. INVESTIGATORS
WHO HAVE MORE ACCESS SUPPORT MAY
STILL RECEIVE ADDITIONAL REWARDS
AS WARRANTED. THANK YOU.
>> DR. FRIESE: THANK YOU VERY
MUCH DRA SRINIVAS, ARE THERE ANY
QUESTIONS, FROM THE BOARD?
HEARING NONE, THE NEXT AGENDA
ITEM IS THE TRIENNIAL REPORT ON
THE INCLUSION OF WOMEN AND
MINORITIES IN CLINICAL RESEARCH.
DR. MOONEY, TCDT IS PRESENTING.
DR. MOONEY, WELCOME AND WE LOOK
FORWARD TO YOUR REPORT.
>> THANK YOU VERY MUCH. I'M
VERY HAPPY THIS MORNING TO ON
BEHALF OF EVERYONE AT THE NCI
ALL THE NCI STAFF AS WELL AS ALL
THE INVESTIGATORS THAT HAVE
COMPLETED RESEARCH TO SHOW THE
REPORT THAT MONITORS OUR
ADHERENCE TO THE POLICY ON THE
INCLUSION OF WOMEN AND
MINORITIES IN CLINICAL RESEARCH.
WE DO THIS OBVIOUSLY EVERY THREE
YEARS AND SO THIS WILL BE A
REPORT FOR EVERYONE R EVERYTHING
FROM FISCAL YEAR 2022 THROUGH
FISCAL YEAR 2024. NEXT SLIDE,
PLEAS
PLEASE. NIH IS LOOKED AT IN ALL
CLINICAL RESEARCH IN A MANNER
APPROPRIATE TO THE SCIENTIFIC
QUESTION UNDER STUDY. THE
PRIMARY GOAL OF THIS ALL WAS TO
ENSURE THAT A RESEARCH FINDINGS
CAN BE GENERALIZABLE TO THE
ENTIRE POPULATION. THERE WAS
ALSO SOMETHING THAT WAS AMENDED.
THE REVITALIZATION ACT AMENDED
BY THE CURES ACT TO PREPARE A
TRIENNIAL REPORT DESCRIBING HOW
THE INSTITUTE HAS COMPLIED WITH
THE GUIDELINES AND TRACKING
REQUIREMENTS. HENCE THIS IS A
RESPONSE TO THAT REQUIREMENT ON
THE DATA INCLUDED. NEXT SLIDE.
THE SOURCE JUST TO GIVE YOU SOME
BACKGROUND OF THE NIH INCLUSION
DATA FOR NIH DEFINED CLINICAL
RESEARCH STUDIES THEY HAVE TO
MEET THE DEFINITION PROVIDED BY
THE NIH OF CLINICAL RESEARCH AND
COLLECT INFORMATION ON
PARTICIPANT SEX, RACE AND
ETHNICITY. AND OBVIOUSLY THE
CLINICAL RESEARCH THE IS
RESEARCH THAT INVOLVES HUMAN
SUBJECTS.
IT CAN BE PATIENT ORIENTED SO IT
COULD BE A CLINICAL TRIAL ITSELF
BUT IT ALSO CAN BE WHEN AN
INVESTIGATOR INTERACTS IN ANY
WAY WITH HUMAN SUBJECTS AND
EXAMPLES ARE GIVEN UNDER POINT
NUMBER ONE. IT ALSO INCLUDES
EPIDEMIOLOGICAL AND BEHAVIORAL
STUDIES AS WELL AS OUTCOMES
RESEARCH AND HEALTH SERVICES
RESEARCH AND ALSO INCLUDES
INFORMATION FROM CLINICAL
RESEARCH WHERE THEY'RE CONDUCTED
EITHER BY GRANTEE WHO IS REPORT
IT ANNUALLY IN THEIR ANNUAL
RESEARCH PERFORMANCE PROGRESS
REPORT.
OR CONTRACTS IN THE INTERMURAL
PROGRAM RESEARCHERS WHO REPORT
ANNUALLY THROUGH THEIR
MECHANISMS. NCI'S PORTFOLIO FOR
THIS REPORT INCLUDES STUDY
SUPPORTED BY THE FOLLOWING NCI
DIVISIONS AND CENTERS AS LISTED
ON THE SLIDE. SO OBVIOUSLY WE
REPORT EVERYTHING RELATED TO
INTRAMURAL RESEARCH AS WELL AS
EXTRAMURAL RESEARCH DONE BY THE
MAJOR, FOUR MAJOR DIVISIONS OF
CLINICAL RESEARCH AT THE NCI BUT
ALSO FROM ALL THE CENTERS AT THE
NCI AS WELL AND YOU SEE ALL
THOSE LISTED ON THE RIGHT-HAND
SIDE OF THE SLIDE. NEXT SLIDE,
WE DO HAVE SOME STRATEGIES FOR
ENSURING COMPLIANCE AND THERE'S
A LOT OF TRAINING THAT GOES WITH
THE STAFF HERE, THE PROGRAM
STAFF AS WELL AS WITH THE
INVESTIGATORS TO MAKE SURE THAT
WE CAN PROVIDE AS ACCURATE
INFORMATION AS POSSIBLE PER THE
SYSTEM THAT IS IN PLACE. SO
THAT'S DONE THROUGH PEER REVIEW
FIRST WHERE REVIEWERS ACTUALLY
EVALUATE THE APPLICATIONS FOR
APPROPRIATENESS OF THE INCLUSION
PLANS AND ANALYSES AND THE
PROGRAM STAFF WORK WITH TIN VEST
GATORS TO RESOLVE ANY ISSUES
BEFORE ANY GRANT IN CASE OF
CONTRACTS.
