GOOD MORNING.
WELCOME TO THE WORKSHOP ON
INCLUSIVE PARTICIPATION IN
CLINICAL RESEARCH.
MY NAME IS DR. VANESSA MARSHAL,
AND I'M A PROGRAM OFFICER AT THE
NATIONAL INSTITUTE ON MINORITY
HEALTH AND HEALTH DISPARITIES.
I AM ONE OF THE CO-CHAIRS FOR
THIS WORKSHOP.
>> HELLO, MY NAME IS GINA RUSSO,
ALSO A PROGRAM OFFICIAL AT THE
NATIONAL INSTITUTE OF MINORITY
HEALTH AND HEALTH DISPARITIES
AND I'M THE OTHER CO-CHAIR FOR
THIS WORKSHOP.
THANK YOU SO MUCH FOR COMING,
WE'RE SO HAPPY THAT YOU'RE HERE.
WE ORGANIZED THIS WORKSHOP WITH
THE HELP OF OUR WONDERFUL
PLANNING COMMITTEE.
SO I WANT TO ACKNOWLEDGE THEM AS
WELL.
JENNIFER IN THE OFFICE OF
DISEASE PREVENTION, DEBORAH
JAFFE FROM THE NATIONAL CANCER
INSTITUTE, LOLA OLUFUNMILOLA
FROM THE NATIONAL INSTITUTE OF
NEUROLOGICAL DISORDERS AND
STROKE, NICOLE REDMOND FROM THE
NATIONAL HEART, LUNG AND BLOOD
INSTITUTE, KATRINA SERRANO FROM
THE NATIONAL INSTITUTE OF
DIABETES AND DIGESTIVE AND
KIDNEY DISEASES, AND DEBBIE I
HAVE TALS FROM THE NATIONAL
HEART, LUNG AND BLOOD INSTITUTE.
>> SO THE PURPOSE OF THIS
WORKSHOP IS TO IMPROVE
IMPLEMENTATION OF EVIDENCE-BASED
BEST PRACTICES TO INCREASE
INCLUSIVE PARTICIPATION IN
CLINICAL RESEARCH.
WITH DISCUSSION ON HOW TO
IMPLEMENT THESE PRACTICES,
CHALLENGES TO OVERCOME AND
LESSONS LEARNED.
THE OVERALL WORKSHOP IS
ORGANIZED BY STAGE IN THE
RESEARCH PROCESS AND WILL
DISCUSS ISSUES TO CONSIDER AND
ACTIVITIES THAT TAKE PLACE
BEFORE THE STUDY, DURING THE
STUDY, AND AFTER THE STUDY.
TODAY'S TALK WILL FOCUS ON THE
AFTER THE STUDY, SPECIAL
POPULATION PANEL, SPECIAL
CONSENT CONSIDERATION,
COLLABORATIVE PERSPECTIVE PANEL
AND POTENTIAL NEXT STEPS FOR
INCLUSIVE RESEARCH.
THE WORKSHOP AGENDA AND SPEAKER
BIOs ARE VIEWABLE ONLINE AND
THE LINK WILL BE ADDED TO THE
CHAT.
>> ALL RIGHT.
SO JUST A FEW HOUSEKEEPING AND
LOGISTICS ITEMS.
THIS MEETING IS BEING RECORDED
AND THE RECORDING WILL BE
PUBLICLY AVAILABLE.
AND WE'RE ALSO BEING LIVE
STREAMED ON NIH VIDEOCAST.
PEOPLE ON JOID CAST CAN SEE
ANYONE WHO'S ON VIDEO SO PLEASE
ONLY TURN ON YOUR VIDEO IF
YOU'RE SPEAKING.
WE HAVE THE CHAT AVAILABLE TO
EVERYONE.
YOU CAN USE THE CHAT TO SHARE
IDEAS, RESOURCES AND IMPRESSIONS
AND INSIGHTS.
ALL CHAT CONTENT INCLUDING
PRIVATE MESSAGES WILL BE SAVED.
FOR ANY ZOOM ISSUES YOU CAN SEND
A PRIVATE MESSAGE TO ANY OF THE
FOLKS ON THE PARTICIPANT LIST
WHO HAVE EVENT SUPPORT IN FRONT
OF THEIR NAME.
AND FOR CLOSED CAPTIONING, YOU
CAN ACCESS THAT BY CLICKING THE
CC BUTTON AT THE BOTTOM OF YOUR
ZOOM SCREEN.
AND IF YOU HAVE ANY ISSUES WITH
CLOSED CAPTIONING, YOU CAN ALSO
CONTACT EVENT SUPPORT.
SO LOGISTICS.
RIGHT NOW, ATTENDEE VIDEO AND
AUDIO IS DISABLED.
BUT IT WILL BE ENABLED DURING Q
& A AND PANEL DISCUSSIONS.
THERE ARE A COUPLE WAYS YOU CAN
SUBMIT QUESTIONS.
YOU CAN USE THE RAISE HAND
FUNCTION IN ZOOM, AND THEN
UNMUTE YOURSELF WHEN YOU'RE
CALLED ON.
YOU CAN GIVE YOUR QUESTION
VERBALLY.
YOU CAN ALSO ENTER QUESTIONS IN
THE CHAT.
SOMSEND THEM VIA EMAIL TO THE EL
ADDRESS ON THE SCREEN.
AND FOLKS WATCHING ON VIDEOCAST
CAN SUBMIT QUESTIONS USING THE
LIVE FEEDBACK BUTTON.
NEXT SLIDE.
I'M GOING TO PASS IT ON TO
DR. KATRINA SERRANO.
>> GREAT.
THANK YOU SO MUCH, GINA.
IT'S REALLY MY PLEASURE TO KICK
OFF THIS MORNING'S SESSION
BUILDING ON THE EXCELLENT
PRESENTATIONS FROM YESTERDAY.
AS MENTIONED MY NAME IS KATRINA
SERRANO, I'M A PROGRAM DIRECTOR
FROM THE NATIONAL INSTITUTE OF
DIABETES AND DIE JUSTTIVE AN DID
KIDNEY DISEASES.
I'LL BE MODERATING SESSION
3 WHICH IS AFTER THE STUDY.
AND THE SESSION WILL COVER THE
ACTIVITIES THAT TAKE PLACE AFTER
DATA COLLECTION IS COMPLETED.
AND THE SESSION IS ALSO
CO-MODERATED BY MY COLLEAGUE,
DR. JARRETT JOHNSON SEEN HERE
FROM THE NATIONAL INSTITUTE ON
MINORITY HEALTH AND HEALTH
DISPARITIES.
SO WE HAVE THREE ESTEEMED
SPEAKERS WHO WILL BE PRESENTING
IN THIS SESSION.
FIRST UP WE HAVE DR. KIRSTEN
BIBBINS-DOMINGO, WHO IS THE 17TH
EDITOR-IN-CHIEF OF THE JOURNAL
FOR THE AMERICAN MEDICAL
ASSOCIATION, AS WELL AS THE LEE
GOLDMAN PROFESSOR OF MEDICINE
AND PROFESSOR OF EPIDEMIOLOGY
AND BIOSTATISTICS AT THE
UNIVERSITY OF CALIFORNIA
SAN FRANCISCO.
AND THEN WE HAVE DR. MONA FOUAD,
PROFESSOR OF MEDICINE IN THE
DIVISION OF PREVENTIVE MEDICINE,
THE EDWARD E. PARTRIDGE ENDOWED
CHAIR FOR CANCER DISPARITY
RESEARCH, DIRECTOR OF THE
MINORITY HEALTH AND HEALTH
EQUITY CENTER, VICE PRESIDENT
FOR DIVERSITY, EQUITY AND
INCLUSION, AND SENIOR ASSOCIATE
DEAN FOR DIVERSITY AND INCLUSION
IN THE HEARSING SCHOOL OF
MEDICINE AT THE UNIVERSITY OF
ALABAMA AT BIRMINGHAM.
AND THEN LAST BUT CERTAINLY NOT
THE LEAST, WE'LL HEAR FROM
DR. LEONARD EGEDE, WHO IS A
GENERAL INTERNIST AND HEALTH
SERVICES RESEARCHER, PROFESSOR
OF MEDICINE, CHIEF OF THE
DIVISION OF GENERAL INTERNAL
MEDICINE, DIRECTOR OF THE CENTER
FOR ADVANCING POPULATION
SCIENCE, THE INAUGURAL MILWAUKEE
COMMUNITY CHAIR IN HEALTH EQUITY
RESEARCH, AND DIRECTOR OF TWO
CLINICAL AND TRANSLATION SCIENCE
INSTITUTE PROGRAMS AT THE
MEDICAL COLLEGE OF WISCONSIN.
AND SO WITH THAT, I'D LIKE TO
TURN IT OVER TO
DR. BIBBINS-DOMINGO.
I BELIEVE SHE IS ON THE LINE.
DR. BIBBINS-DOMINGO, PLEASE TAKE
IT AWAY.
>> WONDERFUL.
THANK YOU SO MUCH FOR HAVING ME
TODAY, AND I'M REALLY PLEASED TO
JOIN THIS DISCUSSION.
I'M GOING TO PULL UP MY OWN
SLIDES HERE.
HOPEFULLY YOU CAN SEE THEM.
SO THANK YOU SO MUCH FOR HAVING
ME HERE TODAY.
I'M HERE TO TALK ABOUT A
COMMITTEE FROM THE NATIONAL
ACADEMIES OF SCIENCE,
ENGINEERING AND MEDICINE THAT I
CHAIRED, THE CONSENSUS REPORT
WAS RELEASED IN MAY OF 2022, AND
REALLY ALIGNED WELL WITH MANY --
THE INTERESTS CERTAINLY OF THIS
DISCUSSION THAT YOU'VE BEEN
HAVING HERE FOR THE LAST TWO
DAYS, AND I WANT TO FOCUS THE
RECOMMENDATIONS IN THIS REPORT
THAT RELATE TO EVENTS THAT
HAPPEN AFTER A STUDY IS
COMPLETED.
BUT I'M GOING TO GIVE YOU AN
OVERVIEW OF THE ENTIRE REPORT
JUST TO SET THE CONTEXT.
SO THE CHARGE OF THIS PARTICULAR
COMMITTEE WAS TO ADDRESS
IMPROVING REPRESENTATION IN
CLINICAL TRIALS AND CLINICAL
RESEARCH, BUILDING RESEARCH
EQUITY FOR WOMEN IN
UNDERREPRESENTED GROUPS.
I CHAIRED THIS COMMITTEE AND DRE
NATIONAL ACADEMIES WAS MY
CO-CHAIR.
THIS IS THE COMMITTEE
COMPOSITION.
WE WERE REALLY FORTUNATE TO HAVE
PEOPLE FROM A VARIETY OF
DIFFERENT INSTITUTIONS, PEOPLE
FROM INDUSTRY, PEOPLE WHO
REPRESENTED A VARIETY OF
DIFFERENT DISCIPLINES, AND I
THINK REALLY REMARKABLY
COMMITTED AND PASSIONATE GROUP
OF INDIVIDUALS THAT I REALLY HAD
THE GOOD FORTUNE TO WORK WITH,
AND TO DO AN IMPORTANT REPORT
THAT WE ALL DID REMOTELY,
AND I THINK THIS REPORT, WE
UNDERSTAND NOW, IS ONE OF THE
MOST DOWNLOADED REPORTS LIKE IN
THE TOP 15 OF THE DOWNLOADED
REPORTS FROM THE NATIONAL
ACADEMIES.
AND I THINK REALLY SPEAKS TO THE
IMPORTANCE OF THE TOPIC AND
REALLY THE COMMITMENT OF ALL OF
THE PEOPLE WHO WORKED ON THIS TO
TRY TO BRING SOME OF THESE
RECOMMENDATIONS TO LIGHT.
WE BEGAN THIS REPORT BY TALKING
ABOUT THE CASE FOR
REPRESENTATION AND INCLUSION IN
CLINICAL TRIALS AND CLINICAL
RESEARCH, AND YOU, OF COURSE,
HAVE GONE OVER MUCH OF THIS, AND
THIS WILL NOT BE UNFAMILIAR TO
YOU.
BUT WE THOUGHT WE HAD TO SET THE
STAGE TO REALLY MAKE THE POINT
FOR ALL OF THE SECTORS IN OUR
BIOMEDICAL ENTERPRISE WHO REALLY
NEED TO ACT IN ORDER TO ACHIEVE
A GOAL THAT WE HAVE NOT ACHIEVED
DESPITE A COMMITMENT AND STATED
COMMITMENT FOR MORE THAN 30
YEARS TO THIS GOAL.
SO WHY IS DIVERSE REPRESENTATION
IN CLINICAL RESEARCH IMPORTANT?
WE STARTED FIRST WITH NOTING
THAT THIS COMPROMISES THE
GENERALIZE ABILITYD TO CLINICAL
RESEARCH TO THE U.S. POPULATION.
IF WE'RE GOING TO SPEND -- THE
MONEY WE SPEND ON BIOMEDICAL
RESEARCH ACROSS GOVERNMENT,
PRIVATE, INDUSTRY SECTORS, WE
WOULD LIKE OUR STUDIES TO BE
GENERALIZABLE TO THE POPULATIONS
IN THE U.S.
THE LACK OF REPRESENTATION
HINDERS NEW DISCOVERY, HINDERS
INNOVATION, WHICH IS ALSO A
MAJOR DRIVER OF THE RESEARCH
THAT WE ARE ALL ENGAGED IN.
LACK OF REPRESENTATION MAY
COMPOUND LOW ACCRUAL THAT CAUSES
MANY TRIALS TO FAIL.
AS YOU ALL KNOW, MANY TRIALS DO
NOT GET TO FULL ACCRUAL AND IF
WE DON'T HAVE ALL OF THE
POPULATIONS IN OUR AREAS THAT WE
WOULD LIKE TO INCLUDE, THAT MAY
COMPOUND THE LOW ACCRUAL THAT
OCCURS OVERALL.
LACK OF REPRESENTATION MAY LEAD
TO LEAD TO LACK OF ACCESS TO
MEDICAL INTERVENTIONS.
OFTENTIMES THE APPROVAL OR
COVERAGE OF THESE INTERVENTIONS
IS DIRECTLY RELATED TO THE TYPES
OF POPULATIONS THAT ARE
REPRESENTED IN A PARTICULAR
STUDY.
AND SO THAT'S IMPORTANT AS WELL.
LACK OF REPRESENTATION MAY
UNDERMINE TRUST, AND WE HAVE
SEEN THIS THROUGHOUT THE
PANDEMIC.
WE SEE THIS IN A VARIETY OF
AREAS AND PARTICULARLY AS MORE
COMMUNITIES ARE ACTIVATED AND
UNDERSTAND THE IMPORTANCE OF
HAVING STUDIES ABOUT THEM,
HAVING THEM INCLUDED IN STUDIES,
AND SO THE LACK OF TRUST AGAIN
THEN FEEDS TO THE LACK OF USE OF
EFFECTIVE MEDICAL INTERVENTIONS
AS WELL.
THAT LACK OF REPRESENTATION
COMPOUNDS HEALTH DISPARITIES,
BECAUSE THE POPULATIONS THAT ARE
CURRENTLY UNDERREPRESENTED IN
CLINICAL TRIALS AND CLINICAL
RESEARCH ARE ALSO THOSE WHO ARE
DISPROPORTIONATELY REPRESENTED
IN THE ADVERSE HEALTH OUTCOMES
THAT WE SEE SO STARKLY AND
CLEARLY IN THE U.S., AND THEN
THE LACK OF REPRESENTATION IS
ACTUALLY QUITE COSTLY TO THE
U.S.
WE COMMISSIONED AN ECONOMIC
STUDY AS A PART OF THIS
CONSENSUS PANEL, AND BASICALLY
THIS ECONOMIC STUDY WAS DESIGNED
TO LOOK AT THOSE POPULATIONS WE
WERE FOCUSED HERE ON RACIAL AND
ETHNIC MINORITY POPULATIONS,
THAT HOW MUCH DO THE DISPARITIES
WE SEE IN COMMON CHRONIC
CONDITIONS ACTUALLY COST
THE U.S.
SO IF WE LOOK AT THOSE
DISPARITIES, THEY COST THE
U.S. -- THIS IS REALLY FOCUSED
ON BLACK AND LATINO POPULATIONS
IN THE U.S. BECAUSE THAT'S WHERE
THE DATA -- WE HAVE THE MOST
AMOUNT OF DATA TO TAKE A
COMPREHENSIVE LOOK AT THE COST
OF THESE DISPARITIES.
IN DIABETES, THEY'RE COSTING
NEARLY ONE YEAR OF INCREASE IN
LIFE EXPECTANCY, MORE THAN A
YEAR IN DISABILITY-FREE LIFE
EXPECTANCY, AND IT'S COSTING
YEARS IN THE WORKFORCE.
WE SEE THE SAME NUMBERS FOR
HEART DISEASE, AND WE SEE THE
SAME NUMBERS FOR HYPERTENSION.
AND THE POINT HERE IS THAT WHEN
WE CONSIDER THE ECONOMIC COST OF
HEALTH DISPARITIES, IS THAT IF
WE WERE TO ELIMINATE LIFE
EXPECTANCY DISPARITIES FOR THESE
THREE CONDITIONS AND JUST THESE
THREE CONDITIONS, THE VALUE
ASSOCIATED WITH THAT CHANGE IN
LIFE EXPECTANCY WOULD BE ON THE
ORDER OF TRILLIONS OF DOLLARS.
THE VALUE FOR EVEN MODEST
REDUCTIONS IN HEALTH DISPARITIES
WOULD THEN BE ON THE ORDER OF
BILLIONS OF DOLLARS, AND LET ME
BE CLEAR, WE ALL KNOW THAT THERE
ARE MULTIPLE FACTORS THAT
CONTRIBUTE TO DISPARATE LIFE
EXPECTANCIES THAT WE SEE IN THE
U.S.
THE TYPE OF WORK THAT IS FUNDED
THROUGH CLINICAL TRIALS AND
CLINICAL RESEARCH REALLY IS NOT
EXPECTED TO ADDRESS ALL OF
THOSE, BUT IF IT ONLY ADDRESSED
A VERY SMALL FRACTION, 1%, WE
ARE STILL TALKING ABOUT LARGE
AMOUNT OF ECONOMIC VALUE THAT WE
ARE POTENTIALLY FOREGOING
BECAUSE WE DO NOT HAVE
REPRESENTATION IN OUR STUDIES.
AND THAT WAS THE POINT OF THIS
ECONOMIC ANALYSIS AS WELL.
SO WE SPENT A BIT OF TIME IN OUR
STUDY TO LOOK AT WHAT THE
CURRENT STATUS IS, AND I KNOW
YOU HAVE ALREADY GONE OVER THESE
NUMBERS.
WHAT OUR COMMITTEE REPORT FOUND
WAS REALLY THAT DESPITE THREE
DECADES, REALLY, OF STATEMENTS
AND OF STATED COMMITMENT TO
IMPROVING REPRESENTATION IN
CLINICAL TRIALS AND CLINICAL
RESEARCH, THAT REALLY THE
PROGRESS PARTICULARLY FOR
INCLUSION OF RACIAL AND ETHNIC
MINORITY POPULATIONS HAVE
LARGELY REMAINED STAGNANT OVER
THIS TIME.
THERE HAS BEEN INCREASE IN THE
REPRESENTATION OF WOMEN, BUT
THIS ALSO IS, IN CERTAIN AREAS,
AND DOESN'T INCLUDE MANY
POPULATIONS OF WOMEN THAT --
PARTICULARLY RACIAL AND ETHNIC
MINORITY POPULATIONS ARE ALSO
UNDERREPRESENTED.
THE OTHER THING THAT WAS QUITE
STRIKING TO THE COMMITTEE WAS
HOW POOR THE DATA IS IN THIS
AREA, WHICH IS IMPORTANT FOR
MONITORING AND SURVEILLANCE.
AND AS YOU HAVE ALSO TALKED
ABOUT, THIS IS NOT BECAUSE OF A
LACK OF WILLINGNESS OF THOSE
COMMUNITIES THAT ARE
UNDERREPRESENTED.
WHAT THE COMMITTEE WAS STRUCK BY
WAS HOW OFTEN IT IS REALLY A
FAILURE TO ASK AND HAVE
INFRASTRUCTURE IN PLACE TO
REALLY -- TO ASK POPULATIONS
THAT ARE CURRENTLY
UNDERREPRESENTED TO PARTICIPATE
IN THESE STUDIES.
SO THESE ARE THE -- I'M GOING TO
MOVE TO THE FIVE OVERARCHING
CONCLUSIONS OF THIS REPORT, AND
THEN GO TO SOME SPECIFIC
RECOMMENDATIONS THAT RELATE TO
WHAT HAPPENS AFTER THE STUDY.
ONE IS THAT WE FOUND THAT
IMPROVING REPRESENTATION IS AN
URGENT PROBLEM THAT NEEDS TO BE
ADDRESSED.
THAT WE HAVE MADE PERSISTENT
STATEMENTS ABOUT THIS BUT WE
HAVE MADE LACK OF PROGRESS AND
THE NEED TO DO THIS IS URGENT.
THAT THIS IS GOING TO REQUIRE
INVESTMENT.
AND INVESTMENT ACROSS MANY
DIFFERENT SECTORS INVOLVED IN
OUR BIOMEDICAL ENTERPRISE.
IT REQUIRES TRANSPARENCY AND
ACCOUNTABILITY.
ONE OF THE THINGS THAT WAS MOST
STRIKING TO US IS HOW MANY
DIFFERENT SECTORS IN OUR
BIOMEDICAL ENTERPRISE STATE THAT
THIS IS IMPORTANT BUT HAVE NOT
TAKEN THE STEPS TO ACT.
IT SEEMS THAT IT IS EVERYONE'S
RESPONSIBILITY AND, THEREFORE,
IT BECOMES NO ONE'S
RESPONSIBILITY, AND THAT'S WHERE
YOU'LL SEE WHERE OUR
RECOMMENDATIONS ARE FOCUSED.
IT IS SOMETHING THAT SOMETHING
THE RESPONSIBILITY OF EVERYONE
INVOLVED IN THE BIOMEDICAL
ENTERPRISE.
EACH PLAYER HAS A PART TO PLAY
IN THIS, AND THAT ULTIMATELY,
WHILE MANY OF OUR
RECOMMENDATIONS ARE FOCUSED ON
THE NEXT STEP, PARTICULARLY
POLICIES THAT SHOULD BE PUT INTO
PLACE TO BASICALLY THROUGH A
COMBINATION OF CARROTS AND
STICKS GET US TO DO THIS WITH
MORE DELIBERATE SPEED,
ULTIMATELY WHAT'S REQUIRED FOR A
MORE EQUITABLE FUTURE HAS A
PARADIGM SHIFT THAT MOVES THE
BALANCE OF POWER AND PUTS THE
COMMUNITIES AND VOICES AND
INTERESTS OF COMMUNITIES AT THE
CENTER OF THE WAY WE THINK ABOUT
INVOLVEMENT IN THE BIOMEDICAL
ENTERPRISE.
AND THAT'S AN IMPORTANT
CONCLUSION OF THIS REPORT AS
WELL.
SO LET ME GO TO THE
RECOMMENDATIONS, AND REALLY AS
THEY RELATE TO WHAT HAPPENS
AFTER THE STUDY.
WE TALKED ABOUT HHS AND AN
INTERDEPARTMENTAL TASK FORCE
CHARGED WITH COORDINATING THE
VARIOUS STAKEHOLDERS TO ENSURE
THAT THERE'S BETTER DATA FOR
SURVEILLANCE.
THE NIH TO STANDARDIZE
SUBMISSION OF DEMOGRAPHIC
CHARACTERISTICS TO
CLINICALTRIALS.GOV.
WE WERE REALLY MISSING A LOT OF
DATA, TO REALLY MONITOR WHAT OUR
PROGRESS IS IN THIS WAY AND WE
REALLY NEED TO HAVE A WAY TO
MONITOR PROGRESS IN THIS REGARD.
I'M NOW IN CHARGE OF A JOURNAL
AND WE DID PUT A CALL TO
JOURNALS AND TO JOURNAL EDITORS
AND PUBLISHERS TO REQUIRE
INFORMATION ON THE
REPRESENTATIVENESS OF TRIALS AND
STUDIES FOR SUBMISSIONS TO THEIR
JOURNALS, AND TO CONSIDER
REPRESENTATIVENESS OF STUDIES IN
THE DECISIONS THAT THEY MAKE
ABOUT THIS.
AND YOU'VE SEEN MANY JOURNALS
ACTUALLY PUTTING MORE
INFORMATION OUT THERE SO THAT
READERS CAN JUDGE THE
GENERALIZABILITY OF FINDINGS TO
THE POPULATIONS IN THE U.S.
WE HAVE RECOMMENDATIONS ON
ACCOUNTABILITY, AND THE FDA
REQUIRING STUDY SPONSORS TO
SUBMIT DETAILED RECRUITMENT
PLANS NO LATER THAN AT THE TIME
OF THE APPLICATION FOR NEW DRUG
AND DEVICABLECATIONS.
THE IDEA HERE IS TO PUT THOSE
REQUIREMENTS INTO PLACE UP
FRONT, AND BECAUSE MANY OF THESE
STUDIES ARE ABOUT APPROVAL OF
NEW DRUGS OR DEVICES, THAT
HAVING THIS EARLY IN THE PROCESS
PROVIDES THAT ACCOUNTABILITY
LAYER.
WE HAVE RECOMMENDATIONS TO THE
NIH OF REALLY ENSURING
ENFORCEABILITY OF BOTH AT THE
TIME OF GRANT REVIEW ALL THE WAY
THROUGH THE YEARLY PROGRESS
REPORTS TO INCLUDE THAT
PARTICIPANT REPRESENTATION IS A
PART OF SCORE -DRIVING CRITERIA.
TO WORK WITH LOCAL IRBs TO
ENSURE THAT REPRESENTATIVENESS
IS ONE OF THE CRITERIA OF SOUND
STUDY DESIGNS, AND TO THINK
ABOUT THIS, AND THIS IS REALLY
IMPORTANT BECAUSE THIS IS AFTER
THE STUDY, THAT COVERAGE
DECISIONS THAT CMS IS ENGAGED
IN, THE CENTER FOR MEDICARE AND
MEDICAID SERVICES, SHOULD BE
BASED ON EVIDENCE DEVELOPMENT
THAT IS BASED ON STUDIES THAT
HAVE DIVERSE REPRESENTATION.
WE TALKED A LOT ABOUT FEDERAL
INCENTIVES.
CONGRESS TO DIRECT THE FDA TO
ENFORCE EXISTING ACCOUNTABILITY
MEASURES, AND THEN TO ESTABLISH
NEW ACCOUNTABILITY MEASURES.
THERE ARE A NUMBER OF MEASURES
THAT ARE CURRENTLY IN PLACE AT
THE FDA THAT COULD BE ENFORCED
TO HOLD ACCOUNTABLE THOSE GOING
TO THE FDA FOR NEW DRUG OR
DEVICE APPROVAL.
WE ALSO HAD RECOMMENDATIONS
RELATED TO INCENTIVES THAT
RELATE TO ACCELERATED APPROVAL
FOR STUDIES THAT ACTUALLY
ACHIEVE THESE TYPES OF CRITERIA.
AGAIN, IN THE SPIRIT OF CARROTS
AND STICKS, WE MADE
RECOMMENDATIONS THAT CMS SHOULD
EXPEDITE COVERAGE DECISIONS FOR
DRUGS AND DEVICES THAT HAVE BEEN
IMPROVED ON THE BASIS OF
CLINICAL DEVELOPMENT PROGRAMS
THAT ARE REPRESENTATIVE OF THE
POPULATIONS MOST AFFECTED BY
TREATABLE CONDITIONS.
THAT CMS SHOULD ACTUALLY WORK TO
INCENTIVIZE COMMUNITY PROVIDERS
THAT MORE COMMUNITY PROVIDERS
HAVE THE INFRASTRUCTURE TO
ENROLL AND RETAIN PARTICIPANTS
AND THAT CMS AS ONE OF THE WAYS
IN WHICH REIMBURSEMENT HAPPENS
COULD PROVIDE THOSE TYPES OF
INCENTIVES TO ENABLE MORE
COMMUNITY PROVIDERS TO BE
INVOLVED IN BIOMEDICAL RESEARCH,
AND THAT THE GAO SHOULD BE
THINKING ABOUT OVERALL
MONITORING AND EVALUATION OF THE
IMPACT OF THE REIMBURSEMENT OF
ROUTINE CARE ASSOCIATED WITH
CLINICAL TRIALS PARTICIPATION
RELATED TO BOTH MEDICARE AND
MEDICAID.
WE TALKED A LOT ABOUT
REMUNERATION OF STUDY
PARTICIPANTS AND THE TYPES OF
FEDERAL POLICIES THAT NEED TO BE
IN PLACE TO MAKE SURE THAT LOCAL
IRBs HAVE EXPLICIT GUIDANCE ON
EQUITABLE COMPENSATION FOR
PARTICIPANT RESEARCH -- FOR
PARTICIPANTS WHO ARE --
PARTICIPANTS OR THEIR
CAREGIVERS, AND THIS WAS A VERY
IMPORTANT POINT FOR THE
COMMITTEE.
IT COST TO PARTICIPATE IN TRIALS
AND STUDY PARTICIPANTS SHOULD BE
COMPENSATED EQUITABLY, AND THAT
ALL SPONSORS SHOULD ENSURE THAT
TRIALS PROVIDE EQUITABLE --
ADEQUATE COMPENSATION FOR
RESEARCH PARTICIPANTS.
AND THEN WE TALKED ABOUT THE
BROADER MILIEU THAT ALL OF
RESEARCH TAKES PLACE AND THAT
THE PRINCIPLES OF EQUITY APPLY
BOTH TO THOSE WHO ARE IN THE
WORKFORCE WHO ARE ENGAGED IN
DOING THIS TYPE OF WORK AS WELL
AS THE PARTNERSHIPS INVOLVED.
THAT ALL ENTITIES INVOLVED IN
THE CONDUCT OF CLINICAL TRIALS,
WE SHOULD ALL BE ENSURING A
DIVERSE AND INCLUSIVE WORKFORCE,
PARTICULARLY IN LEADERSHIP
POSITIONS.
THAT LARGE HEALTH CENTERS SHOULD
BE INVOLVED IN COMMUNITY -- IN
SUPPORTING COMMUNITY ENGAGED
SCHOLARSHIP, AND THAT THAT IS
ESSENTIAL TO PROVIDE THE
INFRASTRUCTURE TO VALUE THIS
TYPE OF WORK, THAT TRAINING AND
COMMUNITY ENGAGEMENT AND THE
PRINCIPLES OF DEI FOR ALL STUDY
PARTICIPANTS IS ESSENTIAL, AND
THAT INVESTMENT IN COMMUNITY
RESEARCH INFRASTRUCTURE TO
IMPROVE THE REPRESENTATION OF
CLINICAL TRIALS AND CLINICAL
RESEARCH IS ESSENTIAL.
OUR RECOMMENDATIONS ARE FOCUSED
ON POLICY BECAUSE WE BELIEVE
THAT THIS IS SOMETHING THAT'S
POSSIBLE.
WE SEE THAT IN MANY OF THE
STUDIES THAT ARE CURRENTLY
INVOLVED AND WHAT WE NEED ARE
POLICY EFFORTS TO ACCELERATE
THAT IN MORE PLACES.
THANK YOU VERY MUCH.
>> THANK YOU SO MUCH,
DR. BIBBINS-DOMINGO, FOR THAT
GREAT PRESENTATION OVERVIEW OF
THE NATIONAL ACADEMIES REPORT.
NOW I'M GOING TO TURN IT OVER TO
DR. FOUAD.
DR. FOUAD, GO AHEAD.
>> I'M GOING TO SHARE MY SCREEN
ALSO, IF YOU CAN GIVE ME A
MINUTE.
CAN YOU SEE MY SCREEN?
>> YES.
>> OKAY, GREAT.
SO THANK YOU,
DR. BIBBINS -DOMINGO, THIS WAS A
GREAT WORK AND I'M GLAD YOU
FOCUSED ON POLICIES BECAUSE, YOU
KNOW, TO MOVE THE NEEDLE
PROBABLY THIS WAS NEEDED.
SO I'M GOING TO PRESENT A STUDY
THAT WE DID JUST ABOUT THE
STRATEGY THAT IMPROVED PROBABLY
THE INFRASTRUCTURE IN OUR HEALTH
SYSTEMS.
AS DR. DOMINGO SAID, IT'S NOT
THAT PEOPLE DON'T WANT TO
PARTICIPATE, BUT WE NEED TO HAVE
THE STRATEGIES AND THE
INFRASTRUCTURE TO DO THAT.
AND I'M JUST GETTING TO CLINICAL
TRIALS AS LIKE WE THINK ABOUT
ALWAYS HEALTHCARE DELIVERY FOR
HEALTH EQUITY, BUT ALSO BEING
INCLUSIVE IN CLINICAL TRIALS
REALLY MAY HELP US TO REACH ALSO
IT'S A HEALTH EQUITY ISSUE.
SO AGAIN, YOU KNOW, I KNOW THAT
DR. DOMINGO TOUCHED ON THIS, BUT
I WANTED ALSO TO TALK ABOUT IT
IS REALLY IMPORTANT FOR US TO
HAVE CLINICAL TRIALS BECAUSE
THAT'S REALLY WHAT DRIVES OUR
DISCOVERY, AND TO KNOW WHAT IS
THE BEST CLINICAL CARE AND
PATIENT CARE SHOULD BE.
AND AGAIN, AS DR. DOMINGO
MENTIONED, THIS IS JUST A FEW
FROM THE LIST THAT SHE ALL
MENTIONED, IS THAT IN THE
ABSENCE OF DIVERSE POPULATIONS,
WE CANNOT GENERALIZE OUR STUDY.
ALSO WE HEARD YESTERDAY AND
TODAY THAT EVEN BEING IN A
CLINICAL TRIAL, ESPECIALLY
THERAPEUTIC TRIALS AND OTHERS,
CAN GIVE OUR PATIENTS AN
OPPORTUNITY FOR ADVANCED CARE,
AND ALSO WITHOUT HAVING CLINICAL
TRIALS, HEALTH DISPARITIES AS WE
HEARD TOO, CAN BE REALLY
INCREASED AND WIDENED.
SO WE KNOW THAT THERE IS AN
INEQUITY IN OUR HEALTHCARE
SYSTEM, AND THIS HAS BEEN
PROVEN, AND THERE IS A LOT OF
BURDEN OF DISEASE AND DEATH IN
SOME POPULATIONS COMPARED TO --
OR MAJORITY OF POPULATIONS IN
THE UNITED STATES.
I WORK HERE IN ALABAMA, AND THIS
IS -- I'M IN THE SOUTH, AND OUR
INSTITUTION IS IN THE SOUTH, AND
YOU CAN SEE THAT IF WE LOOK INTO
THE RATE AND THE BURDEN OF
DISEASE, OF MAJOR CHRONIC
DISEASE, AND THERE ARE OTHERS
BASED ON CDC MAPS, OBESITY,
DIABETES, HEART DISEASE AND
CANCER, REALLY THERE IS A HIGH
BURDEN IN THE SOUTHEAST.
BUT IF YOU JUST LAYERED THIS ON
SOME OF WHAT WE CALLED SOCIAL
DETERMINANTS OF HEALTH, LIKE
EDUCATION, UNEMPLOYMENT,
POVERTY, YOU CAN SEE THAT THERE
IS SOME ASSOCIATION HERE.
BUT ALSO WE HAVE MORE THAN 50%
OF OUR AFRICAN AMERICAN
POPULATION AND A GROWING
HISPANIC POPULATION, THAT THEY
ARE LOW INCOME AND LIVE IN THE
SOUTH AND RURAL COMMUNITIES.
SO WHAT CAUSES HEALTH
DISPARITIES, WHAT FACTORS?
I'M PROBABLY PREACHING TO THE
CHOIR, BUT THESE ARE ALSO VERY
IMPORTANT WHEN WE THINK ABOUT
CLINICAL TRIALS, BECAUSE LACK OF
HEALTH INSURANCE, HEALTHCARE
UTILIZATION, IF WE'RE TRYING TO
ATTRACT PEOPLE THAT THEY DON'T
USE OUR HEALTHCARE SYSTEMS TO
INCLUDE THEM IN TRIALS, THIS
WOULD BE NEEDING SOME MORE
STRATEGIES TO ENGAGE PEOPLE IN
THE HEALTHCARE SYSTEM.
QUALITY OF CARE, BECAUSE WE KNOW
TO OFFER CLINICAL TRIALS, YOU
REALLY HAVE TO HAVE VERY HIGH
QUALITY OF CARE.
PHYSICIAN BIAS, THAT THEY MAY
NOT OFFER A GOOD QUALITY CARE
BUT ALSO THEY MAY NOT OFFER
CLINICAL TRIALS.
THERE IS LACK OF CULTURAL
COMPETENCY, AND PERCEIVED
DISCRIMINATION, AND I'M GLAD TO
SEE WHAT DR. DOMINGO SAID, THAT
OUR INVESTIGATORS AND PEOPLE
INVOLVED IN CLINICAL TRIALS NEED
ALSO TO BE TRAINED IN CULTURAL
COMPETENCY AND DIVERSITY AND
INCLUSION.
AND THEN PATIENT DECISION-MAKING
SKILLS AND HEALTH LITERACY,
THESE ARE VERY IMPORTANT FOR
QUALITY OF CARE AS WELL AS
CLINICAL TRIALS.
I'M NOT GOING TO GO THROUGH THE
SLIDE, BUT I JUST WANT TO SHOW
YOU BASED ON THE WORLD HEALTH
ORGANIZATION, HEALTH DISPARITY
IS VERY COMPLEX.
IT HAS MANY, MANY FACTORS HERE
THAT INVOLVE A DISTRIBUTION OF
HEALTH AND WELL-BEING, SO WHEN
WE THINK ABOUT HOW WE'RE GOING
TO ENGAGE OUR DIVERSE AND LOW
INCOME POPULATIONS AND MINORITY
POPULATIONS' CLINICAL TRIALS,
THERE ARE A LOT OF FACTORS THAT
IMPACT THAT TO DEVELOP OUR
STRATEGIES.
SO I MENTIONED SOCIAL
DETERMINANTS OF HEALTH AND
THAT'S VERY IMPORTANT IN
HEALTHCARE UTILIZATION INCLUDING
CLINICAL TRIALS.
AND WE CAN SEE HERE THAT SOCIAL
DETERMINANTS REALLY IMPACT
HEALTH, PREDICT HEALTH STATUS,
DETERMINES THE INFLUENCE IN
HEALTH BEHAVIOR AND
DECISION-MAKING, AND ALSO IT
INTERACTS WITH HEALTH OUTCOMES.
SO WHAT ARE THOSE AND THESE ARE
THINGS THAT INVESTIGATORS --
CLINICAL TRIALISTS USUALLY DON'T
THINK ABOUT, IS THAT PATIENT
COMING IN THAT HAS SOME
CHALLENGES WITH SOME WHAT WE
CALL SOCIAL DETERMINANTS LIKE
EDUCATION, INCOME, EMPLOYMENT,
HOUSING, SOCIAL RELATIONSHIP,
PERCEIVED DISCRIMINATION, WORK
ENVIRONMENT.
ALL THESE THINGS, WE DON'T THINK
ABOUT THEM WHEN WE DEVELOP
STRATEGIES TO ENHANCE OUR
ENROLLMENT AND BE INCLUSIVE OF
ALL POPULATIONS.
SO WE TOUCHED ON THAT, THERE IS
A LOT OF PERCENTAGE OUT THERE OF
WHAT ARE THE PERCENTAGE OF
MINORITIES AND DIVERSE
POPULATIONS IN CLINICAL TRIALS,
BUT IT'S STILL LOW.
SO WHAT ALL WHAT I JUST VERY
BRIEFLY TOUCHED ON AS SOCIAL
DETERMINANTS OF HEALTH AND OTHER
CHALLENGES FOR OUR PATIENTS,
THAT IT'S A CHALLENGE TO RECRUIT
DIVERSE POPULATIONS AND MINORITY
PATIENTS TO OUR CLINICAL TRIALS,
BUT WE ALSO DON'T THINK ABOUT
IT'S ALSO A GREATER CHALLENGE TO
RETAIN THEM.
AND WE HAVE TO THINK ABOUT HOW
CAN WE RECRUIT TO RETAIN?
WE CAN'T JUST THINK ABOUT
RECRUITMENT.
BUT ALSO WE NEED TO THINK ABOUT
STRATEGIES THAT HAVE INFORMED
PARTICIPANTS THAT ALSO CAN BE
RETAINED.
SO I'M SURE WE ALL KNOW FROM THE
LITERATURES THERE IS A LOT OF
BARRIERS THAT ARE LISTED IN ALL
OF OUR LITERATURE.
I'VE BEEN WORKING IN THIS AREA
FOR PROBABLY TWO DECADES, AND
THEY HAVEN'T CHANGED, YOU KNOW,
LIKE WE HAVE BARRIERS RELATED TO
OUR COMMUNITIES, TO OUR CARE
PROVIDERS AND ALSO OUR OWN
RESEARCH DESIGNS.
AND WE ALL KNOW ABOUT THESE
THINGS THAT ARE OUT THERE THAT
WE NEED TO DEVELOP STRATEGIES TO
ADDRESS FIELD, THE MISTRUST,
TRUST, WE ALL TALK ABOUT
TRUSTING VOICES AND TRUST, HOW
WE CAN BUILD THAT.
LIKE IF A PATIENT HAS ALL THESE
PRIORITIES IN THEIR LIFE AND
SOCIAL DETERMINANTS, THEN HEALTH
PRIORITIES ARE GOING TO BE
DIFFERENT, DO I GO FOR CARE OR
GO FOR PARTICIPATING IN CLINICAL
TRIAL?
NEGATIVE EXPERIENCES, WE ALL
KNOW UNFORTUNATELY ALL THE
NEGATIVE EXPERIENCES WE HAD
REGARDING RESEARCH, AND IT STILL
EXISTS.
DIFFERENCES IN HEALTH BELIEF AND
OTHER ECONOMIC BARRIERS.
NOW FOR HEALTHCARE PROVIDERS
THAT THEY ARE REFERRING PATIENTS
TO US, THAT THEY MAY NOT BE PART
OF THE CLINICAL TRIAL TEAMS, AND
I EXPERIENCED THIS MYSELF WHEN I
REACHED OUT TO MY COLLEAGUES TO
REFER PATIENTS TO CLINICAL
TRIAL.
SOMETIMES THOSE PHYSICIANS FEEL
LIKE IF THEY GIVE YOU THEIR
PATIENTS, THEY'RE GOING TO LOSE
THAT AUTHORITY AND THAT
COORDINATION OF THEIR CARE.
SO IF WE DON'T GIVE THEM
FEEDBACK ON WHAT HAPPENED TO
THEIR PATIENTS WHEN THEY COME TO
OUR CLINICAL TRIALS, THEY'RE
GOING TO FEEL LOSS OF AUTHORITY
AND THEY WILL NOT REFER PATIENTS
TO YOU.
LEGALITY IF SOMETHING HAPPEN
TODAY THIS PATIENT THAT WE PUT
THEM ON A NEW DRUG, THEY'RE
CONCERNED BECAUSE THEY ARE
RESPONSIBLE.
THERE ARE A LOT OF THEM THAT
THEY DON'T DO CLINICAL TRIALS SO
THEY'RE UNCERTAIN AND WE DON'T
TAKE THE TIME TO EDUCATE THESE
PHYSICIANS ABOUT WHAT THIS
CLINICAL TRIAL IS ABOUT AND WHY
WE'RE DOING IT.
AGAIN, THE MENTALITY OF
CLINICIAN VERSUS SCIENTIST,
THOSE ARE -- WANT TO MAKE SURE
EVERY PATIENT IS GETTING THE
DRUG OR THE INTERVENTION THAT IS
NEEDED, AND THE SCIENTISTS WANT
TO DO AN EXPERIMENT, SO THE
CULTURE OF PHYSICIANS CLINICIANS
VERSUS PHYSICIAN SCIENTISTS ARE
A LITTLE BIT DIFFERENT.
AND THEN ALSO LACK OF TIME.
THEY DON'T HAVE TIME TO OFFER A
PATIENT A CLINICAL TRIAL AND
ASSESS ALL THESE SOCIAL
DETERMINANTS AND TALK TO THEM
ABOUT BEING IN A TRIAL.
SO AGAIN, THE LAST THING IS
RANDOMIZATION AND BARRIERS AND
STUDY DESIGN.
WE DEVELOP ALL THESE COMPLEX
LEGAL DOCUMENTS AS CONSENT FORMS
AND WE DON'T THINK ABOUT HOW CAN
WE SIMPLIFY THIS.
AND WORK WITH IRBs TO CHANGE
SOME OF THIS WHICH IS VERY HARD,
HOW WE CAN -- IT'S NOT ONE SIZE
FITS ALL OF HOW WE DEVELOP
CONSENT FORMS TO EVERY PERSON.
PEOPLE DON'T UNDERSTAND
RANDOMIZATION.
WE THINK THAT PATIENTS THAT HAVE
ALL THESE ISSUES IN THEIR LIFE
AND TAKING CARE OF, I DON'T KNOW
IF I'M GOING TO HAVE MY WORK
TOMORROW, IF I GET OUT OF WORK
FOR FOUR HOURS, I'M NOT GETTING
PAID FOR THAT.
I'M TAKING CARE OF MY GRANDKIDS.
ALL THIS, WE THINK THAT THE
PATIENT HAS ALL THE TIME FOR US
TO DO THE TRIAL, BUT IT'S A BIG
TIME COMMITMENT.
AND AGAIN, AS I MENTIONED,
SOMETIMES OUR STUDIES ARE VERY
COMPLEX.
SO COMING TO THAT, THEN WE
RECRUIT THE PATIENTS BUT THEN WE
CARE ABOUT RETAINING THEM.
AND MAYBE THAT'S SOMETIMES THE
BIAS THAT SOME PHYSICIANS DON'T
OFFER CLINICAL TRIALS TO
UNDERRESOURCED OR DIVERSE
PATIENTS, BECAUSE THEY THINK
THEY'RE NOT GOING TO BE ABLE TO
STAY IN THE STUDY AND THEY CAN'T
REPLACE THEM.
SO SOME PATIENTS JUST LOSE
INTEREST IF WE DON'T KEEP
ENGAGING THEM, NOT ASSIGNED TO
THE TREATMENT THEY WANT, MAYBE
THEY HAVE -- THEY'RE OLDER AGE.
THIS IS FROM THE LITERATURE.
LOWER EDUCATION, ALL THE SOCIAL
DETERMINANTS OF HEALTH THAT I
TALKED ABOUT THAT CAN BE PART OF
WE CAN'T RETAIN OUR
PARTICIPANTS.
SO TO DO THIS, WE HAVE A STUDY
THFUNDED BY NIMHD, THE NATIONAL
INSTITUTE OF MINORITY HEALTH AND
HEALTH DISPARITIES, TO FIND A
WAY TO ENHANCE MINORITY
PARTICIPATION IN CLINICAL TRIAL.
THE REASON WE DID THIS TRIAL
WITH OTHER SITES IS BECAUSE OUR
DATA AND OUR UAB CANCER CENTER
SHOWED OUR CATCHMENT AREA AT THE
TIME HAD 23.2% OF OUR CANCER
PATIENTS WERE AFRICAN AMERICAN
BUT WE WERE ONLY ABLE TO ENROLL
11% IN OUR CLINICAL TRIALS.
SO WE GOT WITH OTHER CANCER
CENTERS, AND WE APPLIED FOR THE
IMPACT STUDY, AND WE WANTED TO
NOT ONLY TEST A MODEL AT UAB BUT
ALSO TRY TO TEST THIS MODEL IN
FIVE CANCER CENTERS BECAUSE EACH
CANCER CENTER HAS DIFFERENT
POPULATIONS AND DIFFERENT
ENVIRONMENT.
SO WE DID ASSESSMENTS IN A PHASE
1 AND THEN PHASE 2, BUT BECAUSE
AS I MENTIONED WE KNEW THAT ALL
THESE BARRIERS THAT RELATED TO
THE COMMUNITY AND THE
INDIVIDUAL, WE WANTED TO DO AN
ASSESSMENT OF OUR OWN CANCER
CENTERS AND OUR OWN SYSTEMS.
WHAT ARE THE CHALLENGES AND THE
BARRIERS IN OUR SYSTEMS THAT
INCLUDE OUR CANCER CENTER
ENVIRONMENT, CANCER CENTER
LEADERS, INVESTIGATORS, SO WE
CAN KNOW WHAT TO DO.
BECAUSE WE LEARNED A LOT FROM
THE PATIENTS AND THE COMMUNITY
BEFORE.
AND WE DID A QUALITATIVE
ASSESSMENT AND QUANTITATIVE
ASSESSMENT.
SO FOR THE QUALITATIVE, WE
INTERVIEWED CANCER CENTER
DIRECTORS, INVESTIGATORS, NURSES
AND ADMINISTRATORS.
AND WHAT WE FOUND THAT THERE
WERE THREE THINGS THAT CAME UP
AS CHALLENGES IN OUR CANCER
CENTERS.
ONE, THE INVESTIGATOR SAID, YOU
KNOW, WE NEVER HAVE BEEN TRAINED
ON HOW TO APPROACH DIVERSE
POPULATIONS.
WE WERE JUST TOLD DO CLINICAL
TRIALS.
AND WE NEVER HAVE BEEN TRAINED
ON THAT.
AND THAT'S WHY WE DEVELOPED THAT
WEB PORTAL AS MODULES TO TRAIN
INVESTIGATORS AND RESEARCH
NURSE.
ALSO THE CANCER CENTERS, THEY
SAID WE DON'T KNOW WHAT'S
HAPPENING IN OUR CLINICAL
TRIALS, WE DON'T HAVE A DATA
SYSTEM THAT CAN GUIDE US TO SEE
WHERE ARE THE GAPS IN OUR
CLINICAL TRIALS.
BUT ANOTHER BIG COMPONENT WHICH
I'M GOING TO FOCUS ON, WHICH IS
THEY TOLD US, WE NEED SUPPORT,
WE DON'T HAVE TIME, WE'RE NOT
GOING TO BE TRAINED TO HAVE TO
ADDRESS ALL THESE SOCIAL
DETERMINANTS OF HEALTH WITHIN
OUR WALLS OF THE CANCER CENTERS
AND OUTSIDE OF THE COMMUNITY.
AND THAT IS WHERE WE CAME UP
WITH THE PATIENT NAVIGATION
MODEL FOR CLINICAL TRIAL.
AND SO OUR APPROACH WAS TO
DEVELOP SOMETHING INNOVATIVE
THAT WE BASED IT ON THE
COMMUNITY HEALTH ADVISORS MODEL
TO TRAIN THEM AS PATIENT
NAVIGATORS TO LINK THE PATIENT
WITH THE HEALTHCARE TEAM AND THE
COMMUNITY RESOURCES.
SO TO BE THAT BRIDGE.
AND AGAIN, IT'S BASED ON THE
COMMUNITY HEALTH ADVISORY MODEL
WHERE YOU HAVE A TRUSTED PERSON
THAT REPRESENTS THE COMMUNITY
MEMBERS TO IMPROVE THE HEALTH OR
THEY ARE NATURAL HELPERS IN
THEIR COMMUNITIES.
SO THOSE ADVISORS OR NAVIGATORS
CAN REACH THE POPULATION, SPREAD
EDUCATION INFORMATION, ENCOURAGE
HEALTHY BEHAVIOR, REDUCE
BARRIERS AND FACILITATE HEALTH
SERVICES.
SO THOSE NAVIGATORS, AFTER THEY
WERE TRAINED, THEY WERE PART OF
THE CLINICAL TRIAL TEAMS.
THEY LEARNED ABOUT THE RESEARCH
PROTOCOL, THEY LEARNED ABOUT
SAFETY ISSUES, THEY PROVIDED
FEEDBACK FROM PATIENTS TO THE
RESEARCH NURSES, AND THEY
OBTAINED REFERRAL FROM THE
RESEARCH NURSES AND THE
PHYSICIAN SCIENTISTS.
AND THEY WERE SPREAD IN OUR
ONCOLOGY CLINICS.
SO AGAIN, THAT'S WHERE THE
OBJECTIVES TO GET INFORMATION
ABOUT CLINICAL TRIALS TO OUR
AFRICAN AMERICAN PATIENTS, THEY
SUPPORTED THE PATIENTS TO ENROLL
IN THE TRIALS AND JUST ADDRESS
THEIR BARRIERS AND FIND
RESOURCES TO ADDRESS THESE
BARRIERS AND ALSO PROVIDE
EMOTIONAL SUPPORTS BECAUSE THOSE
ARE ALL CANCER PATIENTS.
SO WHAT WAS OUR IMPLEMENTATION?
AGAIN, THE NAVIGATORS PROVIDED
AND USED THE NCI BOOKLET TO
PROVIDE EDUCATION IN THE CLINICS
WHILE PATIENTS ARE WAITING FOR
THEIR APPOINTMENTS.
THEY WORKED WITH THE RESEARCH
NURSES TO IDENTIFY THOSE
PATIENTS THAT NEEDED TO BE --
NEED SUPPORT TO ENROLL IN
CLINICAL TRIALS, AND THEY SAT
WITH EVERY PATIENT AND DID AN
ASSESSMENT TO SEE WHAT ARE THEIR
BARRIERS, WHY THEY CAN'T
PARTICIPATE IN THE CLINICAL
TRIAL SO THEY CAN DEVELOP A PLAN
FOR THESE PATIENTS.
SO AGAIN, THEY DID THE
EDUCATION, THEY DID COUNSELING
TO THE PATIENTS.
THEN THEY REVIEWED WITH THEM THE
TRIAL TREATMENT REGIMEN AND THE
TRIAL CALENDAR.
THEY IDENTIFY RESOURCES, A LOT
OF THOSE PATIENTS CAME FROM
RURAL COMMUNITIES OR THEY DIDN'T
HAVE TRANSPORTATION.
SOME OF THEM THAT THEY NEEDED
MAYBE RADIATION THERAPY, THEY
DON'T HAVE A PLACE TO STAY TO
GET THAT IN THE CANCER CENTER.
THEY IDENTIFIED LOW COST LODGING
LIKE THE AMERICAN CANCER SOCIETY
HOPE LODGE OR OTHERS.
THEY REFERRED THEM TO SOME
SERVICES, EVEN SERVICES FOR
COMMUNITY SERVICE AND RESOURCES.
AND THEY COUNSELED THE PATIENTS
TO BE PROACTIVE AND ASK
QUESTIONS.
AGAIN, THEY WERE THE BRIDGE,
THEY DID ORIENTATION TO
APPROPRIATE CLINICAL STAFF TO
UNDERSTAND, YOU KNOW, THE
CULTURE OF THE PATIENTS.
THEY WERE JUST PROBLEM SOLVING
AND HAVING A WAY TO GET THE
RESOURCES TO THE PATIENT.
THEY ALSO SERVED AS A PATIENT
ADVOCATE.
THEY WERE AN ADVOCATE FOR EVEN
CHARITY CARE OR WORKING WITH
INSURANCE OR WORKING WITH
ENTITIES TO HELP THE PATIENT
WITHIN OUR WALLS.
THEY PROVIDED SOCIAL SUPPORTS,
AND EVEN THEY VISITED THE
PATIENTS IN THE HOSPITAL WHEN --
WHENEVER THEY BECAME INPATIENTS.
