>>WELCOME TO CTAC MEETING
FOR PARTNERSHIPS IN THE
ONCOLOGY CENTER OF THE
EXCELLENCE WHO IS ATTENDING AS
OUR FDA REPRESENTATIVE IN
THE PLACE OF Dr. PASTOR TODAY.
SO, THERE ARE A FEW HOUSEKEEPING
ITEMS THAT I WILL NEED TO READ
TO YOU BEFORE WE DIVE INTO THE
MEAT OF THE SESSION.
FIRST, I'D LIKE TO JUST REMIND
THE COMMITTEE MEMBERS THAT YOU
MUST -- WHEN YOUR PARTICIPATION
AND DELIBERATIONS ON A PRODUCT,
PROGRAM OR SPECIFIC MATTERS
WOULD CONSTITUTE A CONFLICT OF
INTEREST OR CREATE THE
APPEARANCE OF ONE AND ADVISE THE
EXECUTIVE SECRETARY Dr.
PRINCIPLE DAVILLE AND ABSTAIN
FROM ANY PAPTATION IN DISCUSSION
OR ACTION REGARDING THAT MATTER.
IN LIGHT OF THE CURRENT POLICIES
GOVERNING CONFLICT OF INTEREST
AND BASED ON SPECIAL GOVERNMENT
EMPLOYEES, WHICH TURNING ALL
DISCUSSIONS OF MATTERS THAT CAN
IMPACT THE STATUS OF THOSE
HOLDINGS.
WE TRUST YOUR JUDGMENT IN THOSE
INSTANCES AND AND DURING THIS
MEETING A MINIMUM OF 11
APPOINTED MEMBERS MUST BE
PRESENT TO VOICE THEIR VOTES.
WE CURRENTLY HAVE SUCH A QUORUM
SO THAT SHOULD NOT BE A PROBLEM.
NEW MEMBERS, WHO AREN'T CURRENT
MEMBERS OF ANOTHER NCI ADVISORY
BOARD ARE NOT VOTING UNTIL
THEY'VE BEEN CLEARED BY THE NCI
ETHICS' OFFICE AND THE OFFICE OF
HUMAN RESOURCES.
FINALLY, MEMBERS OF PUBLIC WHO
MAY WISH TO EXPRESS THEIR VIEWS
REGARDING ANY ITEMS DISCUSSED
DURING THE MEETING, MAY DO SO IN
WRITING TO THE EXECUTIVE
SECRETARY WITHIN 10 DAYS OF THE
MEETING AND ANY WRITTEN
STATEMENTS BY MEMBERS OF THE
PUBLIC WILL RECEIVE CAREFUL
CONSIDERATION.
THIS MEETING IS BEING BROADCAST
AND IS CURRENTLY AVAILABLE TO
THE PUBLIC VIA THE NIH VIDEO
CAST WEBSITE.
THE BRED CAST WILL ALSO BE
ARCHIVED FOR VIEWING LATER.
AND I CALL EVERYONE'S ATTENTION
TO THE AGENDA WHERE THE DATES OF
FUTURE MEETINGS ARE LISTED AND
SEVERAL MEETING STAT DATES IN 2,
BELIEVE IT OR NOT WE'RE ALMOST
THERE, HAVE BEEN ADDED.
AND THEN FINALLY, THE CHATBOX
AND THE CHAT WILL BE USED FOR
QUESTIONS AND DISCUSSIONS AMONG
THE MEMBERS OF THE COMMITTEE TO
ASK A QUESTION OR MAKE A
COMMENT, SKATE YOU WOULD LIKE TO
ASK A QUESTION IN THE CHATBOX.
TO SEND YOUR QUESTION COMMENT TO
EVERYONE RATHER THAN A CERTAIN
PERSON IN THE CHATBOX AND I WILL
CALL ON MEMBERS SO WE CAN
CAPTURE YOUR COMMENTS IN THE
MEETING SUMMARY.
PLEASE STAY ON MUTE DURING THE
CALL UNLESS YOU ARE CALLED ON TO
SPEAK SO THAT WE DON'T HAVE A
LOT OF AMBIENT BACKGROUND NOISE.
OK, WITHOUT FURTHER ADIEU, OUR
FIRST WERE THE FOR VOTING IS TO
VOTE HOPEFULLY ACCEPT THE
MEETING SUMMARY FROM THE
MARCH 16th, CTAC MEETING.
I'D LIKE A MOTION TO ACCEPT.
>>SO MOVED.
>>THANK YOU.
AND TO WE HAVE A SECOND.
>>SECOND.
>>GREAT.
WOULD ANYBODY LIKE TO DISCUSS
ANY OF THE CONTENT OF THE
MEETING SUMMARY FROM EARLIER
THIS YEAR?
IF NOT, I'M GOING TO ASK WITH A
SHOW OF HANDS, IF ANYONE TUESDAY
NOT ACCEPT THE SUMMARY, SO WE'RE
LOOKING FOR THE NAYS HERE.
IS THERE ANYONE WHO DOES NOT
BELIEVE WE SHOULD ACCEPT THIS
SUMMARY?
THANK YOU.
AND IS THERE ANYONE WHO WISHES
TO ABSTAIN FROM THE VOTE, PLEASE
SHOW OF HANDS.
OK.
WE WILL CONSIDER THE MEETING
SUMMARY FROM MARCH 16th, 2022,
TO BE ACCEPTED.
ALL RIGHT.
I'D LIKE TO MOVE ONTO THE NEXT
AGENDA ITEM WHICH IS OUR NCI
DIRECTORS' REPORT AND I'D LIKE
TO WELCOME Dr. MONICABERTOLLI
AND FOR THE MEMBERS OF THE
COMMITTEE, WE'LL HAVE AMPLE TIME
FOR DISCUSSION WITH MONICA AFTER
HER REMARKS.
SO, ALL YOURS.
>>THANK YOU, NEIL.
THANK YOU SO MUCH.
I AM SO DELIGHTED TO BE HERE AND
TO SEE SO MANY FRIENDS.
I'VE BEEN IN THIS POSITION AS N
DISTRICT OR E.>>I'VE BEEN GRATL
THE COLLEAGUES AT NCI WHO ARE
TRYING TO GET ME UP TO SPEED ON
AN INCREDIBLY COMPLEX AND DEEP
ORGANIZATION AND YOU KNOW, SO,
BE PATIENT WITH ME, I'M STILL
VERY MUCH IN THE LEARNING PHASE.
THE GOOD THING ABOUT THAT IS I'M
VERY MUCH IN THE LISTENING PHASE
AND THAT'S A LOT OF WHAT I WANT
TO DO HERE TODAY.
SHARE THOUGHTS WITH YOU ABOUT
SOME THINGS THAT I'VE LEARNED
AND ALSO HEAR FROM YOU.
SO, YOU KNOW, I'VE BEEN A MEMBER
OF THE EXTRAMURAL NCI COMMUNITY
AND YOU KNOW, THE FIRST THING
THAT I THOUGHT OF, ON TAKING ON
A JOB LIKE THIS, IS TO JUST GO
BACK TO CORE PRINCIPLES AND
THINK ABOUT WHY WE'RE ALL HERE.
BECAUSE YOU CAN IMAGINE, IT'S --
WE ALL GET BUFFETED BY THE WIND
WHEN WE'RE IN OUR JOB AND CORE
PRINCIPLES KEEP US GROUNDED IN
WHAT WE'RE HERE TO DO.
A COUPLE OF THOUGHTS, FIRST OF
ALL, RIGHT NOW, WE HAVE A
PRESIDENT, PRESIDENT JOE BIDEN,
WHO IS MAKING -- MADE ENDING
CANCER AS WE KNOW IT, A REALLY
SIGNATURE OBJECTIVE, WOW, THAT'S
AN AMAZING OPPORTUNITY FOR ALL
OF US WHO SHARE THAT GOAL.
AND WE WANT TO MAKE THE VERY
BEST USE OF THIS OPPORTUNITY.
AGAIN, CORE PRINCIPLES, WE'RE
HERE TO PREVENT CANCER WE'RE
HERE TO HELP EVERYONE WHO HAS
HAD OR HAS CANCER TO LIVE FULL
AND ACTIVE LIVES.
FREE FROM CANCER'S HARMFUL
EFFECTS.
THAT IS REALLY WHAT EVERYTHING
WE DO IS GEARED TOWARDS.
NCI DOES THIS BY FUNDING
RESEARCH ALSO I THINK CRITICALLY
BY PARTNERING WITH EVERYONE WHO
SHARES THAT GOAL.
NCI CAN'T DO IT ALONE AND IT HAS
A CRITICAL PARTNERING ROLE AND
I'M SURE YOU KNOW THIS BECAUSE
YOU ARE AMONG THE BIGGEST
PARTNERS.
I SEE NCI AS SUPPORTING THE BEST
PEOPLE IN RESEARCH AND MAKING IT
POSSIBLE FOR THEM TO DO THIS
RESEARCH THROUGH THE COURSES
THAT CAN BE PROVIDED.
IT'S ABSOLUTE ESSENTIAL THAT WEE
ENGAGE THE BRIGHTEST MINDS WITH
THE BIGGEST HEARTS.
ENDING HUMAN CANCER A IS A HUMAN
AND SCIENTIFIC ENDEAVOUR AND
IT'S ALSO A CORE PRINCIPLE THAT
I KNOW YOU SHARE.
FOR MANY YEARS NOW, WE'VE ALL
HEARD, WE'RE AT AN INFLECTION
POINT IN CANCER RESEARCH.
THERE'S SO MUCH POSSIBILITY AND
I HAD A FEW PEOPLE CHALLENGE ME,
COME ON, WE'VE BEEN HEARING THAT
HYPE FOREVER WHAT'S IS REALLY
HAPPENING.
I THINK ABOUT WHEN I FIRST
STARTED, AS A BRAND NEW SURGICAL
ONCOLOGIST, THINK BACK, AND THEN
FAST FORWARD TO TODAY AND I
THINK ALL OF CAN YOU CAN THINK
HOW DIFFERENT THE WORLD OF BEING
A CANCER CLINICIAN AND HOPEFULLY
FOR SOME BEING A CANCER PATIENT
IS TODAY, THAN IT WAS WHEN WE
FIRST STARTED.
WHEN YOU THINK IN THE LONG
SWEEP, THERE'S BEEN AMAZING
PROGRESS MADE.
IT'S NOT ENOUGH.
WE'VE GOT A LOT MORE TO DO.
AT THE OTHER THING I BELIEVE IS
HAPPENED, IS THERE HAS BEEN A
LONG-TERM SUSTAINED INVESTMENT
IN SCIENCE, IN CANCER RESEARCH,
AND THAT HAS PRODUCED SOME
OPPORTUNITIES THAT WE HAVE TODAY
THAT WE'VE NEVER HAD BEFORE.
AND PART OF WHAT IS BEFORE US,
REALLY FOR CTAC, I THINK
CRITICALLY FOR CTAC IS HOW TO WE
MAKE THE VERY BEST USE OF THOSE
OPPORTUNITIES THAT ARE AHEAD.
SO, I'LL ADMIT, THAT WHAT WE AIM
TO AS SIRRATIONAL WE NEED TO BE
BOLD AND GO FORWARD WITH WHAT WE
KNOW PEOPLE NEED US TO DO.
I WANT TO CONFIRM YOU CAN ALL
STILL HEAR ME.
GOOD.
SORRY, MY VIDEO IS GOING OUT.
IT GOES IN AND OUT A LITTLE BIT.
SO FIRST OF ALL, YOU KNOW, WE
MUST MODERNIZE CLINICAL TRIALS,
I KNOW WE'VE BEEN SAYING THIS
FOREVER, BUT IT IS MORE
IMPERATIVE THAN EVER AND WE'VE
SET A GOAL.
WE CAN'T LEAVE IMPORTANT WORK ON
THE TABLE BECAUSE WE LAR LACK TE
BANDWIDTH.
WE HAVE TO APPROACH AND DESIGN
CONDUCT OF CLINICAL TRIALS AND
REPORT OUR RESULTS.
WE'VE LEARNED SOME THINGS FROM
COVID BUT THERE'S A LOT MORE
THAT WE CAN THINK ABOUT.
INNOVATION, I THINK IT'S --
INNOVATION IN CLINICAL TRIALS IS
ESSENTIAL.
ON THAT NOTE, I REALLY LOOK
FORWARD TO THE SESSION AT NOON
TODAY, WHICH FOCUSES ON
STREAMLINING CLINICAL TRIALS.
I THINK THAT WILL BE VERY
ILLUMINATING FOR US ALL AND A
WONDERFUL PLACE TO START.
I THINK ALL OF YOU HAVE THE
KNOWLEDGE WE NEED TO ACHIEVE
THESE KIND OF GOALS.
THERE ARE RESOURCES TO MAKE THIS
HAPPEN AND THAT'S WHY YOUR INPUT
IS IMPORTANT.
>>TO HELP REALIZE THAT GOAL.
SOMEONE NEEDS TO MUTE.
THERE YOU GO.
I THINK ONE STEP WE'RE WORKING
TOWARDS IS LAUNCHING A SURVEY
AND EVALUATION OF THE
REPRESENTATION OF UNDER
REPRESENTED GROUPS AND WOMEN
ACROSS NCI AND THE NCTN, THE NCI
COMMUNITY ONCOLOGY RESEARCH
PROGRAM AND THE NCI SCIENCE
STEERING COMMITTEES.
OF COURSE, WE EMBRACE DIVERSITY
IN OUR WORKFORCE.
WE EMBRACE DIVERSITY IN OUR
LEADERSHIP.
THIS IS THE BEST WAY TO SERVE
OUR PATIENTS AND THE FIRST STEP
IS MAKING SURE WE LOOK TO
OURSELVES THAT WE'RE ADHERING TO
THE STANDARDS WE WANT TO SEE.
RIGHT NOW, WE DON'T HAVE A LOT
OF INFORMATION ON LEADERSHIP
REPRESENTATION AND THIS SURVEY
WILL REALLY HELP US COLLECT THE
DEMOGRAPHIC INFORMATION WE NODE
TO BETTER UNDERSTAND AND MAKE
ANY NEEDED IMPROVEMENTS.
THE PLAN IS TO PILOT THE SURVEY
IN NOVEMBER SO I URGE YOU TO
PARTICIPATE IN THAT.
ANOTHER STEP, IS THAT A WEEK
FROM TODAY, NCI IS GOING TO HOST
A SUMMIT ON INCREASING
DIVERSITY, EQUITY AND INCLUSION
IN EARLY PHASE CLINICAL TRIALS.
THIS HAS BEEN RECOGNIZE AS AN
ACUTE NEED.
AS YOU KNOW, EARLY PHASE TRIALS
CAN TAKE MORE RESOURCES AND BE
MORE DIFFICULT BUT ARE SO
IMPORTANT FOR PATIENTS WHO CAN
CAN BENEFIT FROM THEM AND EQUITY
AND ACCESS TO THESE RIALS IS A
VERY IMPORTANT IMMEDIATE
OBJECTIVE.
THE INTENTION IS ALSO IN THIS
INITIATIVE THAT INDUSTRY
PARTICIPANTS WILL WORK TOGETHER
TO STRUCTURE PARTNERSHIPS THAT
WILL IMPROVE THE REPRESENTATION
OF MEDICALLY UNDERSERVED
PATIENTS IN NCI-FUNDED TRIALS.
IF YOU WANT, YOU CAN STILL
RIMMINREGISTERFOR THIS AND ATTE.
OBVIOUSLY, WE NODE TO CONTINUE
TO INVEST VERY HEAVILY IN BASIC
AND TRANSLATIONAL RESEARCH TO
MAKE SURE WE HAVE A STEADY
STREAM OF NEW APPROACHES TO
CANCER PREVENTION AND TREATMENT
AND I ALSO AM VERY HAPPY THAT
I'M SPEAKING TO A GROUP FOCUSED
ON CLINICAL TRIALS AS WELL AS
TRANSLATIONAL RESEARCH AND BAKE
SCIENCES IS THE KNOWLEDGE ON
WHICH TRANSLATIONAL SCIENCE
WHERE IT STANDS, WE NEED THIS TO
PROVIDE THE SOLUTIONS AND BUILD
THE PIPELINE FOR TESTING THE
BASS TICK REPORT YOU WILL HEAR
ABOUT TODAY PRESIDES IN SIGHT
WHY BASIC SIGNS SCIENCE IS SO
IMPORTANT.
NCI CAN BUILD RESOURCES FOR
BASIC SIGNS FOR EXAMPLE IN
ADVERTISE CEASES SUCH AS GASTRO
AND GASTRIC THAT WE NEED TO
BETTER UNDERSTAND.
HOWEVER, AS WE MAKE THOSE
DISCOVERIES, WE HAVE TO ALSO
THINK ABOUT EQUITABLE DELIVERY
OF EVIDENCE BASED CANCER
PREVENTION AND TREATMENT AND
IT'S VISITTAL THAT WE EXPAND OUR
ACTIVITY AND OUR RESEARCH TO
UNDERSTAND HOW TO OVERCOME
FACTORS THAT CAUSE INEQUITY OUR
CURRENT STANDARDS OF SCREENING
DIAGNOSIS IN TREATMENT ARE
AVAILABLE TO EVERYONE WHEN WE
COLLECT SHARE DATA WE NEED TO DO
IT IN A ETHICAL MANNER, OF
COURSE IT'S THE UNDERPINNING OF
WHAT WITH YOU ALL TO WITH YOU WE
NEED TO INCLUDE EFFORTS TO
INCREASE COLLECTION AND USE OF
DATA PARTICULARLY FROM UNDER
REPRESENTED POPULATIONS.
RESEARCH, USING HEALTH DATA,
MUST BE CONDUCTED WITH RESPECT
TO THE WISHES OF THE PATIENT,
INCLUDING HONORING BOTH PATIENT
DESIRED RESTRICTIONS ON DATA USE
OR ALSO ON A DESIRE ON THE PART
OF PATIENTS TO HAVE THEIR DATA
SHARED AS WIDELY AS POSSIBLE.
I SEE THESE PRINCIPLES OF AN
UNDERLYING PHILOSOPHY OF HOW NCI
WILL APPROACH ITS SUPPORT OF ALL
DATA INFRASTRUCTURE AND
COLLABORATION WITH OUR PARTNERS
TO SHARE.
>>Tara: BROADLY AND WE ARE
REALLY AT A TIME WHEN WE BEGIN
TO TRULY HONOR, UNDERSTAND AND
HONOR OUR PATIENTS' WISHES.
WE HAVE TO INREESE THE DIVERSITY
OF CANCER RESEARCH AND CARE
WORKFORCE AND TO REFLECT THE
COMMUNITIES WE SERVE.
IT'S ESSENTIALLY ESSENTIAL TO
BUILDING TRUST AND INCREASING
UPTAKE OF PRE VEN TIVE BEHAVE
YEARS AND EXPANDING CLINICAL
TRAILS PARTICIPATION, AND
IMPROVING THE OVER ALL QUALITY
OF PATIENT CARE.
A RESEARCH AREA THAT IS VERY
IMPORTANT TO US AS WELL.
OF COURSE, WE STILL NEED FUNDING
TO ACHIEVE THE FULL POTENTIAL.
FOR THE CANCER MOONSHOT, AND
NCI'S WORK THAT EXTENDS BEYOND
IT.
IN SEPTEMBER, NCI SHARED ITS
ANNUAL PLAN AND BUDGET PROPOSAL.
I DON'T KNOW IF YOU SAW IT.
IT EXPRESSED THE FUNDING NEEDED
IN FISCAL YEAR 2024 TO BEGIN TO
REALIZE, FULL USE OF THE
OPPORTUNITIES BEFORE US.
IT CAME OUT WITH A PRETTY BIG
NUMBER.
$10 BILLION FOR FUNDING TO THE
NCI FOR OUR WORK.
NCI HAS BEEN AT CANCER RESEARCH
SINCE THE 1930s.
THIS PROPOSAL WAS BASED ON NCI'S
PROFESSIONAL JUDGMENT OF WHAT IT
WILL TAKE TO BEST SUPPORT THE
NATIONAL CANCER PROGRAMS TO
ACHIEVE THE CURRENT PRESIDENT'S
GOALS TO REDUCE CANCER MORTALITY
BY 50% OVER THE NEXT 25 YEARS
AND TO END CANCER AS WE KNOW IT.
YOU WILL SEE A LINE ITEM
SPECIFIC FOR MOONSHOT FUNDING.
THAT'S BECAUSE THESE GOALS ARE
INFUSED INTO TIVE PARTS OF THE
ENTIRE FISCAL YEAR '24.
WE TOO HAVE THIS FUNDING YET.
IN FACT, EVEN FOR 2023, NCI IS
OPERATING UNDER A CONTINUING
RESOLUTION THAT RUNS THROUGH
DECEMBER 16th AND THAT MEANS
OUR CURRENT BUDGET WILL MIRROR
THE FISCAL YEAR '22 BUDGET WHICH
WAS $6.9 BILLION UNTIL CONGRESS
CAN PASS A NEW BUDGET FOR FISCAL
YEAR '23.
IN A LITTLE BIT, M.K.HOLOHAN
WILL TALK ABOUT THE BUDGETS OF
CAPITOL HILL AND IN THE
MEANTIME, NCI IS DOING ALL THAT
IT CAN AND I'M SURE SO ARE YOU,
WITH THE RESOURCES, LOOKING TO
PARTNERS AND TO HELP REALIZE THE
OPPORTUNITIES TO ADVANCE
PROGRESS.
HOW ABOUT ANOTHER NEW PARTNER,
ARPA-H.
I KNOW ALL OF US ARE WON TERRING
WHAT THIS -- WHAT ARRIVAL OF
THIS NEW AGENCY PANES FOR OUR
WORK.
I HAVE BEEN VERY GRATEFUL TO
HAVE OPPORTUNITIES TO WORK WITH
RENEE, THE NEW DIRECTOR OF
ARPA-H.
IT'S A BIG JOB.
SETTING UP AN ENTIRE NEW AGENCY
AND GETTING IT RUNNING AND I CAN
TELL YOU, LOTS OF US ARE GIVING
HER MANY GOOD IDEAS FOR HOW THAT
AGENCY CAN HELP US.
IT'S STILL TAKING SHAPE
OBVIOUSLY.
I CAN CAN GIVE YOU INSIGHTS INTO
THE AND IT'S FOCUSED.
NIMBLE VERY PROJECTOR' ENTERED
AND ENGAGE PARTNERS FROM
GOVERNMENT, ACADEMIA, INTUS
TREMENDOUS AND FOUNDATIONS.
AND MOST IMPORTANT, IT'S NOT
INTENDED TO BE A NEW FUNDER OF
WORK THAT IS BEST ACHIEVED IN AN
ESTABLISHED ORGANIZATION, LIKE
NCI.
IT'S INTENDED TO BE ABLE TO
ACHIEVE THINGS THAT ARE VERY
DIFFICULT FOR ORGANIZATIONS LIKE
NCI BUT REALLY ESSENTIAL TO MAKE
PROGRESS IN HEALTHCARE.
SO, WE ALREADY HAVE NCI AND
OTHER INSTITUTES IN NIH CENTERS
THAT ARE WELL EQUIPPED TO FUND
RESEARCH VITAL FOR PROGRESS AND
THIS WILL NOT REPRODUCE THAT.
ARPA-H INTENDS TO FUND HIGH-RISK
ACTIVITIES THAT REALLY TOO MAKE
SENSE IN THESE OTHER AGENCIES.
BECAUSE THEY'RE JUST OF A
DIFFERENT NATURE.
THINK OF NEW TOOLS TECHNOLOGIES
THAT REALLY ENGAGE THAT ARE
FOCUSED VERY MILESTONE DRIVEN
AND IF ACHIEVED AND DEPLOYED,
CAN REALLY HELP US ALL DELIVER
CARE AND CONDUCT RESEARCH IN A
MUCH MORE EFFECTIVE WAY.
WE'RE VERY EXCITED ABOUT THE
PROSPECT OF WORKING IN WAYS THAT
COMPLIMENT WHAT ARPA-H ACHIEVES
THEM BEG A GREAT PARTNER FOR
WHAT WE DO ALREADY AND HELP
PROVIDE SCIENTIFIC LEADERSHIP
THAT WILL CREATE POTENTIAL FOR
ARPA-H.
ARPA-H IS FOLLOWING THE IT WAS
PROJECT AGENCY O TARPA PLAYBOOK.
THEY DON'T WANT TO SEE GRANT
PROPOSALS WITH YEARS OF
PRELIMINARY DATA.
THAT'S NOT WHAT THEY'RE ABOUT.
I'LL REFER YOU, YOU CAN CAN --
IT'S EASIER TO GOOGLE IT IF YOU
WANT TO SEE HOW TO WRITE AN
ARPA-H PROPOSAL.
IT FOLLOWS THE HEIL MIRE CAT A
KIDS UM.
IT'S FOCUSED QUESTIONS THAT ASK
YOU TO ARTICULATE IN A VERY
SUCCINCT, JUST A FEW PAGES
MANNER WHAT YOU WOULD LIKE TO
ACHIEVE AND WHAT ARE THE CORE
FEATURES TA DEFINE YOUR PROJECT.
AS WE CONSIDER OUR WORK WITH
PARTNERS, ANOTHER PEAL AND WITH
OUR CLINICAL TRIAL AND PARTNERS
AND YOU ALL KNOW THAT THIS IS
VERY NEAR AND DEAR TO MY HEART.
WE WOULDN'T BE ANYWHERE WITHOUT
BASIC SCIENCE.
THAT'S THE SEABED OF INNOVATION.
HOWEVER, WE CAN'T BRING THAT
BENEFIT TO PATIENTS UNTIL THEN
TESTS IT IN WAYS THAT IT'S
ADEQUATELY UNDERSTOOD TO SAFELY
AND EFFECTIVELY USE IN REAL
PATIENTS AND I KNOW ALL OF YOU
HAVE TAKEN ON THAT CHALLENGE.
CLINICAL TRIALS AND
TRANSLATIONAL SCIENCE PLAY A
CENTRAL ROLE IN CANCER RESEARCH.
NOT JUST BECAUSE OF HOW IT
CARRIES SCIENCE FORWARD TO
DIRECT PATIENT BENEFITS, BUT
THIS IS WHY IT'S ALSO THE
TRANSLATIONAL COMMUNITY BECAUSE
OF HOW IT POWERFULLY INFORMS
BASIC SCIENCE AND OFFERS AN
IMPORTANT GUIDE TO PUBLIC
POLICY.
I SEE IN THIS LIGHT THE
ABSOLUTELY AND ESSENTIAL ROLE
THAT THE NETWORK GROUPS PLAY IN
THE MISSION OF THE NCI.
AS A FORMER GROUP CHAIR, I'VE
SEEN THE COMBINATION OF
SCIENTIFIC EXCELLENCE, CARING
FOR PATIENTS, INCREDIBLE
VOLUNTEERISM, THE SPIRIT OF
DOING WHATEVER IT TAKES WITH
RESEARCH EMPOWERED BECAUSE IT'S
BEING CONDUCTED BY THOSE WHO
CARE ABOUT THE PATIENT SITTING
IN FRONT OF THEM IN THE CLINIC.
I REALLY SEE IT AS CRITICAL THAT
NCI THE NETWORK GROUPS WORK
TOGETHER CLOSER THAN EVER BEFORE
TO DEVELOP SOLUTIONS THAT
ADVANCE PROGRESS IN KEY AREAS.
ABSOLUTELY CRITICAL PARTNERSHIP.
TOGETHER, WE CAN LEVERAGE THE
UNIQUE SKILLS AND RESOURCES OF
ALL THE REQUIRED PARTNERS AND
THERE ARE MANY, TO FULFILL THE
REQUIREMENTS FOR EFFICIENT
RESEARCH THAT ADDRESSED THE
NEEDS OF ALL PATIENTS.
WE CAN CAN ADOPT A POLICY OF
DATA SHARING TO THE FULLEST
EXTENT, ALLOWED BY ADHERENCE TO
ETHICAL PRINCIPLES AND THE
WISHES OF OUR PATIENTS.
WE CAN DEVELOP AND IMPLEMENT AN
APPROPRIATELY RESOURCED METHODS
TO MAKE DATA SHARING A ROUTINE
FEATURE OF ALL CANCER RESEARCH.
WE LOCK WAY TOO MUCH KNOWLEDGE
AWAY IF DATA SCIENCE.
WE CAN ESTABLISH MUTUALLY
BENEFICIAL COLLABORATIONS WITH
BASIC SIGNS RESEARCH TO MAINTAIN
A STEADY FLOW OF KNOWLEDGE FROM
THE BENCH TO THE BEDSIDE AND
BACK AGAIN, OH IT'S SUCH AN OLD
PHRASE.
BUT IT'S DIFFICULT TO DO AND
IT'S ALWAYS BEEN CHALLENGING WE
REALLY NEED TO REDOUBLE THOSE
EFFORTS AND FIND THE RESOURCES
AND THE ENGAGE COMMUNITIES THAT
ALLOW US TO HAVE CLINICAL SIGNS
INFORM OUR BASIC SCIENCE NEEDS
AND VICE VERSA.
FINALLY, I THINK THIS IS REALLY
IMPORTANT.
WE NEED TO ADDRESS THE NEEDS OF
OUR CANCER CLINICAL RESEARCH
WORKFORCE.
BY ACHIEVING DIVERSITY AND ALL
BY PROVIDING ADEQUATE SUPPORT SO
OUR CLINICIANS AND RESEARCHERS
AREN'T LOST TO BURNOUT.