ARE FUNDED. WE ALSO WANT TO
CONTINUING BASIS WITH THE
PROGRAM STAFF, MONITOR
ENROLLMENT AND PROGRESS FOR ALL
THE CLINICAL RESEARCH AS
NECESSARY. AND THEN THE GRANTS
MANAGEMENT STAFF ALSO ENSURE
TERMS AND CONDITIONS ARE
INCLUDED. IN THE AWARD FOR THE
FUNDING OF A GRANT. FOR THE
INTRAMURAL PROGRAM, THE
INTRAMURAL INVESTIGATORS PROVIDE
THEIR INCLUSION PLANS DURING
SCIENTIFIC REVIEW AT THE CCR AND
THEN THE ENROLLMENT PROGRESS IS
ALSO REVIEWED AS PART OF THEIR
INTERNAL IRB REVIEW WITH ANY
ISSUES RESOLVED LAST BUT NOT
LEAST THERE'S REGULAR INCLUSION
TRAINING PROVIDE TO ALL PROGRAM
AND REVIEW STAFF AT THE NCI.
NEXT SLIDE. THERE ARE HOWEVER
SOME KEY LIMITATIONS WITH THE
DATA THAT WE'LL PRESENT THIS
MORNING FROM THE TRIENNIAL
REPORT THIS PRESENTATION DOES
COVER JUST THE ENROLLMENT DATA
FOR THE FISCAL YEARS FY 2022-24
AS I SAID, THERE ARE SOME
LIMITATIONS SO I AM JUST GOING
TO EXPLAIN SOME AS WE PRESENT
THE DATA. THE WHOLE REPORT IN
THE SYSTEM IS INTENDED TO GIVE A
BROAD OVERVIEW OF THE GENERAL
INCLUSION TRENDS. BUT IT'S NOT
A PRECISE COUNT OF THE ACTUAL
TRIALS OR PARTICIPANTS PER SE.
THAT'S DONE AT THE MORE DETAILED
LEVEL WITHIN THE PROGRAMS, SO IF
WE'RE ON THE PARTICULAR CLINICAL
RESEARCH GRANTS OR CONTRACTS SO
WHAT YOU WILL SEE IS A MANDATED
SERIES OF TABLES THAT WERE
REQUIRED TO REPORT TO THE NIH
THOSE INCLUDE SOMETHING WE
CALLED INCLUSION DATA RECORDS.
THEY DON'T REALLY REPRESENT AN
ACCOUNT OF TOTAL STUDIES OR
TRIALS. SO MULTIPLE RECORDS
COULD BE SUBMITTED FOR A SINGLE
TRIAL THAT USUALLY OCCURS WHEN A
TRIAL IS CONDUCTED BOTH IN THE
U.S. AND INTERNATIONALLY.
BECAUSE WE HAVE TO REPORT ON
INCLUSION SEPARATED FROM
DOMESTIC ENROLLMENT AND
INTERNATIONAL ENROLLMENT. SAME
THING CAN HAPPEN IN TERMS OF THE
INCLUSION DATA, DON'T
NECESSARILY REPRESENT THE
ENROLLMENT FOR A SINGLE YEAR.
THE DATA ACTUALLY REPRESENT
CUMULATIVE REPORTS ON THAT
RESEARCH PROJECT OR TRIAL BY THE
GRANTEES AND CONTRACTORS IN
INTRAMURAL INVESTIGATORS THAT
DURING THE ENTIRE SPAN OF THEIR
PROJECT RATHER THAN IN A SINGLE
YEAR WHAT WE'RE ACCOUNTING IS
FOR ALL ACTIVE CLINICAL RESEARCH
PROJECTS WE'RE LOOKING AT THE
CUMULATIVE ENROLLMENTS TO THAT
PROJECT WITHIN EACH OF THOSE
FISCAL YEARS. THE LAST ITEM
THAT PROBABLY IS NOT AS RELEVANT
IN THIS TRIENNIAL REPORT IS THAT
GRANTS ARE RECOMPETED IN A
FISCAL YEAR, THEY'RE NOT
INCLUDED IN THE DATA FOR THAT
YEAR.
SO IF WE HAVE VERY LARGE
CLINICAL TRIALS NETWORK
PROGRAMS, FOR EXAMPLE, THAT ARE
BEING RECOMPETED IN A PARTICULAR
FISCAL YEAR BECAUSE THEY'RE
BEING RECOMPETED AND WE DON'T
ACTUALLY KNOW WHAT THE DATA
ENROLLMENT WILL BE FOR THAT
YEAR.
THEY'RE NOT INCLUDED IN THE
REPORT. THAT HAPPENED IN OUR
LAST TRIENNIAL REPORT BUT WE
DON'T HAVE ANY LARGE PROGRAMS
PER SE THAT ARE NOT BEING RE --
ARE BEING RECOMPETED BETWEEN FY
22-24 SO WE DON'T HAVE THAT
DEFICIENCY IN THIS TRIENNIAL
REPORT AND LAST BUT NOT LEAST,
CHARTS THAT YOU MAY SEE IN THE
SEPARATE REPORT OR IN THE SLIDES
MAY NOT EXACTLY ADD UP TO 100%
BUT THAT'S DUE TO NORMAL
ROUNDING ERROR. NEXT SLIDE,
PLEASE. SO TO START WITH IF WE
LOOK AT THE INCLUSION RECORDS
AND ENROLLMENT NUMBERS FOR ALL
CLINICAL RESEARCH YOU CAN SEE
THOSE LAID OUT BY FISCAL YEAR.