SO THESE ARE SOME OF THE CLINICS
AND SOME OF THE SERVICES THAT
THEY PROVIDED THAT YOU CAN SEE
THEY'RE MAINLY SERVICES
ADDRESSING SOCIAL DETERMINANTS
OF HEALTH.
YOU CAN SEE FROM OUR DATA THAT
AT THE BEGINNING, THE
ONCOLOGISTS, THEY DID NOT REFER
MANY PEOPLE TO US, BUT OVER
TIME, THEY STARTED TO REFER MORE
PATIENTS TO THE PATIENT
NAVIGATORS.
AND THEN YOU CAN SEE THAT FROM
THOSE THAT THEY WERE REFERRED TO
THE TRIALS, LIKE 70% OF THEM
WERE ENROLLED IN OUR STUDY.
SO THE MORE PATIENTS THEY
REFERRED, THE MORE PATIENTS
AGREED TO BE SUPPORTED BY THE
NAVIGATORS.
NOW, THIS IS SHOWING YOU THAT
FOR OUR ENROLLMENT OVER FIVE
YEARS PERIOD, WE STARTED AS I
MENTIONED IN THE CANCER CENTER
WITH 11% ENROLLMENT.
IT INCREASED TO OVER 22% WITH
NAVIGATOR SUPPORT.
BUT ALSO, THIS IS VERY IMPORTANT
TO SEE THAT THE NUMBER OF
OVERTIME IN THE CANCER CENTER
WHICH I CAN SAY IS A CULTURE
CHANGE OR SYSTEM CHANGE BECAUSE
WE HAD A LOT OF PUSHBACK FROM
OUR PHYSICIANS AT THE BEGINNING,
RELUCTANT TO OFFER TRIALS TO OLD
PATIENTS OR UNDERRESOURCED
PATIENTS OR MINORITY PATIENTS.
YOU KNOW, THE PERCEPTION WAS
REALLY THAT THOSE PATIENTS ARE
NOT GOING TO BE COMPLIANT.
SO IF YOU LOOK AT THE YELLOW
LINE TO SEE THAT WE INCREASED
THE NUMBER OF PATIENTS REFERRED
TO THE NAVIGATORS, YOU CAN SEE
THE GREEN LINE THAT THERE MORE
PATIENTS ACCEPTED CLINICAL
TRIALS.
THE RED LINE, LESS PATIENTS
DECLINED CLINICAL TRIALS, AND
THE PURPLE LINE, MORE PATIENTS
ENROLLED IN THE CLINICAL TRIAL.
BUT WHAT'S MOST IMPORTANT YOU
CAN SEE THAT THOSE AFRICAN
AMERICAN PATIENTS THAT THEY
CHOSE TO HAVE A PATIENT
NAVIGATOR SUPPORT HAD A MUCH
HIGHER COMPLETION OF THOSE
THERAPEUTIC TRIALS THAN THE
AFRICAN AMERICAN PATIENTS THAT
THEY REFUSED THE PATIENT
NAVIGATION SUPPORT AND THAT WAS
STATISTICALLY SIGNIFICANT.
SO WE PUBLISHED THIS INFORMATION
AND THE RESULTS OF OUR STUDY IN
THE JOURNAL OF ONCOLOGY
PRACTICE, AND WE WERE SO PROUD
THAT THE JOURNAL SELECTED THE
STUDY TO BE ON THEIR COVER -- OF
THE COVER OF THE JOURNAL.
YOU CAN SEE HERE THIS WOULD NOT
HAVE BEEN DONE WI WITHOUT THE
DEDICATED PATIENT NAVIGATORS.
THIS IS OUR TEAM.
AND WHAT IS REALLY IMPORTANT IS
THAT AFTER WE DID THIS TRIAL,
OUR HEALTH SYSTEM DECIDED TO
ADOPT THIS EVIDENCE-BASED
RESULTS AND NOW THE NAVIGATORS
BECAME PART OF THE CLINICAL
TRIAL TEAMS, THAT THEY'RE LINKED
TO EVERY CANCER PATIENT, AND
THEY ARE SUPPORTED -- THEY'RE
COMPENSATED AND BECAME EMPLOYED
BY THE CANCER CENTER.
BUT THERE ARE REAL CHALLENGES OF
DOING THIS, LIKE THE TRAINING
MODALITIES, YOU HAVE TO BE
ADAPTABLE AND CHANGE YOUR
TRAINING AND WE HAVE TO DO
TRAINING ALL THE TIME TO MAKE
CHANGES.
IT IS A RESOURCE INTENSIVE,
BECAUSE THOSE NAVIGATORS HAVE TO
BE LIKE THEY DIDN'T HAVE AN 8 TO
5 SCHEDULE.
THEY RESPONDED TO THE PATIENTS
AND THEIR FAMILIES ANY TIME THEY
NEEDED THEM.
AGAIN, SOME PATIENTS NEED A LOT
OF SUPPORT, SOME DON'T.
AND OUR PATIENT NAVIGATORS, YOU
KNOW, LIKE WE DIDN'T THINK ABOUT
THAT BUT THERE WAS SOME BURNOUT.
BECAUSE THE FAMILIES AND THE
PATIENTS BECAME SO ATTACHED TO
THEM THAT EVEN IF A PATIENT
PASSED AWAY, THIS FAMILY SAID,
YOU HAVE TO COME AND ATTEND THE
FUNERAL.
YOU HELPED MY MOTHER, YOU HELPED
MY BROTHER.
AND WE NEEDED TO DEVELOP
SOMETHING TO ADDRESS THE BURNOUT
OF THOSE PATIENT NAVIGATORS.
SO WHAT DID WE LEARN?
WE HAVE TO ENGAGE PHYSICIANS AND
NURSES IN THE PROCESS EARLY SO
THEY FEEL LIKE THEY'RE PART OF
THE SOLUTION.
WE IDENTIFIED SOME PHYSICIAN
CHAMPIONS BECAUSE AS I
MENTIONED, THERE WERE A LOT OF
OTHERS THAT THEY DIDN'T BELIEVE
THAT REALLY A MINORITY PATIENT
OR DIVERSE PATIENTS CAN REALLY
COMPLETE A TRIAL AND THEY WERE
SHY FROM OFFERING THIS TRIAL, SO
WE HAVE TO WORK WITH THOSE
PHYSICIAN CHAMPIONS SO THEY CAN
ADOPT AND CONVINCE THE OTHER
PHYSICIANS.
WE WERE -- OUR FLOW CHARTS,
WHERE THE NAVIGATORS WOULD START
AND WHERE TO END, WHO TO TALK
WITH AND WHERE THEY WERE HOUSED,
WE HAD TO MAKE CHANGES.
AND THEN WE HAD TO CLARIFY ROLES
AND RESPONSIBILITIES.
AT THE BEGINNING, THE SOCIAL
WORKERS DIDN'T KNOW HOW THE
NAVIGATORS ARE DIFFERENT THAN
THEIR ROLE, BUT AFTER THAT, THEY
BECAME REALLY WORKING TOGETHER
AS A TEAM.
WE'VE HAD TO LEVERAGE RESOURCES
WITH THE INSTITUTION, WORKING
WITH FOUNDATIONS AND OTHER
SUPPORT GROUPS TO HELP PROVIDE
VOUCHERS AND GUEST CARDS AND
LODGING.
AGAIN, WE HAD TO BE PATIENT
ADVOCATES AND SPEAK WITH THE
PATIENT.
EMPOWER THE PATIENTS TO ASK
QUESTIONS AND DEMAND THEIR
QUALITY CARE.
AND WE HAVE TO MEET WITH THE
NAVIGATORS ALL THE TIME TO HEAR
THEM AND GET FEEDBACK FROM THEM.
AND THANK YOU SO MUCH.
I THINK THE QUESTIONS ARE GOING
TO BE AT THE END.
>> GREAT.
THANK YOU SO MUCH, DR. FOUAD.
I'M NOW GOING TO TURN THIS OVER
TO DR. EGEDE.
PLEASE GO AHEAD.
>> OKAY.
THANK YOU, EVERYONE.
AND GOOD MORNING OR GOOD
AFTERNOON, DEPENDING ON WHERE
YOU ARE IN THIS PROCESS.
I'M GOING TO SHARE MY SLIDES.
AND MINE IS A LITTLE BIT
DIFFERENT.
I'LL GIVE YOU A LITTLE BIT ABOUT
MY BACKGROUND BECAUSE THAT WILL
HELP YOU UNDERSTAND SOME OF WHAT
I'M ACTUALLY GOING TO SHARE.
SO I'M A GENERAL INTERNIST BY
TRAINING, FELLOWSHIP IN HEALTH
SERVICES RESEARCH, I'VE DONE
CLINICAL TRIALS NOW SINCE 2006,
MULTIPLE NIH CLINICAL TRIALS,
BUT I ALSO TEACH STATISTICS.
SO NOT ONLY THINGS I'M DOING
HERE, THE CONVERGENCE OF ALL MY
DIFFERENT AREAS OF EXPERTISE.
SO SO MY TOPIC, AS I ALREADY
MENTIONED IS REALLY STUDY
EVALUATION WITH FOCUS ON
DIVERSITY AND INCLUSION METRICS.
SO A COUPLE OF THINGS THAT ARE
REALLY IMPORTANT AS YOU GET INTO
STUDIES, THIS IS SOMETHING THAT
HAPPENS A LOT, MOST OF US THAT
DO CLINICAL TRIALS, YOU ARE
OVERWHELMED WITH RECRUITMENT,
GETTING THINGS DONE, AND THEN
THE MOMENT YOU'RE DONE YOU'RE
THINKING ABOUT THE NEXT STUDY,
OR PUBLICATION.
I THINK IT'S REALLY IMPORTANT AT
THE END OF EVERY STUDY TO DO
SOME DEBRIEFING, SO THIS IS
SOMETHING WE'VE ACTUALLY
INCORPORATED INTO ALL OUR
CLINICAL TRIALS NOW.
AND WE HAVE IT IN SEQUENCE THAT
STARTS FROM WHEN THE STUDY
STARTS ALL THE WAY TO THE END OF
THE STUDY.
A COUPLE OF THINGS, THE FIRST
THING YOU ASK IS BECAUSE MOST OF
OUR WORK IS TIED TO EQUITY,
AFRICAN AMERICANS, HISPANICS,
ASIAN SUBPOPULATIONS AND NATIVE
AMERICANS AND SO WHAT WE
ACTUALLY ASK OURSELVES IS FIRST
OF ALL, BASED ON WHAT WE PLAN TO
DO, HOW DID MINORITY RECRUITMENT
GO RELATIVE TO PROJECTIONS?
SO MOST OF US ARE REQUIRED TO
DECLARE WHAT WE'RE DOING IN
TERMS OF DEI NUMBERS SO THE
QUESTION IS WHAT PROPORTION OF
RECRUITED SUBGROUPS WERE
RELATIVE TO WHAT YOU PLANNED?
WERE YOU SUCCESSFUL, WAS IT
ABOUT THE SAME NUMBER, DID YOU
ACTUALLY OVERRECRUIT,
UNDERRECRUIT, AND THEN LOOKING
AT SOME OF YOUR RACE/ETHNICITY
BREAK DOWNS, WHAT DOES IT LOOK
LIKE IN TERMS OF RACE/ETHNICITY,
IN TERMS OF SEX AND GENDER
BREAKDOWN, IN TERMS OF
INTERACTION.
SO AS YOU LOOK AT SUBGROUPS, AS
YOU ACTUALLY BEGIN TO ASK
YOURSELF, YOU KNOW, RACE BY SEX
AND GENDER AND WHAT DOES IT
ACTUALLY LOOK LIKE.
AND THEN QUESTIONS ABOUT -- AND
THESE ARE THINGS THAT SHOULD BE
HAPPENING AT THE LEVEL OF THE
TEAM BUT INVESTIGATORS ALSO TO
START.
UNEXPECTED LOW ACCRUAL.
WHAT HAPPENED TO CERTAIN
POPULATIONS?
SO WE HAVE THIS STUDY, AN NIDDK
STUDY WHERE WE'RE TRYING TO
RECRUIT EQUAL NUMBERS OF WHITES,
BLACKS, AFRICAN AMERICANS, AND
HISPANIC, BUT WE CHOOSE TO FOCUS
ON ENGLISH-SPEAKING HISPANICS.
IT TURNS OUT THAT AS TIME WENT,
WE REALIZED THAT WE ACTUALLY DID
NOT HAVE, IN OUR -- IN
MILWAUKEE, WE HAD A LOT MORE
NON-ENGLISH-SPEAKING.
SO THE QUESTION WE HAD TO DECIDE
ON WAS WHAT ARE WE GOING TO DO
NOW THAT THIS IS THE CASE, HOW
DOES THAT AFFECT US?
SO YOU ACTUALLY HAVE TO THINK
ABOUT THIS AND IT HAS TO BE
ONGOING.
YOU CAN'T JUST BE AT THE VERY
END OF THE STUDY, IT HAS TO BE
AN ONGOING PROCESS BUT
DEFINITELY AT THE END OF THE
STUDY, ASKING YOURSELF HOW DID
WE DO?
AND THEN YOU ALSO HAVE TO LOOK
AT DIFFERENTIAL LOSS TO
FOLLOW-UP BY SOME OF THESE
GROUPS.
CERTAIN GROUPS -- IF THEY
DROPPED OUT, WHY DID THEY DROP
OUT.
SO SOME OF THESE QUESTIONS AND
BUILDING THAT INTO YOUR STUDY,
ACTUALLY ALLOWS YOU TO ACTUALLY
HAVE A BETTER SENSE OF WHAT IS
HAPPENING IN TERMS OF DEI.
THE NEXT THING IS A PROCESS
EVALUATION, I THINK MOST PEOPLE
ARE NOT REQUIRED TO DO THIS.
WE DO THIS AS PART OF OUR
ROUTINE.
BUT PROCESS EVALUATION IS REALLY
ASKING QUESTIONS LIKE WHAT
WORKED WELL AND WHAT DID NOT GO
WELL WITH MINORITY RECRUITMENT.
YOU KNOW, THINGS LIKE ARE THERE
OBVIOUS GAPS, THINGS WE ACTUALLY
MISSED, THINGS WE DIDN'T THINK
ABOUT?
AND MOST OF THIS REALLY COMES
BACK FROM MULTIPLE SOURCES.
SO FEEDBACK FROM TEAM MEMBERS,
YOUR STUDY COORDINATORS, YOUR
PROGRAM ASSISTANTS, YOUR
EDUCATORS, YOUR COMMUNITY
PARTNERS, WHAT ACTUALLY WENT
WELL, WHAT DID NOT GO SO WELL,
WHAT COULD YOU DO DIFFERENTLY?
BUT THEN, REALLY IMPORTANT TO
TALK TO STUDY SITES.
SO IN A LOT OF OUR STUDIES, WE
HAVE -- AT ANY GIVEN STUDY,
WE'RE TALKING TO ABOUT 450, 500
COMMUNITY PARTNERS, WE'RE
ACTUALLY WORKING WITH HEALTH
SYSTEMS, SO WE HAVE A LOT OF
PEOPLE WE'RE ACTUALLY
INTERACTING WITH, SO GOING BACK
TO SOME OF THESE SITES,
ESPECIALLY THE BIGGER SITES, ASK
QUESTIONS, IS THERE SOMETHING
THAT WENT WRONG, DID YOU OBSERVE
SOMETHING?
OBVIOUSLY WE DO THIS ON AN
ONGOING BASIS BUT REALLY GETTING
FEEDBACK FROM THEM.
THEN WE BUILD IN FEEDBACK FROM
PARTICIPANTS.
SO WE ACTUALLY CALL
PARTICIPANTS, WE DO THIS ON AN
ONGOING BASIS, WE ACTUALLY CALL
PARTS ANTS AND ASK QUESTIONS
LIKE WHAT WENT WRONG WITH THIS
STUDY?
WHAT DID YOU LIKE ABOUT IT, WHAT
DIDN'T YOU LIKE ABOUT IT, WHAT
ARE SOME OF THE PROCESSES THAT
TOOK PLACE, ESPECIALLY MINORITY
PARTICIPANTS, WOMEN AND
MINORITIES, WE ASK QUESTIONS
WHERE -- ADEQUATE, DID THEY HAVE
TRANSPORTATION.
WE ACTUALLY DO HOME VISITS,
COMMUNITY-BASED RECRUITMENT, WE
ACTUALLY DELIVER THINGS OUT IN
THE COMMUNITY, SO WE ACTUALLY
ASK QUESTIONS LIKE WAS IT VEEPT
FOR YOU, WERE YOU ABLE TO GET
INVOLVED, AND HOW DID THIS WORK
OUT FOR YOU?
AND I THINK THAT LEVEL OF
DEBRIEFING IS REALLY IMPORTANT
TO GET CONTEXT TO UNDERSTAND
SOME OF THESE CHALLENGES
PARTICIPANTS FACE.
SO FOR EXAMPLE, WE'RE DOING
STUDIES IN THE MIDDLE OF THE
PANDEMIC, AND WE HAD TO ACTUALLY
ASK SOME OF OUR STUDIES WERE
FOOD DELIVERY, WE'RE DOING BOXES
TO PARTICIPANTS.
WHEN THE PANDEMIC HIT, WE HAD TO
MAKE A DECISION HOW DO WE MANAGE
THIS.
WE HAD TO COME UP WITH CREATIVE
WAYS TO MAKE SURE PARTICIPANTS
ACTUALLY GOT -- SO THAT FEEDBACK
IS REALLY IMPORTANT AND WE
LEARNED A LOT FROM SOME OF THE
FEEDBACK, THINGS ON THE SURFACE
THAT LOOK LIKE THEY'RE WORKING
AND PARTICIPANTS ARE TELLING YOU
THIS REALLY ISN'T WORKING AS
WELL.
BUT THEN ALSO YOUR PARTNERS, HOW
HAPPY ARE THEY WITH THE FLOW,
ENGAGEMENT?
PARTNERS ARE THE FIRST TO TELL
YOU ABOUT THE CENTERS.
ARE YOUR CENTERS FOR THE
PATIENTS -- ARE THE PATIENTS
HAPPY, ESPECIALLY FOR COMMUNITY
PARTNERS, MANY TIMES PEOPLE
DON'T ANTICIPATE THE COST OF
COMMUNITY RESEARCH.
THE IDEA THAT IT ACTUALLY COSTS
MONEY TO HAVE PARTNERS.
YOUR PARTNERS ARE PAYING
ELECTRICITY BILLS, THEY'RE
PAYING RENT.
HOW DO YOU SUPPORT THEM IN THAT
CONTEXT?
MOST OF OUR NIH GRANTS, WE'RE
NOT ALLOWED TO ACTUALLY BUILD
THAT IN, BUT WE HAVE TO FIND
WAYS TO ACTUALLY BE SUPPORTIVE
OF THOSE INDIVIDUALS AND REALLY
ASKING, YOU KNOW, WHAT ARE WE
DOING, HOW CAN WE MINIMIZE
DESTRUCTION TO THAT FLOW AND GED
FEEDBACK.
THEN ANY OBVIOUS LAPSES THAT
SHOULD BE ADDRESSED, THINGS THAT
ARE -- GAPS, GLARING CHALLENGES
THAT SHOULD BE ADDRESSED THAT
BECOME EVIDENT AS YOU DO THIS
PROCESS EVALUATION.
THE NEXT COMPLEMENT OF THIS IS
REALLY NOW LOOKING AT ANOTHER
PART OF PROCESS EVALUATION IS
OBJECTIVE AND SUBJECTIVE
MEASURES OF MINORITY RECRUITMENT
STRATEGIES.
AND THE QUESTION HERE IS, WHAT
ARE YOUR STRATEGIES?
HOW ARE YOU ACTUALLY GOING TO
GET MINORITY PARTICIPANTS?
HOW ARE YOU ACTUALLY GOING TO
GET UNDERREPRESENTED GROUPS?
AND WHERE ARE YOU GOING TO GET
THEM FROM?
WHAT LOCATIONS, SITES, PARTNERS,
PROCESSES ARE YOU GOING TO USE,
AND THEN LOOKING AT YOUR DATA,
ALL THOSE WHO PARTICIPATE, WE
ACTUALLY TRACK THOSE WITH THE
CLIENT.
WE FIND OUT JUST AS IMPORTANT AS
THOSE THAT AGREED TO PARTICIPATE
BECAUSE IT GIVES US A SENSE WHY
DID THEY DECLINE, WHY ARE THEY
CHOOSING NOT TO PARTICIPATE IN
THE STUDY?
SOMETIMES YOU REALIZE THAT SOME
PERCEPTIONS ABOUT THE STUDY,
PERCEPTIONS ABOUT WHAT THIS
ACTUALLY MEANS, EVEN THE
TERMINOLOGY YOU'RE USING.
THE FLYER, WE'VE ACTUALLY COME
ACROSS AND GIVE THE WRONG
IMPRESSION, SO THAT ABILITY TO
ASK PEOPLE AND GATHER
INFORMATION FROM THEM IS REALLY
CRITICAL.
THEN WE ALSO DO -- THE IDEA OF
DOING STRUCTURED INTERVIEWS FOR
COMPLETERS.
THIS IS REALLY IMPORTANT.
YOU KNOW, SO YOU HAVE PEOPLE --
THESE ARE INDIVIDUALS, WHY DID
THEY AGREE TO PARTICIPATE?
WHAT MADE THEM STAY IN THE
STUDY?
AND SO WHEN YOU HAVE STUDIES
ONLINE, I'VE REACHED -- 300 TO
4050.
SO YOU'RE RANDOMIZING PEOPLE,
AND YOU'RE ASKING THE QUESTION,
WHY DID YOU STAY IN THE STUDY?
WHAT KEPT YOU IN THE STUDY, WHAT
DID YOU FIND USEFUL?
AND THEN WE ALSO REACH OUT TO
INDIVIDUALS -- DROPOUTS, WHY DID
YOU DECIDE TO DROP OUT, WHAT
COULD HAVE BEEN DONE DIFFERENTLY
TO KEEP YOU IN THE STUDY?
MANY TIMES IT'S SOMETHING AS
SIMPLE AS SUPPORTING PEOPLE
GOING TO THEIR HOMES TO HELP
THEM DO BLOOD DRAWS RATHER
THAN -- THEY HAVE TRANSPORTATION
CHALLENGES.
THEY MAY ACTUALLY HAVE
CHALLENGES WITH -- THEY GOT
ADMITTED IN THE HOSPITAL, AND NO
ONE WAS ACTUALLY TRACKING.
SO SOME OF THIS DATA MEANS THAT
YOU SHOULD TALK TO PEOPLE, IT
GIVES YOU A SENSE OF MINORITY
GROUPS, SOCIAL DETERMINANTS,
SOCIAL RISK FACTORS, CHALLENGES
WITH TRUST AND DISTRUST IN THE
HEALTHCARE SYSTEM, SO ALL OF
THIS STARTS TO COME OUT AS
YOU'RE DOING DEBRIEFING.
THE NEXT THING THAT'S IMPORTANT,
THIS IS A LOT OF TIMES -- I CALL
THEM STATISTICAL CONSIDERATIONS,
I'M GOING TO TALK ABOUT MULTIPLE
COMPONENTS OF THIS PROCESS.
SO YOU'RE DONE WITH YOUR STUDY,
YOU HAVE YOUR -- NOW YOUR
QUESTION IS, DO YOU STILL HAVE
POWER TO ACTUALLY ANSWER THE
QUESTIONS YOU'VE STILL GOT TO
ANSWER.
IT'S ACTUALLY TWO PART.
ONE OF THEM IS YOU -- BASED ON
ASSUMPTIONS, SO IT TYPICALLY
CALCULATED AFTER THE STUDY, AND
EVIDENCE SUGGESTS THAT MANY
STUDIES ARE UNDERPOWERED.
SO PROSPECTIVE SAMPLE SIZE
CALCULATION WE HAVE
UNDERESTIMATED EXPECTED
DIFFERENCE BETWEEN GROUPS.
SO A REMIT NUMBER -- MAYBE YOU
PLAN TO GET EQUAL NUMBERS, SO
POST HOC POWER ANALYSIS IS A
CALCULATION BASED ON OBSERVED
VALUE OF THE EFFECT SIZE, THIS
IS ACTUAL, THIS IS WHAT YOU
EXPECTED.
WHEN THERE'S NO DIFFERENCE, YOU
ARE TALKING ABOUT -- DO I HAVE
ADEQUATE POWER.
SO NO POWER -- SOMETIMES WE
ACTUALLY DON'T HAVE ENOUGH
POWER.
IN ALL THE CASES, YOU ACTUALLY
HAVE POWER BUT THE EFFECT IS
SMALL.
IT'S REALLY IMPORTANT TO KNOW
AND TO DIFFERENTIATE THE TWO.
SO IF POST HOC POWER IS HIGH, IT
ALSO HELPS YOU UNDERSTAND IF
YOU'RE RECRUITING AND YOU
HAVE - ASSUMPTIONS ABOUT EXPECTD
DIFFERENCES BETWEEN GROUPS,
CORRELATION WITHIN SUBJECTS, MAY
ACTUALLY -- YOU REALIZE THE
CORRELATION ACCOUNTED FOR A VERY
DIFFERENT -- THESE ARE THINGS
THAT HELP YOU AS YOU BEGIN TO
ACTUALLY ANALYZE YOUR DATA AND
DECIDE -- THE NEXT PIECE I WANT
TO TALK ABOUT IS STATISTICAL
ISSUES, HETEROGENEITY OF
TREATMENT EFFECT.
SO THIS IS NOT A VERY COMMON --
IN MOST TRIALS AND EVEN
OBSERVATIONAL STUDIES BECAUSE
MOST STUDIES ARE REALLY FOCUSED
ON AVERAGE TREATMENT EFFECT.
THE ASSUMPTION IS THAT YOU'RE
TAKING TWO GROUPS, COMPARING
TREATMENT EFFECT BETWEEN THE TWO
GROUPS.
WE KNOW PEOPLE RESPOND DIFFERENT
EVEN WITHIN GROUPS.
SO HETEROGENEITY OF TREATMENT
EFFECT IS DEFINED AS NON-RANDOM
VARIABILITY IN THE DIRECTION
OF -- MEASURED USING CLINICAL
OUTCOMES.
THE TWO MAIN GOALS OF THESE
TYPES OF ANALYSIS, ONE IS TO --
CLINICAL RELEVANT SUBGROUPS,
WHAT WE'LL CALL THE SUBGROUP
ANALYSIS.
BUT THE SECOND IS PREDICT WHAT
THAT INDIVIDUAL MIGHT BENEFIT
FROM TREATMENT, SO MOST OF US
THAT DO CLINICAL TRIALS WE DO
SOME KIND OF SUBGROUP ANALYSIS.
THE COMPONENT ACTUALLY LOOKING
AT THE IDEA OF WHO WILL ACTUALLY
BENEFIT FROM TREATMENT BASED ON
WHAT YOU HAVE.
SO IT'S ALWAYS WORTHWHILE TO
CONSIDER SUBGROUP ANALYSIS,
REALLY BEING ABLE TO LOOK AT
SOME ANALYSIS BY RACE/ETHNICITY,
BY AGE, SEX AND GENDER AND
SOMETIMES BY SES FACTORS.
THIS ALLOWS TO YOU ACTUALLY
BEGIN TO DEFINE OTHER SUBGROUPS.
NOW OBVIOUSLY I'M GOING TO TALK
ABOUT THIS IN MY NEXT SLIDE, YOU
HAVE TO RECOGNIZE THAT UNLESS
YOU ARE -- YOU MAY NOT HAVE
ACTUALLY HAVE POWER IN THIS
SUBGROUP ANALYSIS.
SO HOW DO YOU ADDRESS THAT?
THERE ARE FOUR MAIN WAYS TO LOOK
AT HETEROGENEITY OF TREATMENT
EFFECT.
ONE IS TO DO SUBGROUP ANALYSIS
AND ESTIMATE BENEFITS SEPARATELY
FOR SUBGROUPS.
PACED ON IF YOU COMPARE MEN VER,
MINORITY GROUP VERSUS OTHER
MINORITY GROUPS, THESE ARE
SUBGROUP ANALYSIS.
THE SECOND APPROACH IS TO USE
THE STATISTICAL MODEL THAT
ESTIMATES THE RELATIONSHIP.
SUCH A MODEL AS SIZE AND
MULTIVARIABLE SCOPE, YOU CAN
ACTUALLY DETERMINE WHAT HAPPENS
IN INDIVIDUAL PATIENTS.
THE THIRD IS TO CONSTRUCT THE
STATISTICAL MODEL.
YOU CAN ACTUALLY LOOK AT
TREATMENT EX-PORE SURE OF
BASELINE CHARACTERISTICS,
TREATMENT BY INTERACTION WITHIN
TREATMENT, SECOND SUBGROUP
ANALYSIS, AND THAT MODEL CAN
HELP YOU DETECT -- BUT THE
FOURTH APPROACH IS MORE THE
NEWER MACHINE LEARNING METHODS
THAT SEARCH ACROSS ALL POSSIBLE
COMBINATIONS OF POTENTIAL
PREDICTOR VARIABLES AND
INTERACTIONS TO PREDICT
VARIABILITY IN TREATMENT
RESPONSE.
NOW YOU CAN USE THE MACHINE
LANGUAGE YOU CAN SEE IF YOU
ACTUALLY PREDICT.
OBVIOUSLY THE KEY CHALLENGE
WHICH IS -- NOW I WANT TO
FORMALLY TALK ABOUT SUBGROUP
ANALYSIS, WHICH IS WHAT MOST
PEOPLE ACTUALLY DO.
IT'S THE MOST COMMONLY USED
APPROACH FOR EXAMINING
HETEROGENEITY.
IT DEVALUES OF TREATMENT FOR
SEVERAL SUBGROUPS ONE VARIABLE
AT A TIME, SO SUBGROUP VARIABLE
HAS STATISTICALLY SIGNIFICANT
INTERACTION WITH TREATMENT
INDICATOR.
IF THE INTERACTION IS
SIGNIFICANT -- SEPARATELY, SO IF
THERE IS AN EFFECT, AN
INTERACTION, TO ESTIMATE RESULTS
FROM DIFFERENT SUBGROUPS.
ALL GROUPS -- INTERACTION JUST
GENERALLY HAVE NO POWER TO
DETECT DIFFERENCES IN SUBGROUPS.
SO AN EXAMPLE IS IT TAKES ABOUT
FOUR TIMES SAMPLE SIZE TO DETECT
DIFFERENCE IN SUBGROUPS WHEN YOU
HAVE A 50/50 SPLIT.
16 TIMES YOU ACTUALLY HAVE A
DIFFERENT APPROACH.
SO A KEET CONSIDERATION IS AS
YOU DO THE SUBJECT ANALYSIS,
ONE, IF IT'S REALLY IMPORTANT TO
FIND THAT INFORMATION, THEY'LL
BUILD IT INTO YOUR SAMPLE SIZE
CALCULATION UP FRONT.
BUT EVEN WHEN YOU DON'T DO IT,
YOU CAN ALWAYS GO BACK AND TEST,
SO THESE ARE KIND OF THE THINGS
YOU DO AFTER THE STUDIES ARE
DONE, AND THEN IT GIVES YOU
INFORMATION AND POTENTIALLY HELP
YOU GUIDE FUTURE INTERVENTIONS
AS YOU MOVE FORWARD.
THE OTHER PART OF THIS IS
SECONDARY ANALYSIS.
DID YOU YOUR STUDY, WHETHER IT'S
CLINICAL TRIAL, LOTS OF DATA,
BUT MOST CLINICAL TRIALS
ACTUALLY ARE MAYBE -- NOW YOU'VE
COLLECTED DATA ON MOST OF THESE
ARE 4 TO 5 TIME POINTS, EVERY
THREE MONTHS FOR 12 MONTHS.
SOMETIMES WE GO UP TO 18 MONTHS.
WE HAVE ALL THIS DATA, WHAT DID
YOU DO WITH THAT INFORMATION.
YOU CAN USE CLINICAL TRIALS DATA
TO ANSWER ALL THOSE QUESTIONS,
AS LONG AS YOU ARE AWARE OF SOME
OF THE ISSUES THAT ARE TIED --
IT'S ACTUALLY GIVES YOU A CHANCE
TO EXPLORE, YOU CAN USE IT FOR
EXPLORATORY ANALYSIS AND
HYPOTHESIS GENERATION.
SO DATA ON NEW THINGS YOU CAN
ACTUALLY DO.
IF YOU HAVE GRADUATE STUDENTS,
POSTDOC, MEDICAL STUDENTS, THIS
IS IT ON THE OPPORTUNITY TO GET
FEET WET IN TERMS OF DATA
ANALYSIS, AFTER YOU ANSWER SOME
PRIMARY QUESTIONS.
YOU HAVE SO MUCH DATA AT THE END
OF THE STUDY, YOU KIND OF --
YOU'RE GETTING POSTDOC WHO
ACTUALLY SPENDS TIME DIVING IN,
ANSWERING QUESTIONS THAT ARE
REALLY INTERESTING.
YOU CAN ALSO USE IT AS PILOT
DATA FOR FUTURE GRANTS.
A LOT MORE EXPERIENCED PEOPLE,
THIS IS ONE OF THE ADVANTAGES OF
HAVING MORE GRANTS, BECAUSE YOU
ACTUALLY HAVE THIS DATA AND IT
GIVES YOU INSIGHT, YOU CAN LOOK
AT EFFECT SIZE, YOU CAN LOOK AT
CORRELATION BETWEEN
MEASUREMENTS, YOU CAN LOOK AT
MANY OF THE THINGS ACTUALLY --
FEASIBILITY, IN TERMS OF PILOT
DATA FOR FUTURE GRANTS.
HOWEVER, CHALLENGES USING
CLINICAL TRIALS DATA, WHAT IS A
SAMPLE SIZE AND POWER MAY NOT BE
ADEQUATE.
SO IF YOU'RE ASKING QUESTIONS,
YOU REALLY -- IF YOU'RE LUCKY
AND THERE'S A SIGNIFICANT
DIFFERENCE, YOU'RE FINE.
BUT IF THERE'S NO DIFFERENCE, --
DATA IS ALSO ALWAYS CORRELATED
ACROSS CLINICAL TRIALS,
MEASUREMENTS, HIGHLY CORRELATED
SO YOU NEED TO USE APPROPRIATE
STATISTICAL TESTS.
IT'S NOT SUFFICIENT TO DO
CROSS-SECTION ANALYSIS BECAUSE
AT THIS POINT IN TIME, THE
MEASUREMENTS ARE CORE -- THE
EXPERIENCE WITH DATA ANALYSIS IS
REALLY IMPORTANT.
YOU ALSO NEED TO ACCOUNT FOR
RANDOMIZATION AND GREURP
RANDOMIZATION AND GROUP
ASSIGNMENT.
WHEN WE HAVE DONE THAT ANALYSIS,
YOU HAVE TO ASK YOURSELF, HOW DO
I ACCOUNT FOR TREATMENT
ASSIGNMENT, HOW DO I ACCOUNT FOR
TIME?
ALL OF THESE PIECES ARE TO
BECOME USEFUL.
THAT'S WHY YOUR TEAM NEEDS
SOMEONE WITH EXPERIENCE DOING
THIS TYPE OF ANALYSIS TO HELP
YOU DO THAT.
YOUR WAYS ONCE YOU STARTLOOKINGY
NEED TO DO SELECTION BIAS.
THERE ARE ISSUES ABOUT NOT
EVERYONE WHO IS APPROACHED TO
PARTICIPATE IN CLINICAL TRIAL,
YOU HAVE A VERY SELECT GROUP OF
HIGHLY MOTIVATED INDIVIDUALS, SO
YOU HAVE TO ACCOUNT FOR THAT
SELECTION IN THAT CASE.
YOU ALSO HAVE TO LOOK AT
INTERNAL VERSUS EXTERNAL
VALIDITY.
THIS IS A GROUP OF INDIVIDUALS
WHO WERE SELECTED FOR -- NOW
HOW -- AND SOME OF THIS
ACCOUNTED FOR, ESPECIALLY WHEN
YOU'RE PRESENTING, YOU ARE
PUBLISHING THEM, BEING CLEAR AND
TRANSPARENT ABOUT THE TYPE OF
DATA YOU HAVE IS IMPORTANT.
YOU MAY ALSO NEED TO ACCOUNT FOR
MULTIPLICITY OF TESTING.
THIS IS REALLY -- IF YOU'RE NOT
CAREFUL, IT BECOMES A FISHING
EXPEDITION, BUILD IN RIGOROUS --
HOW LIKELY IS THIS APPROACH --
WHAT IS RANDOM, WHAT IS ACTUALLY
JUST ERROR, SO ACTUALLY BUILDING
THE RIGHT KIND OF MODELS WILL BE
VERY HELPFUL.
THEN MEARN TIMES MANY TIMES YOUE
MULTIPLE CLINICAL TRIALS DATA,
FROM MULTIPLE CLINICAL TRIALS,
INCREASED SAMPLE SIZE.
SO SYSTEMATIC -- SYSTEMATIC
REVIEWS, IF YOU'RE DOING -- IF
YOU'RE ACTUALLY ABLE TO -- FOR
MULTIPLE -- YOU CAN INCREASE
YOUR SAMPLE SIZE AND -- TO DO
MORE INTEREST -- ANALYSIS, AFTER
THE DATA IS AVAILABLE.
WHAT THEN DO YOU DO NOW THAT --
HOW DO YOU INCORPORATE YOUR
LESSONS LEARNED INTO FUTURE
STUDIES?
FIRST QUESTION YOU HAVE TO ASK
IS WHAT NEEDS TO CHANGE BASED ON
YOUR EXPERIENCE?
MULTIPLE THINGS YOU LEARNED FROM
THIS, FROM YOUR PROCESS
EVALUATION, SECONDARY ANALYSIS,
HETEROGENEITY, HOW DO YOU BUILD
THAT INTO FUTURE STUDIES.
THE NEXT QUESTION IS WHERE DO
YOU INVEST RESOURCES TO BOLSTER
FUTURE RECRUITMENT EFFORTS?
SO YOU FIND THINGS THAT -- USING
BEST RESOURCES, AND HOW DO YOU
LEVERAGE THE PARTICIPATE TO
BUILD WORD OF MOUTH FOR FUTURE
STUDIES?
WE FIND A LOT OF OUR STUDIES,
BECAUSE OF GOODWILL THAT WAS
GENERATED, WE ACTUALLY GET
PEOPLE SAY OH, SOMEONE FROM ONE
OF THE STUDIES ACTUALLY HEARD
ABOUT YOUR TEAM FROM A STUDY
THAT YOU PARTICIPATED IN.
SO LEVERAGING THAT IS ACTUALLY
VERY IMPORTANT.
WE TEND TO DO WHAT WE CALL THE
COMMUNITY REPORT-OUT.
AFTER THE STUDY IS DONE, YOUR
RESULTS ARE AVAILABLE, WE INVITE
ALL THOSE THAT WERE IN THE STUDY
AND WE ALSO INVITE FOR THE
STAKEHOLDERS COMMUNITY PARTNERS
AND WE PROVIDE -- TO SHARE --
IT'S REALLY IMPORTANT IN GETTING
FEEDBACK AND CLOSING DOWN THE
STUDY AND COMPLETION.
AND THEN HOW DO YOU USE YOUR
EXPERIENCE TO MODIFY A BUDGET
AND RESOURCE ALLOCATION FOR
FUTURE STUDIES?
LIKE I SAID, FOR THOSE
PARTICIPATING IN CLINICAL
TRIALS, NO MATTER HOW EFFICIENT
YOU ARE, YOU TEND TO
UNDERESTIMATE THE TRUE COST OF
THE STUDY.
THERE'S SO MUCH THAT HAPPENS AND
YOU ACTUALLY CANNOT ACCOUNT FOR.
SO WE CAN GO BACK -- WHERE DID
WE OVERSPEND, WHERE DID WE
UNDERSPEND, THAT ALLOWS US TO
DEFINE THE BUDGET.
TRANSPORTATION IS -- ESPECIALLY
IF YOU DO COMMUNITY -BASED WORK,
PARTNERS, HOW DO YOU KEEP
PARTNERS ENGAGED, SO ALL OF
THESE PARTNERS NEED TO BE
ACCOUNTED FOR AND IN FUTURE
STUDIES -- TO HELP YOU.
SO I THINK THIS IS MY LAST
SLIDE.
THESE ARE MY REFERENCES.
BUT I HOPE THIS INFORMATION IS
HELPFUL AS PEOPLE ACTUALLY START
TO THINK ABOUT WHAT TO DO WHEN
THE STUDIES ARE OVER.
THANK YOU.
>> THANK YOU SO MUCH, DR. EGEDE.
I THINK YOU PROVIDED REALLY
EXCELLENT INFORMATION AND
CONSIDERATIONS AND REALLY
INSIGHTFUL.
I THINK I ECHO THE CHAT COMMENTS
THAT THIS HAS BEEN REALLY
HELPFUL AND PEOPLE ARE THINKING
ALL THE SPEAKERS.
NOW WE DO HAVE DEDICATED TIME
FOR QUESTIONS AND ANSWERS.
I BELIEVE WE STILL HAVE ABOUT 15
TO 20 MINUTES LEFT.
I'M NOT SURE IF WE NEED TO PUT
UP THE INFORMATION ABOUT HOW TO
SUBMIT SOME QUESTIONS, I THINK
THROUGHOUT THE DISCUSSION AND
THROUGHOUT THE PRESENTATIONS,
THERE HAVE BEEN QUESTIONS COMING
IN.
OH, YES, HERE.
AND AGAIN, IF THERE -- THERE ARE
SEVERAL WAYS TO COMMIT
QUESTIONS.
YOU CAN RAISE YOUR HAND,
OBVIOUSLY ENTER IN THE CHAT OR
EMAIL THE ADDRESS HERE.
AND FOR THOSE WHO ARE VIEWING ON
VIDEOCAST, THEY CAN CLICK THE
LIVE FEEDBACK BUTTON.
I'M ACTUALLY GOING TO START WITH
ONE QUESTION, AND I THINK,
DR. EGEDE, YOU'VE SORT OF
TOUCHED ON THIS, BUT I THINK IT
WOULD BE HELPFUL FOR ALL THE
SPEAKERS TO SPEAK TO THIS.
YOU KNOW, THERE'S AN OBLIGATION
FOR RESEARCH FINDINGS TO BE MADE
AVAILABLE TO STUDY PARTICIPANTS.
AND THEN, YOU KNOW, TO GENERALLY
BE KEPT INFORMED ABOUT THE
OUTCOMES OF THE RESEARCH THEY
CONTRIBUTED TOWARDS.
SO WOULD YOU BE ABLE TO DESCRIBE
HOW INVESTIGATORS COULD
SUCCESSFULLY ACHIEVE THIS
DISSEMINATION PROCESS AND IF
THERE ARE ANY SORT OF CHALLENGES
AND BARRIERS TO DISSEMINATING
RESEARCH FINDINGS TO A DIVERSE E
POPULATIONS?
>> I CAN START AND THEN LET
OTHERS WEIGH.
SO I THINK TRADITIONAL
APPROACHES, PUBLICATIONS IN
JOURNALS, IS IMPORTANT.
ESSENTIALLY THIS COMMUNITY TENDS
TO GO TO JOURNALS TO FIND
INFORMATION.
RIGHT NOW THE COMMUNITY DOES NOT
RECENOTREAD JOURNALS, SO HOW DOT
THIS INFORMATION TO PEOPLE WHO
MAY NOT BE SCIENTIFICALLY
ORIENTED, BUT ALSO OUR POLICY
MAKERS MANY TIMES ARE NOT GOING
TO SPEND THE TIME TO REALLY DIVE
THROUGH, YOU KNOW, A SCIENTIFIC
PAPER.
SO HOW DO WE ACTUALLY TAKE THIS
INFORMATION AND BREAK IT DOWN
INTO MESSAGING THAT ACTUALLY IS
EASY TO INGEST?
AND I THINK THAT'S WHERE THE
SKILL IN TERMS OF GETTING
INFORMATION ON THIS, SO WE ARE
BEGINNING TO RECOGNIZE NOW THE
POLICY REALLY MATTERS.
I THINK EVERYBODY HAS ALWAYS
KNOWN THIS.
YOU PUBLISH ALL THESE PAPERS,
HOW DO WE GET THIS INFORMATION
TO COMMUNITY MEMBERS AND TO
PARTICIPANT MEMBERS, SO
DIFFERENT STRATEGIES, I THINK,
SOMEONE ELSE MAY WANT TO WEIGH
IN ON THIS BUT I THINK THERE ARE
DIFFERENT STRATEGIES.
WE DO WHITE PAPERS, WE DO
BRIEFINGS, AND THAT WAY WE GET
FEEDBACK FROM PARTICIPANTS, WE
GET FEEDBACK FROM COMMUNITY
MEMBERS, WE ALSO GET THIS OUT TO
POLICY MAKERS WHO ACTUALLY CAN
THEN USE THAT INFORMATION IN A
WAY THAT IS MEANINGFUL.
>> CAN I ALSO FOLLOW UP ON THAT,
ACTUALLY I LEARNED THIS FROM MY
MENTOR PROBABLY 15 YEARS AGO, 20
YEARS AGO.
HE ALWAYS, WHEN WE FINISHED A
TRIAL, WE WOULD PREPARE A
VERY -- A SHORT LETTER WITH A
VERY LAY LANGUAGE WITH THE
RESULTS OF THE STUDY AND WE SEND
TO ALL PARTICIPANTS.
THIS IS ONE THING WE DO.
BUT SOMETIMES WHEN THE STUDY
ENDS, YOU DON'T HAVE RESOURCES,
WHICH I'M GOING TO GO TO
DR. DOMINGO ABOUT THE RESOURCES
HERE, IT'S NOT IN THE BUDGET TO
DO THAT, BUT HE USED TO FIND THE
RESOURCES AND WE FOLLOWED HIM TO
DO THAT.
THE SECOND THING, WE DO MOST OF
OUR STUDIES, WE HAVE A COMMUNITY
ADVISORY BOARD.
SO WE GO BACK AND MEET WITH THE
COMMUNITY ADVISORY BOARD AND LET
THEM KNOW ABOUT THE FINDINGS
BECAUSE THEY WERE THE ONES LIKE
THE GATE KEEPERS THAT HELPED US
TO GET THE WORD OUT TO OUR
PARTICIPANTS OR PATIENT POOLS.
AND THEN WE TRY SOMETIMES IF WE
HAVE TOWN HALL MEETINGS IN OUR
COMMUNITY ENGAGEMENT ACTIVITIES,
WE ALSO TALK ABOUT FINDINGS OF
OUR CLINICAL TRIALS.
BUT THE DIRECT LETTER TO THOSE
PARTICIPANTS, I ALWAYS FOUND TO
BE VERY, VERY GOOD AND A LOT OF
THEM SEND US BACK AND SAY THANK
YOU FOR LETTING US KNOW THE
RESULTS OF WHAT WE PARTICIPATED
IN, WHAT WE CONTRIBUTED TO.
>> AND I WOULD JUST SAY, SO
WHILE WE DIDN'T ADDRESS IT
SPECIFICALLY IN THE REPORT, WHAT
THE REPORT FOCUSES ON IS THE --
IF WE COULD IMAGINE THE IDEAL
WORLD WHERE THERE IS AN ONGOING
BIDIRECTIONAL COMMUNICATION
BETWEEN PEOPLE IN COMMUNITIES
WHO ARE PARTICIPATING IN STUDIES
AND STUDY INVESTIGATORS, THAT
IT'S DONE IN AN EQUITABLE WAY,
THAT -- AND THAT WE ARE THINKING
ABOUT THE TYPES OF
INFRASTRUCTURE TO SUPPORT THIS
WORK THAT FUNDERS CONTRIBUTE TO,
INVESTIGATORS CONTRIBUTE TO,
COMMUNITY MEMBERS CONTRIBUTE TO,
AND THAT IT DOESN'T GO JUST
STUDY TO STUDY BUT THAT THIS IS
SOME BIDIRECTIONAL WAY OF
COMMUNICATING STUDY FINDINGS
THAT EXISTS ACROSS MULTIPLE
STUDIES, NOT JUST STUDY TO
STUDY.
>> GREAT, THANK YOU.
I'M GOING TO TURN THIS OVER TO
MY COLLEAGUE JARRETT.
I THINK THERE HAVE BEEN SEVERAL
QUESTIONS IN THE CHAT.
>> SURE.
THANKS, KATRINA.
AGAIN, I'LL JUST SAY TO ALL THE
SPEAKERS, THANK YOU SO MUCH.
IT BEEN VERY INSIGHTFUL.
SO OUR FIRST QUESTION IS FOR DR.
LET ME JUST NAVIGATE PROPERLY TO
MAKE SURE -- OKAY, SO THIS
QUESTION SENT FROM THE AUDIENCE
SAYS, IS THERE STILL MOVEMENT TO
INCLUDE GENDER IDENTITY IN OUR
REPORTING?
FROM MY EXPERIENCE, THERE'S AN
UNDERREPRESENTATION OF
TRANSGENDER INDIVIDUALS,
ESPECIALLY IN PHASE 1 STUDIES
WHERE OVERNIGHT HOUSE IS
REQUIRED.
I'VE LONG WONDERED IF WE'RE
BEING -- I'M SORRY -- I'VE LONG
WONDERED IF WE ARE MISSING BEING
INCLUSIVE OF A HISTORICALLY
HIDDEN POPULATION.
HOPEFULLY THAT CAME ACROSS CLEAR
TO YOU, DR. BIBBINS-DOMINGO.
>> THANK YOU FOR THAT QUESTION.
ONE OF THE THINGS THAT WE NOTED
AT THE OUTSET IN THIS COMMITTEE
REPORT IS THAT OUR CHARGE WAS TO
LOOK AT THE REPRESENTATION FOR
RACIAL AND ETHNIC MINORITIES AND
WOMEN.
THAT WAS THE CHARGE.
WHAT WE DID NOTE, WE SPENT A LOT
OF TIME AS A COMMITTEE THINKING
ABOUT THE MANY POPULATIONS THAT
ARE UNDERREPRESENTED IN
RESEARCH.
AND THAT WE WANTED TO NOTE THAT
SOME OF THE PRINCIPLES THAT WE
OUTLINED IN THIS REPORT DO APPLY
TO A NUMBER OF OTHER
UNDERREPRESENTED POPULATIONS,
INCLUDING SEXUAL AND GENDER
MINORITY POPULATIONS, WHAT THE
QUESTION IS REFERENCING.
WE DIDN'T FEEL WE COULD DO
JUSTICE TO BROADEN THE SCOPE OF
OUR REPORT BY TALKING ABOUT ALL
THESE GROUPS BECAUSE
CONSIDERATIONS ARE DIFFERENT FOR
EACH, BUT THE GENERAL PRINCIPLE
OF THE IMPORTANCE OF THESE
POPULATIONS, THE IMPORTANCE OF
DOING ONGOING ENGAGEMENT WERE
THERE, AND SO THAT'S A COMMENT
WE MAKE IN THIS REPORT.
FOR THE OTHER SPECIFIC THING
THAT YOU MENTION, I THINK IT'S
REALLY STRIKING HOW MUCH DATA
COLLECTION IS, OF COURSE, NOT
THE END RESULT BUT IT IS AN
ESSENTIAL ELEMENT FOR KNOWING
WHETHER WE'RE MAKING PROGRESS,
HOW WE UNDERSTAND WHAT
REPRESENTATION MEANS, AND WHAT
WAS REALLY STRIKING TO US AS A
COMMITTEE IS THAT WE COULDN'T
REALLY EVEN MEASURE PROGRESS ON
REPORTING FOR RACIAL AND ETHNIC
MINORITIES FOR WOMEN IN STUDIES,
AND THOSE ARE ONES WHERE WE'VE
HAD CRITERIA FOR REPORTING FOR
QUITE SOME TIME, AND IF WE DON'T
HAVE DATA COLLECTED AND
CONSISTENT REPORTING ON THOSE TO
UNDERSTAND REPRESENTATION IN
STUDIES, WE ARE CERTAINLY
LACKING THAT FOR OTHERS, AND I
THINK FOR SEXUAL AND GENDER
MINORITY POPULATIONS THAT YOU'RE
POINTING OUT, I THINK THAT THIS
IS A VERY REAL ISSUE, AND THAT
DATA COLLECTION IS A VERY REAL
THING THAT NEEDS TO BE FOCUSED
ON AS WELL.
>> THANK YOU SO MUCH FOR THAT
ANSWER.
SO WE DO HAVE SOME RAISED HANDS,
SO I'LL NAVIGATE TO ONE OF THESE
FIRST AND THEN GO BACK TO SOME
OTHER QUESTION.
SO PARTICIPANTS HERE, GOKUL DAS.
CAN YOU UNMUTE, PLEASE?
THERE YOU GO.
>> THANK YOU.
SO MY QUESTION IS TO -- OR
ANYONE ELSE ON THE PANEL.
SO IF THERE'S AN INVESTIGATOR,
IF I'M PLANNING A CLINICAL
TRIAL, LET'S SAY ABOUT 50
PATIENTS, WHY 50 PATIENTS,
BECAUSE FOR EXAMPLE IF I'M
WRITING A CLINICAL TRIAL R01 AT
NCI, GIVEN THE LIMIT OF THE
AMOUNT FOR A FIVE-YEAR GRANT,
THAT'S THE NUMBER OF PATIENTS
ONE CAN RECRUIT.
SO IF IT IS, YOU KNOW,
MULTI-INSTITUTIONAL IN ORDER TO
GET THE SUFFICIENT
REPRESENTATION OF DIFFERENT
ETHNICITIES, FOR EXAMPLE, IF I'M
JUST FOCUSING ON AFRICAN
AMERICAN, CAUCASIAN -AMERICAN AND
AFRICAN AMERICAN PATIENTS NEED
TO BE INCLUDED, THEN IT BECOMES
A CHALLENGE BECAUSE AS YOU KNOW
FROM THE STATISTICAL APPROACH
YOU'VE DESCRIBED EARLIER, YOU
NEED A REASONABLE NUMBER OF
PEOPLE TO GET STATISTICAL ROBUST
IN YOUR DATA.
SO IF YOU WANT TO HAVE GOOD DATA
FROM BOTH THE RACIAL
BACKGROUNDS, YOU NEED TO
PROBABLY -- IF THE
STATISTICIANS -- 50, IF YOU NEED
TWO ETHNIC POPULATIONS, RACIAL
POPULATIONS, YOU MAY HAVE TO AT
LEAST DOUBLE IT.
SO HOW DO YOU PRAGMATICALLY
APPROACH SUCH A CHALLENGE, OR IN
ONE CHALLENGE, OF COURSE, YOU
NEED TO HAVE ACCESSIBILITY TO
THESE PATIENTS MEANS YOU HAVE TO
INCLUDE -- YOU HAVE TO HAVE A
MULTI-INSTITUTIONAL TRIAL TO
BEGIN WITH, THAT ITSELF WILL --
IN DIRECT COST WILL, YOU KNOW,
INCREASE VERY MUCH.
PLUS THE NUMBER OF PATIENTS HAVE
TO BE INCREASED.
SO HOW DO YOU APPROACH THIS
DILEMMA?
>> WHO IS THE QUESTION FOR?
IS IT FOR DR. EGEDE?
>> DR. EGEDE CAN ANSWER IT OR
ANYONE WHO FEELS COMFORTABLE
ANSWERERRING IT.
>> I CAN START.