WE'VE ALL SEEN WAY TOO MUCH.
WE NEED TO SUPPORT EDUCATION AND
REIMBURSEMENT THAT MAKE IT
POSSIBLE FOR THEM TO TO THEIR
WORK.
AND FINALLY, BY HIGHLY VALUING
THE UNIQUE CONTRIBUTION OF
CLINICIANS WHO SUPPORT THEIR
PATIENTS BY CONDUCTING CLINICAL
RESEARCH.
CLINICIANS WHO TO THIS ON BEHALF
OF THEIR PATIENTS AND EVERYONE
ELSE HAVE A VERY SPECIAL PLACE
IN OUR WORLD.
AND VERY CERTAIN THAT THIS
APPROACH WILL MAXIMIZE THE
STRENGTH OF THE NETWORK GROUPS
IN THEIR CENTRAL POSITION OF
TRANSLATING EFFECTIVE KNOWLEDGE
INTO BETTER CARE FOR PATIENTS
AND LAYING THE FOUNDATION FOR
CLINICAL RESEARCH IT LEADS TO
BETTER CARE OVER ALL AND INFORMS
PUBLIC POLICY.
THIS PUTS NCI IN THE BEST
POSSIBLE POSITION TO SUPPORT
CRITICAL WORK FOR THE PEOPLE WHO
ARE COUNTING ON US TO COME
THROUGH FOR THEM.
NAMELY, ALL PEOPLE LIVING WITH
CANCER TODAY, AND THE REST WE
HOPE WILL NEVER HAVE TO FACE
THAT CHALLENGE.
SO, NOW I HOPE TO HEAR FROM YOU
AND I HAVE A FEW QUESTIONS FOR
YOU, REALLY, THE MAIN ONE, WHAT
DO YOU SEE?
WHAT TO WE NEED TO TALK ABOUT?
THE AREAS OF GREATEST
OPPORTUNITY AND ALSO, YOUR
GREATEST CONCERNS WITH RAR TO
CLINICAL TRAILS ASK
TRANSLATIONAL RESEARCH.
I WOULD LIKE TO START A SERIOUS
CONVERSATION, NOT ENDING TODAY
BUT ON GOING FOR MY ENTIRE
TENURE, ABOUT HOW WE CAN MAKE
THE KIND OF PROGRESS THAT WE
WANT AGAINST CANCER A REALITY
FOR EVERYBODY.
SO, WITH THAT, I'D LIKE TO TURN
IT BECOME OVER TO NEIL AND HE
CAN CAN HELP ME MODERATE SOME
QUESTIONS.
GREATEST OPPORTUNITIES AND
GREATEST CHALLENGES.
>>SOUNDS GREAT.
SO Dr. BERTAGNOLLI, I AM
EXCITED HOW YOU HIT THE GROUND
AND RUNNING AND THE FOCUS AREAS
YOU'VE PRESSED.
EXPRESSED.
I'VE LIKE TO OPEN IT UP TO THE
COMMITTEE TO OFFER SUGGESTIONS,
DISCUSSES TOPICS FOR MONICA.
>>I SEE PATTY SPEARS HAS RAISED
HER HAND.
>>IT'S SO GOOD TO SEE YOU IN
THIS ROLE.
WE MISS YOU AT THE ALLIANCE FOR
SURE BUT OF COURSE, I AGREE WITH
EVERYTHING YOU HAVE SAID ABOUT
YOUR GOALS AND OBJECTIVES
BECAUSE I'VE BEEN HEARING THEM A
LONG TIME AND I THINK YOU ARE ON
TRACK.
I THINK THAT YOU KNOW, ONE OF
THE THINGS THAT I HAVE SEVERAL
THINGS WRITTEN DOWN BUT YOU
KNOW, A LOT OF IT AS PATIENTS IS
ACCESS, ACCESS, ACCESS, ACCESS
SO WHETHER IT'S ACCESS TO
CLINICAL TRAILS OR ACCESS TO
QUALITY CARE IN GENERAL FOR
CANCER CARE, I THINK THAT'S
REALLY WHERE IT IS I THINK THE
OPPORTUNITY IS WHAT WE'VE SEEN
HAPPEN WITH COVID, WHERE IT'S A
LOT OF THE CLINICAL TRIALS HAS
BEEN MORE PATIENT CENTERED
RATHER THAN INSTITUTIONAL
CENTERED.
AND SO, KIND OF KEEPING SOME OF
THOSE THINGS GOING, THAT ARE
REALLY ADVANTAGEOUS FOR PATIENTS
AND INCREASING THE PARTICIPATION
AND TRIALS IN THE PARTICIPATION
AND CARE AND JUST ACCESS TO CARE
SO THE EQUITY AND CARE I THINK
IS A REALLY HUGE, HUGE PART OF
WHAT PATIENTS ARE LOOKING FOR.
>>I ABSOLUTELY AGREE.
YOU KNOW, COVID TAUGHT US A LOT
BECAUSE IT PUT PRESSURE ON US TO
THINK DIFFERENTLY, RIGHT.
AND I DON'T THINK WE TRULY
KNOW -- I DON'T THINK WE TRULY
KNOW THE IMPLICATIONS OF WHAT
THE CHANGES THAT ARE HAPPENING
WITH COVID AND LIKE ANYTHING,
THERE WERE SOME POSITIVE AND
SOME NEGATIVE AND THAT IS WHY
IT'S ABOUT RESEARCH, RIGHT.
WE JUST DO MAKE ASSUMPTIONS WE
DESIGN RESEARCH THAT REALLY
TESTS AND UNDERSTANDS THE RISKS
AND BENEFITS OF ANY APPROACH
INCLUDING SOME OF THE NEW
ACCESS-DRIVEN APPROACHES.
I THINK NCI, I'M PROUD TO SAY,
HAS AN INCREASING PORTFOLIO OF
IMPLEMENTATION SCIENCE, AND
REALLY DIRECTED TOWARD THE
HEALTHCARE ENVIRONMENT AND HOW
IT CAN BE BETTER.
YOU KNOW, THAT IS ONLY GOING TO
HELP CLINICAL TRAILS TO TO THAT
AS WELL AND FINALLY, WE'VE BEEN
SAYING THIS FOREVER, THE
AVAILABILITY OF CLINICAL TRIALS
PARTICIPATION IN CLINICAL
RESEARCH IS A STANDARD OF CARE
IMPERATIVE.
THE LEARNING HEALTH SYSTEM IS
WHAT WE ALL NEED.
YOUR ADVOCACY AND ALL THE HARD
WORK.
>>WOVE GOT A LOT OF HANDS UP IN
THE ROOM.
RUBEN, YOU ARE UP NEXT.
>>WELL, THANK YOU AND THANK YOU
FOR THOSE WONDERFUL COMMENTS IN
CLINICAL RESEARCH WHAT THAT
OPPORTUNITY BRINGS, AS I BRAIN
STORMED ALONG WITH MIKE WHO IS
OUR SWAG P.I. AND AS WELL AS
LEADS OUR CTO CORE CENTER, YOU
KNOW, WHAT ARE SHOULD KEY
TAKEAWAYS WE WANTED TO SHARE AND
A FEW THINGS I WOULD HIGHLIGHT.
ONE THE COMPLEXITY OF OUR TRIAL
DESIGNS.
DURING MY CAREER, THE
COMPLEXITIES OF OUR TRIALS HAS
EXPLODED TO WHERE WE NOW HAVE
10-PAGE LONG INCLUSION CRY TER
WHY FOR CLINICAL TRIALS THIS IS
VERY COUNTER PRODUCTIVE ON MANY
LEVELS.
THE COMPLEXITY OF THE NUMBER OF
COR LA TIVE STUDIES TUN AND I
KNOW IN TERMS OF FEDERAL TRIALS
AND YOU KNOW, OUR TEAM SAYS
AGAIN, MANY OF THESE CAN CAN
REALLY BE A TREMENDOUS BURDEN IN
TERMS OF BEING ABLE TO IMPLEMENT
THESE TRIALS AND TO USE
TELEHEALTH AND TELE CONTENT BOTH
FOR SCREENING AND CONSENTING AND
IT'S A HUGE OPPORTUNITY AND
WE'RE THE CENTER FOR SOUTH TEXAS
AND IT'S THE SIZE OF
PENNSYLVANIA.
IT'S ENORMOUS.
SO THOSE REMOTE PARTS ARE
CRUCIAL AND THE LACK OF REALLY
QUALIFIED COORDINATORS OXYGEN,
AS WE THINK OUTSIDE THE BOX, AS
INDIVIDUAL INSTITUTIONS AND YOU
THINK HOW DO WE LEVERAGE ALL OF
THESE OPPORTUNITIES TO CREATE A
GREATER PIPELINE OF PEOPLE
INTERESTED IN THESE SORT OF
CAREERS AND THEY REALLY HELP TO
SUPPORT OUR CLINICAL RESEARCH.
IF WE CAN EXTEND WITHOUT REALLY
THINKING ABOUT STRIPPING THEM
DOWN TO THEIR MOST BASIC AND
CRUCIAL ELEMENTS SO THEY'RE
PORTABLE, ACCESSIBLE, AND THEY
REALLY ARE ABLE TO BE ENROLLED
BY THE DIVERSE SWATH OF PEOPLE
THAT REALLY CONSTITUTE OUR
COMMUNITY, YOU KNOW, WE WON'T BE
SUCCESSFUL COMING UP WITH OUR
STAFF AND CLINICAL INVESTIGATORS
AND I THINK IT'S ANOTHER CRUCIAL
PIECE AND I'VE SEEN SOME NEW
ELEMENTS THAT I'VE BEEN INVOLVED
WITH A REVIEW OF THE R50s FOR
INDIVIDUALS TO BE INVOLVED IN
TRIALS AND I THINK EFFORTS LIKE
THAT, TO SUPPORT CLINICAL
INVESTIGATORS AT "POLITICAL
CONNEECONOMICINSTITUTIONS IS KE.
A LOT ON YOUR PLATE BUT STAND BY
READY TO ROLL UP OUR SLEEVES TO
HELP IN ANYWAY THAT WE CAN.
>>THAT'S WONDERFUL.
LET ME JUST RESPOND TO THIS ONE.
WE'VE BEEN TALKING ABOUT THIS
FOR A LONG TIME, RIGHT.
I MEAN, AS LONG AS I WAS GROUP
CHAIR WE'RE SAYING MANY OF THESE
SAME THINGS.
WE HAVE TO DO SOMETHING ABOUT
IT.
WE'VE GOT TO QUIT TALKING ABOUT
IT AND WE HAVE GOT TO DO
SOMETHING ABOUT IT AND I CAN CAN
TELL YOU THAT ONE THING FOR
SURE, WILL FIND A WAY THAT WE
CAN PARTNER WITH THE CLINICAL
TRIALS COMMUNITY AND PARTNER
WITH THE ONES WOULD EX ON THESE
STUDIES AND DESIGN THEM AND MAKE
THEM HAPPEN AND PARTNER AS NEVER
BEFORE AND SOLVE THESE PROBLEMS
TOGETHER.
WE HAVE TO SOLVE THIS TOGETHER
AND OR NEITHER SIDE WILL DO IT
BY OURSELVES WE NEED TO NULL
OTHER PARTNERS THAT ARE GOING TO
HELP US SOLVE THIS.
MAYBE FDA, RIGHT, THERE ARE
OTHER GOOD PARTNERS THAT CAN
HELP US SOLVE SOME OF THOSE
THINGS, WE'LL FIND, WE'RE
WORKING ON A WAY THAT AT THE
WILL REALLY HOLD OUR FEET TO THE
FIRE AND MAKE SURE WE DO BETTER
HERE I TOO SEE IT HAPPENING
WITHOUT HARD WORK AND HAVING TO
MAKE SOME CHOICES THAT YOU KNOW,
MAYBE THERE'S CHOICES WE HAVEN'T
MADE AND THEY'RE ADULT TO
ACHIEVE SOME OF THIS AND WE'LL
DO IT TOGETHER.
>>SO UNFORTUNATELY, WE HAVE
LOTS OF INTEREST AND ONLY A FEW
MORE MINUTES SO I'M GO T IS
EVERYONE TO SPEAK IN BULLET
POINTS AND NOT PARAGRAPHS.
I'M GOING TO START WITH MAYA.
>>THANK YOU, I JUST WANT TO
TAKE MY ONE LITTLE PARAGRAPH
WHICH WAS I REALLY APPRECIATED
THE SENTIMENT THAT YOU SAID
ABOUT VOLUNTEERING AND OUR
PASSION AND I THINK THAT
REPRESENTS A LOT OF THE PEOPLE
AND I'M THE CHIEF MEDICINE
OFFICER OF FOUNDATION MEDICINE
AND DATA SHARING IS A BIG PART
OF WHAT WE ARE FOCUSED ON WITH
OUR COLLABORATIONS WITH NCI AND
OTHERS AND WE ANTICIPATE THAT
THE ENVIRONMENT FOR DATA SHARING
AND IS GOING TO BE A LITTLE BIT
MORE CHALLENGING MORE RELATED TO
SOCIAL MEDIA THAN TO MAYBE
MEDICAL AND ONE OF YOUR GOALS OF
LEARNING FROM THE EXPERIENCES OF
EVERY PATIENT IS HINDERED BY OUR
OWN LACK OF CLARITY AROUND
CONSENT AND SECOND TARRY USE OF.
>>Tara: AND HOW THAT CAN MOVE
FORWARD AND I HOPE THAT IN YOUR
ADMINISTRATION, WE CAN CONTINUE
TO MAKE PROGRESS IN THIS RECORD.
IT'S VERY NEAR AND DEAR TO BOTH
NEIL AND MY HEARTS SO WE'RE ON
THE SUBCOMMITTEES AND I KNOW
THAT MANY OTHERS IN THIS GROUP,
ADAM AS WELL, SO, WE HAVE SOME
REGULATORY AND CONGRESSIONAL
BATTLES AHEAD OF US THAT WE AS A
COMMUNITY NEED TO STAY FOCUSED
ON.
>>RIGHT.
WE DO, WE NEED TO PARTNER ON
THIS AND OF COURSE, THIS IS A
REALLY KEY FEATURE, NOT ONLY
HERE IN THE BUDGET ASK IN THE
MOONSHOT AND I WILL TAKE IT OFF
LINE, YOU KNOW, I'M HAPPY TO
PARTNER WITH YOU ON ALL OF THIS
AND WE KNOW THAT FMI IS
CURRENTLY WORKING WITH NCI AND
SOME IMPORTANT THINGS AND WE'RE
VERY GRATEFUL FOR THAT SO, YOU
ARE RIGHT, AGAIN, WE HAVE TO DO
WHAT OUR PATIENTS WANT US TO DO.
WHAT OUR PATIENTS WANT IS WHAT
WE HAVE TO DO SO WE GET TO WORK
TOWARD THAT.
>>THANK YOU.
>>SETH LEARNER.
I'M A YOU'RE LOGICAL CONNOLOGIST
AND I CHAIR THE LOCAL BLADDER
COMMITTEE, SO IT'S ONE OF THE
PERSPECTIVES I HAVE BUT I ALSO
CHAIRED THE BLADDER TASK FORCE
MOST RECENTLY THE GU STEERING
COMMITTEE.
SO, AS ONE OF THE SURGEONS ON
THIS COMMITTEE, PLEASE DON'T
FORGET INNOVATION AND THE
SURGERY AND SPECIFIC
OPPORTUNITIES FOR SURGICAL
TRIALS WITHIN THE NCTM.
I JUST WANTED TO SHARE A THOUGHT
ABOUT INNOVATION AND TRANSLATION
AND I THINK THAT ONE OF THE
OBSERVATIONS THAT I SUSPECT MANY
OF US HAVE ARE THE CHALLENGES OF
DOING SORT OF COMPLEX CLINICAL
TRIALS WITHIN THE NCTN.
I THINK BY HISTORY, WE TEND TO
TO SEQUENTIAL TRIALS, BUILDING
ON ONE TO THE NEXT AND I THINK
THERE'S A VERY RICH OPPORTUNITY
FOR USING EITHER MULTIPLE
DISEASE STATES WITHIN AN ORGAN
SITE CANCER MULTIPLE TREATMENTS
I GUESS THE PODEL IS I SPY FOR
INSTANCE AND REALLY INVESTING
ENCOURAGING INFRASTRUCTURE TO BE
ABLE TO DO THESE MORE COMPLEX
TRIALS THAT I THINK ARE GOING TO
TEND TO MOVE THE FIELD FORWARD
MUCH QUICKER.
I WOULD ALSO LIKE TO SEE AND I
GUESS I JUST DID KNOW HAVING
BEEN INVOLVED IN THE TCGA FOR A
DECADE NOW CP TECH IS IF THERE
ARE SPECIFIC OPPORTUNITIES TO
FUND TRANSLATION OPPORTUNITIES
INTO CLINICAL TRIALS FROM THOSE
PROGRAMS AND AS YOU KNOW, IT'S
JUST A MASSIVE INVESTMENT AND I
THINK THAT THE BENEFIT OF THOSE
TWO PROGRAMS IS JUST OFF THE
CHART AND SKYROCKETING AND I
THINK IN TERMS OF THE WORKFORCE
YOU WILL HEAR THIS THEME OVER
OVER AGAIN.
I'VE BEEN SORT OF HARPING ON IT
AND THAT THERE HAS TO BE A
FINANCIAL INVESTMENT.
WE'VE GOT TO BE ABLE TO
COMPENSATE PEOPLE AT COMPETITIVE
RATES.
EVERY CANCER CENTER THAT I'VE
HEARD FROM IS REALLY STRUGGLING
WITH THIS RETENTION AND
OBVIOUSLY THE DIVERSITY OF THE
WORKFORCE IS VERY CRITICAL BUT
JUST HAVING A WORKFORCE IS
CRITICAL TO MEET YOUR OBJECTIVE
WHICH WE'RE ALL THRILLED TO HAVE
ABOUT IN DOUBLING THE CLINICAL
TRIALS APPROVAL SO THANK YOU SO
MUCH FOR EVERYTHING THAT YOU TO
AND FOR SHARING YOUR TIME WITH
US THIS MORNING.
>>LET'S MOVE ON TO MICHAEL NAP.
>>THANK YOU SO MUCH FOR REALLY
BRINGING A LOT OF CONCRETE
CONCEPTS TO THE OVER ALL VISION
THAT YOU ARE PUTTING ON THE
TABLE.
I WANTED TO BRING THREE
DIFFERENT TOPICS TOGETHER,
NUMBER ONE, YOU HIGHLIGHTED
REALLY THE PATIENT WISHES ON
THEIR PARTICIPATION AND THE DATA
AND I THINK WE COULDN'T GROW AGE
MORE AND IT NEEDS TO BE
REFLECTED BETTER AND IT'S GREAT
TO HEAR YOUR PASSION ON THIS.
THE SECOND, I THINK, WHAT YOU
ARE HEARING FROM ALL OF US IS
THE COMPLEXITY THAT IS BECOMING
MAJOR CHALLENGE AND THE THIRD,
IS THE OPPORTUNITY OF TYING REAL
WORLD DATA IN ADDITION TO
CLINICAL TRIALS TOGETHER.
>>REDUCTION ON COMPLEXITY.
>>THANK YOU, LET'S MOVE TO ADAM
DICKER AND MONICA, SPEAK UP IF
YOU WANT TO RESPOND TO ANY OF
THESE JUST INTERRUPT US.
I THINK THERE'S A TENSION
BETWEEN QUALITY OF THE PROCESS
IT DOESN'T ALWAYS WORK WELL
ACROSS SILOS SO IF THERE WAS AN
INCENTIVIZATION TO WORK ACROSS
SILOS AND MAINTAINING SOME RIG
OR AND QUALITY I THINK THAT
WOULD GO A LONG WAY TO REDUCING
THE ACTIVATION TO ACHIEVE MANY
OF THE VISIONS YOU TALKED ABOUT.
>>ADD MANY, COULD YOU SAY A ADT
WHAT SILOS?
>>WHETHER IT'S A DATA SILO FOR
CLINICAL TRIALS, I THINK THERE'S
CONCERN ABOUT -- RIGHTFULLY SO
IN TERMS OF THAT IF WE, YOU
KNOW, IF WE'RE NOT AS CAREFUL,
WE WON'T GET THE SAME QUALITY OF
INFORMATION ET CETERA.
IT'S A RISK OF TOWING MORE
CREATIVE APPROACHES AND COMES AT
A RISK OF INCREASING THE TIME
FOR APPROVAL, ET CETERA.
AND I THINK THAT'S A NORMAL
TENSION AND THE QUESTION IS, YOU
KNOW, IF THERE WAS AN NCI AND
BARRIERS TO REDUCE OBSTACLES AND
TO ACHIEVE SPEED, IT'S A
DIFFERENT PERSPECTIVE ON THAT WE
ALL VOLUNTEER ON COMMITTEES FOR
GRANTS AND OTHER TYPES OF,
ESPECIALLY RELATED TO CLINICAL
TRIALS.
>>THANK YOU.
ALL RIGHT, WE'RE GOING TO HAVE
TWO MORE COMMENTS AND WE'LL LET
MONICA CLOSE IT OUT.
CAROLINE MULLER MANY OF.
>>HI, THANK YOU.
I APPRECIATE EVERYBODY'S
COMMENTS.
I'M GOING TO TAKE ONE ADDITIONAL
LEAP AND JUST FOR ON TEXT, I'M A
ONCOLOGIST AND RUN UNDERSERVED
IN NEW MEXICO SO MY POINT IS THE
STAKEHOLDERS FOR CLINICAL TRIALS
ARE SO MANY DIFFERENT GROUPS
THAT GET PUSHED OUT BECAUSE THE
CULTURE OF CLINICAL TRIALS IS
NOT STRONG.
IT'S NOT A PRIORITY.
EVERYTHING ELSE PUSHES IT OUT.
SO I THINK ONE OF THE THINGS
THAT WOULD BE VERY IMPORTANT
MOVING FORWARD, AND BUILDING
THAT WORKFORCE AND BUILDING THE
COMMITMENTS AND OUR COMMUNITIES
AND OUR COMMUNITY ONCOLOGY
COMMITTEES IS TO STRENGTHEN
THETURE OF CLINICAL TRIALS, THE
IMPORTANCE, THE CAREER PATHS FOR
OUR STAFF, THE INTEGRATION OF
OUR APPs AND TAKE HOLDERS AND
OUR HOSPITALS TO REALLY
RECOGNIZE THAT IT HAS TO BE A
PRIORITY OVER BILLING REVENUES
AND OTHER THINGS GENERATED AND
I'M NOT QUITE SURE HOW TO DO
THAT BUT UNDERSTANDING THEM FOR
EACH COMMUNITY IS GOING TO BE
CRITICAL TO REALLY OVERCOMING
SOME OF THE BURDENS OF TOWING
THAT.
>>MONICA, FIRST OF ALL
CONGRATULATIONS I'M EXCITED AND
LOOKING FORWARD TO WORKING WITH
YOU AND I WILL BRING UP THIS
ISSUE ABOUT NCTN TRIALS.
WE ENROLL CLOSE TO 20,000
PATIENTS EVERY WEAR CONDUCT BIO
SAMPLES WITH ALL THE COMPLEXITY
THAT WAS MENTIONED EARLIER.
HOWEVER, WHEN IT COMES TO USING
THESE BIOSPECIMENS TO DO
BIOMARKER RESEARCH OR OTHER
TRANSLATIONAL WORK, I BELIEVE
THAT THERE'S AN OPPORTUNITY TO
IMPROVE THE PROCESS LOOKING AT
HOW QUICKLY CAN WE GET THESE
SAMPLES TO THE RESEARCHERS AND
LOWER THE BAR AND NOT PERFECT
PER BETHEN PEE OF GOOD.
SO I BELIEVE THAT THERE ARE
OPPORTUNITIES THERE ASK THAT'S
MY PLEA.
>>THANK YOU.
THE FLOOR IS YOURS.
SO, FIRST OF ALL, THANK YOU SO
MUCH.
AMAZING INSIGHTS.
I CAN REALLY VALIDATE EVERYTHING
THAT WAS SAID HERE TODAY.
AND I COULD TALK A LONG TIME.
SO I DON'T HAVE TIME.
LET ME JUST END WITH WHAT I
THINK IS ONE OF THE MOST KEYS TO
EVERYTHING WE'RE DOING AND THAT
WAS THE COMMENTS ABOUT CULTURE.
WHAT AN INCREDIBLE TREASURE WE
HAVE IN THE PEOPLE WHO ARE
DEVOTED TO CLINICAL AND
TRANSLATIONAL RESEARCH.
THE CULTURE IS THERE BECAUSE SO
MANY OF YOU LIVE IT ALL THE TIME
MANY OF NURTURING AND EXPAND
PARTICULAR AND NOT ITING VICTIM
OF BURNOUT AND IS A HUGE
PRIORITY.
IT'S GIVING.
EVERYONE TA DOES IT WORK DOESN'T
DO IT BECAUSE IT'S I'M LOOKING
TO HAVE YOU HELP ME EXPAND IT
OUT, IT'S OUR BIGGEST TREASURE,
FRANKLY.
>>THANK YOU.
>>GREAT.
THANK YOU.
THANK YOU, VERY MUCH.
YOU'VE GOT A SLIDE THAT YOU CAN
PROJECT AT THIS POINT.
>>WE'RE GOING TO MOVE ONTO THE
RECOGNITION OF A ROTATING MEMBER
AND WE'LL LEAVE THAT CAN YOU
BRING UP THE SLIDE.
>>OK.
SO, THANK YOU VERY MUCH.
SO, AS YOU KNOW, ANGIE DAVIS IS
ROTATING OFF CTAC AND WE REALLY
LIKE TO TAKE A MOMENT TO THANK
HER FOR HER DEDICATIONS AND HER
CONTRIBUTIONS TO CTAC.
I KNOW SHE'S BEEN A LEADER IN
THE CANCER RESEARCH COMMUNITY
AND FOR NCI AND SHE'S PROVIDED
SUBSTANTIAL SERVICES, NOT JUST
AS A CTAC MEMBER BUT A CHAIR OF
THE NATIONAL COUNCIL OF RESEARCH
ADVOCATES.
IT WAS A MEMBER OF CTAC
STRATEGIC PLANNING WORKSHOP
GROUP THAT PROVIDED IMPORTANT
RECOMMENDATIONS FOR MODERNIZING
NCI'S CLINICAL TRIALS SYSTEM.
SO, REALLY, THANK YOU SO MUCH
FOR YOUR SERVICE YOUR AMAZING
CONTRIBUTIONS AND WE REALLY HOPE
THIS ISN'T GOOD-BYE BUT WE LOOK
FORWARD TO WORKING WITH YOU IN
MANY WAYS, OTHER WAYS, IN THE
FUTURE.
THANK YOU SO MUCH.
>>>THANK YOU, ANGIE FOR
EVERYTHING THAT YOU DO EVERYDAY.
I'D LIKE TO MOVE ON TO THE NEXT
ITEM WHICH IS OUR LEGISLATIVE
UPDATE.
WE HAVE M.K.HOLOHAN TO GIVE HER
INSIGHTFUL REPORT.
YOU CAN CAN TELL US WHO IS
WINNING THE RACE THAT'S HAVEN'T
BEEN ANNOUNCED YET.
GIVE US THE INSIDE SCOOP.
WE'RE ALL EARS.
[LAUGHTER]
>>I WILL DO MY BEST.
THANK YOU, Dr. MEROPOL.
CAN CAN I HAVE THE SLIDES,
PLEASE.
THANK YOU FOR THE OPPORTUNITY TO
TALK WITH YOU TODAY AND I'M
GOING TO TRY TO BE QUICK.
Dr. BER -- SO, NEXT SLIDE,
PLEASE.
I'M GOING TO BRIEFLY COVER WHAT
WE KNOW ABOUT PRESIDENTIAL
APPOINTMENT WHAT WE KNOW ABOUT
THE ELECTIONS AND WE'RE GOING TO
TALK ABOUT APPROPRIATIONS FOR
FY23 AND 24 AND TOUCH ON THE
CANCER MOONSHOT AND ARPA-H AND
WHAT TO EXPECT FOR THE NAME DUCK
CONGRESS.
SO THE NIH DIRECTOR IS A
PRESIDENTIAL APPOINTMENT AND
EVERYONE KNOWS THAT AND THE NCI
IS THE ONLY INSTITUTE AT NIH
THAT ALSO HAS A PRESIDENTIAL
APPOINTEE AS THEIR DIRECTOR.
SO THAT VERY EXCITING.
PRESIDENT JOE BIDEN IS ALSO
NOMINATED THREE ACCOMPLISHED
CANCER RESEARCHERS TO SERVE ON
THE PRESIDENT'S CANCER PANEL
INCLUDING Dr. LIZ JAFFY WHO
WAS THE CHAIR OF THE NATIONAL
CANCER BOARD FOR NCI AND PLAYED
A LARGE LEADERSHIP ROLE IN THE
INITIAL CANCER MOON SHOOT AND IN
SEPTEMBER, PRESIDENT JOE BIDEN
FOR HEALTH IT'S EXPECTED TO TAKE
ON RESEARCH CHALLENGES AND
CONGRESS HAS MADE IF CLEAR THEY
EXPECT WORK IN THE AREAS OF
CANCER, DIABETES AND ALS AND
ALZHEIMER'S.
NEXT SLIDE, PLEASE.
SO, I REALLY THOUGHT THAT I WAS
GOING TO HAVE FANTASTIC INSIGHTS
AND I WOULD BE ABLE TO GIVE YOU
SOME REALLY DEFINITIVE
INFORMATION.