THERE WAS A SLIGHT INCREASE IN
THE NUMBER OF I.E.R RECORDS,
AGAIN, THAT'S NOT THE NUMBER OF
STUDIES PER SE.
IT'S THE NUMBER OF RECORDS WE
GOT FROM THEIR VARIOUS STUDIES
DEPENDING ON HOW THEY WERE
COMPOSED. YOU ALSO SEE THE
TREND IN TOTAL ENROLLMENT. AND
JUST TO POINT OUT THAT WENT DOWN
SLIGHTLY IN FY24 AND THE REASON
FOR THAT WAS THAT THERE WERE
SEVERAL LARGE STUDIES THAT WERE
COHORT STUDIES. AND IN ONE CASE
AN INTRAMURAL PROGRAM THAT HAD
MORE THAN 500,000 PARTICIPANTS
THAT CLOSED IN FY 23 SO THAT'S
NOT REPRESENTED IN FY24 SO
WITHIN THAT SHORT SHAME OF --
FRAME OF FOUR YEARS YOU'LL SEE
THE INCREASES AND DECREASES THAT
ARE RELATED TO ONE LARGE TRIAL
HAVING CHANGED THE COMPOSITION
WITHIN THAT THREE YEAR PERIOD.
YOU ALSO SEE THE BREAKDOWN BY
U.S. ONLY ENROLLMENT. AND
APPROXIMATELY FOR ALL OUR
CLINICAL RESEARCH ANYWHERE FROM
85-86% OF PATIENTS DO COME FROM
THE UNITED STATES. NEXT SLIDE,
PLEASE. SO WHEN WE FIRST LOOK
AT THE INCLUSION DATA FOR ALL
CLINICAL RESEARCH STUDIES, IF WE
BREAK THAT DOWN BY SEX, YOU CAN
SEE IT FOR THE THREE INDIVIDUAL
FISCAL YEARS HERE. IT'S BEEN
FAIRLY STABLE. OVER THIS THREE
YEAR PERIOD OF TIME AND REFLECTS
THE NUMBER OF PATIENTS OF A
PARTICULAR SEX WHO ARE ENROLLED
IN THE VARIOUS CLINICAL RESEARCH
STUDIES. NEXT SLIDE, PLEASE.
DO THE SAME THING WHEN WE BREAK
DOWN BY SEX BUT WE TRY TO
EXCLUDE SINGLE SEX STUDIES.
HOWEVER, THE WAY SINGLE SEX
STUDIES ARE DEFINED IT'S ANY
STUDY THAT DOES NOT HAVE SIMPLY
ALL WOMEN OR ALL MEN IN THE
TRIAL OR THE CLINICAL RESEARCH
PROJECT AT THE TIME OF
REPORTING. SO YOU CAN SEE IT'S
A FAIRLY EVEN SPLIT ABOUT 50/50
WITH A LITTLE BIT OF UNKNOWN OR
NON REPORTED FOR SOME SMALLER
STUDIES ACROSS THE THREE FISCAL
YEARS. NEXT SLIDE, PLEASE.
WE ALSO LOOK AT THE INCLUSION
DATA FOR ALL CLINICAL RESEARCH
BY ETHNICITY AND YOU SEE THIS
BROKEN DOWN BY HISPANIC OR
LATINO. VERSUS NON-HISPANIC OR
LATINO OR OTHER UNKNOWN OR NON
REPORT AND WHAT THIS REALLY
REFLECTS IS WE DID HAVE A BIG
CHANGE WHERE A LARGE INTRAMURAL
COHORT STUDY CONTRIBUTED
SIGNIFICANTLY TO THE CHANGES IN
OVERALL ETHNICITY PARTICULARLY
IN FISCAL YEAR 2024 WHEN IT WAS
A VERY LARGE STUDY THAT WAS
MOSTLY NON-HISPANIC AND LATINO
THAT LARGE INTRAMURAL STUDY THAT
WAS OVER 500,000 PATIENTS IT WAS
AN ELDERLY POPULATION MOSTLY IN
THE UNITED STATES AND IT WAS
PRIMARILY WHITE. SO ONCE THAT
STUDY WAS NO LONGER PART OF THE
REPORTING IN THESE THREE YEAR
PERIOD, YOU CAN SEE THAT OUR
NUMBER OF NON-HISPANIC AND
LATINOS DECREASED ONCE THAT
TRIAL CLOSED AT THE END OF FY 23
AND WAS NOT REPORTED IN FY24.
NEXT SLIDE, PLEASE. WE ALSO
BREAK DOWN THE INCLUSION DATA BY
RACE. YOU SEE THE VARIOUS OMB
CATEGORIES OF RACE LISTED ON THE
RIGHT-HAND SIDE OF THE SLIDE AND
THEN IN ALL THREE FISCAL YEARS,
YOU SEE THE BREAKDOWN IN EACH OF
THOSE PERCENTAGES PER THE
DEFINITIONS THAT ARE PROVIDED BY
OMB FOR THIS INCLUSION REPORT.