I DON'T THINK THAT ANY EASY
ANSWERS TO THIS BECAUSE
DEPENDING ON THE KIND OF STUDY
YOU'RE CONDUCTING, IF IT'S A
CLINICAL TRIAL, OBVIOUSLY YOU
HAVE SAMPLE SIZE -- BUDGET
LIMITATIONS.
SO I THINK YOU HAVE TO A PRIORI
DECIDE WHAT IS IMPORTANT TO YOU.
AND WHAT IS IMPORTANT TO THE
QUESTION YOU'RE TRYING TO
ANSWER.
SO IF YOU ARE -- SO FOR EXAMPLE,
WHEN YOU DO STUDIES THAT COMPARE
RACIAL GROUPS, THE SAMPLE SIZE
BY DEFINITION HAS TO BE LARGER
THAN A STUDY THAT DOES NOT DO
ANY RACIAL GROUP COMPARISON.
SO THAT INCREASES THE COST OF
YOUR STUDY.
THE OTHER THING THAT YOU COULD
ACTUALLY DO IS AFTER YOUR STUDY
IS DONE, YOU COULD ACTUALLY GO
IN AND REVIEW SO MAYBE BUILD IN
QUALITATIVE INTERVIEWS, SO YOU
CAN GET CONTEXT FOR MINORITY
GROUPS.
SO YOU MAY NOT HAVE THE SAMPLE
SIZE TO DO A FULL-FLEDGED
ANALYSIS OF COMPARISON, BUT YOU
CAN ACTUALLY DO SOME QUALITATIVE
WORK TO ACTUALLY SEE
PERSPECTIVES, BARRIERS THAT ARE
UNIQUE TO SPECIFIC GROUPS, BUT
YOU COATHIRD THING YOU COULD ACY
DO IS BASED ON INFORMATION --
COW DO A FOCUSED STUDY FOCUSED
ON ONE PARTICULAR GROUP.
SO ALL OF THESE ARE THINGS YOU
HAVE TO THINK ABOUT AS YOU WRITE
THAT GRANT, AS YOU DEVELOP THAT
PROTOCOL GOING FORWARD.
>> AND THEN CAN I ALSO SAY, THIS
IS A QUESTION THAT CAME UP
OFTENTIMES IN THE REPORT, WE
WERE FOCUSED IN THE REPORT ON
TRACKING, SURVEILLING AND USING
TO MODIFY PROGRAMS ACROSS AN
ENTIRE NIH PORTFOLIO TO LOOK AT
REPRESENTATION.
DOES THIS MEAN THAT EVERY STUDY
OF 50 PARTICIPANTS WHERE THAT'S
THE APPROPRIATE SAMPLE SIZE FOR
THE STUDY QUESTION SHOULD
HAVE -- SHOULD MEET CRITERIA FOR
ALL OF THE HIGHER LEVEL
REPRESENTATION THAT A PARTICULAR
INSTITUTE, FOR EXAMPLE, IS
TRYING TO ACHIEVE?
NO, THAT'S NOT POSSIBLE, AND IT
SPEAKS TO WHAT DR. EGEDE IS
SAYING, IF THE GOAL OF YOUR
STUDY IS TO TEST FOR DIFFERENCES
ACROSS GROUPS, YOU HAVE TO
DESIGN A STUDY TO DO THAT.
BUT I WOULD SAY THAT THE -- AND
SOME STUDIES WHERE YOU ARE
LOOKING AT THE SPECIFIC ISSUES
IN A PARTICULAR POPULATION,
SHOULD HAVE SOMETHING THAT'S
COMPATIBLE.
WE DID NOT MEAN TO BE THAT EVERY
SINGLE STUDY HAS TO DO EXACTLY
THE SAME THING.
IT DOES NEED TO CONSIDER THE
POPULATIONS THAT ARE AFFECTED BY
THE CONDITION THAT'S BEING
STUDIED, ENSURING THAT THE
PEOPLE WHO ARE INVOLVED IN THE
STUDY, THAT IT'S COMPATIBLE WITH
THE DEMOGRAPHICS FOR THE
CONDITION THAT'S BEING STUDIED,
AND THAT OVERALL, FUNDERS LIKE
THE NIH WHO ARE LOOKING ACROSS A
LARGE PORTFOLIO HAVE TO MAKE
SURE THAT ACROSS MULTIPLE STU
STUDIES THAT THEY DO HAVE THAT
IN PLACE.
AND FOR THE INVESTIGATOR, IN
YOUR STUDY IT REALLY MATCHES THE
COMPOSITION OF THAT.
>> THANK YOU TO UR OH PANELISTS.
WE HAVE TO MOVE ON TO OUR NEXT
QUESTION.
EDWARD, PLEASE GO AHEAD AND
UNMUTE.
GO FOR IT.
THANK YOU.
>> THANK YOU.
MY NAME IS ED.
I'M A NURSE PRACTITIONER AND I
WORK IN AN ONCOLOGY CLINICAL
TRIAL.
THE QUESTION IS FOR EITHER
DR. BIBBINS-DOMINGO OR DR. EGEDE
OR ANYONE ELSE.
IN COLLECTING RACE /ETHNICITY AND
SOGE DATA, THERE'S SO MUCH
VARIANCE IN WHAT PATIENTS
SELF-REPORT AND THE METHODS THAT
THE DATA IS COLLECTED, SO FOR
INSTANCE, IN ONE CLINIC, THEY
MIGHT ASK THE PATIENTS, ANOTHER
THEY MIGHT SELF-REPORT.
WORST-CASE SCENARIO, SOMETIMES
SOMEONE AT A DIFFERENT DESK
DECIDES WHAT THEY THINK SOMEONE
IS, AND THIS ALL CREATES -- OR I
THINK JUST REALLY IMPEDE US
REALLY COLLECTING DATA
ACCURATELY.
ANY MAYBE TIPS OR STRATEGIES TO
HELP AT AN INSTITUTIONAL LEVEL
GET PAST THAT?
>> WELL, I WOULD JUST SAY THAT
COMMITTEE CAME -- SO THANK YOU
FOR THE QUESTION.
THE COMMITTEE CAME DOWN VERY
STRONGLY ENDORSING WHAT I THINK
THE LITERATURE SUPPORTS, WHICH
IS USING SELF-REPORT OF
RACE/ETHNICITY, BUT THAT ACROSS
A STUDY, THE PRAGMATIC NATURE OF
IS IT SELF-REPORT ON A WRITTEN
FORM OR SELF-REPORT BECAUSE
SOMEBODY ASKED, I THINK THAT --
BUT IT IS -- SELF-REPORT IS
GRANTED SO THE IDEA OF MULTIPLE
WAYS OF GETTING AT THAT
INCLUDING SOMEONE ELSE'S BEST
GUESS AT WHAT A PERSON'S
RACE/ETHNICITY IS, THAT WOULD
NOT BE CONSIDERED APPROPRIATE.
BUT I THINK THAT WE -- WE BOTH
ENDORSED SELF-REPORT OF
RACE/ETHNICITY AND THEN
UNDERSTANDING THAT THE STUDIES
THAT ARE DOING THIS WELL REALLY
THINK ABOUT THE WAYS TO GET AT
THE QUESTION IN A WAY THAT'S
COMPATIBLE WITH THE DESIGN OF
THEIR STUDY.
>> SO I AGREE WITH DR. DOMINGO,
WE ALWAYS JUST TAKE THE
SELF-REPORT BECAUSE THE PERSON
KNOWS, YOU KNOW, THEIR RACE AND
ETHNICITY.
WHEN YOU IS DEVELOP YOUR STUDY
PROTOCOL, YOU HAVE TO PUT A
GUIDELINES HOW YOU'RE COLLECTING
SO YOU HAVE A STANDARDIZED
METHOD, HOW YOU'RE COLLECTING
DEMOGRAPHICS AND RACE AND
ETHNICITY.
SO THIS IS PART OF -- WE DO A
LOT OF QUALITY CONTROL ON THAT,
AND THIS HAS TO BE PART OF YOUR
PROTOCOL.
I AGREE, IF YOU ARE DOING A
TRIAL USING ELECTRONIC HEALTH
RECORDS OR IT'S NOT LIKE YOU'RE
DOING -- COLLECTING THE DATA
YOURSELF FOR YOUR TRIAL, THIS
GETS A LITTLE BIT MURKY BECAUSE
YOU ARE RELYING ON INFORMATION
IN THE EHR THAT YOU DIDN'T KNOW
HOW IT WAS COLLECTED, BUT FOR
THEN, YOU JUST TAKE WHAT'S
THERE, BUT IF YOU ARE DESIGNING
YOUR OWN STUDY AND YOU'RE DOING
YOUR OWN ORIGINAL DATA
COLLECTION, I WOULD RECOMMEND
THAT THIS CAN BE PART OF THE
TRAINING AND CERTIFICATION OF
STAFF.
>> THANK YOU.
THAT'S SIMILAR TO WHAT WE DO
NOW, WE HAVE BASICALLY FORMS
THAT WE CREATED FOR EVERYONE WHO
ENTERS ON ANY OF OUR TRIALS,
THEY SELF-REPORT.
BUT IT'S OFTEN -- VERY OFTEN IN
CONFLICT WITH WHAT'S IN THE EMR.
>> AND YOU DON'T KNOW HOW THE
EMR WAS COLLECTED.
THAT'S THE THING.
BUT AT LEAST YOU CAN MAKE SURE
WITH SOME QA AND QUALITY, YOU
KNOW, WE DO LISTEN TO SOME OF
THOSE AND DO WHATEVER OUR BEST
TO DO, BUT AGAIN, IT'S ONE OF
THIS NOT THE HARD DATA BUT I A
GIAGREE WITH DR. DOMINGO, WHAT
EVERYBODY USES AS THE
SELF-REPORT.
>> THANK YOU.
THANK YOU ALL.
>> THANK YOU SO MUCH.
UNFORTUNATELY WE WON'T BE ABLE
TO GET TO ALL OF THE QUESTIONS.
HOPEFULLY SOME OF THE QUESTIONS
HAVE BEEN ANSWERED VIA CHAT.
THERE ARE SPECIFIC ONES TO EACH
OF THE PANELISTS AND SPEAKERS.
AGAIN I WANT TO THANK THE
PANELISTS FOR THEIR EXCELLENT
PRESENTATIONS, AND THE AUDIENCE
FOR THEIR ENGAGEMENT AND
QUESTIONS.
I THINK NOW WE ARE GOING TO A
SHORT BREAK.
THANK YOU SO MUCH, EVERYBODY.
YES, WE HAVE NOW A 5-MINUTE
BREAK.
I AM A SENIOR PORTFOLIO MANAGER
IN THE NATIONAL INSTITUTE FOR
NEUROLOGICAL DISTORDERS IN
STROKE.
I AM ALSO FOUNDER AND CHAIR OF
THE SPECIAL POPULATIONS RESEARCH
FORMS CLINICAL RESEARCH
RECOMMENDATION COMMITTEE.
THE COMODERATOR FOR THIS PANEL
DISCUSSION IS MY COLLEAGUE,
DR. JENNIFER ALVIDREZ IN THE
OFFICE OF THE DIRECTOR HERE AT
NIH.
WE'LL FOCUS ON SHARING BEST
PRACTICES FOR PERFORMING
CLINICAL RESEARCH IN SPECIAL
POPULATIONS.
OUR FIRST PANEL DISCUSSION WILL
COVER BEST PRACTICES FOR
PERFORMING CLINICAL RESEARCH IN
UNDERREPRESENTED RACIAL AND
ETHNIC POPULATIONS.
THIS IS A 40-MINUTE PANEL AND IT
WILL END AT 1:15.
IF YOU HAVE ANY QUESTIONS,
PLEASE USE ANY OF THE METHODS
THAT HAVE BEEN CITED PREVIOUSLY.
YOU CAN PUT YOUR QUESTIONS IN
THE CHAT BOX IF YOU ARE ON ZOOM.
USE THE LIVE FEEDBACK OPTION IF
YOU'RE WATCHING BY VIDEOCAST OR
RAISE YOUR HAND AND JENNIFER OUR
COMODERATOR WILL HELP COORDINATE
GETTING YOUR QUESTION ASKED.
SO LET'S GET STARTED.
I'D LIKE TO INTRODUCE OUR
PANELISTS.
I'D ASK THAT EACH PROVIDE A
BRIEF DU INTRODUCTORY REMARK.
DR. LUCILE ADAMS-CAMPBELL.
SENIOR ASSOCIATE DEAN FOR
COMMUNITY OUTREACH AND
ENGAGEMENT, AND PROFESSOR OF
ONCOLOGY AT THE LOMBARDI
COMPREHENSIVE CANCER CENTER AT
GEORGETOWN UNIVERSITY MEDICAL
CENTER.
>> GOOD AFTERNOON.
THANK YOU VERY MUCH FOR HAVING
ME ON THIS PANEL.
I AM VERY ENGAGED IN CLINICAL
TRIALS FOCUSED ON AFRICAN
AMERICANS, BLACKS IN PARTICULAR,
AND ALSO HISPANICS.
I AM THE P.I. OF THE NCORP GRANT
AT GEORGETOWN LOMBARDI CANCER
CENTER AND WE ARE REALLY
REACHING OUT BECAUSE WE ARE
MINORITY -- WE HAVE MADE MANY
STRIDES IN INCREASING AND
OVERCOMING MANY BARRIERS LINKED
TO CLINICAL TRIALS.
>> THANK YOU,
DR. ADAMS-CAMPBELL.
NEXT WE HAVE DR. DENISE DILLARD,
PROFESSOR AND CO -DIRECTOR OF THE
INSTITUTE FOR RESEARCH AND
EDUCATION TO ADVANCE COMMUNITY
HEALTH AT WASHINGTON STATE
UNIVERSITY.
>> GOOD MORNING OR GOOD
AFTERNOON, DEPENDING ON WHERE
PEOPLE ARE IN THE COUNTRY.
SO MY NAME IS DENISE DILLARD.
I AMY MOTHER WAS FROM KING ISLA,
ALASKA, A SMALL ISLAND.
I'VE SPENT THE 30 YEARS OF MY
CAREER EITHER PROVIDING CLINICAL
SERVICES OR DOING RESEARCH WITH
AMERICAN INDIAN AND ALASKA
NATIVE PEOPLE.
MUCH OF MY WORK HAS BEEN BASED
IN ALASKA, BUT I'VE ALSO
PARTNERED WITH MULTIPLE TRIBES
ACROSS THE NATION.
MY PORTFOLIO IS VERY DIVERSE.
I'M A PSYCHOLOGIST BY TRAINING,
BUT I HAVE LED DIFFERENT EFFORTS
THAT ARE IN PARTNERSHIP WITH
CONTENT EXPERTS IN VERY DIVERSE
AREAS TO INCLUDE
PHARMACOGENETICS OR
CARDIOVASCULAR DISEASE, AND MY
PORTFOLIO IS PURPOSEFULLY
DIVERSE IN ORDER TO REALLY
RESPOND TO THE NEEDS THAT
COMMUNITY MEMBERS RAISE.
>> THANK YOU, DR. DILLARD.
DR. MAY SUDDENHINARASET.
>> GOOD MORNING, AFTERNOON,
EVERYONE.
I'M ASSOCIATE PROFESSOR AND VICE
CHAIR IN COMMUNITY HEALTH
SCIENCES AT THE FIELDING SCHOOL
OF PUBLIC HEALTH AT UCLA.
I'M A SOCIAL EPIDEMIOLOGIST BY
TRAINING AND CONDUCT RESEARCH
WITH IMGRANT POPULATION,
SPECIFICALLY ASIAN GROUPS ACROSS
DIFFERENT IMMIGRATION STATUSES,
INCLUDING THOSE WHO ARE
UNDOCUMENTED.
I'M CURRENTLY LEADING A STUDY
CALLED THE BRAVE STUDY WHICH
STANDS FOR BUILDING COMMUNITY
RAISING ALL IMMIGRANT VOICES FOR
HEALTH EQUITY.
THIS FOCUSES ON UPLIFTING ASIAN
IMMIGRANT VOICES AND
UNDERSTANDING HOW IMMIGRATION
STATUS STRUCTURES REPRODUCTIVE
RIGHTS, IMMIGRANTS' RIGHTS AND
SEXUAL AND REPRODUCTIVE
HEALTHCARE USE ACROSS THE U.S.
ASIANS ARE CRITICALLY
UNDERREPRESENTED IN NIH RESEARCH
STUDIES DESPITE BEING THE
FASTEST GROWING RACIAL AND
ETHNIC GROUP IN THE U.S., AND
I'M LOOKING FORWARD TO THIS
DISCUSSION.
>> THANK YOU.
NEXT WE HAVE DR. GREG TALAVERA,
PROFESSOR IN THE DEPARTMENT OF
PSYCHOLOGY AT SAN DIEGO STATE
UNIVERSITY, ALSO THE FOUNDER AND
CO-DIRECTOR OF THE SOUTH DE
LATINO RESEARCH CENTER.
>> GOOD DAY, EVERYBODY.
I AM A FACULTY MEMBER AT
SAN DIEGO STATE BUT MY RESEARCH
FOCUSES ON THE LATINO COMMUNITY
AND THE SOUTH BAY REGION OF
SAN DIEGO NEAR THE BORDER.
SO THESE ARE LATINOS BY NATIONAL
BACKGROUND AND BORDER HEALTH
ISSUES, THEY CROSS THE BORDER
QUITE A BIT, AND MY ABILITY TO
DO RESEARCH AND REACH THIS HARD
TO REACH POPULATION IS THAT I
WORK WITH A LARGE COMMUNITY
HEALTH CENTER RIGHT ON THE
BORDER WHICH HAS 100,000
REGISTERED PATIENTS, AND I HAVE
DEVELOPED A 20 -YEAR RELATIONSHIP
WITH THEM CONDUCTING RANDOMIZED
CLINICAL TRIALS, MOSTLY FOCUSED
ON DIABETES, BUT ASSISTED THEM
WITH LONGITUDINAL RESEARCH
PROGRAMS ALSO FOCUSING ON
LATINOS, AND MOST RECENTLY
ASSISTING THEM WITH THE COVID
RESPONSE FUNDING THAT CAME DOWN
DURING THE EPIDEMIC TO REACH THE
SPANISH SPEAKING COMMUNITY IN
OUR AREA.
AND I AM A VIZ BY TRAINING,
TRTRAIN -- APHYSICIAN BY TRAINI.
MY CLINICAL TRIAL WORK ALSO
FOCUSES ON THE INTEGRATION OF
BEHAVIORAL AND MEDICAL CARE.
THANK YOU FOR INVITING ME.
>> THANK YOU.
AND LAST BUT NOT LEAST, WE HAVE
MR. VA' A TOFAEONO, PRINCIPAL
INVESTIGATOR AT THE AMERICAN
SAMOA CANCER COALITION.
>> GREETINGS, EVERYONE.
I WAS THE MPI FOR INDIGENOUS
SAMOAN PARTNERSHIP TO INITIATE
RESEARCH EXCELLENCE WHICH LOOKED
TO BUILD CAPACITY HERE IN
AMERICAN SAMOA AND ALSO STUDY
HEALTH LITERACY AS A
CONTRIBUTING FACTOR TO
COLORECTAL CANCER SCREENING.
THAT ALSO LED TO OUR FIRST
R01 AWARD WE JUST GOT LAST YEAR
THAT IS NOW LOOKING AT
ALZHEIMER'S DISEASE AND RELATED
DEMENTIA OF PREVALENCE ON
ISLAND.
A MAJORITY OF OUR POPULATION
HERE IS SAMOAN, BUT WE ALSO DO
HAVE OTHER PACIFIC ISLANDER
POPULATIONS SUCH AS FIJI AND
FILIPINO, WHO ARE ALSO
UNDERREPRESENTED IN NIH STUDIES.
SO GLAD TO BE PART OF THE PANEL
AND LOOKING FORWARD TO THE
DISCUSSION.
>> THANK YOU ALL.
FIRST FOR YOUR COMMITMENT OF THE
WORK YOU DO FOR THIS VERY
IMPORTANT WORK.
THANK YOU FOR PROVIDING THAT
BACKGROUND INFORMATION.
LET'S DIVE RIGHT INTO OUR
DISCUSSION.
IT IS OFTEN SAID THAT CERTAIN
POPULATIONS ARE HARD TO REACH.
BUT EACH OF YOU HAVE BEEN
SUCCESSFUL IN PERFORMING
RESEARCH IN UNDERREPRESENTED
POPULATIONS.
DEMONSTRATING THAT IT IS
FEASIBLE TO REACH THESE
POPULATIONS.
CAN YOU PLEASE DESCRIBE THE
STRATEGIES AND TOOLS THAT YOU
HAVE USED FOR OUTREACH TO THESE
POPULATIONS?
AND ANYONE CAN START FIRST.
>> I'LL START FIRST IF I MAY.
I THINK THAT'S A MISNOMER, IT'S
LABOR-INTENSIVE.
I THINK THAT'S A BIG
DISTINCTION.
I WOULD LIKE TO HEAR THAT
THEY'RE LABOR -INTENSIVE, THEY DO
NOT UTILIZE THE SAME METHODOLOGY
THAT MAJORITY POPULATIONS USE,
WHICH MEANS THEY REQUIRE MORE --
YOU CAN'T DO CODE MAILINGS, YOU
HAVE TO HAVE MORE DIRECT
CONTACT, MORE TRUST BUILDING IN
THE COMMUNITY, INVOLVE MORE AND
ENGAGE MORE WITH THE LEADERSHIP
IN THE COMMUNITY, AND BE PART OF
THE COMMUNITY AND NOT JUST DO
HELICOPTER SCIENCE.
SO WHEN I THINK ABOUT REACHING
OUT AND WORKING IN THE COMMUNITY
AS WE DO, MY OFFICE EVEN IS
LOCATED IN THE COMMUNITY NOW, SO
THAT WE ARE PART OF THE FABRIC
OF THE COMMUNITY.
WE HAVE A LOT OF EDUCATIONAL
PROGRAMS SO THAT WE CAN EDUCATE
THEM ABOUT CLINICAL TRIALS IN
PARTICULAR.
AND WE HAVE SUCCESS BECAUSE WE
REALLY WORK WITH THE COMMUNITY,
FINDING OUT WHAT THEY NEED,
UTILIZING OUR COMMUNITY ADVISORY
COUNCIL THAT IS VERY
INSTRUMENTAL IN REACHING OUT TO
THE COMMUNITY, HAVING THEIR
FINGERS ON THE PULSE OF THE
COMMUNITY, KNOWING WHAT'S OF
INTEREST AND HOW WE SHOULD BRING
PEOPLE IN AND START DISCUSSING
UPCOMING CLINICAL TRIALS AND
CURRENTLY ONGOING CLINICAL
TRIALS.
SO I THINK HARD TO REACH SHOULD
NOT BE THE WORD GOING FORWARD.
IT'S JUST LABOR-INTENSIVE.
>> I'LL GO NEXT.
I AGREE, IN FACT, MY APPROACH IS
ONE WHERE I'D SAY IT'S HARD NOT
TO REACH.
I'VE BEEN WORKING WITH COMMUNITY
HEALTH CENTERS FOR OVER 30
YEARS, AND WHEN YOU DO THAT KIND
OF WORK, IT VERY GENERALIZABLE
BECAUSE THERE ARE OVER 1,400
COMMUNITY HEALTH CENTERS IN THE
UNITED STATES SERVING 30 MILLION
PATIENTS.
20% OF THE SAMPLE IS UNINSURED,
59% ARE PUBLICLY INSURED, 90%
ARE LOW INCOME, MANY OF THEM
SPEAK DIFFERENT LANGUAGES, AND
SOME OF THEM ARE RURAL.
SO I'VE ALWAYS BEEN A BIG
PROMOTER OF WORKING WITH THOSE
HEALTH CENTERS BECAUSE YOU
ELIMINATE THE HARD TO REACH,
BECAUSE IT'S HARD TO REACH THE
GENERAL POPULATION IF YOU'RE
SAMPLING FROM THAT COHORT.
BUT THE OTHER THING, TOO, IS
THAT THEY'RE COMMUNITY-BASED,
AND SO WHAT I DID WAS RATHER
THAN SET UP MY RESEARCH LAB ON
CAMPUS AT A UNIVERSITY DISTANT
FROM THE TARGET POPULATION, I
CREATED ONE IN THE COMMUNITY
WHERE THIS HEALTH CENTER IS TO
FACILITATE CLINICAL TRIALS AND
LONGITUDINAL STUDIES AND HAVE
THE SPACE AND THE EQUIPMENT TO
DO THE KIND OF RESEARCH THAT I
DO.
SO I ALWAYS RECOMMEND IF YOU'RE
TRYING TO REACH THE HARD TO
REACH, DEFINITELY THE COMMUNITY
HEALTH CENTERS ARE A GOOD WAY TO
DO THAT.
THE OTHER BENEFIT IS THEY
ALREADY HAVE ACCESS TO CARE IN
SOME FORM, SO IF YOU DO DETECT
HEALTH CONDITIONS OR SCREEN FOR
THE THINGS THAT THEY DON'T KNOW,
THEY HAVE ACCESS TO CARE AND
THAT'S NOT AN ISSUE.
SO THAT'S BEEN MY MODEL FOR
TRYING TO REACH THE HARD TO
REACH.
>> SO I WANTED TO JUMP IN HERE
AND JUST ADD THAT I THINK, YOU
KNOW, IF YOU'RE DOING, YOU KNOW,
CROSS-SITE WORK WHERE IT'S NOT
POTENTIALLY FEASIBLE TO HAVE A
KIND OF BRICK AND MORTAR
LOCATION, YOU KNOW, WITHIN THE
COMMUNITIES THAT YOU'RE WORKING,
I THINK TIME IN THE COMMUNITY IS
REALLY CRITICAL, AND REALLY
WORKING WITH, I THINK, NIH AND
OTHER FUNDERS TO REALLY
UNDERSTAND THAT THIS -- THE
TRAVEL FUNDING REALLY IS
NECESSARY, AND THAT IT'S A
CRITICAL PART OF THE WORK SO YOU
HAVE RESOURCES TO SPEND TIME IN
THE COMMUNITY SO IT'S NOT AS DRD
HELICOPTER, WE CALL IT MOS
RESEARCH WHERE YOU FLY IN, TAKE
YOUR SAMPLES, DATA, AND FLY BACK
OUT.
I ALSO THINK EVERYTHING THAT THE
PANELISTS HAVE SAID IN TERMS OF
REALLY LISTENING TO WHAT THE
COMMUNITIES NEED AND REALLY
BUILDING ON THAT.
SO YOU MAY START IN A CERTAIN
AREA BUT REALLY BE LISTENING TO
WHAT COMMUNITIES NEED.
AND IF YOU AREN'T ABLE TO REALLY
RESPOND TO THAT NEED, YOU KNOW,
REALLY HELPING TO IDENTIFY
PARTNERS THAT REALLY COULD
RESPOND TO THOSE NEEDS.
>> I'D LIKE TO ADD ONE MORE
THING.
I THINK -- I FORGOT TO MENTION
THE CONCEPT OF COMMUNITY-BASED
PARTICIPATORY RESEARCH, WHICH
HAS BEEN THEMATIC THROUGHOUT
BOTH DAYS OF THIS CONFERENCE.
SO MY RESEARCH HAS NOT BEEN
FOCUSED ON THINGS THAT I WANT TO
DO.
IT'S ALWAYS BEEN WHAT THE CLINIC
NEEDS FOR THEIR COMMUNITY TO
HELP UNDERSTAND THE HEALTH
CONDITIONS, THROUGH EPIDEMIOLOGY
AND TO DESIGN INTERVENTIONS FOR
CHRONIC DISEASE THAT COULD
POSSIBLY BE IMPLEMENTED BASED ON
THE ECONOMIC ENVIRONMENT THAT
THEY'RE WORKING, THE CHANGING
DEMANDS OF HRSA, WHICH KIND OF
DICTATE WHAT DIRECTION THEY
SHOULD BE GOING, SO SITTING DOWN
WITH THEM, FICKING FIGURING OUT
THEY WANT TO DO, WHAT THEY NEED,
AND THEN LOOKING FOR THE
FUNDING, RATHER THAN VICE VERSA
IS ALSO A GOOD STRATEGY.
>> GREAT.
MAY?
>> I'LL JUST ADD TO THAT.
LIKE OUR PREVIOUS PANELISTS SAID
AND I THINK THROUGHOUT THESE
PAST TWO DAYS IS THAT
PRIORITIZING THE STRUCTURE OF
THE TEAM IS VERY CRITICAL, SO
INCLUDING COMMUNITY MEMBERS AS
EQUAL PARTS IN THE STUDY FROM
QUESTION DEVELOPMENT TO FUNDING,
DATA ANALYSES AND DISSEMINATION.
I KNOW FOR ASIAN POPULATIONS,
ENSURING THAT THERE'S A COVERAGE
OF CULTURAL, LINGUISTIC,
IMMIGRATION STATUSES, THAT MEETS
THE NEEDS OF THE COMMUNITY ALSO
ENSURE SUCCESS IN TERMS OF
OUTREACH AND RECRUITMENT.
WE KNOW THAT OUTREACH IS BEST
ACCOMPLISHED THROUGH OUR
COMMUNITY PARTNERS, THOSE WHO
ARE ACTUALLY FROM THE COMMUNITY
ORGANIZATIONS WHO HAVE TRUSTED
RELATIONSHIPS AND HAVE NETWORKS
ALREADY IN PLACE.
AND INFORMING STUDENTS THAT
AOPPORTUNITIES THATALREADY EXIS.
I'D ALSO SAY IN TERMS OF
OUTREACH AND THINKING ABOUT THE
POPULATIONS THAT WE'RE TRYING TO
FOCUS ON, I THINK THAT DOING
STRATEGIES LIKE COMMUNITY
MAPPING, AND SO TRIANGULATING
EXISTING DATA USING CENSUS TRACT
DATA WITH KEY INFORMANT
INTERVIEWS, WITH GOOGLE
METADATA, THINKING ABOUT THE
DIFFERENT LANDSCAPES OF AREAS
WHERE YOUR POPULATIONS MIGHT
SPEND TIME, I THINK IS ANOTHER
WAY TO COMPREHENSIVELY
UNDERSTAND HOW BEST TO RECRUIT
FOLKS.
AND I WOULD ALSO JUST ECHO KIND
OF MEETING THE PARTICIPANTS
WHERE THEY ARE SO HAVING HYBRID
STUDY PROCEDURES, TRANSPORTATION
REIMBURSEMENTS, PROVIDING MEALS
DURING GROUP DISCUSSIONS.
AND ACCOMMODATING FOR
PARTICIPANT TIME IS REALLY
CRITICAL TO MEETING COMMUNITIES
WHERE THEY'RE AT.
>> THANK YOU.
VA'A, DID YOU WANT TO ADD
SOMETHING?
>> SURE, I AGREE WITH EVERYTHING
EVERYONE HAS SHARED.
KIND OF PUTTING THAT INTO
PRACTICE FOR OUR STUDY, WE USE
RESPONDENT-DRIVEN SAMPLING TO
CONNECT WITH OUR COMMUNITY.
AND WE DID ACTUALLY HAVE A
CONVERSATION WITH SOME COMMUNITY
MEMBERS ABOUT THAT BEFORE.
SO IT'S KIND OF LIKE A SNOWBALL
SAMPLING DESIGN.
WE LIMIT TO THREE PEOPLE, SO IF
A PERSON WOULD COME IN, TAKE OUR
SURVEY, AND THEN THEY WOULD GET
THREE COUPONS -- I'M SORRY, ONCE
THEY COMPLETE THE SURVEY, THEY
WOULD RECEIVE AN INCENTIVE, A
CASH INCENTIVE OF $25.
THEN THEY WOULD GET THREE
COUPONS.
AND THOSE COUPONS, IF THOSE
THREE PEOPLE CAME IN, THEY GOT
AN ADDITIONAL $15 PER PERSON FOR
THOSE PEOPLE THAT CAME IN, AND
THEN THE WAVES CONTINUED LIKE
THAT.
WE FELT THAT INCENTIVIZING WAS A
GOOD WAY TO CONNECT WITH THEM AS
WELL, BUT ALSO ALLOWING THEM TO
USE THEIR SOCIAL NETWORKS AND
WAYS OF COMMUNICATING TO RECRUIT
PEOPLE BACK INTO OUR STUDY.
OUR SAMPLE SIZE WAS 78 780 PEOE
WITHIN OUR FIRST GROUP, AND
WE'VE ACHIEVED OUR SAMPLE WITHIN
50 DAYS OF STARTING, 50 BUSINESS
DAYS.
SO IT WAS REALLY -- WELL, IT WAS
SUCCESSFUL FOR US AND OTHER
PARTNERS THAT WE HAD AND SOME
OTHER INSTITUTIONS REALLY HAD
PROBLEMS CONNECTING WITH THE
SAME GROUP.
SO AGAIN, WHAT EVERYONE ELSE IS
KIND OF SHARING HERE, WE KIND OF
PUT THAT INTO PRACTICE, AND IT
WORKED OUT WELL FOR US.
>> THANK YOU.
YOU GUYS ARE VERY CLEARLY
ARTICULATING WHY IT'S NOT HARD
TO REACH, IT'S REALLY
LABOR-INTENSIVE.
I WANT TO GO TO JENNIFER,
BECAUSE I KNOW THAT THERE ARE
SOME QUESTIONS COMING IN FROM
THE CHAT.
JENNIFER?
>> SURE.
SO ONE QUESTION I THINK MAY BE
DIRECTED TO GREG.
BUT ALSO OTHERS.
IS THERE COMMUNITY
REPRESENTATION ON THE CLINIC'S
BOARD AND INVOLVED IN
DECISION-MAKING?
>> YEAH, THAT'S A GOOD POINT.
MY FEDERAL REGULATION, IF YOU'RE
A FEDERALLY QUALIFIED COMMUNITY
HEALTH CENTER, YOU'RE SUPPOSED
TO HAVE TO BE 1% -- WELL, NOT
COMMUNITY, ACTUALLY REGISTERED
PATIENTS ON YOUR BOARD.
SO THE CHAIR OF THE BOARD OF
DIRECTORS FOR OUR COMMUNITY
HEALTH CENTER IS A PATIENT --
ACTUAL PATIENT AND A PARTICIPANT
OF ONE OF MY -- MATCHED TRIALS
ON THE BOARD.
SO THEY'RE AWARE OF THE RESEARCH
THAT'S GOING ON, BUT ABOUT 20
YEARS AGO, WE CREATED A RESEARCH
DEPARTMENT WITHIN THE COMMUNITY
HEALTH CENTER, SEPARATE LINE
ITEM/ENTITY WITHIN THERE
COMPOSED OF STAFF MEMBERS FROM
THE HEALTH CENTER, AND THEY
CHANNEL THE INFORMATION UP TO
THE CEO AND OFTEN OUR DIRECTOR
OF RESEARCH PRESENTS TO THE
BOARD OF DIRECTORS, SO THEY'RE
AWARE AND VERY INTERESTED IN THE
RESEARCH PROJECTS THAT ARE BEING
CONDUCTED WITH THE PATIENTS OF
THE HEALTH CENTER.
HOPE THAT ANSWERED YOUR
QUESTION.
>> THANK YOU.
JENNIFER, DO YOU WANT TO GO TO A
QUESTION IN THE CHAT?
>> SURE.
ANOTHER QUESTION IS, I THINK
THIS IS FOR EVERYBODY, CAN YOU
COMMENT ON RECRUITING
COMMUNITIES WHO MAY HAVE LOW
LEVELS OF LITERACY OR EDUCATION
OR KNOWLEDGE ABOUT THE CONDITION
YOU'RE STUDYING?
IS THERE ROOM FOR EDUCATION?
>> I WILL START.
THE ANSWER IS YES.
RESOUNDING YES.
I DON'T THINK ANYBODY CAN BE
TARGETED TO BE LEFT BEHIND.
WE HAVE A STUDY ON GENETICS, SO
IF YOU THINK ABOUT GENETICS,
GENETIC TESTING, GENETIC
COUNSELING, MANY MINORITIES,
UNDERSERVED, LOW HEALTH LITERACY
AND LOW LITERACY IN GENERAL KNOW
NOTHING ABOUT GENETIC TESTING
AND COUNSELING.
WE HAVE SPENT A WHOLE LAST
COUPLE OF YEARS FOCUSING ON
EDUCATING THE COMMUNITY ABOUT
GENETIC TESTING.
COUNSELING.
AS IT RELATES TO BREAST CANCER.
AND YOU'D BE SURPRISED THE
COMMUNITIES, WE'RE IN PUBLIC
HOUSING, WE'RE IN AREAS WHERE
THE LITERACY LEVEL IS QUITE LOW,
AND YOU BECOME VERY ENGAGED WITH
THOSE IN THE COMMUNITY BY HAVING
INFO GRAPHICS, HAVING SMALL
DISCUSSION GROUPS, HAVING THINGS
VERY COLORFUL, HAVING PEOPLE
TALK IN LAY TERMINOLOGY.
AND WE ACTUALLY HAD A VERY
SUCCESSFUL CLINICAL TRIAL
FOCUSING ON GENETICS AND
COUNSELING.
BUT IT TAKES TIME.
AGAIN, I JUST REITERATE,
LABOR-INTENSIVE.
YOU CAN DO A LOT, EVEN WITH LOW
LITERACY, WE ALWAYS SAY FROM THE
NIH PERSPECTIVE, WE ALWAYS READ
ABOUT YOU SHOULD HAVE EVERYTHING
AT AN 8TH GRADE LEVEL.
8TH GRADE IS PRETTY HIGH FOR
SOME PEOPLE.
BULL THE IDEA OF TALKING AND
COMMUNICATING AND DRILLING DOWN
AND MEETING PEOPLE WHERE THEY
ARE, YOU CAN BEGIN TO EXPLAIN.
WE DO A STUDY WITH THE HUMAN
GENOME RESEARCH INSTITUTE CALLED
FAMILY SHARES.
AND IN THAT STUDY, THEY LEARN
ABOUT THEIR FAMILY HISTORY,
ABOUT GENETICS.
THEY EVEN ARE GIVEN A BOOKLET TO
TAKE HOME AFTER THEY HAVE GOTTEN
THEIR FAMILY TO PARTICIPATE IN
IDENTIFYING WHAT DISEASES DO YOU
HAVE, WHAT THINGS DO YOU HAVE?
THEY NOW OWN BOOKLETS THAT THEY
CAN TAKE TO THEIR PRIMARY CARE
DOCTOR OR SOMEBODY THAT THEY
HELPED DEVELOP WITH THE
SCIENTISTS, WITH THE COMMUNITY,
WITH THEIR FAMILY MEMBERS THAT
THEY SAID THEY WOULD NEVER HAVE
KNOWN ABOUT THEIR FAMILY HISTORY
OR ANYTHING ABOUT GENETICS.
SOME HAVE BEEN TESTED FOR
BRCA1 AND BRCA2, BUT THEY LEARN
ALL OF THIS AND THEN THEY CARRY
THIS BOOKLET THAT'S BEING GIVEN
TO THEM, SO THEY GET A CHANCE TO
REALLY, REALLY DELVE INTO
SOMETHING THEY HAVE NEVER HAD AN
INTEREST IN AND NEVER KNEW
ANYTHING ABOUT.
WE ALL ARE TEACHABLE.
>> I AGREE.
>> ONE OF THE THINGS WE
RECOGNIZED TOO WITH LOW LITERACY
IS THE VALIDITY OF THE DATA, AND
WHEN WE CAN, AND IT'S EXPENSIVE,
WE PREFER TO DO INTERYOU HAVE
ADMININTERVIEWADMINISTERED QUESO
WE CAN ELIMINATE SOME OF THE
MISUNDERSTANDING OR THE ROUTINE
YES/NO CHECK ANSWERS, THINGS
LIKE THAT.
SO IF YOU CAN AFFORD IT FOR LOW
LITERACY, INTERVIEW ADMINISTERED
IS MORE RELIABLE.
>> CAN I JUST ADD ON ONE THING,
YOU SAID THE WORD AFFORD.
WHEN WE WRITE GRANTS, WE ARE
EXPECTED TO REACH A CERTAIN
NUMBER OF MINORITIES,
UNDERSERVED, WHATEVER THE
POPULATION MAY BE.
BUT WE NEED NIH TO SUPPORT THAT
FINANCIALLY, BECAUSE WE NEED TO
PAY PEOPLE.
WHEN THEY SIT ON MY COMMUNITY
ADVISORY COUNCIL OR BOARD, I PAY
THEM AN HONORARIUM, BECAUSE
THEIR TIME IS JUST AS VALUABLE
AS OUR TIME.
IF HE WITH DON'T HAVE OUR
FINGERS -- IF WE DON'T HAVE OUR
FINGERS ON THE PULSE OF THE
COMMUNITY, WE WON'T HAVE
SUCCESS.
AND WHEN WE PUT IN COMMUNITY
PARTNERS, WE'VE SEEN THOSE
PARTNERS BE OMITTED FROM THE
GRANTS.
YOU JUST DON'T UNDERSTAND HOW
VALUABLE IT IS, HAVING THOSE
PARTNERSHIPS AND REALLY
RESPECTING THEIR INPUT,
RESPECTING THEIR VALUE SO THAT
WE CAN BE SUCCESSFUL.
SO YOU GIVE US THE MONEY AND WE
WANT TO GIVE IT OR SHARE IT WITH
THE COMMUNITY PARTNERS, AND THEY
SAID NO, WE'LL TAKE THAT OUT,
WE'LL CUT THE BUDGET BY THIS%.
YOU CUT THE COMMUNITY NEARTS BY
15%, 10%, WHATEVER, WE HAVE TO
WORK TWICE AS HARD TO GET THINGS
DONE.
AND SOMETIMES THEY'RE NOT HAPPY
WITH US.
THAT'S IT.
>> I'D LIKE JUST TO ADD ON TOO.
FOR US, WITH OUR HEALTH LITERACY
ASSESSMENT TOOL, WE'VE FOUND
THAT OVER 60% OF THE SAMPLE HAD
INADEQUATE OR MARGINAL HEALTH
LITERACY.
SO MOVING FORWARD, WE HAVE TO
REALLY CONSIDER THAT EVERYBODY
HAS LOW HEALTH LITERACY.
AND REALLY HAVE TO ADDRESS OUR
APPROACH TO THAT.
OTHER THINGS WE NEED TO CONSIDER
ESPECIALLY IN INDIGENOUS
POPULATIONS ARE THEIR
TRADITIONAL WAYS OF SHARING
KNOWLEDGE.
FOR US, PACIFIC ISLANDERS
MOSTLY, IT'S ABOUT ORAL SHARING.
SO LIKE DR. CAMPBELL MENTIONED,
IT'S ABOUT DISCUSSION, IT'S
ABOUT WE ARE MOVING FORWARD WITH
OUR ALZHEIMER'S PROJECT USING
COMMUNITY TALKS.
ON THE VILLAGE LEVEL AND REALLY
APPROACHING THE PEOPLE, MAKING
SURE THAT THEY UNDERSTAND WHAT
THE GENETIC APPROACH IS, WHAT'S
GOING TO HAPPEN WITH THEIR
SAMPLES, THEY HAVE THE SAY ON
WHAT'S GOING TO REALLY -- HOW
THE RESEARCH IS GOING TO BE USED
AND HOW DISSEMINATION IS GOING
TO HAPPEN.
SO THAT'S REALLY IMPORTANT.
>> LET ME JUST ADD ONE THING.
THIS WEEKEND OUR COMMUNITY
PARTNER INVITED US TO THEIR
HOUSE BECAUSE WE HAVE THE
PAPER -- I'M NOT ON THE PAPER,
MY TEAM IS, BUT THE COMMUNITY
PARTNERS ARE CO -INVESTIGATORS ON
THE PAPER WITH OUR INVESTIGATORS
FROM OUR -- FROM LOMBARDI, AND
THE PAPER IS BEING PUBLISHED ON
GENETICS IN CANCER.
THEY HAD A HUGE PARTY, LIKE NINE
OF US THERE.
THE COMMUNITY WAS SO EXCITED.
THE COMMUNITY PARTNERS WERE SO
EXCITED.
THEY EVEN HAD THE ARTICLE BOUND.
SO WE TALK ABOUT DISSEMINATION,
JUST THINK, HAVING THEM AS
CO-AUTHORS.
I MEAN, ELATED.
THEY'RE ASKING US NOW, WHAT'S
NEXT?
SO I THINK, YOU KNOW, THAT HAS
BEEN A CULTIVATION OF TIME, BUT
IT WORKS, AND SEEING THEM ON
PAPERS IS GOING TO BE A VERY BIG
AND VERY POSITIVE STATEMENT.
AND WE'VE BEEN DOING THIS
BEFORE, BUT THIS WAS JUST
UNUSUAL, THAT THEY REALLY HAD
A -- THEY REALLY BELIEVED THAT
WE WERE TAKING THEM THE RIGHT
DIRECTION, AND WE TAUGHT THEM A
LOT.
>> THANK YOU.
MAY, I THINK YOU WANTED TO ADD
SOMETHING?
>> YES.
I THINK FOR IMMIGRANT
POPULATIONS IN PARTICULAR, WE
NEED TO ALSO CONSIDER THE
MISINFORMATION THAT OUR
POPULATIONS ARE RECEIVING, NOT
JUST LOW LITERACY OR LACK OF
KNOWLEDGE.
FOR IMMIGRANTS, THERE'S A
HISTORY OF LACK OF INFORMED
CONSENT RELATED TO REPRODUCTIVE
RIGHTS INJUSTICE, THERE'S BEEN
NON-CONSENTED STERILIZATION, IN
CALIFORNIA, THERE'S A LOT OF
MISTRUST.
EVEN MORE RECENTLY, PUBLIC
CHARGE AND LOTS OF
MISINFORMATION DURING THAT TIME
ON WHAT BENEFITS, YOU KNOW,
IMMIGRANTS COULD OR COULDN'T
ACCESS.
AND SO I THINK ONE THING FOR US
TO JUST BE CLEAR ABOUT IS
THINKING ABOUT OUR LANGUAGE,
MATERIALS, GIVING INFORMATION IN
A WAY THAT IS EASY TO
UNDERSTAND, WORKING WITH
COMMUNITY-BASED ORGANIZATIONS
AND TRUSTED PARTNERS TO PROVIDE
THAT INFORMATION AND TIMELY
INFORMATION WHEN THERE IS
MISINFORMATION OUT THERE IN THE
NEWS, COMMUNITY NAVIGATORS ARE
CRITICALLY IMPORTANT.
AND THEN THE LAST THING I JUST
WANTED TO NOTE IS JUST THE IDEA
OF INFORMED CONSENT AS WELL, AND
JUST ENSURING THAT DEFINITIONS
OF INFORMED CONSENT IS THE SAME
FOR PATIENTS AS IT IS FOR
RESEARCHERS OR PROVIDERS, AND
SPECIFICALLY TRAINING
RESEARCHERS AND ALSO PROVIDERS
TO UNDERSTAND WHAT INFORMED
CONSENT ACTUALLY MEANS
THROUGHOUT THE ENTIRE CLINICAL
PROCEDURE AND PROCESSES.
>> I ALSO WANTED TO KIND OF
OFFER A COUPLE OF COMMENTS.
I THINK THAT SOME OF THE
LANGUAGE THAT WE SOMETIMES USE
CAN BE VERY OFF-PUTTING TO
PARTICIPANTS, AND WHEN WE
DESCRIBE COMMUNITY, SO I
PERSONALLY DON'T LIKE THE
TERMINOLOGY OF LOW LITERACY.
I THINK, YOU KNOW, MANY
RESEARCHERS HAVE LOW LITERACY ON
HOW TO COMMUNICATE, LIKE, WITH
OTHER PEOPLE WHO ARE NOT
TECHNICAL EXPERTS.
BECAUSE WE KNOW THAT EDUCATIONAL
OPPORTUNITIES ARE NOT EQUALLY
AFFORDED TO ALL COMMUNITIES, AND
THEN WITH INDIGENOUS
POPULATIONS, YOU KNOW, THE
RELATIONSHIP WITH EDUCATION,
IT'S NOT A GOOD HISTORY.
IT'S ALSO NOT A GOOD HISTORY
WHEN YOU LOOK AT RELATIONSHIPS
WITH PROVIDERS WHO, YOU KNOW,
MAY HAVE, YOU KNOW, HAD VERY
STEREOTYPICAL VIEWS OR, YOU
KNOW, FORCED STERILIZATION,
THOSE TYPES OF THINGS HAPPENED
IN AMERICAN INDIAN, AND WITH
ALASKA NATIVE PEOPLE, AND PART
OF WHAT I THINK IS REALLY
CRITICAL IN THIS WORK IS HAVING
AN ATTITUDE OF HUMILITY AND THAT
EVERYBODY BRINGS KNOWLEDGE TO
THE TABLE AND I HAVE LEARNED SO
MUCH FROM COMMUNITY MEMBERS.
YOU KNOW, SO I VIEW LEARNING
VERY MUCH AS BIDIRECTIONAL, BUT
RESEARCHERS AND PROVIDERS NEED
TO BE OPEN AND YOU NEED TO
REALLY LISTEN TO KIND OF
APPROACH THE RELATIONSHIP KIND
OF WITH RESPECT AND WITH KIND OF
THIS SPIRIT OF KIND OF
COLLABORATION AND PARTNERSHIP.
>> THANK YOU.
JENNIFER, I THINK WE HAVE TIME
FOR ONE MORE QUESTION.
>> OKAY.
AND I WILL NOTE THERE ARE MOSTLY
AFFIRMATIONINGS IN THE CHAT OF
WHAT EVERYONE IS SAYING MORE
THAN QUESTIONS.
THERE ARE A COUPLE QUESTIONS,
AND LUCILE, YOU TOUCHED ON THIS
A LITTLE REGARDING THE BUDGET,
BUT THERE ARE QUESTIONS ABOUT
BUDGET.
HOW DO YOU THINK ABOUT THE
BUDGET AND ENGAGING COMMUNITY
PARTNERS, EITHER STAFFING OR
ADDRESSING BARRIERS TO
RECRUITMENT?
DOES ANYONE WANT TO SPEAK TO
THAT?
>> WELL, I'M A FIRM BELIEVER
THAT YOU SHOULD BUDGET FOR WHAT
YOU REALLY NEED.
WE CAN'T DO STUDIES IN THE
COMMUNITY WITHOUT THE COMMUNITY.
SO WE ACTUALLY ADEQUATELY BUDGET
FOR OUR PARTNERSHIPS.
TIME, EFFORT, AND THE
RECRUITMENT -- WE CAN'T GO FROM
GEORGETOWN AND WALK INTO
COMMUNITIES AND SAY LET ME
RECRUIT.
I HAVE HIRED PEOPLE FROM THE
COMMUNITY TO BE PART OF THE
STUDY, PART OF THE SOLUTION, NOT
PART OF THE PROBLEM, PART OF THE
SOLUTION, AND PUT THE MONEY IN.
AND A CLASSIC EXAMPLE IS THE
WOMEN'S SELF INITIATIVE.
I GO BACK THAT FAR BECAUSE WE
HAVE ONE OF THE UNIQUE
RECRUITMENT ASPECTS, IT WAS A
MINORITY SITE, KIND OF -- 40
WOMEN INITIATIVE SITES WERE
MINORITY.
WE HAD A MINORITY SITE, AND I
KNEW THE LABOR INTENSITY THAT
WAS NEEDED, SO WE ASKED FOR LIKE
FIVE RECRUITERS, AND WHEN WE
WERE SITE VISITED, THEY SAID WHY
WOULD YOU WANT THAT?
I SAID BECAUSE WE'D NOT BE
PUTTING THE TYPICAL WHITE WOMAN
IN A STUDY -- ANY STUDY THAT
GOES ALONG OR READ ABOUT.
WE HAVE TO GO OUT AND EDUCATE
PEOPLE.
SO IT'S VERY IMPORTANT, AND I
ALWAYS HAVE MY KREE KREUTERS --
I HAVE AT LEAST ONE RECRUITER IN
EVERY GRANT, BUT BY HAVING THE
COMMUNITY ADVISORY COUNCIL, AND
HAVING A WIDER SPREAD AND WE
HAVE NAVIGATORS AND COMMUNITY --
I HAVE A LARGE STAFFING THAT
ADDRESSES THE COMMUNITY AND
THEY'RE OUT IN THE COMMUNITY
EVERY DAY OF THE WEEK.
SO WE HAVE A BIG GRASP BUT
STILL, WE WANT TO PAY HOMAGE TO
THE COMMUNITY WE'RE WORKING WITH
AND MAKE CERTAIN THAT WE PROVIDE
SUPPORT AND FUNDING FOR THEM AS
WELL.
>> IN MY MODEL OF WORKING WITH
THE COMMUNITY HEALTH CENTER, WE
ALWAYS CUT A SUBCONTRACT TO
THEM, AND IT GOES -- THAT COMES
WITH A P.I., SOMEONE IN THE
RESEARCH DEPARTMENT, A PROGRAM
MANAGER, A RECRUITER, AND
INTERVENTION SPECIALIST.
BECAUSE NOT ONLY DOES THAT BIAS
TRUST AND MUTUAL RELATION -- BUY
US TRUSS AND MUTUAL
RELATIONSHIP, BUT IF THE
INTERVENTION IS SUCCESSFUL, THE
CURRICULUM, THE METHODOLOGIES
RESIDE WITH THE ORGANIZATION FOR
FUTURE INCORPORATE INTO THEIR
HEALTH EDUCATION PROGRAMS AND
DEPARTMENT.
SO THAT'S ANOTHER STRATEGY TO
THINK ABOUT.
>> MAY?
WOULD YOU LIKE TO ADD SOMETHING?
>> YES.
I THINK THERE'S A LOT AROUND
THIS, RIGHT?
SO I THINK THE FIRST THING IS
THAT IT'S REALLY IMPORTANT TO
TALK TO COMMUNITY MEMBERS WAY
BEFORE YOU'RE DOING THE WORK,
RIGHT?
SO AT THE PLANNING PHASE,
CONSULT WITH THEM.
UNDERSTAND HOW THEY WILL BE
INVOLVED IN THE PROJECT AND THEN
PAY THEM ACCORDINGLY.
I THINK, LI SOME COINVESTIGATOR
COMMUNITY ORGANIZATIONS ARE ABLE
TO DO A SUBCONTRACT, SMALLER
ORGANIZATIONS MIGHT FIND THAT
VERY CUMBERSOME AND SO BEING A
VENDOR MIGHT ACTUALLY BE MORE
FEASIBLE, SO UNDERSTANDING THAT
BEFORE YOU ACTUALLY EVEN
IMPLEMENT THE STUDY, I THINK IS
REALLY IMPORTANT BECAUSE AS WE
ALL KNOW, SUBCONTRACTS CAN TAKE
WEEKS TO MONTHS TO IMPLEMENT.
I WOULD ALSO SAY, TO ME, IT'S
REALLY IMPORTANT TO THINK ABOUT
BUDGET IN TERMS OF HOW CAN WE
FUND AND SUPPORT OUR COMMUNITIES
AND ORGANIZATIONS SO THAT IT
DOESN'T DISRUPT THE FLOW OF
THEIR ACTIVITIES AND WORK, AND
THAT MIGHT MEAN, YOU KNOW,
HIRING A RESEARCH MANAGER, OR
FUNDING A PART-TIME OF A
RESEARCH MANAGER WITHIN THE
ORGANIZATION.
ABSOLUTELY BUDGETING FOR
TRANSPORTATION, BUDGETING FOR
SLOW RECRUITMENT, RIGHT?
LIKE THAT'S SOMETHING THAT WE
MIGHT BUFFER WITHIN OUR BUDGETS.