WHAT I CAN CAN TELL YOU RIGHT
NOW IN THE TIME WE'VE BEEN IN
THIS MEETING, THE SENATE NUMBERS
IS NOW 49-48.
RON JOHNSON IN WHICH IS CON SON
HAS HELD ON TO HIS SEAT, THEY
CALLED THAT JUST A FEW MINUTES
AGO AND THE SENATE MAY NOT BE
DECIDED UNTIL DECEMBER AND IT'S
LOOKING LIKELY.
IF THE DEMS HOLD ARIZONA IT'S
ABOUT 51-46 CURRENTLY AND THE
Rs FLIP NEVADA IT'S ABOUT
49-47 THEN GEORGIA WILL ONCE
AGAIN DECIDE CONTROL OF THE
SENATE AND THERE'S I THINK
EVERYONE KNOWS THIS BY NOW, YOU
NEED 50% PLUS ONE IN GEORGIA TO
WIN OUTRIGHT.
IT DOESN'T LOOK LIKE SENATOR
WORNAK WILL GET THERE SO WE MAY
NOT KNOW WHAT THE SITUATION IN
THE SENATE UNTIL THEN AND THE
HOUSE, RIGHT NOW, IS STILL
184-202.
184 DEMS TO 202 Rs.
THE DEMOCRATIC CAMPAIGN
CONGRESSIONAL CAMPAIGN COMMITTEE
CHAIRMAN, THE DCCCC, JOHN
PATRICK MALONEY CONCEDED THEIR
RACE AND THEY HAVEN'T LOST TO
THE OTHER SIDE SINCE 1980 SO
IT'S A BIGGY MOTIONAL LOSS RIGHT
THERE AND IT ALSO LOOKS LIKE
LAUREN BOBERT FROM COLORADO'S
THIRD DISTRICT, IT LOOKS LIKE
SHE LOST HER SEAT TO ADAM RICH.
WE CAN SAY THERE WAS NO RED
WAVE.
DEALS REALLY OUT PERFORMED
EXPECTATIONS AND HISTORY TELLS
US THAT THE PRESIDENT'S PARTY
LOSES SEATS IN MIDTERM ELECTIONS
AND IT SEEMS MUCH OF THE COUNTRY
IS READY TO MOVE ON TALKING
ABOUT THE RESULTS OF THE 2020
PRESIDENTIAL ELECTIONS.
THIS IS A BIT OF HISTORY.
THERE'S ONLY BEEN TWICE SINCE
THE MID-40S THAT THE PRESIDENT
PARTY HASN'T LOST SEATS IN THE
HOUSE IN MIDTERMS AND THE FIRST
EXCEPTION WAS IN BILL CLINTON'S
SECOND TERM AND THE SECOND WAS
IN GEORGE W. BUSH'S FIRST TERM
RIGHT AFTER 9/11.
WE ANTICIPATED DEMS LOSING SEATS
WHAT WE TOO KNOW IS HOW MANY
THEY WILL LOSE.
ONE THING THAT IS REALLY
IMPORTANT TO NOTE HERE AND MOST
OF THE POLITICAL PROGOSTICATOR
ARE SAYING THIS MORNING IT LOOKS
LIKE THE REPUBLICANS WILL TAKE
CONTROL OF THE HOUSE AND FLIP
THE MAJORITY.
THE EXPRESSIONS ELECTIONS MATTER
IS TRUE BUT MAJORITIES MATTER
ALSO.
HAVING A VERY SLIM MA COR TEE
MAKES IT VERY HARD FOR THE
LEADERS OF THAT PARTY IF KEVIN
McCARTHY WILL BE THE SPEAKER
HE WILL NAVIGATE THAT AS WELL
AND HE CAN BE VERY HAM STRUNG IF
THEY TOO HAVE ENOUGH VOTES TO
MOVE THINGS WITHOUT PLACATING
EVERYONE.
SO I WANTED TO TALK ABOUT HOW
NCI RECEIVES ITS FUNDING.
UNLIKE OTHER ICs AT THE NIH,
NCI HAS THE AUTHORITY AND THE
OBLIGATION, IT'S ACTUALLY IN OUR
STATUTE OF THE NATIONAL CANCER
ACT, TO PRESENT A PROFESSIONAL
BUDGET TO CONGRESS AND THE WHITE
HOUSE EACH YEAR.
YOU WILL HEAR THIS PREFERED TO
AREFERRED TOAS THE BY PASS.
IT'S REFERENCING THAT IT BY
PASSES THE TRADITIONAL BUDGET
PROCESS WHICH HAPPENS WITH EVERY
FEDERAL AGENCY AND MANAGEMENT
AND BUDGET.
THAT'S THE OFFICIAL PRESIDENT'S
BUDGET REQUEST AND NCI HAS THE
OPPORTUNITY TO IT THEIR OWN.
THIS PROVIDES AN OPPORTUNITY TO
PRESENT A PLAN FOR WHAT THE
INSTITUTES' LEADERSHIP BELIEVES
IS APPROPRIATE FOR THE SIZE AND
SCOPE OF INVESTMENT IN CANCER
RESEARCH AND TO TAKE ADVANTAGE
OF OPPORTUNITIES.
SO THE TIMING GETS A LITTLE BIT
CONFUSING.
SO, THE PIGGY BANK AT THE
FAR-LEFT BEFORE STEP ONE IS
SUPPOSED TO SHOW WE SUBMIT OUR
PROFESSIONAL JUDGE JUDGMENT BUDT
BEFORE TWO FISCAL YEARS EARLIER.
SO WE WERE WORKING ON THAT IN
FISCAL YEAR '22 AND WE SUBMITTED
IT AND RELEASED IT IN FISCAL
YEAR IN '22 SEPTEMBER 15th AND
FISCAL YEAR '23, CAN WE GO BACK
TO THAT SLIDE.
FISCAL YEAR '23, GANNON
OCTOBER 1st.
SO, WE SUBMITTED FOR OUR FY
'24 PROFESSIONAL BUDGET ON
SEPTEMBER 15th, 2022.
THEN WHAT THE BUDGET YEAR WE ARE
IN NOW, IT'S FY '23 AS WE ARE ON
A CONTINUING RESOLUTION THROUGH
DECEMBER 16th.
THEY HAVEN'T MADE A LOT OF
PROGRESS FROM THE PAST SEVERAL
MONTHS BECAUSE THE MIDTERMS
REALLY WERE, THE NEGOTIATIONS
WILL NOT BE BEGIN IN EARNEST
UNTIL CONGRESS COMES BACK
NOVEMBER 14th.
THE COMMITTEE CHAIRS AND THE
LEADERSHIP KNOWS THE HAND
THEY'RE DEALT SOME THEY'LL
DECIDE WHAT THEY'RE GOING TO DO
WITH FY '23 AND WILL THEY GET
CONSENSUS TO MOVE FORWARD WITH
THAT.
SO, WE'RE IN THE BETWEEN STEPS 2
AND 3 SO WE'VE HAD THE HEARINGS
ON THE FY23 BUDGET PROPOSAL AND
WE ARE WAITING TO SEE WHAT
CONGRESS DOES WITH THAT AND OUR
FY '24 PROFESSIONAL BUDGET
RELATES TO THE PRESIDENT'S FY
'24 REQUEST WHICH WILL GO TO
CONGRESS USUALLY IT'S THE SECOND
WEEK OF FEBRUARY.
SO OMB WORKS ACROSS THE FEDERAL
GOVERNMENT TO FORMULATE THAT
PRESIDENT'S BUDGET REQUEST.
THEY WORK WITH EVERY AGENCY AND
WE PARTICIPATE IN THAT PROCESS
AS WELL AS PART OF THE NIH.
AND NEXT SLIDE, PLEASE.
WE HAVE BEEN TALKING A BIT ABOUT
NCI PROFESSIONAL BUDGET BUDGET
THE PRESIDENT'S BUDGET REQUEST
AND IT'S IMPORTANT TO PUT THESE
IN CONTEXT.
THESE ARE JUST REQUESTS.
THE CONSTITUTION GIVES CONGRESS
THE POWER OF THE PURSE, THEY CAN
RAISE TAXES ORIGIN RATE MONEY
AND THEY CAN SPEND MONEY AND THE
EXECUTIVE BRANCH CAN'T DO THAT.
YOU OFTEN HEAR APPROPRIATORS
TAKE THIS SERIOUSLY AND YOU
OFTEN HEAR THEM QUOTING SLITLY
QUOTING FRANKLIN ROOSEVELT WHO
SAID IT'S THE DUTY OF THE
PRESIDENT TO PROPOSE AND IT'S A
PRIVILEGE OF CONGRESS TO
DISPOSE.
YOU OFTEN HEAR APPROPRIATORS SAY
THE PRESIDENT PROPOSES AND
CONGRESS DISPOSES.
THEY HAVE THE FINAL SAY ON WHAT
PROGRAMS, WHAT AGENCIES GET WHAT
LEVELS OF FUNDING.
AND HOW LONG THEY HAVE TO SPEND
THAT MONEY AND WHAT THEY CAN
SPECIFY DELIVERABLES AND
REPORTING OUT BASED ON THE MONEY
THAT THEY'RE GIVING TO EXECUTIVE
BRANCHES AND AGENCIES.
NOW, WE WOULD EXPECT THAT THE
PRESIDENT'S PARTY WOULD STRIVE
TO THEREFORE FUNDING PRESSURE
REFLECTED ITHEIR FUNDING BUT ITE
50/50 SENATE AND ONE PARTY
CONTROLS ONE OF THE CHAMBERS.
APPROPRIATORS HAVE TO WORK
TOGETHER EACH YEAR TO DELIVER
FUNDING BILLS THEY MAY NOT
ADVANCE AMOUNT OF LEGISLATION.
APPROPRIATORS HAVE TO DO THEIR
WORK.
SO THE CULTURE IS DIFFERENT AND
FORTUNATELY, THEY ARE OFTEN LESS
PARTISAN AND MORE PRAGMATIC THAN
WE SEE SOMETIMES IN OTHER
COMMITTEES AND NIH AND NCI HAVE
BEEN FORTUNATE EVEN IN REALLY
BITTERLY PARTISAN TIMES THE
MEMBERS OF OUR SUBCOMMITTEE HAVE
MADE BIOMEDICAL RESEARCH AND NIH
AND NCI IN PARTICULAR, A
PRIORITY.
THERE'S A LOT OF CHAMPIONS OF
BIO MEDICAL RESEARCH RETIRING IN
SENATE APPROPRIATIONS SO WE ARE
VERY HOPEFUL THAT THIS CONTINUES
TO BE A PRIORITY.
THIS SLIDE SHOWS US HEARINGS
FROM THE FY23 BUDGET REQUEST
HEARINGS IN THE HOUSE AND
SENATE.
THE PICTURE, THESE HAPPENED
LATE.
TYPICALLY THEY WOULD BE MARCH OR
APRIL BUT THE BUDGET REQUEST
WASN'T RELEASED UNTIL
MARCH 29th SO THAT WAS A GOOD
FIVE OR SIX WEEKS AFTER IT WOULD
BE EXPECTED.
TO THE RIGHT YOU SEE Dr. LARRY
TABAK AND TONY FAUCI AT WHAT
TURNED OUT TO BE HIS LAST
APPROPRIATIONS HEARING IN THE
SENATE AND Dr. LOWY
REPRESENTED NCI AT THE HOUSE
HEARING AND THERE WERE A LOT OF
THOUGHTFUL COMMENTS FROM THE
LEADERSHIP THAT THEY'RE AWARE OF
THE RANKING MEMBERS VERY AWARE
OF VOLUME OF APPLICATIONS TO END
NCI AND THEY UNDERSTAND PAYLINE
AND SUCCESS RATES AND THEY'RE
EXCITED ABOUT THE OPPORTUNITIES
FOR PROGRESS.
I LIKE THIS PHOTO OF Dr. LOWY
TALKING WITH THEM AFTER THE
HEARING AND THERE'S TWO POINTS I
WANT TO MAKE.
THESE MEMBERS HAVE WORKED
TOGETHER FOR A LONG TIME AND
THEY HAVE PASSED THE GAVEL BACK
AND FOURTH AND THEY MAY BE DOING
THAT AGAIN SOON.
THEY HAVE JOINTLY SUSTAINED MANY
YEARS OF SUSTAINED FUNDING
INCREASES.
BOTH MEMBERS, AS I SAID, THEY'RE
REALLY EDUCATED AND INFORMATION
ABOUT A LOT OF SPECIFIC CANCER
ISSUES AND THOSE ARE POSITIVE
THINGS FOR US AND WE'RE LOOKING
FORWARD TO THEM GETTING TO KNOW
Dr. BERTGNOLLI.
ONE THEME IN THE HOUSE AND
SENATE HEARINGS, YOU KNOW, THERE
WAS RECENT ACTIVITY AMONG
CONGRESS ABOUT THE ARPA-H
PROPOSAL.
THERE WAS BIG NUMBERS REQUESTED
FOR THEM TO START THEIR BUDGET.
I THINK IT WAS 6.5 BILLION WAS
REQUESTED.
THE MEMBERS WERE REALLY CLEAR,
THEY WANT MORE DETAILS AND THEY
TO NOT WANT FUNDING FOR THE NEW
AGENCY TO COME AT EXPENSE OF THE
SUSTAINED INCREASES FOR NIH AND
NCI THAT THEY'VE WORKED TOGETHER
FOR MANY YEARS AND SO THEY MAY
MADE COMMENTS AND I THINK THAT
THIS AGENCY IS JUST GETTING KIND
OF OFF OF GROUND AND THEY'LL BE
MET WITH RECENT ACTIVITY BUT
THEY'RE UNDER A LOT OF PRESSURE
TO MOVE QUICKLY AND SO IT'S
REALLY HELPFUL TO KNOW AND IT'S
REALLY CONSTRUCTIVE THAT THEY'RE
WORKING CLOSELY WITH OTHER PARTS
OF FEDERAL RESEARCH SCIENTIFIC
AGENCIES.
AND I WANTED TO SEE THE NEXT
SLIDE, PLEASE.
THESE ARE THE NUMBERS PROPOSED
FOR FY23.
THE NUMBER NUMBERS SHOWED THE
HOUSE AND THE SENATE PROPOSED
INCREASES FOR FY23.
THESE ARE NOT BIPARTISAN
NEGOTIATIONED NUMBERS.
THE HOUSE DID HAVE THE VOTES TO
MOVE THEIR BILL THROUGH
COMMITTEES AND THEY DID NOT
ACTUALLY HAVE THE VOTES TO MOVE
IT TO A FLOOR VOTE.
BECAUSE THEY HAD A MAJORITY THEY
MOVED THIS.
THIS IS NOT REFLECTING THE
MINORITY'S VIEW POINTS.
THE 466 MILLION-DOLLAR INCREASE
FOR NCI, ALSO THE SENATE, THEY
DIDN'T ACTUALLY HAVE THE VOTES
TO GET THEIR BILLS OUT OF
COMMITTEE SO THE MAJORITY
DEMOCRATS POSTED THE BILLS AND
THEY POSTED A DRAFT, THAT'S
THEIR PREROGATIVE AND BOTH SIDES
HAVE DONE THIS AND YOU SEE THE
LOWER NUMBERS THERE.
THE TWO PARTIES HAVE NOT AGREED
ON THE TOP-LEVEL SPLIT OF
DEFENSE VERSUS NON DEFENSE.
SO A GOOD 6 O% 60% IS MANDATOR.
REST IS DISCRETIONARY AND
PAYMENT ON THE DEBT.
SO THEY NEED TO -- THIS IS A
PERENNIAL DISPUTE ABOUT WHAT IS
THE SPLIT GOING TO BE.
REPUBLICANS ALWAYS WANT PARITY
AND 50/50 AND DEMOCRATS TEND TO
HAVE A TIVE VIEWPOINT AND THEY
MEET SOMEWHERE IN THE MIDDLE AND
ELECTION YEAR OBVIOUS WILL HE
MAKE THIS A LITTLE BIT TOUGHER
AND THERE'S ALSO OTHER ISSUES
ABOUT IMMIGRATION, BORDER
SECURITY, ABORTION RIGHTS, THESE
THINGS HAVE MADE IT MORE
COMPLICATE SOD WE EXPECT WHEN
CONGRESS COMES BACK ON THE
14th:14th THEY WILL GET BACK DON
TO THE BRASS ABOUT
APPROPRIATIONS.
ONE THING I NEED TO SAY HERE IS
IT'S NOT -- THE CR RUNS THROUGH
DECEMBER 16th.
IT'S NOT IMPOSSIBLE, IT'S NOT
LIKELY AND I DON'T THINK IT WILL
HAPPEN BUT IT'S NOT IMPOSSIBLE
THAT THEY WILL BE UNABLE TO
AGREE ON AN OMNIBUS FUNDING AS
WELL MANY OF IF THE REPUBLICANS
TAKE THE HOUSE THEY CAN IS MORE
SAY ABOUT THE FINAL NUMBERS.
THERE'S A STRONG MOTEL VISION TO
GET IT DONE FOR THE RETIRING
MEMBERS.
SENIOR REPUBLICAN APPROPRIATORS
NOT ONLY BECAUSE THEY WANT TO
FINISH THE BILLS WITH THEIR
IMPRINT ON THEM AND THEY WANT TO
GET WHAT WE'RE CALLING COMMUNITY
FUNDING PROJECTS NOW AND THEY'RE
EARMARKS THAT HAVE BEEN BROUGHT
BACK FOR LAST FISCAL YEAR AND
THIS FISCAL YEAR AND THEY DO
KNOW IF THEY'LL BE MAINTAINED IN
THE FUTURE AND THEY MAY NOT BE
SO WE'LL SEE WHAT HAPPENS BUT
THERE'S A LOT OF MOMENTUM TO GET
THESE BILLS DONE.
ALSO, IF YOU ARE TAKING OVER THE
MAJORITY IN THE 118th CON
118th CONGRESS, LEADERSHIP
MIGHT FEEL LIKE THEY DO WANT TO
DEAL WITH FY '23 AND THEY WANT
TO DEAL WITH A CLEAN SATE.
CLEAN SLATE.
I JUST WANTED TO POINT OUT THAT
THE TIMING OF THIS, WE DON'T --
WE HAVE ASKED, TIVE DIRECTORS
HAVE TAKEN DIFFERENT APPROACHES
OVER TIME.
SOME HAVE BEEN VERY BIG
ASPIRATIONAL BUDGETS AND SOME
MUCH MORE MODEST ASKS AND SO WE
HAVE SEEN IF YOU TRACK THE TWO
TOGETHER OVER TIME, THEY HAVE
BOTH GONE UP OVER TIME WHICH IS
ENCOURAGING BUT WE HAVE NOT
SEEN, USUALLY NOT PARITY FOR
WHAT WE REQUEST WE GET BUT THIS
IS REALLY IMPORTANT TOO IS IT
EXPLAINS THE VISION AND THAT IS
WHY WE HAVE THE AUTHORITY TO SAY
WHAT IS IT REALLY GOING TO TAKE
AND NCI WE'RE ASKING YOU
DIRECTLY.
AND.
>>THAT WOULD TINKER WITH THIS
AND THE ONE THAT PASSED THE
HOUSE WOULD PUT ARPA-H WITHIN
HHS BUT NOT INSIDE NIH AND THE
SENATE BILL WAS A LITTLE BIT
MORE NOT HIRING ANYONE NOT
WORKED FOR NIH IN THROW YEARS
AND THEY COULDN'T BE IN THE DC
AREA.
I DON'T KNOW THAT'S GOING TO
MOVE BUT IT WON'T HAVE AN AFFECT
HOW THIS ORGANIZATION WILL WORK.
WE'LL SEE WHERE THEY GET PASSED
IF THEY PASS AUTHORIZATION
LEGISLATIONMENT WE'LL SEE WHAT
HAPPENS WITH THAT.
THERE'S NOT A LOT OF TIME LEFT
WHEN CONGRESS COMES BACK.
THERE'S 17 LEGISLATIVE DAYS
WHERE BOTH THE HOUSE AND SENATE
ARE IN SESSION BEFORE THE CR
EXPIRES.
WE HAVE APPROPRIATIONS GETTING
DONE BEFORE THE CHRISTMAS
HOLIDAY IT'S THE NATURE OF THE
BEAST.
WHEN THEY COME BACK ON THE
14th, THE FIFTH OF REPUBLICANS
THE HOUSE REPUBLICAN ALSO HAVE
THEIR ORGANIZING ELECTIONS AND
FIGURE OUT WHO WILL BE IN CHARGE
NEXT CONGRESS.
THE DEMOCRATS WILL HOLD THEIRS
AFTER THANKSGIVING SO THAT WILL
TAKE TIM FROM THEM.
SO WHEN THEY COME BACK IN THE
LAME DUCK CONGRESS THERE ARE
THINGS THEY NEED TO DO THEY NODE
TO PASS APPROPRIATIONS.
THEY NEED TO PASS THE NATIONAL
DEFENSE AUTHORIZATION ACT AND
SOME OF THE OTHER MUST PASS
LEGISLATION ROW AUTHORIZATION
AND SBIR THOSE WERE TUN BEFORE
THEY LEFT FOR THE MID TERMS TO
CAMPAIGN.
WE'LL SEE WHAT HAPPENS IF THEY
TAKE ON TALK ABOUT A HEALTH
OMNIBUS BILL, IT MIGHT ADDRESS
MORE EXTENDING MEDICATION
TELEHEALTH COVERAGE AFTER THE
PUBLIC-HEALTH EMERGENCY EXPIRES
IN JANUARY AND MAYBE FDA
LEGISLATION TO TAKE ON LDTs.
THE ADMINISTRATION MAY TRY AGAIN
TO GET FUNDING FOR MORE PANDEMIC
PREPAREDNESS AND COVID AND
ADDITIONAL AID FOR UKRAINE, NOT
WANTING AND AID AND WE'LL SEE A
LOT OF IT AND OF THE MIDTERMS
AND WE'RE HAPPY TO HEAR FROM YOU
OR YOUR STAFF.
THANK YOU, VERY MUCH.
>>THANK YOU FOR ALL OF THESE
INSIGHTS AS ALWAYS.
WE DON'T HAVE TIME FOR
DISCUSSION TODAY AND WE'LL POV
ALONG.
THANK YOU FOR JOINING US.
AND WE'RE 10 OR 15 MINUTES
BEHIND IN THE SCHEDULE.
WE'LL RECOUPE A FEW MINUTES HERE
AND THERE THROUGH THE REST OF
THE DAY.
WE'LL MOVE ON TO OUR NEXT ITEM
WHICH IS STREAMLINING THE
CLINICAL TRIALS WORKING GROUP
WHICH IS COMING FORWARD WITH AN
INTERIM REPORT TODAY.
THERE WILL BE AN ACTION ITEM FOR
THE COMMITTEE FOLLOWING
PRESENTATIONS DISCUSSIONS.
WHICH WILL BE A MOTION VOTE TO
ACCEPT THE INTERIM REPORT AS
PROVIDED THROUGH THE COMMITTEE
MEMBERS.
I WANT TO KICK THIS OFF WITH
SOME HISTORICAL PERSPECTIVE ON
HOW WE GOT TO WHERE WE ARE AND
THAN I'LL TURN THIS OVER TO
INTEREST MANTREKAR WHO IS
CO-CHAIRING THIS WORKING GROUP
AND HE IS PROFESSOR OF BIAS
STATS AND ONCOLOGY AND SHE'S IN
THE DEPARTMENT OF -- ABOUT THREE
YEARS AGO, CTAC STOOD UP A
STRATEGIC PLANNING WORKING GROUP
WHICH WAS CHARGED WITH STATING A
VISION IF YOU WILL, FOR WHAT THE
CLINICAL TRIALS SYSTEM IN 2030
AND BEYOND AND TO MAKE
RECOMMENDATIONS TO THE NCI,
ABOUT WHAT ARE THE STEPS THAT
SHOULD BE TAKEN BY NCI TO HELP
US ACHIEVE THAT VISION.
IT CAME OUT IN NOVEMBER OF 2020
THAT STATED THE ENVISIONING OF A
MORE FLEXIBLE, FASTER, SIMPLER,
LESS EXPENSIVE AND HIGH-IMPACT
CLINICAL TRIALS SYSTEM THAT
WOULD SEAMLESSLY INTEGRATE
RESEARCH AND CLINICAL PRACTICE
AS INTEREST BERTAGNOLLI
REPORTED.
IT HAD THREE OPERATIONAL
INITIATIVES SPANNING EIGHT
THEMES, THOSE EIGHT THEMES ARE
LISTED HERE AN INCLUDE TRIAL
ACTIVITIES, PROMOTING ACCRUAL
AND ACCESS, NEW APPROACHES TO
DATA COLLECTION, PROs, FOR
CLINICAL TRIALS, AND OPERATIONAL
BURDEN, STATISTICAL
ENHANCEMENTS, AND WORKFORCE
OUTREACH AND TRAINING.
NEXT SLIDE, PLEASE.
SO THE NCA IN CONSIDERING THE
RECOMMENDATIONS OF THE STRATEGIC
PLANNING WORKING GROUP,
UNDERTOOK SIPS THAT TIME A
SERIES OF INITIATIVES RELATED TO
THE REPORT AND ONE OF THE THINGS
THAT WAS SET UP TO HELP THE NCI
FURTHER ADDRESS CERTAIN ASPECTS
OF THE STRATEGIC PLAN, WAS
ESTABLISHING A STREAMLINING
CLINICAL TRIALS WORKING GROUP
WHICH IS A SUB GROUP OF CTAC.
THIS WORKING GROUP WAS
ESTABLISHED IN JULY OF 2021 AND
IT WAS CHARGED WITH ADDRESSING
THE IMPLEMENTATION OF THREE MANY
OF RECOMMENDATIONS LISTED ON
THIS SLIDE.
AND THE THIRD TO ENGAGE HEALTH
RECORDS AND CLINICAL TRIAL
MANAGEMENT SYSTEM VENDORS TO
CREATE MECHANISMS FOR
INTEGRATING STUDY-SPECIFIC
DOCUMENTS INTO LOCAL
IMPLEMENTATIONS OF THEIR
PRODUCTS.
THE CLINICAL TRIALS WORKING
GROUP, MEMBERS ARE LISTED HERE
FOR REFERENCE.
MANY OF THESE FOLKS ARE ON THE
CALL TODAY.
AND NEXT SLIDE, PLEASE.
THE QUESTION ARISES WHY AN
INTERIM REPORT?
AND I GUESS TO STATE IT MOST
SUCCINCTLY, THERE'S URGENCY TO
MOVE FORWARD THE CLINICAL TRIALS
TO EVOLVE THE CLINICAL TRIAL
SYSTEM ON B BEHALF OF OUR PATIES
AND THERE ARE CURRENT STRESSES
ON THE SYSTEM AND THERE ARE
OPERATIONAL WORKFORCE ISSUES
THAT NEED TO BE ADDRESSED AND
THE STRATEGIC WAS ABLE TO
RAPIDLY COME TO CONSENSUS TASK
AND RELATED TO THE DATA
COLLECTION AND BURDEN AND THE
REPORT ALLOWS THE NCI TO
CONSIDER RECOMMENDATIONS NOW
RATHER THAN WAITING FOR THE
FINAL STREAMLINE AND CLINICAL
TRIALS AND REPORT AND THE WORK
OF THE SUBCOMMITTEE THAT WILL
CULMINATE TOO A REPORT TO NCI
WHEN THE DELIBERATIONS FOR ALL
THE TASKS ASSIGNED TO THE
WORKING GROUP ARE COMPLETED.
SO, THESE STRATEGIC CONTEXT FOR
THE LIMIT DATA COLLECTION ITEM
THE FOCUS OF THIS INTERIM
REPORT, IS THAT BECAUSE OF
ADVANCES IN SCIENCE AND
ASSOCIATED COMPLEXITY AND
RELATED TO STUDIES IN RARE
POPULATIONS AND AND THE
ASSOCIATIONED EXPENSE OF
CONDUCTING CLINICAL TRIALS WHICH
THREATENS THE CLINICAL TRIALS
ENTERPRISE.
WE LEARNED A LOT FROM THE
PANDEMIC AND WE EXPERIENCED LOTS
OF OPERATIONAL WORKFORCE
CHALLENGES THAT EXACERBATED
EXISTING PROBLEMS AND ALSO,
HIGHLIGHTED POTENTIAL
OPPORTUNITIES AND MECHANISMS TO
STREAMLINE TRIAL DESIGN AND
REDUCE THE BURDENS OF CLINICAL
TRIAL ARE URGENTLY NEEDED.
SO ONE STRATEGY RELATES TO WHAT
DATA ARE WE ACTUALLY COLLECTING
ON CLINICAL TRIALS TODAY AND
COULD WE ECONOMIZE ON THAT DATA
COLLECTION BURDEN IN A RATIONAL
WAY THAT DOESN'T ADVERSELY
EFFECT THE LEARNINGS FROM
STUDIES IN TERMS OF EFFICACY OF
NEW AGENTS AND POTENTIAL HARMS
OR SIDE EFFECTS OF TREATMENTS.
SO HOW FURTHER ADIEU, THE NEXT
SLIDE WILL ALLOW US TO
TRANSITION TO WHERE WE ARE
TODAY.
SO IF TERMS OF THESE
RECOMMENDATIONS, IN MID-JULY,
THE STREAMLINING AND CLINICAL
TRIALS WORKING GROUP HAD ITS
FIRST MEETING AND AFTER CASE
REPORT TOMORROW'S OF ENACTED AND
COMPLETED NCTN CLINICAL TRIALS
THE FRIENDSHIP DISCUSSED
POTENTIAL CANDIDATES LOW VOW IF
YOU WILL,.