AGAIN, WE FOUND THAT WHEN WE
TOOK, WE SAW THAT THIS LARGE
INTRAMURAL COHORT STUDY
CONTRIBUTED SIGNIFICANTLY TO THE
CHANGES IN OVERALL RACE IN FY
2024 WHEN IT CLOSED SO THAT THE
NUMBER OF WHITE PATIENTS
ACTUALLY DID DECREASE THERE
BECAUSE THAT WAS A LARGE ELDERLY
POPULATION MOSTLY WHITE WHO,
THAT WAS CLOSED AT THE END OF FY
2023. NEXT SLIDE, PLEASE. HERE
YOU SEE THE INCLUSION DATA WHERE
WE COMBINED RACE AND ETHNICITY
AND, AGAIN, THE TREND IS USUALLY
FAIRLY STABLE BETWEEN FY 22 AND
FY 23 THE BIG JUMP UP IN FY 24
DOES REFLECT THE LARGE
INTRAMURAL STUDY THAT CLOSED.
NEXT SLIDE, PLEASE. HERE WE
WERE ASKED LAST TIME WHEN WE
PRESENTED THE TRIENNIAL REPORT
TO MAYBE COMPARE WHAT WE HAD IN
THE TRIENNIAL REPORT AGAINST AT
LEAST THE DATA, THE ESTIMATED
NUMBER OF CASES PER ETHNICITY
AND RACE AT THE TIME OF
DIAGNOSIS. SO WE HAVE PROVIDED
THAT HERE. IT IS AN IMPERFECT
COMPARISON IN A SENSE THAT THE
INCLUSION DATA YOU'RE SEEING IS
GOING TO INCLUDE U.S. AND
INTERNATIONAL PATIENTS WHO
PARTICIPATED -- OR PARTICIPANTS
WHO PARTICIPATED IN CLINICAL
RESEARCH OR TRIALS. BUT
OBVIOUSLY ABOUT, ALMOST 90% OF
THOSE PARTICIPANTS AND PATIENTS
WILL ACTUALLY HAVE BEEN FROM THE
U.S. COMPARED TO WHAT YOU SEE IN
SEER WHICH IS FAIRLY COMPARABLE.
WE ALSO DO IT NOT JUST BY RACE,
BUT ALSO BY ETHNICITY. IN TERMS
OF WHETHER PATIENTS WHO ARE
HERETO DEEMED, OR REPORTED
THEMSELVES TO BE HISPANIC OR
LATINO. NEXT SLIDE, PLEASE.
THERE ARE ALSO SPECIAL
CONSIDERATIONS IN THE ACT THAT
DRIVES THE REQUIREMENT FOR
MONITORING AND REPORTING ON
ADHERENCE TO THIS POLICY. FOR
PHASE THREE CLINICAL TRIALS.
AND SO WHAT THAT PART OF THE ACT
WANTED TO MAKE CONGRESSIONAL ACT
WANTED TO MAKE SURE IS THAT OUR
TRIALS ARE DESIGNED TO PERMIT
VALID ANALYSIS OF GROUP
DIFFERENCES BASED ON RACE, SEX,
AND ETHNICITY UNLESS THERE WAS
CLEAR REASON THAT SUCH
DIFFERENCES WERE UNLIKELY TO BE
SEEN. SO I WON'T READ THE
DIFFERENT IN ADDITION HERE OF
NIH DEFINED PHASE THREE CLINICAL
TRIAL BUT IT DOES INCLUDE ANY
KIND OF CLINICAL TRIAL THAT IS
TRYING TO, THAT OBVIOUSLY
INVOLVES HUMAN SUBJECTS AND IS
REALLY EVALUATING AN
EXPERIMENTAL INTERVENTION AND
USUALLY IN COMPARISON WITH A
STANDARD OR CONTROLLED
INTERVENTION, MAY OR MAY NOT BE
RANDOMIZED BUT IT WOULD COMPARE
AT LEAST TWO OR MORE EXISTING
TREATMENTS. THE AIM OF SUCH
INVESTIGATION IS TO PROVIDE THE
EVIDENCE FOR CONSIDERATION AND
CHANGING STANDARD OF CARE FOR
PARTICIPANTS AND SO WE WANT TO
MAKE SURE IT'S AS
GENERALIZABILITY AS POSSIBLE.
AND SO BECAUSE OF THESE
ADDITIONAL REQUIREMENTS, NCI AND
NIH DO CONDUCT ANALYSES ON THE
INCLUSION DATA FROM THESE
TRIALS. WHAT WE'RE REPORTING
HERE IS THE SAME INFORMATION
THAT WE JUST REPORTED FOR ALL
CLINICAL RESEARCH AND NOW IT'S
JUST FOR THE, THOSE STUDIES AND
PROJECTS THAT FIT THE DEFINITION
OF NIH DEFINED PHASE THREE
CLINICAL TRIALS. SO YOU SEE THE
SAME ISSUES IN TERMS OF THE
RECORDS THAT ARE REPORTED, THE
TOTAL ENROLLMENT, THE U.S.
ENROLLMENT AND YOU CAN SEE THAT
THE PERCENTAGE OF U.S.
ENROLLMENT RANGE FROM 76.5% IN
2024 BUT STARTED AT 82.2% IN
2022. WE DO WANT TO POINT OUT
THAT THE HIGHER PROPORTION OF
NON-U.S. PARTICIPANTS LARGELY
DROVE THE DECREASE IN U.S.
ENROLLMENT BECAUSE OF THE LARGE
SCREENING CANCER STUDY. MUCH OF
WHICH WAS DONE INTERNATIONALLY.