WE NEED TO ALSO BUDGET THAT WITH
COMMUNITY ORGANIZATIONS, OTHER
PERSONNEL TIMES.
THE OTHER THING I JUST WANTED TO
NOTE IS THAT WITH NIH BUDGET
CUTS, WHICH I THINK IS PRETTY
STANDARD ACROSS THE BOARD,
UNIVERSITIES MIGHT BE ABLE TO
TAKE THAT HIT, BUT OUR
COMMUNITY-BASED ORGANIZATIONS
AREN'T, AND SO BUFFERING FOR
THAT, I THINK IS ALSO REALLY
IMPORTANT.
>> THANK YOU FOR THAT.
WE'VE GOT ONE MORE MINUTE LEFT.
I WANTED TO GIVE DENISE OR VA'A
AN OPPORTUNITY TO ADD ANY
COMMENTS THEY MIGHT HAVE.
>> I DON'T HAVE A LOT TO ADD IN
TERMS OF BUDGET, BUT YOU KNOW, I
AGREE, SUBCONTRACTS, LIKE HAVING
THE INFRASTRUCTURE TO DO
SUBCONTRACTS, SOMETIMES THAT'S
JUST REALLY NOT PRESENT, YOU
KNOW, WITHIN SOME ORGANIZATIONS
THAT YOU MAY WORK WITH, AND SO I
THINK WORKING WITH NIH AS WELL
AS WITHIN UNIVERSITIES -- HOW
CAN WE STILL HAVE SOUND FISCAL
APPROACHES, BUT ALSO TO BE AS
FLEXIBLE AS POSSIBLE, BECAUSE
SOMETIMES THERE'S A LOT OF
BARRIERS PUT UP LIKE WAYS TO
FUND LIKE OFFERING A SMALL GIFT,
YOU KNOW, TO A COMMUNITY MEMBER
WHO MAYBE HAS VOLUNTEERED THEIR
TIME, AND THAT'S AN IMPORTANT
ACKNOWLEDGMENT BUT CULTURALLY,
SO HOW DO YOU PAY FOR THAT, AND
SO ALL OF THOSE TYPES OF THINGS
ARE REALLY -- ARE REALLY
CRITICAL.
>> I JUST WANTED TO ADD, I AGREE
WITH WHAT EVERYONE IS SAYING.
ON THE FEDERAL SIDE, BECAUSE WE
ARE A COMMUNITY-BASED
ORGANIZATION.
AND I THINK NIH NEEDS TO SUPPORT
MORE FUNDING FOR COMMUNITY-BASED
ORGANIZATIONS AND WHAT WE SERVE.
I'M PUTTING A PLUG FOR JENNIFER
BECAUSE SHE WAS MY PROGRAM
OFFICER FOR OUR U24 GRANT.
BUT THAT BUILT OUR FOUNDATION
BECAUSE IT ALLOWED -- IT WAS
BUILDING RESEARCH CAPACITY
SPECIFICALLY IN PACIFIC ISLANDS,
AND THE ORGANIZATION HAD TO BE
IN THE ISLANDS AND COULD NOT --
IT COULDN'T BE ANOTHER
INSTITUTION FROM OFF ISLAND,
LIKE WAS MENTIONED BEFORE, LIKE
THAT MOSQUITO APPROACH.
SO IT REALLY ALLOWED US TO DO
THAT, BUILD OUR INFRASTRUCTURE,
BUILD WITHIN THE COMMUNITY, AND
THEN DO THE RESEARCH -- THE
STUDY AS WE NEEDED.
AND LIKE I MENTIONED, THAT
ALLOWED US TO GET OUR DEMENTIA
GRANT, WHICH THIS IS THE FIRST
R01 THAT'S HAPPENING IN OUR
COMMUNITY.
WE HAVE OTHER INSTITUTIONS DOING
R01s COMING IN, GRABBING
SAMPLES AND THEY'RE LEAVING, BUT
THIS ALLOWS US THE OPPORTUNITY
TO CONTROL THE STUDIES AND
WHAT'S HAPPENING WITH THE DATA.
THANK YOU.
>> THANK YOU SO MUCH.
THAT BRINGS US TO THE END OF OUR
FIRST PANEL DISCUSSION FOR
SESSION 4.
I WANT TO THANK OUR PANELISTS
FOR SHARING THEIR WORDS OF
WISDOM AND THEIR BEST PRACTICES
AS FAR AS PERFORMING INCLUSIVE
RESEARCH ON UNDERREPRESENTED
POPULATIONS.
THANK YOU SO MUCH FOR THE WORK
THAT YOU'RE DOING.
IT'S TRULY INSPIRING.
AND THANK YOU TO THE AUDIENCE
FOR TUNING IN AND SENDING IN
QUESTIONS.
PLEASE STAY AROUND FOR OUR NEXT
PANEL DISCUSSION.
WE'LL NOW HAVE A 5-MINUTE
BREAK.
GOOD AFTERNOON.
WE JUST HAD A GREAT SESSION ON
BEST PRACTICES FOR CONDUCTING
CLINICAL RESEARCH WITH SPECIAL
POPULATIONS, AND NOW I WELCOME
YOU TO SESSION 4, SPECIAL
CONSENT CONSIDERATIONS.
WE WILL HAVE 30 MINUTES ON THIS
TOPIC.
MY NAME IS SONIA ARTEAGA,
PROGRAM OFFICER FOR THE ECHO
PROGRAM IN THE OFFICE OF THE
DIRECTOR AT NIH.
MY CO-MODERATOR IS DR. KATRINA
SERRANO, PROGRAM DIRECTOR AT THE
NATIONAL INSTITUTE OF DIABETES
AND DIGESTIVE AND KIDNEY
DISEASES.
EACH PANELIST WILL HAVE A MINUTE
OR SO TO GIVE A BRIEF
INTRODUCTORY REMARK REGARDING
THEIR TOPIC.
AFTER EACH PANELIST SPEAKS, I
WILL BEGIN WITH QUESTIONS AND
THEN ASK THE ATTENDEES TO ALSO
SUBMIT THEIR QUESTIONS.
OUR PANELISTS TODAY INCLUDE, AND
I WILL BEGIN WITH DR. HENGAMEH
RAISSY.
SHE IS THE INTERIM VICE
PRESIDENT FOR RESEARCH AT THE
UNIVERSITY OF NEW MEXICO, HEALTH
SCIENCES CENTER.
RESEARCH PROFESSOR IN THE
DEPARTMENT OF PEDIATRIC IN THE
SCHOOL OF MEDICINE.
DR. RAISSY.
>> HELLO.
IT'S GREAT TO BE HERE, AND THANK
YOU FOR THE INVITE.
SO TODAY I AM GOING TO SHARE MY
EXPERIENCE AND THOUGHTS ABOUT
CONSENTING ADOLESCENT AND
PEDIATRIC PATIENTS.
WE WOULD ALSO LIKE TO TALK TO
YOU ABOUT A SPECIAL POPULATION,
SPECIFICALLY WE CAN TALK ABOUT
PATIENTS THAT DO NOT SPEAK
ENGLISH, WHAT WOULD BE AN
APPROPRIATE WAY TO CONSENT THEM
OR MAYBE -- WELL, APPROPRIATE
WAYS TO HAVE THE CONSENT --
LANGUAGE BUT WHO SHOULD BE THE
SUPPORT SYSTEM, IS THIS ENOUGH
TO HAVE JUST A COORDINATOR THAT
SPEAKS THE LANGUAGE OR SHOULD WE
HAVE INVESTIGATORS THAT HAVE --
THAT THEY ALSO SPEAK THE
LANGUAGE IN ORDER TO BUILD TRUST
AND COMFORT WITH THE PATIENTS.
IN ADDITION, WE ARE GOING TO
TALK ABOUT DIFFERENT METHODS OF
PATIENT RECRUITMENT AND HOW
THERE ISN'T ONE MODEL THAT WOULD
WORK FOR ONE PLACE, ONE STATE
VERSUS ANOTHER.
>> GREAT.
THANK YOU SO MUCH.
SO NEXT WE HAVE DR. CAREY
NIEMAN, ASSOCIATE PROFESSOR IN
THE DEPARTMENT OF OTOLARYNGOLOGY
HEAD AND NECK SURGERY AT JOHNS
HOPKINS AND IS CORE FACULTY AT
THE JOHNS HOPKINS COCHLEAR
CENTER FOR HEARING IN PUBLIC
HEALTH.
DR. NIEMAN.
>> WONDERFUL.
THANK YOU VERY MUCH.
I'M EXCITED TO BE HERE TO SHARE
THE PERSPECTIVE OF WORKING WITH
OLDER ADULTS.
SO AS I REFLECTED ON, WAY LOT OF
OUR WORK IS FOCUSED ON WORKING
WITH OLDER ADULTS WITH HEARING
LOSS AND SOME OF THOSE
INDIVIDUALS ALSO HAVE COGNITIVE
IMPAIRMENT, TWO THINGS REALLY
STOOD OUT FOR ME THAT I THINK
ALSO CARRY FORWARD FROM THE
DISCUSSION BEFORE US AND REALLY
KIND OF THROUGHOUT THIS TIME, IS
THINKING ABOUT THE MORE THAT WE
UNDERSTAND THE GROUP THAT WE ARE
WORKING WITH IN TERMS OF THE
POTENTIAL PARTICIPANTS, THE
COHORT, THE COMMUNITY, THE
POPULATION, THE MORE THAT WE
UNDERSTAND KIND OF THEIR NEEDS
AND THEIR PRIORITIES, ESPECIALLY
WHEN IT COMES TO WHAT CONSENT
MAY MEAN FOR THEM IN THE CONTEXT
OF RESEARCH, I THINK THE BETTER,
AND I WOULD ALSO SAY, YOU KNOW,
WHENEVER IN DOUBT ABOUT ANY OF
THAT, TO REMEMBER TO ASK.
YOU KNOW, YOU COU DO NOT HAVE TO
NAVIGATE THIS ALONE IN TERMS OF
PARTNERING WITH THE GROUPS THAT
YOU ARE LOOKING TO RECRUIT AND
INVOLVE IN YOUR RESEARCH.
AND I WOULD SAY THEN THE SECOND
THING I THINK THAT IS ALWAYS
IMPORTANT TO CONSIDER AND KEEP
IN MIND IS IF WE ARE WORKING TO
MAKE THE CONSENT PROCESS MORE
ACCESSIBLE FOR ONE PARTICULAR
GROUP, WHETHER WE'RE TALKING
ABOUT INDIVIDUALS WITH COGNITIVE
IMPAIRMENT, AND INCLUDING THEIR
CARE PARTNERS OR WHETHER WE'RE
TALKING ABOUT INDIVIDUALS WITH
HEARING LOSS, OFTENTIMES, THE
CHANGES THAT WE'RE MAKING IN
THAT PROCESS ARE GOING TO
BENEFIT EVERYBODY IN TERMS OF
THE CONSENT PROCESS.
SO I THINK THOSE THINGS ARE
HOPEFULLY THINGS WE CAN ALSO
TALK A LITTLE BIT MORE, BUT I
THINK ARE A GOOD STARTING POINT
WHEN THINKING ABOUT OLDER
ADULTS.
SO THANK YOU.
>> GREAT.
THANK YOU SO MUCH.
NEXT WE HAVE DR. EMILY WANG,
SHE'S A PROFESSOR IN THE YALE
SCHOOL OF MEDICINE, DIRECTOR OF
THE CENTER FOR HEALTH AND
JUSTICE, DIRECTOR OF THE HEALTH
JUSTICE LAB AND CO-FOUNDER OF
THE TRANSITIONS CLINIC NETWORK.
DR. WANG.
>> HI.
IT'S REALLY EXCITING TO BE HERE
AND I'VE ENJOYED THE AGENDA AS
OF YET, AND SO I'M HERE, THE
FOCUS OF OUR WORK IS REALLY
IMPROVING THE HEALTH OF THOSE
DISPROPORTIONATELY IMPACTED BY
MASS INCARCERATION.
SO CURRENTLY THERE ARE ALMOST
2 MILLION PEOPLE THAT ARE BEHIND
BARS, 5 MILLION OR SO THAT ARE
UNDER A SYSTEM OF COMMUNITY
CORRECTIONS, AND GIVEN THE
HISTORY OF TRIALS IN THIS
COUNTRY, IN THE 1970s AS MANY
OF YOU ALL KNOW, THERE WERE
FEDERAL REGULATIONS PUT INTO
PLACE TO RESTRICT THE UNETHICAL
PRACTICES OF RESEARCH THAT WAS
TAKING PLACE.
THIS IS IN THE 1970s.
SINCE THEN, WE'VE SEEN FIVE
DECADES OF MASS INCARCERATION
THAT GET US TO THIS POINT.
WHEREBY WE INCARCERATE MORE
PEOPLE THAN ALMOST ANY COUNTRY
THE IN THE WORLD.
THESE ARE INDIVIDUALS
DISPROPORTIONATELY OF
MINORITIZED POPULATIONS,
DISPROPORTIONATELY POOR, AND
SHARE A LARGE BURDEN OF CHRONIC
HEALTH CONDITIONS THAT ARE
INCREASINGLY WORSENING AND I
THINK DRIVING A LOT OF THE
DISPARITIES WE SEE IN THIS
COUNTRY.
AND THE REAL CRUX HERE IS THAT
BECAUSE OF THE FEDERAL
RESTRICTIONS THAT HAVE BEEN PUT
INTO PLACE, WE KNOW SO LITTLE
ABOUT HOW MASS INCARCERATION HAS
AFFECTED HEALTH AND HOW BEST TO
MITIGATE THE HEALTH HARMS OF
MASS INCARCERATION.
SO THIS CONVERSATION ABOUT
CONSENT, I JUST WANT TO PUT IN
THAT FRAMEWORK OF REALLY
UNDERSTANDING OUR HISTORY, OUR
CURRENT POLICIES, AND HOW THAT
MAY REALLY PLAY INTO KIND OF
THESE ISSUES OF CONSENT AS WE
MOVE FORWARD.
>> GREAT.
SORRY ABOUT THAT.
I HAD A BIT OF TECHNICAL
DIFFICULTIES.
NEXT WE HAVE DR. TUNG NGUYEN.
HE'S A PROFESSOR OF MEDICINE AT
THE UNIVERS UNIVERSITY OF CALIFA
SAN FRANCISCO.
WHERE HE PROVIDES PRIMARY CARE
TO A DIVERSE PATIENT POPULATION.
HIS RESEARCH FOCUSES ON
ACHIEVING HEALTH EQUITY, USING
COMMUNITY-BASED PARTICIPATORY
RESEARCH, PATIE PATIENT-CENTERED
OUTCOMES RESEARCH AND OTHER
STAKEHOLDER ENGAGED METHODS.
DR. NGUYEN.
>> THANK YOU.
THANK YOU FOR INVITING ME TO
TALK ON THIS IMPORTANT TOPIC.
I WANTED TO SAY THAT I'VE BEEN
WORKING WITH PEOPLE WHO SPEAK
OTHER LANGUAGES EVER SINCE THE
FIRST WAVE OF RESEARCH ON
RECRUITMENT FOR MINORITIES
AROUND THE TURN OF THE CENTURY.
AND AS A CTSA CONSULTANT, I
STILL SEE PEOPLE MAKE THE SAME
MISTAKES WITH MINORITY
RECRUITMENT THAT HE THIS MADE 20
YEARS AGO, AND THE FACT THAT WE
ARE STILL STRUGGLING WITH THIS
MEANS THAT THERE ARE FUNDAMENTAL
PROBLEMS THAT HAVE TO CHANGE.
WE HAVE TO LOOK AT THE THREE
Ps, PARADIGM, POLICY AND
PRACTICE, AND FOR NOW, I'LL JUST
FOCUS ON PARADIGM.
IN THE PRIOR SESSION, I THINK
THE PARADIGM OF INVOLVING THE
COMMUNITY, I THINK IS REALLY
IMPORTANT.
I WON'T TALK TOO MUCH ABOUT
THAT.
BUT THE THREE THAT I WANTED TO
TALK ABOUT IN TERMS OF WORKING
WITH PEOPLE, QUOTE-UNQUOTE,
NON-ENGLISH SPEAKERS, THE FIRST
IS THAT WE HAVE TO CHANGE THE
PARADIGM OF BEING
ENGLISH-CENTRIC.
WE START WITH NOT USING THE TERM
NON-ENGLISH SPEAKERS, OR EVEN
THE TERM LIMITED ENGLISH
PROFICIENT.
NO ONE SHOULD BE DEFINED BY WHAT
THEY ARE NOT.
OR HOW THEY COME UP SHORT ON
SOMEBODY'S SCALE.
WE TALK ABOUT RECRUITMENT OF
WOMEN, NOT NON-MEN OR LIMITED
MALE PROFICIENCY.
THE SECOND IS THE ISSUE AROUND
SCIENTIFIC VALIDITY AND
EXCLUSION CRITERIA.
IF LANGUAGE IS NOT RELEVANT TO
THE TOPIC BEING STUDIED, PEOPLE
SHOULDN'T BE EXCLUDED BECAUSE
THEY SPEAK ANOTHER LANGUAGE.
YET SCIENCE AS A FIELD THINK
THAT THIS IS SCIENTIFICALLY
VALID.
RECENT REVIEWS, EMERGENCY
MEDICINE AND PEDIATRIC RESEARCH
SHOW THAT MANY STUDIES DON'T
REPORT THE LANGUAGES USED, WHICH
IN AN ENGLISH-CENTRIC WORLD
PROBABLY MEANS ONLY ENGLISH AND
MANY OTHERS SPECIFICALLY EXCLUDE
PEOPLE THAT SPEAK OTHER
LANGUAGES.
IN MY VIEW, IF THAT'S GOING TO
HAPPEN THEN THE TITLE OF THE
STUDY SHOULD RECOGNIZE THAT.
A RANDOMIZE THE TRIAL OF DRUG X
ON PEOPLE WHO SPEAK ENGLISH.
THE THIRD IS ETHICS.
WE TEND TO THINK OF PEOPLE WHO
SPEAK OTHER LANGUAGES AS A
CATEGORY TO BE PROTECTED.
THIS MAKES SENSE IN AN ENGLISH
CENTRIC WORLD.
TESTIMONY MY RESEARCH TEAM ONLY
SPEAKS CHINESE AND HAVE THEIR
DOCUMENTS IN CHINESE THEN THE
ENGLISH SPEAKERS ARE THE
PROTECTED CATEGORY.
AND YOU WOULD SAY TUNG, WHY
WOULD YOU DO THAT?
I WOULD THEN SAY, BUT WE ALL ARE
DOING THAT.
AND I'LL TAKE IT A STEP FURTHER
THAT RESEARCH ETHICS IS NOT ONLY
ABOUT PROTECTION OR RESEARCH
BURDEN, IT'S ALSO ABOUT BENEFIT.
SO MY CONTENTION IS THAT
EXCLUDING PEOPLE OR INADEQUATELY
RECRUITING THEM IS UNETHICAL,
AND THAT RESEARCH BUDGETS THAT
DON'T ACCOUNT FOR THIS IS
VIOLATING THE PRINCIPLE OF
DISTRIBUTIVE AND ALLOCATIVE
JUSTICE.
AND YOU MAY THINK I'M BEING
RATHER EXTREME ABOUT THIS, BUT
AS UCSF OUR IRB IS STARTING TO
SEND BACK STUDIES THAT HAVE
INADEQUATE JUSTIFICATION FOR
LANGUAGE EXCLUSION.
>> THANK YOU FOR YOUR REMARKS.
I'M GOING TO START OFF BY ASKING
A QUESTION FOR ALL OF YOU.
FOR EACH OF THE POPULATIONS
YOU'RE REPRESENTING, WHAT ARE
THE UNIQUE CONSENT CHALLENGES
AND HOW CAN THOSE CHALLENGES BE
ADDRESSED?
I KNOW SOME OF YOU TOUCHED ON
THAT A LITTLE BIT, BUT CAN YOU
ALSO TALK ABOUT HOW CAN WE
ADDRESS THOSE CHALLENGES?
DR. RAISSY, WOULD YOU LIKE TO
START US OFF?
>> SURE.
I'D BE HAPPY TO DO THAT.
SO ONE OF THE CHALLENGES THAT WE
FACE, OTHER THAN THE LANGUAGE
BARRIER THAT WAS TOUCHED BEFORE,
JUST BECAUSE WE TONIGHT HAVE DOE
ENOUGH PERSONNEL TO BE ABLE TO
FLUENTLY SPEAK THE LANGUAGE,
OTHER LANGUAGES OTHER THAN
ENGLISH IS THE PROCESS AND
ASSENT AND CONSENT WHEN IT COMES
TO CHILDREN.
I THINK WE SHOULD ALWAYS BE VERY
MINDFUL AND CONSIDER THE CHILD
THAT IS PARTICIPATING IN THE
STUDY, JUST BECAUSE A PARENT
DECIDES A CHILD HAS TO BE IN THE
STUDY, WE HAVE TO FIND A WAY TO
COMMUNICATE AND SPEND TIME WITH
THE CHILD SO THEY WOULD FEEL
COMFORTABLE TO BE PART OF THE
STUDY TOO.
SO WE TAKE OUR TIME FOR THAT
PROCESS, AND WE WILL TRY TO
HAVE, YOU KNOW, FOR THE CHILD TO
FEEL COMFORTABLE TO SHARE WITH
US IF THEY WANT TO DO THIS OR
NOT.
WE ALSO TELL THEM, AND WE MAKE
IT VERY CLEAR THAT AT ANY POINT
IN THE STUDY IF THEY DON'T WANT
TO BE POKED OR SO, THEY DON'T
HAVE TO.
SO WE TRY TO MAKE THEM FEEL
COMFORTABLE AND ALSO TO DEVELOP
THAT TRUST THAT AT ANY POINT
DURING THE STUDY IF THEY DON'T
WANT TO DO THE STUDY, PARENTS
ARE NOT GOING TO MAKE THEM TO
CONTINUE.
>> THANK YOU.
DR. NIEMAN?
>> SURE.
SO WHEN THINKING ABOUT OLDER
ADULTS, WE DO NEED TO KEEP IN
MIND AS A DEMOGRAPHIC TO OLDER
ADULTS HAVE SOME OF THE HIGHEST
LEVELS OF LIMITED HEALTH
LITERACY.
SO JUST IN GENERAL, WHEN YOU'RE
THINKING ABOUT OLDER ADULTS,
REALLY PUSHING FOR AS CLEAR AND
PLAIN LANGUAGE AS POSSIBLE,
WHICH OBVIOUSLY, AGAIN, BENEFITS
EVERYBODY AND WE SHOULD ALWAYS
BE PUSHING FOR THAT.
BUT THEN WE'RE ALSO THINKING IN
TERMS OF COGNITIVE IMPAIRMENT,
RIGHT?
AGE IS THE BIGGEST RISK FACTOR
FOR COGNITIVE IMPAIRMENT, SO
THEN, YOU KNOW, WE CAN'T JUST
BLANKET ASSUME THAT INDIVIDUALS
CAN'T PARTICIPATE IN RESEARCH.
WE SHOULD BE GIVING INDIVIDUALS
AN OPPORTUNITY.
AND HAVING A LITTLE BIT MORE
SPECIFICITY OF UNDERSTANDING
WHETHER OR NOT THEY ARE ABLE TO
CONSENT FOR THEMSELVES.
SO THERE ARE A NUMBER OF
VALIDATED TOOLS AND MEASUREMENTS
THERE THAT HAVE BEEN USED BUT WE
KNOW THAT ARE UNDERUTILIZED WHEN
IT COMES TO UNDERSTANDING
SOMEBODY'S ABILITY TO CONSENT TO
THE RESEARCH PROCESS AND
UNDERSTAND.
SO FOR EXAMPLE, THERE CAN BE
SOME REALLY QUICK AND EASY TOOLS
THAT ARE OUT THERE, SO FOR
EXAMPLE, UNIVERSITY OF
CALIFORNIA SAN DIEGO'S BRIEF
ASSESSMENT OF CAPACITY TO
CONSENT OR THE UBACC IS A TOOL
THAT'S OUT THERE THAT'S LESS
THAN FIVE MINUTES AND REALLY
TRIES TO GET AT WHETHER SOMEBODY
UNDERSTANDS AND APPRECIATES,
WHICH ARE TWO FUNDAMENTAL PIECES
OF THE CONSENT PROCESS, SO
TRYING TO PUSH OURSELVES TO USE
SOME OF THESE VALIDATED
ASSESSMENTS THAT ARE OUT THERE
THAT HAD BEEN PROVEN CAN BE ONE
TOOL BECAUSE, AGAIN, WE DO, JUST
LIKE THINKING ABOUT POPULATIONS
WITH DIFFERENT LANGUAGES, WE
WANT TO INCLUDE AS MANY OLDER
ADULTS REGARDLESS OF MAYBE
THEIR DEGREE OF COGNITIVE
IMPAIRMENT OR SOME OF THEIR
SENSORY LIMITATIONS WITHIN OUR
RESEARCH PROCESS AS WE PUSH, YOU
KNOW, OBVIOUSLY FOR EXTERNAL
VALIDITY.
SO I THINK THOSE ARE SOME THINGS
TO KEEP IN MIND.
AND THEN ALSO REALLY PUSHING IN
TERMS OF WAYS IN WHICH WE MAY
PRESENT INFORMATION AROUND
CONSENT IN TERMS OF HAVING
MULTIPLE MODALITIES, WHETHER
IT'S WRITTEN, WHETHER IT'S
AUDIO, WHETHER THERE'S VIDEOS,
WHETHER THERE'S FIGURES, IN
TERMS OF SUPPORTING THE ACTUAL
INFORMATION.
>> THANK YOU SO MUCH.
DR. WANG?
>> SURE.
AND I'LL SAY THAT CERTAINLY KIND
OF IN THINKING ABOUT
INCARCERATED POPULATIONS AND
THEN THOSE THAT HAVE JUSTICE
INVOLVEMENT, THERE ARE ALL SORTS
OF PROCESS MEASURES THAT, YOU
KNOW, AGAIN IN THE PROCEDURES OF
INFORMED CONSENT THAT DR. NIEMAN
IDENTIFIED THAT WOULD BE
IMPORTANT FOR ATTENDING TO
ESPECIALLY THINKING ABOUT KIND
OF WHO IS INCARCERATED AND HOW
THEY'RE INCARCERATED.
I THINK FOR THIS POPULATION IN
PARTICULAR, I THINK IT'S
IMPORTANT TO JUST THINK ABOUT
WHAT IT IS -- WHAT CONSENT IS,
YOU KNOW, AND HOW IT IS THAT
PEOPLE ARE ABLE TO APPROPRIATELY
MEASURE THEIR RISKS AND BENEFITS
OF PARTICIPATION AND ULTIMATELY
KIND OF MULTIPLY IN
CONVERSATIONS IT GOES TO THESE
ISSUES OF COERCION AND
ESPECIALLY STRUCTURAL COERCION.
TO ME, WHAT IS PROBLEMATIC ABOUT
CURRENT GU GUIDANCE, WHAT I THIK
REALLY NEEDS TO CHANGE IS A
NUMBER OF ISSUES.
AGAIN, GIVEN FIVE DECADES OF
MASS INCARCERATION IS THAT
CONCERNS OF COERCION ARE
ACTUALLY -- IF YOU'VE SEEN ONE
JAIL OR PRI SORNTION YOU'VE SEEN
ONE JAIL OR PRISON.
THERE'S 6,000 PLUS OF THEM OF
OUR PRISONS AND JAILS.
AND BECAUSE OF WHO WE'VE
INCARCERATED AND HOW WE'VE
INCARCERATED, THE EXPERIENCE OF
INCARCERATION IS VERY DIFFERENT
FOR A PERSON THAT'S IN AND OUT
OF JAILS VERSUS A PERSON THAT'S
BEEN -- PATIENTS OF MINE THAT
HAVE BEEN IN THERE 40, 50 YEARS.
THEIR EXPERIENCE OF THAT PLACE,
THEIR EXPERIENCE OF COERCION IS
REALLY DIFFERENT, AND OUR
POLICIES RIGHT NOW ARE ONES THAT
MAKE THAT EXPERIENCE ENTIRELY
MONOLITHIC.
THEY DO NOT INCLUDE INCARCERATED
PEOPLE, THEY'VE NEVER BEEN IN
THIS DECISION-MAKING PROCESS,
AND SO TO ME, I THINK IT'S
BROADER ISSUES OF HOW IT IS THAT
WE SEE THEIR PERSONHOOD, CAN
PEOPLE ACTUALLY GIVE CONSENT
WHEN THEY'RE INCARCERATED, AND
IF SO, CAN WE SEE NUANCE IN THE
LAYERS OF STRUCTURAL COERCION
FOR DIFFERENT PEOPLE AS THEY'RE
INCARCERATED IN DIFFERENT SORTS
OF SETTINGS.
A PRISON IN ALABAMA IS GOING TO
LOOK REALLY DIFFERENT THAN AN
ICE FACILITY UP NORTH WHICH
LOOKS REALLY DIFFERENT THAN A
JAIL, LET'S SAY, IN NEW YORK
CITY.
>> THANK YOU.
DR. NGUYEN?
>> YES, THANK YOU.
I DO AGREE WHEN WE TALKED ABOUT
OTHER LANGUAGES, WE START WITH
THE SOURCE MATERIAL, WHICH IS
THE ENGLISH, AND I LIKE TO SAY
THAT IS NOT ACTUALLY ENGLISH
THAT WE PUT IN OUR CONSENT IN
THE RESEARCH DOCUMENT, IT'S
USUALLY SCIENTIFIC ENGLISH.
AND THE WAY TO DO THAT IS, OF
COURSE, YOU NEED TO MAKE SURE
YOUR ENGLISH MATERIAL IS LOW --
AT LEAST -- THE APPROPRIATE
LITERACY LEVEL, AND IT'S EASY TO
DO THAT THESE DAYS.
YOU KNOW, MICROSOFT WORD WOULD
GIVE YOU A KINCAID LITERACY
LEVEL ON ANY DOCUMENT YOU STICK
IN IT, AND MOST OF THE TIME IT'S
22 -- GRADE 22 OR HIGHER, MOST
OF THE RESEARCH THINGS I SEE,
WHICH MEANS THAT YOU HAVE TO
HAVE A PH.D. TO UNDERSTAND IT.
SO IF YOU'RE GOING DO THAT,
YOU'RE GOING TO GET TRANSLATED
DOCUMENTS THAT SUCK BECAUSE
PEOPLE REALLY CAN'T TRANSLATE
GRADE 22 MATERIALS TO OTHER
LANGUAGES IN A WAY THAT MAKES
SENSE.
THEN OF COURSE ONCE YOU
TRANSLATE IT YOU HAVE TO MAKE
SURE IT'S THE APPROPRIATE
LITERACY LEVEL FOR THE OTHER
LANGUAGE.
AND OBVIOUS OBVIOUSLY THERE'S SE
REGULATORY THINGS, USING
CERTIFIED TRANSLATORS BUT EVEN
CERTIFIED TRANSLATORS ARE NO
GUARANTEE OF APPROPRIATE
DOCUMENTS BECAUSE FOR ONE, GIVEN
THE FACT THAT MANY LANGUAGE
GROUPS ARE VERY HETEROGENEOUS A
PERSON MAY BE REALLY GOOD AT THE
LANGUAGE AND GET CERTIFIED MAY
ACTUALLY NOT USE THE RIGHT
DIALECT OR USE THE RIGHT TYPES
OF WORDS, IMMIGRANTS USE
DIFFERENT WORDS, WHICH I
THINK -- SPANISH, PERSON FROM
SPAIN TO TRANSLATE SOMETHING MAY
NOT READ VERY WELL WITH A
MEXICAN PARTICIPANT AND SO ON
AND SO FORTH.
SO YOU ACTUALLY ALSO NEED --
AFTER THE TRANSLATION IS DONE,
YOU NEED REVIEWS AND TYPICALLY
COMMUNITY REVIEWS, PEOPLE FROM
THE COMMUNITY THAT YOU'RE TRYING
TO REACH TO MAKE SURE THAT THE
THING ACTUALLY MAKES SENSE IN
THE LANGUAGE THAT YOU'RE AIMING
FOR.
OTHER THINGS, I REALLY LIKE THE
IDEA OF VIDEO CONSENT NOWADAYS
BECAUSE -- FOR TWO REASONS.
ONE, IT DOESN'T PRESUME THAT THE
PERSON IS LITERAL IN THEIR OWN
LANGUAGE.
SO THERE ARE MANY PEOPLE WHO ARE
NOT LITERATE IN EITHER ENGLISH
OR THEIR NATIVE LANGUAGE.
AND SO A PIECE OF PAPER WILL
JUST, YOU KNOW, BE NO GOOD.
AND SECOND, THERE IS ALSO THE
POSSIBILITY OF HAVING A PERSON
WHO HAS SOME PROXY TRUST ASKING
FOR CONSENT OR DESCRIBING THE
INFORMATION, SO A PERSON WHO'S A
TRUSTED HEALTH PROFESSIONAL OR A
COMMUNITY LEADER OR SOMEBODY WHO
LOOKS LIKE THE PERSON THAT
YOU'RE TRYING TO REACH TELLING
THEM ABOUT THE STUDY, EVEN AT
THE CONSENT LEVEL IN A VIDEO,
THAT WOULD HELP QUITE A BIT.
THERE ARE OTHER THINGS REALLY
THAT ARE MUCH MORE SUBTLE AND
SOPHISTICATED, THINGS AROUND THE
KIND OF WORD CHOICES THAT YOU
USE THAT CAN REALLY HURT
RECRUITMENT, THINGS AROUND
RANDOMIZATION, FOR EXAMPLE, THAT
ARE VERY TRICKY TO EXPLAIN
CONCEPTUALLY, AND ALSO THINGS
ABOUT BEING IN CONTROL GROUPS.
AND AGAIN, GOING BACK TO
COMMUNITY-BASED PARTICIPATORY
RESEARCH, COMMUNITY ENGAGED
RESEARCH, HAVING PEOPLE WHO KNOW
HOW TO WORK IN THOSE AREAS CAN
HELP YOUR DOCUMENTS AND YOUR
CONSENT PROCESSES.
>> THANK YOU SO MUCH.
SO DR. NGUYEN, YOU TOUCHED A
LITTLE BIT ON VIDEO CONSENT AND
I WANT TO ASK ALL OF THE
PANELISTS ABOUT REMOTE
CONSENTING.
SO WE KNOW IT BECAME MUCH MORE
COMMON DUE TO COVID-19.
WHAT ARE SOME OF THE CHALLENGES,
TECHNOLOGICAL AND OTHERWISE
OTHER CHALLENGES, RELATED TO
REMOTE CONSENTING?
>> I CAN START.
I MEAN, IT'S HARD BECAUSE,
AGAIN, WHEN YOU WORK WITH
CERTAIN POPULATIONS, TRUST IS
PARAMOUNT.
YOU CAN'T EVEN GET TO THE POINT
OF TALKING ABOUT RESEARCH UNLESS
THEY HAVE SOME TRUST OF YOU.
AND REMOTELY, IT'S JUST HARDER
TO ESTABLISH TRUST.
EVEN THOUGH ON ZOOM, IT'S HARD
TO GET TRUST BUILT, RIGHT?
SO I THINK IT'S NECESSARY. IT
COULD BE GOOD IN A SENSE THAT
YOU COULD EXPAND THE REACH OF
WHO YOU CAN TALK TO IN CONSENT.
IT CAN ALSO ALLOW YOU, FOR
EXAMPLE, IF YOU HAVE A
TRANSLATOR, IT'S EASIER FOR THE
TRANSLATOR OR INTERPRETER TO DO
IT REMOTELY, RIGHT?
BECAUSE YOU DON'T HAVE TO GO
FROM ONE CLINIC TO ANOTHER, WE
DO THIS IN CLINICAL CARE TOO,
IT'S THE SAME PROBLEM.
WHEN YOU GO FROM ONE CLINIC TO
ANOTHER, IT'S THE INTERPRETER'S
TIME THAT BECOMES THE PROBLEM,
NOT THE PROVIDER'S TIME.
SAME THING WITH CONSENT.
IF YOU CAN DO IT REMOTELY, THAT
CAN BE REALLY, REALLY HELPFUL.
BUT REALLY, IT REALLY RAISES UP
THE WHOLE PROBLEM OF TRUST.
AND DO YOU HAVE TRUST WITH THESE
PEOPLE AND THEN AGAIN THAT GOES
BACK TO COMMUNITY ENGAGED
PRINCIPLE, IF YOU'RE WORKING
WITH PEOPLE THROUGH WHAT I CALL
PROXY TRUST THAT THEY ARE
TRUSTING THE COMMUNITY
ORGANIZATIONS THAT YOU'RE
WORKING WITH, THEN YOU HAVE A
BETTER CHANCE.
>> GREAT, THANK YOU.
>> I'LL ADD TO THIS.
DURING COVID, WE HAVE RECEIVED
FUNDING TO LOOK AT WHAT WERE THE
BEST MITIGATION STRATEGIES
WITHIN CARCERAL SYSTEMS.
WE WERE UNABLE TO GO IN AND DO
FOCUS GROUPS SO ENDED UP HAVING
TO SWITCH TO VIDEO INTERVIEWING,
VIDEO CONSENT.
SO CERTAIN ISSUES PRESENTED
THEMSELVES INCLUDING BUT NOT
LIMITED TO, YOU KNOW, MANY
PRISONS AND JAILS DON'T PERMIT
KIND OF ANY SORT OF VIDEO
INTERACTION, SO HOW DO YOU KIND
OF SET THAT UP.
SECONDARILY, THERE WERE CONCERNS
ALSO THAT WE COULDN'T, AS
RESEARCHERS, REALLY KIND OF SEE
IF THERE WEREN'T, YOU KNOW,
TRYING TO CREATE A SPECIAL SPACE
WHERE CORRECTIONAL OFFICERS
WOULDN'T BE LET IN, SO FOR THE
JAIL AND PRISON ADMINISTRATORS,
THEY HAD TO FIND AN OFFICE WHERE
IT WAS QUIET, WHERE THE
INCARCERATED PERSON OR THE
CORRECTIONAL WORKER COULD SIT
AND TALK TO US FACE-TO-FACE AND
MAKE CERTAIN THERE WAS NO ONE
ELSE IN THE ROOM.
AND THEN THIRDLY, TO KIND OF
CONTEND WITH PRISON POLICIES OF
HOW IT IS THAT THEY WANTED TO
SEE THAT WE WEREN'T
COMMUNICATING ANYTHING UNDUE OR
BRINGING ANYTHING INTO THE SPACE
THAT WAS AGAINST PRISON
POLICIES.
SO THERE WERE UNIQUE
CONSIDERATIONS THAT WE HAD TO
MAKE OF HOW BEST TO MAKE CERTAIN
THAT CONFIDENTIALITY WAS
PRESERVED AND ALSO KEEP WITH THE
POLICIES OF THE CORRECTIONAL
SYSTEMS.
>> THANK YOU.
>> SO I CAN ALSO ADD A FEW
COMMENTS ABOUT THIS.
WE HAVE TO BE MINDFUL WITH THIS
E-CONSENTING THAT IT BECOMES
SOMETIMES VERY CONVENIENT FOR
THE PATIENTS AND THEY MAY SIGN A
CONSENT FORM WITHOUT HAVING A
GOOD UNDERSTANDING OF WHAT THEY
ARE CONSENTING TO.
SO WE HAVE TO MAKE SURE THAT THE
CONSENT PROCESS IS STILL IN
PLACE.
EITHER VIA ZOOM OR VIA PHONE
CALL DESCRIBING THE STUDY, EVEN
IF THEY JUST SIGN THE CONSENT
FORM AND SEND IT TO YOU, WE DO
NOT ACCEPT IT UNTIL WE ACTUALLY
HAVE THAT CONVERSATION TO MAKE
SURE WE GO OVER IMPORTANT
FACTORS IN THE CONSENT FORM,
ANSWER QUESTIONS IF THERE IS
ANY, SO AGAIN, HAVING THE
CONSENT PROCESS FOR THESE
E-CONSENTING IS VERY IMPORTANT.
THE LIMITATION THAT THESE
E-CONSENTING AS VAWL EU
ESPECIALLY IF IT'S H ECHO PROGR,
WE TRY TO RECRUIT FAMILY FROM
RURAL AREAS.
OF COURSE ACCESS TO TECHNOLOGY
IS ALWAYS CHALLENGING.
>> THANK YOU.
>> I CAN ADD A LITTLE BIT IN
TERMS OF JUST FOR OLDER ADULTS,
JUST LIKE WE'RE DISCUSSING, YOU
KNOW, I THINK IT IS A MIXED BAG.
I THINK ON ONE SIDE, FOR MANY
OLDER ADULTS WHO ARE FACING
TRANSPORTATION CHALLENGES,
MOBILITY LIMITATIONS, YOU KNOW,
BEING ABLE TO CONNECT AND
ELIMINATE ONE MORE VISIT OR
OUTING, I THINK CAN BE A VERY
POWERFUL TOOL IN TERMS OF
INCREASING ACCESSIBILITY.
YOU KNOW, IN TERMS OF FROM A
SENSORY PERSPECTIVE, YOU KNOW,
WHILE AUTOMATED CAPTIONING ON
ZOOM OR WHATNOT MAY NOT BE
PERFECT, BUT IT IS A SUPPORT AND
A SUPPLEMENT FOR INDIVIDUALS WHO
MAY BE STRUGGLING A LITTLE BIT
IN TERMS OF HEARING, SO TAKING
ADVANTAGE OF THAT AND HAVING
THEIR OWN ABILITY TO KIND OF
ADJUST THE AMPLIFICATION NEEDED.
I WILL ALSO SAY, THOUGH, YOU
KNOW, IN TERMS OF THINKING ABOUT
TECHNOLOGY, ACCESS THAT'S
REQUIRED FOR A LOT OF THIS, ON
ONE SIDE OLDER ADULTS FOR MANY
POPULATIONS, THERE ARE THE
DIGITAL DIVIDE IS VERY REAL IN
TERMS OF BEING ABLE TO REACH AND
HAVE THE ABILITY TO CONNECT WITH
STABLE INTERNET AND WHATNOT.
BUT ON THE OTHER SIDE ALSO KIND
OF CHECKING, KIND OF AGES
PERSPECTIVES ABOUT ASSUMPTIONS
ABOUT WHETHER OR NOT THE GROUP
THAT YOU WOULD LIKE TO BE
WORKING WITH, YOU KNOW, WHAT IS
THEIR LEVEL OF TECHNOLOGY USE
AND COMFORT AND NOT JUST
NECESSARILY ASSUMING BECAUSE
THEY'RE OLDER ADULTS THAT THEY
DON'T HAVE INTEREST OR ACCESS OR
THE SAVVINESS, YOU KNOW, TO
NAVIGATE ZOOM.
SO I THINK CIRCLING BACK TO
KNOWING WHO YOU'RE WORKING WITH,
BUT I THINK THOSE ARE SOME
CONSIDERATIONS WHEN IT COMES TO
OLDER ADULTS.
>> GREAT.
THANK YOU SO MUCH.
SO NOW I'M GOING TO ASK
DR. SERRANO TO BRING UP ANY
DISCUSSIONS FROM THE CHAT.
>> THANK YOU.
AND THERE WAS ONE ON THE TOPIC
OF CONSENT.
THERE IS A PARTICIPANT WHO SAID,
YOU KNOW, I VERY MUCH WANT TO
USE VIDEO CONSENT FOR A TRIAL I
HAVE FUNDED TO IMPROVE DISCHARGE
TEACHING.
HOW DO YOU GO ABOUT AND MAKE THE
VIDEOS?
BECAUSE THIS PERSON HAD
CONSIDERED JUST DOING A ZOOM
RECORDING, BUT WHEN SHE WAS
QUOTED FOR IT FROM A PRODUCTION
COMPANY, IT WOULD BE $15,000 FOR
FOUR LANGUAGES.
SO CAN SPEAKERS COMMENT ON THAT?
>> I THINK ZOOM HAS BEEN GREAT
FOR THIS.
I MEAN, EVERYONE IS SO USED TO
BEING ON CAMERA AND TALKING AND
RECORDING IS SO EASY THAT I
DON'T SEE WHY YOU HAVE TO PAY
ANYBODY.
IF YOU HAVE STAFF THAT ACTUALLY
SPEAKS THE LANGUAGE, JUST RECORD
THEM.
IF YOU DON'T, YOU KNOW, WORK
WITH SOME COMMUNITY PARTNERS
WHO'S WILLING TO DO THAT FOR A
LOT LESS.
THE MAIN THING WITH A THE VIDEO
THING, BESIDES THE TRANSLATION,
IS ABOUT SORT OF HOW TO MAKE IT
MORE ACCESSIBLE.
WHAT YOU DON'T WANT TO DO IS GET
ON VIDEO AND JUST READ THE WHOLE
THING.
IT'S BORING, IT'S HARD TO FOLLOW
AND SO ON AND SO FORTH.
BUT I THINK STRUCTURE, A
QUESTION AND ANSWER FORMAT.
I FORGOT TO MENTION THAT IN SOME
CULTURES, DECISION -MAKING ISN'T
INDIVIDUAL-BASED.
IT CAN BE GROUP BASED.
OFTENTIMES YOU GET A NO WHEN YOU
CONSENT BECAUSE YOU HAVE THE
WRONG PEOPLE IN THE ROOM OR YOU
DON'T HAVE ENOUGH PEOPLE IN THE
ROOM.
SO YOU CAN MODEL THAT IN YOUR
CONSENT VIDEOS BY HAVING SEVERAL
PEOPLE ASKING QUESTIONS OF
FAMILY MEMBER ALONG WITH THE
PARTICIPANT, SO THERE ARE WAYS
TO USE THIS IN A VERY
INEXPENSIVE WAY.
>> THANK YOU.
ANY OTHER THOUGHTS REGARDING
VIDEO CONSENTING?
IF NOT, WE CAN GO ON TO THE NEXT
QUESTION.
DR. SERRANO, WAS THERE ANOTHER
QUESTION IN THE CHAT?
>> YEAH, THIS ONE IS GOING BACK
TO VALIDATION TOOLS.
THIS PARTICIPANT SAYS ONE OF THE
ARGUMENTS I'VE SEEN FOR NOT
RECRUITING INDIVIDUALS WHO
READ/WRITE ENGLISH ARE
QUESTIONNAIRES AND ASSESSMENTS
TRANSLATIONS THAT ARE BEING USED
BY THE STUDY TEAM ARE NOT
AVAILABLE IN THE LANGUAGE THAT
IS COMMON IN THEIR AREA.
SO FOR EXAMPLE, ARABIC, CHINESE,
ET CETERA.
AS ALREADY MENTIONED, EVEN IF A
CERTIFIED TRANSLATOR IS USED, A
TRANSLATION OF
QUESTIONNAIRE /ASSESSMENT IS NOT
VALIDATED SCIENTIFICALLY.
AND MOST TRANSLATORS ARE NOT
SCIENTISTS OR HAVE A STRONG
SCIENTIFIC BACKGROUND.
SO HOW WOULD YOU ENCOURAGE STUDY
TEAMS TO ADAPT OR HAVE OTHER
OPTIONS FOR POTENTIAL
PARTICIPANTS WHO SPEAK ANOTHER
LANGUAGE TO PARTICIPATE IN THE
STUDY?
>> I CAN TAKE A FIRST CRACK AT
THAT.
SO THIS IS A REALLY IMPORTANT
POINT ACTUALLY, VALIDATION.
BUT I SOMETIMES THINK THAT A
LITTLE KNOWLEDGE IS A DANGEROUS
THING WITH VALIDATION TOOLS,
BECAUSE THEN YOU END UP
EXCLUDING PEOPLE, BECAUSE YOU'RE
SO WORRIED ABOUT INTERNAL
VALIDITY, YOU LOSE VALIDITY BY
EXCLUDING PEOPLE.
SO I WANT TO MAKE THAT A BIG
POINT.
LIKE ANYTHING ELSE IN RESEARCH,
YOU'RE MAKING DECISIONS.
YOU'RE MAKING RISK/BENEFIT
CHOICES, AND JUST MAKE SURE THAT
YOU UNDERSTAND WHAT RISK AND
BENEFIT CHOICES YOU'RE MAKING.
SECOND THING ABOUT TRANSLATION
COMPLETELY TRUE, EVEN A GOOD
TRANSLATOR DOING A SINGLE DIRECT
TRANSLATION MAY ACTUALLY GET TO
A DOCUMENT THAT IS NOT
CONCEPTUALLY VALID, RIGHT?
SO WE HAVE CLASSICALLY -- WE
TEACH THINGS LIKE IN THE OLD
DAYS, THEY SAY DO YOU FEEL BLUE,
BECAUSE THAT'S HOW ENGLISH
SPEAKERS COLLOQUIALLY REFER TO
BEING DEPRESSED, THEN YOU
TRANSLATE TO ANOTHER LANGUAGE,
YOU BACKTRANSLATE IT AND IT
BECOMES ARE YOU A COLOR OR
SOMETHING.
SO IT'S SORT OF VERY IMPORTANT
TO UNDERSTAND CONCEPTUAL
VALIDITY.
BUT WHAT YOU CAN'T DO IS DO THE
GOLD STANDARD, WHICH IS FORWARD
AND BACKWARD TRANSLATION,
BECAUSE IN A MULTILINGUAL WORLD,
IF YOU DO FORWARD AND BACKWARD
TRANSLATION, YOU GO CRAZY.
FIRST OF ALL, IT WOULD TAKE YOU
FOREVER.
HOW ARE YOU REQUESTING TO RECONE
FORWARD AND WHACK WARD BACKWARD
TRANSLATION, SO I WOULD
RECOMMEND FORWARD BACKWARD
TRANSLATION AND THEN COMMUNITY
REVIEW.
THAT'S HOW THE -- SURVEY DOES
IT, WHEN THEY HAVE SIX OR EIGHT
DIFFERENT LANGUAGES.
AND THEN, YOU KNOW, WHAT YOU CAN
SAY THEN IS, OH, MAYBE THE
INSTRUMENT HASN'T BEEN VALIDATED
IN HMONG OR CHINESE.
I'LL DO THE VALIDATION.
RIGHT?
BECAUSE I DON'T THINK AS A
SCIENTIST YOU SHOULD BE
RESTRICTED BY THE TOOL.
IF THE TOOL IS LIMITING YOU, YOU
SHOULD EXPAND THE TOOL.
NOT ACCEPT THAT AS A LIMITATION.
>> GREAT.
THANK YOU SO MUCH.
THIS HAS BEEN A REALLY
INFORMATIVE PANEL.
BECAUSE WE WANT TO MAKE SURE OUR
PARTICIPANTS ARE WELL INFORMED
AND AWARE OF WHAT THEY'RE
CONSENTING TO.
SO I WANT TO THANK THE PANELISTS
FOR YOUR VALUABLE INSIGHTS ON
SPECIAL CONSIDERATIONS FOR THE
CONSENT PROCESS.
AND I'D LIKE TO THANK ALSO
CO-MODERATOR DR. SERRANO, AND
THANK YOU TO AUDIENCE MEMBERS
FOR YOUR QUESTIONS AND
PARTICIPATION.
SO NOW WE WILL TAKE A BRIEF
BREAK.
THANK YOU SO MUCH, EVERYONE.
SO THERE'S ACTUALLY -- THERE
WILL NOT BE A BREAK, AND WE ARE
ABOUT TO START THE NEXT SESSION,
SO DR. MENDOZA.
THANK YOU SO MUCH.
CAN EVERYONE HEAR ME?
YES?
I'LL TAKE THAT AS A YES.
OKAY.
SO GOOD AFTERNOON, EVERYONE, AND
WELCOME TO PANEL DISCUSSION 3 ON
BEST PRACTICES FOR CONDUCTING
CLINICAL RESEARCH WITH
POPULATIONS REQUIRING SPECIAL
CONSIDERATIONS, SPECIAL
POPULATIONS.
SO OUR PANEL WILL GO TO ABOUT
2:25 TODAY.
I'M DR. MARTIN MENDOZA, DIRECTOR
OF HEALTH EQUITY FOR THE
ALL-OF-US RESEARCH PROGRAM HERE
AT NIH.
I'M ALSO PLEASED TO BE JOINED BY
MY CO-MODERATOR, DR. DEBBIE
VITALIS, WHO IS A POLICY FELLOW
AT THE NATIONAL HEART, LUNG AND
BLOOD INSTITUTE HERE AT NIH.
SO WE REALLY HAVE A FANTASTIC
SESSION FOCUSED ON SPECIAL
POPULATIONS.
THERE'S BEEN A REALLY LARGE
FOCUS ON FO THOSE WHO
SELF-IDENTIFY -- WHILE THIS IS
REALLY SUPER IMPORTANT FOR
OBVIOUS REASONS THERE ARE MANY
OTHER EQUALLY IMPORTANT
POPULATIONS THAT ALSO NEED TO BE
INCLUDED AND CONSIDERED IN ORDER
TO HAVE A TRULY DIVERSE
POPULATION WITHIN THE STUDY AND
ENSURE THAT ANY MEDICAL PRODUCTS
OR BREAKTHROUGHS THAT COME
FROM THAT RESEARCH WILL WORK AND
BE RELEVANT FOR EVERYONE.
SO WHAT WE'RE GOING TO DO NOW IS
I'M GOING TO BRIEFLY INTRODUCE
EACH PANELIST, AND FOR OUR
PANELISTS, AFTER I SAY YOUR NAME
AND AFFILIATION, PLEASE TAKE A
MINUTE TO SELF-INTRODUCE
YOURSELF.
AND THEN WE'LL GO FROM THERE.
SO FIRST PANELIST THAT I WANT TO
INTRODUCE IS DR. BILLY CACERES.
AND DR. CACERES IS FROM THE
COLUMBIA UNIVERSITY SCHOOL OF
NURSING.
CAN YOU PLEASE TAKE A MINUTE TO
TELL US A LITTLE BIT MORE ABOUT
YOURSELF, DR. CACERES?
>> SURE.
SO I'M ASSISTANT PROFESSOR AT
COLUMBIA UNIVERSITY SCHOOL OF
NURSING.
I'M A CLINICAL NURSE BY TRAINING
AND MY RESEARCH FOCUSES ON
CARDIOVASCULAR HEALTH.
AMONG SEXUAL AND GENDER MINORITY
POPULATIONS WITH FOCUS ON
INTERSECTIONAL APPROACHES TO
STUDY CARDIOVASCULAR HEALTH.
>> THANK YOU SO MUCH.
OUR NEXT PANELIST IS DR. SINDHU
SRINIVAS.
AND DR. SRINIVAS IS FROM THE
UNIVERSITY OF PENNSYLVANIA.
DR. SRINIVAS.
>> GOOD AFTERNOON.
THANK YOU SO MUCH.
MY NAME IS SINDHU SRINIVAS.
AND I'M A PROFESSOR OF
MATERNAL-FETAL MEDICINE AND VICE
CHAIR FOR QUALITY AND SAFETY IN
THE DEPARTMENT OF OB-GYN AT THE
UNIVERSITY OF PENNSYLVANIA.
AND I'M ALSO ON THE EXECUTIVE
COMMITTEE FOR THE SOCIETY FOR
MATERNAL FETAL MEDICINE.
I'M A PRACTICING MATERNAL-FETAL
MEDICINE SPECIALIST AND A HEALTH
SERVICES AND HEALTHCARE DELIVERY
AND EQUITY RESEARCHER, AND I'M
HERE, I'M REALLY EXCITED TO BE
ON THIS PANEL AND THANKS FOR
INCLUDING ME TO TALK ABOUT THE
INCLUSION OF PREGNANT AND
LACTATING PEOPLE IN CLINICAL
TRIALS, WHICH IS, I THINK, A
CRITICAL PUBLIC HEALTH
IMPORTANCE.