>>Tara: ELEMENTS THAT COULD BE
CONSIDERED FOR ELIMINATION AND
AND CAME UP WITH CATEGORIES AND
WHERE REDUCTION AND DATA
COLLECTION MIGHT BE APPROPRIATE
AND THERE'S IN-PERSON MEETINGS
AS WELL AS LOTS OF ELECTRIC RON
I CAN COMMUNICATION THAT ALLOWED
US TO DRAFT AND REFINE
RECOMMENDATIONS TO BE CONSIDERED
BY CTAC AND ULTIMATE LOW TO BE E
PROVIDED TO THE NCI LEADERSHIP.
TODAY WE'RE READY TO PRESENT THE
INTERIM REPORT TO CTAC FOR
DISCUSSION.
AND I'M GOING TO TURN IT OVER
NOW TO PRESENT THE
RECOMMENDATIONS.
>>THANK YOU, NEIL.
I THINK NEXT SLIDE.
I THINK NEIL YOU IT A GREAT JOB
OF PROVIDING THE CONTEXT TO WHAT
WE DID SO I'M SURE EVERYBODY IS
EAGER TO KNOW WHAT OUR
RECOMMENDATIONS ARE.
WE'LL GET INTO THAT RIGHT AWAY.
SO THE RECOMMENDATION FROM THE
WORKING STREAMLINING LEGAL
TRIALS WORKING GROUP IS TO
ESTABLISH A SET OF STANDARD
PRACTICES FOR DATA COLLECTED IN
NCI PHASE 3 AND PHASE 2, 3 ADULT
TREATMENT TRIALS.
SO SPECIFICALLY, IN ORDER TO
REALIZE THIS RECOMMENDATION THE
WORKING GROUP PROPOSES THE SET
OF STANDARD PRACTICES THAT WE
WILL REVIEW IN THE NEXT FEW
SLIDES AND INTENDED TO COVER
TRIALS THAT ARE MEETING THE CRY
TER WHY LISTED ON THIS SLIDE.
SO, IT WILL BE APPLICABLE TO THE
NCI STUDIES PHASE 3, PHASE 2, 3
STUDIES FOCUSING ON TREATMENT
TRIALS IN THE ADULT POPULATION
AND EXAM WHICH COMPRISE OF 0% OF
THE NCTN TRAILS.
-- 40%.
THE FUTURE RECOMMENDATIONS ARE
HOW WE CAN EXTEND THESE
PRACTICES TO LATE PHASE IND
TRIALS AND PEDIATRIC TRIALS AND
THE WORKING GROUP RECOGNIZES
THAT EARLY PHASE TRIALS HAVE
DISTINCTIVE SIGN I HAVE I CAN
CHALLENGES SO THOSE WOULD
REQUIRE CAPITAL CONSIDERATION
FOR THOSE IN THE RECOMMENDATIONS
TODAY.
THE WORKING GROUP BELIEVES THESE
PROPOSED PRACTICES WILL BE IN
OUR -- CAN DEFINE A NEW NORMAL
FOR DATA COLLECTION SO THEY'LL
BE LESS BURDEN SOME AND THE
TRIAL ALS WILL BE MORE EFFICIENT
SUSTAINABLE THAN EVERYTHING
WE'VE DISCUSSED IN TERMS OF
WORKFORCE CHALLENGES.
THE WORKFORCE RECOGNIZES THAT
THESE PRACTICES ARE NOT INTENDED
TO BE APPLIED AT THE COST OF
COMPROMISING OF KEY STUDY
OBJECTS, HOWEVER, THEY CAN EVERY
PROPOSED AND WE MUST PROVIDE
JUSTIFICATION SPECIFIC TO THE
CLINICAL SO THE CATEGORY FALL IN
ADVERSE EVENTS, COLLECTION OF.
>>Tara: SURRODATA AND PHYSICALB
TESTS, IMAGING AND OTHER
ASSESSMENT PROCEDURES PATIENT
REPORTED OUTCOMES.
NEXT SLIGHT.
SO STARTING WITH ADVERSE EVENTS,
OUR PROPOSAL FROM THE
STREAMLINING CLINICAL TRIALS
WORKING GROUP IS TO COLLECT ONLY
ADVERSE EASTBOUND EVENTS OF
GRADE THREE AND HIGHER UNLESS
ASSESSMENT OF RELATED TO A
ADVERSE EVENT IS A STATED OBJECT
WITH A PRO SPECIFIED ANALYSIS
PLAN.
WE PROSE POSE FOR EACH ADVERSE
OFTEN WE COLLECT ONLY THE CTCA
TERM AND THE COMMON TOX SIT TEE
CRITERIA ADVERSE -- AND ADVERSEP
TIMES.
WE PROPOSE COLLECTION REGARDLESS
OF GRADE WHEN THEY ARE LIMITED
IT THOSE THAT RESULT IN A DOSE
MODIFICATION, TREATMENT
CONTINUATION OR NOT ADHERENCE.
AND WE DEFINE SOLICITED ADVERSE
EVENTS AS ACQUIRED TO BE
ASSESSED AND REPORTED ON A
REGULAR SCHEDULE AND ASSESSED ON
THE PATIENT WHETHER IT'S
PRESENTED OR ABSENT IN EVERY
CYCLE.
MOVING TO MEDICAL HISTORY
DEFINED AS EVENTS, MEDICAL
EVENTS ARE ON GOING CONDITIONS.
IDENTIFIED AT THE BASELINE AND
EITHER THROUGH A PATIENT REPORT
OR REVIEW OF THE PATIENT MEDICAL
REPORTS, OUR PROPOSAL IS TO
COLLECT ONLY THOSE MEDICAL
HISTORY ITEMS RELEVANT TO A
TRIAL EXCLUSION CRITERIA, NEXT
SLIDE.
IN TERMS OF MEDICATIONS, WE
PROPOSE THAT A BASELINE WE
COLLECT THOSE MEDICATIONS AND
THEIR USE REQUIRES MODIFICATIONS
OF THE STUDY TREATMENT FOR THE
PATIENT AND DURING THE TRIALS,
WE PROPOSE COLLECTION OF ONLY
CHANGES AND MEDICATIONS THAT
WILL COST MODIFICATION OR
DISCONTINUATION OF THE STUDY
TREATMENT.
NEXT SLIDE.
A PROPOSAL IS THOSE SHOULD BE
CONDUCTED ACCORDING TO STANDARD
OF CARE, AUGMENTED BY ANY TRIALS
SPECIFIC REQUIREMENTS AS THE
CASE MAY BE BUT ONLY THE
FOLLOWING EXAM FINDINGS SHOULD
BE COLLECTED.
FINDINGS THAT ARE
PROTOCOL-SPECIFIED END POINTS
ARE REQUIRED TO ACCESS
PROTOCOL-SPECIFIC FEED END
ONTPROTOCOL-SPECIFIED END POINTS
AND FINDINGS THAT RESULT IN
THOSE MODIFICATIONS OR TREATMENT
ADVERTISE CONTINUATION.
WE HAVE A CLARIFICATION ON
PHYSICAL EXAM FINDINGS
PERFORMANCE STATUS IS
CONSIDERING A PHYSICAL EXAM
FINDING AND SHOULD BE COLLECTED
IF IT PETES THE CRITERIA
SPECIFIED ABOVE.
IN TERMS OF LAB TESTS, WE
PROPOSE THOSE SHOULD BE
CONDUCTED ACCORDING TO STANDARD
OF CARE.
AGAIN, AUGMENTED BY NEED BID ANY
TRIAL SPECIFIC REQUIREMENTS
HOWEVER WE PROPOSE ONLY THOSE
TEST RESULTS TO BE COLLECTED
THAT ARE ASSOCIATED WITH
PROPERTY-SPECIFIC END POINTS AND
REQUIRED TO ASSESS
PROTOCOL-SPECIFIED END POINTS OR
THOSE THAT RESULT IN THOSE
MODIFICATIONS OR TREATMENTS.
WE WILL LIMIT IMAGING TO THOSE
THAT REQUIRE TO MET
PROTOCOL-SPECIFIED OBJECTIVES
AND MODIFICATION AND ASSESSMENT
OF CLINICAL OUTCOMES AND SO ON
AND THE COST OF ANY IMAGING OR
OTHER ASSESSMENT PROCEDURES,
THAT IS NOT COVERED BY INSURANCE
MUST BE COVERED BY THE RESEARCH
STUDY.
IN TERMS OF PATIENT REPORTED
OUTCOMES, PATIENT REPORTED DATA,
THE PROPOSAL IS TO NOT REQUIRE
COLLECTION OF PATIENT
MEDICATIONS DIARIES UNLESS THE
PROTOCOL THEDEFINES HOW IT WILLD
TO ADDRESS THE TRIAL SPECIFIED
OBJECTS.
FOR PROs THEY MUST CLEARLY
ADDRESS HOW THOSE PRO
INSTRUMENTS WILL BE CHOSEN AND
HOW THE DATA COLLECTION SCHEDULE
WILL BE INCLUDED IN THE
PROTOCOLS, SO THAT WE CONTINUE
TO ACHIEVE THE SCIENTIFIC
OBJECTIVE MINIMIZING PATIENT
BURDEN.
OUR CLARIFICATIONS ON THE PRO
INSTRUMENTS INCLUDE COMPLETE
INSTRUMENTS, SELECTED WE SEE
FROM AN INSTRUMENT AND READING
SCALE AS APPROPRIATE WHATEVER IS
IMPORTANT FOR THE TRIAL
SCIENTIFIC OBJECTIVES IN TERMS
OF DATA COLLECTION SCHEDULE WE
HAVE TIMING WHEN THESE ARE
COLLECTED THE FREQUENCY OF
COLLECTION AND THE DURATION OF
FOLLOW-UP AND ENSURING THESE ARE
COORDINATED WITH OTHER
ACTIVITIES ON THE TRIAL.
SO, IN CONCLUSION, I THINK IT'S
CLEAR IF YOU HAVE SEEN THE SAME
PRAISE REPEATED OVER OVER AGAIN
AND SPECIFIED OBJECTS OUR
DEFINING THEME FROM THIS
STREAMLINING TRIALS WORKING
GROUP IS TO RECOMMEND COLLECTION
OF DATA THAT ARE ABSOLUTELY
NECESSARY TO ADDRESS TRIAL
OBJECTIVES AND THEY HAVE CLEARLY
DEFINED ANALYSIS PLANS.
SO, WE BELIEVE THAT THE
IMPLEMENTATION OF THESE
PRACTICES FOR DATA COLLECTION
AND PHASE 3 AND 2, 3 ABOUT THE
TREATMENT TRAILS WILL REDUCE
OPERATIONAL PUSHED AND I KNOW
IT'S EXPECTED TO BUT COMING FROM
AN NETWORK I KNOW THIS WILL
REDUCE OPERATIONAL BURDEN AND
THAT IT WOULD PROVIDE IMPORTANT
INSIGHTS THAT WILL CONTINUE TO
INFORMATION DEVELOPMENTAL DATA
COLLECTION STANDARDS FOR OTHER
TYPE OF TRIALS THAT WE DIDN'T
ADDRESS RIGHT HERE AND WE ALSO
UNDERSTAND AND RECOGNIZE THAT A
LOT OF THESE RECOMMENDATIONS
WILL REQUIRE STAKEHOLDER
ENGAGEMENTS SO WE HOPE TO
CONTINUE TO WORK WITH OUR
STAKEHOLDERS SO THAT WE CAN
SUCCESSFULLY IMPLEMENT SOME OF
THESE PROPOSE STANDARDS.
>>THANK YOU SO MUCH.
BEFORE I OPEN THIS UP TO
DISCUSSION, I WANT TO HIGHLIGHT
SOME BESTS THAT ARE PRESENT ON
THE CALL WHO WILL BE ABLE TO
ADDRESS CERTAIN ASPECTS OF THIS
WORK STREAM AND AS HAVE
PERSPECTIVE.
THE FIRST IS ORIN GRAD.
JUDY WITH THE SCIENCE AND
TECHNOLOGY POLICY INSTITUTE AND
MARK FROM THE FDA WHO
PARTICIPATED IN SOME OF THESE
DISCUSSIONS.
SO, WITHOUT FURTHER ADIEU, LET'S
OPEN IT UP TO DISCUSSION.
PLEASE RAISE YOUR HANDS AND
WE'LL GO FROM THERE.
I SEE RUBEN.
>>LET ME KNOW WHAT IS GOING ON.
>>SO, I THINK THIS VERY MUCH IS
ALIGNED WITH THE ADVERT DISPARIE
DISCUSSED BEFORE TRYING TO MAKE
THINGS EASIER.
IT'S A SET OF RECOMMENDATIONS
AND CERTAINLY I VOW THAT THIS
PROBABLY WILL BE AN ITERATIVE
PROCESS IF IT'S CONTINUAL TO
VALUE WAIT OTHER OPPORTUNITIES
FOR STREAMLINING.
WITHOUT QUESTION, I THINK THESE
ARE PRETTY IMPACTFUL.
THERE'S A LOT OF WORK THAT GOES
INTO EACH OF THESE WITH HISTORY
MEDS, ADVERSE EVENTS AT A
VARIETY OF THESE THINGS SO IT'S
A GREAT PLACE TO BEGIN BUT
CERTAINLY WITH A GOAL OF
REASSESSING IT AFTER A PERIOD OF
TIME AND DRILLING DOWN INTO
FURTHER AREAS IN AN ITERATIVE
WAY.
>>THANK YOU.
PATTY SPEARS.
>>HI, THAT WAS A NICE
PRESENTATION.
I LIKE THE IDEA OF KIND OF ABOUT
THING THAT THREAT WITH THE
BENEFIT TYPE OF THING.
AND GETTING THE BEST DATA AS WE
CAN BUT ALSO, YOU KNOW, YOU
MENTIONED STAKEHOLDER ENGAGEMENT
AND TO ININCLUDED SOME PATIENTS
IN THERE AS WELL SO WE DO FORGET
THE PATIENT BENEFIT INFORMATION
AND KIND OF PLAYING ON THAT TOO,
YOU MENTIONED KEY OBJECTIVES.
TUESDAY THAT INCLUDE PRIMARY,
SECONDARY OBJECTIVE,
EXPLORATORY, WHERE DID THOSE
EXPLORATORY COME IN IN THERE?
>>YOU WANT TO TAKE THAT?
>>YEAH, THANK YOU, PATTY.
IT'S GO AHEAD TO SEE YOU AGAIN.
I THINK A LOT OF WHAT WE WERE
FOCUSING ON WERE PRIMARY AND
SECONDARY OBJECTIVES, ESPECIALLY
WHEN YOU THINK OF YOU KNOW, LA
OR TORI ASSESSMENTS AND IMAGING
AND ADVERSE EVENTS BUT THERE
COULD BE EXPLORATORY OBJECTS BUT
I THINK THE WHOLE IDEA BEHIND
THE WORKING GROUP WAS WE DON'T
PUT ANYTHING FOR DATA COLLECTION
UNLESS WE HAVE A CLEARLY
SPECIFIED UNDERSTANDING OF HOW
THOSE.
>>Tara: WDATA WILL BE UTILIZEDS
FOR VARIOUS REASONS YOUR NOT
COLLECTING IT ON EVERY PATIENT
OR ON SEVERAL PATIENCE OR IT'S A
DIFFERENT QUESTION YOU WANT TO
ASK, AS LONG AS YOU HAVE A CLEAR
PLAN OF I'M GOING TO COLLECT A
AND I'M GOING TO USE THIS AND
ANALYZE AND UTILITY OF
COLLECTING A, I THINK THAT'S
VALID.
BUT YEAH, IN GENERAL, WE WERE
PRIMARILY FOCUSED ON CLEARLY
DEFINED PRIMARY AND SECONDARY
OBJECTIVES BUT THEY'RE TOTALLY
INCLUDED AS WELL IF YOU CAN
DEFINE THEM CORRECTLY.
>>ANY OTHER COMMENTS?
NANCY DAVIDSON.
>>BEAUTIFUL PRESENTATION.
I'VE BEEN WATCHING THIS OFF AND
ON FOR A NUMBER OF YEARS BUT
GETTING WHAT WE NEED AND NOT
DOING THE THINGS WE DON'T NEED.
DID YOU MAKE AN EFFORT TO THINK
ABOUT WHAT WOULD HAPPEN IF YOU
APPLIED THIS TO AN NCTN TRIAL OR
TWO?
IF YOU TOOK WHAT WE DID FOR THAT
TRIAL AND YOU TOOK WHAT WE MIGHT
HAVE DONE IF WE USED THESE
GUIDELINES, WE WOULD HAVE MISSED
ANYTHING BIG?
WE WOULD HAVE MISSED CONCERNS,
TOXICITY CONCERNS OR THINGS LIKE
THAT BECAUSE WE USED THESE
GUIDELINES?
IS IT POSSIBLE TO BOTTLE THAT?
>>THAT'S AN EXCELLENT QUESTION,
NANCY.
HAVE WE DONE THAT IN THESE
AREAS, PROBABLY NOT, BECAUSE
IT'S NOT VERY EASY TO IDENTIFY
STUDIES THAT YOU KNOW COLLECTED
ON MEDS AND THOSE ARE THE
EASIEST ONCE, WE NEVER UTILIZE
CON MEDS SO IT'S A WAY THAT
THERE WAS NOT A LOT OF VALUE FOR
THIS DATA COLLECTED.
IT'S KIND OF HARD TO TO THAT IN
A SYSTEMATIC WAY BUT THIS IS A
GREAT IDEA.
ONE OF THE THINGS THAT OTHERS
DID WAS TO GO THROUGH OUR CASE
REPORT FORUMS ACROSS A NUMBER OF
LARGE TRIALS AND THAT'S HOW WE
LANDED ON THESE PARTICULAR
CATEGORIES BECAUSE IT WAS VERY
INCONSISTENTLY COLLECTED AND IT
WASN'T STANDARD ACROSS TRIALS,
IT WAS NOT SYSTEMATIC AND
STANDARDIZED.
I'LL PUT IT THAT WAY.
THAT'S WHAT BROUGHT US TOGETHER
TO THINK THROUGH THESE SPECIFIC
DATA ELEMENTS AND SAY OK, WHY
ARE WE COLLECTING IT AND SOME
TRAILS NOT ON ALL TRIALS?
WHY DO WE COLLECT IT IN SUDDEN
WAYS AND TRIALS AND NOT
COMPREHENSIVE OTHERWISE SO WE
KIND OF, THAT'S WHERE WE LANDED
AND THE SECOND ONE I WILL SAY IS
IN TERMS OF HAVING TRIED TO SEE
IF WE DIDN'T COLLECT THIS WHAT
WOULD HAVE HAPPENED?
I DON'T THINK WE'VE DONE THAT
EXAM.
WE ARE, I WILL PUT A PLUG IN FOR
AN ALLIANCE DRIVE COMING UP.
WHERE WE ARE ATTEMPTING TO NOT
COLLECT ATTRIBUTION ON THAT
STUDY BECAUSE IT'S ON APPROVED
AGENTS AND RANDOMIZED STUDY AND
WE GOT IT FROM THE NCI AND STUDY
TEAM TO SAY OK WE ONLY COLLECT
WHAT THE STUDY TEAM IS REPORTING
WE CAN FIGURE OUT YOU KNOW, WHAT
JUST BY SUBTRACTING THE RATES OF
ADVERSE EVENTS WE WOULD BE ABLE
TO FIGURE OUT THE TREATMENT.
SO WE'RE MAKING SOME PROGRESS
WHILE WE ARE WORKING ON THIS BUT
YEAH, YOURS IS A GREAT QUESTION
AND WE SHOULD TAKE IT BACK TO
THE WORKING GROUP TO SEE IF
THERE'S A WAY TO ADDRESS THAT.
>>I WOULD JUST UNDERSCORE
EXACTLY WHAT YOU SAID AND THAT
IS THAT THE PROCESS THAT LED TO
THIS CATEGORIES, BASICALLY ASKED
THE GROUP TO PRESSURE TEST WHAT
IF.
WHAT IF WE ELIMINATED THIS.
WAS THERE -- WITH THESE DATA
THAT WERE COLLECTED ANALYZED IN
ANYWAY AT ALL?
AND WE FOUND THAT A LOT WERE
NOT.
ALSO, THE RELIABILITY OF CERTAIN
PARAMETERS WAS LOW.
SO FOR EXAMPLE, ATTRIBUTION, THE
COMMITTEE HIGHLIGHTED THAT WORK
HAD BEEN DONE TO SHOW
INCONSISTENCY AND ATTRIBUTIONS
FROM EVALUATOR TO EVALUATOR
WHICH LED US TO CONCLUDE THAT
ATTRIBUTION IS REALLY NOT USEFUL
AND AT LEAST THAT'S OUR
HYPOTHESIS FOR WHY IT FOUND ITS
WAY INTO THE RECOMMENDATIONS.
>>THANK YOU, VERY MUCH.
REALLY WONDERFUL WORKING GROUP
RESULTS, SO THANK YOU TO NEIL
AND THE TEAM.
>>THANK YOU.
>>MARK --
>>HI, CAN CAN YOU HEAR ME?
>>YEP.
>>GREAT.
>>Rachelle: , SO I WAS
FORTUNATE TO BE ABLE TO
PARTICIPATE AND I THINK WHICH
BACK WHEN THE ORIGINAL
RECOMMENDATIONS WERE COMING
ABOUT FOR THE 2030
RECOMMENDATIONS AND I WAS ABLE O
SIT IN MEETINGS US BECAUSE OF
EXEMPT MEANING THEY'RE NOT
TRIALS THAT WOULD BE INTENDED TO
SUPPORT A NEW INDICATION OR
MEANINGFUL CHANGES TO THE
LABELING, YOU HAVE A MUCH TIVE
CONSIDERATIONS FROM THE FTA
PERSPECTIVE AND WE HAVE
ABSOLUTELY HAPPY TO PARTICIPATE
IN A MORE, I GUESS, INTEGRATED
AND LONGITUDINAL WAY, WHEN YOU
START THINKING ABOUT THE
TRANSLATION TO IND STUDIES
CONDUCTED HERE AND ONE OF THE
THINGS THAT WE'RE CERTAINLY
THINKING ABOUT IS SITUATIONS IN
GENERAL WHERE COLLECTION OF
LIMITED DATA WOULD BE A
INTERESTED VERY SPECIFIC SCIENCE
QUESTIONS AND I JUST WANTED TO
HIGHLIGHT EVEN IN THE INDA
EXEMPT, WE'RE TALKING ABOUT
MARKET OF PRODUCTS SO THERE'S A
DIFFERENCE BETWEEN COLLECTION OF
SAFETY INFORMATION AND THE
REPORTING REQUIREMENTS, OF
COURSE, FOR MARKETED PRODUCTS
BUT NO I JUST WANTED TO SAY THAT
WE'RE HAPPY TO, AS THIS MOVES
FORWARD AND THINKING ABOUT WAYS
TO LIMIT DATA COLLECTION AND IN
THE IND AND YOU KNOW, SPACE AND
I'M HAPPY TO PROVIDE ADDITIONAL
INPUT.
>>YES, THANK YOU SO MUCH FOR
YOUR INPUT TO DATE AND YOUR
WILLINGNESS TO JUMP IN AS THIS
NOT FOLDS FURTHER.
YOU KNOW, TO THE POINTS THAT YOU
MADE AND THAT PATTY MADE
REGARDING CO STAKEHOLDERS,
THERE'S A RECOGNITION THAT WE
NOW NEED TO BROADEN OUT THE
LAYERS OF THE ONION IN TERMS OF
WHO IS WEIGHING IN AND TO BUILD
FURTHER CONSENSUS SO THAT IF THE
NCI CHOSES TO PURSUE A SET THE
STANDARD PRACTICES, THAT WE HAVE
STAKEHOLDER BUY IN SUCH THAT WE
HAVE ROBUST IMPLEMENTATION.
AT THIS FOR ALL COMMENTS.
WITH THAT, I WOULD LIKE TO MOVE
ON TO CONSIDERATION OF ACCEPTING
THE INTERIM REPORT.
SO, I WOULD LIKE A COMING TO MOO
ACCEPT THE INTERIM REPORT.
>>SO MOVED.
>>IS THERE A SECOND.
>>SECOND.
>>WOULD ANYONE LIKE ANY FURTHER
DISCUSSION?
OK, NOW BY A SHOW OF HANDS, I'M
ASKING IF ANYONE TUESDAY NOT
ACCEPT THE INTERIM REPORT.
SO LOOKING FOR THE NAYs.
BY SHOW OF HANDS, ANY AB
ABSTENTIONS.
OK, WE WILL THEREFORE CONSIDER
THE INTERIM REPORT ACCEPTED.
OK.
THANK YOU, EVERYBODY, FOR GOOD
DISCUSSION THERE AND WE HAVE ONE
MORE A AGAIN TA ITEM, 5 BEFORE
TAKING A QUICK BREAK.
AND THIS IS LEVERAGING THE NCTN
NCORP CLINICAL TRAILS
POPULATIONS FOR OBSERVATIONAL
CANCER SURVIVER SHIP RESEARCH
AND THIS PRESENTATION AND
DISCUSSION WILL BE LED BY Dr.
LISA GALLICCHIO FROM RESEARCH
PROGRAM AND IN THE DIVISION OF
CANCER CONTROL AND POPULATION
SCIENCES, WHICH IS THE TCRPS AT
THE NCI.
SO, LISA, IT'S ALL YOURS.
>>ALL RIGHT.
THANK YOU, INTEREST MEROPOL.
THIS WILL BE A INTERESTING
DISCUSSION IN LIGHT OF THE
PREVIOUS PRESENTATION ASK
DISCUSSION.
I AM PRESENTING THE FINDINGS
FROM OUR REQUEST FOR INFORMATION
ON LEVERAGING NCTN AND CLINICAL
TRIAL POPULATIONS FOR
OBSERVATIONAL CANCER SURVIVOR
SHIP RESEARCH.
THIS IS BEEN A THREE-DIVISION.
STAFF AT DCCPS AND DCP TCTD HAVE
BEEN INVOLVED AND SOME ARE ON
THE CALL TODAY.
HERE IS THE TIMELINE FOR OUR
REQUEST FOR INFORMATION WORK.
THIS REQUEST FOR INFORMATION WAS
DEVELOPED IN RESPONSE TO A 2019
NATIONAL CANCER ADVISORY BOARD
WORKING GROUP REPORT
RECOMMENDATION TO LEVERAGE NCTN
AND NCORP FOR CANCER SURVIVE OR
SHIP CO SHORTS STUDIES.
THIS WAS PUBLISHED IN THE NIH
GUIDE -- TO NOTE, WE HAD ONE
RESPONSE THAT WAS SUBMITTED FROM
THE RESEARCH BASE ECOG-ACRIN
FROM MULTIPLE INVESTIGATORS.
NEXT SLIDE.
WHAT THE RFI ASKED OF THE
COMMUNITY WAS WHAT RESEARCH GAPS
IN CANCER SURVIVE OR SHIP COULD
BE ADDRESSED BY LEVERAGING AS WL
AS THE AREA ON THE CANCER
SURVIVORSHIP WHERE WE BELIEVE
THERE'S THE GREAT OF THE
OPPORTUNITY TO FILL RESEARCH
GAPS AND LEVERAGE NCTN AND ENCOR
POPULATIONS.
AS THIS GROUP KNOWS, NCTN
SUPPORTS TREATMENT TRIALS WITH
ADVERTISE SEIZEDISEASE END PONTH
STUDIES AS WELL AS END-OF-LIFE
STUDIES TREATMENT-RELATED
ADVERSE EVENTS RESEARCH.
NCTN AND NCORP HAVE INITIAL
TREATMENT FOCUSED STUDIES SO
WITHIN THE FIRST FIVE YEARS OF
DIAGNOSIS FOR A PATIENT ALTHOUGH
THEIR FOLLOW-UP FOR THESE TRIALS
CAN BE LONGER.
WE SEE THAT THERE COULD BE AN
OPPORTUNITY TO LEVERAGE THESE
TRIAL POPULATIONS TO FILL SOME
GAPS IN THIS LONGER-TERM
SURVIVORSHIP PERIOD OR FIVE
YEARS POST DYING KNO DIAGNOSIS .
WHAT DID WE ASK?
FIRST SPECIFIC RESEARCH
QUESTIONS OR EVIDENCE GAPS IN
CANCER SURVIVORSHIP THAT CAN BE
ADDRESSED UTILIZING EXITING NCTN
ENCORE POPULATIONS AND SECOND,
TO CONDUCT OBSERVATIONAL
RESEARCH STUDIES UTILIZING THE
POPULATIONS.
THIRD, STRATEGIES TO USE
EXISTING INFRASTRUCTURE TO
SUPPORT LONG-TERM CANCER
SURVIVORSHIP STUDIES AND
FINALLY, INFRASTRUCTURE THAT
MIGHT BE NEEDED TO FACILITATE
LONG-TERM CANCER SURVIVORSHIP
STUDIES.
SO ON THE NEXT FOUR SLIDES, I'LL
SUMMARIZE SOME OF THE RESPONSES
TO THESE FOUR BULLET POINTS.
NEXT SLIDE, SO FIRST WITH
RESPECT TO RESEARCH QUESTIONS.