NEXT SLIDE, PLEASE, HOWEVER
WE'VE -- HERE WE'VE TAKEN THE
TRIALS AND DONE THE ANALYSIS BY
SEX.
YOU SEE THE LARGE NUMBER OF
FEMALE PARTICIPANTS THAT YOU SEE
INCREASING UP TO 81% IS DRIVEN
LARGELY BY SIGNIFICANT
ENROLLMENT TO A VERY LARGE
BREAST CANCER SCREENING STUDY.
NEXT SLIDE, PLEASE. WE HAVE
DONE IT HERE AS WELL. LOOKED AT
SEX BUT WE'VE TRIED TO EXCLUDE
THOSE STUDIES THAT WERE JUST
SINGLE SEX STUDIES. THE
DIFFICULTY WITH THIS ANALYSIS IN
THE PARTICULAR SYSTEM THAT IF WE
HAVE A LARGE BREAST CANCER TRIAL
AND IT DOES ALLOW MALE
PARTICIPANTS BECAUSE THERE IS A
SMALL PERCENTAGE OF MEN WHO DO
GET BREAST CANCER AND THEY
ACTUALLY ENROLL IN THAT TRIAL
THEY'LL STILL BE INCLUDED THAT
BREAST STUDY WILL STILL BE
INCLUDED IN THIS ANALYSIS SO
THAT'S WHY YOU DO SEE SUCH A
LARGE PERCENTAGE OF WOMEN IN
FY24 AGAIN BECAUSE WE HAD LARGE
BREAST CANCER TRIALS BUT THEY
DID INCLUDE SOME MEN. NEXT
SLIDE, PLEASE. THIS IS BY
ETHNICITY AND AGAIN, YOU SEE A
DIFFERENCE BETWEEN FY 2022 AND
FY 2024 THERE IS A HIGHER
PERCENTAGE OF HISPANIC OR LATINO
PATIENTS. AGAIN, LARGELY DRIVEN
BY SIGNIFICANT LATIN AMERICAN
ENROLLMENT TO LARGE CANCER
SCREENING TRIAL THAT HAPPENED
DURING THIS PERIOD. NEXT SLIDE,
PLEASE. WE HAVE TAKEN THE
INFORMATION FROM THE CLINICAL
TRIALS AND BROKEN IT DOWN HERE
BY RACE AND SO YOU CAN SEE THE
INFORMATION AGAIN AND IT'S BEEN
FAIRLY STABLE OVER THESE YEARS
ALTHOUGH WE TRIED TO DO A BETTER
JOB PARTICULARLY IN CLINICAL
TRIALS MAKING SURE THAT TUN
KNOWN AND NON REPORTED CATEGORY
IS AS SMALL AS POSSIBLE BUT
OCCASIONALLY IT'S A CONSTANT
PROCESS OF TRYING TO TRAIN
PATIENTS AND PARTICIPANTS AS
WELL AS THE CLINICAL STAFF WHO
ARE PARTICIPATING IN COLLECTING
THE DATA TO MAKE SURE AS MUCH AS
POSSIBLE WE CAN GET THIS
INFORMATION.
NEXT SLIDE, PLEASE. HERE WE
HAVE SHOWN THE POPULATION FOR
THE PHASE THREE CLINICAL TRIALS
BY RACE AND ETHNICITY COMBINED
AGAIN THE BIG JUMP UP IN MORE
MINORITY PARTICIPANTS BY RACE
AND ETHNICITY IN FY 23 AND THEN
FY24 IS REALLY LARGE LY DRIVEN Y
A LARGE BREAST CANCER SCREENING
TRIAL. THERE ARE ALSO OTHER
SCREENING TRIALS THAT EFFECT
THIS IN THAT REGARD AS WELL BUT
IT WAS MAINLY IN THIS THREE YEAR
PERIOD DRIVEN BY THAT LARGE
CANCER SCREENING TRIAL. NEXT
SLIDE. THIS IS BROKEN DOWN WITH
THE COMPARISON TO SEER CENSUS
POPULATION ESTIMATES. AND SO
YOU CAN SEE THE COMPARISON
BETWEEN THE PHASE THREE CLINICAL
TRIALS INCLUSION DATA. BY RACE
ON THE LEFT-HAND SIDE OF THE
SLIDE. AND ON THE RIGHT HAND
SIDE YOU SEE IT BROKEN DOWN BY
HISPANIC ETHNICITY. AND YOU SEE
THE LARGE INTERNATIONAL BREAST
CANCER SCREENING TRIAL WE HAD A
HIGHER PROPORTION OF HISPANIC
AND LATINOS BECAUSE IT WAS
LARGELY DRIVEN BY THAT. NEXT
SLIDE. SO WE JUST LIKE TO SAY
THANK YOU TO ALL THE NCI STAFF
AND PARTICULARLY TO GRACE
MICHIGAN WHO HEADS UP THE TEAM
THAT PUTS ALL THIS INFORMATION
TOGETHER TO THE STAFF AND
SUPPORT INVESTIGATORS WHO
ENSURED THE ACCURACY OF THE
INCLUSION DATA THAT IS PRESENTED
IN THE TRIENNIAL REPORT. THANK
YOU.
>> DR. FRIESE: SO MUCH
DR. MOONEY, WE APPRECIATE THE
WORK OF YOUR TEAM AND THANK YOU
FOR YOUR RESPONSIVENESS AND
COMPARING THE DATA TO THE SEER
DATA. WE'RE A LITTLE BIT BEHIND
SCHEDULE SO I WILL SAY, WE'LL
TAKE ONE QUESTION AT THIS POINT
SO WE CAN KEEP THE AGENDA MO
MOVING. FRED, PLEASE?