SO THANKS AGAIN FOR INCLUDING
ME.
>> THANK YOU SO MUCH.
NEXT, OUR NEXT PANELIST IS
DR. ANGEL MILES.
AND SHE IS FROM THE NATIONAL
INSTITUTE ON DISABILITY,
INDEPENDENT LIVING AND
REHABILITATION RESEARCH
ADMINISTRATION FOR COMMUNITY
LIVING.
DR. MILES.
>> GOOD AFTERNOON, EVERYONE.
AND THANK YOU FOR HAVING ME.
I'M A PROGRAM SPECIALIST AT
THE -- AT NIDILRR, AND I'M
REALLY HAPPY TO BE HERE.
NIDILRR'S MISSION IS TO GENERATE
NEW KNOWLEDGE AND TO IMPROVE ITS
EFFECTIVE USE TO IMPROVE THE
ABILITIES OF INDIVIDUALS WITH
DISABILITIES TO PERFORM
ACTIVITIES OF THEIR CHOICE IN
THE COMMUNITY, AND WE ARE THE
FEDERAL GOVERNMENT'S PRIMARY
DISABILITY RESEARCH
ORGANIZATION.
I SPECIALIZE IN INTERSECTIONAL
APPROACHES TO DISABILITY
RESEARCH, AND I HAVE A PH.D. IN
WOMEN'S STUDIES AND THANKS FOR
HAVING ME.
>> THANK YOU, DR. MILES.
OUR NEXT PANELIST IS DR. GLORIA
CORONADO, FROM THE KAISER
PERMANENTE CENTER FOR HEALTH
RESEARCH.
DR. CORONADO.
>> HI, EVERYONE.
MY NAME IS DR. GLORIA CORONADO,
EP DEEP YOM GIST AT KAISER
CENTER FOR HEALTH RESEARCH IN
PORTLAND, OREGON.
I TODAY AM KIND OF REPRESENTING
KIND OF RURAL POPULATIONS, AS
WELL AS KIND OF DIVERSE RURAL
POPULATIONS SO THE INTERSECTION
BETWEEN THE TWO.
THANK YOU.
>> THANK YOU, DR. CORONADO.
AND OUR NEXT PANELIST IS
DR. KALI ZHOU, WHO IS FROM THE
KECK SCHOOL OF MEDICINE AT THE
UNIVERSITY OF SOUTHERN
CALIFORNIA.
>> HI, EVERYONE.
IT'S REALLY A PLEASURE TO BE
HERE.
MY NAME IS KALI ZHOU.
I AM A TRANSPLANT HEPATOLOGIST
BY TRAINING, AND I AM ON THE
P.I. -- WE FOCUS ON FIGURING OUT
WHY THERE'S A SIGNIFICANT
GEOGRAPHIC AGGREGATION OF LATE
STAGE LIVER CANCER IN THE LOWEST
INCOME NEIGHBORHOODS HERE IN
LOS ANGELES.
TO DEVELOP METHODS TO
EFFECTIVELY AND EFFICIENTLY
COMBAT THE SOCIOECONOMIC
DISPARITIES, I'LL BE FOCUSING ON
THE SOCIOECONOMICALLY
DISADVANTAGED POPULATION.
THIS HAS BEEN INCREDIBLY EYE
OPENING AND I DEFINITELY PLAN ON
TAKING WHAT I'VE LEARNED FROM
ALL OF THE SPEAKERS BACK TO MY
WORK.
THANKS.
>> THANK YOU SO MUCH, DR. ZHOU.
SO BEFORE WE GET STARTED, JUST A
FEW HOUSEKEEPING ITEMS.
SO I WILL START OUT THIS PANEL
BY ASKING SOME OF MY OWN
QUESTIONS, AND THEN WE'LL OPEN
THE FLOOR TO AUDIENCE QUESTIONS.
SO IF YOU'RE A MEMBER OF THE
AUDIENCE TO ASK A QUESTION YOU
HAVE A COUPLE OF OPTIONS.
IF YOU'RE ON THE ZOOM, THEN YOU
CAN JUST USE THE -- PLEASE USE
THE RAISE YOUR HAND FEATURE.
YOU HAVE ANOTHER OPTION TO EMAIL
YOUR QUESTIONS TO INCLUSIVE
CLINRES -- WE'LL PUT THAT IN THE
CHAT FOR YOU.
BUT YOU CAN SEND THAT TO THAT
EMAIL.
OR IF YOU ARE WATCHING ON THE
VIDEOCAST, YOU CAN USE THE LIVE
FEEDBACK OPTION.
ONE REQUEST IF YOU ARE CALLED ON
TO ASK A QUESTION, PLEASE GO ON
VIDEO AND INTRODUCE YOURSELF
PRIOR TO ASKING YOUR ACTUAL
QUESTION.
OKAY.
SO WITH THOSE HOUSEKEEPING ITEMS
OUT OF THE WAY, LET'S GO AHEAD
AND GET STARTED WITH OUR FIRST
QUESTION HERE.
SO OUR FIRST QUESTION IS FOR
EVERYBODY.
SO IT IS -- FOR EACH OF THE
SPECIAL POPULATIONS THAT YOU ARE
REPRESENTING, CAN YOU TELL US A
BIT ABOUT SOME OF THE -- WHAT
ARE SOME OF THE BENEFITS, EITHER
FOR SCIENCE AND/OR SOCIETY,
INCLUDING THAT POPULATION IN
CLINICAL RESEARCH?
AND DR. ZHOU, LET'S START WITH
YOU, IF YOU DON'T MIND.
>> SURE.
SO OBVIOUSLY THE SOCIAL
ECONOMICALLY DISADVANTAGED GROUP
IS VERY UNDERREPRESENTED AND I
THINK ONE OF THE ISSUES IS THAT
IT'S VERY DIFFICULT CONCEPT TO
UNIFORMLY COLLECT ACROSS STUDIES
SO UNDERSTANDING THE EXTENT OF
HOW MUCH IS UNDERREPRESENTED IS
STILL PRETTY UNCLEAR, BUT WE DO
KNOW THAT THERE'S A SIGNIFICANT
HIGHER BURDEN OF DISEASE ACROSS
NEARLY ALL CONDITIONS AMONG THE
SOCIOECONOMICALLY DISADVANTAGED.
AND WHILE IT'S DIFFICULT TO
MEASURE, I THINK THIS IS AN
EXTREMELY IMPORTANT GROUP TO
INCLUDE BECAUSE OF THAT HIGH
BURDEN OF DISEASE AND NOT
INCLUDING THEM IN CLINICAL
RESEARCH WOULD REALLY PREVENT
THEM AS WE SAID ACROSS THESE
PANELS FROM ACCRUING THE
POTENTIAL HEALTH BENEFITS OF
THESE STUDIES.
ALSO I THINK IT'S IMPORTANT TO
HIGHLIGHT THIS GROUP BECAUSE OF
THAT INTERSECTIONALITY THAT
SOCIOECONOMICALLY
DISADVANTAGED -- WE TALK ABOUT
RACIAL AND ETHNIC DISPARITIES
BUT POVERTY IS SUCH A VITAL
COMMON FACTOR TO WHY THESE
GROUPS EXPERIENCE DISPARITIES.
AND WE KNOW IN RESEARCH AND WE
APPRECIATE THAT OFTEN RACIAL
DIFFERENCES, FOR EXAMPLE, ARE
ATTENUATED OR EVEN AMELIORATED
WHEN YOU ADJUST FOR
SOCIOECONOMIC STATUS.
SO WE SEE -- WELL, NOT
COLLECTING DATA ON
SOCIOECONOMICALLY DISADVANTAGED
WOULD BE POTENTIALLY MISSING OUT
ON UNDERSTATING THAT
RELATIONSHIP.
AND THEN ALSO POTENTIALLY SUCH
AS WHITE PERSONS LIVING IN
POVERTY.
>> REALLY GREAT POINTS.
DR. CACERES, CAN WE GET YOUR
PERSPECTIVE HERE.
>> SO I AGREE WITH WHAT DR. ZHOU
SAID.
I THINK ACROSS ANY POPULATION
THAT'S BEEN DISCUSSED TODAY, I
THINK SOCIOECONOMIC DISPARITY
CERTAINLY IS I THINK A DRIVING
FACTOR WHY WE SEE DISPARITIES IN
THE SEXUAL AND GENDER MINORITY
COMMUNITY, WE SEE THAT BISEXUAL
AND TRANSGENDER INDIVIDUALS TEND
TO HAVE WORSE HEALTH DISPARITIES
AND THAT'S IN MANY WAYS
ATTRIBUTED TO THEIR HIGH RATES
OF POVERTY.
BUT I THINK WHY IT'S IMPORTANT
TO INCLUDE SEX AND GENDER
MINORITY INDIVIDUALS IN ROW
SEARCH, I MADE THIS POINT A FEW
YEARS AGO, IF WE DESIGN AN
INTERVENTION FOR BLACK WOMEN TO
REDUCE THEIR CARDIOVASCULAR RISK
BUT WE DON'T ACTUALLY TAKE INTO
ACCOUNT THEIR SEXUAL ORIENTATION
OR THEIR GENER GENDER IDENTITY H
HAVE BEEN KNOWN TO INFLUENCE
CARDIOVASCULAR RISK IN DIFFERENT
POPULATIONS THEN ARE WE TRULY
DESIGNING BEHAVIORAL
INTERVENTIONS TAILORED TO THE
NEEDS OF THESE COMMUNITIES?
SO IF WE DON'T TAKE AN
INTERSECTIONAL APPROACH TO
THINKING ABOUT WHO WITHIN A
POPULATION IS AT GREATEST RISK
FOR SOMETHING AND HOW CAN WE
TAILOR INTERVENTIONS TO MAXIMIZE
THE BENEFITS OF INTERVENTIONS OR
ANY RESEARCH OBSERVATIONAL STUDY
FOR DIFFERENT GROUPS THEN WE'RE
SORT OF MISSING A BIG PIECE OF
THE EQUATION.
I THINK THAT BEYOND THE SPECIFIC
NEEDS OR CONCERNS OF SEXUAL AND
GENDER MINORITY COMMUNITIES,
THINK IF WE DON'T ASK, IF WE
DON'T INCLUDE THESE INDIVIDUALS
IN CLINICAL RESEARCH, THEN WE'RE
MISSING SORT OF A BIG PIECE OF
THE PUZZLE IN TRYING TO IMPROVE
POPULATION AND HEALTH OUTCOMES
IN GENERAL.
>> YES, I COMPLETELY AGREE WITH
YOUR STATEMENTS.
YOU KNOW, DR. MILES, ABOUT A
QUARTER OF THE U.S. POPULATION
IDENTIFIES WITH A DISABILITY.
I'M CURIOUS, OBVIOUSLY A VERY
IMPORTANT ASPECT.
SO AGAIN, WHAT ARE SOME BENTS
BEN FIBENEFITSTO INCLUDING THOST
SELF-IDENTIFY WITH A DISABILITY,
THAT POPULATION, IN CLINICAL
RESEARCH?
>> CAN YOU HEAR ME OKAY?
>> YES.
>> OKAY.
SORRY.
SO YES, PEOPLE WITH DISABILITIES
ARE A SIGNIFICANT PART OF THE
POPULATION, ABOUT 1 IN
4 AMERICANS HAVE A DISABILITY.
AND SO IF WE WANT TO CREATE
RELEVANT CLINICAL RESEARCH, YOU
KNOW, IT'S IMPERATIVE THAT YOU
INCLUDE THAT POPULATION.
ELSE THERE MAY BE CONTRIBUTORS
TO OUTCOMES THAT ARE BEING
UNACCOUNTED FOR, BECAUSE YOU
HAVEN'T CONSIDERED THE
IMPLICATION OF DISABILITY AND
DISABLED PEOPLE ARE ONE OF THE
LARGEST MINORITY GROUPS IN THE
COUNTRY.
HISTORICALLY, PEOPLE WITH
DISABILITIES HAVE BEEN PRIMARILY
THOUGHT OF IN SCIENCE AND
MEDICINE AS SOLELY RECEIVERS OF
CARE AND SERVICES, SOCIAL AND
ECONOMIC DEPENDENCE IN SOCIETY
THAT CAN ONLY BE OBJECTS OF
STUDY OR LIABILITIES TO THE
RESEARCH ENTERPRISE.
AND THAT PERSPECTIVE IS STARTING
TO CHANGE, THANKS TO MOVEMENTS
LIKE DISABILITY RIGHTS MOVEMENT
AND WHICH LED TO THE PASSAGE OF
LEGISLATION LIKE THE 1973
VOCATIONAL REHABILITATION ACT,
WHICH LED TO THE ESTABLISHMENT
OF THE NATIONAL INSTITUTE ON
DISABILITY AND INDEPENDENT
LIVING, REHABL RESEARCH, WHERE I
WORK RIGHT NOW, SO IT'S REALLY
IMPERATIVE THAT WE INCLUDE
PEOPLE WITH DISABILITIES.
THE BENEFITS ARE MANY, INCLUDING
THE FACT THAT MANY OF THE
RESOURCES THAT WE USE EVERY DAY
ORIGINALLY HAD PEOPLE WITH
DISABILITIES IN MIND, SUCH AS
CURB CUTS AND THINGS LIKE THAT,
SO LOTS OF RESOURCES THAT WE USE
THAT WERE THOUGHT OF AS ONLY
BENEFITING DISABLED PEOPLE
ULTIMATELY BENEFIT ALL OF US IF
WE LIVE LONG ENOUGH, WE'RE ALL
GOING TO BECOME DISABLED OR AT
LEAST KNOW SOMEBODY WHO WILL, SO
IT'S IMPORTANT TO CONSIDER THAT
ASPECT OF OUR COUNTRY, ELSE WE
CAN'T PRODUCE RESEARCH THAT'S
GENERALIZABLE.
>> THANK YOU, DR. MILES.
DR. SRINIVAS, PREGNANT AND
LACTATING PERSONS ARE OFTEN NOT
THOUGHT ABOUT, YOU KNOW,
INCLUDING THIS POPULATION, THIS
VERY IMPORTANT POPULATION IN
CLINICAL RESEARCH, AND SO I WAS
WONDERING, CAN YOU TELL US A BIT
MORE ABOUT WHY IT'S SO IMPORTANT
TO CONSIDER THIS POPULATION IN
CLINICAL STUDIES?
>> ABSOLUTELY.
THANK YOU.
SO I THINK, YOU KNOW, FIRST OF
ALL, EACH YEAR MORE THAN 3 1/2
MILLION INDIVIDUALS GIVE BIRTH,
AND WE KNOW THAT MORE THAN 80%
OF THOSE PEOPLE WILL TRY TO
BREASTFEED AND ABOUT 55% OF
THOSE INFANTS WILL BE BREASTFED
AT SIX MONTHS, AND ADDITIONALLY,
DATA SUGGESTS THAT 70 TO 90% OF
PREGNANT WOMEN TAKE AT LEAST ONE
MEDICATION DURING PREGNANCY, AND
PREGNANT AND LACTATING WOMEN, AS
YOU JUST -- PEOPLE AS YOU JUST
DESCRIBED HAVE HISTORICALLY BEEN
EXCLUDED FROM CLINICAL TRIALS,
WHICH HAS REALLY BEEN AN
INCREDIBLE DISSERVICE TO THEM
AND TO ALL OF US AS PHYSICIANS
THAT TAKE CARE OF PREGNANT
PEOPLE, IN TRYING TO PROVIDE THE
OPTIMAL CARE TO BOTH PREGNANT
AND LACTATING INDIVIDUALS.
AND BECAUSE OF THIS EXCLUSION,
YOU KNOW, THERE HASN'T --
THERE'S NOT REALLY ENOUGH KNOWN
ABOUT THE SAFETY AND EFFICACY OF
MEDICATIONS USED IN PREGNANCY OR
EVEN OPTIMAL TREATMENTS OR
OPTIMAL INTERVENTIONS DURING
PREGNANCY OR WHILE LACTATING,
AND THIS LEAVES US WITH SORT OF
LITTLE TO NO INFORMATION.
I THINK WE SAW THAT SORT OF
REALLY PLAY OUT A LOT FOR THOSE
OF US, YOU KNOW, THAT WERE
TAKING CARE OF A LOT OF PREGNANT
PEOPLE DURING THE PANDEMIC, WITH
VACCINATION, AND OTHER
MEDICATIONS, THIS CAME UP EVEN
MORE THAN IT SORT OF NORMALLY
COMES UP.
AND THE LAST THING I'LL JUST
MENTION IS I THINK THAT THE
PUBLIC HEALTH NEED FOR INCLUSION
OF PREGNANT AND LACTATING
INDIVIDUALS JUST BASED ON THE
NUMBER OF PEOPLE IN THAT
POPULATION AND THE LACK OF
INFORMATION HOPEFULLY SPEAKS FOR
ITSELF, BUT ADDITIONALLY,
PHYSICIAN SPECIALTY SOCIETIES
AND OTHER STAKEHOLDERS LIKE THE
SOCIETY FOR MATERNAL-FETAL
MEDICINE RECOGNIZED THIS PROBLEM
A WHILE BACK AND ACTUALLY HELPED
TO CREATE A COALITION TO ADVANCE
MATERNAL THERAPEUTICS SINCE
2014, AND STILL AS OF 2022, WHEN
YOU GO TO CLINICALTRIALS.GOV,
YOU KNOW, ONLY 1% OF CLINICAL
TRIALS MENTIONS THE WORD
"PREGNANCY" OR "PREGNANT" AND
ONLY A HALF A PERCENT MENTION
"BREASTFEEDING" OR "LACTATION."
SO I APPRECIATE THE SORT OF
FOCUS ON THIS POPULATION AND I
THINK FROM A PUBLIC HEALTH
PERSPECTIVE TO HAVE REALLY THE
KNOWLEDGE WE NEED TO TAKE THE
BEST CARE OF PREGNANT AND
LACTATING PEOPLE, INCLUSION IN
TRIALS AND TRYING TO PROTECT
THOSE PEOPLE THROUGH RESEARCH
RATHER THAN FROM RESEARCH IS
REALLY NEEDED.
>> THANK YOU SO MUCH,
DR. SRINIVAS.
DR. CORONADO, RURAL POPULATIONS,
THEY OFTEN FACE SO SOME REAL
BARRIERS FROM PARTICIPATING IN
CLINICAL RESEARCH.
AND SO CAN YOU TELL US, YOU
KNOW, WHY IS IT SO IMPORTANT
THAT WE INCLUDE THEM IN OUR
STUDIES?
>> YEAH, THANK YOU FOR THAT
QUESTION.
I JUST WANT TO ECHO, I THINK,
WHAT THE OTHER PANELISTS TALKED
ABOUT AND EVEN SOME OF THE
PANELISTS EARLIER IN THE DAY
TALKED ABOUT THE BENEFITS OF
INCLUSION.
SO IT MAKES OUR RESEARCH
FINDINGS MORE GENERALIZABLE, IT
CAN REALLY HELP WITH OUR ACCRUAL
TO STUDIES, AND REALLY MAKING
SURE THAT THE BENEFITS OF
SCIENTIFIC DISCOVERIES ARE
REACHING, YOU KNOW, DIVERSE
POPULATIONS, I THINK IS A REALLY
IMPORTANT POINT FROM AN ETHICAL
PERSPECTIVE.
BUT WHAT I WANT TO FOCUS ON IN
TERMS OF RURAL IS NOT JUST THAT
THE VAST MAJORITY OF CLINICAL
TRIALS PARTICIPANTS LIVE WITHIN
A FEW MILES OF AN ACADEMIC
MEDICAL CENTER AND A LOT OF
RURAL POPULATIONS ARE EXCLUDED
FROM PARTICIPATION JUST FOR THAT
VERY REASON, BUT I WANT TO TALK
ABOUT ONE OF THE KEY BENEFITS OF
INCLUDING RURAL POPULATIONS AND
OTHER DIVERSE POPULATIONS, AND
THAT INTILD IS IN BUILDING TRUSN
CLINICAL RESEARCH.
I THINK WE SAW IN OUR EXPERIENCE
WITH COVID AND ATTITUDES ABOUT
VACCINATION, FOR EXAMPLE, THAT
THERE'S A BIG AND IMPORTANT
RURAL DIVIDE IN OUR COUNTRY, AND
THE MORE THAT WE CAN DO TO MAKE
SURE WE'RE INCLUDING RURAL
POPULATIONS AND W WHERE WE'RE
BRIDGING THAT GAP, AND THE MORE
THAT WE CAN BRIDGE THAT GAP, WE
CAN BUILD TRUST IN ALLOWING
PEOPLE TO KNOW THAT THE
SCIENTIFIC DISCOVERIES THAT ARE
COMING OUT OF URBAN CENTERS,
THAT ARE COMING OUT OF OUR
FEDERAL GOVERNMENT ARE ONES THAT
APPLY TO THEIR POPULATION.
BECAUSE THEIR POPULATION
CONTRIBUTED TO THOSE FINDINGS
AND WERE PARTICIPANTS IN THE
TRIALS.
SO I THINK THAT THERE'S A HUGE
NEED TO BUILD TRUST IN THE
SCIENTIFIC ENTERPRISE IN TODAY'S
WORLD AND ONE WAY TO DO THAT IS
TO THINK ABOUT RURAL
POPULATIONS.
THE OTHER POINT I WANT TO MAKE,
AND I KNOW THAT WE'RE PROBABLY
LATER GOING TO GET INTO
INTERSECTIONALITY, BUT FROM THE
SPER SPECULFROM THEPERSPECTIVE D
DIVERSE, ONE OF THE KEY POINTS I
OFTEN MAKE IS THE AVERAGE
EDUCATION LET FOR A LATINO
LIVING IN A RURAL POPULATION IS
ABOUT FOURTH GRADE.
THE AVERAGE EDUCATION LEVEL OF A
LATINO LIVING IN AN URBAN
POPULATION IS EIGHTH GRADE.
SO WHEN YOU CREATE MATERIALS TO
ENROLL STUDY PARTICIPANTS,
THERE'S A BIG DIFFERENCE IN WHAT
YOU CAN SAY AND HOW YOU RECRUIT
PARTICIPANTS WHO HAVE A FOURTH
GRADE READING LEVEL VERSUS AN
EIGHTH GRADE READING LEVEL, AND
I THINK IT'S REALLY IMPORTANT
THAT WHEN WE DO RESEARCH THAT
INCLUDES RURAL POPULATIONS, THAT
WE ALSO THINK OF THOSE
SUBGROUPS, THE LATINOS LIVING IN
THOSE POPULATIONS, THE
FARMWORKERS IN THOSE
POPULATIONS, THOSE WITH
DISABILITIES OR DIVERSE GENDER
AND SEXUAL ORIENTATIONS AND ALL
THAT, BECAUSE IT ALL EXISTS IN
RURAL COMMUNITIES, AND I THINK
THAT'S AN IMPORTANT POINT I WANT
TO MAKE AS WELL.
>> YES, REALLY GOOD POINTS,
DR. CORONADO.
SO EACH OF YOU HAVE REALLY
TALKED ABOUT, YOU KNOW, WHY THE
SPECIAL POPULATION YOU'RE
REPRESENTING HERE TODAY, WHY
IT'S IMPORTANT AND TO INCLUDE
THESE POPULATIONS AND THE
BENEFITS OF DOING THAT, BUT I
ALSO WANT TO MOVE A LITTLE BIT
INTO THE SOLUTIONING SPACE HERE.
SO AGAIN THIS IS A QUESTION FOR
EACH OF YOU, AND I WONDER IF
EACH OF YOU COULD TAKE, YOU
KNOW, ONE TO THREE MINUTES AND
TALK TO US, TELL US SOME
STRATEGIES, SOME BEST PRACTICES
THAT CAN BE USED TO HELP
SPONSORS INCLUDE THE POPULATION
YOU'RE REPRESENTING TODAY IN
CLINICAL RESEARCH.
WHAT SHOULD THEY BE DOING, WHAT
ARE SOME STRATEGIES?
SO DR. K CACERES, LET'S START WH
YOU.
>> WELL, FOR MANY SEXUAL AND
GENDER MINORITY INDIVIDUALS,
THEY MIGHT BE INVISIBLE.
IT'S NOT -- IT'S -- LIKE IT'S
DIFFERENT FROM RACE OR OTHER
ATTRIBUTES THAT YOU COULD
POTENTIALLY -- YOU CAN'T REALLY
HIDE YOUR RACE.
OR HOW PEOPLE INTERPRET YOUR
RACE.
BUT FOR SOME INDIVIDUALS WITH
SEXUAL MINORITIES, THEY MAY BE
ABLE TO HIDE THEIR MINORITY.
SO SOMETHING THAT RESEARCH
CLINICIANS CAN DO TO ENHANCE
PARTICIPATION IN RESEARCH
STUDIES IS TO INCREASE
VISIBILITY OF EITHER YOUR ROLE
AS AN ALLY OR THE FOCUS OF YOUR
STUDY BEING ON THESE DIFFERENCES
ACROSS THESE DIFFERENT
IDENTITIES, SO IT'S CLEAR TO
PEOPLE BEFORE THEY ENROLL IN A
STUDY THAT THEY'RE GOING TO BE
WELL TAKEN CARE OF AND THAT
THEIR SEXUAL IDENTITY OR GENDER
IDENTITY ISN'T GOING TO BE USED
AS A WEAPON.
I THINK RIGHT NOW FOR MANY
SEXUAL AND GENDER MINORITY
INDIVIDUALS IN THIS COUNTRY,
THIS YEAR I THINK WE HAVE CLOSE
TO 500 ANTILGBTQ POLICIES BEING
PASSED IN ALL DIFFERENT LEVELS
OF GOVERNMENT, AND THERE'S A LOT
OF FEAR FOR TRANSGENDER PEOPLE
IN PARTICULAR SEEKING HEALTHCARE
OR IF THEY PARTICIPATE IN A
STUDY AND IDENTIFY AS A
TRANSGENDER PERSON, LIKE HOW
MIGHT THAT IMPACT THEIR CARE
THAT THEY'LL RECEIVE, THEIR
INSURANCE, OTHER ASPECTS OF
THEIR LIFE, SO I THINK AS MUCH
AS WE CAN DO TO BE OPEN ABOUT
THE NEED AND THE IMPORTANCE OF
RECRUITING THESE GROUPS INTO
CLINICAL RESEARCH AND BEING
UNDERSTANDING OF SOME OF THE
BARRIERS AND ACKNOWLEDGING THEM
EARLY ON IN THE CONSENT PROCESS
OR RECRUITMENT PROCESS, I THINK
CAN GO A LONG WAY TO SORT OF
ENHANCE TRUST IN THE RESEARCH
TEAM.
>> THANK YOU FOR THAT.
DR. SRINIVAS, SIMILAR QUESTION,
YOU KNOW, TO YOU, WHAT ARE SOME
BEST PRACTICES FOR -- AND SOME
STRATEGIES TO INCLUDE PREGNANT
AND LACTATING PERSONS IN
CLINICAL RESEARCH, AND I DON'T
KNOW IF YOU SAW THE QUESTION IN
THE CHAT, BUT MAYBE YOU CAN
SIMULTANEOUSLY ADDRESS, YOU
KNOW, WHAT IS THE RECOMMENDATION
FOR IMPROVING RECRUITMENT OF
THIS POPULATION IN CLINICAL
TRIALS?
>> SURE.
THANK YOU FOR THE QUESTION.
I THINK FIRST, YOU KNOW, JUST
BROADLY, THERE'S A FEAR OF, I
THINK, INCLUSION OF PREGNANT AND
LACTATING PEOPLE.
THEY'VE BEEN CONSIDERED SORT OF
A VULNERABLE POPULATION AND BY
DOING THAT, SORT OF THIS -- IT'S
SORT OF ALMOST AN AUTOMATIC
EXCLUSION.
AND I THINK THE FIRST THING IS
TO SORT OF REMOVE PREGNANT WOMEN
AS AN EXAMPLE OF A VULNERABLE
POPULATION IN THE COMMON RULE
AND REALLY THINK ABOUT SHIFTING
OUR FOCUS TO REALLY INCLUDING
AND INTEGRATING PREGNANT PEOPLE
AND LACTATING PEOPLE IN THE
CLINICAL RESEARCH AGENDA.
I THINK THERE ARE SOME
REGULATORY BARRIERS TO RESEARCH
IN PREGNANT PEOPLE, AND SO
RECOGNIZING THE SORT OF AUTONOMY
OF PREGNANT PEOPLE AND THE
EVOLUTION OF A FAMILY STRUCTURE
AND REALLY JUST, I THINK,
INCORPORATING THEM, AND ACTUALLY
I THINK ONE OF THE OTHER
PANELISTS MENTIONED JUST SORT OF
THE TRUST IN CLINICAL RESEARCH
AND WHAT WE CAN DO TO SORT OF
IMPROVE THAT MORE BROADLY, AND I
THINK THE INCLUSION OF DIFFERENT
POPULATIONS AND CREATING A
CULTURE OF TRUST IN RESEARCH
AROUND -- AND THEN THAT IS SORT
OF, I THINK, A CRITICAL PIECE
FOR ALL OF OUR POPULATIONS TO
REALLY MOVE A RESEARCH AGENDA
FORWARD THAT'S MORE
INCLUSIVEMENT I THINK ONE OF THE
THINGS IS THAT PEOPLE TALK A LOT
ABOUT IS JUST THE VULNERABILITY
OF THE POPULATION BECAUSE OF NOT
BEING ABLE TO PROVIDE INFORMED
CONSENT, AND WE SORT OF HEARD
THAT PANEL AT THE LAST PANEL
AROUND INFORMED CONSENT, SO SOME
CONSIDERATIONS WHEN YOU'RE
TRYING TO RECRUIT PREGNANT AND
LACTATING PEOPLE, PREGNANT
PEOPLE IN PARTICULAR SORT OF
WHERE THE LOCATION OF THE STUDY,
WHEN YOU'RE TRYING TO RECRUIT,
WHAT ARE SORT OF SOME OPPORTUNE
TIMES AND INOPPORTUNE TIMES, SO
FOR EXAMPLE, AS A LABOR AND
DELIVERY RESEARCHER, CONSENTING
PEOPLE WHEN THEY'RE IN LABOR AND
THEY'RE IN A LOT OF PAIN IS NOT
A GOOD TIME TO SORT OF FEEL LIKE
YOU HAVE -- YOU'RE GETTING REAL
INFORMED CONSENT.
BUT TAKING THAT INTO
CONSIDERATION AND THINKING ABOUT
SOME OF OUR STUDIES WILL SAY
AFTER A PATIENT HAS ADEQUATE
PAIN CONTROL OR THEY HAVE
REGIONAL ANESTHESIA OR SOMETHING
LIKE THAT, SO WE KNOW THAT THE
INFORMED CONSENT PROCESS IS
APPROPRIATE.
SO THAT'S JUST A SPECIFIC
EXAMPLE OF SOME SPECIAL
CONSIDERATIONS IN A POPULATION
WHERE I THINK -- BUT THE IDEA
THAT THE VULNERABILITY IS
PRESENT ALL THE TIME AND THAT
THERE'S NO TIME DURING A
PREGNANCY OR DURING A LABOR AND
DELIVERY PROCESS THAT YOU COULD
FIND A TIME WHERE PATIENTS CAN
BE ADEQUATELY CONSENTED, I THINK
HAS BEEN THE WRONG APPROACH.
>> AGREE, THANK YOU,
DR. SRINIVAS.
DR. ZHOU, CAN YOU TELL US ABOUT
SOME OF THE -- WHAT YOU THINK
SOME OF THE BEST STRATEGIES ARE
TO INCLUDE SOCIOECONOMICALLY
DISADVANTAGED POPULATIONS IN
CLINICAL RESEARCH?
>> YEAH, DEFINITELY.
SO I THINK THE KEY IN THIS GROUP
IS ACTUALLY FLEXIBILITY.
SO FLEXIBILITY IN MANY SENSES.
FLEXIBILITY IN TERMS OF THE
PHYSICAL ENVIRONMENT YOU'RE
PERFORMING YOUR RESEARCH,
CONSIDER DOING IT IN A
PARTICIPANT'S HOME OR TRUSTED
LOCATION OR PROVIDE
TRANSPORTATION VOUCHERS OR
RIDESHARES TO THE RESEARCH SITE.
FLEXIBILITY IN HOW YOU PRESENT
INFORMATION TO THESE
PARTICIPANTS.
CONSIDERING VERBAL IMAGE
NUMERICAL, VIDEO FORMS TO
OVERCOMING LITERACY ISSUES,
FLEXIBILITY IN DATA CHECK SHOULD
COLLECTION,CERTAIN GROUPS RESPOO
CERTAIN STRATEGIES, INTERNET
TECHNOLOGY, THESE STRATEGIES
MIGHT BE BETTER IN YOUNGER
GROUPS WHEREAS TELEPHONE OR
FACE-TO-FACE WITH OLDER GROUPS,
THE TIME, THE DAY, THE WEEK,
PROVIDE OPTIONS TO DO THIS AFTER
HOURS, WEEKENDS, WHEN THESE
PARTICIPANTS AREN'T GOING TO BE
BUSY AT WORK.
AND THEN OBTAINING SOME
FLEXIBILITY IN FORMS OF CONTACT,
ENSURING YOU HAVE MULTIPLE FORMS
OF CONTACT FOR EACH INDIVIDUAL
PARTICIPANT SO THAT YOU CAN
MAINTAIN CONTACT WITH THESE
GROUPS, THAT CAN BE MUCH MORE
CHALLENGING.
THE LAST THING TO TOUCH ON IN
THIS GROUP IS CERTAINLY
FINANCIAL INCENTIVES.
THIS IS A FREQUENTLY USED
RECRUITMENT TOOL, SUCCESS IN
STUDIES HAVE BEEN SORT OF MIXED,
BUT I THINK WE DO THINK THAT
THIS IS IMPORTANT FOR SOCIAL
ECONOMICALLY DISADVANTAGED
GROUPS TO ALLOW THEM TO BE FAIR
AND WHAT I DO IS OFTEN I WILL --
FOR ALL OF THESE POINTS, I SORT
PILOT, PILOT, PILOT, SEE WHICH
WAY IS BEST FOR THE GROUP THAT
I'M STUDYING, AND MAKING SURE
IT'S VALID AND FAIR.
>> YES, THANK YOU FOR THAT.
DR. MILES, MANY CLINICAL TRIALS
AND CLINICAL RESEARCH STUDIES
ARE OFTEN NOT ACCESSIBLE TO
PERSONS WITH DISABILITIES.
CAN YOU TELL US A LITTLE BIT
ABOUT WHAT ARE SOME OF THE
STRATEGIES AND CONSIDERATIONS
THAT NEED TO BE TAKEN INTO
ACCOUNT WHEN -- TO INCLUDE THIS
POPULATION IN CLINICAL RESEARCH
STUDIES?
>> I HAVE SO MUCH TO SAY BUT I
WILL JUST SAY THIS, IF WE'RE NOT
AWARE OF A PROBLEM, WE CAN'T
CREATE SOLUTIONS TO THEM, AND
PEOPLE WITH DISABILITIES WITH
LIVED EXPERIENCES MAKE THEM
UNIQUELY POSITIONED TO IDENTIFY
AND SOLVE THE VERY PROBLEMS THAT
THEY FACE INCLUDING THE BARRIERS
TO THEIR PARTICIPATION IN
CLINICAL TRIALS.
SO IT'S REALLY IMPERATIVE THAT
PEOPLE WITH DISABILITIES ARE
HIRED TO BE RESEARCHERS AND TO
TAKE PART IN THE SCIENTIFIC
ENTERPRISE.
PEOPLE WITH DISABILITIES HAVE
ADAPTIVE CRITICAL THINKING AND
PROBLEM SOLVING SKILLS THAT THEY
USE REGULARLY TO NAVIGATE A
BARRIER-FILLED SOCIETY, AND
THOSE SKILLS CAN BE EXTREMELY
USEFUL IN THE SCIENTIFIC
ENVIRONMENT.
AND -- BUT UNFORTUNATELY,
THERE'S PEOPLE WITH DISABILITIES
WHO ARE RESEARCHERS EXPERIENCE A
LOT OF BARRIERS IN THE ACTUAL
FIELD INCLUDING AN ACCESSIBLE
LABORATORY FACILITY, RESEARCH
STEUMENTSINSTRUMENTS, ET CETERAY
WILL HAVE SOME OF THE SKILLS AND
KNOW-HOW TO HELP CREATE MORE
ACCESSIBLE RESEARCH INSTRUMENTS
AND TO REACH THE DISABLED
COMMUNITY THAT A NON-DISABLED
PERSON WHO DOES NOT HAVE THAT
POSITIONALITY, EVEN IF THEY'VE
STUDIED ALL ABOUT IT, MAY NOT
THINK TO DO.
SO WHEN WE NEED TO -- WE NEED TO
HAVE DISABLED RESEARCHERS AND
OTHER DISABLED PEOPLE PART OF
THE STAFF AND RESEARCH
ENTERPRISE AND WE NEED TO LISTEN
TO DISABLED COMMUNITIES, TOWN
HALLS, REACH OUT TO DISABLED
ORGANIZATIONS AND GO WHERE
DISABLED PEOPLE ARE.
LEARN ABOUT DISABILITY -- LEARN
ABOUT LANGUAGE AND CONSIDER THE
TYPE OF LANGUAGE THAT'S BEING
USED TO DESCRIBE DISABLED
POPULATIONS.
OFTEN PEOPLE WITH DISABILITIES
DON'T SEE AFFIRMING LANGUAGE OR
LANGUAGE THAT THEY FEEL IS
RESPECTFUL AND NOT ABLEIST, THEY
WILL AUTOMATICALLY NOT WANT TO
PARTICIPATE, SO IF YOU USE TERMS
MAYBE -- SO REALLY LEARN ABOUT
DISABILITY ETIQUETTE, AND SO
TERMS SUCH AS CONFINED TO A
WHEELCHAIR, WHEELCHAIR-BOUND
MIGHT TURN SOMEBODY OFF TO
PARTICIPATING IN YOUR STUDY IF
YOU DON'T USE MORE INCLUSIVE
LANGUAGE LIKE DISABILITY,
WHEELCHAIR USER, FOR EXAMPLE.
AND FOR SOME OF THE DISABLED
PEOPLE, THAT MIGHT NOT MATTER.
SO UNDERSTANDING THAT DISABLED
PEOPLE ARE A DIVERSE GROUP OF
PEOPLE WHO SEE THEIR DISABILITY,
SOME AS A PRIMARY PART OF THEIR
IDENTITY, SOME AS JUST A
CHARACTERISTIC THAT THEY LIVE
WITH, AND NOT EVERYONE IS JUST
TRYING TO PREVENT OR CURE THEIR
DISABILITY.
THE VAST MAJORITY OF PEOPLE WITH
DISABILITIES HAVE TO LIVE WITH
THEIR DISABILITIES.
SO ALSO UNDERSTANDING THAT
REALITY AND HOW PEOPLE WITH
DISABILITIES, YOU KNOW, RESPOND
TO THAT REALITY VARIES.
SO THOSE ARE JUST SOME OF THE
WAYS THAT YOU CAN INCREASE
DISABILITY PARTICIPATION.
>> THANKS FOR THAT VERY
THOUGHTFUL RESPONSE, DR. MILES.
DR. CORONADO, CAN YOU TELL US A
LITTLE BIT ABOUT HOW CAN
SPONSORS BEST INCLUDE RURAL
POPULATIONS IN CLINICAL
RESEARCH, ARE THINGS LIKE
DIGITAL CLINICAL TRIALS AND
OTHER SUCH TECHNOLOGIES HELPFUL,
OR -- I'M SURE YOU ALSO HAVE TO
BE AWARE OF THINGS WITH THE
DIGITAL DI SATELLITE /RADAR AS DF
YOU CAN TALK TO US ABOUT IN YOUR
VIEW, WHAT ARE SOME OF THOSE
BEST STRATEGIES?
>> REALLY GOOD, REALLY GOOD
QUESTION.
I CERTAINLY -, YOU KNOW, ECHO WT
THE OTHER PANELISTS HAVE
MENTIONED, AND I WANT TO START
BY KIND OF APPLAUDING SOME OF
THE POLICY CHANGES THAT HAVE
BEEN MADE IN PRACTICE, CHANGES
IN PRACTICES THAT HAVE BEEN MADE
AT THE NATIONAL LEVEL.
SO WE KNOW THAT BACK IN 2000,
MEDICARE ADOPTED A POLICY TO
COVER THE ROUTINE EXPENSES
ASSOCIATED WITH PARTICIPATION IN
CLINICAL TRIALS, AND IN 2020,
MEDICAID ALSO ADOPTED THAT
POLICY.
SO JUST RECENTLY, THE 70 MILLION
PEOPLE ACROSS THE COUNTRY THAT
ARE ENROLLED IN MEDICAID WHICH
IS TYPICALLY ABOUT 25% OF A
STATE'S POPULATION NOW HAVE
GREATER ACCESS TO CLINICAL
TRIALS BECAUSE IT WILL BE PAID
FOR BY THEIR INSURANCE, AND THIS
ALSO PARENTHETICALLY ALLOWS FOR
THE YOUNGER POPULATION, THOSE
YOUNGER THAN 65 THAT ARE
TYPICALLY ELIGIBLE FOR MEDICAID,
TO HAVE THEIR CARE COVERED.
SO THIS IS BIG NEWS AND I WAS
RECENTLY PART OF THE NATIONAL
ACADEMY'S COMMITTEE ON IMPROVING
REPRESENTATION IN CLINICAL
TRIALS IN RESEARCH, AND ONE OF
THE THINGS THAT IS INCLUDED IN
THEIR RECOMMENDATION IS THE
GENERAL ACCOUNTING OFFICE
EVALUATE THIS POLICY, MAKING
SURE THAT IT'S BEING IMPLEMENTED
ACROSS THE COUNTRY.
SO ARE THERE ANY BARRIERS TO
IMPLEMENTATION THAT NEED TO BE
SOLVED IN TERMS OF THAT POLICY.
SO I THINK THAT'S A BIG ONE.
IT'S A BIG ONE THAT AFFECTS NOT
JUST RURAL POPULATIONS BUT URBAN
POPULATION AS WELL.
I ALSO WANT TO SAY THERE'S BEEN
SOME ADVANCES IN TERMS OF
CREATING NATIONAL DATA SYSTEMS
TO ALLOW PHYSICIANS IN RURAL
AREAS TO KNOW ABOUT CLINICAL
TRIALS THAT MIGHT BE ONGOING.
SO I THINK THAT THERE IS AND
AWARENESS AND EDUCATION GAP
AMONG PROVIDERS IN KNOWING WHICH
CLINICAL TRIALS MIGHT BE
AVAILABLE FOR A GIVEN PATIENT
THAT THEY'RE SEEING IN THEIR
PRACTICE, SO I THINK THAT
THERE'S OPPORTUNITY THERE TO
MAKE SURE THOSE DATA TRACKING
SYSTEMS ARE -- OR THE TRACKING
SYSTEMS OR REPOSITORIES ARE
BEING USED EFFECTIVELY IN RURAL
POPULATIONS AND I THINK THE LAST
BUCKET IS REALLY WHAT YOU'RE
GETTING AT, DR. MENDOZA, WHEN
YOU TALK ABOUT THE DIGITAL
DIVIDE.
LEVERAGING THE FACT THAT
TELEHEALTH IS MORE COMMONLY USED
NOW, SO THIS MIGHT CREATE
OPPORTUNITIES FOR CLINICAL
TRIALS THAT ARE BEING LED BY
ACADEMIC MEDICAL CENTERS TO
REALLY THINK ABOUT ENGAGING MORE
OF THE RURAL POPULATION, USING
TETELEHEALTH APPROACHES WHICH AE
NOW MORE COMMONLY USED.
I THINK THERE ARE SOME ISSUES
AMONG THE DIGITAL DIVIDE AND
SOME INDIVIDUALS FROM RURAL
AREAS NOT HAVING AS MUCH ACCESS
TO INTERNET CONNECTIONS THAT
MIGHT FACILITATE USE OF
TELEHEALTH, BUT I THINK WE CAN
GET AROUND THAT BY PERHAPS USING
TELEHEALTH IN CLINICAL SETTINGS
WHERE INTERNET ACCESS WOULD BE
KNOWN TO BE AVAILABLE AND SO
FORTH.
I THINK THERE'S ALSO SOME
ADDITIONAL KIND OF HEADWAY THAT
COULD BE MADE IN TERMS OF
CREATING APPS, SO THESE APPS
COULD BE LINKED TO THESE
NATIONAL TRACKING SYSTEMS SO
THAT PHYSICIANS COULD HAVE A
VERY ACCESSIBLE PLACE TO LOOK
FOR CLINICAL TRIALS OR TO TYPE
IN THE PATIENT'S CONDITION OR
STAGE OF DISEASE TO REALLY SEE
WHAT TYPES OF CLINICAL TRIALS
THAT PATIENT MIGHT BE ELIGIBLE
FOR.
SO I THINK THERE'S SOME
ADDITIONAL HEADWAY THAT COULD BE
MADE IN TERMS OF CREATING THE
DIGITAL TOOLS THAT CAN HELP
FACILITATE ENROLLMENT.
>> THANK YOU SO MUCH,
DR. CORONADO.
WE HAVE TIME FOR ONE MORE
QUESTION AND WE'LL DO IT FROM
THE AUDIENCE.
SO THIS QUESTION IS FOR
DR. CACERES.
SO DOCTOR, DO YOU HAVE SPECIFIC
RESOURCES YOU CAN RECOMMEND FOR
RESEARCHERS WHO WANT TO BE
ALLIES TO THE LGBT PLUS
COMMUNITY?
AS YOU KNOW, THIS COMMUNITY CAN
BE WARY OF PEOPLE WHO WANT TO BE
VISIBLE AS ALLIES WITHOUT
ACTUALLY HAVE BEEN EDUCATIONAL
AWARENESS ABOUT SGM.
>> SO THAT'S A VERY GOOD
QUESTION.
I THINK WE HAVE MANY MORE
RESOURCES AROUND SORT OF
CREATING INCLUSIVE CLINICAL
ENVIRONMENTS FOR SEXUAL AND
GENDER MINORITY PEOPLE AND FEWER
RESOURCES AROUND SORT OF
CLINICAL RESEARCH, BUT I THINK A
LOT OF THE RECOMMENDATIONS
PROVIDED BY THE NATIONAL ACAD HE
MOO OF MEDICINE HOW TO REPORT I
THINK IN 2020, THEY PROVIDED
SOME RECOMMENDATIONS THAT COULD
BE APPLIED, RECOMMENDATIONS FOR
CLINICAL PRACTICE COULD ALSO BE
APPLIED FOR RESEARCH.
AS WELL AS THE GLMA, WHICH IS
THE HEALTH PROFESSIONALS
ADVANCING LGBTQ QUALITY, IT'S A
NATIONAL ORGANIZATION THAT HAS A
FEW RESOURCES AROUND FOR
PROVIDERS AND RESEARCHERS.
BUT I THINK THE BIGGEST THING
REALLY IS TO ENSURE THAT IF YOU
ARE -- PARTICULARLY IF YOU'RE
NOT A MEMBER OF ANY OF THESE
COMMUNITIES WE'RE TALKING ABOUT
TODAY BUT INTERESTED IN DOING
RESEARCH ON THE POPULATION, TO
PARTNER WITH INDIVIDUALS THAT
ARE FROM THAT COMMUNITY SO THAT
THE WORK -- IN A WAY THAT THE
WORK IS NOT EXTRACTING FROM THE
COMMUNITY BUT ACTUALLY ENHANCING
AND BRINGING YOUR OWN STRENGTHS
AS A RESEARCHER OR CLINICIAN TO
IMPROVE THE HEALTH OF THOSE
GROUPS.
I THINK THE MORE YOU CAN DO TO
HAVE A RESEARCH WEBSITE WHERE
PEOPLE CAN ACTUALLY GO ON YOUR
WEBSITE, SEE WHO'S WORKING ON
YOUR RESEARCH TEAM, THE MORE
THAT YOU CAN SORT OF HAVE
MATERIALS AND RESOURCES THAT
PEOPLE CAN ACTUALLY ACCESS WHILE
THEY'RE DECIDING IF THEY WANT TO
PARTICIPATE IN THE STUDY OR
BEFORE THEY DO THAT, I THINK CAN
DO A LOT TO SORT OF ENHANCE
VISIBILITY AND TRUST IN THE
RESEARCH TEAM.
>> THANKS SO MUCH, DR. CACERES.
SO THAT CONCLUDES OUR PANEL FOR
TODAY.
I WANT TO THANK ALL OF OUR
PANELISTS FOR THEIR TIME AND ALL
THEIR EXCELLENT INPUT.
WE ARE GOING TO TAKE A
15-MINUTE-ISH BREAK, AND THEN
WE'LL COME BACK FOR OUR NEXT
PANEL.
THANK YOU, EVERYONE.
GOOD AFTERNOON, EVERYONE.
IT'S MY PLEASURE TO BRING TO YOU
ALL SESSION 5, COLLABORATOR
PERSPECTIVES AND PANEL
DISCUSSION FOR PANEL 1,
COMMUNITY AND PATIENT
PERSPECTIVES.
MY NAME IS DR. KARRIEM WATSON,
CHIEF ENGAGEMENT OFFICER FOR THE
NIH ALL-OF-US RESEARCH PROGRAM
AND IT IS MY HONOR AND PRIVILEGE
TO BE JOINED BY DR. DEBBIE
VITALIS, WITH THE NHLBI.
WE ALSO HAVE FOUR AMAZING
PANELISTS JOINING US TODAY.
I'M GOING TO INTRODUCE EACH OF
OUR PANELISTS AND AFTER I
INTRODUCE THOSE PANELISTS I'M
GOING TO ASK THEM TO EACH
PROVIDE A ONE MINUTE OVERVIEW
THROUGH THEIR LENS ON THE
IMPORTANCE OF COMMUNITY
COLLABORATIONS AND FROM THE
PATIENT AND COMMUNITY
PERSPECTIVE.
SO WE'RE GOING TO START WITH
REVEREND DR. KENDRICK CURRY,
MEMBER OF THE COMMUNITY
ENGAGEMENT ALLIANCE AGAINST
COVID-19 DISPARITIES AND
PENNSYLVANIA AVENUE BAPTIST
CHURCH.
>> GOOD AFTERNOON, EVERYONE.
I AM KENDRICK CURRY, PASTOR OF
PENNSYLVANIA AVENUE BAPTIST
CHURCH AND EXCITED TO BE WITH
YOU TODAY.
I'M PART OF THE COMMUNITY
ENGAGEMENT ALLIANCE AGAINST
COVID-19 DISPARITIES.
AND I'M JUST EXCITED TO BE HERE
AND HAVE SOME GREAT DISCUSSION.
I WILL SAY JUST BRIEFLY THAT WE
ARE IN DESPERATE NEED OF MAKING
SURE THAT WE HAVE COLLABORATION
WITH THE COMMUNITY.
AND THE COMMUNITY IS ESSENTIAL
FOR MAKING SURE THAT WE HAVE
CONNECTIVITY TO A RESEARCH
POPULATION THAT IS OFTENTIMES
OVERLOOKED AND MISSED QUITE
FREQUENTLY IN RESEARCH.
SO THIS IS AN IMPORTANT
CONVERSATION THAT WE'RE HAVING
TODAY.
>> THANK YOU SO MUCH.
NEXT WE HAVE MISERY KEY FARLEY,.
>> GOOD AFTERNOON, EVERYONE.
IT'S GREAT TO BE HERE WITH YOU
GUYS AND SEE SOME FRIENDS ON THE
ZOOM.
CLEARLY I REPRESENT THE PATIENT
VOICE.
I'M AN 11-YEAR SURVIVOR OF
TRIPLE NEGATIVE BREAST CANCER
AND I DON'T THINK WE CAN MAKE
ANY VALID HEALTH DECISIONS
WITHOUT THE PATIENT VOICE, AND
WE ARE THE VOICE OF TRUST OF OUR
PATIENTS.
PATIENTS LISTEN TO US MORE THAN
THEY LISTEN TO DOCTORS,
RESEARCHERS OR ANYBODY IN THE
ECOSYSTEM.
BECAUSE WE HAVE A LIVED
EXPERIENCE AND CAN SPEAK FROM
OUR HEARTS AS TO WHAT WE WENT
THROUGH.
AND WE'VE DONE A LOT OF WORK
WHICH I CAN SPEAK TO IN A FEW
MINUTES ABOUT KIND OF HELPING
BLACK WOMEN UNDERSTAND THE
CRITICAL NATURE OF CLINICAL
TRIAL PARTICIPATION AND OUR BEST
MESSAGES COME FROM THE VOICE --
>> THANK YOU SO MUCH FOR THAT
FRAMING.
>> GOOD AFTERNOON, EVERYONE.
LIKE MY FELLOW PANELISTS, I AM
SO EXCITED TO BE WITH ALL OF YOU
TODAY.
AS WE THINK ABOUT THE IMPORTANCE
OF PARTNERSHIPS WITH
COMMUNITY-BASED ORGANIZATIONS,
WE HAVE TO UNDERSTAND THAT IT'S
ACTUALLY IN COMMUNITIES WHERE
HEALTH ACTUALLY TAKES PLACE.
IT IS NOT WITHIN THE FOUR WALS
OF THE HEALTHCARE SYSTEM BUT THE
COMMUNITY ITSELF.
SO IF THAT IS WHERE HEALTH IS
TAKING PLACE, THEN WE REALLY
CAN'T THINK ABOUT A PATH FORWARD
THAT IS VOID OF COMMUNITY
ENGAGEMENT.
AND THAT IS COMMUNITY ENGAGEMENT
WITH COMMUNITY-BASED
ORGANIZATIONS, WITH OUR
FAITH-BASED ORGANIZATIONS, WITH
ORGANIZATIONS LIKE RICKI AND
TOUCH.
SO AS WE THINK ABOUT OUR PATH
FORWARD, THIS NEW NARRATIVE
AROUND CLINICAL RESEARCH AND
CLINICAL TRIAL DESIGN, WE CAN'T
THINK ABOUT THAT WITHOUT MAKING
SURE THAT WE CREATE SPACE IN
THIS NARRATIVE FOR COMMUNITIES
TO BE ENGAGED.
AND THAT'S NOT A ONE-TIME
ENGAGEMENT, THAT'S A CONTINUAL
ENGAGEMENT.
SO WE REALLY HAVE TO THINK ABOUT
HOW DO WE MAKE SURE THAT
COMMUNITY ENGAGEMENT BECOMES
PERPETUAL AND IS ACTUALLY ACTIVE
IN THE ENTIRE PROCESS FOR
SOMEONE'S JOURNEY AS THEY THINK
ABOUT THEIR CLINICAL EXPERIENCE.
SO I'M LOOKING FORWARD TO OUR
CONVERSATION.
>> THANK YOU SO MUCH, SHONTA.
I LOVE THE FACT THAT YOU
HIGHLIGHTED THE IMPORTANCE OF
CONTINUITY, OF THE FACT THAT
THIS IS CONTINUAL.
WE'RE NOW GOING TO HAVE
MS. ALISSA TORRES.
>> HELLO, EVERYONE.
FLIEM MY NAME IS ALISSA TORRES,
PRONOUNS ARE SHE/HER.
AS A VISUAL DESCRIPTION I AM A
BROWN SKINNED LATINA WOMAN
WEARING BLACK RIMMED GLASSES AND
I HAVE MY HAIR BACK IN A BUN.