THE OVERWHELMING RESPONSE TO
THIS BULLET POINT WAS THESE
POPULATIONS CAN CAN BE LEVERAGED
TO FILL GAPS WITH OUTCOMES
ASSOCIATED WITH NEW OR
COMBINATION ANTI CANCER
THERAPIES INCLUDING AMINO
THERAPIES AND TARGETED THEORIES.
THERE WERE A NUMBER OF OUTCOMES
THAT WERE MENTIONED RELATED TO
THIS TOPIC.
AND SOME OF THEM ARE LISTED
HERE.
SECOND.
SOMETHING MENTIONED WAS
LONG-TERM SURVIVORSHIP OUTCOMES
AMONG INDIVIDUALS DIAGNOSED WITH
RARE CANCERS.
WHICH HEARD THE ROLE OF SOCIAL
DETERMINANTS ON LONG-TERM
SURVIVORSHIP AS WELL AS
TECHNOLOGY BASED STRATEGIES FOR
MANAGEMENT OF LONGER TERMS AND
CANCER TREATMENT WERE ALSO AREAS
THE COMMUNITY THOUGHT THESE
TRIAL POPULATIONS COULD BE
LEVERAGED TO FILL GAPS.
NEXT SLIDE.
THE SECOND BULLET POINT WAS
GENERAL METHODOLOGIES THAT CAN
BE UTILIZED TO ANSWER THESE
RESEARCH QUESTIONS WITH THESE
POPULATIONS.
FIRST, AND MENTIONED IN MULTIPLE
RESPONSES, WAS ESTABLISHING A
CLINICAL TRIAL SURVIVORSHIP
REGISTRY THAT ENCLOUDS ALL
PATIENTS ENROLLED IN NCTN
TREATMENT TRAILS AND NCORP
STUDIES FOR LONG-TERM CANCER
SURVIVORSHIP FOLLOW-UP STUDIES.
SECOND AND NOT SURPRISING,
CONDUCTING SURVEYS STUDIES FOR
LONGER TERM FOLLOW-UP DATA.
THIRD AND SOMETHING THAT SOME OF
THE RESEARCH BASIS AND
CO-OPERATIVE GROUPS HAVE BEEN
SUCCESSFUL IN DOING IS LINKING
CLINICAL TRIALS DID HE DO TO
MEDICARE, MEDICAID AND OTHER
CLAIMS.
FOURTH METHODS FOR DATA
COLLECTION SUCH AS THE EASY PRO
AND FINALLY, SOMETHING HAPPENS
MENTIONED BY ONE RESPOND AROUND,
SPECIFICALLY RELATED TO
HEALTHCARE DELIVER RE RESEARCH
WAS TO ESTABLISH A NETWORK OF
PRIMARY CARE PRACTICES WITHIN
NCORP FOR LARGE-SCALE STUDIES OF
SURVIVORSHIP CARE.
NEXT WERE THE BARRIERS THAT THE
COMMUNITY SAW IN CONDUCTING
LONG-TERM SURVIVORSHIP STUDIES
AND NCTN AND NCORP.
THIS WAS MENTIONED ON 99% OF THE
RESPONSES WAS THAT CLINICAL
TRIAL PATIENTS ARE NOT CONSENTED
FOR ANCILLARY OR FOLLOW-UP
STUDIES, A LOT OF THE TIMES.
NOT THINK A CENTRAL MECHANISM
AND TO BE IN LONGER TERM
FOLLOW-UP STUDIES OR ANCILLARY
STUDIES, THEY NEED TO BE
RECONSENTED AND THAT CAN CAN BE
PROBLEMATIC BECAUSE IT CAN BE
DIFFICULT TO RELOCATE TRIAL
PARTICIPANTS FOR RECONSENT OR
FOLLOW-UP.
SECOND, IT'S SOMETIMES DIFFICULT
TO GET COMMUNITY SITES TO OPEN
ANCILLARY STUD S AN SIL AR STUDY
BE INFORMATION WITHOUT RECONTACT
TO ENABLE STRONG LINKAGES AND
ONE RESPONDENT MENTIONED IT CAN
BE EXPENSIVE TO COLLECT
EPIDEMIOLOGIC DATA IN CLINICAL
TRIALS.
AND FINALLY, STRATEGIES TO
UTILIZE EXISTING NCTN AND NCORP
INFRASTRUCTURE FOR LONG-TERM
CANCER SURVIVORSHIP STUDIES.
ONE RESPONSE WAS THE ROUTINE
COLLECTION OF PATIENT CONSENT
FOR SURVIVORSHIP STUDIES AT THE
TIME OF CLINICAL TRIALS
ENROLLMENT AND RELATED TO THIS
IS DOCUMENT THIS INFORMATION
CENTRALLY WITH PATIENT CONTACT
INFORMATION AND AND A SMALL
NUMBER OF PATIENTS DEMOGRAPHIC
CHARACTERISTICS.
NEXT SLIDE.
SO, ONE COMMON THEME THAT I
MENTIONED ON ONE OF MY PREVIOUS
SLIDES, THROUGHOUT SOME OF THE
RESPONSES, WAS THIS IDEA OF THE
CLINICAL TRAILS SURVIVORSHIP
REGISTRY TO FACILITATE THESE
LONG-TERM CANCER SURVIVORSHIP
STUDIES.
THIS IS NOT A NEW IDEA.
IT WAS MENTIONED IN A MANUSCRIPT
PUBLISHED BY PATTY GANTZ IN
2009.
HERE IS ONE OF THE QUOTE FROM
ONE OF THE RESPONSE TO THE RFI
ABOUT WHAT THIS RESPONDENT
THOUGHT A CLINICAL TRIAL
REGISTRY WOULD ENTAIL.
WHAT IS NEEDED IS THE
ESTABLISHMENT OF A CLINICAL
TRIAL SURVIVORSHIP REGISTRY WITH
PARTICIPANTS ACROSS NCORP TRIALS
THROUGH ROUTINE COLLECTION OF
PATIENT CONSENT, AND COLLECTING
PATIENTS AGREEMENT TO BE
CONTACTED FOR FUTURE RESEARCH
AND PATIENT CONTACT INFORMATION
TO ALLOW INVESTIGATORS TO FEES
BLEE COLLECT DATA FROM LONG-TERM
COHORTS.
IMPLEMENTING A MECHANISM THAT
WILL ALLOW INVESTIGATORS DIRECT
ACCESS TO SURVIVE OR COHORTS
THROUGH CONTACTING POTENTIAL
PARTICIPANTS DIRECTLY AND
ASSUMING APPROPRIATE APPROVALS
WILL GREATLY MAXIMIZE
FEASIBILITY FOR SURVIVORSHIP
COHORT RESEARCH.
NEXT SLIDE.
HERE, I JUST, WE JUST PUT THIS
INTO FIGURE FORM.
THE CONCEPTUAL MODEL OF THIS
CLINICAL TRIAL SURVIVORSHIP
REGISTRY.
AGAIN, UPON CONSENT INTO THE
NCTN OR NCORP STUDY THE PATIENT
WOULD BE RECONTACTED IF HE OR
SHE CONSENTED TO RECONTACT, HIS
OR HER NAME, CONTACT
INFORMATION, AND CLINICAL TRIALS
INFORMATION WOULD BE PUT INTO A
REGISTRY.
DEMOGRAPHIC OR HEALTH
CHARACTERISTICS ARE OTHER
INFORMATION COULD BE COLLECTED
FOR THE PURVIEW OF THE CLINICAL
TRIALS SURVIVORSHIP REGISTRY
GOVERNING COMMITTEE.
DURING THE TIME THAT THE
PARTICIPANT IS PARTICIPATING IN
THE NCTN AND NCORP STUDY HIS OR
HER DATA WOULD BE UPDATED
THROUGH THE PARTICIPATE IN THOSE
STUDIES.
AFTER THE PARTICIPATION IN THOSE
STUDIES ENDED, FOLLOWING UP
THROUGH THE REGISTRY COULD
CONTINUE FOR A PERIOD OF TIME.
THROUGHOUT THE PARTICIPANT'S
PARTATION AND THE REGISTER TEE,
HE OR SHE O SHE COULD BE CONTACR
FURTHER STUDIES.
AFTER WE HAD SOME INTERNAL
DISCUSSIONS AT NCI, WE REACHED
OUT TO SURVIVORSHIP
INVESTIGATORS AT THE NCORP
RESEARCH BASES.
ENCLOUDED WAS WE TALKED TO HER
ABOUT THE CHILDREN'S ONCOLOGY
GROUP AND THE UMBRELLA PROTOCOLS
WHICH IS ONE MODEL OF CLINICAL
TRIALS SURVIVORSHIP REGISTRY.
BUT HERE I SUMMARIZED SORT OF
THE MAIN TAKEAWAY POINTS FROM
OUR CONVERSATIONS WITH THESE
SURVIVORSHIP INVESTIGATORS ABOUT
THE CLINICAL TRIAL SURVIVORSHIP
REGISTRY IDEA AND FIRST, IT
SEEMS THAT THERE WAS A HIGH
LEVEL OF ENTHUSIASM BY THE
SURVIVORSHIP INVESTIGATORS.
IT'S DISCUSSED BY ALL ENCORE
RESEARCH BASIS AND THIRD, MOST
OF THE INVESTIGATORS THAT WE
TALKED TO RECOGNIZE A NEED TO BE
CLINICAL TRIAL POPULATIONS FOR
IN CONCLUDED INTO THE REGISTRY
AND FOURTH MENTIONED BEFORE
THERE'S SOME EXISTING
INFRASTRUCTURE THAT COULD BE
UTILIZED FOR THIS REGISTER ARE
TREE AND FIFTH.
THE INVESTIGATORS THOUGHT THAT
PATIENTS WOULD BE WILLING TO
CONTENT TO BE IN A REGISTRY AND
THE PATIENT ENGAGEMENT AND
INVOLVEMENT OF PATIENT ADVOCATES
IS KEY.
WE ALSO DISCUSSED A NUMBER OF
KEY CONSIDERATIONS SUCH AS THE
PROJECTION OF PERSONAL HEALTH
INFORMATION, AS WELL AS THE NEED
TO PREVENT COLLECTION BY AS WITH
INTO THE REGISTRY.
OF COURSE.
THE PRIMARY BARRIER ACKNOWLEDGED
THROUGHOUT ALL OF OUR
DISCUSSIONS IS THE FUNDS TO
BUILD AND SUPPORT RECONTACT OF
PATIENTS ONCE IN THE REGISTRY.
SO IN SUMMARY, THIS REQUEST FOR
INFORMATION IDENTIFIED GAPS IN
RESEARCH PERTAINING TO CANCER
SURVIVORSHIP THAT CAN BE LEDGED
BY LEVERAGING NCTN CLINICAL
TRIAL ASK NCORP STUDY
POPULATIONS INCLUDING IN THESE
GAS NEW TREATMENTS AND TREATMENT
REGIMENT AND OUTCOMES AMONG
INDIVIDUALS WITH RARE CANCEL AND
SECOND BUILDING A CLINICAL TRIAL
REGISTRY COULD ALLOW
INVESTIGATORS TO EFFICIENTLY
LEVERAGE NCTN CLINICAL TRIALS
AND STUDY POPULATION FORCE
CANCER SURVIVORSHIP RESEARCH.
NEXT BEFORE I END, I WANT TO
ACKNOWLEDGE THERE ARE MANY GAPS
IN KNOWLEDGE REGARDING THE
PATIENT POPULATIONS ELIGIBLE FOR
THE REGISTRY AND PATIENT
WILLINGNESS TO THE WORKLOAD BY
THE END CORE AND COOPERATIVE
GROUPS TO CONSENT AND COLLECT
DATA GIVEN THE CURRENT WORKLOAD
ALREADY AND A RESEARCH BASE
ABILITY TO CONDUCT FOLLOW-UP AND
FOR HOW LONG.
OTHER.
>>Tara: TO BE COLLECTED AND I
THINK WE JUST HEARD IN THE
PREVIOUS PRESENTATION ABOUT
LIMITING DATA COLLECTION SO IT'S
A CONSIDERATION, AND OF COURSE,
THE BIG GAP IN KNOWLEDGE IS THE
PROJECTED EFFORT AND COST FOR
BUILDING AND MANAGING A REGISTRY
AND CONDUCTING FOLLOW-UP.
THANK YOU FOR THE WITH FOR
INFORMATION AND I HAVE A COUPLE
DISCUSSIONS POINTS HERE THAT WE
CAN DISCUSS IN THE NEXT SEVERAL
MINUTES.
OTHER ADDITIONAL GAPS IN CANCER
SURVIVORSHIP KNOWLEDGE NOT
MENTIONED IN THIS PRESENTATION
TA YOU THINK THE STUDY
POPULATIONS CAN CAN BE LEVERAGED
TO ADDRESS.
WHAT DO YOU THINK OF THIS
CLINICAL TRIAL REGISTER
TREMENDOUS CONCEPTUAL MODEL AND
WHAT ARE THE PROS AND CONS OF
VERYING A CLINICAL TRIAL
SURVIVORSHIP REGISTER TREE FOR
OBSERVATIONAL CANCER
SURVIVORSHIP RESEARCH.
THANK YOU.
>>THANK YOU SO MUCH FOR THIS
PRESENTATION.
A LOT TO CHEW ON HERE AND
APPARENTLY A SUBSTANTIAL
OPPORTUNITY.
SO, I'D LIKE TO OPEN THIS UP TO
MEMBERS OF CTAC FOR DISCUSSION.
VICTOR SANTANA.
>>THANK YOU, NEIL.
THANK YOU, LISA.
I'M A PEDIATRIC ONCOLOGIST SAYS
YOU KNOW FROM MY NAME AND WHERE
I'M AFFILIATED WITH.
AS I WAS LISTENING TO THIS, THIS
IS REALLY IMPORTANT BUT THERE
WERE TWO ISSUES THAT YOU CAN
DIDN'T MENTION THAT YOU MAY WANT
TO CONSIDER AS THIS GETS
DEVELOPED FURTHER.
ONE IS THE BIDIRECTIONAL TEE OF
THE REGISTRY, RIGHT.
RIGHT NOW THE WAY YOUR
CONCEPTUALIZING ALL THE
INFORMATION IS FLOWING FROM A
PRIMARY GROUP OR A PRIMARY
NUMBER OF CLINICAL TRAILS INTO A
REGISTRY AND THEN SOME OF THAT
BASIC INFORMATION ON PATIENTS
WILL LEAD TO IDENTIFICATION OF
PATIENTS OR POPULATIONS THAT MAY
BE ELIGIBLE FOR OBSERVATIONAL
STUDIES OR OTHER TYPES OF
STUDIES BUT WHAT YOU LEARN FROM
THOSE STUDIES, HOW IS THAT.
>>Tara: DATAFEEDING BACK INTO Y
STUDIES THAT MAY HAVE IMPORTANT
INFORMATION FOR THEM, RIGHT.
FOR EXAMPLE, LONG-TERM ADVERSE
EVENTS FOR THINGS LIKE THAT WERE
NOT COLLECTED AS PART OF THE
PRIMARY OUTCOMES OF THE PRIMARY
STUDIES, IT'S MORE OF A PROCESS
ISSUE RATHER THAN A CONCEPTUAL
ISSUE BUT IT'S GOING TO BE
REALLY IMPORTANT TOO SO THAT
THERE'S VALUE FROM THE OTHER END
NOT JUST THE REGISTER TREE.
YOU THINK ABOUT RESEARCH IN THIS
AREA AND I KNOW IT'S NOT THE
PURPOSE OR THE PRESENTATION
TODAY AND WE CAN CAN TALK MORE
ABOUT THAT BUT THE THING WE FACE
IN PEDIATRICS IS THE TRANSITION
OF CARE FROM CHILDREN WHEN THEY
BECOME YOUNG ADULTS AND THEN HOW
THAT TRANSITION OF CARE AND
SURVIVORSHIP OCCURS OUTSIDE OF
THE PRIMARY PEDIATRIC CENTER.
THINKING OF THAT AS A POTENTIAL
WAY TO BUILD A REGISTRY THAT
ALSO REFLECTS THAT TRANSITION OF
CARE AND ALL THE ISSUES THAT ARE
ASSOCIATED WITH THAT AND SHE MAY
HAVE COMMENTS ABOUT THAT BUT
THOSE ARE MY TWO OBSERVATIONS,
IT'S A FANTASTIC IDEA.
THESE ARE MORE JUST PROCESS
ISSUES, THANK YOU FOR ALLOWING
ME TO COMMENT.
>>THANK YOU, GREAT COMMENTS.
>>DO I HAVE PERMISSION?
>>YOU CERTAINLY DO, THANK YOU
FOR STEPPING FORWARD.
>>HI, LISA, THANK YOU FOR
PRESENTING THIS.
AS YOU WERE PRESENTING IT, I WAS
THINKING THAT THIS IS ALREADY,
WORE DOING THIS IN PEDIATRICS SO
WHAT WE ARE DOING, AND I'M
LEADING THE EFFORT, IS THAT AT
THE TIME WHEN A CHILD GETS DONE
WITH THEIR TREATMENT, THEY'RE
ENROLLED WITHIN SIX MONTHS ON A
LONG-TERM FOLLOW-UP CENTER.
AND WE THEN FOLLOW THEM FOR LIFE
BY ANNUALLY CONTACTING THEM TO
MAKE SURE THAT WE ARE STAYING
UP-TO-DATE ON THEIR CONTACT
INFORMATION WE ASK THEM FOR A
BRIEF SURVEY USING PROMISE
MEASURES.
THIS IS FOR LIFE.
ALL CHILDREN.
AND VICTOR BROUGHT NOT THE ISSUE
ABOUT WHAT HAPPENS WHEN THEY
RAGE THE AGE OF MAJORITY AND SO
WE RECONSENT THE PATIENT AT THAT
TIME WHEN THEY TURN 18 SO THE
BATON PASSES OFF FROM THE
PARENTS TO THE PATIENT THEM
SELLS TO THE SURVIVE OR
THEMSELVES AND I WANTED TO BRING
UP A DIFFERENT ISSUE, SO THIS IS
SOMETHING THAT WE DO ANYWAY.
WE ALSO AT THE TIME OF DIAGNO
DIAGNOSIS, OBTAIN THE COCK
INFORMATION AS WELL AS CONSENT
FOR FUTURE CONTACT.
BUT, THE LONG-TERM FOLLOW-UP
CENTER BRIDGES THAT EFFORT
BECAUSE YOU CAN CAN OBTAIN THAT
CONTACT INFORMATION BUT THE
UNITED STATES POPULATION IS SO
MOBILE, RIGHT, AND ESPECIALLY AT
LEAST IN OUR POPULATION, THEY
POV FROM PLACE TO PLACE AND THE
CONTACT GETS LOST FAST.
THAT'S WHY THE LONG-TERM
FOLLOW-UP CENTER MAINTAINS THE
REGISTRY AND DEVELOPS THE
INFRASTRUCTURE FOR DOING ANY
SURVIVORSHIP WORK THAT WE MIGHT
WANT TO DO WITH THESE PATIENTS.
COMING BACK TO THE QUESTION OF,
IS THIS POPULATION GOING TO BE
THE ADULT POPULATION, IS IT
GOING TO BE REPRESENTATIVE OF
SURVIVORSHIP AND THE GENERAL
CANCER POPULATION, AND THAT IS
SOMETHING THAT ONE SHOULD PAUSE
AND GIVE SOME THOUGHT TO IS THAT
LESS THAN 10% OF THE PATIENTS
ARE BEING PLACED ARE MUCH LESS
THAN 10% ARE BEING PLACED ON
CLINICAL TRIALS SO DOES THAT
REPRESENT WHAT IS GOING ON IN
TERMS OF OUTCOMES IN THE GENERAL
POPULATION AND THAT'S ALL I HAVE
TO SAY.
>>THANK YOU.
ALONG THOSE LINES.
I WOULD LOVE TO HEAR LISA
WHETHER THIS QUESTION CAME UP
ABOUT INCLUDING INDIVIDUALS IN
THE REGISTRY WHO HAD NOT TAKEN
PART IN A PUBLIC AND ENROLLED
AFTER A STANDARD OF CARE REAL
WORLD AND.
>>IT DIDN'T COME UP AND THAT IS
A GOOD POINT.
HOW DO YOU EGGMENT THE
POPULATION THAT IN CLINICAL
TRIALS WITH PERHAPS MORE REAL
WORLD PARTICIPANTS TO GET A
BETTER REPRESENTATION OF THE
SURVIVE OR POPULATION.
>>ONE OTHER COMMENT I WOULD
MAKE AND HEARING ALL OF YOUR
PRESENTATIONS, AND I WAS STRUCK
BY THE COMMENT ABOUT HOW
EXTENSIVE SUCH A SYSTEM COULD BE
AND I WONDER WHETHER THERE ARE
PUBLIC PUBLIC PRIVILEGE AT
PARTNERSHIP AROUND SPECIFIC
RESEARCH QUESTIONS AND THAT CAN
HELP SUPPORT SUCH AN ENTERPRISE.
>>WE HAVEN'T GOTTEN THAT PAR
BUT IT'S A GOOD POINT.
>>I WOULD LIKE TO TALK YOU
ABOUT THE LONG-TERM FOLLOW-UP
CENTER WE HAVE AND IN THE
PEDIATRIC POPULATION WE FUNDED
IT.
>>>>IT'S CLEAR THAT COG IS
YOUR GROUP IS WAY AHEAD OF THE
OTHER GROUPS IN TERMS OF LOOKING
AT THESE POPULATIONS FOR LONGER
TERM SURVIVE OR STUDIES AND
LEVERAGING THEM.
>>IF WE CAN LEARN, WE CAN TAKE
WHAT HAS WORKED.
>>PATTY SPEARS, YOU HAVE YOUR
HAND UP.
>>I'M A SURVIVOR AND I THINK
THIS IS A GREAT IDEA.
BEYOND 10 YEARS, I LIKE HOW THEY
DO THE LIFETIME OF THE PEDIATRIC
PATIENTS THAT WOULD BE REALLY
HELPFUL AS WELL BUT TOO, I THINK
LISTENING TO THE SURVIVORSHIP
POPULATION IS THE OFFICE OF
CANCER SURVIVORSHIP AT THE NCI
REALLY HAS BEEN REALLY COGNIZANT
OF REALLY RECOGNIZING THOSE
PATIENTS THAT ARE ALSO LIVING
WITH METASTATIC DISEASE AND
ADVANCE DISEASE AND IT'S A
POPULATION THAT'S REALLY MISSING
FROM THIS.
I THINK THAT WE HAVE A LOT OF
LONG-TERM SURVIVE OR IN THAT
FIVE TO GREATER THAN 10 YEAR
RANGE NOW AND THAT POPULATION
NOW THAT THE OUTCOMES AND
QUESTIONS MIGHT BE DIFFERENT BUT
I THINK IT WOULD BE REALLY
HELPFUL TO ACTUALLY PUT THEM IN
THE CATEGORY THAT THEY
ACKNOWLEDGE THEY'RE ALSO SURVIVE
OR IN THERE BECAUSE IT'S A REAL
BIG PUSH OF THE OFFICE OF CANCER
SURVIVORSHIP AND IT WOULD BE
MORE INCLUSIVE OF A -- OTHERWISE
YOU REALLY NEED TO CHANGE THE
NAME TO A LONG-TERM EARLY STAGE
CANCER SURVIVORSHIP PROGRAM TO
REALLY BE CLEAR OF WHAT YOU ARE
LOOKING AT.
I WOULD JUST KEEP THAT IF MIND
AS YOU GO FORWARD.
>>THANK YOU.
AND WE DEFINITELY DO NOT MEAN TO
EXCLUDE THEM FROM OUR
DEFINITION, WE ACKNOWLEDGE THAT
THEY ARE PART OF THE CANCER
SURVIVORSHIP COMMUNITY.
>>SO, I REALLY LIKE THIS
DESPITE THE FACT WE JUST
FINISHED THE TALK ABOUT BURDEN
OF DATA.
I DO THINK THAT THERE ARE
SEVERAL WAYS IN WHICH THIS CAN
BE UTILIZED, EVEN HOW OUR
CURRENT TRIAL INFRASTRUCTURE IS
BUILT WHERE SOME TRIALS FOLLOW
OUR PATIENT FOR 10 YEARS AND 10D
SOME FOR FIVE YEARS AND FOLLOW
THE PATIENTS INTO THE SORT OF
REGISTRY OR A DATABASE WHERE YOU
DON'T PUT THE BURDEN ON
INDIVIDUAL TRIALS AT THAT POINT
AND YOU MINIMIZE THE DATA
COLLECTION AND THEN YOU MOVE
THEM TO THE SORT OF REGISTRY
HOWEVER WE ENVISION THAT
REGISTER WOULD BE STRUCTURED AND
IT WOULD DEFINITELY ACTUAL LIE
TIE IN WELL WITH WHAT WE JUST
PRESENTED.
IF WE TRY TO STAND THIS UP AS AN
INDEPENDENT REGISTRY AND
CONTINUE COLLECTION HERE AND
THEN IT'S NOT GREAT.
WE HAVE TO THINK ABOUT HOW WE
CAN PARTNER WITH WHAT WE JUST
HEARD AND THE NEWS IS REGISTRY
TO REALLY UTILIZE HOW WE COLLECT
DATA ON ALL CLINICAL TRIALS
BEYOND A CERTAIN POINT AND DO WE
HAVE TO COLLECT ALL THAT
INFORMATION ON INDIVIDUAL
CLINICAL TRIALS SO CAN CAN WE
USE THIS REGISTRY TO MINIMIZE
DATA COLLECTION AND LEVERAGE A
LOT MORE INFORMATION ON THESE
PATIENTS FOR LONGER TERM SO
YEAH, SO I REALLY LIKED THIS
IDEA BUT I THINK THERE'S A LOT
TO THINK THROUGH.
>>I LOVE THAT COMMENT.
THE PARTNERING WITH INSTEAD OF
ONE WAY OR THE OTHER WAY.
THANK YOU.
>>LEASE A. I'L
>>LISA, WHAT ARE THE NEXT
STEPS?
>>WE'RE JUST COLLECTING
INFORMATION AND DISCUSSING THIS
INTERNALLY AMONGST THE
DIVISIONS.
IT'S VERY COMPLICATED AND IT'S
MADE EVEN MORE COMPLICATED BY
THE FACT AS YOU SAID IN THE LAST
PRESENTATION, CLINICAL TRIALS,
IT'S SUCH A COMPLEX SYSTEM AND
THE WORKLOAD IS IMMENSE ALREADY.
SO, I REALLY LIKE THE LAST
COMMENT ABOUT PARTNERING AND
FIGURING OUT HOW TO DO THIS
WITHIN THE STRUCTURE OF ABOUT
WHAT IS THERE BECAUSE I THINK IT
CAN CAN BE DONE, YOU HAVE TO
FIGURE OUT HOW TO DO IT.
>>THANK YOU SO MUCH.
WE'RE NOW GOING TO TAKE A BREAK,
EVERYBODY DESERVES TO STRETCH
THEIR LEGS.
IT IS 1:10 AND EASTERN TIME AND
WE'LL RECONVENE IN 15 MINUTES.
AT 1:25 EASTERN.
SEE YOU ALL BACK THEN.
>>WELCOME BACK,
EVERYBODY.
WE ARE ABOUT TO EMBARK ON AGENDA
ITEM 6.
WHICH IS AN INFORMATIONAL ITEM
WITH AN OPPORTUNITY FOR
DISCUSSION AFTERWARDS.
THIS IS CANCER SCREENING TRIALS
WORKING GROUP.
WITH AN UP TATE ON
IMPLEMENTATION OF THEIR
RECOMMENDATIONS.
THIS PRESENTATION WILL BE CO LED
BY Dr. McCASKILL-STEVENS AND
RESEARCH GROUP AT THE NCI Ms.
LINDA PARRECO, A NURSE
CONSULTANT IN THE TA VISION OF R
PREVENTION AT NCI.
>>THANK YOU, NEIL.
GOOD AFTERNOON, EVERYONE.
I'M PRESENTING ON THE NCI'S
IMPLEMENTATION OF
RECOMMENDATIONS FROM THE WORKING
GROUP AND I'M GOING TO TALK
ABOUT PART 1.
TMIST.
A BIT OF BACKGROUND ABOUT THE
WORKING WORK.
IT WAS ESTABLISHED IN NOVEMBER
OF 2020 MANY OF THE PURPOSE OF
THE WORKING GROUP WAS TO ADVISE
THE NCI DIRECTOR AS WELL AS CT
AC ON THE REAL WORLD IMPACT ON
COVID.
THE ON GOING TRIAL AND THE
LARGEST AT THE TIME WAS FOCUSED
TO BE FOCUSED ON THE IMAGING
TRIAL OR TMIST.
THERE WERE THREE VIRTUAL WORKING
GROUP MEETINGS BETWEEN
DECEMBER 2020 AND FEBRUARY OF 21
TATE.
THERE WERE 12 MEMBERS ON THE
COMMITTEE THAT EXPERTISE AND
BREAST CANCER IN BREAST CANCER
CLINICAL TRIALS AND OTHER EXTRA
SCREENING EXPERTISE IN THIS
AREA.
THERE ARE TWO SETS OF
RECOMMENDATIONS AS I MENTIONED.
I'M GOING TO DO THE TMIST AND
LINDA WILL PRESENT ON DCP'S
CANCER SCREENING TRIALS IF
GENERAL.
ON BEHALF OF THE TRANS DCP
CLINAL TRIALS WORKING GROUP.
SO, JUST A BIT OF BACKGROUND ON
TMIST.