>> FRED: THANK YOU DR. MOONEY
FOR PRESENTING THESE VERY
HELPFUL DATA. I AM GLAD TO SEE
THAT THE INCLUSION REPORTING IS
MANDATED BY LAW AND WE CANNOT
OVEREMPHASIZE THE IMPORTANCE OF
INCLUSION DATA FOR THE
EFFECTIVENESS OF THE THERAPIES
THAT COME OUT OF THESE CLINICAL
TRIALS AND THE PREVENTIVE
MEASURES THAT ARE DESIGNED FROM,
FROM THIS. THE QUESTION THAT I
HAVE IS HOW IS, HOW IS THIS
COMPLIANCE EVALUATED IN THE
NEWER FRAMEWORK OF PEER REVIEW
THAT HAS BEEN REORGANIZED TO THE
THREE FACTORS? SNOON IT'S STILL
PART OF THAT REVIEW AND THE I
FORGET THE THREE FACTORS OFF THE
TOP OF MY HEAD. IT USED TO BE
SEPARATE CRITERIA FOR THE, WHEN
WE HAD THE FIVE FACTORS AND WE
HAD ADDITIONAL INFORMATION THAT
WAS INCLUSION BUT NOW IN THE
THREE FACTORS, DATA ON INCLUSION
IS INCLUDED AS I UNDERSTAND IT,
WITHIN ONE OF THOSE THREE
FACTORS. AND SO IT'S NOT THAT
IT HAS DISAPPEARED AT ALL, IT'S
STILL PART OF PEER REVIEW AND IT
SHOULD STILL BE INCLUDED.
>> DR. FRIESE: VERY BRIEFLY. I
SEE YOUR QUESTION, WE'LL LET HER
ANSWER THAT OFFLINE.
>> I THINK ONE THING TO START
CONTEMPLATING IS HOW WE'RE
ACTUALLY GOING TO DO SOMETHING
LIKE THIS MOVING FORWARD. I
THINK IT'S INEVITABLE THAT WE'RE
LOOKING AT PRIVATIZATION OF MANY
OF THESE TYPES OF CLINICAL
TRIALS AND MANY, MANY MORE
INDUSTRY SPONSORED CLINICAL
TRIALS AND YOU'RE NOT GOING TO
HAVE A MECHANISM FOR ACCOUNTING
WHERE THESE PATIENTS ARE COMING
FROM, THEIR BACKGROUND, ET
CETERA, BECAUSE THEY'RE NOT
GOING TO BE NECESSARILY NCI AND
THAT'S OBVIOUSLY A LIMITATION OF
THE DATASET THAT YOU HAVE AT
HAND SO HAS THERE BEEN ANY
DISCUSSION WITH REGARDS TO HOW
THIS MANDATE IS GOING TO WORK
MOVING FORWARD? BECAUSE AGAIN
THE VAST MAJORITY IS GOING TO
SHIFT TO PRIVATE.
>> I THINK OBVIOUSLY THE MANDATE
HERE FROM THE NIH IS FOR
PUBLICLY FUNDED NIH TRIALS SO IN
THAT SENSE, OBVIOUSLY WHATEVER
WE DO AT THE NCR OR NIH WILL
STILL REPORT THIS INFORMATION IN
TERMS OF PRIVATE CLINICAL TRIALS
I CERTAINLY KNOW THE FDA IS VERY
INTERESTED IN THIS INFORMATION
AND DOES ASK COMPANIES FOR THIS
INFORMATION IN PART OF THEIR
REVIEW AND DECISION-MAKING
PROCESS, EVEN IF THE TRIAL WAS
DONE COMPLETELY PRIVATELY. SO
THE EXTENT OF THAT, I AM NOT
BEING AT THE FDA I DON'T KNOW
THE EXTENT TO WHICH THEY REQUIRE
CERTAIN CATEGORIES BUT THEY
CERTAINLY ARE VERY INTERESTED IN
WHERE THE PATIENTS COME FROM AND
OBVIOUSLY THE SEX, RACE AND
ETHNICITY. THAT'S WHAT I CAN
SAY ABOUT THE PRIVATE SECTOR
SINCE I'M IN THE PUBLIC SECTOR.
>> YEAH, BUT THEY'RE PROBABLY
GOING TO HAVE TO PAY FOR THAT
MOVING FORWARD BECAUSE I CAN'T
SEE A COMPANY THAT IS PRIVATE
TURNING THAT OVER. THEY'RE
GOING TO HAVE TO COME UP WITH
SOME KIND OF FUNDING MECHANISM
TO SUPPORT COMPANIES DOING THAT.
>> DR. MOONEY: I WOULD HAVE TO
REFER TO THE REST OF HHS
REGARDING THAT AND STUDIES THAT
ARE IN THE PRIVATE SECTOR THAT
THEY HAVE TO REVIEW AND ASSESS.
>> DR. FRIESE: DR. MOONEY THANK
YOU AGAIN SO MUCH AND A FEW
QUESTIONS FOR YOU IN THE CHAT
THAT WILL BE HELPFUL FOR YOU AS
WELL. SO THE BOARD WILL NOW
CONSIDER ONGOING AND NEW
BUSINESS AND THE FIRST NEW
BUSINESS ITEM WE HAVE, OH,
EXCUSE ME, I HAVE TO BACK UP AND
WE HAVE TO VOTE ON DR. MOONEY'S
REPORT, APOLOGIES. SO I WOULD
LIKE TO ASK A BOARD MEMBER TO
MAKE A MOTION TO ACCEPT
DR. MOONEY'S REPORT.