IT IS REALLY IMPORTANT THAT WE
ARE ALL HERE HAVING THIS
DISCUSSION TODAY.
ESPECIALLY AROUND THE IMPORTANCE
OF COMMUNITY-BASED RESEARCH.
IT'S VITAL THAT WE ALL HAVE THE
ABILITY TO NOT JUST REACH OUT TO
COMMUNITIES WHO HAVE BEEN
UNDERREPRESENTED AND
UNDERSERVED, BUT ACTUALLY TO
INVOLVE THESE COMMUNITIES FROM
THE GET-GO WITH ALL OF THE
RESEARCH AND ALL OF THE CONTENT
THAT WE AS PROFESSIONALS CREATE.
SO I'M REALLY EXCITED TO BE HERE
AND EXCITED FOR THIS
CONVERSATION.
IT'S A MUCH NEEDED CONVERSATION
AND LIKE I SAID, IT'S IMPORTANT
THAT WE ALWAYS PUT OUR
COMMUNITIES FIRST AND THAT THEY
ARE THE ONES HELPING TO INITIATE
OUR RESEARCH AND THE WORK THAT
WE DO.
>> THANK YOU SO MUCH,
MS. TORRES.
AND I'M GOING TO START WITH
REVEREND CURRY AND KIND OF
POUNCING OFF OF WHAT MS. TORRES
SAID ABOUT THIS CONCEPT OF
PUTTING THE COMMUNITIES FIRST.
WITHIN YOUR SPIRIT OF INFLUENCE
AND THE WORK THAT YOU'VE DONE
WITH CEAL AND OTHERS, WHAT ARE
SOME BEST PRACTICES YOU'VE SEEN
IN HOW WE CAN CENTER COMMUNITY
IN THE PATIENT VOICE IN THIS
WORK?
>> EXCELLENT QUESTION.
ONE OF THE WAYS YOU BEGIN TO
THINK THROUGH THIS WHOLE PIECE
ABOUT CENTERING THE VOICES IS
BEING A PARTICIPANT AMONG THE
COMMUNITY.
I OFTEN SAY THAT, YOU KNOW, THE
COMMUNITY IS ACTUALLY VERY
LOYAL, IT HAS A LONG MEMORY.
AND IF YOU'RE WILLING TO GO IN
AND PARTICIPATE WITH THE
COMMUNITY, AND TAKE THE TIME
THAT IT NEEDS TO FRIEND-RAISE,
IF YOU WILL, AND DEVELOP DEEP
ABIDING RELATIONSHIPS, THEN YOU
HAVE CREDIBILITY TO SPEAK.
AND WHEN YOU HAVE THAT
CREDIBILITY TO SPEAK, IT BECOMES
AN ENGAGEMENT.
IT IS NOT A ONE-WAY
CONVERSATION.
IT'S REALLY A CONVERSATION.
AND NOT JUST MONOLOGUE, BUT IT
BECOMES A DIALOGUE.
AND FOLK BEGIN TO TRUST YOU WHEN
WE CAN ENGAGE IN DIALOGUE.
THE MOST IMPORTANT THING IN
TERMS OF OUR DISCUSSION IS HOW
DO WE DO THIS INCLUSIVE
PARTICIPATION AND THINK ABOUT
CLINICAL TRIALS WITH, AS OPPOSED
TO TRYING TO DO SOMETHING TO A
COMMUNITY.
SO THE COMMUNITY IS ACTUALLY
SMARTER THAN YOU THINK.
AND THAT MOST PEOPLE REALIZE.
WE HAVE ALL SORTS OF FOLK IN THE
COMMUNITY THAT ARE REALLY PRETTY
ADEPT AT UNDERSTANDING THINGS IF
WE DO WHAT IS NECESSARY TO BUILD
THE RELATIONSHIP, HAVE THE
DIALOGUE, AND OH, BY THE WAY,
PUT RIGHT TRANSLATORS IN THE
CONTEXT OF COMMUNITY SO THAT WE
CAN BUILD FROM GRASSROOTS TO
GRASSTOP, HAVING AN
UNDERSTANDING AND REALIZATION OF
THAT THE VOICE COMES LITERALLY
FROM THE COMMUNITY AND BUBBLES
UP.
AND I THINK THOSE ARE SOME OF
THE THINGS WE NEED TO DO, BUT I
THINK WE NEED TO LEAN IN WITH
SOME ADDITIONAL QUESTIONS AS
WELL, AND ONE OF THE MOST
PRESSING QUESTIONS IS, WHAT IS
AT STAKE IF WE DON'T ENGAGE THE
COMMUNITY?
BECAUSE IF WE DON'T ENGAGE THE
COMMUNITY, THEN WE WON'T GET THE
RESULTS IN CLINICAL TRIALS THAT
ARE HEALTHY AND HELPFUL TO BLACK
AND BROWN FOLK.
IF WE'RE REALLY GOING TO TALK
ABOUT THIS TODAY.
SO I'M VERY MUCH LOOKING AT HOW
WE BUILD TRUST, HOW WE PROVIDE
THE NECESSARY TRANSLATION, HOW
WE MAKE SURE THAT WE ARE
LISTENING AND DOING WHAT THE
COMMUNITY NEEDS IN TERMS OF
BRINGING FOLK TOGETHER AND HOW
WE'RE INCLUSIVE IN TERMS OF
MAKING SURE THAT EVERYONE IN THE
COMMUNITY IS HEARD.
SO WE CAN'T JUST SHOW UP ONE
TIME.
WE HAVE TO SHOW UP MULTIPLE
TIMES AND BE IN THE SPACE AND
LET THE COMMUNITY KNOW THAT
WE'RE NOT JUST THERE TO DO
SOMETHING TO THEM, BUT WE'RE
HERE TO DO SOMETHING WITH, SO
THAT WE'LL BE ABLE TO MOVE
FORWARD AND TRANSFORM THE LIVES
OF HUMAN BEINGS IN THE CONTEXT
OF OUR COMMUNITY.
>> THANK YOU SO MUCH FOR THAT.
I'M GOING TO COME TO YOU NEXT
BECAUSE THAT CONCEPT OF ENGAGING
WITH IS SOMETHING YOU'VE BEEN
ABLE TO DO WITH THE TRIAL
MOVEMENT AND THE STRATEGIES YOU
AND YOUR ORGANIZATION HAVE TAKEN
TO WORK WITH BLACK WOMEN.
THIS CONCEPT IN THE EARLY YEAR
PANEL CAME UP WITH A POPULATION
THAT ARE USUALLY
UNDERREPRESENTED IN BIOMEDICAL
RESEARCH AND WE'RE MOVING AWAY,
AND I LOVE THAT, FROM THAT HARD
TO REACH POPULATION.
AS A CANCER DISPARITIES
RESEARCHER, I ENGAGE AFRICAN
AMERICAN MEN IN MY WORK.
PEOPLE WOULD SAY KARRIEM, HOW
ARE YOU GOING TO REACH YOUR
ENROLLMENT CRITERIA BECAUSE
AFRICAN AMERICAN MEN ARE HARD TO
REACH.
FIRST OF ALL I SAID I AM AN
AFRICAN AMERICAN MAN, I'M NOT
HARD TO REACH, SO REVEREND CURRY
TALKED ABOUT THE IMPORTANCE OF
DOING RESEARCH WITH.
AND I THINK YOU HAVE SOME GREAT
EXAMPLES OF THAT, MS. FAIRLEY.
>> I LOVE THAT HE CHANGED THE
PREPOSITION WITH, AND WE DO SAY
WITH -- WE ALSO CHANGED THE
PRONOUNCE FROM GOING TO
DR. GOOGLE AND SEEING YOU AND
THEY TO WE AND US.
SO WE REALLY STARTED ON THIS
PATH ABOUT TWO YEARS AGO, WE DID
A RESEARCH STUDY TO UNDERSTAND
WHAT WAS PREVENTING BLAME WOMEN
FROM PARTICIPATING IN RESEARCH.
EVERYBODY WANTS TO BLAME IT ON
THE SOCIAL DETERMINANTS OF
HEALTH AND THEY'RE A FACTOR BUT
NOT THE MAIN ONE, BUT THE REAL
FACTOR, THE REAL FEAR IS FEAR OF
THE UNKNOWN.
THEY DON'T UNDERSTAND THE
SCIENCE.
THEY DON'T UNDERSTAND WHAT SPHAN
DARSTANDARD OF CARE IS.
WE DO DON'T REALLY UNDERSTAND TT
THAT ADVIL YOU TOOK LAST WEEK
WAS IN THE CLINICAL TRIAL, THAT
TYLENOL YOU GAVE YOUR BABY WAS
IN A CLINICAL TRIAL, THAT HEART
MEDICINE YOU GAVE YOUR DOG WAS
IN A CLINICAL TRIAL.
AND WHEN YOU BREAK DOWN THE
SCIENCE IN ELEMENTARY TERMS, IN
SIMPLE TERMS AND EXPLAIN THAT
YOU'RE GOING TO GET A DRUG,
THERE IS NO -- PILL IN CANCER
RESEARCH, YOU'RE GOING TO GET A
DRUG THAT'S IN THE MARKET AND
THEN MAYBE SOMETHING ON TOP OF
IT THAT'S BETTER.
AND YOU BREAK IT DOWN FOR THEM
FROM THE VOICE OF A BREASTIE,,
SOMEBODY THEY TRUST AND THEY GET
IT, THEY WANT TO SIGN UP.
NOBODY WANTS TO DIE AND IF IT'S
A WAY NOT TO DIE, THEY'RE GOING
TO BE ALL OVER IT.
I THINK IT'S THE VOICE THAT
YOU'RE GIVING THE INFORMATION
WITH, BUT ALSO JUST SIMPLIFYING
THE SCIENCE FOR THEM.
WHO UNDERSTANDS WHAT A CLINICAL
TRIAL IS?
YOU KNOW, A LOT OF DOCTORS DON'T
EVEN UNDERSTAND IT.
SO IT'S REALLY HOW YOU EXPLAIN
THE SCIENCE TO THEM.
AND WE ARE SMART.
WE DO GET IT.
AND WE DO -- YOU KNOW, WE WANT
TO LIVE.
SO IF YOU JUST GIVE THEM THE
RIGHT WORDS AND THE RIGHT WAY
FROM THE RIGHT VOICE, IT WORKS.
AND SO WE LAUNCHED OUR WHEN WE
TRIAL CAMPAIGN A YEAR AGO, AND I
KNEW WHERE TO FIND BREASTIES ON
SOCIAL MEDIA, I WANTED TO
EDUCATE THEM FIRST BECAUSE I
WANTED TO MAKE SURE THEY WERE
PASSING ON THE RIGHT INFORMATION
TO OTHER BREASTIES.
THEN WE DID A RADIO CAMPAIGN ON
HIP-HOP STATIONS BECAUSE FRANKLY
YOU NEED TO UNDERSTAND WHAT A
TRIAL IS BEFORE SOMEONE IN YOUR
FAMILY NEEDS ONE.
SO WE EDUCATED THEM.
THEN WE HIT THE ROAD, I WANTED
TO GO WHERE BLACK WOMEN LIVE,
PRAY, WORK, AND EXPLAIN SCIENCE
TO THEM.
WE WENT INTO THE COMMUNITY, WE
WENT TO -- WE WENT TO THE URBAN
LEAGUE CONVENTION, WE WENT TO
THE JACK AND JILL CONVENTION,
YOU KNOW, WE WALKED THE BEACH
AND MARTHA'S VINEYARD WHERE
BLACK PEOPLE ARE THERE IN
BIKINIS, WE WALKED STREETS AND
HAD A DJ WITH A BIG PARTY IN THE
STREET.
SO WE WENT TO THEM WHERE THEY
DIDN'T EXPECT US TO BE AND
EXPLAINED THE SCIENCE.
SO WE DID ABOUT 25 EVENTS
BETWEEN MAY AND DECEMBER LAST
YEAR, WE'D ALREADY DONE FIVE,
WE'RE ABOUT TO DO ONE TOMORROW
WITH MY FRIEND SHONTA, SO
EXCITED ABOUT THAT.
WE'VE NOW SIGNED UP 8500 BLACK
WOMEN FOR CLINICAL TRIAL
PORTALS.
SO WE KNOW THAT OUR FORMULA IS
WORKING.
BECAUSE IT'S US TALKING.
AND IT IS WITH US.
THANK YOU, REVEREND CURRY, IT IS
US, FOR US AND BY US.
CLEARLY WE HAVE A LONG WAY TO GO
TO GET TO THAT 3%
PARTICIPATION -- ADVANCE THAT
LEVEL, BUT WE KNOW HOW TO DO IT
NOW.
AND WE WANT TO SCALE IT AND EACH
OTHERS HOW TO DO IT.
>> THANK YOU SO MUCH.
I'M GOING TO COME TO YOU,
SHONTA, AND AS A FRIEND AND
COLLEAGUE, I KNOW YOU LIVE THIS
WORK FOR PATIENT ADVOCACY, YOU
LIVE IT.
AND THAT CONCEPT OF ADVOCACY,
YOU KNOW, COMES INTO PLAY.
JUST DESCRIBE SOME OF THE WORK
THAT YOU'VE BEEN ABLE TO DO IN
BEING A PATIENT ADVOCATE AND THE
IMPORTANCE OF THE PATIENT ADD VO
KA ROADVOCATE ROLE IN THIS SPAC.
>> I THINK AS I BEGIN TO RESPOND
TO THIS QUESTION, I THINK AS
NATIONAL ORGANIZATIONS, WE NEED
TO OWN OUR RESPONSIBILITIES TO
COMMUNITIES.
AND THAT SOMETIMES MEANS THAT WE
HAVE TO LEVERAGE OUR BRAND, OUR
REPUTATION, OUR INFLUENCE TO
HELP BRING COMMUNITY-BASED
ORGANIZATIONS AND OTHER
ORGANIZATIONS ALONG WITH US.
YOU KNOW, THERE IS THIS
METHODOLOGY IN PUBLIC HEALTH,
ASSET-BASED COMMUNITY
DEVELOPMENT, AND IT ACTUALLY
REALLY CENTERS AROUND BUILDING
ON THE ASSETS THAT EXIST WITHIN
A COMMUNITY.
WE TEND TO WANT TO THINK ABOUT
COMMUNITIES FROM THIS DEFICIT
MODEL, RIGHT?
BUT WE REALLY THINK ABOUT EVEN
EARLY DAYS FROM CIVIL RIGHTS
MOVEMENT TO EVEN NOW, IT'S THE
ASSETS, IT'S THE MOTIVATION,
IT'S THE PASSION, IT'S THE
DETERMINATION WITHIN COMMUNITIES
TO HAVE THEM THE BEDROCK THAT
HAVE BUILT AND SUSTAINED THIS
COUNTRY FOR SO MANY YEARS.
SO WHEN WE THINK ABOUT
COMMUNITIES, WHEN WE THINK ABOUT
ADVOCACY, WHEN WE THINK ABOUT
WHAT'S IN IT FOR THEM, THAT IS
THE GREAT OPPORTUNITY FOR US TO
BE ABLE TO MOBILIZE AND ENGAGE
OUR COMMUNITIES IN ADVOCACY.
THE CHALLENGE HAS ALWAYS BEEN
WE'VE GONE TO COMMUNITIES WITH
THIS NARRATIVE OF THIS AGENDA
AROUND WHAT WE THINK THEY NEED
VERSUS CREATING SPACE TO ASK
THEM THE QUESTION AND ACTUALLY
LISTEN FOR THEIR RESPONSE AROUND
NOT ONLY WHAT THEY NEED BUT ALSO
WHAT'S THE OPPORTUNITY, WHAT'S
THE SPACE FOR THEM TO
PARTICIPATE IN THE SOLUTION.
THE SOLUTION FOCUSED OPPORTUNITY
FOR COMMUNITIES IS ALL THAT
THEY'VE EVER DESIRED TO DO.
UNFORTUNATELY, WE JUST THINK WE
KNOW BEST SOMETIMES, AND WE'VE
LEARNED OVER TIME THAT WE DON'T
KNOW BEST.
COMMUNITIES KNOW THEIR
COMMUNITIES.
THEY'RE THERE DAY, EVENING AND
NIGHT.
SO FOR US AT PAF, THE WAY THAT
WE'VE ENGAGED WITH COMMUNITIES
AROUND ADVOCACY IS REALLY
APPLYING THIS PRINCIPLE AROUND
100 CUPS OF COFFEE.
AND THAT LITERALLY MEANS THAT
YOU'RE GOING INTO A COMMUNITY,
YOU'RE SITTING ON FRONT PORCHES,
BACK PORCHES, YOU'RE SITTING
WHEREVER YOU NEED TO SIT, THE
LAUNDROMAT OR WHAT HAVE YOU AND
ASKING POINTED QUESTIONS OF THE
COMMUNITY TO REALLY UNDERSTAND
THROUGH THEIR EYES, WHAT DO THEY
THINK ARE THE MOST PRESSING
CHALLENGES, BUT MORE
IMPORTANTLY, WHAT DO THEY SEE AS
THE SOLUTION AND LET THEM IGNITE
A MOVEMENT WITHIN THEIR
RESPECTIVE COMMUNITIES TO REALLY
HELP TO SUSTAIN AND FORTIFY THEM
IN A WAY THAT WE HAVE NOT DONE
HISTORICALLY.
SO FOR US WHEN WE THINK ABOUT
THIS ADVOCACY AGENDA, YOU CAN'T
BUILD AN AGENDA UNLESS YOU'VE
HAD YOUR 100 CUPS OF COFFEE.
SO WE WANT TO HAVE A SIEVE WHEN
WE GO INTO COMMUNITIES.
WE DON'T WANT TO SIT DOWN,
LISTEN, UNDERSTAND, AND THEN
WE'RE WONDERING WHY THE THINGS
WE DO DON'T WORK.
WONDERING WHY OUR COMMUNITIES
WON'T TAKE OUR CALLS WHEN WE
COME INTO THEIR COMMUNITY AND
WANT TO DO SOMETHING AND MOVE
SOMETHING.
BECAUSE WE HAVEN'T TAKEN THE
TIME TO CREATE SPACE FOR THEM AT
THE TABLE, BUT WE WANT THEM TO
EAT WHAT WE PREPARE.
SO AS WE THINK ABOUT OUR PATH
FORWARD, WE REALLY, REALLY,
REALLY AGAIN, AS I SAID IN MY
OPENING STATEMENT, HEALTH TAKES
PLACE IN COMMUNITIES.
THE ABSENCE OF HEALTH IS ALSO
PRESENT IN COMMUNITY.
BUT MORE IMPORTANTLY, THE
SOLUTIONS TO ALL OF THOSE THINGS
ARE WITHIN THE COMMUNITY.
>> THANK YOU SO MUCH.
I WISH YOU ALL COULD SEE MY
PHONE GOING OFF WITH TEXT
MESSAGES, I'M GETTING AMENS,
THIS IS THE CHOIR BUT WE'RE
SINGING THE SONG THAT NEEDS TO
BE HEARD, SO I APPRECIATE THIS
MESSAGING.
AND I REALLY LOVE, SHONTA, THE
WAY YOU TALKED ABOUT FROM AN
ASSET PERSPECTIVE AND REALLY
GETTING THE MESSAGE OUT THERE,
AND MS. TORRES, WHEN I THINK
ABOUT GETTING THE MESSAGE OUT
THERE, I THINK ABOUT THE WORK
YOU'VE DONE THROUGH THE MENTAL
HEALTH SITUATION AND EVEN THINGS
LIKE THE BIPOC MENTAL HEALTH
MONTH CAMPAIGN AND WAYS THAT
YOU'RE CENTERING THIS
CONVERSATION.
CAN YOU TALK A LITTLE BIT ABOUT
THAT WORK, PLEASE?
>> YEAH.
SO ONE OF THE KEYWAYS THAT
MENTAL HEALTH AMERICA SEEKS TO
SUPPORT INDIVIDUALS IN ADVOCACY
IS THAT WE PUT OUT TOOL KITS
SEVERAL TIMES A YEAR M SO MENTAL
HEALTH MONTH IN PAY, BIPOC
MENTAL HEALTH MONTH IN JULY, AS
WELL AS BACK TO SCHOOL, WE HAVE
A WORKPLACE TOOLKIT AS WELL, SO
WE HAVE SEVERAL DIFFERENT TOOL
KITS THAT WE PUT OUT THERE THAT
GIVE PEOPLE THE OPPORTUNITY TO
SHARE REMADE CONTENT, SO FOR
EXAMPLE, WE HAVE INFOGRAPHICS ON
STATISTICS, WE HAVE SAMPLE
MESSAGES FOR SOCIAL MEDIA, WE
HAVE FACT SHEETS THAT YOU CAN
SHARE IN YOUR COMMUNITIES, WE
HAVE LISTS OF RESOURCES THAT
YOU CAN SHARE.
SO WE OFFER THESE DIFFERENT
KINDS OF TOLL K TOOL KITS THROUT
THE YEAR THAT ALLOW INDIVIDUALS
TO TAKE ALL THIS INFORMATION IN
ONE PLACE AND GO WITH IT AND
JUST TAKE IT OUT INTO THEIR
COMMUNITIES AND SPREAD IT
HOWEVER THEY FEEL IS BEST.
BECAUSE WITHIN THIS
CONVERSATION, WE REALLY
UNDERSTAND HOW VITAL IT IS TO
NOT JUST SUPPORT OUR
COMMUNITIES, YOU KNOW, THROUGH
THE CONTENT THAT WE PUT OUT BUT
TO GIVE OUR COMMUNITIES THE
TOOLS TO ACTUALLY TAKE THAT AND
RUN WITH IT.
SO WITHIN THE BIPOC TOOLKIT THAT
WE DID LAST YEAR FOR NATIONAL
MINORITY MENTAL HEALTH AWARENESS
MONTH, WE WERE ABLE TO PUT OUT
INFORMATION SPECIFIC TO -- WE
SPLIT UP THE TERM BIPOC INTO SIX
DIFFERENT CULTURAL CATEGORIES,
BECAUSE OUR GOAL WAS NOT TO JUST
TALK ABOUT BIPOC, NOT JUST TO
TALK ABOUT PEOPLE OF COLOR, NOT
JUST TO TALK ABOUT PEOPLE OF THE
GLOBAL MAJORITY, BUT TO TALK
ABOUT SPECIFICS TO EACH
INDIVIDUAL COMMUNITY.
WHAT ARE THE BARRIERS, WHAT ARE
THE HISTORICAL FACTORS THAT WE
NEED TO CONSIDER AS
PRACTITIONERS, AS PEOPLE WHO
WORK ALONGSIDE THESE
COMMUNITIES?
WHAT ARE THE THINGS THAT THESE
COMMUNITIES WANT US TO HEAR?
ONE THING THAT CAME OUT OFTEN
WITHIN THAT WAS THE NEED FOR
MORE CONNECTION WITH GATE
KEEPERS WITHIN THOSE
COMMUNITIES.
SO SPECIFICALLY COMMUNITY
LEADERS, INDIVIDUALS THAT ARE
ALREADY TRUSTED ACTIVISTS,
PEOPLE WHO ARE BOOTS ON THE
GROUND THAT HAVE ACTUALLY BEEN
ALREADY DOING THIS WORK, LONG
BEFORE MANY OF US HAVE.
SO IT'S VITAL THAT WE REACH OUT
TO THOSE GATE KEEPERS AND ARE
ABLE TO ACTUALLY FIND PEOPLE WHO
CAN GET INTO EACH COMMUNITY AND
CAN ALREADY HAVE THAT
ESTABLISHED TRUST AND THEN THAT
CAN ALLOW US TO BE ABLE TO WORK
WITH INDIVIDUAL COMMUNITIES AND
TO BE ABLE TO ACTUALLY USE
COMMUNITY INITIATED CONCEPTS AND
COMMUNITY INITIATED EDUCATION TO
FURTHER THE WORK THAT WE DO.
>> THANK YOU SO MUCH.
>> CAN I BUILD ON THAT?
>> SURE, AND THEN WHICH HAVE AN
AMAZING QUESTION -- AS YOU BUILD
ON THAT, I'M GOING TO ASK YOU TO
BUILD ON A QUESTION IN THE CHAT.
BECAUSE THERE'S A QUESTION IN
THE CHAT THAT ACTUALLY TALKED
ABOUT THE MORNS IMPORTANCE OF TS
TRUSTED VOICES PIECE AND THE
IMPORTANCE OF TRUSTED VOICES SO
AS YOU BUILD ON THAT,
MS. FAIRLEY, PLEASE BUILD ON THE
ROLE OF TRUSTED VOICES.
>> I HATE THE TERM BIPOC.
I'M SORRY.
I'M A BLACK WOMAN, YOU KNOW,
YOU'RE LATINO, SO I THINK THAT
YOU CAN'T JUST PUT EVERYBODY IN
A BUCKET AND SAY OKAY, THEY HAVE
SOME COLOR IN THEIR MELANIN,
RIGHT?
BECAUSE THERE ARE CULTURAL
NUANCES THAT MAKE US ALL
DIFFERENT.
MAKE EVERYBODY DIFFERENT.
BUT UNLESS YOU ADDRESS THAT --
I'M A MARKETING PERSON BY TRADE
SO MAYBE THAT'S HOW I THINK, BUT
YOU HAVE TO APPROACH THESE
CONVERSATIONS WITH CULTURAL
HUMILITY.
THAT'S WHY THE VOICE TO YOUR
POINT IS SO IMPORTANT.
IT IS ABOUT THE VOICE, IT IS
ABOUT WHERE THE TRUST COMES
FROM, AND IT DOES COME FROM YOUR
CULTURE, YOUR UPBRINGING, HOW
YOU WERE RAISED, IT COMES FROM,
YOU KNOW, NUANCES IN OUR
COMMUNITIES THAT MAKE US
DIFFERENT AND MAKE US UNIQUE AND
MAKE US RESPOND DIFFERENTLY TO
INFORMATION.
AND THERE ARE SOME BLACK THINGS
THAT ARE DIFFERENT FROM THE
LATINX THINGS THAT ARE DIFFERENT
FROM ASIAN THINGS THAT ARE
DIFFERENT FROM WHITE THINGS, AND
I THINK YOU REALLY HAVE TO
CONSIDER THOSE FACTORS AND
CONSIDER OUR CULTURAL
DIFFERENCES TO MAKE THE MESSAGES
RELEVANT.
AND I KNOW -- I DON'T WANT
ANYBODY TO DIE OF BREAST CANCER
BUT I KNOW MY CONVERSATION WITH
A BLACK BREASTIE IS DIFFERENT
FROM A WHITE BREASTIE.
MY CONVERSATION EVEN WL A
HISPANIC BLACK BREASTIE IS
DIFFERENT.
AND I REALLY HAVE TO TAKE INTO
CONSIDERATION WHO THEY ARE TO
GIVE THEM THE INFORMATION IN THE
WAY THAT'S GOING TO MAKE THEM
TRUST ME AND MAKE A BEHAVIOR
CHANGE TO PARTICIPATE IN A
TRIAL.
AND I THINK YOU HAVE TO BE
INTENTIONAL ABOUT HOW YOU TALK
TO PEOPLE, WHAT YOU SAY, WHEN
YOU SAY IT, WHERE YOU SAY IT,
AND ESPECIALLY WHO SAYS IS.
>> THIS CONCEPT OF WHERE WE SAY
IT, MS. FAIRLEY, REVEREND CURRY
I SEE YOU AND I THINK YOU'RE
GOING TO GET TO THIS WHERE WE
SAY IT.
>> HE'S CHOMPING AT THE BIT.
>> I WOULD LOVE FOR YOU TO
COMMENT ON THE WHERE PIECE.
WE DON'T TALK ENOUGH ABOUT SPACE
AND PLACE, AND THE FAITH-BASED
COMMUNITY HAS OFTEN BEEN A PLACE
WHERE THESE TRUSTED
CONVERSATIONS CAN BE HAD BY
TRUSTED MESSENGERS IN TRUSTED
PLACES.
CAN YOU BUILD UPON THAT PLACE
AND SPACE, PLEASE?
>> YEAH, PLACE AND SPACE IS SO
CRITICALLY IMPORTANT BECAUSE IT
IS SAFE SPACE.
IT'S A SAFE PLACE TO BEGIN TO
HAVE THESE CONVERSATIONS.
I CAN'T TELL YOU HOW MANY
CONVERSATIONS I'VE HAD WITH FOLK
THAT ARE I WOULDN'T EVEN -- I
COULDN'T REPEAT HERE, BUT THEY
FEEL SAFE ENOUGH TO COME TO A
HOUSE OF WORSHIP OR TO A SMALL
GROUP THAT WE'RE HAVING OR TO
SOME OTHER EVENT, AND REALLY
WE'RE INTENTIONAL, AND I LOVE
THAT THE WAY RICKI FAIRLEY JUST
SAID IT.
I MEAN, THAT INTENTIONALITY WITH
WHICH THEY COME AND THEY'RE
HUNGRY TO BE ABLE TO BE OPEN, TO
BE THOSE WHO WILL FIND
THEMSELVES JUST WILLING TO
SHARE, AND THERE ARE TWO WORDS
I'D JUST LIKE TO INTRODUCE IN
THIS SPACE.
ONE IS AUTHENTICITY AND ANOTHER
IS ACCEPTANCE.
WHEN I START TO DEAL WITH
AUTHENTICITY AND ACCEPTANCE, I'M
NOT CONCERNED ABOUT WHAT YOU
HAVE ON OR HOW YOU SOUND.
I'M NOT CONCERNED AS MUCH ABOUT
YOUR OWN CULTURAL NUANCES OR
ANYTHING ELSE.
I ACCEPT YOU AS YOU ARE.
AND WHEN I CAN BEGIN TO ACCEPT
YOU AS YOU ARE, AND I KNOW THAT
GOES A LONG WAY, BECAUSE AS A
BLACK MALE, THERE ARE SOME
SPACES DUE TO STRUCTURAL RACISM,
ET CETERA, THAT I JUST AM NOT
VIEWED THE SAME WAY.
AND SO WHEN WE COME IN THE
CONTEXT OF COMMUNITY AND TALK
ABOUT PLACE AND WE NEED TO TALK
ABOUT SAFE PLACES AND SAFE
SPACES, AND WHEN WE TALK ABOUT
THOSE SAFE PLACES AND SAFE
SPACES, WE NEED TO BRING THE
WORDS AUTHENTICITY UP BECAUSE I
WANT YOU TO BE HONEST AND KEEP
IT REAL.
ONCE YOU'RE HONEST AND YOU KEEP
IT REAL, THEN WHAT HAPPENS IS
FOLK BEGIN TO SHARE MORE THAN
ANYTHING ELSE.
BECAUSE THEY'RE HEARD.
THE DAY IS OVER FOR US ALL BEING
INVISIBLE.
I NEED YOU TO SEE ME.
AND I NEED TO KNOW THAT YOU SEE
ME.
NOT ONLY DO I NEED TO KNOW THAT
YOU SEE ME, I NEED TO KNOW THAT
YOU FEEL ME.
AND IF YOU SEE ME AND FEEL ME,
NOW YOU BRING MY HUMANITY BACK.
AND THAT'S REALLY WHAT WE'RE
TALKING ABOUT, IS UNDERSTANDING
HOW WE MOVE IN THIS WAY IN
HOUSES OF WORSHIP, WHERE WE CAN
BE VULNERABLE, WE CAN ACCEPT
PEOPLE FOR WHO THEY ARE, WE CAN
SPEAK AUTHENTICALLY, AND FOLK
WILL BE ABLE TO SAY THEIR TRUTH,
EMBRACE THEIR TRUTH, UNDERSTAND
THEIR TRUTH, AND NOW WE BUILT
FRIENDS.
AND WE HAVE RELATIONSHIP.
AND ONCE WE HAVE THAT
RELATIONSHIP GOING ON, NOW WE
CAN VALUE THE OTHER PERSON.
AND IT GETS -- STARTS TO GET
BEYOND SOME OF THE OTHER STUFF
THAT SEEMS TO DIVIDE US RATHER
THAN UNIFY US.
>> THANK YOU SO MUCH, REVEREND
CURRY.
SHONTA, I'M GOING TO COME TO YOU
NEXT, THIS CONCEPT OF
RELATIONSHIP AND ELEVATING THE
PATIENT VOICE.
AT PAF, I KNOW YOU ALL THINK A
LOT ABOUT SUSTAINABILITY.
YOU DON'T WANT THAT ONE TOUCH
AND THEN YOU MOVE.
CAN YOU SPEAK A LITTLE BIT TO
THE SUSTAINABILITY PIECE OF
THIS?
>> SO THE FORK FOR WORK FOR US,E
THINK ABOUT SUSTAINABILITY, IT
COMES BACK TO COMMUNITY.
BECAUSE AS AN ORGANIZATION,
WE'RE NOT BRICK AND MORTAR,
ALTHOUGH WE'RE A NATIONAL
ORGANIZATION SERVING ALL 50
STATES AND TERRITORIES, BECAUSE
WE'RE NOT BRICK AND MORTAR IN
EVERY SINGLE COMMUNITY, OUR
RELATIONSHIPS WITH OUR COMMUNITY
PARTNERS IS THE LIFELINE TO
HELP, A, UNDERSTAND WHAT ARE
THOSE SOCIAL NEED GAPS THAT ARE
MOST PREVALENT IN EACH
COMMUNITY?
IT MAY BE TRANSPORTATION IN
CHICAGO, IT MAY BE FOOD
INSECURITY IN PHILADELPHIA, IT
MAY BE CHILD CARE SOMEPLACE
ELSE.
SO IT IS BY HAVING THESE
AUTHENTIC RELATIONSHIPS BECAUSE
WE SPENT TIME WITH PEOPLE, WE'RE
ABLE TO UNDERSTAND IF THE
SERVICES AND -- THAT WE PROVIDE
AS AN ORGANIZATION ARE ACTUALLY
MEETING PEOPLE WHERE THEY ARE,
AT THE PLACE THAT THEY NEED IT,
AND IT'S ALSO REALIZING THAT IT
MIGHT NOT BE SHONTA CHAMBERS
THAT HELPS TO CONNECT A
COMMUNITY TO A PAF RESOURCE, IT
MAY BE RICKI.
IT MAY BE PASTOR CURRY.
IT MAY BE ALISSA.
BECAUSE THEY ARE THE TRUSTED --
THEY ARE THE ENTITY THAT HAS
MOVED BEYOND JUST A RELATIONSHIP
OF TRUST, BUT THEY HAVE
DEMONSTRATED THEMSELVES AS BEING
TRUSTWORTHY.
BECAUSE THAT'S SOMETHING VERY
DIFFERENT, BECAUSE TRUST CAN BE
EVASIVE, BUT TRUSTWORTHINESS IS
THE INTEGRITY OF AN INDIVIDUAL
OR AN ORGANIZATION.
AND THAT IS WHAT HAS ALLOWED US
TO BE ABLE TO SUSTAIN OUR WORK,
BY BUILDING THESE AUTHENTIC
RELATIONSHIPS.
AND LIKE I SAID BEFORE, WE
DON'T -- WE CAN'T INVITE
SOMEBODY TO SIT AT OUR TABLE IF
WE'RE NOT WILLING TO SIT AT
THEIR TABLE WITHOUT ANY TYPE OF
AGENDA.
>> I LOVE THAT CONCEPT, WITHOUT
ANY TYPE OF AGENDA.
MS. TORRES, I'M GOING TO ASK YOU
TO SPEAK TO TWO THINGS.
ONE, I LOVE THE CONCEPT OF WHAT
YOU DESCRIBED AS
LIBERATION-BASED PRACTICE.
WITHIN THIS CONCEPT OF
LIBERATION-BASED PRAK TI THERE
WAS A QUESTION IN THE CHAT ABOUT
HOW DO WE GET OTHERS TO BEGIN TO
UNDERSTAND THIS LANGUAGE OF
AUTHENTICITY, INTENTIONALITY.
TO ME, THAT'S ALL A PART OF THAT
LIBERATION WORD.
I'D LOVE FOR YOU TO COMMENT ON
THAT.
>> ABSOLUTELY.
AND I COMMENTED THIS IN THE CHAT
EARLIER, BUT IT'S ALL ABOUT
RELATIONSHIP BUILDING.
ESPECIALLY WHEN WE THINK OF
COMMUNITIES OF COLOR, WE HAVE TO
CONSIDER THAT THE VAST MAJORITY
OF THESE COMMUNITIES ARE
COLLECTIVIST COMMUNITIES.
THEY RELY ON THE INTERDEPENDENCE
BETWEEN THEMSELVES AND OTHERS
WITHIN THEIR COMMUNITY.
AND SO WHEN WE TALK ABOUT HEALTH
OF AN INDIVIDUAL, WE'RE TALKING
ABOUT THE HEALTH OF A COMMUNITY,
REALLY.
WE'RE TALKING ABOUT THE HEALTH
OF A FAMILY.
WE'RE TALKING ABOUT THE HEALTH
OF A NEIGHBORHOOD.
SO IT'S VITAL THAT WE'RE ABLE TO
ACTUALLY REACH OUT TO
INDIVIDUALS WITHIN THESE
COMMUNITIES FROM THE GET-GO,
FROM INITIATION OF OUR PLANNING
TO ACTUALLY BE ABLE TO CREATE
THESE RELATIONSHIPS.
SO WHEN I TALK ABOUT LIBERATION,
I LIKE TO THINK OF IT AS THERE'S
THIS GRAPHIC THAT I'M SURE MANY
OF YOU HAVE SEEN WITH PEOPLE
STANDING OUT IN A BASEBALL
FIELD, IN FRONT OF THEM IS A
FENCE, AND SO IF WE WERE TO TALK
EQUALITY, ALL OF THESE PEOPLE,
REGARDLESS OF HEIGHT, ARE
STABBING ONSTANDING ON THIS FENE
MAY BE ABLE TO SEE WHAT'S ON THE
BASEBALL FIELD, SOME MIGHT NOT
BE ABLE TO SEE WHAT'S ON THE
BASEBALL FIELD.
BUT THEN IF WE'RE TALKING ABOUT
EQUITY, MAYBE THE LITTLELESS KID
GETS A BOX AND HE CAN SEE OVER
THE FENCE AND THEN HE CAN SEE
WHAT'S HAPPENING IN THE BASEBALL
FIELD.
BUT IF WE'RE TALKING ABOUT
LIBERATION, LET'S REMOVE THE
FENCE ALL TOGETHER.
AND YOU KNOW WHAT, LET'S
QUESTION WHY ARE THEY OUTSIDE OF
THE BASEBALL STADIUM TO BEGIN
WITH?
WHY AREN'T THEY IN THE STANDS?
WHY AREN'T THEY IN THE FRONT ROW
OF THE STANDS?
SO WHEN WE TALK ABOUT
LIBERATION, WE'RE TALKING ABOUT
GETTING RID OF THOSE BARRIERS.
AND THE KEY TO GETTING RID OF
THESE BARRIERS WITH RESEARCH,
WITH EDUCATION, WITH ANYTHING,
IS REALLY TO BUILD THOSE
RELATIONSHIPS, TO BUILD THAT
TRUST.
TO GO OUT AND NOT JUST TALK
ABOUT AUTHENTICITY BUT LIVE IT.
ACTUALLY GO OUT, ASK QUESTIONS,
YOU KNOW, GET ANSWERS AND
QUESTION IF YOU FEEL A FUNKY WAY
ABOUT THE ANSWER THAT YOU'RE
GETTING, ASK YOURSELF WHY?
WHAT IS GOING ON IN ME, WHAT
BIAS MIGHT I HAVE HERE THAT
MIGHT LEAD TO ME FEELING THIS
TYPE OF WAY ABOUT THE WAY THAT
THIS PERSON IN THIS COMMUNITY
ANSWERED?
IT'S REALLY VITAL THAT WHEN WE
TALK ABOUT EQUITY FOR RESEARCH,
FOR EDUCATION, FOR ANYTHING THAT
WE ARE ABLE TO ACTUALLY CHECK IN
ON OURSELVES CONSTANTLY.
IF WE TALK ABOUT SUSTAINABILITY,
IT HAS TO BE CONSTANT.
EDUCATION TO OURSELVES,
EDUCATION TO THOSE AROUND US HAS
TO BE CONSTANT.
AND THESE RELATIONSHIPS HAVE TO
BE CONSTANT.
SO JUST AS MS. CHAMBERS SAID
ABOUT A HUNDRED CUPS OF COFFEE,
YEAH, ABOUT OUT THERE AND GO
HAVE COFFEE WITH THE FOLKS THAT
YOU'RE TRYING TO REACH.
GO GET INTO THESE SPACES IN
WHICH THERE ARE COMMUNITY HUBS,
THAT THERE ARE CULTURAL HUBS
THAT MIGHT BE THESE AFFIRMING
SAFE SPACES FOR INDIVIDUALS.
AND WE ALSO HAVE TO REMEMBER
THAT THESE CONCEPTS ARE NOT NEW,
THESE CONCEPTS OF AFFIRMING SAFE
SPACES ARE NOT NEW.
MANY OF THESE -- MANY OF THESE
COMMUNITIES AND CULTURES HAVE
BEEN DOING THESE PRACTICES FOR
YEARS, FOR HUNDREDS OF YEARS,
FOR THOUSANDS OF YEARS.
SO AS WE'RE TALKING ABOUT
RESEARCH, WE'RE NOT TALKING
ABOUT THIS NEW CONCEPT.
WE HAVE TO REALIZE THAT MANY OF
THESE COMMUNITIES HAVE BEEN
TAKING CARE OF THEMSELVES
BECAUSE THEY RELY ON EACH OTHER
SO MUCH AND BECAUSE THEY FRANKLY
HAVE NOT HAD THE SUPPORT THEY
NEED OUTSIDE OF THAT.
SO THEY HAVE HAD NO CHOICE BUT
TO RELY ON THEMSELVES IN ORDER
TO GET THEIR COMMUNITY INTO A
PLACE IN WHICH THEY FEEL
COMFORTABLE AND WHICH THEY FEEL
IT IS HEALTHY.
SO WE HAVE TO BE ABLE TO LOOK TO
THE COMMUNITY, WE HAVE TO BE
ABLE TO TALK TO FOLKS, WE HAVE
TO MEET THEM WHERE THEY'RE AT,
WE HAVE TO ALSO UNDERSTAND THAT
WE'RE NOT GOING TO KNOW
EVERYTHING, YOU KNOW?
ONE OF THE TERMS I HATE THE MOST
IS THE IDEA OF CULTURAL
COMPETENCE.
WE'RE NOT TALKING ABOUT
COMPETENCE.
WE ARE NEVER TALKING ABOUT
COMPETENCE.
NOT YOU, NOR I, NOR ANYONE ELSE
HERE WILL EVER BE ABLE TO SAY I
KNOW 100% ABOUT XYZ COMMUNITY.
NO, YOU DON'T.
BECAUSE EVEN IF YOU THINK YOU
DO, YOU DON'T KNOW EACH
INDIVIDUAL'S EXPERIENCE.
AND THAT IS ABSOLUTELY VITAL
THAT WE ARE ABLE TO DO.
>> I LOVE THAT CONCEPT.
MS. FAIRLEY, WE'RE ALMOST AT THE
FIVE MINUTE MARK, WE'RE A LITTLE
OVER BUT WITHIN THIS LAST FOUR
MINUTES, I'M GOING TO ASK EACH
OF YOU TO TAKE 45 SECONDS FOR A
CALL TO ACTION.
I'M GOING TO START WITH YOU, MSU
WANT TO RESPOND TO WHAT
MS. TORRES SAID BUT AFTER YOUR
RESPONSE, IF YOU COULD END US
WITH YOUR 452ND CALL TO ACTION.
>> SURE.
AND I'LL TRY TO DO IT ALL
TOGETHER.
SO YOU KNOW, WE LIVE IN THIS
WORLD OF HEALTH INEQUITY.
WE DON'T HAVE HEALTH EQUITY.
AND THE ONLY WAY WE'RE EVER
GOING TO GET IT IS IF EVERYBODY
PRACTICES THE GOLDEN RULE.
WHAT YOUR MOTHER TAUGHT YOU WHEN
YOU WERE 2 YEARS OLD.
TREAT OTHERS AS YOU WANT TO BE
TREATED.
AND FRANKLY, I DEAL WITH A LOT
OF SICK BLACK WOMEN, AND I --
I'M A BAD ASS BUT I KNOW I CAN'T
CHANGE THE MINDSET OF, YOU KNOW,
RACIST -- OR A WHITE DAR WITH
ELICIT BIAS.
I CAN'T CHANGE THOSE DOCTORS
THAT AREN'T CARING ABOUT OUR
COMMUNITY.
BUT WHAT I CAN DO IS I CAN
EDUCATE BLACK WOMEN.
AND I CAN TEACH THEM HOW TO
DEMAND THE CARE THEY DESERVE.
HOW TO SAY, HOLD ON, DOC, IS
THAT WHAT YOU -- IS THAT THE
TREATMENT YOU WOULD GIVE TO YOUR
MOM, YOUR GRANDMA, YOUR AUNTUE,,
YOUR DAUGHTER?
I CAN EQUIP THEM WITH THE
INFORMATION THEY NEED TO DEMAND
THE QUALITY OF HEALTHCARE THEY
DESERVE.
SO THAT'S WHERE I FOCUS MY
ENERGY.
AND I THINK WHEN YOU START
WORKING IN THE COMMUNITY, THAT'S
WHERE WE CAN MAKE A DIFFERENCE.
WE CAN TEACH OUR COMMUNITY, WE
CAN TEACH OUR MEEM TO SAY HOLD
ORANGES WAIT A MINUTE, TAKE YOUR
HAND OFF, I'M NOT DONE OR GUESS
WHAT, DOCTOR, YOU'RE FIRED,
YOU'RE NOT GIVING ME THE CARE I
DI SERVE.
DESERVE.
THAT'S WHERE WE CAN FOCUS AND
HELP OUR PEOPLE UNDERSTAND THAT
THEY ARE, WE ARE THE CEOs OF
OUR OWN HEALTH AND WE CAN TAKE
IT INTO OUR CONTROL AND DO RIGHT
BY OURSELVES WHEN OTHERS AREN'T
DOING RIGHT BY US.
>> THANK YOU SO MUCH.
REVEREND CURRY, WE'RE GOING TO
COME TO YOU FOR A 32ND CALL TO
ACTION.
>> I ENCOURAGE EVERY SINGLE
PERSON ON HERE TO MAKE SURE THEY
MAJOR IN FOUR THINGS, I'LL JUST
ILL LIT RATE THEM WITH THE Ls.
EVERY NE NEEDS TO SEEK LIGHT.
ENLIGHTENMENT, INFORMATION,
LEARNING AS MUCH AS THEY K NOT
ONLY FOR YOUR SAKE, BUT FOR THE
SAKE OF OTHERS.
WHEN YOU LEARN AND HAVE THAT
LIGHT, YOU'RE ABLE TO SHARE THAT
LIGHT.
I WANT TO ALSO TELL YOU THAT
YOU'RE NOT ONLY LIVING BASED ON
YOUR OWN -- FOR YOUR OWN SELVES.
WE'RE LIVING ON BEHALF OF EACH
OTHER.
WE ARE COMMUNITY.
AND THE ONLY THING WE HAVE IS
US.
AND WE HAVE TO BE FOR US, BY US,
THROUGH US, AROUND US, AND WITH
US SO THAT WE CAN MOVE TOGETHER.
BUT I'LL ALSO SAY, WE NEED TO
THINK ABOUT WHAT MS. TORRES SAID
IN TERMS OF LIBERATION.
LIBERATION IS SOMETHING WE NEED
TO THINK ABOUT DEEPLY.
AND IT'S ONLY WHEN THE OPPRESSED
AND THE OPPRESSOR GOES FREE THAT
WE ARE TOTALLY LIBERATED.
SO IF I'M STUCK AND YOU'RE NOT
WILLING TO UNSTICK ME OR HELP ME
GET UNSTUCK, THEN I'M STILL
BOUND, YOU'RE STILL BOUND, AND
WE'RE STILL CAUGHT IN THE SAME
THING WE HAD BEFORE.
IF WE ARE GOING TO LIBERATE ONE
ANOTHER, WE HAVE TO NOT ONLY DO
THINGS WITH, WE HAVE TO ALSO
TREAT ANOTHER AS THOUGH THEY
HAVE A KINSHIP RELATIONSHIP TO
US.
SO WE EXTEND OUR OLIVE BRANCH,
LET EVERYBODY KNOW THAT I'VE
EXTENDED MYOLI MYO OLIVE BRANCHI
WANT TO BE FREE, DO YOU WANT TO
BE FREE AS WELL.
AND THE LAST THING IN TERMS OF
LOVE, I WILL JUST SAY THIS.
WHAT MS. CHAMBERS SAID ABOUT
LOVE IS REALLY FOUND IN 101s.
IT'S HAVING THOSE 100 CUPS OF
COFFEE, LITERALLY TELLING
EVERYBODY AND THE WORLD THAT WE
MUST DO WHAT IS NECESSARY TO
TRANSFORM THE WORLD THROUGH OUR
LOVE OF ONE ANOTHER.
>> AND ON THAT NOTE, REVEREND
CURRY, I APOLOGIZE TO THE OTHER
PANELISTS, WE'LL HAVE TO END
WITH THE CONCEPT OF LOVE AND
WE'LL HAVE TO PICK UP THIS
CONVERSATION ON OUR NEXT PANEL.
THANK YOU ALL SO MUCH.
PLEASE CONTINUE THIS
CONVERSATION IN THE CHAT, AND
THANK YOU.
>> THANKS FOR HAVING US, YOU
GUYS.
HAVE A BLESSED DAY.
>> THANK YOU FOR HAVING US.
HAVE A BLESSED DAY.
THANK YOU, PANELISTS.
YOU'RE AMAZING.
>> GREAT.
TAKE CARE, EVERYBODY.
>> BYE-BYE.
>> WOW!
I JUST NEED TO TAKE A MOMENT TO
ACKNOWLEDGE THAT LAST PANEL.
WHAT AN INCREDIBLE CONVERSATION.
APPLAUSE FOR EVERYBODY, PLEASE.
THAT WAS GREAT.
THANKS TO ALL THOSE PANELISTS.
DR. WATSON, GREAT JOB
MODERATING.
SO MUCH ENERGY, SO MANY GREAT
IDEAS.
THAT'S FANTASTIC.
SO I'M HOPING WE CAN MAINTAIN
THAT ENERGY WE HEARD IN THAT
PANEL WITH OUR NEXT PANEL.
IT IS MY GREAT PLEASURE TO
WELCOME EVERYONE GREAT DAY,
FEATURING PERSPECTIVES FROM
FUNDERS, REGULATORY AGENCIES AND
POLICY ORGANIZATIONS.
I'M BOB MCNELLIS, NIH'S OFFICE
OF DISEASE PREVENTION.
IT'S MY HONOR TO BE MODERATING
THIS PANEL WITH THE STELLAR CAST
HERE.
WE HAVE ANOTHER AMAZING PANEL
FOR YOU THIS AFTERNOON.
THIS IS THE FINAL PANEL FOR THIS
WONDERFUL WORKSHOP.
THEY'RE ESSENTIALLY THE CLOSERS,
TO BORROW A TERM FROM BASEBALL'S
OPENING DAY, AND HOPEFULLY THEY
CAN HELP BRING IT ALL TOGETHER
FOR US.
SO I'D INVITE ALL OF OUR
PANELISTS TO COME ON VIDEO NOW.
WHAT I'M GOING TO DO IS A LITTLE
DIFFERENTLY, I'M GOING TO
INTRODUCE THE PANEL FIRST AND
THEN I WILL ASK FOR SOME
INTRODUCTORY REMARKS AND HAVE Q
& A.
BRITTANY GERALD IS SENIOR
MANAGER FOR CLINICAL TRIAL
DIVERSITY AND INCLUSION AT
MODERNA.
WE HAVE DR. PETER EMBI,
PROFESSOR AND CHAIR OF THE
DEPARTMENT OF BIOMEDICAL
INFORMATICS, PROFESSOR OF
MEDICINE, AND SENIOR VICE
PRESIDENT FOR RESEARCH AND
INNOVATION AT VANDERBILT
UNIVERSITY MEDICAL CENTER.
JOINING US ALSO TODAY, WE HAVE
DR. ROBERT CALIFF, THE 25TH
COMMISSIONER OF FOOD AND DRUGS
AT THE U.S. FOOD AND DRUG
ADMINISTRATION.
WE ALSO HAVE DR. NAKELA COOK,
EXECUTIVE DIRECTOR OF THE
PATIENT-CENTERED OUTCOMES
RESEARCH INSTITUTE OR PCORI.
THEN MS. JENNY LURAY,
RESEARCH!AMERICA.
DR. OLGA HERREN, COAL MODERATOR,
AND DR. HERREN WILL BE HELPING
TO GATHER QUESTIONS FROM THE
AUDIENCE.
THIS SESSION IS MEANT TO BE
INTERACTIVE LIKE THE LAST ONE.
SO IF YOU HAVE A QUESTION FOR
ANY OF OUR PANELISTS, RAISE YOUR
HAND, PUT YOUR QUESTION IN THE
CHAT, SEND TO THE WORKSHOP EMAIL
ADDRESS IN THE LIVE FEEDBACK IN
THE VIDEOCAST, YOU KNOW THE
DRILL AT THIS POINT, WE'RE THE
LAST PANEL OF THE DAY.
WE ONLY HAVE ABOUT 35, 40
MINUTES FOR THIS DISCUSSION SO
LET'S GET IT ROLLING.
I'M GOING TO START BY EACH YOU
TO TAKE ABOUT 60 SECONDS TO
PROVIDE SOME INTRODUCTORY
REMARKS ON YOUR PERSPECTIVE AND
YOUR ORGANIZATION'S PERSPECTIVE
REGARDING INCLUSIVE CLINICAL
RESEARCH AND AFTER ALL, WE WILL
DIVE INTO THE Q & A.
BRITTANY GERALD, CAN YOU START
OFF WITH SOME OPENING REMARKS,
PLEASE?
>> YES, CAN EVERYONE HEAR ME?
>> CLEAR.
>> BEAUTIFUL SPRING IN ATLANTA
BUT THAT ALSO MEANS POLLEN SO
I'M A LITTLE CONGESTED.
VERY EXCITED TO BE HERE.
I AM AT MODERNA AND WE'RE REALLY
COMMITTED TO DIVERSITY IN
CLINICAL RESEARCH.
I KNOW THERE ARE A COUPLE SLIDES
YESTERDAY ON WHAT WE DID IN OUR
COVID STUDY BULL -- TO MAKE SURE
WE'RE INCLUSIVE NOT ONLY FOR OUR
PARTICIPANTS BUT ALSO OUR
INVESTIGATORS AND SITES AS WELL
SO WE REALLY TRY TO MAKE SURE
THAT WE COMMUNICATE WITH ALL OF
OUR PARTNERS OUR EXPECTATION OF
DIVERSE RESEARCH AND THEN WE DO
HAVE OUR SITES -- THEY ARE
PROVIDED WITH DEMOGRAPHIC
OBJECTIVES, SO WHEN THEY ARE
DOING A STUDY, WE'VE ALIGNED
WITH WHAT THEIR PATIENT
POPULATION IS AND PROVIDE THEM
OBJECTIVES TO MEET DURING THE
STUDY, AND ALONG THE STUDY WE
PROVIDE BENCHMARKS TO MAKE SURE
THEY'RE MEETING THAT.
EXCITED TO BE ON THIS PAM AND
PANEL ANDHEAR FROM OTHER PERSPES
WELL.