THE PRIMARY OBJECTIVE OF THIS
STUDY WAS TO DETERMINE WHETHER
THE CUMULATIVE RATE OF ADVANCE
CANCERS IN BREAST CANCER IN
WOMEN UNDERGOING SCREENING WITH
DIGITAL MAMMOGRAPHY AND TOM OWE
SYNTHESIS IS REDUCED WITH
GENERAL MAMMOGRAPHY ALONE.
JUST AS A BIT OF INFORMATION,
PARTICIPANTS MET THEIR PRIMARY
IMPORT AT THE ADVANCED CANCER AT
ANY TIME DURING THE PERIOD OF
4.5 YEARS.
SO AFTER ACTIVE SCREENING TO THE
LAST SCREENING ROUND, PRE
MENOPAUSAL WOMAN WERE RANDOMIZED
TO ANNUAL SCREENING, POST
MENOPAUSAL WOMAN TO BY ANNUAL
SCREENING UNLESS ME MET THE
CRITERIA FOR INCREASED RISK.
A SAMPLE SIZE OF 64,000
PARTICIPANTS WITH COMPLETE DATA
IN HARMS PROVIDED A 90% POWER TO
DETECT A RELATIVE REDUCTION OF
20% AND AFTER THE ADJUSTMENT,
THE SAMPLE SIZE IT WAS 164,000
AND IT HAD INCLUDED IN IT A BUY
REPOSITORY FOR WHICH BIOPSIES
THAT WERE SUBMITTED WERE TO BE
MOLECULAR CHARACTERIZED, THERE
WAS TISSUE OF BLOOD AND BUCKLE
CELLS AS WELL.
I HAVE LISTED AT THE BOTTOM OF
THE SLIDE THE DEFINITION OF
ADVANCE BREAST CANCER
ESSENTIALLY WAS DIS STAND
DISEASE, SMALLER TUMORS THAT ARE
VERY HIGH-RISK AND ANY INVASIVE
CANCER THAT WAS GREATER THAN TWO
CENTIMETERS UNLESS IT MET THE
CRITERIA FOR A GOOD PROGNOSIS OF
SUBTYPE.
SO, THE OVERARCHING
RECOMMENDATION FOR TMIST FROM
THE WORKING GROUP WAS THE TMIST
SHOULD CONTINUE WITH
MODIFICATIONS HELPING TO
EXPEDITE TO BE COMPLETED MORE
QUICKLY AND TO ANSWER THE
PRIMARY QUESTION IN MAXIMIZING
THE LIKELIHOOD THAT THE
INSTITUTE IN QUESTION WOULD
RESULT IN INFORMED INFORMATION
FOR THE PATIENT AND TO ENHANCE
SCREENING RESEARCH.
SO, IN DECEMBER OF 2021, THERE
WAS AN AMENDMENT AFTER
SIGNIFICANT DISCUSSIONS ABOUT
THE RECOMMENDATIONS AND HERE ARE
THE CHARACTERISTICS OF THE
DESIRED MODIFICATIONS.
PARTICIPANTS WOULD REACH THE
PRIMARY END POINT AT THE
CURRENTS OF ADVANCE BREAST
CANCER AT ANY TIME UP TO SEVEN
YEARS FROM RANDOMIZATION.
TIME TO INVENT AND IT WAS
POWERED AT 85% CONTINUE OF THE
20 PER PRODUCTION IN ADVANCE
CANCER AT 4.5 YEARS OF
RANDOMIZATION.
AFTER FOLLOW-UP LOSS, ACROSS
OFFERS THE SAMPLE SIZE GOING
INTO THE CONTINUED TRIAL WAS
128,905.
THERE WERE NO CHANGES WITH THE
BIO REPOSITORY.
IT WAS CITED TO BE A SIGNIFICANT
RESOURCE MOVING FORWARD.
SO, ONE OF THE RECOMMENDATIONS
WAS TO ESTABLISH A REALISTIC
TIME FOR OVER ALL MINORITY
ACCRUAL AND CRY TER WHY FOR
TERMINATION AND THE STUDY GOES.
SO THE PROTOCOL TRIAL DESIGN
MODIFICATIONS, AS THEY ARE NOW,
ARE EXPECTED TO END THE TRIAL IN
2024, EARLY 2025.
THE.
>>Tara: SFURTHER RECOMMENDATIOY
AND HE HAVE EFFICACY AND 50% A
PERSON YEAR FOLLOW-UP DATA IS IN
HAND MANY OF THE CONDITIONAL
POWER FOR FUTILITY ANALYSIS IS
25% SUCH THAT IF THE CONDITIONAL
POWER IS LOWER THAN THAT, AT THE
TIME THE TIME OF ANALYSIS THE
RECOMMENDATION WOULD BE TO STOP
THE TRIAL.
OVER ALL RECRUITMENT AND
ENROLLMENT ARE MONITORED IN MANY
WAYS AT MANY TIMES POINTS WITHIN
AN END CORE WE HAVE MONTH LOO
DISSEMINATION AND MORE OFTEN
THAN NOT MORE FREQUENTLY
DEPENDING UPON REQUEST FROM
CONGRESS OR OTHER MEDIA, THE
COMMITTEE MEETS MONTHLY AS DOES
A COMMITTEE THAT'S LED BY THE
PROJECT DIRECTOR WITH THE
TECHNICAL WITH IT AND THAT IS
MONTH LOO AND BY ANNUALLY
THERE'S A DESIGNATED DATA SAFETY
MONITOR MEETING FORAY
ACHIEVEMENT.
MINORITY ENROLLMENT IN ADDITION
TO A NETWORK WITH A TARGET WITH
SPECIFIC POPULATIONS AND
ENROLLMENT AND IS MONITORED BY
PARTICIPATING SITE AND TO
INCENTIVIZE THOSE WHO NEED
ADDITIONAL HELP OR SOME OF THE
TOOLS THAT WE HAVE IF HOUSE AND
WE SHARE BEST PRACTICES AND
SUPPORT NEW INITIATIVES IN SIGHT
FOR EXAMPLE, VIRTUAL NURSE IN
LOUISIANA THAT HAS DONE
TREMENDOUS JOB IN REACHING OUT
THROUGHOUT THE STATE FO FOR
ENHANCING AND ENGAGING THE HBC
AND OPENING SITES THAT HAVE NOT
HAD ACCESS OR PARTICIPATING
IMAGING GROUPING THAT HAVE
PARTICIPATED IN CLINICAL TRIALS
SUCH AS IN MISSISSIPPI.
ANOTHER CONSIDERATION WAS THE
INCORPORATING AND TO THE ADVANCE
DEFINITION OF BREAST CANCER WAS
GENOMIC INFORMATION INTO THE
DEFINITION AND THE STUDY TEAMS
THIS TOOK PLACE WHEN WE WERE AT
41,000 INDIVIDUALS.
SO, ANOTHER RECOMMENDATION WAS
TO NOT SURE THAT THE.
>>Tara: COLLECTION FOR THE
SECONDARY ENDPOINTS WERE INCLUDE
AND HAD STATISTICAL PLANS.
THE PROTOCOL AMENDMENT WAS DONE
IN THE YEAR HAS BEEN AMENDED
WITH FULL ANALYSIS PLANS FOR ALL
OF THE STEADY AIMS.
I SHARE WITH YOU THAT I WON'T GO
THROUGH ALL THE SECONDARY
ENDPOINTS BUT THEY HAVE IMAGING
ASSESSMENT, LONG-TERM FOLLOW-UP,
BIOLOGY AND MEDICAL PHYSICS.
WE'VE BEEN HAVING ON GOING WITH
WHAT WAS REFERENCED IN THE
REPORT.
THERE ARE RANDOMIZED TRIALS IN
THE U.K., GERMANY AND NORWAY AND
THE LAST TWO FROM GERMANY AND
NORWAY HAVE ALREADY BEEN
PUBLISHED AND WE HAVE SCHEDULED
A MEETING TO MEET THE NEXT
COUPLE OF WEEKS WITH THE U.K.
TRIAL WHICH IS STILL ON GOING
TRIAL AND WE HAVE A COMMITMENT
FROM ALL OF THEM TO SHARE DATA
AND THINK ABOUT WAYS IN WHICH WE
MIGHT COLLABORATE ON SECONDARY
IMPORTS.
NEXT SLIDE, PLEASE.
SHOWN HERE IS THE ENROLLMENT
FROM THE INCEPTION OF THE TRIAL.
I'VE HIGHLIGHTED THE TIME OF
PEOPLE -- CIRCLE ONE IS THE LAST
TIME WE PRESENTED AT ABOUT
41,000 IN MARCH.
AND WHERE WE ARE NOW.
AS OF TODAY, THERE IS 78,186
PARTICIPANTS IN THE TRIAL WITH
124 SITES WITH ABOUT 12 SITES IN
LINE TO OPEN THEIR TRIAL IN A
COUPLE OF WEEKS.
AND WE SEE VALLEYS AND PEAKS.
SOME ARE CHARACTERIZED BY
VARIABILITY WE SEE IN SCREENING
IN GENERAL AND AROUND THE
HOLIDAYS AND WE HAVE POST COVID
EFFECTS WITH.
>>Saphia: ING STAFFING.WE'RE CE
CONFIDENT WITH THE NEW
ONBOARDING AND THE CONTINUED
INTEREST IN THE TRIAL COMING ON
AS NEW SITES THAT THIS WILL
CONTINUE.
NEXT SLIDE.
SHOWN HERE ARE THE DEMOGRAPHICS
OF THE PARTICIPANTS.
AS YOU CAN SEE, WE HAVE
CATEGORIZED THAT BY U.S.,
CANADA, WHICH WAS THE LEAD
ORGANIZATION FOR THE 3,000 LEAD
IN STUDY.
THE INTERNATIONAL PARTICIPATION
AS WELL.
THERE WAS AN INTEREST IN THE
MINORITY ACCRUAL.
WE WERE AT 20% WHEN WE WERE LAST
AND 21% NOW SO WE'VE HAD
STRATEGIES IN PLACE TO SUSTAIN
AND HOPEFULLY INCREASE OUR
MEMBERS AND OF COURSE WE'LL HAVE
DATA FROM SOUTH AMERICA FOR
THOSE WHO PRESENT THEMSELVES AS
A REPORT THEMSELVES AS BEING
HISPANIC AND GIVE US AN
OPPORTUNITY TO LOOK AT THE
MOLECULAR DIFFERENCES MANY OF
THESE POPULATIONS THAT ACTUALLY
EMIGRATE INTO THE STATES.
I'M SHOWING THE RESULTS OF THE
BY REPOSITORY FUNDED BY THE
BREAST CANCER STAMP SO THIS THE
TOP CORNER IS WHAT HAPPENED IN
MARCH AT THE LAST PRESENTATION
AND WHERE WE ARE NOW SO, WHAT WE
SHOW IS FOR BLACK AND AFRICAN
AMERICAN WHICH WAS A SUBGROUP OF
INTEREST, IN THE MEETING IS THAT
THE THERE'S BEEN A LITTLE
DECREASE AND TO COLLECT THE
BUCKLE SPECIMENS DURING THE
COVID AND THERE WAS AN AMENDMENT
MADE TO THE TRIAL WHICH CHANGED
FROM BEING ABLE TO CONSENT AND
COLLECT SPECIMENS ANY TIME
DURING THE ROUNDS AND NOW, OR
BLOOD THE SPECIMENS HAVE TO BE
COLLECTED THAT T2 SO FOR THE
BUCKLE AT T3 IS WE IT WAS FUNDED
AND COMMON FOUNDATION GRANT TO
ENHANCE AND TO HOPEFULLY CHANGE
THE CULTURE WITH MORE TO
INCREASE MORE FOR AFRICAN
AMERICAN WOMEN AND FOR OUR BY
OWE SPECIMEN COLLECTION.
SO, IN SUMMARY, I'D LIKE TO
SHARE WITH YOU SOME OTHER
MODIFICATIONS WHICH WE THINK IT
WILL CONTRIBUTE TO ENHANCING AND
SUSTAINING THE INTEREST IN THE
TRIAL CONTRIBUTING TO THE
SCIENCE OF SCREENING.
ONE IS THAT ON THE SITE LEVEL,
WE HAVE REDUCED SOME OF THE
QUALITY FREQUENCY OF QC
REPORTING.
WE WILL STILL REQUIRE THAT THE
SITES COMPLY WITH THE
MAMMOGRAPHY AND THE FDA AND WE
HAVE A CATEGORY OF SITES THAT
HAVE GREAT PERFORMANCE AND WE'LL
HAVE A LESS FREQUENT COLLECTIONS
OF DATA WE HAD SOME WORK AROUNDS
INITIALLY SO WE HOPE THIS
MODIFICATIONS FOR NON ONCOLOGY
DISCIPLINES WILL HELP AND ALLOW
OTHER SITES TO CONTINUE TO COME
IN AND WE NEED TO WORK WITH OUR
COMMUNICATIONS PEOPLE TO HELP US
PROMOTE SPANISH PARTICIPATION IN
THE TRIAL AND THE BIO SPECIMENS
AS WELL AND WE HAD BEEN ABLE TO
INCENTIVIZE THOSE SITES THAT
HAVE BEEN EXTREMELY HIGH ACCRUE
ALS AND OVER TIME, AS THE WOMEN
RETURN FOR THEIR SUBSEQUENT
ROUNDS, IT'S SIGNIFICANTLY
CAUSING A BURDEN ON THE SITES SO
WE HAVE INSEN TA VO INCENTIVIZEE
HAVE BEEN AT LEAST OVER A
HANDFUL OF SCIENTIFIC INTEREST
IN THE UTILIZING THE TMIST
DATABASE OR INCORPORATING THOSE
INTO IT.
AND THE INTEREST OF TIME I'M
JUST GOING TO MENTION THROW OF
THOSE, ONE OF THEM IS A
COLLABORATION WITH ALL OF US AND
TMIST DESIGNED FOR PRECISION
SCREENING FOR ADVANCES CANCER,
IMAGE FAIL YOUR AND FALSE
POSITIVE AND ANOTHER EXAMPLE IS
COMPARING MRIs WHERE VERSUS
CONDITIONAL DYING THIS IS TICK
IMAGING AND THOSE PATIENTS WHO
ARE PRESENTING FOR DIAGNOSTIC
RISK IMAGING AND FINALLY, THE
DEVELOPMENT OF PROGNOSTIC
THERAPY USING A TOOL WITH THE
DATABASE AND SO ON THAT, I'M
GOING TO END AND TURNED THE
PODIUM OVER TO LINDA.
>>THANK YOU.
I'M LINDA AND I'M A NURSE
CONSULTANT IN THE DIVISION OF
CANCER PREVENTION I'LL HAVE AN
UPDATE ON DCPC PROGRESS IN THE
OVERARCHING RECOMMENDATIONS.
THE WORKING GROUP SHE HAD
OVERARCHING RECOMMENDATIONS THAT
ENCOURAGED OUR DIVISION, DCP, TO
LOOK AT OUR ENTIRE SCREENING
PORTFOLIO AND ENSURE WE HAVE A
PLAN FOR MONITORING OVER ALL
ACCRUAL AS WELL AS ACCRUAL OF
DAY VERSE POPULATIONS ON TO OUR
SCREENING TRIALS.
AND ALSO, RECOMMENDED THAT WE
HAVE EARLY TERMINATION CRITERIA
DEFINED AND APPLIED BEFORE
SCREENING STUDIES ARE LAUNCHED
ESPECIALLY LARGE STUDIES.
NEXT SLIDE, PLEASE.
SO, FIRST I'LL REVIEW
ORGANIZATIONAL STRUCTURES THAT
WE USED FOR THIS EFFORT ON THE
LEFT AND YOU WILL SEE THE MEMBER
OF OUR TRANS DCP CLINICAL TRIALS
WORKING GROUP WHICH I'LL REFER
TO AS CTWG.
MY COLLEAGUE AND I WERE ASKED TO
CO-CHAIR THIS GROUP AND IT
STARTED IN EARLY 2021.
THE GROUP HAS THE DIRECTOR AND
THE DIVISIONS CLINICAL TRIAL
LEADERSHIP INDIVIDUALS.
AND THE ROLE OF THIS GROUP IS TO
OOHED ROXs GROUP WE COINED THE
TEAM STRIKE TEAM BECAUSE WE
THOUGHT IT WOULD BE FAST AND IT
WASN'T AS FAST AS WE EXPECTED IT
TO BE AND YOU SEE THE MEMBERSHIP
OF THE STRIKE TEAM SO THE
MEMBERS INCLUDED REPRESENTATIVES
FROM THE THREE AREAS WITHIN THE
TA VISION THAT HAVE SCREENING
TRIALS IN THEIR PORTFOLIO SO
SPECIFICALLY, THE NCORP AND
CECILIA LEE AND THE SECOND AREA
OUR HPV STUDIES AND FROM THE
PROTOCOL INFORMATION OFFICE.
THE CHARGE WAS TO ASSESS DCP'S
CURRENT AND PLAN SCREENING
PROTOCOLS AGAINST THE
RECOMMENDATIONS AND THE METHODS
ATTITUDES BY THE TEAM WERE TO
IDENTIFY AND REVIEW ALL THE
RELEVANT PROGRAM MATERIALS FOR A
PORTFOLIO REVIEW AND ASSESS THE
IT THOSE STUDENTS BY PROGRAM
STAFF TO MONITOR ACCRUAL BOTH
OVER ALL MINORITY ACCRUAL.
NEXT SLIDE, PLEASE.
THE STRIKE TEAM PRODUCED TWO
DOCUMENTS BOTH OF WHICH WERE
DISTRIBUTED TO THE CTAC MEMBERS
AND THE FIRST IS OUR REPORT
WHICH RESPONDS TO THE
RECOMMENDATIONS AND INCLUDES THE
METHODS AND DESCRIBES THE
FINDINGS, ANALYSIS AND OUR
RECOMMENDATIONS AND THAT WAS
ACCEPTED BY DCP LEADERSHIP IN
APRIL AND THE STRIKE TEAM WAS IN
TASK WITH IMPLEMENTING THE
RECOMMENDATIONS FROM THE REPORT
WHICH I'LL FOCUS ON TODAY.
NEXT SLIDE, PLEASE.
SO BASED ON THE STRIKE TEAM
FINDINGS, IN DISCUSSION WITH OUR
LEARNING CLINICAL TRIALS WORKING
GROUP INCLUDING DCP LEADERSHIP,
A SET OF NEW DCP SCREENING TRIAL
REQUIRE MANIES WAS DEVELOPED.
THE COMPLETE LIST OF THESE
REQUIREMENTS IS AVAILABLE IN THE
IMPLEMENTATION PLAN AND THIS
SLIDE IS A SAMPLE OF THOSE
REQUIREMENTS.
THEY PERTAIN TO ALL FUTURE TCP
SPONSORED SCREENING TILES AND
THEY MUST BE ADDRESSED IN THE
PROTOCOL AND THE GOAL OF THESE
THEY'RE HAVING PLANNING BUILDING
ON BASIC GOOD CLINICAL TRIALS
PRINCIPLES AND SO THESE
REQUIREMENTS WILL ENSURE THAT
ACROSS THE DIVISION, WE'RE
TAKING A SYSTEM AT TRICK
APPROACH TO OUR SCREENING
PORTFOLIO.
A WORKING GROUP WILL PLAY A
FUNCTION IN THIS IMPLEMENTATION
PROCESS.
THE FIRST PHASE ENSURES ALL THE
RELEVANT PROGRAM DOCUMENTS IN
THE AREAS ARE REVIEWED, ASSESSED
AND REVISED TO COMPLY WITH THE
NEW SCREENING TRIAL
REQUIREMENTS.
THE EXPECTED OUT SOME OF THIS
PHASE IS DCP WILL COMMUNICATE
THESE AND TO THEIR GROUPS AND
THE SCREENING PROTOCOLS ADDRESS
THESE REQUIREMENT AND DCP'S
INTERNAL SCIENTIFIC REVIEW
PROCESS REVIEWS THOSE PROTOCOLS
AND INSURES THAT THESE
REQUIREMENTS HAVE BEEN
SATISFACTORY ADDRESSED.
THE SECOND FACE IS WE WILL
INITIATIVE, WE'LL IPSOS-REID
TAUGHT A NEW WORK FLOW THAT
ROUTES THE PROTOCOLS TO THE
DIRECTOR FOR REVIEWING ALLOWING
THEM TO HAVE REVIEW AT THE
APPROPRIATE POINT TO BE ABLE TO
AND SIGNIFICANT AMENDMENT WOULD
BE DEFINED AS A CHANGE IN
DESIGN, STUDY ENDPOINTS OR
SAMPLE SIZE.
AND THE THIRD PHASE IS TCP
MONITORING AND THIS IS PERFORMED
BY THE DCP CLINICAL TRAILS
WORKING GROUP AND AT QUARTERLY
MEETINGS, A DESIGNEE FROM EACH
AREA WILL PRESENT THE SCREENING
TRIALS IN THE PORTFOLIO AND THE
PURPOSE OF THIS STEP IS NOT TO
REPLICATE OR REPLACE ALL THE
CURRENT ON GOING MONITORING
ACTIVITIES BUT IT'S TO PROVIDE A
STRUCTURE AND A PROCESS WITHIN
OUR DIVISION TO SYSTEMATICALLY
ASSESS AND STUDY PROGRESS AND TO
ENSURE THAT IF MORNING LETTERS
NEED TO BE ISSUED, THAT'S BEEN
DONE AND IF THERE'S CORRECTIVE
ACTION PLANS IN PLACE, TO SUN
TIM ATTICLY REVIEW PROGRESS WE
WILL LOOK BROADLY AT CHANGES IN
SCIENCE OR TECHNOLOGY LANDSCAPE
THAT MAY HAVE IMPACT ON THE
TRIAL AND IT GIVES PEOPLE IN THE
DIVISION LEADERSHIP IN THE TA
VISION THE OPPORTUNITY TO LOOK
ACROSS THE DIVISION AT THE
ENTIRE SCREENING PORTFOLIO AND
TO DISCUSS CHALLENGE TO LOOK AT
OPPORTUNITIES AND TO HAVE A LOT
MORE COMMUNICATION AND A
SYSTEMATIC APPROACH.
WE'RE DEVELOPING AN EVALUATION
PLAN THAT WILL LAUNCH IN EARLY
2023.
DEVELOPING NEW CANCER SCREENING
TRIALS WITH THE ASSISTANCE OF
KEVIN DoD FROM OUR BUY BRANCH,
THERE WAS ON GOING AND PAST
SCREENING PROTOCOLS AND THE PAST
LARGE PREVENTION TRIALS.
12 TRIALS WERE EVALUATED FOR
ACCRUAL.
OBVIOUSLY THAT IS AN
INSUFFICIENT NUMBER TO BE ABLE
TO ESTABLISH A DEFINITIVE SET OF
STOPPING RULES HOWEVER IT SERVES
AS A USEFUL TOOL TO DEVELOP
PRELIMINARY AND IMPLEMENTED NOW
AND REFINED OVER TIME AS
ADDITIONAL DATA IT IS AT
AVAILABLE.
IT'S ACHIEVING A PERCENTAGE OF
EXPECTED ACCRUAL AND AN
IDENTIFIED POINT IN THE
TIMEFRAME FORAY CRUEL.
WE HAVE FIVE EVALUATION WE'RE
CALLING THEM BREAK POINTS AND SO
IF WE LOOK AT THE FIRST BREAK
POINT, THIS IS AT 25% OF THE
TIME OF THE EXPECTED ACCRUAL
PERIOD OF THE PROTOCOL SO THE
PROTOCOL NEEDS TO DEFINE THE
EXPECTED ACCRUAL PER IDEA AT 25%
AND ELAPSED AND 10% HAS TO BE
COMPLETED.
THIS CHECKPOINT ACKNOWLEDGES
START UP TIME AND ISSUES AND
WHEN HALF OF THE TIME OF THE
EXPECTED ACCRUAL PER IDEA HAS
ELAPSED WE WILL SEE 25% OF THE
ACCRUAL BEING COMPLETE AND THE
THIRD CHECKPOINT IS 75% OF THE'
CLAPSED TIME HALF SHOULD BE
COMPLETE AND ADDITIONAL
CHECKPOINT AT 8 A% OF TIME TO
ENSURE THAT 65% OF ACCRUAL IS
COMPLETE AND AT 100% TIME, IF
90% OF ACCRUAL HAS BEEN ACHIEVED
WE WILL CONSIDER THAT SUCCESSFUL
AND EXPECT SUCCESSFUL COMPLETION
OF THE TRIAL.
SO, IMPLEMENTING THE STOPPING
RULES, THIS WILL BE DONE WITH
THE OVERSIGHT OF OUR CLINICAL
TRAILS WORKING GROUP LOOKING AT
THE STUDIES AT EACH OF THE
QUARTERLY MEETINGS.
SO THE ACTUAL ACCRUAL VERSUS THE
EXPECTED ACCRUAL WILL BE
ASSESSED FOR EACH BREAK POINT
AND IF THE BREAK POINT IS MET OR
EXCEEDED, THE STUDY WILL
CONTINUE AND BE ASSESSED AGAIN
AT THE NEXT BREAK POINT.
THE TRIAL IS NOT MEETING ITS
EXPECTED ACCRUAL AT THE BREAK
POINT DCP ISSUES A WARNING
LETTER, REQUESTS A CORRECTIVE
ACTION PLAN.
IF THE TRIAL IS ABLE TO IMPROVE
IT CONTINUES AND IT'S MONITORED
CLOSELY ON THE OTHER HAND IF THE
TRIAL ACCRUAL DOES NOT MEET THE
BREAK POINT, IT WILL BE
TERMINATED FOR IN ABILITY TO
ACCRUE.
NEXT SLIDE, PLEASE.
SO GOING FORWARD, SOME THINGS
THAT WILL BE HAPPENING RELATED
IT OUR SCREENING PORTFOLIO IN
2023.
FIRST, THIS IN EARLY 2023, THERE
WOULD BE A SIMPLIFIED NCI
REGISTRATION PROCESS FOR THOSE
PARTICIPATING IN SCREENING
PROTOCOLS.
THIS IS PASS DIFFICULTY IN BAR
WE ARE AND WE'RE LOOKING FORWARD
TO OVERCOMING THAT.
THIS IS AN R34 AND U34 GRAB
PROGRAM THAT PROVIDES FUNDING
FOR FEASIBILITY ASSESSMENTS THE
CANCER SCREENING RESEARCH
NETWORK THAT WILL BE CONDUCTING
CANCER SCREENING TRIALS WILL BE
SPLIT UP AND THERE WILL BE
SCREENING RULES AND THE
SCREENING REQUIREMENTS AND THE
STOPPING RULES FROM THE VERY
BEGINNING IN THE MEANTIME, WE'LL
CONTINUE THE FULL IMPLEMENTATION
OF THESE SCREENING REQUIREMENT
WE LOOKED AT OUR SYSTEMS
DEVELOPING REQUIREMENT THIS IS
THE PROCESS SO IN CLOSING, I'D
LIKE TO ACKNOWLEDGE THE MEMBERS
OF THE STRIKE TEAM AND THE DCP
CLINICAL TRIALS WORKING GROUP
AND I KNOW MY DCP COLLEAGUES
JOINED WITH ME IN THANKING
INTEREST DAVIDSON AND THE TRIALS
WORKING GROUP FOR THEIR
THOUGHTFUL WORK AND THEIR
RECOMMENDATIONS.
>>THANK YOU SO MUCH, DOCTOR.
GREAT PRESENTATION AND A LOT OF
PROGRESS.
AYED LIKE TO OPEN UP THE
DISCUSSION, WE HAVE ABOUT 10
MINUTES, I'D LIKE TO ASK Dr.
DAVIDSON, NANCY, YOU WERE CHAIR
OF THE CANCER SCREENING TRIALS
WORKING GROUP AND I'M WONDERING
IF YOU HAVE ANY INITIATION OR
INITIATING COMMENTS?
>>THANK YOU, NEIL.
YOU REMINDED ME THAT WAS OUR
HOLIDAY PROJECT AND THE 13 OF US
IN THE FIRST WINTER OF THE
PANDEMIC BECAUSE WE STARTED JUST
ABOUT TWO YEARS AGO NOW.
AND WE DID TAKE UP TWO TOPICS AS
YOU PUT IT OUT.
THE FIRST HAD TO DO WITH A TMIST
TRIAL AND I'M GLAD TO SEE THE
TMIST INVESTIGATORS WERE ABLE TO
REVISE THE TRIAL IN A WAY THAT
IT SEEMS TO GO GOING REALLY
SMOOTHLY, AS BEST AS I CAN CAN
TELL.
IT LOOKS LIKE ONE OF OUR BIG
ISSUES WHICH WAS TO MAKE SURE
THAT THEY REALLY RAMPED UP THEIR
SPECIMEN COLLECTION AND THEY
WERE ABLE TO THINK ABOUT DIVERSE
POPULATIONS AND THOSE WERE
STRENGTHENS OF THE TRAIL.
I PRAY THEY WILL MAINTAIN THE
ACCRUAL THEY'VE BEEN SEEING AND
THEY WILL BE ABLE TO FINISH
ACCRUAL, HOPEFULLY EARLIER THAN
THE END OF 2024 AND IT'S PARTLY
BECAUSE AS WE KNOW THIS IS A
TECHNOLOGY WHICH IS WIDELY
AVAILABLE IN THE COMMUNITY AND I
THINK THE LONGER WE GO AND THE
MORE IT PENETRATES, IT MAKING
THE FINAL END POINT MAY BE LESS
MEANINGFUL BECAUSE OF WHAT HAS
TRANSPIRED WITH FROM.