>> I'LL MAKE A MOTION. SNEEZE
>> DR. FRIESE: MOVED AND
SECONDED. ANY DISCUSSION?
OKAY. THANK YOU. ANY NAYS TO
ACCEPTING THE REPORT? ANY
ABSTENTIONS? PAULETTE.
>> YOU'RE GOOD TO GO, IT'S
UNANIMOUS.
>> DR. FRIESE: THANK YOU.
THANKS SO MUCH. SO NOW THE
BOARD WILL CONSIDER ONGOING NEW
BUSINESS AND THE FIRST ITEM IS
TO ACCOMPESTABLISH THE AD HOC W
GROUP. THIS WAS SENT A DOCUMENT
FOR YOUR CONSIDERATION ON
ESTABLISH AING WORKING GROUP TO
ADVISE THE NCI IN ITS
CONSIDERATION OF CONCEPTS AND
OTHER RELATED PROGRAMS. I WILL
PAUSE HERE TO SEE IF ANY
QUESTIONS TO THAT DOCUMENT THAT
YOU RECEIVED PRIOR TO THE
MEETING. OKAY HEARING NONE, WE
MUST VOTE AS A BOARD TO APPROVE,
DISAPPROVE --
>> SORRY, CHRIS. I JUST DIDN'T
GET MYSELF TURNED ON FAST
ENOUGH. SORRY I HAD SOME
QUESTIONS ABOUT WHAT, LIKE WHAT
THIS IS REPLACING. WHAT IS, I
NEED TO UNDERSTAND A LITTLE BIT
MORE BEHIND THIS IT FEELS LIKE
IT'S PERHAPS FIXING AN ISSUE BUT
I'M NOT SURE WHAT IT IS. CAN
SOMEONE SAY MORE ABOUT THE
GENESIS OF THIS.
>> AS YOU MAY BE AWARE THE
ADMINISTRATION HAS WANTED TO
DECREASE THE NUMBER OF
COMMITTEES AND SO TO THAT END,
THEY HAVE ELIM LILIM LILIMIT -
THREE OF OUR COMMITTEES AND WE
CLEARLY APPRECIATE THE ABILITY
OF THE NCAB TO LOOK AT NEW
CONCEPTS AND CONSIDER THEM. BUT
THE, YOU KNOW, ESSENTIALLY, THE
BOARD OF SCIENTIFIC ADVISORS
USED TO HAVE THAT AS PART OF ITS
REMIT. SO WE THOUGHT IT COULD
BE USEFUL TO HAVE A LARGER GROUP
AVAILABLE FOR REVIEWING NEW
CONCEPTS. AND JUST AS AN
EXAMPLE, WE STILL HAVE THE
TRANSITIONAL ADVISORY COMMITTEE.
SO IT MIGHT BE REASONABLE TO
CONSIDER APPOINTING SOME MEMBERS
OF THAT GROUP OBVIOUSLY PEOPLE
FROM THE NCAB IF THEY WANTED TO
BE PART OF THIS WORKING GROUP
TOTALLY APPROPRIATE. BUT IT
GIVES IN PRINCIPLE MORE
FLEXIBILITY TO HAVE A WIDER
RANGE OF REPRESENTED EXPERTISE.
>> THANK YOU.
>> DR. FRIESE: THANKS SO MUCH
FOR THE QUESTION AND ANSWER
KAREN AND DOUG, ANY OTHER
QUESTIONS ON THIS PROPOSAL?
>> I HAVE ONE QUESTION ON THIS,
DOES THIS GROUP HAVE A THE
ABILITY TO VOTE ON CONCEPTS FOR
ACCEPTING THEM? AS WE HAVE SEEN
WITH DSA OR WOULD THE REVIEW BE
DIFFERENT, WITH THE REVIEW IN
RECOMMENDATION VERSUS IN VOTING
TO ACCEPT.
>> THE VOTE WOULD BE DONE BY THE
NCAB. THE PERSON ON THE WORKING
GROUP WILL BRING FORWARD THEIR
RECOMMENDATIONS.
>> DR. CARPTEN THE
RECOMMENDATIONS, OKAY, GREAT,
THANKS, PAULA.
>> DR. LOWY: THIS WOULD REST
WITH THE NCAB BASED ON THE
ADVISE IF YOU WILL OF THE
WORKING GROUP. DOES THAT SOUND
OKAY?
>> YOU'RE GOOD TO GO, DOUG.
>> DR. FRIESE: OKAY WE HAVE KIM
AND WE HAVE KAREN AND THEN I'M
GOING TO ASK TO CALL THE
QUESTION IF I MAY. SO KIM,
PLEASE, BE BRIEF IF YOU CAN,
THANK YOU.
>> IF I TALK ABOUT HOW MEMBERS
WILL BE SELECTED WHAT WOULD THE
PROCESS BE FOR THAT?
>> THE PROCESS WILL BE THE SAME
AS WITH ANY OTHER WORKING GROUPS
THE NCI LEADERSHIP WILL COME UP
WITH RECOMMENDATIONS AND ET
CETERA. AND THOSE INDIVIDUALS
THAT THEY RECOMMEND WILL
APPROACHED TO ASCERTAIN THE
INTEREST IN PARTICIPATING.