>> TERRIFIC.
DR. EMBI, WOULD YOU MIND GOING
ABOUT NEXT, ABOUT 60 SECONDS OF
INTRO STUFF?
>> SURE, HAPPY TO.
HI, EVERYONE.
PETER EMBI, DEPARTMENT CHAIR OF
BIOMEDICAL INFORMATICS AND
SENIOR VICE PRESIDENT HERE AT
VANDERBILT UNIVERSITY MEDICAL
CENTER.
ACTUALLY CUBAN AMERICAN AND
PHYSICIAN AND A RESEARCHER AND
MY RESEARCH IN PARTICULAR HAS
BEEN ON HOW WE CAN IMPROVE
RECRUITMENT AND PARTICIPATION IN
CLINICAL TRIALS AND TO DO THAT
VERY BROADLY TO BE ABLE TO HAVE
THE BEST EVIDENCE POSSIBLE TO BE
ABLE TO TREAT ALL OF OUR PEOPLE,
OF COURSE IN THE U.S., BUT
ABROAD AS WELL.
IT DOESN'T GO WITHOUT SAYING
GENERALLY BUT IN THIS GROUP IT
MIGHT, THAT IF WE'RE NOT
INCLUSIVE AND REALLY EMBRACE THE
IMPORTANCE OF DIVERSITY AND
INCLUSIVENESS IN OUR TRIALS THEN
WE DON'T GET THE EVIDENCE WE
NEED TO ACTUALLY TAKE CARE OF
EVERYONE.
TOO MANY OF OUR CLINICAL TRIALS
AND CLINICAL RESEARCH STUDIES
ARE VERY SKEWED IN THE WAY THAT
OUR DEMOGRAPHICS ARE REPRESENTED
AND, THEREFORE, THE RESULTS FROM
THOSE STUDIES ARE NOT APPLICABLE
TO SO MANY OF OUR POPULATION,
INCLUDING SOME OF THE MOST NEEDY
YOU ANDSERVED AMONG US.
YOUNEEDYAND UNDERSERVED AMONG U.
IN TERMS OF HOW WE RUN THINGS AT
INSTITUTIONS LIKE VANDERBILT AND
OTHERS, WE WORK VERY CLOSELY
WITH COLLABORATORS AT OTHER
INSTITUTIONS AND WE HAPPEN TO BE
A PART OF, FOR INSTANCE, A
COLLABORATION RIGHT NOW WITH --
THAT IS ACTUALLY SPONSORED BY
FAR THAT CALLED EQUITABLE
BREAKTHROUGHS IN MEDICINE
DEVELOPMENT, WHERE WE ARE
WORKING ON SCIENTIFIC STUDIES
AND LEARNING SYSTEMS AND
APPROACHES TO REALLY DO REAL
WORLD ANALYSIS AND STUDY OF HOW
DO WE REALLY FOCUS ON DIFFERENT
WAYS THAT WE NEED TO BE ENGAGING
WITH UNDERSERVED,
UNDERREPRESENTED COMMUNITIES,
AND WE KNOW THAT THE WAY WE HAVE
TO APPROACH THAT IS
FUNDAMENTALLY DIFFERENT TO THE
WAY WE'VE BEEN DOING IT
TRADITIONALLY IN ORDER TO BE
ABLE TO OVERCOME THE DISPARITIES
WE SEE IN OUR CLINICAL RESEARCH
ENTERPRISE.
SO HAPPY TO TALK ABOUT THAT AND
OTHER THINGS AS WE MOVE FORWARD.
THANK YOU, BOB.
>> TERRIFIC.
THANK YOU.
DR. CALIFF, THANKS FOR JOINING
US TODAY.
DO YOU MIND SAYING ABOUT
60 SECONDS OF INTRO TO THE
AUDIENCE TODAY?
>> THANKS.
GOOD TO BE WITH YOU.
I AGREE WITH MY COLLEAGUE FROM
ATLANTA, THE POLLEN IS PROFOUND
HERE IN DURHAM, NORTH CAROLINA,
BACK HOME FOR THE WEEKEND.
SO HOPEFULLY THE VOICE WILL HOLD
UP HERE IN THE MIDST OF ALL THIS
BUT IT'S BEAUTIFUL, I HAVE TO
SAY.
I'LL JUST ADD A BIT HERE OF
PERSPECTIVE.
I'VE BEEN ON ALL SIDES OF THE
FENCE.
I'VE BEEN IN ACADEMIA, I'VE BEEN
A PATIENT IN CLINICAL TRIALS,
I'VE BEEN IN THE INDUSTRY,
INCLUDING THE TECH AND THE
BIOMEDICAL INDUSTRY.
NOW OF COURSE I'M IN THE
REGULATORY SPHERE AND I THINK
WE'RE ALL -- I FEEL LIKE
TREMENDOUS PROGRESS HAS BEEN
MADE BUT WE'VE STILL GOT A LONG
WAY TO GO IN TERMS OF
UNDERSTANDING INCLUSIVENESS AND
ALL OF ITS DIMENSIONS.
QUICKLY TO POINT OUT AT FDA,
THERE'S A BIG FOCUS ON PATIENT
FOCUSED DRUG DEVELOPMENT AND
DEVICE DEVELOPMENT, AND AN
ENORMOUS INTEREST IN MEASURING
QUALITY OF LIFE AND PREFERENCES
AND OTHER ASPECTS OF HOW PEOPLE
ARE DOING WITH THEIR DISEASES
AND THE DIAGNOSTIC TESTS AND
INTERVENTIONS RELATED TO THEM.
BUT I WANTED TO MENTION THAT MAY
NOT OTHERWISE COME OUT THAT I
THINK IS REALLY IMPORTANT, WE'RE
REGULATING GLOBAL INDUSTRIES,
AND IF WE LOOK AT THE GLOBAL
MEDICAL PRODUCTS INDUSTRY, THERE
ARE 8 BILLION PEOPLE IN THE
WORLD NOW.
WE'RE ABOUT 4% OF THE WORLD'S
POPULATION.
SO WHEN WE START TALKING ABOUT
INCLUSIVENESS WITH THE
INDUSTRIES THAT WE REGULATE,
OVER 250 ETHNICITIES, FOR
EXAMPLE, AROUND THE WORLD, WE
RUN INTO MANY ISSUES OF HOW TO
GET THE TRIALS DONE, HOW BIG
SHOULD THEY BE, WHAT DO WE
REALLY MEAN BY INCLUSIVENESS
WHEN WE'RE DEALING WITH AN
INDUSTRY THAT'S DISTRIBUTING AND
SELLING PRODUCT ALL OVER THE
WORLD.
I'M NOT PRETENDING TO HAVE
ANSWERS TO ALL THAT BUT IT'S
SOMETHING WE'RE REALLY GRAPPLING
WITH RIGHT NOW.
>> TERRIFIC.
THANK YOU, DR. CALIFF.
APPRECIATE THAT.
DR. COOK, LET ME GIVE YOU
60 SECONDS FOR A QUICK INTRO.
>> THANK YOU.
AND GOOD AFTERNOON, EVERYONE.
IT'S SUCH A PLEASURE TO BE HERE.
I'M NAKELA COOK, EXECUTIVE
DIRECTOR AT PCORI.
WE'RE AN INDEPENDENT RESEARCH
FUNDING ORGANIZATION THAT
FULFILLS REALLY WHAT I THINK IS
A UNIQUE SPACE IN THE RESEARCH
ECOSYSTEM, AND OUR MISSION IS
REALLY ABOUT HELPING PEOPLE MAKE
INFORMED HEALTHCARE DECISIONS
AND IMPROVE HEALTHCARE DELIVERY
THROUGH RESEARCH THAT'S GUIDED
BY PATIENTS, CAREGIVERS AND THE
BROADER HEALTHCARE COMMUNITY,
AND IT'S REALLY THAT LATTER
PIECE THAT WE THINK MAKES US
QUITE UNIQUE IN THE RESEARCH
ECOSYSTEM.
WE CALL THIS RESEARCH DONE
DIFFERENTLY.
AND AT THE HEART OF THIS
RESEARCH DONE DIFFERENTLY IS THE
ENGAGEMENT OF PATIENTS AND
CAREGIVERS AND CLINICIANS AND
OTHER STAKEHOLDERS THROUGHOUT
THE ENTIRE RESEARCH PROCESS.
AND IN SOME WAYS, THIS WHOLE
PATIENT-CENTERED APPROACH TO
OUTCOMES IN CLINICAL COMPARATIVE
EFFECTIVENESS RESEARCH HELPS US
TO THINK ABOUT THE ISSUES OF
EQUITY AND WE TALK ABOUT THIS
APPROACH BEING INHERENTLY
EQUITY-MINDED BECAUSE IT REALLY
TAKES INTO ACCOUNT THE VOICES
AND THE LIVED EXPERIENCES OF ALL
PEOPLE TO EP BE SURE THAT THE EE
FUNDING IS REALLY ABOUT WHAT
MATTERS MOST TO THE PEOPLE WE'RE
TRYING TO BENEFIT.
SO MAYBE I'LL PAUSE THERE AND I
LOOK FORWARD TO TALKING ABOUT
THAT MORE.
>> TERRIFIC.
THANK YOU VERY MUCH.
AND LAST BUT OF COURSE NOT
LEAST, MS. LURAY, WOULD YOU LIKE
TO PROVIDE A FEW INTRODUCTORY
COMMENTS AS WELL?
>> SURE.
THANK YOU SO MUCH.
WHAT A PANEL TO FOLLOW.
I'M STILL BUZZED, AND WROTE DOWN
MANY THINGS THAT THE REVEREND
SAID AND OTHERS FROM THAT LAST
PANEL.
JUST FABULOUS.
BUT RESEARCH!AMERICA IS AN
ALLIANCE OF OVER 300
ORGANIZATIONS AND INSTITUTIONS
THAT REPRESENT DIFFERENT ASPECTS
OF THE MEDICAL AND PUBLIC HEALTH
ECOSYSTEM INCLUDING MANY OF THE
FOLKS ON THE SCREEN TODAY.
ACADEMIA, INDUSTRY, PATIENT
ADVOCACY GROUPS, SCIENTIFIC
SOCIETIES.
WE'RE DELIGHTED TO BE PART OF
THIS.
WE WORK CLOSELY WITH DR. CALIFF
AND DR. COOK BOTH OF THOSE
AGENCIES AS WELL AS NIH HAVE
CRITICAL ROLES TO PLAY IN REALLY
MAKING PROGRESS ON THIS ISSUE.
AND ONE OF THE THINGS I'D LIKE
TO TALK ABOUT LATER IS THOSE OF
US WHO ARE WORKING AT THE
NATIONAL LEVEL, HOW CAN WE
SUPPORT THE REALLY IMPORTANT
WORK THAT HAS TO HAPPEN AT THE
COMMUNITY LEVEL.
THANKS.
>> TERRIFIC.
WELL, THANK YOU ALL FOR SHARING
YOUR PERSPECTIVES WITH OUR
AUDIENCE.
LET ME ENCOURAGE THE AUDIENCE TO
SEND IN THEIR QUESTIONS.
BUT IN THE MEANTIME, I'M GOING
TO START OFF WITH A QUICK
QUESTION FOR ALL OF YOU.
OVER THE LAST TWO DAYS, WE'VE
HEARD MULTIPLE PERSPECTIVES ON
HOW TO TAKE CLINICAL RESEARCH
AND MAKE IT MORE INCLUSIVE,
INCLUDING SHIFTING THE BALANCE
OF POWER BETWEEN INSTITUTIONS TO
COMMUNITIES, CHANGING THE
DYNAMIC THERE OR THE PARADIGM.
FROM YOUR PERSPECTIVE, YOU KNOW,
HOW CAN YOU SEE MULTIPLE
ENTITIES ACROSS ACADEMIC
INSTITUTIONS, COMMUNITY-BASED
ORGANIZATIONS, PHARMACEUTICAL
COMPANIES, FUNDING
ORGANIZATIONS, EVERYBODY WHO'S
IN THIS SPACE, HOW CAN YOU SEE
OPPORTUNITIES FOR THEM TO
COLLABORATE, TO EFFECTIVELY
IMPROVE RECRUITMENT AND
RETENTION?
BECAUSE IT'S ALL ABOUT
RELATIONSHIPS, AS WE HEARD IN
OUR LAST PANEL TOO.
WHAT IDEAS DO YOU HAVE ABOUT
BROADER COLLABORATION?
JENNY, I'M GOING TO YO TURN TO U
FIRST IF THAT'S OKAY SINCE THIS
IS REALLY IN RESEARCH!AMERICA'S
SPACE.
>> SURE.
ONE WAY THAT WE ARE
COLLABORATING ALREADY IS IN
TERMS OF FEDERAL POLICY.
SO SOME OF THE POLICIES THAT DRS
WILL BE IMPLEMENTING AROUND
CLINICAL TRIAL DIVERSITY IN THE
LAST USER FEE AGREEMENT IS
SOMETHING WE'VE WORKED ON, SOME
OF THE WORK THAT PCORI IS DOING,
THE PATIENT FOCUSED DRUG
DEVELOPMENT PROVISIONS, THE
ADOPTION OF REAL WORLD EVIDENCE
AND REAL WORLD DATA WHERE YOU
CAN ACTUALLY INVOLVE PATIENTS IN
CLINICAL TRIALS WHILE THEY'RE
SITTING IN THE DOCTOR'S OFFICE.
SO THOSE SORTS OF POLICIES ARE
THINGS THAT WE AND OUR ALLIANCE
MEMBERS ARE WORKING ON.
>> TERRIFIC, THANK YOU.
ANYBODY ELSE WANT TO WEIGH IN ON
THIS ONE?
COLLABORATION, WHAT IDEAS DO YOU
HAVE FOR COLLABORATION?
BRITTANY, YOU GO.
>> WANT TO ADD IN ALSO, GREAT
WITH REGULATORY, BUT I THINK US
COLLABORATING, JUST HAVING MORE
ACCESS OF THE INVESTIGATORS
DOING THE TRIALS.
IN A CLINICAL OPERATION, IT'S
THE SAME PIs OVER AND OVER
AGAIN, SO IF WE CAN EXPAND WHO
CAN BE AN INVESTIGATOR.
I KNOW THERE'S A COUPLE
INITIATIVES TO TRAIN YOUNG
PHYSICIANS TO BE INVESTIGATORS.
THAT CAN HELP EXPAND WHAT
COMMUNITIES THEY HAVE ACCESS TO.
THAT'S SOMETHING WE CAN HELP
ACROSS THE BOARD, WHETHER IT'S
ACADEMIC CENTERS, REALLY
IDENTIFYING AND NURTURING AND
JUST REALLY BRINGING UP NEW
INVESTIGATORS OR EVEN
INVESTIGATORS THAT HAVE BEEN
PRACTICING FOR YEARS, HAVING THE
OPPORTUNITY TO BE A PRINCIPAL
INVESTIGATOR, TO BRING THEM INTO
RESEARCH TO HAVE ACCESS TO MORE
WIDE COMMUNITIES.
>> LOVE THAT.
DR. CALIFF, DID YOU WANT TO JUMP
IN?
>> SURE.
I USUALLY PLAY THE ROLE OF BEING
THE DOWNER IN THE GROUP.
I'M GOING TO GO AHEAD AND DO IT
AGAIN.
I CAN'T RESIST IT.
IT'S PART OF MY PERSONALITY AND
JOB, I THINK.
I MEAN, I THINK THE LAST PANEL
DID A REALLY GOOD JOB OF SAYING
ONE OF THE MANY THINGS THAT CAME
OUT WAS, WE HAVE STRUCTURAL
ISSUES IN OUR HEALTHCARE SYSTEM
THAT PLAY OUT IN MULTIPLE
DIRECTIONS FOR PEOPLE THAT ARE
ADVERSE AND AMONG THEM IS
CLINICIANS ON THE FRONT LINES
TRYING TO PARTICIPATE IN
CLINICAL RESEARCH.
IT IS REALLY HARD RIGHT NOW.
THE INCENTIVES ARE ALIGNED
AGAINST SPENDING THE TIME DOING
IT.
THE PRACTICE LOSES MONEY, THEY
GET BEAT UP BY THEIR
ADMINISTRATORS.
IT GOES ON AND ON.
AND WE'RE VERY MUCH SEEING THIS
NOW.
SO IF WE WANT TO COLLABORATE,
IT'S NICE TO SAY GOOD THINGS.
I'M ALL FOR IT AND YOU ALL ARE
REALLY GOOD AT GENERATING
ENTHUSIASM, WHICH YOU REALLY
NEED, BUT UNLESS WE MAKE
PROGRESS IN THESE STRUCTURAL
AREAS LIKE WHAT ARE WE
PRACTICALLY GOING TO DO WITHIN
HEALTH SYSTEMS TO GIVE
CLINICIANS TIME TO TALK WITH
THEIR PATIENTS ABOUT INCLUDING
THEM IN CONVERSATIONS THAT TAKE
TIME?
>> TERRIFIC.
PETER, I SEE YOU ITCHING TO GET
IN.
HOP IN ON THIS ONE.
>> I COULDN'T AGREE MORE WITH
WHAT'S BEEN SAID.
I'LL JUST ADD A LITTLE BIT FROM
OUR RECENT EXPERIENCE TRYING TO
WORK ACROSS A MULTIDISCIPLINARY
TEAM TO ADDRESS SOME OF THIS IN
THIS PILOT FASHION THAT WE'RE
DOING NOW WITH THIS LEARNING
COLLABORATIVE.
I THINK AS -- JUST TO BUILD ON
DR. CALIFF'S POINTS, I THINK THE
LIMITED ACCESS TO TRIALS IS AN
ISSUE.
ESPECIALLY FOR HISTORICALLY
UNDERREPRESENTED COMMUNITIES.
JUST BEING ABLE TO ACTUALLY HAVE
THE OPPORTUNITY TO BE ASKED IS A
LIMITATION, AND OF COURSE THAT
MEANS GETTING OUT INTO THOSE
COMMUNITIES AND ACTUALLY BEING
ABLE TO DO THAT IN A WAY THAT IS
INFORMED BY WHAT IT IS THE
MEMBERS OF THOSE COMMUNITIES
ACTUALLY WANT TO HEAR AND HOW
THEY WANT TO HEAR IT, AND IT
REALLY REQUIRES A RECOGNITION
THAT THAT REALLY IS A
COLLABORATIVE ACTIVITY WHERE
WE'VE GOT TO BRING PEOPLE TO THE
TABLE.
WE LEARNED A LOT OF THIS DURING
COVID IN TERMS OF BEING ABLE TO
DO CERTAIN KINDS OF ACTIVITIES
WELL AND NOT SO WELL.
AS WAS MENTIONED, THE LIMITATION
IN DIVERSITY OF THE
INVESTIGATORS AND THE STAFF WHO
SERVE THESE COMMUNITIES IS A
CRITICAL PART OF THIS.
AND SO HOW ARE WE GOING TO FUND
THAT, HOW ARE WE GOING TO
SUSTAIN IT.
A LOT OF THE INSTITUTIONS AND
GROUPS THAT COULD DO THIS, THE
OTHER PROBLEM IS, I THINK AGAIN
DR. CALIFF WAS MENTIONING THIS,
VERY LIMITED RESOURCES, SO WHAT
HAPPENS IS YOU MIGHT RAMP UP AND
HAVE CAPABILITIES FOR A
PARTICULAR STUDY, BUT THEN THE
SPONSORSHIP GOES AWAY, THE STUDY
GOES AWAY AND THE PERSONNEL
DON'T HAVE A JOB ANYMORE AND NOW
YOU'VE GOT TO START AGAIN FROM
GROUND ZERO.
AND SO HOW ARE WE GOING TO MAKE
THAT SUSTAINABLE?
AND DEAL WITH THE FINANCIAL AND
TIME BURDENS AS WAS MENTIONED,
AND THEN, OF COURSE, THERE'S THE
ISSUE OF MISTRUST OR DISTRUST OR
MISUNDERSTANDING AND THE ONLY
WAY TO DO THAT IS TO HAVE THIS
BE SOMETHING THAT IS REALLY
DRIVEN FROM THE COLLABORATIVE
INCLUDING MOST IMPORTANTLY THE
COMMUNITIES THEMSELVES.
>> CAN I DROP IN?
>> YES, PLEASE.
>> QUICKLY.
I JUST WANTED TO TALK ABOUT THE
IMPORTANT ROLE OF HBCUs AND
OTHER SO CALLED MINORITY SERVING
INSTITUTIONS.
AS HBCUs, WE'LL BE GETTING
ADDITIONAL RESEARCH FUNDING FROM
THE FEDERAL GOVERNMENT, LONG
OVERDUE.
THEY HAVE FABULOUS MODELS FOR
COMMUNITY ENGAGEMENT IN CLINICAL
TRIALS, AND WE REALLY NEED TO
SUPPORT THOSE INSTITUTIONS FAR
MORE THAN WE ARE NOW.
THEY REALLY ARE WHERE THE RUBBER
MEETS THE ROAD.
OTHER INSTITUTIONS CAN LEARN
FROM THEM BUT PROBABLY CAN'T
REPLICATE THE LEVEL OF COMMUNITY
RELATIONSHIP THAT THEY HAVE.
SO I JUST WANTED TO MENTION
THOSE INSTITUTIONS.
>> IF I COULD JUST ACCENTUATE
THAT, YOU KNOW, JUST WITH A
CONCRETE EXAMPLE, I TOTALLY
AGREE, FOR INSTANCE HERE IN
NASHVILLE, WE'RE WORKING CLOSELY
WITH OUR COLLEAGUES AT MAHERIA,
A HISTORICALLY BLACK MEDICAL
SCHOOL, AND IN TALKING TO THEM,
WHILE YOU'RE 100% CORRECT IN
TERMS OF THE CONNECTION, AND
THEY'RE GOING TO BE ABLE TO DO
THIS FROM A MUCH BETTER POSITION
THAN, LET'S SAY, VANDERBILT
UNIVERSITY COULD, THERE'S ALSO
RESOURCE LIMITATIONS AND ISSUES
OF UNDERFUNDING AND SUPPORT THAT
ARE MISSING.
AND SO REALLY GETTING DOWN TO
THE LEVEL OF REALLY FIGURING OUT
HOW DO WE FIX THAT, HOW DO WE
MAKE THAT SOMETHING THAT'S
SUSTAINABLE AND CAN ACTUALLY BE
FUNCTIONAL IS WHAT WE'RE
FOCUSING ON.
BECAUSE YOU'RE RIGHT, WE HAVE TO
ENABLE AND EMPOWER THOSE
ENTITIES, BUT WE ALSO HAVE TO
RECOGNIZE THAT THEY NEED MORE
SUPPORT AND FUNDING TO DO THAT
WORK.
>> THAT'S GREAT.
DR. COOK, PCORI HAS BEEN LEADING
THE CHARGE ON PATIENT
ENGAGEMENT.
CAN YOU WEIGH IN ON THE PATIENT
COLLABORATION QUESTION?
>> I THINK WE ALL REPRESENT
THINGS THAT HAVE MORE ENTRY INTO
THIS RESEARCH CONTINUUM THAT THE
ISSUES WE'RE TALKING ABOUT ARE
GOING TO NEED OUR COLLECTIVE
WISDOM, EXPERTISE AS WELL AS
EFFORTS.
ONE OF THE THINGS I THINK KIND
OF UNITES A LOT OF THE
DISCUSSION HAS BEEN AROUND THE
ENGAGEMENT OF PATIENTS AND
COMMUNITIES, BUT THAT HAS TO
COME WITH A STRONG ENGAGEMENT
INFRASTRUCTURE AS WELL, AND SO
THAT MAY BE ANOTHER PLACE OF
COLLABORATION THAT WE COULD
REALLY THINK ABOUT, AND WE JUST
TALKED ABOUT HBCUs AS PART OF
THAT INFRASTRUCTURE, BUT I THINK
THAT KIND OF SUPPORT AND
TRAINING CAPACITY BUILDING ON
BOTH THE SIDE OF COMMUNITIES AS
WELL AS RESEARCHERS TO REALLY
UNDERSTAND WHAT ENGAGED RESEARCH
AND INCLUSIVE RESEARCH LOOKS
LIKE AND HOW IT'S CONDUCTED IS
GOING TO BE CRITICAL.
SO I MAY ALSO MENTION THAT PCORI
HAS TRIED TO DO SOME OF THIS
WORK WITH SUPPORTING THE TYPE OF
CAPACITY BUILDING OPPORTUNITIES
THAT ALLOW FOR COMMUNITIES AND
PATIENTS TO RAISE THE ISSUES OF
IMPORTANCE TO THEM, AS WELL AS
THINK ABOUT WHAT'S NECESSARY FOR
THEM TO PARTICIPATE FULLY IN THE
RESEARCH ENTERPRISE.
AND I THINK THAT'S GOING TO BE
CRITICAL FOR US TO REALLY
ADDRESS SEVERAL OF THESE ISSUES.
>> IT'S SO IMPORTANT, ACTUALLY
AT THE NETWORKING SESSION LAST
NIGHT, I MET A COUPLE OF EARLY
STAGE INVESTIGATORS WHO WERE
INSPIRED BY MANY OF THESE
CONVERSATIONS, BUT REALLY WANT
TO KNOW WHAT KIND OF SUPPORT IS
GOING TO BE THERE FOR THEM.
THEY'RE THE PIPELINE FOR OUR
FUTURE, AND HOW CAN WE HELP
SUPPORT THEM.
OLGA, I WANT TO TURN TO YOU REAL
QUICK.
YOU'VE BEEN KEEPING AN EYE ON
THE CHAT.
ARE THERE SOME QUESTIONS YOU
WANT TO BRING FORWARD FOR OUR
PANEL?
>> THERE ARE BASICALLY TWO MAIN
THEMES THAT I'VE BEEN SEEING IN
THE MANY QUESTIONS AND COMMENTS
THAT ARE COMING IN.
AND I THINK THAT ONE OF THEM IS
REALLY SPEAKING TO DEVELOPING
THE RESOURCES AND
INFRASTRUCTURE, AND I THINK THAT
EVERYBODY DOES AGREE THAT THESE
THINGS DO NEED TO BE BUILT UPON,
PARTICULARLY FROM THE LAST
PANEL'S COMMENTS ON NOT HAVING
SO MUCH OF A TRANSACTIONAL
RELATIONSHIP WITH HBCUs THAT
IT'S LOPSIDED.
SO HOW SPECIFICALLY HOW WOULD
YOU ALL SUGGEST TO CREATE THOSE
OPPORTUNITIES, AND THEN THE
SECOND ONE, I CAN PROVIDE
WHENEVER YOU FEEL WE HAVE TIME
FOR THAT.
>> TERRIFIC.
WHO'D LIKE TO GO FIRST?
>> I'D BE HAPPY TO.
>> GO AHEAD, NAKELA.
>> I'D BE HAPPY TO JUMP IN
BECAUSE YOU KNOW, I THINK WE
CERTAINLY HAVE SEEN THAT THERE
IS A NEED FOR THESE TYPES OF
RESOURCES FOR ALL MEMBERS OF A
MULTI-STAKEHOLDER RESEARCH TEAM,
RIGHT, AND SO I THINK THAT'S ONE
OF THE POINTS THAT OLGA WAS JUST
POINTING OUT, IS THAT AS MUCH
NEEDED FOR IN TERMS OF
INFRASTRUCTURE FOR RESEARCHERS
AS IT IS FOR COMMUNITIES TO
THINK ABOUT HOW TO DO THIS
DIFFERENTLY.
SO WE'VE ACTUALLY STARTED TO PUT
TOGETHER SOME MODULES THAT HELP
TO START TO BUILD AN
UNDERSTANDING OF WHAT THIS WORK
IS REALLY ABOUT.
WE HAVE SOMETHING CALLED A
RESEARCH FUNDAMENTALS COURSE
THAT IS MORE LIKE A
COMPREHENSIVE TRAINING TO
PROVIDE THE WAYS THAT COMMUNITY
MEMBERS AND OTHERS CAN LEARN
ABOUT THE RESEARCH PROCESS AND
HOW TO BE INVOLVED IN THE
RESEARCH PROCESS, BUT THEN WE
ALSO HAVE MODULES AROUND
BUILDING MULTI-STAKEHOLDER
RESEARCH TEAMS TO THINK ABOUT
HOW ARE YOU EFFECTIVE PARTNERS
AND COLLABORATING AND REALLY
SHARING THE PARTNERSHIP OF
THINGS LIKE AUTHORITY AND
DECISION-MAKING IN THE PROCESSES
OF RESEARCH, AND THAT REALLY
REQUIRES A NEW PARADIGM SHIFT
FOR RESEARCHERS AS WELL AS AN
INTRODUCTION INTO HOW THIS WORKS
FOR COMMUNITY MEMBERS AND
PATIENTS TO FEEL EMPOWERED IN
THE RELATIONSHIP.
AND THEN WE ALSO HAVE RECOGNIZED
THAT THERE ARE SOME OTHER TOOLS
AND RESOURCES THAT COULD HELP IN
THIS INFRASTRUCTURE THAT HAVE
BEEN DEVELOPED BY A LOT OF
AWARDEES WHO HAVE WORKED IN THIS
SPACE BEFORE, AND WE'VE CREATED
THIS REPOSITORY OF TOOLS AND
RESOURCES THAT ARE AVAILABLE ON
OUR WEBSITE AND THEN USED IN
RESEARCH PROJECTS THAT I THINK
COULD BE A RESOURCE MORE
BROADLY.
MAYBE I'LL PAUSE AND SEE IF
OTHERS WANT TO CHIME IN.
>> THANK YOU.
OTHERS WANT TO WEIGH IN?
>> PCORI IS OFTEN ON THE FRONT
END OF MAKING REALLY CRITICAL
RESEARCH RESOURCES AVAILABLE TO
THE COMMUNITY.
BUT PLEASE.
>> THIS TO A LARGE EXTENT IS WHY
PCORI WAS CREATED, SO I'M REALLY
GLAD TO SEE DR. COOK AND
COLLEAGUES ARE DOING WHAT THEY
WERE INTENDED TO DO.
IT'S SHOWING THE WAY.
BUT I THINK THE NEXT QUESTION
IS, HOW DO YOU WEAVE THIS INTO
THE FABRIC OF THE WORK THAT'S
GOING ON IN OUR HEALTH SYSTEMS
ACROSS THE COUNTRY.
I THINK THAT'S BEEN A TOUGHER
NUT TO CRACK.
BUT YOU KNOW, FOR EXAMPLE, IT
MIGHT BE GOOD IF THERE WAS A
PAYMENT FOR PARTICIPATION IN
RESEARCH, BUT IT ALSO MEANS THAT
THE HEALTH SYSTEMS OR THOSE
DOING RESEARCH HAVE TO REACH OUT
MUCH FURTHER, AS WAS MENTIONED
IN THE LAST PANEL.
I KNOW, PETER, THAT VANDERBILT
HAS BEEN DOING A LOT OF THIS
STUFF SO YOU MAY HAVE SOMETHING
TO SAY THERE.
>> YEAH, ABSOLUTELY.
I THINK, YOU KNOW, I THINK
YOU'RE ALLUDING TO IT AS WELL,
AND FRANKLY WE LIVE IN A HEALTH
SYSTEM RIGHT NOW WHERE A LOT OF
RESEARCH ACTIVITIES ARE
SUBSIDIZED BY CLINICAL WORK,
RIGHT?
AND SO TO A DEGREE, THERE IS A
HAVES VERSUS HAVE NOT SITUATION
THAT WE'RE DEALING WITH AND SO
HAVING RESOURCES LIKE THE ONES
THAT ARE COMING OUT AT PCORI ARE
CRITICAL, BUT HAVING THE
INFRASTRUCTURE AND THE
SUSTAINABLE INFRASTRUCTURE IS
OFTEN THE DIVIDE, BECAUSE YOU'LL
HAVE INSTITUTIONS THAT ARE THE
MORE TRADITIONAL PLACES WHERE
RESEARCH TAKES PLACE WHERE
THERE'S ENOUGH OF A DIVERSITY OF
FUNDING AND CAPABILITY TO BE
ABLE TO SUSTAIN THE
INFRASTRUCTURE BECAUSE OF THIS
DIVERSE FUNDING PORTFOLIO, AND
THAT AS WE CONTINUE TO ENGAGE
WITH RESEARCH CENTERS AT
MINORITY INSTITUTIONS AND OTHER
PLACES, IT'S INCREASINGLY
EVIDENT THAT THAT'S A BIG
DIVIDE.
THE TECHNOLOGY INFRASTRUCTURE IS
NOT THE SAME, THE RESOURCES FOR
PERSONNEL AND SUSTAINING THAT
TBEEN DIFTHATBETWEEN DIFFERENT T
THE SAME.
THE TURNOVER THAT TAKES PLACE
AND HAVING PEOPLE WHO CAN
ACTUALLY TRANSLATE MATERIALS
INTO DIFFERENT LANGUAGES AND
MAKE THEM AVAILABLE AND ENGAGE
WITH THE COMMUNITIES, ALL THOSE
THINGS ARE EXPENSIVE, AND OFTEN
NOT AVAILABLE BECAUSE THE
PARADIGM IS SORT OF BUILT ON A
PARADIGM THAT EXPECTS SOME OF
THE LARGER ACADEMIC HEALTH
CENTERS AS SORT OF WHAT WE'RE
DEALING WITH.
SO I THINK ONE OF THE THINGS
WE'RE LEARNING IS IF WE'RE GOING
TO OVERCOME THE DISPARITIES,
WE'VE GOT TO BE LOOKING AT THIS
FROM A VERY DIFFERENT
PERSPECTIVE, AND OF COURSE THE
PEOPLE WHO ARE GOING TO INFORM
THAT ARE THE ONES WHO ARE LIVING
THIS ON THE GROUND AT THE
HBCUs AND OTHER PLACES.
SO I THINK THAT'S BEEN THE
CONVERSATION THAT WE'RE HAVING
NOW TO FIGURE OUT WHAT ARE THOSE
LOGISTICAL AND RESOURCE GAPS AND
THEN WHERE DO THE RESOURCES AND
DOLLARS NEED TO BE SPENT AND HOW
DOES THAT THEN BACK UPSTREAM AND
HOW WE FUND THE OVERALL
ENTERPRISE.
>> I WANTED TO ADD TO SOMETHING
WE DISCUSS AT MODERNA, OF COURSE
WE WANT MORE EXPERIENCED
INVESTIGATORS BUT NOT FOR
MODERNA TRIALS, SO HOW DO WE
WORK WITH OUR INDUSTRY PARTNERS
TO MAKE SURE WE'RE ENCOURAGING
MORE INVESTIGATE ARES TO TO HAVE
ACCESS TO ALL TRIALS, SO REALLY
JUST KIND OF FIGURE OUT HOW WE
CAN SUPPORT THAT BUT ALSO FOR
EVERYONE ELSE, IT'S SOMETHING
WE'RE KIND OF TRYING TO FIGURE
OUT BECAUSE AGAIN, WE WOULD LOVE
FOR THEM TO WORK ON MODERNA
TRIALS, BUT WE WANT THEM TO WORK
ON ALL TRIALS AS WELL, SO REALLY
UNDERSTANDING THOSE LOGISTICS OF
HOW WE SUPPORT NEW INVESTIGATORS
BUT WE SUPPORT THEM AS AN
INDUSTRY AND NOT JUST ONE
COMPANY HERE AND THERE.
>> THESE ARE GREAT.
ACTUALLY I JUST WONDERED,
THERE'S A LONG QUESTION IN THE
CHAT FOR DR. CALIFF.
BEFORE WE GET TO THAT ONE,
DR. CALIFF IF I COULD ASK YOU,
BECAUSE YOU HAVE A NATIONAL AND
GLOBAL PERSPECTIVE, WHICH YOU
SAID AT THE OUTSET, ARE THERE
THINGS WE CAN LEARN FROM OUR
PARTNERS ACROSS THE GLOBE ABOUT
HOW TO DO THIS?
ARE THERE ANY GOOD MODELS OUT
THERE?
>> UM, YOU KNOW, I WOULD SAY THE
MODELS ARE DEPENDENT ON THE
PURPOSE AND THERE'S SO MANY
FACTORINGS IN PLAY, IT'S VERY
HARD TO GENERALIZE.
BUT I'D SAY THE U.S. IS
PARTICULARLY GOOD AT INDUSTRIAL
STRENGTH HIGH-TECH EARLY PHASE
RESEARCH AND PARTICULARLY BEHIND
THE CURVE IN LARGE PRAGMATIC
STUDIES WHERE OUR EUROPEAN
COLLEAGUES CLEETION AND OUR COLN
COLLEAGUES ARE BETTER EQUIPPED
BECAUSE THEIR HEALTH SYSTEMS ARE
DESIGNED TO BE MORE EQUITABLE
AND REACH INTO EVERY SECTION.
I JUST READ A FABULOUS ARTICLE
ABOUT THE DECLINE OF LIFE
EXPECTANCY IN THE U.S., WHICH IS
STARKLY DIFFERENT THAN ALL THE
OTHER COUNTRIES THAT WE'RE
TALKING ABOUT, AND I THINK IT'S
FOR ALL THE SAME REASONS THAT
RESEARCH IS HARD TO DO HERE.
WE'RE NOT DELIVERING THE GOODS
OUT IN THE COMMUNITIES WHERE
IT'S NEEDED.
A POINT MADE IN THE LAST PANEL.
SO I THINK FOR THE FDA
PERSPECTIVE, I HAVE TO ASK THE
QUESTION, WHY DID I HAVE TO CALL
ISRAEL TO FIGURE OUT WHAT TO DO
WITH THE NEXT VACCINE DOSE?
AND WHY DID I HAVE TO CALL THE
U.K. TO FIGURE OUT WHICH
TREATMENTS WERE EFFECTIVE FOR
COVID?
IT'S BECAUSE THEY HAD NATIONAL
SYSTEMS THAT ARE INTEGRATED,
DISTRIBUTED, AND MUCH MORE
EQUITABLE WITHIN THEIR
POPULATIONS.
BUT I COULD POINT OUT MANY
PROBLEMS WITH THEIR SYSTEMS TOO.
LIKE ISRAEL IS EQUITABLE FOR
SOME POPULATIONS BUT NOT OTHER
PARTS OF THE POPULATION.
SO I THINK THERE'S A LOT TO
LEARN FROM AROUND THE WORLD.
AND WE HAVE CERTAIN STRENGTHS IN
THE U.S. THAT OTHERS ENVY A LOT
AT THE SAME TIME.
>> TERRIFIC.
THANK YOU FOR THAT RESPONSE.
APPRECIATE THAT.
LET ME JUST THROW THIS OUT AS A
GENERAL QUESTION AND THEN --
OLGA, GIVE ME A HIGH 5 IF
THERE'S SOMETHING ELSE THAT YOU
THINK WE SHOULD ASK FROM THE
CHAT.
A QUESTION ABOUT DATA HAS BEEN A
BIG QUESTION, AND I KNOW IT'S
SOMETHING THAT'S OF INTEREST TO
MANY OF YOU.
WE'VE GOT LOTS OF DATA, I THINK,
AROUND THE -- ABOUT
REPRESENTATIVE, BUT IT'S
DIFFICULT TO ACCESS AND
MANIPULATE.
ANYBODY HAVE ANY STRATEGIES
ABOUT HOW WE MIGHT GET AT THAT
DATA TO UNDERSTAND WHAT'S GOING
ON UNDERNEATH THE SURFACE?
AND I'M LOOKING AT YOUR NICE --
THANK YOU, I CAN SEE DR. EMBI,
YOU'RE ALREADY READY TO GO WITH
THIS ONE.
>> AND I'M HAPPY TO JUMP IN
FIRST, BUT I KNOW MY COLLEAGUES
WILL ALL HAVE AN OPINION ABOUT
THIS, AND I'M PARTICULARLY
INTERESTED IN DR. CALIFF'S POINT
OF VIEW TOO, BUT I WILL TELL
YOU, IT SORT OF MIRRORS TO SOME
EXTENT WHAT ROB JUST SAID ABOUT
SORT OF THE -- WE HAVE A LOT OF
STRENGTHS IN THIS COUNTRY, BUT
AGAIN, THEY ARE APPLIED AND
AVAILABLE DIFFERENTIALLY,
DEPENDING ON WHO YOU ARE AND
WHERE YOU COME FROM, RIGHT?
SO WE KNOW THAT WHILE WE HAVE
VERY ROBUST DATA ASSETS AND THEY
CAN BE LEVERAGED AND THEY ARE
BEING LEVERAGED FOR DISCOVERY
AND RECRUITMENT AND ALL THE
OTHER THINGS WE'RE TALKING ABOUT
IN VERY INNOVATIVE AND EXCITING
WAY, THERE ARE ALSO LIMITATIONS
TO THOSE DATA THAT ARE -- THAT
BASICALLY INHERIT THE STRUCTURAL
AND SYSTEMIC RACISM AND OTHER
THINGS THAT EXIST IN OUR
SOCIETY, RIGHT, AND THE
DIFFERENTIAL IN TERMS OF PEOPLE
THAT HAVE HEALTHCARE COVERAGE
AND THOSE WHO DON'T, ET CETERA,
WE'RE SEEING THAT PLAY OUT NOW
AS WE'RE TRYING TO LEVERAGE THE
DATA FOR ARTIFICIAL INTELLIGENCE
TECHNOLOGIES WHERE WE SEAL BIAS
AND DISPARITIES GET SORT OF
BAKED IN.
THE SAME SORT OF THINGS HAPPENS
WHEN IT COMES TO IDENTIFYING AND
APPROACHES PEOPLE FOR CLINICAL
RESEARCH STUDIES.
WE'VE ACTUALLY HAD STUDYS THAT
INADVERTENTLY DEMONSTRATE THAT
WHEN YOU START TO USE
TECHNOLOGIES AND CAPABILITY AND
DATA TO BETTER IDENTIFY PEOPLE
WHO MIGHT BE ELIGIBLE FOR
STUDIES, YOU CAN ACTUALLY, IN A
REVERSE FASHION TO WHAT YOU
MIGHT INTEND, INCREASE
RECRUITMENT OF THOSE WHO ARE THE
HAVES OVER THE HAVE-NOTS BECAUSE
YOU JUST HAVE BETTER DATA ABOUT
THEM.
SO ONE OF THE THINGS WE HAVE TO
ADDRESS IS, HOW DO WE EVEN THAT
PLAYING FIELD WHILE
SIMULTANEOUSLY RECOGNIZING THAT
WE HAVE A LOT OF DATA THAT ARE
FLOWING AROUND US THAT WE CAN
AND SHOULD BE LEVERAGING, AND
RIGHT NOW FOR THE MOST PART,
THOSE DATA ARE NOT BEING USED
FOR GOOD.
THEY'RE BEING USED FOR, YOU
KNOW, MARKETING AND ELECTIONS
AND VARIOUS OTHER THINGS.
SOME OF WHICH, YOU KNOW, MAY BE
GOOD, MAYBE NOT SO GREAT, AND
FRANKLY IN TERMS OF WHAT HE WITH
NEED TO DO FOR IMPROVING
PEOPLE'S HEALTH, THERE IS
INCREDIBLE POTENTIAL BUT A LOT
MORE ATTENTION NEEDS TO BE PAID.
SO I'M VERY BULLISH ON IT.
I THINK THERE'S A LOT -- I'M
QUITE BIASED, OF COURSE, BUT I
THINK THERE'S A LOT WE CAN AND
SHOULD BE DOING WITH OUR DATA TO
IMPROVE HEALTH AND HEALTH
RESEARCH.
IT'S WHAT I'VE SPENT MOST OF MY
CAREER DOING BUT I'M ALSO VERY
AWARE OF THE DISCREPANCIES THAT
EXIST IN THAT REGARD.
>> TERRIFIC.
THANK YOU.
ANYBODY ELSE WANT TO WEIGH IN ON
THAT ONE, ON DATA?
>> I THINK WE HAVE TO DO A
BETTER JOB OF ASKING PEOPLE IF
THEY'RE WILLING TO SHARE THEIR
DATA.
RESEARCH!AMERICA DOES SURVEYS
AND THE LAST NATIONAL SURVEY WE
DID ON CLINICAL RESEARCH WAS IN
2017.
WE HOPE TO DO A NEW ONE.
BUT IN THE 2017 STUDY, AFRICAN
AMERICANS WERE WILLING TO SHARE
THEIR PERSONAL HEALTH DATA SO
THAT RESEARCHERS COULD BETTER
UNDERSTAND DISEASE, IMPROVE
PATIENT CARE, ADVANCE MEDICAL
RESEARCH.
SO OFTEN IT COMES DOWN TO
ASKING, AND OBVIOUSLY THERE
ARE -- YOU KNOW, THERE'S HIPAA
AND THERE'S LOTS OF VARIOUS
REGULATORY AND LEGAL HURDLES,
BUT I DO THINK IT'S THE ASK THAT
NEEDS TO HAPPEN MUCH MORE
UNIVERSALLY.
WHEN IT COMES TO DATA.
>> WONDERFUL.
DR. CALIFF, PLEASE.
>> I'M VERY OPTIMISTIC ON WHERE
WE'RE HEADED WITH THE DATA
BECAUSE TECHNOLOGY HAS IMPROVED
SO MUCH.
I THINK IT'S JUST A MATTER OF
TIME UNTIL THE TECHNOLOGY MAKES
IT REALLY, REALLY EASY.
BUT THE PROBLEM WE HAVE IS WHAT
WAS JUST ALLUDED TO, WHICH IS
JENNY POINTED OUT, WE NEED TO
ASK PEOPLE, BUT I ALSO THINK ALL
OF US NEED TO SPEND A LOT MORE
TIME MAKING SURE WE ALL
UNDERSTAND THE BARGAIN, THE
DEAL, WHAT IS THE REASON PEOPLE
SHOULD VOLUNTEER THEIR DATA AND
WHAT ASSURANCE ARE THEY GET THAT
IT'S GOING TO BE USED FOR GOOD,
BECAUSE IT'S BEEN THE CASE FOR
30 YEARS, AND SURVEY AFTER
SURVEY, PEOPLE SAY IF MY DATA
CAN HELP SOMEONE ELSE WITH A
HEALTH PROBLEM, I'M ALL FOUR IT.
IT'S LIKE 90% OF PEOPLE.
SAY YES
TO THAT.
BUT THEY ALSO KNOW THAT RIGHT
NOW, THEIR DATA IS BEING USED BY
ALL KINDS OF PEOPLE IN WAYS THEY
DON'T KNOW, NOT NECESSARILY FOR
THEIR BENEFIT, INCLUDING BY OUR
OWN HEALTH SYSTEMS WHO ARE OFTEN
USING TO LOOK AT WHAT'S CALLED
PAYOR MIX, WHICH IS BASICALLY
WHAT TYPES OF PATIENTS GET US
THE MOST PROFIT.
AND THAT DETERMINES WHERE
CLINICS GO AND ALL SORTS OF
OTHER THINGS.
SO I THINK WE NEED TO HAVE A
SOCIETAL DISCUSSION.
IT'S TIME TO HAVE IT.
ONE THING WE LEARNED FROM COVID,
IT'S NOT A NEW LESSON BUT IT WAS
VERY CLEAR THAT HAVING THE DATA
THAT GOT US INTO WHAT TREATMENTS
WERE EFFECTIVE AND COULD SAVE A
LOT OF LIVES.
WE NEED THAT FOR EVERY DISEASE
AND EVERY MEDICAL PROBLEM.
>> I JUST WANTED TO ADD ONE
QUICK POINT TO THIS GREAT
DISCUSSION AND IT RELATES TO
ASKING THE RIGHT QUESTIONS AND
OF THE RIGHT PEOPLE.
ONE OF THE THINGS THAT WE'VE
BEEN RECENTLY WORKING ON AT
PCORI IS SOMETHING WE'RE CALLING
OUR INCLUSIVE DATA STRATEGY,
WHICH REALLY RELATES TO THE TYPE
OF DEMOGRAPHIC DATA THAT'S
COLLECTED AROUND RESEARCH DATA.
THERE WERE FUNDAMENTAL QUESTIONS
THAT WE'RE WORKING WITH
STAKEHOLDERS ON.
YOU KNOW, BASICALLY WHO IS
THE -- WHO NEEDS THE DATA, AND
FOR WHAT REASONS, AND WHAT DATA
SHOULD BE COLLECTED, AND ABOUT
WHICH GROUPS OF PEOPLE, AND WHEN
SHOULD THAT DATA BE COLLECTED
AND HOW SHOULD THAT DATA BE
COLLECTED, PROTECTED AN USED AND
WITH WHOM SHOULD IT BE SHARED?
HAVING THOSE QUESTIONS
EXPLICITLY DISCUSSED WITH THOSE
THAT YOU'RE REALLY THINKING TO
COLLECT DATA ABOUT IS INCREDIBLY
INFORMATIVE.
SO THERE MAY BE SOMETHING
EXTRAPOLATABLE FROM THE WAY THAT
WE'RE TALKING ABOUT THIS AND
THINKING ABOUT THIS TYPE OF
STRATEGY THAT COULD BE QUITE
HELPFUL AS WE THINK ABOUT DATA
MORE BROADLY.
WE'RE ACTUALLY HOPING TO PUBLISH
THIS LANDSCAPE ANALYSIS THAT
WE'RE DOING IN ORDER TO BE ABLE
TO SHARE THAT MORE BROADLY, SO
THOUGHT IT WAS WORTH A MENTION
HERE.
>> MAKE SURE WE SEE THAT AT FDA
WHEN YOU DO IT BECAUSE WE'RE
GOING TO WANT TO PILE ON AND
SUPPORT IT.
IT'S WHAT I WAS ALLUDING, TO WE
NEED TO REALLY HAVE THE
DISCUSSION ABOUT THESE THINGS.
>> GREAT COMMENTS.
I LOVE THIS DISCUSSION AROUND
BUILDING COLLABORATIONS AND
INFRASTRUCTURE AND HOW WE MANAGE
AND COLLECT DATA.
WE'VE GOT ABOUT ONE MINUTE LEFT,
SO ONE QUICK SPEED DATING
QUESTIONS.
THERE'S LOTS OF QUESTIONS IN THE
CHAT, PLEASE IF YOU GET A CLANS
TO LOOK IN THE CHAT, I THINK
THERE'S SOME TERRIFIC QUESTIONS
IN THERE, BUT HERE'S THE QUICK
ONE.
IN THE NEXT SESSION, IT'S REALLY
GOING TO BE ABOUT ACTIONABLE
SOLUTIONS.
I'D LIKE TO ASK EACH OF YOU TO
PROVIDE ONE RECOMMENDATION FOR A
SYSTEM-LEVEL ACTION THAT CAN
DRIVE CHANGE TO REALLY IMPROVE A
DIVERSE AND INCLUSIVE
REPRESENTATION IN CLINICAL
TRIALS.
SO ONE RECOMMENDATION.
QUICK SPEED DATING ROUND.
SO WHO WANTS TO GO FIRST?
OKAY.
I'M GOING TO START CALLING ON
PEOPLE.
SO JENNY.
WHY DON'T YOU JUMP IN.
OH, SORRY.
>> YES.
SO CREATE INCENTIVES FOR
UNIVERSITIES LIKE VAN DE, CASE
WESTERN, CLEVELAND CLINIC TO
WORK WITHIN THEIR COMMUNITIES
AND HELP CREATE THOSE COMMUNITY
INTERFACES THAT WILL ALLOW FOR
MORE COMMUNITY INVOLVEMENT.
VANDY IS ALREADY DOING IT, CASE
WESTERN IS ALREADY DOING IT.
HOW CAN WE INCENTIVIZE MORE OF
THESE HUBS, CLINICAL RESEARCH
HUBS.
FOCUSED ON DIVERSITY.
THANK YOU.
>> WONDERFUL.
THANK YOU.
PETER, PLEASE.
>> GOSH, THERE'S SO MANY.
IT'S SO HARD TO CHOOSE.
I'LL JUST MENTION ONE WHICH IS
WE HAVE TO ACHIEVE CONSISTENCY
AND THE LIKE IN TERMS OF HOW IT
IS WE'RE COLLECTING DATA ON THE
FRONT END, PARTICULARLY AROUND
ISSUES THAT ARE RELEVANT TO
OVERCOMING DISPARITIES AND
ACHIEVING HEALTH EQUITY, WE HAVE
A LOT OF DIFFERENT WAYS WE
INTERPRET WHAT IT IS WE'RE
SUPPOSED TO BE DOING RIGHT NOW.
I WOULD GO AS UPSTREAMS AS WE
CAN TO ALIGN STANDARDS TO DO
THAT IN WAY THAT WILL HELP US
MAKE SENSE OF OUR DATA AND USE
IT FOR GOOD.
>> I LOVE THAT.
BRITTANY, ONE RECOMMENDATION,
PLEASE.
>> I WOULD SAY REALLY JUST
TRANSPARENCY.
THERE ARE ORGANIZATIONS AND
COMPANIES THAT ARE DOING THINGS
REALLY WELL AND I THINK SHARING
WITH OTHERS HOW THEY CAN HELP IN
THE ORGANIZATION IS GREAT,
SHARING OUR CHALLENGES,
OPPORTUNITIES, I THINK WILL HELP
THE INDUSTRY OVERALL.
>> TERRIFIC.
NAKELA?
>> BROADENING THE CONCEPT OF
WHAT YOU THINK ABOUT IN A
RESEARCH TEAM.
AND TO REALLY THINK ABOUT THE
WORKFORCE AND THE RESEARCH TEAM
MUCH MORE BROADLY THAN WE HAVE
IN THE PAST, INCLUDING THINKING
ABOUT HOW WE MOVE RESEARCH FROM
THE ACADEMIC INSTITUTIONS INTO
COMMUNITIES AND REALLY
RECOGNIZING THAT COMMUNITIES RB
A PIAREA PIECE OF THAT RESEARCHI
THINK THAT ACTUALLY MAKES THAT
CONNECTION INTO THE COMMUNITIES
THAT WE'RE REALLY TRYING TO
INCLUDE IN THE CLINICAL TRIAL
ENTERPRISE.
>> FANTASTIC.
ROB, BRING US HOME.
LAST WORD HERE.
>> SOMETHING PROVOCATIVE AT THE
END, IF I WERE KING, WHICH I
WILL NEVER BE, WHAT I WOULD DO
IS TO TAKE OUR INSURERS, BOTH
PRIVATE AND -- ALLOCATE SOME
AMOUNT LIKE A HALF A PERCENT,
THIS IS NOT A NEW IDEA, OR 1%
INTO THE RESEARCH ENTERPRISE,
CALL IT LEARNING INSTEAD OF
RESEARCH, REQUIRE THAT IT BE
DISTRIBUTED TO WHERE IT'S
NEEDED, PROPORTIONATELY TO THE
COMMUNITY, AND TO THE RESEARCH
CENTERS AND CLINICIANS WHO NEED
TO OVERSEE HIGH RISK RESEARCH,
WHERE PATIENTS ARE INVOLVED.
AND THAT THE FINDINGS OF THAT
RESEARCH BE RETURNED BACK TO
STOP DOING THINGS IN OUR
HEALTHCARE SYSTEMS THAT DON'T
WORK AND FOCUS ON THE THINGS
THAT ACTUALLY MAKE A DIFFERENCE.
VERY SIMPLE.
I'M SURE IT COULD HAPPEN
TOMORROW.
>> FOCUS ON THE THINGS THAT CAN
MAKE A DIFFERENCE.
VERY GOOD.
THOSE ARE GREAT PARTING WORDS.
THANK YOU TO THE WHOLE PANEL FOR
YOUR PARTICIPATION TODAY.