THE SECOND GOES BACK TO I
APPOINT THAT MAYBE ONE OF THE
FEW POSITIVES THAT CAME OUT OF
COVID WAS THE NEED TO LOOK AT
THESE LARGE TRIALS AND REALIZE
WE NEEDED TO BRING MORE RIGGER
HOW WE MONITOR THESE LARGE
PREVENTION TRIALS SO I'M REALLY
IMPRESSED BY WHAT THE CTWG IN
THE STRIKE TEAM OF PROPOSED
PROCESS LOOKS REALLY GOOD TO ME
AND I HAVE TO BELIEVE THIS IS
MORE IMPORTANT BECAUSE AS I
UNDERSTAND, THE PRESIDENT'S
GOALS AND YOU KNOW THE NEXT
MOONSHOT AND OUR GOAL OF
REDUCING CANCER MORTALITY BY A
SUBSTANTIAL AMOUNT, THESE ARE
EARLY TRIALS WILL BE REALLY
IMPORTANT.
SO I'M GLAD WE HAVE A FRAMEWORK
TO BRING THEM INTO PLACE.
THANK YOU SO MUCH FOR ALL THAT
HARD WORK AND THANK YOU FOR THE
FEEDBACK.
I AM HOPING WE CAN GET THIS TO
THOSE 13 PEOPLE WHO DID SPEND
THEIR HOLIDAY SEASON WITH ME SO
THEY CAN SEE WHAT TRANSPIRED.
THANK YOU.
>>THANK YOU, NANCY.
WHILE FOLKS ARE THINKING OF
QUESTIONS, ONE THING THAT KIM TO
MIND FOR ME WAS, WE HAVE A
PRETTY LENGTHY EXPERIENCE NOW
THROUGH THE NCTN CANCER
TREATMENT STUDIES WITH REGARDS
TO EARLY STOPPING FORAY CRUEL,
IT'S BEEN GOING ON MORE THAN A
DECADE NOW AND I WONDER IF
LEARNLEARNINGS HAVE INFORMED ONE
PERSPECTIVE OF HOW YOU'VE
DECIDED TO UPON TER THE
PREVENTION STUDIES?
>>THANK YOU FOR THAT.
NON PREVENTION, SORRY.
>>I HAVE.
TRP'S DEPUTY DIRECTOR ON THE
CALL WITH ME TODAY AND WHO IS
HERE TO FIELD DIFFICULT
QUESTIONS.
>>THANK YOU, LY LINDA.
WE'VE SPENT TIME, 10 YEARS AGO
WE WENT BACK AND LOOKED AT THE
CANCER CONTROLS TRIALS TO LOOK
AT EARLY STOPPING RULES AND WHAT
WE DID DO IS WHEN WE APPLIED THE
RULES TO THE CANCER CONTROL
STUDIES THEY DIDN'T FIT AND SO
WE DEVELOPED AN INDEPENDENT SET
OF STOPPING RULES WHICH HAS
SERVED ACTUALLY PRETTY WELL.
KEVIN DoD, OUR STATISTICIANS
HELPED DEVELOP THOSE RULES SO
WHEN LINDA AND Dr. CASTLE
DECIDED WE WOULD START DOWN THIS
ROAD, THAT IS WHY.
WE WENT BACK TO OUR LARGE
PREVENTION TRIALS AND OUR
PREVIOUS SCREENING TRIALS TO
REALLY LOOK AT BOTH THE ACCRUAL,
THE ACCRUAL RATES AS WELL AS THE
TIME AND THAT IS HOW WE
DEVELOPED OR ACTUALLY HOW KEVIN
DEVELOPED THE NEW STOPPING RULES
BECAUSE THEY SEEM TO BE
CONSISTENT WITH THE DATA THAT
WE'VE GENERATED.
MIND YOU, OVER TIME, AS WE
LAUNCH OTHER SCREENING TRIALS,
WE WILL RE-EVALUATE THEM AND
EXPLORE THEIR UTILITY AND
POTENTIALLY MODIFY THEM.
>>THANK YOU, LORI.
WE'VE GOT SOME HANDS UP.
>>FIRST OF ALL, I WANT TO
RECOGNIZE THE FANTASTIC WORK AND
THE DECISION ON TMIST MANY OF
IT'S SUPPOSE AN IMPORTANT TRIAL
AND I THINK THAT GUIDANCE HAS
BEEN INVALUABLE.
SO POSITIVE ASPECTS.
ONE THING I WANT TO HEAR A
LITTLE BIT MORE ABOUT, IT'S
FANTASTIC TO ENVISION THE CANCER
SCREENING NETWORK.
MY CONCERN IS HOW WILL THIS BE
INTEGRATED INTO THE OTHER
NETWORK STRUCTURES SO THAT WE
HAVE THE SINNER GEEZ SI SYNERGYE
PURPOSE OF SIMPLIFICATION AND
MAKING THINGS LESS COMPLEX.
>>THANK YOU, I'M HAPPY TO TAKE
THAT QUESTION AS WELL BECAUSE
I'M LEADING THAT EFFORT.
SO, THE CANCER SCREENING
RESEARCH NETWORK WILL USE THE
ENTIRE BACK END INFRASTRUCTURE
THAT NCTN AND NCORP USE.
THEY'LL USE THE REGISTRATION
PROCESS AND THE CENTRAL IRB AND
WE WILL, THE SCREENING NETWORK
WILL ALSO USE THE STEERING
COMMITTEE REVIEWS FOR CONCEPTS
AND SO MUCH OF THE PROCESS WILL
LOOK VERY SIMILAR AND HOWEVER,
BECAUSE THERE HAVE BEEN UNIQUE
CHALLENGE THIS IS RUNNING TA
BEING SAID, WE FULLY ENVISION
THAT THERE MAY BE CERTAIN
POPULATIONS THAT POTENTIALLY
OVERLAP OR THERE MAY BE A LAND
OFF AND YOU COULD SEE A STUDY IN
ASYMPTOMATIC INDIVIDUALS WHICH
WOULD BE PARTICULARLY SUCCESSFUL
IN A CANCER SCREENING RESEARCH
NETWORK BUT SAY A POPULATION OF
CANCER PATIENTS THAT ARE
LONG-TERM SURVIVORS MIGHT BE
BETTER EVALUATE INSIDE NCORP OR
NCTN MANY OF THERE'S AN
OPPORTUNITY NOW WITH THESE
INCREDIBLE TECHNOLOGIES TO
IDENTIFY EARLIER STAGE DISEASE
THAT WOULD BE RIPE FOR
PARTICIPANTS INTERESTED IN
CANCER PREVENTION AND
INTERCEPTION STUDIES SO WE
REALLY SEE THIS AS ANOTHER ARM
OF OUR RESEARCH TO EXTEND ALL OF
THE SUCCESS THAT WE'VE HAD IN
CLINICAL TRIALS TO NON
ONCOLOGIST.
>>THAT WAS A GREAT PRESENTATION
AND SCREENING TRIALS ARE SO
DIFFERENT SO PUTTING PARAMETERS
ON THERE.
I HAVE ONE COMMENT AND A
QUESTION ABOUT IT.
SO, I HEARD SOMETHING AT THE A
BIANCE MEETING THAT WAS JUST
KIND OF AN EYE OPENING
EXPERIENCE WHERE THEY MAPPED OUT
IN THE U.S. MAP YOU KNOW THE
HIGHEST INCIDENTS FROM MORTALITY
I THINK THEY WERE LOOKING AT OF
LUNG CANCER AND THEY MAPPED OUT
WHERE WE OPENED THE SCREENING
TRAILS AND THEY DID NOT OVERLAP.
SO, I'M WONDERING IF FOR SOME OF
THESE TRIALS, IF YOU ACTUALLY
MAP OUT THE INCIDENTS MORTALITY
AND THIS IS OUR CHANCE, I THINK
OF SCREENING TRIALS IS THAT
OPPORTUNITY TO REALLY GET OUT OF
THE NCTN NETWORKS AND REALLY GO
TO THE COMMUNITY BECAUSE THAT'S
WHERE YOU WANT IT TO BE MOST
SUCCESSFUL AND IF YOU ARE
LOOKING INTO ANY OF THOSE IDEAS
AS WELL MATCHING.
>>WE HAVE ALL KINDS OF
OPPORTUNITIES WITH A BRAND NEW
NETWORK TO EXPLORE, INNOVATIVE
WAYS OF COMMUNICATING, OF
REACHING OUT.
THE NOTICE OF INTENT TO PUBLISH
IS CURRENT LELY ON OUR WEBSITE.
IN ADDITION, THERE WILL BE
DIFFERENT REQUIREMENTS FOR THE
COR TCOORDINATING CENTER AND THE
STATISTICAL CENTER.
THEY'LL BE FAMILIAR BUT LOOK
DIFFERENT.
THE EXPERIENCE WE'VE HAD WITH
THE SCREENING TRIALS HAS ALSO
LED US TO THE DEVELOPMENT OF THE
NEW PILOT AND FEASIBILITY
MECHANISM, THE U-34, R-34 WAS
NOT USED BY NCI AT ALL BUT
THROUGH THE EXPERIENCE OF A
COUPLE OF THE CANCER CONTROL
STUDIES AND OTHER INSTITUTES
WE'VE IMPLEMENTED IT NOW AND
WE'VE HAD SOME REALLY ROBUST
RESPONSES TO MECHANISMS SO WE'RE
SEEING IDEAS IN THIS FACE FOR
WHAT WE'VE LEARNED FROM COVID
PUT INTO PLACE.
>>CAROLYN.
I JUST WANT TO SAY, YOU KNOW,
THE SCREENING TRIALS ARE
CRITICAL AND I WANT TO PIGGYBACK
ON WHAT LORI SAID IS THAT WHEN
WE DO THESE TRIALS, OUR
COMMITMENT IN THE TRIALS OF
ONCOLOGY WE'RE ALL VERY MUCH
PASSIONATE ABOUT DOING THAT BUT
WHEN WE GO OUTSIDE TO THE
COMMUNITY AND NON CONIOLOGY AND
RADIOLOGY FIRST GREETING FOR JOY
AND 008 ALL THESE TYPE OF TRIALS
IT TAKES QUITE A BIT OF TIME TO
ENGAGE THE STAKEHOLDERS AND TO
GET BUY IN AND TO DEVELOP WORK
FLOW PROCESSES AND WHAT WE TO
WELL IS WE HEAR WHAT WORKS AT
OTHER CENTERS AND WE CHANGE THE
GAME TO GET THIS ALL TO WORK SO
I JUST WANT TO MAKE A SUGGESTION
AS THE EVALUATION IN THOSE FOUR
STEPS IN FEASIBILITY AND
STOPPING OF SCREENING TRIALS
THAT WE KIND OF ALSO VALUE WAIT
WHAT IT TAKES TO GET THAT
STARTED BECAUSE WE CAN PUT A LOT
OF EFFORT GETTING THE WORKFLOWS
DONE AND THIS COULD HAPPEN IN
ALL OF THESE SITES AND THE TRIAL
GETS PULLED BACK POSSIBLY SO,
THAT IS JUST KIND OF A CRITICAL
ISSUE WITH GETTING THESE
STARTED.
>>THANK YOU.
I'LL GIVE YOU THE LAST WORD
HERE.
>>I THINK THERE ARE TWO THINGS
THAT WE NEED TO KEEP IN MIND
THAT THERE ARE STILL SO MANY
PARTS OF THE COUNTRY WHERE
THEY'RE JUST NOTTEN GAGED IN
RESEARCH SO I THINK WE NEED TO
FOCUS TIME ON TRYING TO CHANGE
THE CULTURE PEOPLE WHO ARE
GRAINED AND NOT EXPERIENCING
CLINICAL TRIALS AND IT'S NOT
GOING TO HAPPEN OVERNIGHT.
NOR TO THEY HAVE ACCESS.
THE MONEY WILL BE LIMITED BUT WE
CAN'T FORGET ABOUT SMALLER PLACE
AND SOME ARE FANTASTIC IN
ENROLLING AND OTHER AREAS WHERE
WE LOVE TO HAVE GETTING INTO
THEM SO THEY CAN HAVE ACCESS THE
SAME ACCESS AS OTHER PLAYERS
THAT TO WELL THROUGHOUT THE
COUNTRY.
MOVING ON TO THE NEXT IDEA WHICH
IS A PRESENTATION AND DISCUSSION
OF THE GASTRIC CANCERS WORKING
GROUP REPORT WHICH THE MEMBERS
HAVE HAD THE OPPORTUNITY TO
REVIEW AND THIS SESSION WILL BE
LED BY INTEREST KAREN GOODMAN
THE PROFESSOR AND DEPARTMENT OF
RADIATION ONCOLOGY AT THE ICON
SCHOOL OF MEDICINE AND Dr.
NEIL RUSTGI.
SO, I DON'T KNOW WHO WILL GO
FIRST AND TAKE IT AWAY KAREN AND
A KNEEL >>THANK YOU SO MUCH,
EVERYBODY.
Dr. GOODMAN IS AWAY AT A
MEETING WHICH REQUIRED HER
MANDATORY ATTENDANCE SO I WILL
PRESENT ON OUR COLLECTIVE BEHALF
AND MOST IMPORTANTLY, I WANT TO
AGO KNOWLEDGE THE DIFFERENT
WORKING GROUPS THAT ARE LIVED TO
WHEN THE NCI STAFF BECAUSE
WITHOUT THEIR EFFORT THIS REPORT
WOULD NOT HAVE BEEN POSSIBLE I
WILL PROMPT THE TEAM TO ADVANCE
THE SLIDESMENT NEXT SLIDE.
SO OUR OVERVIEW IS BRIEF.
THE EPIDEMIOLOGY RECOGNIZING
THAT TOPIC ALONE FOR CANCER
COULD BE EXTENDED FOR A LONG
PERIOD OF TIME AND WE'LL TALK
ABOUT THE WORKING GROUP BACK
GROUND AND THE PROCESS AND THAT
LED TO THIS REPORT WITH A SERIES
OF RECOMMENDATIONS THAT I'LL
ELABORATE UPON AND THE SPECIFIC
RACE?
THE NEXT 25 MINUTES AND I WILL
RECOMMEND YOUR QUESTIONS AND
COMMENTS.
SO, GASTRIC CANCER AND ACCOUNTS
FOR GASTRIC ACCOUNTS FOR MOST
GAS TICK CANCER.
95%.
THE REMAINING IS HODGKINS
LYMPHOMA OR NON HODGKINS
LYMPHOMA.
IN THE UNITED STATES AS OF 2022,
IT'S ESTIMATED THERE WILL BE
26,000 NEW CASES TRIGGERING
11,100 DEATHS.
100 YEARS IN THE UNITED STATES,
IT WAS THE MOST COMMON CANCER IN
THE UNITED STATES AND IF YOU
LOOK INTERNATIONALLY, IT REALLY
IS A GLOBAL PROBLEM.
THERE ARE OVER 1 MILLION CASES
EVERY YEAR AND NOT 80,000 DEATHS
SO IT'S THE FIFTH MOST COMMON
CANCER WORLDWIDE AND THE THIRD
LEADING CAUSE OF CANCER RELATED
MORTALITY WORLDWIDE.
WHILE THE PER PONDERANCE ARE
SPORADIC IN NATURE, 10% OR LESS
ARE MER HE HEREDITARY IN NATURD
THERE'S A DISORDER CALLED GERM
LINE MUTATIONS AND BUT FOR THE
SPORADIC SUPPOSE TYPE, DIFFUSED,
IT'S ASSOCIATED WITH INFECTION
WITH HPYLORI, AN ORGANISM IN
2 BILLION INDIVIDUALS IN THE
UNITED STATES AND THE WORLD
HEALTH ORGANIZATION, CLASSIFIED
IT AS A CLASS 1 CARCINOGEN AND
DIETARY FACTORS SUCH AS
NUTRITIONAL DEFICIENCIES, LOW
FRUIT, CIGARETTE SMOKING, ANEMIA
WHICH LEADS TO ABLATION OF ACID
PRODUCING CELLS ARE OTHER RISK
FACTORS AND THEY OFTEN ACT IN
COMBINATION.
SO, WHILE CLASSICALLY, IT WAS
SUB TYPED INTO TWO INTESTINAL
TYPE.
GENOMIC SEQUENCES, TRANSRIPTOME
I CAN PROFILING HAS LEFT TO A
MOLECULAR SUB CLASSIFICATION TO
FOUR SUBTYPES LISTED AND IT REMS
LOW AT ABOUT 30% AND THE
DIFFUSED SUBTYPE IS DECREASING
IN YOUNG CAUCASIAN FEMALES.
THERE ARE TWO MAJOR SUBTYPES.
IF YOU AGGREGATE IT, SIMILAR TO
GAS TICK CANCER, ABOUT 20,000
NEW CASES ANNUALLY IN THE UNITED
STATES AND 11,000 DEATHS BUT
GLOBALLY SPEAKING, THE NUMBERS
ARE STAGGERING.
OVER 600,000 CASES WORLDWIDE,
PROJECTED TO BE 1 MILLION BY THE
YEAR 2040 AND 540,000 DEATHS
RELATED TO E.S.O. PHAGEAL
CANCER, SO CAME US CELL CANCER
IS ASSOCIATED WITH CIGARETTE
SMOKING ASK ALCOHOL.
ADDEN OWE CARCINOMA INCREASING
IN THE, S. AND WESTERN EUROPE
WITH CENTRAL ADD POS TEE AND
CHRONIC ACID REFLUX MORE COMMON
IN THE JUNCTION AND IT'S PRE
CURSE SER THE WELL DEFINED
PATHOLOGIC ENTITY CALLED
BARRETT'S H H H ESOPHAGEUS.
GLOBALLY ESCC IS MORE COMMON AND
THIS IS IN A SETTING OR AGE
HAVEN'T SO WITH THIS PREAMBLE
AND THE RECOGNITION THAT GASTRIC
AND HE IS SOF FEAL CANCER ARE
LETHAL AND FORCE SURVIVAL, SURVR
SHIPS OF THESE CANCERS SO, THE
NCI FORMED OUR WORKING GROUP TO
HELP IDENTIFY STRATEGIES THAT
ARE IMPACTFUL IN THE CONTEXT OF
TRANSLATIONAL RESEARCH TO
ADVANCE PREVENTION, DIAGNOSIS,
EARLY DETECTION AND TREATMENT OF
THESE UPPER G.I. CANCERS.
SO, MY CO-CHAIR IS Dr. GOODMAN
AND A GROUP OF WORKING MEMBERS
AND A LOT OF HELP FROM THE NCI
COLLEAGUES AND STAFF.
IT WOULD NOT HAVE BEEN POSSIBLE
WITHOUT THIS COLLECTIVE SPIRIT
AND COLLECTIVE EFFORT.
OUR MISSION WAS TO SURVEY THE
SCIENTIFIC HORIZONS IN A
HOLISTIC FASHION, VERY BROADLY
SPEAKING TO IDENTIFY WHAT IS
KNOWN AND AT THE SAME TIME TO
IDENTIFY GAPS.
AND TO TAKE THE POWER OF
TRANSLATIONAL RESEARCH TO FILL
THESE GAPS.
AND TO A REPLY NEW TECHNOLOGIES
TO FOR THE TRANSLATIONAL
RESEARCH AND ESCR AND
RECOGNIZING LYMPHOMA AND SOME
OTHER UPPER BI CANCERS ARE
UNCOMMON SO WE DIDN'T FOCUS TOO
MUCH ON THOSE SUBTYPES.
WE MET A YEAR AGO AND WE WERE
CHARGED BY Dr. SHARPLESS, WE
HAD A AN EXTENSIVE REVIEW OF THE
EXISTING NCI BRANT PORTFOLIO FOR
UPPER GI CANCERS AND THE
PORTFOLIO FOR UPPER GI CANCERS
AND WE THEN MET WITH THE WORKING
GROUP AND WE DIVIDED THEM INTO
SUPPOSE GROUPS AND MEETINGS
THERE WAS A FOLLOW-UP MEETING IN
JUNE AND BASED UPON DISCUSSIONS,
REPORT BACK, RECOMMENDATIONS,
AND MODIFICATIONS OF THOSE
RECOMMENDATIONS WE WENT THROUGH
SEVERAL ITERATIONS OF A REPORT
AND THAT CULMINATED IN THE
REPORT THAT IS IN YOUR HANDS AND
THAT I'M SUMMARIZING IN THIS
PRESENTATION.
SO THE SUB GROUPS WERE FOUR IN
NUMBER.
THE FIRST RELATED TO OMICS.
FUNCTIONAL GENOMICS,
TRANSCRIPTOMIC, METABOLOMICS,
LED BY INTEREST SANDY MARCOWITS
AT CASE WESTERN.
THE SECOND GROUP, THE MODEL
SYSTEMS WHAT DO I MEAN BY THAT?
IT'S MOUSE TO HUMAN.
MOUSE MODEL, GENETIC, NON
GENETIC, HUMAN TISSUE AND AIM AG
FROM MOUSE TO HUMAN THIS WAS LED
AT VANDER.
COUNTRIES WHERE UPPER G.I.
CANCER ARE ENDEMIC AND HIGH-RISK
IN THE UNITED STATES.
LED BY MARCIA CRUZ-KOREA THE
EXECUTIVE OF THE CANCER CENTER
AT THE UNIVERSITY OF PUERTO RICO
AND THEN, FINISHING IN PARALLEL
TREATMENT, MOLECULAR COREL TIVE
STUDIES AND ENABLING
TECHNOLOGIES SUCH AS RADIO OMICS
AND IMPORTANT COM UPON ANT OF
THIS BY OWE BANKING LET BY Dr.
IKBAL.
I HAVE THE FOUR WORKING GROUPS
AND HOPE THAT IT MAKES SENSE TO
YOU.
WE WANTED TO GET A GOOD SENSE, A
DEEP SENSE OF THE CURRENT
LANDSCAPE AND EVALUATE AVAILABLE
TARGETED AND IMMUNO THERAPEUTIC
DRUGS THAT HAVE HAD MODEST
IMPACT SO FAR IN TREATMENT OF
UPPER G.I. CANCERS.
WE WANTED TO ALSO ASSESS THE
COST AND INVASIVENESS OF
EXISTING ASSESSMENT MODALITIES
WHICH REALLY ARE NOT ABLE TO BE
A PLAYED TO THE AVERAGE RISK
GENERAL POPULATION AND MOST
COUNTRIES, SOME COUNTRIES, YES
BUT THERE'S RE SOURCE
RESTRICTION IN THOSE COUNTRIES
AND WHAT IS OUR PROGRESS ON
PREVENTION?
ESPECIALLY FOR H PYLORI
INFECTION?
OUR WORKING GROUP CONCLUDED,
THIS IS NOW AGAIN, FROM AN
OVERARCHING VIEWPOINT, THAT WE
SHOULD FOCUS ON BUILDING A MORE
ROBUST PIPELINE OF TRANSLATIONAL
OPPORTUNITIES.
SO SOMEWHAT MORE TARGETED IN
NATURE AND WE SHOULD ADDRESS
BOTH ENABLING RESOURCES,
INFRASTRUCTURE, IN FLOWERS AND
GOALS THAT ARE ACHIEVABLE AND SO
THAT INVOLVES STRENGTHENING OUR
KEY ENABLING RESOURCES AND TOOLS
AND TO IDENTIFY NEW BIOMARKERS
AND THEY ARE PEWS I CAN TARGETS
AND INTERVENTIONS BOTH INVASIVE
AND NON-INVASIVE APPLY THIS TO
APPROPRIATE POPULATIONS WITH
SUFFICIENT PROMISE TO JUSTIFY
THESE FOCUS TRANSLATIONAL
EFFORTS.
SO, WE WISH TO BUILD
REPOSITORIES OF WELL
CHARACTERIZED BY OWE SPECIMENS
AND MODEL SYSTEMS THAT WOULD
REALLY UNIFY INVESTIGATORS
CLINICAL ACROSS THE COUNTRY AND
HOPEFULLY GLOBALLY EVENTUALLY
ACROSS DIVERSE POPULATIONS.
WE FURTHER DEVELOP THESE TOOLS
AND OR ANALYTIC TOOLS
COMPUTATIONAL METHODS TO
CHARACTERIZE THE UNDERLYING THE
PATHO PHYSICAL LOGIC PROCESSES
AND WE SEEK TO IDENTIFY
ACTIONABLE MARGARET AND TARGETS
AND DEVELOP CLINICAL ASSESSMENT
TOOLS AND INTERVENTIONS AND FROM
PREVENTION AND SCREENING AND
SURVEILLANCE.
SPECIFIC RECOMMENDATIONS, BY A
SPECIMEN REPOSITORY AND RESEARCH
TOOLS WHICH LAYS THE FOUNDATION
FOR CURRENT AND FUTURE RESEARCH
DIRECTIONS, FOR IN SIGHTS INTO
UNDERLYING MECHANISMS AND
APPLICATIONS TO PREVENTION AND
TREATMENT.
NEXT SLIDE, NEXT SLIDE.
SO WHAT TO WE MEAN BY
BIOSPECIMEN REPOSITORY.
BIOSPECIMENS WOULD DEFINE
DISEASE RELATED CHARACTERISTICS
ARE CRITICAL ENABLING RESOURCES
FOR THE RESEARCH NEDDED TO
IDENTIFY BIOMARKERS FOR RISK
RATIFICATION AND NEW TARGETS FOR
THERAPEUTIC INTERVENTIONS BOTH
CONVENTIONAL THERAPEUTICS AND
REAPPLICATION OF CONVENTION AS
WELL AS IF YOU THERAPEUTICS AND
IT'S REALLY IMPORTANT TO HAVE
EXISTING GENERAL BIO
REPOSITORIES TO BE ABLE TO APPLY
TO GASTRO H GAS CANCER AND WE WO
MAKE THESE BIOSPECIMEN
REPOSITORIES AVAILABLE TO
RESEARCHERS THAT HAVE BEEN
LIMITED THUS FAR SO THAT THEY
CAN GENERATE NEW HYPOTHESIS AND
AS WELL AS TO VALIDATION
STUDIES.
NEXT SLIDE.
HIGH-LEVEL RECOMMENDATIONS, SO,
THEY'LL BE ABBREVIATED BY A
SPECIMEN BR/123 CONSECUTIVELY.
BC THEY ARE ONLY GOOD WITH WHAT
IS GOING ON AND THE QUALITY OF
THE SPECIMENS AS WELL AS THE
CLINICAL ANNOTATION AND BR2,
IDENTIFYING AN INITIAL SET OF
HIGH PRIORITY BIAS SPECIMENS TO
BE MADE AVAILABLE THROUGH A
CENTRALIZED NATIONAL REPOSITORY
THAT IS THEN ACCESSIBLE FOR
MERITORIOUS PROPOSALS.
THESE TWO ARE INTER RELATED.
BR-1.
SUB RECOMMENDATION THAT'S
SUPPORT THE BROADER
RECOMMENDATIONS.
COLLECT SPECIMENS FROM
OBSERVATIONAL AND INTERVENTIONAL
STUDY COHORTS AND BR-2 CREATE
OBSERVATIONAL AND INTERVENTIONAL
STUDY COHORTS THAT ENABLE
EFFICIENT COLLECTION OF
SPECIMENS AND BR-S3.
STANDARDS FOR COLLECTION WE HAVE
A TENDENCY TO HAVE A DESIRED TO
MAKE COLLECTIONS BUT THE
PROTOCOLS FOR COLLECTIONS ARE
DISPARATE IN NATURE SO WE SEEK
TO HAVE STANDARDIZED PROTOCOLS
SO THE TISSUES, THE BLOODS, THE
BODY FLUIDS THAT ARE OBTAINED
ARE UNIFORM AND STANDARDIZED IN
NATURE SO THE MOLECULAR ANALYSIS
IS ROBUST AND THE COMPUTATIONAL
ANALYTICS IS ROBUST AS WELL.
RESEARCH TOOLS.
WE TALKED ABOUT SWELLED ON ABOUL
SYSTEMS, PRECLINICAL TO
CLINICAL, LABORATORY ANALYTIC
METHODS, PROFILING, DNA AND RNA,
AND THE COMPUTATIONAL PLATFORMS.
THESE NEED TO BE DONE IN A
COMBINATION FASHION TO GENERATE
NEW INSIGHTS AND FACILITATE THE
EYE TEN INDICATION OF BIO
MARKERS AND THERAPEUTIC TARGETS.
EACH APPROACH REQUIRES FURTHER
DEVELOPMENT TO ACHIEVE ITS FULL
POTENTIAL.
THE BEGINS THAT WILL BE ACCUSED
IN EACH OF THESE DOMAINS CAN
EASILY THEN BE EXTENDED ALSO TO
OTHER CANCERS AS WELL, USING
UPPER GI CANCERS AS THE INITIATE
OR.
RESEARCH TOOLS.
HIGH LEVEL RECOMMENDATIONS,
RT-1, DEVELOP AND REFINERY
SEARCH TOOLS FOR OUR A LOT TO
DERIVE INSIGHTS INTO THE BIOLOGY
OF UPPER GI CANCERS AND SUB
RECOMMENDATIONS ARE RELATED
INFORM WHAT IS LISTED HERE.
RT-MS1, MS FOR MODEL SIS TOLLS.
WE WANT TO EMPHASIS THAT THERE
ARE EXISTING, ESTABLISHED,
PUBLISHED PRECLINICAL ANIMAL
MODELS, GENETIC ASK NON GENETIC
THAT COPY A GREAT JOB IN
RECAPITULATING GI CANCER AND WE
WANT TO AUGU AUGMENT THESE AND E
CARE OF DIFFERENT DRIVERS IN
UPPER G.I. CANCERS.