>> THANK YOU.
>> DR. FRIESE: KAREN?
>> CHRIS, THAT WAS MY QUESTION.
>> DR. FRIESE: THANK YOU SO
MUCH. COULD I HAVE A MOTION,
PLEASE TO ESTABLISH A WORKING
GROUP?
>> SO MOVED.
>> DR. FRIESE: JOHN, THANK YOU.
>> SECOND.
>> SECOND, KAREN, THANK YOU.
ANY FURTHER DISCUSSION? OKAY
I'LL ASK FOR THE NAYS. ANY N
NAYS? ANY ABSTENTIONS?
>> IT'S UNANIMOUS.
>> THANKS PAULA. THANK YOU,
ALL, WE'RE IN THE LIGHTNING
ROUND HERE BEFORE WE ADJOURN THE
OPEN SESSION I, IF WE CAN GO
VERY, VERY QUICKLY, IF YOU HAVE
AN AGENDA ITEM FOR A FUTURE
MEETING. IF YOU COULD JUST LIST
IT, SPEAK UP AND LIST IT. WE
WILL RECORD THOSE AND IF TOPICS
COME TO YOU LATER, PLEASE SEND
THEM TO MYSELF OR PAULETTE FOR
FURTHER CONSIDERATION. BUT ANY
AGENDA ITEMS YOU'D LIKE TO PUT
ON THE LIST RIGHT NOW?
>> DR. CARPTEN IT'D BE GREAT TO
GET A BETTER UNDERSTANDING OF
SORT OF THE INTERNAL PROCESSES
THAT ARE IN PLAY NOW FOR
REVIEWING MECHANISMS AND NOTICES
OF FUNDING OPPORTUNITY THAT MAY
BE PULLED DOWN.
I MEAN, WE'RE SEEING IT AND
WE'RE HEARING ABOUT IT BUT IT
WOULD BE GREAT TO UNDERSTAND
THAT PROCESS A BIT BETTER.
>> DR. FRIESE: THANK YOU. OTHER
TOPIC ITEMS? OKAY WELL, AGAIN,
IF YOU HAVE ITEMS FOR FUTURE
AGENDA, FEEL FREE TO PASS THEM
ONTO PAULETTE OR TO MYSELF. AND
WE'RE HAPPY TO ADDRESS THOSE.
THERE BEING NO --
>> DR. CARPTEN ONE MORE
QUESTION, CHRIS, I APOLOGIZE, I
WAS WONDERING IF WE WILL SORT
OF, WHEN WE CONVENE AGAIN LATER
WILL WE HAVE THE LEGISLATIVE
REPORT? WILL THAT CONTINUE SORT
OF THE, IN FUTURE MEETINGS WILL
THE AGENDA BE SIMILAR TO WHAT
IT'S BEEN PREVIOUSLY? I KNOW
WE'RE HAVING SORT OF A, SORT OF
ABBREVIATED MEETINGS TODAY BUT I
AM WONDERING, MEETINGS LATER
THIS YEAR, WILL WE HAVE A
LEGISLATIVE REPORT IN WILL WE GO
BACK TO THE STANDARD AGENDA OR
DO WE HAVE AN IDEA OF WHAT THE
AGENDAS WILL LOOK LIKE GOING
FORWARD?
>> DR. LOWY: TO ME THIS IS TBD.
TA MEANS TO BE DETERMINED.
AND --
>> DR. CARPTEN I HAVE TO ASK.
>> DR. LOWY: YOU'RE SO FAR
OUTSIDE THE BELTWAY, EXCUSE ME.
WHAT YOU MAY NOT BE AWARE OF IS
THAT THE NIH IS TRYING TO REALLY
BRING TOGETHER THE LEGISLATIVE
ACTIVITIES UNDER THE NIH, THIS
IS CALLED CENTRALIZATION, HOW
THAT WILL PLAY OUT AND WHAT IT
WILL LOOK LIKE REMAINS TO BE
DETERMINED. THEY'RE STILL HERE
WITH US. BUT WE'RE JUST NOT
QUITE SURE OF WHAT THE GROUND
RULES ARE GOING TO BE, OKAY?
>> DR. CARPTEN THANKS. I'M
SORRY TO BE THAT GUY. I
APPRECIATE IT.
>> DR. LOWY: I LIKE TO GIVE
PEOPLE AS UP-TO-DATE INFORMATION
AS WE HAVE BUT REALLY THIS IS
WHAT WE OFTEN REFER TO AS A WORK
IN PROGRESS.
>> DR. CARPTEN THANKS, DOUG
>> DR. FRIESE: THANK YOU ALL
VERY MUCH. SO THERE BEING NO
FURTHER BUSINESS, THE OPEN
MEETING IS ADJOURNED. THIS
CONCLUDES THE OPEN SESSION.
THERE WILL BE A BRIEF BREAK ONLY
BOARD MEMBERS AND DESIGNATED NCI
STAFF SHOULD REMAIN. ALL OTHERS
SHOULD SIGN OFF NOW AND THOSE
USING THE CLOSED SESSION SHOULD
SIGN ON IN THE NEXT FIVE
MINUTES. THE CLOSED SESSION
WILL BEGIN PROMPTLY AT 12:05.
THANK YOU, ALL, FOR JOINING US
TODAY AND I WILL SEE THE NCAB
MEMBERS SHORTLY.