RT-MS2 IS TO MATH MAT TICK
MODELERS AND ORGANIC CHEMIST SO
DEVELOP MODEL SYSTEMS THAT
REFLECT THE HETERO AGAIN A TEE
OF UPPER G.I. CANCERS THAT HAVE
TAKEN BEYOND OUR EXISTING ANIMAL
MODELS.
RT-M3 IS TO EMPLOY OUR BIOEN
GUINEARS CHEENGINEER FOR CULTURO
REPLICATE AND DISTRIBUTE MODEL
SYSTEMS.
AN EXAMPLE OF THAT, NOT THE ONLY
EXAMPLE, THREE DIMENSIONAL
ORGANOIDS WHICH CAN HAVE A LOT
OF VARIABILITY AND IT'S NOT
WITHOUT EXPENSE SO A SYNTHETIC
PHYSICAL GEL CALLED HYDRO GEL IS
BEING USED MORE AND MORE WHICH
CAN BE FABRICATED MUCH MORE SEEM
LESLEY AND MUCH MORE COST
EFFECTIVE SO YOU CAN TAKE YOUR
PRE CANCER OR CANCER CELLS AND
PUT THEM ON HYDRO GEL AND
RECAPITULATE THE TUMOR AND DO CO
CULTURE WITH IMMUNE CELLS AND AS
WELL AS FIBRO BLAST AND WE WANT
THESE METHODS FOR THESE MODEL
SYSTEMS IN MS4.
SOME RECOMMENDATIONS ON
LABORATORY AN ANALYTIC.
THIS IS AM-1.
DEVELOP AND REFINE BIOLOGICAL
AND CHEMICAL AND PHYSICAL
ANALYTIC METHODS SO THIS IS
TAKING STOCK OF ALL OMICS
SCHOOLS ABOUT THEM AROUND US AND
WITH US AND APPLY THEM IN A
THOUGHTFUL AND RATIONAL WAY INTO
THE ANNAL SEES OF THE MODEL
SYSTEM AND BY OW BIOSPECIMENS.
THE THIRD DOMAIN IS
COMPUTATIONAL METHODS SO THIS IS
SUB RECOMMENDATIONS CM1 AND WE
WANT TO BRING IN OTHER
DISCIPLINES TO DEVELOP AND
VALIDATE MACHINE LEARNING
APPROACHES FOR ASSESSING
PATTERNS WITHIN A CROSS THESE
DIFFERENT OMICS AND OTHER DATA
TYPES TO INSURE IN VALIDATE IN
VIVO INTERVENTIONAL TARGETS FROM
PREVENTION TO TREATMENT OF UPPER
G.I. CANCERS.
I'LL SWITCH DIRECTIONS AND YOUR
ATTENTION TO FUTURE RESEARCH
DIRECTIONS.
NEXT SLIDE.
SO THE GOAL IS TO HARVEST OUR
MANY ON GOING ADVANCES IN UPPER
G.I. CANCER AND RESEARCH METHODS
BY APPLYING THEM TO BIOLOGICAL
QUESTIONS THAT ARE EVEN MORE
TARGETED AND PRIORITIZED FOR
THESE CANCERS IN ORDER TO BUILD
AND EXPAND A ROBUST PIPELINE OF
TRANSLATIONAL OPPORTUNITIES.
THERE WAS AN RFA ISSUED BY THE
NCI IN CALENDER YEAR 2021 AWARDS
WERE MADE IN CALENDER YEAR 2022
TO SIX TIVE WORKING GROUPS WITH
MULTI P.I.-RO1s AND A
COORDINATING CENTER.
SO WE SEEK TO TAKE ADVANTAGE OF
THE PROWESS AND WHAT WE ARE
ARTICULATING NOW.
SO, HIGH-LEVEL RECOMMENDATIONS
FOR BIOLOGICAL INSIGHTS APPLY
OMICS AND OTHER EMERGING
ANALYTICAL TOOLS AND
COMPUTATIONAL METHODS TO
CHARACTERIZE UPPER G.I. CANCERS
WITH EVEN GREATER PRECISION AND
IDENTIFYING ACTIONABLE
BIOMARKERS AND APPLICABLE
THERAPEUTIC TARGETS AND NEXT
SLIDE.
ACCESSING TISSUE AND PRE
TREATMENT, POST TREATMENT, AS
WELL AS AND YOU KNOW, CAN WE
APPLY THIS TO STANDARD OF CARE
APPROACHES AND CAN CAN WE
OVERCOME OUR MECHANISMS OF
RESISTANCE WHETHER IT'S DINOVO
OR ACQUIRED THROUGH OUR
KNOWLEDGE OF THE EXCEPTIONAL
RESPONDERS.
TREATMENT.
SURGICAL IS POTENTIALLY CURE
TIVE FOR THE SMALL SUBSET OF
PATIENTS WITH LOCALIZED
ADVERTISE SEIZE WHETHER IT'S
CANCER, OR GASTRIC CANCER OFTEN
IN THOSE INSTANCES PATIENTS WILL
STILL GET CHEMO RADIATION OR
IMMUNOTHERAPY AS A PRELUDE TO
SURGICAL RE SECTION.
NONE OF LESS, THE NEW APPROACHES
HAVE LIMITED SURVIVAL.
WITH THE MODEST EXCEPTION OF
TREATING HER2-POSITIVE TUMORS
TARGETED AS WELL AS THERAPY FOR
METASTATIC ESCC MORE THAN EAC
TARGETED THERAPIES HAVE BEEN
SOMEWHAT LIMITED IF NOT
DISAPPOINTING TO DATE.
AS I MENTIONED, IMMUNO
THERAPIES, IN THE NEW SETTING IN
THE ARE SHOWING PROMISE BUT
THESE TUMORS ARE FUNDAMENTALLY
IMMUNE LOGICALLY COLD,
REMINISCENT OF PANCREATIC
CARCINOMA WITH A VERY ROBUST AND
STROM MA SO WE NEED TO IDENTIFY
ADDITIONAL TARGETS IMMUNE
TARGETS THAT ARE ON IMMUNE CELLS
AND TARGETS THAT ARE ON FIBER
BLAST AND TAKE A APPROACH BASED
ON OUR HIGH LEVEL AND TREATMENT
RESEARCH AND NEXT SLIDE.
DEVELOP IMPROVE METHODS FOR PRE
TICKETING AND RESPONSE IN
RESISTANCE AND THIS CAN BE DONE
THROUGH NON-INVASIVE APPROACHES,
INVASIVE APPROACHES SUCH AS
ENDOSCOPY AND TISSUE-DERIVED
PLATFORM SUCH AS ORGANOIDS AND
SURROGATE MARKERS OF AND
RESPONSE FOR RESISTANCE AND
THOSE THAT RESPOND WHO MIGHT
HAVE THAT MIGHT ACQUIRE
RESISTANCE.
I THINK THIS IS DOABLE GIVEN THE
AN OWE TOPIC LOCATION OF THESE
CANCERS.
T-S3 IMPROVE TREATMENTS AND ONE
CAN'T EMPHASIS THAT ENOUGH.
AND THIS IS GOING TO BE IN
NATURE AND TAKING ADVANTAGE OF
THE ADVANCES MADE IN
IMMUNOTHERAPY AND TARGETED
THERAPY OF RECEPTORS KINASE AND
CELL BASED THERAPIES POSSIBLY
BUT IT'S BEEN DIFFICULT WITH
SOLID MALIGNANCY SO WE'LL SEE
ABOUT THAT AND T-S4, DEVELOPING
METHODS FOR IMAGE GUIDED
TREATMENT THROUGH ENDOSCAPY AS
WELL AS RADIOLOGY AND T-S5
DEVELOP NEW APPROACHES FOR
PREVENTING OR MITIGATING ADVERSE
EFFECTS ASSOCIATED WITH
TREATMENT OR TREATMENT.
PREVENTION FROM A GLOBAL
VIEWPOINT MAKES THE MOST SENSE
FOR THE REGIONS I MENTIONED AT
THE OUTSET WITH A ORGANISM AND
INFECTING 2 BILLION PEOPLE YET
IT'S LESS THAN 1% OF THOSE
2 BILLION PEOPLE THAT WILL
DEVELOP CARCINOMA IN ASSOCIATION
WITH H PYLORI THINKING OF GERM
LINE POLY MOTHISM AND AS WELL AS
CO FACTORS THAT ARE INTER
PLAYING WITH H PYLORI INFECTION
SO IT'S A DIFFICULT CHALLENGE
FOR POPULATION SCALE PROGRAMS
EVEN IF COUNTRIES IN WHICH H.
PYLORI IS ENDEMIC AND THE
COMPLEXITY OF H. PIE LORI ARE A
BROAD BASED APPROACH THAT ARE
CURRENTLY AVAILABLE ANTIBIOTIC
REGIMENTS AND A VACCINE REGIMENT
AND VACCINES HAVE BEEN THEY'RE
RELATED FOR NON H. PYLORI
CANCER.
P-1.
TRANSLATE THE EMERGING
BIOLOGICAL INSIGHTS INTO
PRACTICAL TOOLS AND STRATEGIES
FOR SCREENING, SURVEILLANCE,
EARLY DETECTION, AND RISK
STRATIFICATION AND NEXT SLIDE.
P-S1 DEVELOP SENSITIVE TOOLS FOR
SCREENING AND EARLY DETECTION
AND THIS COULD AGAIN BE
NON-INVASIVE ESPECIALLY IN
COUNTRIES THAT ARE UNDER
RESOURCED AS WELL AS INVASIVE IN
DEVELOPED COUNTRIES AND
DEVELOPED MORE SENSITIVE AND
ACCURATE ASSESSMENT TOOLS AND
DEVELOP MORE SENSITIVE AND
ACCURATE ASSESSMENT TOOLS FOR
DISEASE SURVEILLANCE.
NEXT SLIDE.
P-S4, NOVEL PREVENTATIVE
INTERVENTIONS AND ASPIRIN IS
EFFECTIVE AS CHEMO PREVENTION
FOR CARCINOMA BUT WE NEED MORE.
SUPPLY STATE OF THE ART
TECHNOLOGIES GO BEYOND THAT TO
THE NEXT GENERATION OF VACCINES
AND PERHAPS THINGS THAT ARE MRNA
BASED TO ADVANCE THE DEVELOPMENT
OF H. PYLORI VACCINES AND
DEVELOP ANTIBODY STEWARDSHIP AND
ERADICATION BECAUSE THERE'S A
AMOUNT OF ANTIBIOTIC RESISTANCE
IN THROUGH OUT THE WORLD AND LET
ALONE THE UNITED STATES SO
PEOPLE HAVE REOCCURRING H PYLORI
INFECTION WHICH IS CULTIVATED IN
CLOSE QUARTERS AND IS BY ORAL
FECAL TRANSMISSION.
CONCLUSIONS, THE 'EM TOMMY
LOGICAL AND CLINICAL REALITIES
THAT AR STAGGERING IN NATURE AND
NEED TO BE ACKNOWLEDGED IN THE
UNITED STATES OF UPPER G.I.
CANCERS DEFY A COMPELLING NEED
FOR FURTHER FOCUS AND
SUBSTANTIAL ADVANCES IN
PREVENTION AND DETECTION AND
SCREENING, SURVEILLANCE AND
TREATMENT.
WE'RE REVIEWING TWO DECADES OF
PROGRESS AND I WANT TO ALSO
EMPHASIZE PROGRESS HAS BEEN
MADE.
THE WORKING GROUP CONCLUDED A
CONCERTED AND SUSTAINED EFFORT
IS NEEDED TO BUILD A MORE
ASPIRATIONAL ROBUST PIPELINE OF
TRANSLATIONAL OPPORTUNITIES INTO
THE REMAINING PART OF THIS
DECADE.
NO WONDER INTERVENTION OR
PRIORITY WILL SERVE AS A
PANACEA.
IT REQUIRES A MULTI-DISCIPLINARY
INTER INSTITUTIONAL AND
COLLABORATIONAL AT THE NCI
MULTI-PRONGED APPROACH.
THAT'S WHY THE WORKING GROUP,
THROUGH ITS WORKING SUPPOSE
GROUPS RECOMMEND A BROAD BASED
APPROACH CRITICAL TO THIS IS A
CENTRALIZED NATIONAL BIOSPECIMEN
REPOSITORY AND THERE WAS MUCH,
MUCH EMPHASIS ON THIS AND MUCH
ENTHUSIASM FOR THIS AND WE THINK
THAT IT WILL BE TRANSFORMATIVE
IN NATURE TO DO THIS.
AND IT REQUIRES COLLABORATIONS
BETWEEN A PRIVATE AND PUBLIC
ENTITIES AND FEDERAL AGENCIES,
INDUSTRY AND PHILANTHROPY WHICH
IS EMERGING IN THE FIELD AND I
WELCOME YOUR COMMENTS AND
QUESTIONS.
I WANT TO REEMPHASIZE THE HARD
WORK OF INTEREST GOODMAN,
EVERYONE IN THE WORKING GROUP
AND OUR NCI COLLEAGUES THAT
WOULD NOT HAVE BEEN POSSIBLE
OTHERWISE.
>>THANK YOU SO MUCH.
THE THOROUGHNESS OF THE EFFORT
BY THE WORKING GROUP IS
REFLECTED IN YOUR PRESENTATION
AS WELL AS IN THE WORLD ITSELF.
WE WILL HAVE COMMENTS,
DISCUSSION, WHICH WILL BE
FOLLOWED BY COMMITTEE VOTE ON
THE APPROVAL OF THE REPORT
BEFORE WE CLOSE.
TO START US OFF, KAREN GOODMAN
JOINED BY PHONE AND I WOULD LOVE
TO GIVE HER.
I THINK THIS IS HOT OFF THE
PRESS.
>>IT'S IMPORTANT THAT Dr.
GOODMAN SPEAK UP AS WELL.
>>SO, KAREN, IT'S ALL YOURS.
>>HI, THANK YOU, CAN CAN YOU
HEAR ME?
>>YES.
>>OK, GREAT.
I'M GOING TO TRY TO GET MY VIDEO
ON, I'M HAVING ISSUES WITH THE
CONNECTION HERE AND I'M IN
ISRAEL AT A DINNER FOR OUR
EXTERNAL ADVISORY BOARD MEETING
AND THERE WERE ISSUES WITH
GETTING ON-LINE.
I JUST WANT TO THANK YOU, NEIL,
FABULOUS JOB OF PRESENTING WHAT
THE GROUP HAS REALLY PUT
TOGETHER OVER THESE LAST NINE
MONTHS OR SO.
I THINK THIS WAS A CHALLENGING
TOPIC.
WE HAD REALIZED IN GOING INTO
THIS THAT THERE WAS STILL A LOT
OF FUNDAMENTAL DATA AND
INFORMATION THAT WE NEEDED TO
ACQUIRE BEFORE WE COULD TACKLE
SOME OF THE QUESTIONS RELATED TO
WHAT ARE THE BEST OPTIONS FOR
PREVENTION, AND TREATMENTS,
OPTIMAL TREATMENT REGIMENTS FOR
THESE PATIENTS AND IT GOES BACK
TO A NEED FOR HAVING THE OPTIONS
TO HAVE PRECLINICAL DATA AND
CLINICAL DATA BASED ON HAVING
MORE ROBUST BIOSPECIMEN
REPOSITORIES TO REALLY
UNDERSTAND OUR TRANSITION FROM
NORMAL TO ADVERTISE PLASIA SO
CANCER AND UNDERSTANDING THE
EFFECT OF TREATMENT,
UNDERSTANDING THE BASELINE
TISSUE AND CANCER TISSUE AND
POST TREATMENT SO I THINK THIS
IS REALLY BEEN AN OPPORTUNITY
FOR US TO EX TOGETHER WITH A LOT
OF DIFFERENT SPECIALITIES AND
BACKGROUNDS TO REALLY PUT
FORWARD A REPRESENTATION I
REALLY HAVE TO THANK NEIL.
HE HAS BEEN WONDERFUL TO WORK
WITH.
WE HOPE PRIORITIZING THE NEED
HAVING CENTRALIZED RE SOURCE TO
BRING TOGETHER BIOSPECIMENS
WHETHER IT'S THROUGH OUR
CLINICAL TRIALS NETWORK AND OR
FROM OBSERVATIONAL STUDIES WE
HAVE BIO MARKERS AND TREATMENT
STRATEGIES.
>>CERTAINLY IT'S NOT YOU NECK
TO THESE ON STILLATION OF
CANCERS TO GO FROM NORMAL TO PRE
CANCER TO CANCER.
BUT WHAT IS DISTINCTIVE IS THE
ACCESSIBILITY TO TISSUES AT TIVE
STAGES, NORMAL PRE CANCER TO
CANCER SO THE MORE WE LEARN
ABOUT PRE CANCER, THE MORE IT
WILL HELP US INFORM ABOUT
PREVENTION AND INTERVENTION FOR
CANCER.
SO, BY BUILDING A CENTRALIZED
BIO REPOSITORY WE REALLY WANTED
TO INCLUDE PRE CANCER TISSUES AS
WELL.
>>THANK YOU.
I'D LIKE TO CALL ON NANCY
DAVIDSON WHO IS A MEMBER OF CTAR
AND ALSO CO-CHAIRS THE CTAC
TRANSLATIONAL RESEARCH STRATEGY
COMMITTEE, TRSS IS THE ACRONYM.
DO YOU HAVE ANY COMMENTS THAT
YOU WOULD LIKE TO MAKE ON BEHALF
OF THE TRSS.
>>THANK YOU SO MUCH.
FANTASTIC REPORT.
VERY COMPREHENSIVE.
THE MEMBERS OF THE TRSS AND
KEVIN SHANNON, DAVID AND MYSELF
ALL HAD A CHANCE TO REVIEW THIS
IN ADVANCE AND I THINK WE WERE
REALLY IMPRESSED BY THE
COMPREHENSIVE NATURE OF YOUR
ANALYSIS AND THE ONE THING WE
HOPED FOR WAS PRIORITIZATION AND
I HEARD THAT FROM YOU TODAY.
I BELIEVE I HEARD A REAL, REAL
MAJOR GOAL OF TRYING TO
PRIORITIZE TISSUE ACQUISITION
AND SPECIMEN ACQUISITION AS THE
FIRST STEP IN ALL OF THIS.
THANK YOU AND WE APPRECIATE IT.
>>AND THEN, HAVING THE
APPROPRIATE MODEL SYSTEMS TO BE
ABLE TO DO THE WORK WE WALKED A
FINE LINE BETWEEN BEING TOO
BROAD AND TOO SPOKE AND IT CAN
CAN APPLY TO ANY CANCER SO WE
DIDN'T WANT TO BE SO RESTRICTIVE
AND PRECLUDE HYPOTHESIS-DRIVEN
RESEARCH BUT THEN ESTABLISH AN
INFRASTRUCTURE THAT WOULD
APPLY -- ALLOW PEOPLE TO TAKE
DIFFERENT APPROACHES, NOVEL
APPROACHES TO THE ISSUES AT HAND
AND WE'RE GRATEFUL FOR THE
COMMENTS THAT WE RECEIVED FROM
THEM IN ADVANCE AND DID DISCUSS
THEM IN GREAT DETAIL AS WELL.
>>I I SEE ERNIE TALKS.
THE ONLY CTAC MEMBER THAT
PARTICIPATED IN THIS GROUP.
ERNIE, YOUR PERSPECTIVE IS
WELCOME.
>>YOU ARE ON MUTE.
WE CAN'T HEAR YOU.
>>THIS WAS A VERY JUST AS WE'VE
HEARD, A VERY COMPREHENSIVE
EFFORT TO TOOK AT THE PROGRESS
THAT'S MADE BUT THE REMAINING
GAPS AND OPPORTUNITIES THAT
EXIST AND WE WERE HOPING TO
PRIORITIZE EVEN MORE THAN YOU
HEARD AND IT'S A VERY LONG LIST.
PART OF THE CHALLENGE HERE IS
THAT WE'RE WORKING ACROSS THE
FULL SPECTRUM OF ADVERTISE SEIZE
AND AS WELL AS NOT ACROSS ONE
DISEASE BUT AT LEAST TWO
DISEASES OR SIX DISEASES
CONSIDERING MOLECULARLY AND NEIL
HIGHLIGHTED AT THE BEGINNING AND
IT'S PART OF THE CHALLENGE, I
THINK, IN TRYING TO PRIORITIZE.
IN OUR WORKING GROUP, IT WAS
FOCUSED ON PREVENTION, EARLY
TEXT AND SCREENING, OUR SUB
GROUP THAT IS, WE TALKED ABOUT
IS THERE ANYWAY TO TRY TO
PRIORITIZE ACROSS THOSE SIX
DISEASES AS WE WERE CONSIDERING
THEM FROM THE PERSPECTIVE.
WE DIDN'T A ARRIVE SATISFYING
CONCLUSIONS TO THAT AND THERE
WERE ARGUMENTS THAT PERHAPS WE
SHOULD CONCENTRATE ON THE
DISEASES THAT ARE MOST PREVALENT
IN BURDENSOME TO THE AMERICAN
POPULATION BUT THE OTHER HAND,
NCI PLAYS A IMPORTANT ROLE AS AN
INTERNATIONAL CATALYST IN TRYING
TO RESOLVE INEQUITIES AND AS
THEY RELATE TO CANCER GLOBALLY
AND SO AGAIN, WE DECIDED TO BACK
AWAY FROM THAT PRIORITIZATION.
AT LEAST TWO AREAS THAT I WOULD
HIGHLIGHT THAT PROBABLY DESERVE
SOME PRIORITIZATION WOULD BE
GENETICALLY BASED CANCER BECAUSE
IT'S THE GROUP THAT'S IN
GREATEST POTENTIAL IMMEDIATE
NEEDS AND THEREFORE MAY BE
WILLING TO UNDERGO THE SORTS OF
ANALYSIS PARTICIPATE IN A LEVEL
THAT WOULD PROVIDE THE MOST
INSIGHTS AND THE SECOND ONE WE
THOUGHT OF AT LEAST WAS IN ONE
OF THOSE DISEASES THAT IS STILL
ON THE RISE AND IN TERMS OF
MORBIDITY MORTALITY AND WE DO
HAVE SOLUTIONS.
I WANT TO CONSIDER NCI FOR
TAKING THE LEADERSHIP TO CONVENE
US AND IN PARTICULAR KAREN AND
NEIL FOR THEIR LEADERSHIP OF THE
EFFORT.
I KNOW FROM MY PAST EXPERIENCE
IT'S DIFFICULT TO TO AND THEY IT
A MARVELOUS JOB.
I'M END THERE AND THANK YOU.
>>THANK YOU, ERNIE.
I SEE RUBEN'S HANDS EXTENDED.
RUBEN, YOU ARE UP.
>>WONDERFUL.
I JUST APPLAUD THIS ENDEAVOR.
I THINK NCI IS SUCH A UNIQUE
ABILITY TO CONVENE.
BOTH KIND OF CONTINUOUS SPECTRUM
ACROSS THE GI TRACT AS YOU TAKE
THIS AS WELL AS FORGING
COLLABORATIONS ACROSS
INSTITUTIONS.
I'VE BEEN INVOLVED WITH A
PARALLEL EFFORT ON A SMALLER
SCALE THAT WAS CONVENED BY THE
LEUKEMIA SOCIETY AS IT RELATED
TO ACUTE LEUKEMIA TRYING TO
CONVENE STAKEHOLDERS FROM A
AROUND THE COMMUNITY WITH
MOLECULAR DATA TIED TO A
THERAPEUTIC PIECE.
THIS DEEP DIVE IN A TIME OR BOTH
LOOK SUCCESSFUL BUT ALWAYS
RAISES THE QUESTIONS ARE THERE
OTHER AREAS THAT ARE A SIMILAR
METHODOLOGY CAN BE APPLIED TO.
>>THANK YOU.
DOES ANYBODY ELSE ON CTAC HAVE
ANY COMMENTS THAT THEY WOULD
LIKE TO OFFER?
>>WROTE SEE ANY HANDS EXTENDED.
I'LL THEREFORE MOVE TOWARDS
APPROVAL OF THE REPORT.
TO I HAVE A MOTION TO ACCEPT THE
REPORT?
>>SO MOVED.
>>AND IS THERE A SECOND.
>>SECOND.
>>THANK YOU.
ANY DISCUSSION?
ANY FURTHER DISCUSSION?
IF NOT, I WOULD LIKE TO ASK FOR
A SHOW OF HANDS IF ANYONE DOES
NOT ACCEPT THE REPORT.
THESE ARE THE NAY VOTES.
AND ARE THERE ANY ABSTENTIONS?
SHOW OF HANDS.
OK.
I THINK WE CAN THEN GO AHEAD AND
ACCEPT THIS REPORT FROM THE
CANCER WORKING GROUP.
THANK YOU SO MUCH.
WE ARE ALMOST AT THE END OF OUR
MARATHON.
I WANT TO TAKE THIS MOMENT TO
THANK EVERYBODY FOR STICKING
WITH US TODAY AND FOR ALL THE
EXCELLENT DISCUSSION THAT WE
HAD.
I WOULD LIKE TO GIVE A SPECIAL
SHOUT OUT TO SHEL SHELIA FOR MAG
THIS HAPPEN IN SO MANY WAYS AT
NCI AND SO THANK YOU FOR THE
EXCELLENT WORK IN OUR NATION'S
CAPITOL.
AND I NOW LIKE TO TURN IT OVER
TO Dr. PRINDIVILLE FOR ANY
FINAL REMARKS.
>>YOU ARE MUTED.
>>SORRY.
I JUST HAVE TWO SLIDES THAT I
WANT TO CALL YOUR ATTENTION TO
TIGER WOODS THINYOUR MEETING MA.
I WANT TO MAKE SURE YOU ARE
AWARE OF THESE PROGRAMS.
ONE OF THEM, IF YOU GO TO THE
NEXT SLIDE.
ONE OF THEM IS THE PROGRAM THAT
RUBEN MENTIONED, JUST REMIND YOU
ALL THAT NCI HAS CREATED THIS
NEW AWARD IT'S CALLED THE R50
AWARD AND WE'VE TALKED ABOUT IT
BEFORE SO ARE CALL FAMILIAR WITH
IT AND I DO WANT TO NOTE THERE
ARE ACTUALLY IS AN OPEN FUNDING
ANNOUNCEMENT ON THE STREET SO
THESE SLIDES ARE IN YOUR NEW
BUSINESS SECTION.
YOU CAN GO TO THE PAR.
MOST IMPORTANTLY THE NEXT AWARD
ACCEPTANCE CYCLE IS
FEBRUARY 7th.
I WANT TO CALL THAT ALL TO YOUR
ATTENTION.
AND THEN, THE NEXT -- THIS IS
THE NCI SUMMIT THAT'S COMING UP
NEXT WEEK FOCUSING ON INCREASING
DIVERSITY AND EQUITY AND
INCLUSION FOCUSING ON
EARLY-PHASE CLINICAL TRIALS SO
WE HOPE TO HAVE A BROADEN
GAGEMENT WITH OUR PHARMACEUTICAL
PARTNERS AND OTHERS AND FOLKS
ARE TALLLY VIRTUAL FOLKS ARE
ACTUALLY ABLE TO REGISTER AND
WATCH THIS SO THE LINK TO THAT
REGISTRATION IS AT THE BOTTOM OF
THE SLIDE.
AND THEN, AGAIN, THESE LINKS ARE
ALSO IN THE MATERIALS SO YOU CAN
SIGN UP FOR THIS IF YOU WOULD
LIKE TO ATTEND AND THEN FINAL
SLIDE IS JUST REMINDING YOU OF
OUR FUTURE MEETI MEETI MEETINGSE
ACTUALLY SET THROUGH 2024 SO
PLEASE NOTE YOUR CALENDARS.
SO, NEAL, THAT'S ALL OTHER THAN
THANKS TO THE GREAT TEAM THAT I
HAVE SUPPORTING ME HERE AND AS
YOU ALL KNOW FROM INTERACTING
WITH TAWNI, IRIS AND ASHLEY VERY
MUCH IN THE LAST SEVERAL WEEKS
GETTING READY FOR THIS.
SO THANK YOU.
WILL WE BE IN-PERSON AT OUR NEXT
MEETING?
>>WELL, OK, SO, TWO COMMENTS ON
THAT.
SO, NUMBER ONE, TRADITIONALLY
WE'LL ACTUALLY ALWAYS MET
VIRTUALLY IN THE WINTER WHEN WE
MEET IN MARCH BECAUSE WE'VE HAD
A LOT OF CHALLENGES GETTING
PEOPLE HERE WITH SNOW STORMS.
WE CAN BEGIN TO HAVE IN-PERSON
MEETINGS BUT, IT'S HARD SO THE
QUESTION IS WHETHER WE DO IT IN
NEAR OR WE DO IT IN THE SUMMER
WHEN WE'RE MORE LIKELY TO HAVE
NO CHALLENGES GETTING PEOPLE
HERE.
WE'RE WORKING ON DOING THAT AND
WE HOPE THAT MEMBERS WILL COME.
I THINK A LOT OF THIS WILL --
WE'RE STILL IN THIS VIRTUAL
HYBRID WORLD AS WELL.
WE ARE AIMING FOR THAT.
>>GOOD.
THANK YOU FOR THE VOTE OF ON TA
MITCH.
OPTIMISM.
>>THANK YOU, EVERYBODY.
ENJOY THE REST OF THE DAY.
>>THANK YOU, BYE-BYE.