THANKS FOR ALL THE GREAT
QUESTIONS FROM THE AUDIENCE.
VANESSA AND GINA, I'M GOING TO
TURN IT BACK OVER TO YOU BUT
THANKS FOR A GREAT SESSION.
THANK YOU ALL.
THANK YOU.
YES, THANK YOU, EVERYONE.
NOW WE'RE GOING TO HAVE A
10-MINUTE BREAK AND COME BACK.
THANK YOU.
HI, WELCOME BACK.
EVERYONE.
THIS IS OUR NEXT SESSION, WHICH
IS SESSION 6.
AND SO OVERALL, THE LAST TWO
DAYS, WE'VE HAD A GREAT
DISCUSSION ABOUT HOW TO IMPROVE
IMPLEMENTATION OF EVIDENCE-BASED
BEST PRACTICES TO INCREASE
INCLUSIVE PARTICIPATION IN
CLINICAL RESEARCH ACTIVITIES
THAT TAKE PLACE BEFORE THE
STUDY, DURING THE STUDY, AND
AFTER THE STUDY.
OUR PARTICIPANTS, SPEAKERS,
PANELISTS AND MODERATORS HAVE
SHARED THEIR GREAT EXPERTISE AND
INSIGHTS REGARDING INCLUSIVE
PARTICIPATION IN CLINICAL
RESEARCH.
>> YES.
AND SO THIS SESSION, AND WE'RE
GOING TO BE MOVING STRAIGHT TO
THE DISCUSSION PART, THIS IS FOR
ALL PARTICIPANTS TO BE ABLE TO
CONTINUE THE DISCUSSIONS FROM
YESTERDAY AND EARLIER TODAY.
THIS IS YOUR OPPORTUNITY TO ASK
ANY FOLLOW-UP QUESTIONS FOR
SPEAKERS OR PANELISTS.
I THINK FOR EVERY SESSION, WE
DIDN'T GET TO ALL OF THE
QUESTIONS IN THE CHAT, AND THIS
IS ALSO THE OPPORTUNITY FOR YOU
TO OFFER YOUR OWN KNOWLEDGE AND
YOUR OWN PERSPECTIVES BECAUSE WE
KNOW THERE'S A WEALTH OF
KNOWLEDGE AMONG EVERYONE HERE
NOT JUST THE PEOPLE WHO WERE
SPEAKERS OR PANELISTS.
SO AS BEFORE, THERE ARE A COUPLE
OF WAYS THAT YOU CAN
PARTICIPATE.
FOR THIS SESSION, WE'D REALLY
LIKE TO BE AS INTERACTIVE AS
POSSIBLE, SOG WE VERY MUCH
ENCOURAGE YOU TO COME ON VIDEO
AND SPEAK VERBALLY, GIVE ANY
COMMENTS, THOUGHTS, QUESTIONS,
YOU CAN ALSO PUT COMMENTS OR
QUESTIONS IN THE CHAT, SUBMIT TO
THE EMAIL ADDRESS, AND IF YOU'RE
WATCHING ON VIDEOCAST, YOU CAN
USE THE LIVE FEEDBACK BUTTON.
SO I WILL POSE A QUESTION TO GET
US STARTED, AND SO -- OKAY, SO
IN DESIGNING THIS WORKSHOP,
VANESSA AND I AND THE PLANNING
COMMITTEE, WE WORKED VERY HARD
TO TRY TO ADDRESS AS MANY TOPICS
AS POSSIBLE, BUT WE KNOW WE HAD
IT FINITE AMOUNT OF TIME SO WE
WEREN'T ABLE TO GET TO
EVERYTHING.
SO I'D LOVE TO HEAR FROM YOU ALL
IF YOU FEEL THERE WERE TOPICS
NOT TOUCHED ON DURING THIS
WORKSHOP THAT DO NEED TO BE
ADDRESSED TO PROMOTE INCLUSIVE
PARTICIPATION IN CLINICAL
RESEARCH.
MONICA, WOULD YOU LIKE TO SPEAK?
>> HI.
THE ONLY SUGGESTION I MADE IN
ONE OF THE EARLIER SESSIONS WAS
IN ATTENDANCE TO NUMBER OF
DIFFERENT SYMPOSIUMS WHERE THE
IMPORTANCE OF FAITH-BASED
LEADERS AND FAITH-BASED
COMMUNITIES IN PARTNERING INTO
MANY DIVERSE COMMUNITIES, THAT
THERE'S OFTEN BEEN A LOT OF
REPRESENTATION OF PROTESTANT
CHRISTIAN BLACK PASTORS AND
LEADERS, AND I ALSO WANTED TO
ENCOURAGE OUTREACH TOWARDS BLACK
CATHOLIC AND BLACK MUSLIM
FAITH-BASED COMMUNITIES AS WELL
BECAUSE THERE ARE NUANCES IN HOW
THOSE DIFFERENT COMMUNITIES
RESPOND TO RESEARCH, AND RESPOND
TO THE SENSE OF COMMUNITY.
SO THAT WAS THE ONLY SUGGESTION
I WOULD MAKE.
>> THANK YOU.
I REMEMBER SEEING THAT COMMENT,
THAT'S SUCH A GOOD POINT THAT I
FEEL LIKE CHRISTIANITY IS KIND
OF THE DOMINANT RELIGION IN THE
UNITED STATES BUT THERE IS MANY
RELIGIOUS TRADITIONS AND -- TO
CONNECT WITH FOLKS.
>> IN PARTICULAR WITH THE BLACK
COMMUNITY, I THINK, HAVING LIVED
BOTH IN THE SOUTH AND NORTH
CAROLINA AND IN THE NORTH IN
NEW YORK, THERE'S A STRONG BLACK
CATHOLIC SERVICE SENSIBILITY AND
OBVIOUSLY THERE'S A STRONG BLACK
MUSLIM FAITH-BASED COMMUNITY AS
WELL.
INTEGRATING THOSE INTO ACTIVISM
AROUND RESEARCH WOULD BE GREAT.
>> THANK YOU.
A POPULATION WE DIDN'T TOUCH ON
THAT COULD BE IMPORTANT TO
HIGHLIGHT?
IF YOU'RE A MODERATOR, FEEL FREE
TO PARTICIPATE.
OH, WONDERFUL!
BEVERLY, TAKE IT AWAY.
>> HI.
I'M HAPPY TO BE IN THIS SPACE
WITH YOU ALL.
SO I'M A REPRODUCTIVE BIOLOGIST
AS WELL AS A DEI PRACTITIONER,
AND I THINK ONE OF THE CONCERNS
I HAD FOR THESE LAST TWO DAYS
WAS THERE'S KIND OF A LOT OF
EMPHASIS ON TEACHING PEOPLE WHO
SEEM TO BE NOT ENGAGED OUTSIDE
OF ACADEMIA TO INFILTRATE OUR
COMMUNITIES.
I DIDN'T SEE A LOT OF EMPHASIS
ON THE EFFORTS TO MAKE SURE THAT
BLACK AND BROWN FOLKS AND THOSE
FROM OTHER MARGINALIZED
COMMUNITIES WERE PIs.
AND I FEEL LIKE THAT IS AN
IMBALANCE IN HOW THIS IS BEING
DISCUSSED.
WE HAVE TO TEACH OTHER PEOPLE
WHO ARE NOT A PART OF OUR
COMMUNITY TO BUILD TRUST WITH
OUR COMMUNITY.
PERHAPS AN EMPHASIS ON MAKING
SURE THAT WE'RE LEADING THE WORK
BECAUSE EVEN IF YOU DO ALL OF
THIS WORK TO COME INTO THE
COMMUNITY TO RECRUIT PEOPLE FOR
THEIR PROJECT, YOU KIND OF --
AFTER YOU GET WHAT YOU NEEDED SO
WE'RE PRE PE TWAITING A CYCLE OF
PILLAGING, AND I THINK THAT
SHIFTS A BIT WHEN THE PI
REPRESENTS THE COMMUNITY.
AND SO I'M HOPING THAT IN THE
FUTURE, THERE'S A BALANCED
CONVERSATION AROUND RECRUITING
AND EDUCATING.
PEOPLE COME FROM THESE
COMMUNITIES TO LEAD THIS WORK
BECAUSE THEY'RE INVESTED IN
STAYING IN THOSE COMMUNITIES AND
NOT PEOPLE WHO MAY BE DOING THIS
SIMPLY BECAUSE THERE'S A
REQUIREMENT TO DIVERSIFY THEIR
RESEARCH.
>> YEAH, DEFINITELY.
VERY IMPORTANT POINT.
AND I THINK WE'D EVEN TALKED
ABOUT HAVING A SPECIFIC TALK ON
THIS IN THE WORKSHOP AND THEN,
YOU KNOW, THERE ARE SO MANY
OTHER TOPICS.
I WILL PIGGY BACK OFF THAT AND
JUST GIVE A SHOUT OUT FOR THE
FIRST PROGRAM THROUGH THE COMMON
FUND IS A PROGRAM TO INCREASE
THE DIVERSITY OF THE BIOMEDICAL
RESEARCH WORKFORCE, FIRST
FACULTY INSTITUTIONAL
RECRUITMENT FOR SUSTAINABLE
TRANSFORMATION.
THERE'S ACTUALLY -- WE'RE NOT
TAKING APPLICATIONS ANYMORE,
SO -- BUT IT'S A -- ANYWAY,
THAT'S AN EXAMPLE OF AN EFFORT
THAT'S HAPPENING TO ADDRESS,
YEAH, DEFINITELY AN IMPORTANT
FACTOR.
HAVE PEOPLE WHO CAN LOOK LIKE
THE COMMUNITIES THAT THEY'RE
SERVING.
>> SO I WOULD LIKE TO JUST
CONTINUE FROM EARLIER TODAY,
LIKE A FURTHER DISCUSSION ON IF
WE CAN PROVIDE SOME MORE
ACTIONABLE SOLUTIONS FOR SYSTEM
LEVEL ACTIONS TO DRIVE THE
CHANGE FOR THE BROAD SCALE TO
IMPROVE OUR DIVERSITY, EQUITY,
INCLUSION AND ACCESSIBILITY FOR
REPRESENTATION OF CLINICAL
TRIALS.
JUST SEEING IF ANYONE OF OUR
PARTICIPANTS HAD ANY ADDITIONAL
COMMENTS OR SUGGESTIONS.
>> ANY OF THE MODERATORS?
>> WE DO HAVE A COMMENT IN THE
CHAT, AND ERIC RUBENSTEIN?
>> I'LL UNMUTE MYSELF.
I'M ACTUALLY ON VACATION.
BUT I JUST WANTED TO COMMENT ON
THIS BECAUSE I REALLY ABSOLUTELY
AGREE WITH WHAT THE MODERATOR
SAID.
WE NEED MORE DIVERSE
REPRESENTATION AS FAR AS
PHYSICIAN INVESTIGATORS.
BUT I ALSO FEEL THAT SOMETIMES
THERE IS A BIT TOO MUCH OF
SEGREGATION, AS IF, YOU KNOW,
BLACK INVESTIGATORS NEED TO
INVESTIGATE -- TO CONDUCT
STUDIES IN BLACK COMMUNITIES OR
VICE VERSA.
I FEEL LIKE THERE SHOULD BE MORE
COLLABORATION SORT OF ACROSS
COMMUNITIES.
>> THANK YOU.
DEFINITELY A GOOD POINT.
I'VE HEARD BEFORE RESEARCHERS
FEELING LIKE IF THEY'RE A PERSON
OF COLOR THAT THEY HAVE TO DO
RESEARCH IN THAT -- IN HEALTH
DISPARITIES, FOR EXAMPLE.
SO YEAH, DEFINITELY IT'S
SOMETHING TO KEEP IN MIND.
WE HAVE A COMMENT FROM THE
VIDEOCAST THAT I THINK I WILL
JUST SHARE FROM EUGINA BROOKS.
RESEARCH DOES NOT HAVE A GOOD
REPUTATION IN COMMUNITIES OF
COLOR IN GENERAL.
ESPECIALLY THE BLACK
COMMUNITIES.
THE ATTITUDE ON INCLUSION WITHIN
THE MEDICAL COMMUNITY ONLY
REINFORCES THE ISSUE.
YEAH, DEFINITELY GOOD POINT.
THERE'S A LOT OF HISTORY OF --
AND PRESENT, YOU KNOW, REASONS
FOR DISTRUST AND MISTRUST.
THAT WE NEED TO ADDRESS.
WE HAVE A QUESTION FROM THE
VIDEOCAST.
NICOLETTE, I DO NOT KNOW HOW TO
PRONOUNCE THE LAST NAME, I
SHOULDN'T HAVE DECIDED TO READ
PEOPLE'S NAMES.
ARE THERE RESOURCES TO SUPPORT
NON- DEGREE HOLDING INDIVIDUALS,
SO LEAVE RESEARCH IN THE
EXTRAMURAL SPACE OR THROUGH
SMALL BUSINESS?
OOO, THAT IS A REALLY GOOD
QUESTION FOR ANY OF OUR NIH
COLLEAGUES WHO ARE IN THE ZOOM
MEETING OR OTHER FOLKS FROM
FUNDING ORGANIZATIONS.
>> HI, GINA.
I CAN JUMP IN.
>> THANK YOU, JENNIFER.
>> A COUPLE PROGRAMS THAT THE
SMALL BUSINESS GRANT PROGRAM,
WHICH FOCUSES ON OBVIOUSLY SMALL
FOR-PROFIT BUSINESSES DOESN'T
HAVE THE SAME SORT OF
EXPECTATIONS OF WHAT KIND
OF DEGREE YOU MIGHT HAVE, SO
JUST AS LONG AS YOU'RE RUNNING A
BUSINESS AND YOU'RE DOING
SOMETHING IN THE HEALTH-RELATED
FIELD THAT, YOU KNOW, YOUR
BUSINESS IS ENGAGED IN, AND THEN
THERE ARE SOME PROGRAMS LIKE THE
COMPASS PROGRAM THAT NIH --
THROUGH THE NIH COMMON FUND.
THAT'S ANOTHER ONE THAT'S NOT
ACCEPTING APPLICATIONS FOR
RESEARCH PROJECTS, BUT THAT
PROGRAM, THE PROJECTS ARE GOING
TO COMMUNITY ORGANIZATIONS
RATHER THAN ACADEMIC
INSTITUTIONS, SO AGAIN, THERE'S
GOING TO BE A VARIETY OF
BACKGROUNDS OF FOLKS WHO ARE
SERVING AS PRINCIPAL
INVESTIGATORS OF THOSE PROJECTS.
>> GREAT.
THANK YOU SO MUCH, JENNIFER.
IT LOOKS LIKE THERE WAS A
QUESTION IN THE CHAT EARLIER.
HOW DO YOU DEAL WITH RESEARCHERS
WHO THINK DEI IN CLINICAL
RESEARCH IS A FORM OF REVERSE
DISCRIMINATION?
THAT IS A GOOD QUESTION.
DOES ANYONE WANT TO SHARE ANY
THOUGHTS, INSIGHTS?
OH, MY GORK.
GOSH, OUR CLOSING
SPEAKER, DR. MARIE BERNARD.
>> I COULDN'T HELP IT.
>> THANK YOU.
>> ONE OF THE THINGS THAT IS
REALLY IMPORTANT IN HELPING
PEOPLE TO UNDERSTAND THE BENEFIT
OF DEI IS THE DATA THAT SHOWS
THAT WHEN YOU HAVE DIVERSE
PERSPECTIVES, YOU HAVE BETTER
SCIENCE.
GREATER CREATIVITY, GREATER
INNOVATION.
IT'S NOT A HANDOUT, IT'S NOT
REVERSE DISCRIMINATION, IT'S
JUST TRYING TO MAKE SURE WE DO
THE BEST SCIENCE.
>> THANK YOU.
>> YES, THANK YOU.
>> BEVERLY?
DID YOU ALSO WANT TO --
>> I THINK I'M REALLY GLAD THAT
SOME OF THE QUESTIONS ARE COMING
IN TO THE CHAT BECAUSE IT REALLY
SPEAKS TO THE MINDSET WHERE
PEOPLE ARE WHEN WE BRING THESE
TOPICS IN.
AND THINKING ABOUT DOING A
PRIMER TO MAKE SURE THAT WE'RE
ALL UNDERSTANDING WHAT WE'RE
DOING AND WHY IS CRITICAL,
BECAUSE THERE'S MAYBE A THOUGHT
THAT WE JUST DON'T KNOW HOW TO
DIVERSIFY OUR RESEARCH AND WHAT
WE'RE SEEING IN THE COMMENT
SECTION IS PEOPLE ACTUALLY ARE
DEALING WITH OTHER THINGS FROM
PERCEPTIONS ABOUT WHAT THIS
REALLY MEANS AND WHY WE'RE DOING
THIS.
AND SO IT'S NOT JUST ABOUT HOW
CAN YOU RECRUIT DIVERSE
CANDIDATES FOR YOUR RESEARCH.
IT REALLY IS UNDERSTANDING THE
HISTORY OF THIS COUNTRY AND HOW
WE GOT HERE.
WHERE THESE PROBLEMS ARISE, AND
WHY IT'S IMPORTANT.
THIS ISN'T JUST ABOUT CORRECTING
A WRONG.
THIS IS ACTUALLY -- I THINK THE
FIRST SPEAKER FROM YESTERDAY,
REALLY TALKING ABOUT SOME OF THE
EVOLUTIONARY CHANGES THAT HAVE
HAPPENED IN COMMUNITIES THAT
IMPACT HOW THEY RE-UPTAKE SOME
OF THE THINGS THAT WE'RE
CREATING.
IT IMPACTS HOW WE RESPOND TO
TREATMENTS, AND UNDERSTANDING
THE KIND OF BIOLOGY THAT IS
UNDERPINNING WHY WE NEED TO
DIVERSIFY THE BODIES THAT ARE
INVOLVED IN OUR WORK SO THAT OUR
TREATMENTS WORK FOR MULTIPLE
DIFFERENT POPULATIONS.
BUT I'VE DONE ENOUGH WORKSHOPS
TEACHING PEOPLE ABOUT GENETICS
VERSUS EPIGENETICS VERSUS RACE
BEING A SOCIAL CONSTRUCT TO KNOW
THAT PEOPLE STILL DON'T
UNDERSTAND THOSE FOUNDATIONAL
TERMS.
THERE WAS A COMMENT I MADE
EARLIER THAT SOMEONE SOMEHOW
JUMPED TO SE SEGREGATION.
SO WE WANT TO MAKE SURE WE HAVE
THAT FOUNDATIONAL UNDERSTANDING
OF WHAT'S BEING DISCUSSED HERE
AND WHAT'S NOT BEING DISCUSSED
HERE, BECAUSE THERE IS NO REA
REVERSE DISCE DISCRIMINATION, IS
EXPANDING THE WORK BECAUSE IN
ORDER FOR OUR TREATMENTS TO
SERVE ALL POPULATIONS.
>> DEFINITELY.
I THINK YOU RAISE A REALLY GOOD
POINT, BEVERLY, ABOUT CULTURE,
ABOUT CHANGING THE CULTURE THAT
PEOPLE ARE IN AND THE SOCIAL
NORMS.
VANESSA, DO YOU WANT TO READ --
SOMEONE RESPONDED TO THIS
QUESTION ON THE VIDEOCAST.
>> SURE.
ONE SECOND.
LET ME JUST OPEN THIS.
LET'S SEE.
SO FROM LAURIE LO.
EDUCATION FOR EMPLOYEES WHO ARE
ACTIVELY DOING RECRUITMENT ON
WHERE MISTRUST COMES FROM IN
RESEARCH.
HOW TO TACKLE THAT MISTRUST AND
ORGANIZATION LEVEL CAN HELP
TACKLE INEQUITIES AND BIAS FROM
THOSE WHO INTERACT WITH
PARTICIPANTS THE MOST.
>> THEN THERE WAS ANOTHER
QUESTION IN THE CHAT, DO YOU
HAVE ANY EXAMPLES OF COMMUNITY
BENEFIT COMMUNITY
[UNDER A SCHEDULE H BUILDING
EFFORTS IN RESEARCH EFFORTS?
I DON'T UNDERSTAND WHAT THIS IS
ASKING ABOUT.
BUT I KNOW THAT THERE ARE PEOPLE
IN THIS MEETING WHO DO.
>> SORRY, I WAS REFERRING TO
COMMUNITY BUILDING.
>> SURE, BUT THE ACA SCHEDULE H,
IS THAT SOMETHING SPECIFIC TO
COMMUNITY BUILDING?
>> YES.
>> CAN YOU EXPAND UPON THAT A
LITTLE BIT?
>> SO FOR THE ACA, SO IN
ADDITION TO REQUIRING A
COMMUNITY HEALTH NEEDS
ASSESSMENT, THEY'VE ALSO SORT OF
OPENED -- KIND OF OPENED UP THE
FIELD AS FAR AS WHAT
INSTITUTIONS CAN DO TO BENEFIT
THE COMMUNITY, INCLUDING
PROVIDING SERVICES OR ACTUALLY
BUILDING STRUCTURES THAT PROVIDE
BENEFIT TO THE COMMUNITY SUCH AS
GROCERY STORES OR IN THIS CASE
SOMETHING LIKE A RESEARCH
INTERVENTION.
>> I THINK MAYBE THE COMPASS
EFFORT THAT JENNIFER HAD
MENTIONED IS A GOOD EXAMPLE OF
THAT, WHERE IT'S PROVIDING
FUNDING DIRECTLY TO COMMUNITY
ORGANIZATIONS AND SO -- TO A
RESEARCH ENTITY THAT THEN HAS TO
SHARE IT WITH THE COMMUNITY
ORGANIZATION.
I THINK THAT'S ONE PROBLEM.
MONIKA?
>> JUST AN IDEA, I'M NOT SURE
HOW THE NIH CAN SUPPORT THIS,
BUT I KNOW IN MY EXPERIENCE,
WORKING AS A NON-PROFIT WITH
UNIVERSITY OF IDAHO AND THE
UNDERGRAD AND GRADUATE RESEARCH
ASSISTANTS THERE WHO ARE FUTURE
INVESTIGATORS, AND BEING ABLE TO
BRING THEM WITH FUNDING TO
INTERNATIONAL CONFERENCES WHERE
WE'RE PRESENTING OUR RESEARCH
POSTERS AND SO FORTH, AND HOW
INFLUENTIAL THAT IS AND
IMPACTFUL FOR THEIR FUTURES IN
TERMS OF MENTORSHIP, ARE THERE
WAYS THAT THE NIH CAN SUPPORT
NEW DIVERSE POPULATION, FUTURE
INVESTIGATORS TO BE ABLE TO BE
MENTORED TO COME TO CONFERENCES,
TO LEARN MORE ABOUT HOW THEY CAN
CONDUCT RESEARCH, AND ALSO TO DO
LISTENING SESSIONS, LISTENING
SESSIONS WHERE YOU CAN INVITE
THEM IN TO SAY WHAT ARE YOU
INTERESTED IN RESEARCHING, WHAT
DO YOU THINK NEEDS TO BE
RESEARCHED AS A YOUNG PERSON IN
AMERICA TODAY?
>> THANK YOU.
I SEE A LONG COMMENT FROM TINA
DOTHARD PETERSON.
WOULD YOU COME OFF MUTE AND
SPEAK MORE ABOUT WHAT YOU WROTE
IN THE CHAT?
>> HI.
YES, I'M AN ALUMNI OF AN HBCU,
AND MY RESEARCH -- I'M A SOCIAL
WORKER, ACADEMIC, ASSOCIATE
PROFESSOR AT THE UNIVERSITY OF
CINCINNATI SCHOOL OF SOCIAL
WORK.
I JUST KNOW DEURN DURING THE HEF
COVID THAT A LOT OF THE HBCUs
WERE HOSTING TOWN HALLS AND THEY
WERE ALREADY DOING A LOT OF WORK
PRIOR TO THE COMMUNITY
ENGAGEMENT THAT TOOK PLACE IN
TERMS OF OUTREACH IN THE
COMMUNITY.
SO I APPRECIATED THAT AND WE
KNOW THE LIMITED RESOURCES ARE
THERE, THEY REMAIN.
THE OTHER THING IS, I THINK THAT
WE ALSO NEED TO CONTINUE TO TAKE
A LOOK AT WHO IS ACTUALLY
GAINING ACCESS ON A REGULAR
BASIS TO THE MENTORING NETWORKS,
AND WHO IS NOT, BECAUSE WE KNOW
THAT THIS PLAYS A CRUCIAL ROLE
IN ABSOLUTELY EVERYTHING THAT
WE'RE TALKING ABOUT IN TERMS OF
THE PREVIOUS SPEAKER WHO SAID
SOMETHING ABOUT NOT JUST FUNDING
ABOUT THE PIs AND PIs THAT
MATCH THE COMMUNITIES.
AND WE KNOW THAT STARTS
SOMEWHERE WITH ACTUALLY
CONNECTING WITH SOMEONE'S
RESEARCH, RESEARCH LABS,
SOMEBODY'S GRADUATE RESEARCH,
AND SO I APPRECIATE BECAUSE
THERE ARE MANY VIRTUAL WORKSHOPS
THAT I'VE BEEN ABLE TO ATTEND
THAT ORDINARILY PRE-COVID, I
WASN'T AWARE OF THEM.
>> THANK YOU SO MUCH FOR
SHARING.
>> THANK YOU.
>> LET'S SEE.
ANYONE ELSE LIKE TO SHARE ANY OF
YOUR QUESTIONS?
>> THERE'S A QUESTION FROM
SHIRLEY DORVAL IN THE CHAT.
HOW DO WE TACKLE BIAS BY TRIAL
SITES TO OFFER TRIAL
PARTICIPANTS FROM VULNERABLE
POPULATIONS OUTSIDE -- OH, NO,
THE CHAT MOVED.
OUTSIDE OF RACE AND ETHNICITY,
FOR EXAMPLE, ELDERLY AND PEOPLE
WHO ARE DIFFERENTLILY ABLED
COGNITIVELY OR PHYSICALLY.
THAT'S A GREAT QUESTION.
I THINK MAYBE IF ANY OF OUR
PANELISTS FROM THE SPECIAL
CONSENT CONSIDERATIONS PANEL ARE
STILL ON, THAT COULD BE
SOMETHING -- CARRIE NIEMAN WAS
OUR OLDER ADULTS EXPERT.
ANGEL MILES WAS OUR PEOPLE WITH
DISABILITIES EXPERT.
RICHARD HARVEY, WOULD YOU LIKE
TO -- OH, WONDERFUL.
YES.
COME OFF VIDEO, RICHARD.
TELL US YOUR THOUGHTS.
>> YEAH, THANK YOU.
THIS IS AN AMAZING PRESENTATION.
I WAS RESPONDING TO SHIRLEY D'S
QUESTION.
IT'S NOT ONLY IN REGARDS TO
PARTICIPANTS, BUT ALSO
INVESTIGATIVE TEAMS THEMSELVES.
AND SOMETIMES THERE'S VARIOUS
TYPES OF BIASES OR PRACTICES
THAT ARE -- IT'S TOUGH SOMETIMES
TO DO RESEARCH.
I'M GOING TO STOP THERE.
THERE'S A LONG RIFT IN THE CHAT.
>> OKAY.
VIRGINIA, DID YOU WANT TO SHARE?
>> YES, I DID.
I THINK THIS IS A GREAT WORKSHOP
AND I THINK IT DEMONSTRATES TO
ALL OF US HOW MUCH TIME IT TAKES
UP FRONT TO DEVELOP A STRONG
GRANT APPLICATION BECAUSE YOU
KNOW, ONE OF THE PRESENTATIONS,
I THINK IT WAS DR. EGEDE FROM
MEDICAL COLLEGE OF WISCONSIN
ABOUT DIFFERENT SUBGROUPS TRYING
TO GET THIS, THERE'S A LOT WE
DON'T KNOW ABOUT THE PREVALENCE
OF THE DISEASE IN THESE
DIFFERENT GROUPS.
WE DON'T KNOW HOW MUCH WHAT
PERCENTAGE OF WOMEN SHOULD WE
EXPECT TO ENROLL GIVEN WHAT THE
DISEASE PREVALENCE IS IN WOMEN,
AND WITH RACE AND ANY OF THESE
SUBGROUPS, BECAUSE FOR EXAMPLE,
WE DON'T HAVE DATA ON DIFFERENT
GENDER GROUPS.
THOSE ARE JUST NOT -- AS WE
COLLECT DATA ON THAT.
SO IF WE ARE TRYING TO GET
ENOUGH PEOPLE ENROLLED IN OUR
STUDIES ACROSS DIFFERENT GROUPS
AND HAVE SUFFICIENT SAMPLE SIZES
TO BE ABLE TO DO MEANINGFUL
SUBGROUP ANALYSES OR TEST FOR
INTERACTION, THEN WE NEED TO
KNOW WHAT'S A REALISTIC
EXPECTATION.
IT'S ALSO TRUE FOR MONITORING
COMMITTEES, MONITORING BOARDS
AND FOR REVIEWERS OF OUR GRANTS
TO SAY WELL, THEY'RE GOING TO
GET 50% OF THIS.
SO WE HAVE TO DO A LOT OF
PRELIMINARY WORK ON OUR SAMPLE
SIZES AND OUR PLANNING AND WHO
DO WE WANT TO ENROLL IN THE
SENSE OF WHERE ARE OUR LOCATIONS
THAT MAYBE THEY SEE MORE OF THE
DISEASE.
IN OUR BREAKOUT SESSION
YESTERDAY, SOMEBODY WAS TALKING
ABOUT WHERE THEY DO THEIR
RESEARCH FROM, AND THEY ARE
ISOLATED IN A CERTAIN PART OF A
BIG CITY, AND THEY DON'T SEE THE
PEOPLE WHO ARE SOCIALLY
DISADVANTAGED.
THEY ONLY SEE KIND OF LIKE, OH,
THE WEALTHIER PEOPLE COME TO
THAT HOSPITAL.
SO HOW DO WE REALLY COLLABORATE
AND SO A LOT OF TIME HAS GOT TO
BE SPENT REALLY, REALLY
DEVELOPING THIS, A COUPLE YEARS,
YOU KNOW, BEFORE YOU CAN WRITE A
STRONG GRANT APPLICATION THAT
YOU HAVE ALL OF YOUR
JUSTIFICATION AND DOCUMENT WHY
YOU THINK THIS AND WHY YOU DO
THAT.
SO IT'S GREAT SESSIONS FOR ALL
OF US TO BUILD ON FUTURE
PROJECTS.
>> SURE.
THANK YOU.
I FEEL LIKE THAT WAS SOMETHING
THAT HAD BEEN MENTIONED IN THE
COMMENTS BEFORE, IS THAT IT IS
VERY DIFFICULT TO GET STARTED SO
ANY RESOURCES WE CAN SHARE WITH
EARLY STAGE INVESTIGATORS IS
IMPORTANT AND MENTORSHIP IS A
BIG PART OF THAT.
VANESSA, HOW ARE WE WITH THE
VIDEOCAST?
ANY ADDITIONAL QUESTIONS THERE?
>> NO ADDITIONAL QUESTIONS WITH
OUR VIDEOCAST.
I'M JUST LOOKING NOW THROUGH THE
CHAT.
>> HERE'S A QUESTION FROM
DUSTIN.
WHY DO YOU THINK THE ISSUE OF
DISPARITIES IS FRAMED THROUGH
THE LENS OF RACE AND ETHNICITY
RATHER THAN THROUGH OTHER
UNDERLYING ISSUES THAT MOST
UNDERREPRESENTED POPULATIONS
EXPERIENCE LIKE INCOME LEVEL,
EDUCATION, ET CETERA?
GOOD QUESTION.
ANYONE WANT TO PROVIDE FEEDBACK
ON THAT?
>> MAYBE IF I MAY, CAN YOU HEAR
ME?
>> YES, YES.
GO AHEAD.
>> EXPAND.
THIS HAS BEEN SUPER HELPFUL, AND
I HAVEN'T BEEN ABLE TO ATTEND
ALL THE SESSIONS BUT I'VE BEEN
ABLE TO ATTEND A FEW HOURS, AND
I GUESS THAT'S ONE QUESTION.
I THINK THIS IS TENDENCY IN THE
LANGUAGE ALWAYS SEEMS TO CAST
THESE DIFFERENCES BASED ON RACE
AND ETHNICITY, AND YET IF YOU
LOOK AT SOME OF THE UNDERLYING
ISSUES WHEN YOU GET DOWN TO IT
AS SAID IN SOME OF THE TALKS
HERE, SOME OF THESE ARE ISSUES
REGARDING ACCESS OR EDUCATION OR
INCOME LEVEL, AND THESE ARE BIG
ISSUES TO ADDRESS BUT I DON'T
UNDERSTAND SOMETIMES WHY AS A
SOCIETY WE DON'T CAST THINGS IN
THAT LIGHT OR MAYBE IN THAT
PERSPECTIVE.
LIKE MAYBE THE CURRENT -- I
DON'T KNOW, I HAD SOME QUESTION
ABOUT THAT IN TERMS OF SOME OF
THE UNDERLYING ISSUES MIGHT
ACTUALLY GET CLOSER TO THE HEART
OF SOME OF THESE -- SOME OF
THESE PROBLEMS IN TERMS OF
POVERTY AND EDUCATION AND INCOME
AND HEALTH ACCESS AND SOME OF
THOSE OTHER THINGS.
>> SO I HAVE A RESPONSE BUT I
WANTED TO GIVE OUR ATTENDEES
FIRST AN OPPORTUNITY IF ANYONE
WANTS TO JUMP IN AND OFFER
THOUGHT ON THEM, ON THIS.
WELL, I THINK THE FOCUS ON RACE
AND ETHNICITY FROM MY
UNDERSTANDING IS BECAUSE THROUGH
SO MUCH OF OUR HISTORY AND
PRESENT, THERE HAVE BEEN A LOT
OF RACE-SPECIFIC DISCRIMINATORY
THINGS, BIASES, POLICIES, AND SO
FOR EXAMPLE, YOU KNOW, LIKE RED
LINES WAS A HOUSING POLICY THAT
BASICALLY CREATED THE SEGREGATED
COMMUNITIES THAT WE HAVE TODAY,
AND THAT WAS A POLICY VERY
SPECIFICALLY ABOUT RACE THAT DID
HAVE SOCIOECONOMIC CONSEQUENCES
AND THAT REDLINED AREAS WEREN'T
ABLE TO BE AS PROSPEROUS BECAUSE
REALTORS OR INVESTORS WEREN'T
WILLING TO PUT PROPERTIES THERE,
BUT THE ROOT CAUSE OF THAT OR --
YEAH, THE ROOT CAUSE OF THAT
REDLINING WAS RACIAL BIAS, AND
THERE'S ALSO WORK IN DIFFERENT
AREAS WHAT I'M MOST FAMILIAR
WITH IS MATERNAL MORTALITY,
WHERE YOU KNOW, EDUCATION AND
SES DO INFLUENCE RATES OF
MATERNAL MORTALITY, BUT WE STILL
ACTUALLY DO SEE RACIAL
DISPARITIES AMONG THE HIGHLY
EDUCATED WOMEN, AND THAT'S ONE
OF THE -- I THINK CURRENTLY
RIGHT NOW ONE OF THE THINGS
WE'RE TRYING TO WORK ON, IS
OKAY, IF WE ADDRESS THE ISSUE OF
JUST, YOU KNOW, POVERTY AND
EDUCATION, WHY IS THERE STILL A
GAP?
IT MUST BE SOMETHING ELSE, IT
MUST BE SOMETHING SPECIFIC TO
RACE BECAUSE WE CONTROLLED FOR
THE OTHER FACTORS.
>> THAT'S A GOOD POINT.
I JUST THINK SOME OF -- SO ON A
NATIONAL OR SORT OF POLICY
LEVEL, WHEN WE BEGIN ADDRESSING
THIS, HAS BEEN RELATIVELY
RECENT, RIGHT?
SO YOU'RE REFERRING TO SOMETHING
THAT WAS BACK, YOU KNOW, DECADES
AGO AND I THINK SOME OF THE
INSTITUTIONS CERTAINLY FROM
YEARS AGO HAVE BEEN VERY RACIST.
I THINK WE -- I'M GLAD AS A
COUNTRY, WE ARE MAKING SOME
PROGRESS, BUT I THINK THE
MEASURING STICK SOMETIMES, EVEN
IN THE STUDIES AND THE RESEARCH
THAT'S PRESENTED THAT'S FROM THE
90s OR THE 50s OR -- AND I
THINK SOMETIMES IT MAY BE
INTERESTING, WE MIGHT GET A
DIFFERENT PICTURE IF WE COMPARE
THINGS OVER THE LAST FIVE YEARS
WHEN THIS HAS BECOME MORE OF A
NATIONAL SORT OF POLICY WHEN
IT'S BEEN ADDRESSED, RIGHT?
I DON'T THINK -- I THINK WE
MIGHT GET JUST A LITTLE BIT MORE
ACCURATE PERCEPTION TO WHERE WE
ARE IF WE LOOK AT THESE THINGS
IN RELATIONSHIP TO THE LAST
COUPLE YEARS RATHER THAN THINGS
FROM LONG TIME PAST BECAUSE THAT
GIVES US A BETTER SENSE OF SORT
OF THE RATE AT WHICH WE ARE
CHANGING RATHER THAN CREATING A
PERCEPTION THAT THERE HAS NOT
BEEN CHANGE.
OR THAT CHANGE IS NOT OCCURRING.
JUST A THOUGHT.
>> BEV EARLY, BEVERLY, WOULD YO
COMMENT?
>> ABSOLUTELY.
DR. RODANTE, I TAKE YOUR POINT
AND I WOULD LIKE TO ADD
SOMETHING TO THAT.
SO FROM A BIOLOGICAL
PERSPECTIVE, THE ISSUES THAT
HAVE AFFECTED COMMUNITIES IN
THIS COUNTRY FOR HUNDREDS OF
YEARS, THEY DON'T CHANGE IN TWO
YEARS.
YOU CAN'T REVERSE THAT BIOLOGY
IN A PERSON'S LIFETIME.
SO IF I'M GOING TO LOOK AT THE
CONSEQUENCES OF AFRICAN AMERICAN
MATERNAL RATES AND I UNDERSTAND
EPIGENETICS, I UNDERSTAND THAT
IT TAKES A MINIMUM OF THREE
GENERATIONS TO REVERSE THAT
BIOLOGY BACK TO THE ORIGINAL
HOMEOSTASIS.
AND SO I CAN'T THEN JUST LOOK AT
SOME POLICIES THAT HAVE BEEN
CHANGED AND MAY OR MAY NOT BE
EFFECTIVELY IMPLEMENTED WITHIN
COMMUNITIES AND THINK THAT THAT
IS SOMEHOW A MEASURE THAT IS
STATISTICALLY SIGNIFICANT
BECAUSE -- AND WE DIDN'T GET TE
CONDITIONS IN TWO YEARS AND
WE'RE NOT GOING TO GET OUT OF
THEM IN THAT PERIOD OF TIME, SO
I JUST WANT TO KIND OF POINT
THAT OUT, AND UNDERSTANDING THAT
RED LINING PERSISTS, IT IS NOT
SOMETHING FROM THE PAST.
IF YOU LOOK AT MILWAUKEE,
WISCONSIN, WHICH WHERE I'M FROM,
OR CHICAGO OR A NUMBER OF
DIFFERENT SPACES, THERE IS
RECENT PUBLICATIONS THAT THE ZIP
CODE FOR WHICH PEOPLE COME FROM
DETERMINES THEIR HEALTH
OUTCOMES, DETERMINES THEIR LIFE
EXPECTANCY, BECAUSE OF ALL OF
THE THINGS THAT THAT ZIP CODE
DICTATES FINANCIALLY, FROM
POLICY, FROM MONEY DISTRIBUTION,
FROM SCHOOLS.
SO I JUST -- I UNDERSTAND THE
HESITATION THAT RACE MAY BE NOT
ENOUGH, BUT IT'S HOW RACE IS
TREATED IN THIS COUNTRY AND NOT
RACE ITSELF THAT'S THE DRIVER OF
THESE OUTCOMES.
AND I THINK THAT'S AN IMPORTANT
DISTINCTION, THAT RACE ISN'T A
DRIVER, IT'S HOW RACE IS TREATED
IN THIS COUNTRY THAT DRIVES
THESE OUTCOMES.
>> THAT'S A GREAT POINT.
THANK YOU FOR SHARING THAT.
ONE LAST THING, SO WHEN YOU LOOK
AT THESE STUDIES WHERE WE'RE
COMPARING PEOPLE, LIKE THERE'S
ALWAYS A TENDENCY TO COMPARE, I
THINK, PEOPLE BASED ON
ETHNICITY, AND I'M JUST
WONDERING IF YOU LOOK WITHIN
THOSE ETHNIC SUBGROUPS THAT WE
TRADITIONALLY DIVIDE.
SO DOES ANYONE KNOW OFFHAND WHAT
THEN -- OR THESE RATES OF
POVERTY OR ACCESS OR DISPARITIES
BASED ON -- SO IF YOU'RE LOOKING
AT A RURAL APPALACHIAN COUNTY IN
TENNESSEE OR ALABAMA WHO IS
LARGELY REPRESENTED BY WHITE, DO
THEY HAVE THE SAME RATE AND BARE
THE SAME OR SIMILAR BURDEN OF
DISEASE AS THE SAME ETHNIC
GROUPS THAT LIVE IN CERTAIN ZIP
CODES IN URBAN AREAS THAT ARE
TYPICALLY DISADVANTAGED?
>> THAT IS A POINT TO CONSIDER.
WE ARE ABOUT AT TIME BUT I DID
SEE THAT THERE WAS ONE QUESTION
FROM THE VIDEOCAST AND I WANT TO
MAKE SURE WE REPRESENT THE VIEWS
OF CHAT FOLKS AND THE VIDEOCAST
FOLKS SO I THINK I'D LIKE TO END
ON THIS QUESTION FROM NICOLETTE.
SO WE SPEND A LOT OF TIME ON OUR
CELL PHONES AND MOBILE DEVICES.
HOW CAN WE USE INTELLIGENT GAMES
AND GAMIFICATION TO TRANSFORM
PERCEPTIONS AND TO HELP
UNDERSERVED POPULATIONS TO BE
HEALTHIER?
SHOULD WE ATTEMPT TO CHANGE THE
PARADIGM FROM PUSHING FOR
DECREASING SCREEN TIME TO
INFUSING GAMES /CONTENT INTO THAT
SCREEN TIME THAT EMPOWER
INDIVIDUALS AND COMMUNITIES TO
MAKE HEALTHIER CHOICES AND HAVE
MORE INFORMED PREVENTIVE
DISCUSSIONS?
THIS IS A RE A REALLY GOOD QUES.
I WILL SAY USE OF GAMES FOR GOOD
IS SOMETHING THAT I WAS REALLY
INTERESTED IN, IN GRAD SCHOOL,
AND I THINK IT'S DEFINITELY AN
AREA THAT WE CAN CAPITALIZE ON.
YEAH, THAT INTEREST THAT
ESPECIALLY YOUNG PEOPLE HAVE
WITH, YOU KNOW, THEIR GAMES AND
THEIR APPS.
ANYONE ELSE WANT TO -- FINAL
THOUGHTS?
ABOUT THAT OR ANYTHING ELSE?
>> WELL, IN DUE OF TIME, WE WANT
TO MOVE TO OUR LAST SESSION, AND
IT'S OUR CLOSING SESSION.
THANK YOU, EVERYONE, FOR THIS
GREAT DISCUSSION.
AND SO NEXT, NOW WE'RE GOING TO
PROVIDE CLOSING REMARKS, AND
PLEASE WELCOME DR. MARIE
BERNARD, OUR CHIEF OFFICER OF
SCIENTIFIC WORKFORCE DIVERSITY
AT NIH.
>> WELL, THANK YOU VERY MUCH.
THIS HAS REALLY BEEN EXCITING
SETS OF DISCUSSIONS.
I AM A RECOVERING GERIATRICIAN.
I WAS DEPUTY DIRECTOR OF THE
NATIONAL INSTITUTE ON AGING FOR
13 YEARS.
IN THE LAST COUPLE YEARS, I'VE
BEEN SERVING AS THE NIH CHIEF
OFFICER FOR SCIENTIFIC WORKFORCE
DIVERSITY.
SO IT WAS WONDERFUL TO INCLUDE
ISSUES OF OLDER ADULTS BASED
UPON RACE/ETHNICITY, GENDER, I
HOPE THERE WAS DISCUSSION OF
CHILDREN.
BUT I'M GOING TO TALK ABOUT VERY
BRIEFLY WHAT WE ARE CURRENTLY
DOING AT NIH, JUST TO MAKE SURE
THAT EVERYONE IS AWARE.
SO I'LL START OFF WITH TALKING
ABOUT ADUCANUMAB.
I'M GLAD ROB CALIFF HAS LEFT,
THIS IS A DRUG THAT RECEIVED
ACCELERATED APPROVAL FROM THE
FDA BECAUSE OF THE IMPACT THAT
IT HAD ON AMYLOID PLAQUES.
AGAIN AS I SAID, I'M A
RECOVERING GERIATRICIAN.
WITH ALZHEIMER'S DISEASE, WE
KNOW THAT VERY EARLY ON, PEOPLE
GET THESE AMYLOID PLAQUES AND
TAU TANGLES, AND THE THEORY WAS
IF YOU COULD PREVENT THE
DEVELOPMENT OF THE PLAQUES, THAT
YOU MIGHT SLOW OR PREVENT THE
DEVELOPMENT OF THE DISEASE.
IT'S A VERY CONTROVERSIAL COUPLE
OF TRIALS THAT LED TO AN
ACCELERATED APPROVAL OF THE DRUG
BASED UPON WORK ON PEOPLE WHO
HAD MILD COGNITIVE IMPAIRMENT,
MEANING JUST -- THEY WERE
COGNITIVELY IMPAIRED BUT NOT
WITH DEMENTIA, OR MAYBE EARLY
ALZHEIMER'S DISEASE.
IT WAS INITIALLY APPROVED
BROADLY AND THEN AGAIN VERY
CONTROVERSIALLY IT WAS APPROVED
FOR MEDICARE COVERAGE IN A
CLINICAL TRIAL, BECAUSE THERE IS
SO MUCH CONTROVERSY ABOUT THE
DATA.
I WILL NOT ADDRESS THE DATA, BUT
I WILL ADDRESS WHO WAS INCLUDED
IN THE TRIALS.
ONE OF THE BIG ISSUES IS THAT
UNDERREPRESENTED GROUPS AND,
YES, WE USE RACE AND ETHNICITY
AS A MARKER FOR SOCIOECONOMIC
STATUS IN MANY CASES, THEY OFTEN
EXPERIENCED MISSED OR DELAYED
DIAGNOSES OF DEMENTIA COMPARED
TO NON-HISPANIC WHITES.
FOR NON-HISPANIC WHITES, A LOT
OF PEOPLE HAVE THE DIAGNOSIS
MISSED.
41% HAVE THE DIAGNOSIS MISSED.
BUT 46% OF NON-HISPANIC BLACKS
AND 54% OF HISPANICS DO NOT GET
THAT DIAGNOSIS EARLY ON, AND
JUST BASED UPON THAT, IT WOULD
SKEW A STUDY OF THE SORT IN
TERMS OF HAVING REPRESENTATIVE
NUMBERS.
AND THEN WHEN YOU LOOK AT WHO
ACTUALLY PARTICIPATE IN THE
STUDY, 89% OF THE PARTICIPANTS
WERE NON-HISPANIC WHITES, 9%
WERE ASIAN, LEAVING A VERY SMALL
PERCENTAGE FOR OTHER GROUPS, AND
YET WHEN YOU LOOK AT THE DATA,
WITH REGARDS TO THE PREVALENCE
OF ALZHEIMER'S DISEASE IN THE
UNITED STATES, YOU FIND THAT THE
HIGHEST PREVALENCE IS AMONG
AFRICAN AMERICANS AND BLACKS,
AND HISPANICS, AND MUCH LOWER
PREVALENCE IN NON-HISPANIC
WHITES AND ASIANS, BEGGING THE
QUESTION, WAS THE POPULATION
TRULY A REPRESENTATIVE
POPULATION?
WHY WAS THAT?
I WILL PUT FORTH THAT PART OF
THE ISSUE IS THAT THERE WAS NOT
A VERY DIVERSE SCIENTIFIC TEAM.
I CAN TELL YOU WHEN YOU LOOK AT
WHO THE INVESTIGATORS ARE IN
ALZHEIMER'S, IT'S FAIR LEA
HOMOGENEOUS.
THE NATIONAL INSTITUTE ON AGING
IS TRYING TO WORK ON THAT.
BUT THAT'S AN IMPORTANT ISSUE
AND IT'S BEEN RAISED HERE, THAT
BLACK AFRICAN AMERICAN HISPANIC
AND NATIVE AMERICAN PHYSICIANS
ARE MORE LIKELY THAN WHITE
PHYSICIANS TO PRACTICE IN
UNDERSERVED COMMUNITIES.
AND THAT THE PATIENTS WHO HAVE A
CHOICE ARE MORE LIKELY TO SELECT
A HEALTHCARE PROFESSIONAL OF
THEIR OWN RACIAL OR ETHNIC
BACKGROUND.
AND I THINK THAT TRANSLATES INTO
RESEARCH AS WELL, ALTHOUGH IT
WOULD BE NICE TO HAVE SOME
REALLY GOOD SOLID DATA ABOUT
THAT.
WE AS NIH THINK IT'S REALLY
IMPORTANT TO HAVE DIVERSE
PERSPECTIVES, DIVERSE TEAMS
CONDUCTING THE SCIENCE.
I'M NOT -- I DIDN'T INCLUDE ALL
OF MY DATA SLIDES, BUT IF YOU
WANT TO SEE THE DATA, TAKE A
LOOK AT NATURE MEDICINE,
NOVEMBER 2021 AND AN ARTICLE
WHERE LARRY TABAK, ALFRED
JOHNSON AND I TALKED ABOUT THE
NEEDS FOR DIVERSE PERSPECTIVES.
WHAT WE'RE TRYING TO ADDRESS IN
BIOMEDICAL RESEARCH AND
BEHAVIORAL RESEARCH IS LIKE
TRYING TO DESCRIBE AN ELEPHANT
WITHOUT SIGHT.
YOU HAVE TO COME AT IT IN A LOT
OF DIFFERENT WAYS.
PART OF WHAT WE'RE DOING TO MAKE
THIS HAPPEN IS THAT WE HAVE A
DIVERSITY, EQUITY, INCLUSION AND
ACCESSIBILITY STRATEGIC PLAN
THAT WAS JUST PUBLISHED.
IT LAYS OUT THE FRAMEWORK FOR
WHAT WE WILL BE DOING HERE AT
NIH FOR THE NEXT FIVE YEARS.
IT INCLUDES EVERYTHING THAT THE
INSTITUTES AND CENTERS ARE
DOING, THAT THE VERY SPECIAL
OFFICES LIKE MINE ARE DOING.
ONE OF THE THINGS THAT'S
HIGHLIGHTED IN THAT IS SOMETHING
CALLED THE COMMUNITY ENGAGEMENT
ALLIANCE THAT GOT STARTED DURING
THE HEIGHT OF THE COVID
PANDEMIC.
YES, AS HAS BEEN DISCUSSED, NIH
RESEARCH IS OFTEN HELICOPTERED
IN AND HELICOPTERED OUT.
IT WAS REALLY CLEAR WHEN THERE
WAS A NEED TO MAKE OUTREACH TO
POPULATIONS WHO WERE
DISPROPORTIONATELY IMPACTED, YOU
NEED TO WORK WITH PEOPLE IN THE
COMMUNITY.
IT WAS ALSO VERY CLEAR THAT JUST
HELICOPTERS OUT WOULD NOT BE
SATISFACTORY SO THE INTENT HERE
IS TO KEEP THIS ALLIANCE GOING.
AND THEN WE HAVE THE NIH UNITE
INITIATIVE THAT I HAVE THE
PRIVILEGE OF CO-LEADING.
UNITE IS AN INITIATIVE WITH A
VERY BOLD GOAL OF ENDING
STRUCTURAL RACISM.
IT WAS BORN FROM WHAT WE SAW IN
THE SPRING OF 2020, WITH
DISPROPORTIONATE MORBIDITY AND
MORTALITY, DEATHS, SEVERE
HOSPITALIZATIONS FOR PEOPLE,
AFRICAN AMERICANS AND BLACK,
HISPANIC, LATINOS, AMERICAN
INDIAS, ALASKA NATIVES, AND THEN
PUNCTUATED BY THE VIDEOTAPED
MURDER OF GEORGE FLOYD.
AND WE SPENT A LOT OF TIME,
PEOPLE ACROSS THE COUNTRY DID,
SEARCHING OUR SOUL, TRYING TO
FIGURE OUT WHAT WE SHOULD DO
ABOUT THIS.
AND CAME UP WITH THIS GOAL.
WE RECOGNIZE THAT SYSTEMIC
RACISM OR STRUCTURAL RACISM IS
MUCH BROADER ISSUE THAN NIH
ALONE CAN SOLVE BUT WE ARE THE
LARGEST FUNDER OF BIOMEDICAL AND
BEHAVIORAL RESEARCH IN THE
UNITED STATES, AND WE ARE INTENT
UPON USING OUR INFLUENCE TO MAKE
A DIFFERENCE IN THESE FOUR
CONTENT AREAS: MINORITY HEALTH
AND HEALTH DISPARITIES RESEARCH,
WE'VE DONE A LOT OF LOOKING AT
THE PROBLEMS TO MAKE A
DIFFERENCE.
GETTING OUR OWN INTERNAL
WORKFORCE IN PLACE AND DOING
THINGS FOR THE EXTERNAL
WORKFORCE.
ALL PEOPLE DRIVEN AND PEOPLE
FOCUSED AND DATA-DRIVEN.
SOME OF THE DATA THAT WE'VE
LOOKED AT ARE DATA SUCH AS THESE
THAT SHOW THE LONG-STANDING
DIFFERENCE IN LONGEVITY FOR
AFRICAN AMERICANS AND BLACKS
VERSUS NON-HISPANIC WHITES
VERSUS LATINOS HISPANICS.
IN FACT, THIS IS CALL WOULD THE
LATINO PARADOX, BECAUSE LATINO
HISPANICS HAVE THE SAME BURDEN
OF HYPERTENSION AND DIABETES OF
AFRICAN AMERICANS OR BLACKS AND
YET GREATER LONGEVITY, THOUGH
EVERYONE SUFFERED AS A RESULT OF
THE PANDEMIC.
HERE IS A LINE OF NON-HISPANIC
WHITES, IT WAS APPEARING THAT
HISPANIC LATINOS MIGHT BE LOSING
THE ADVANTAGE THAT THEY
PREVIOUSLY HAD.
SO, AS A RESULT OF THOUGHTS FROM
UNITE, WE FIRST HAD SOME COMMON
FUND INITIATIVES FOR
TRANSFORMATIVE RESEARCH IN
HEALTH DISPARITIES AND MINORITY
HEALTH, SOME $58 MILLION OVER
FIVE YEARS.
THE UNITE TEAM SAID THAT'S
REALLY NOT ENOUGH, AND WE RELY
HAPPILY -- THE COMPASS, THE
COMMUNITY LED HEALTH EQUITY
STRUCTURAL INTERVENTIONS, UP TO
25 COMMUNITIES WILL SAY THIS IS
WHAT WE SEE AS A PROBLEM, THIS
IS WHAT WE WANT TO HAVE DONE.
PARTNERING WITH ACADEMIC HUBS
AND A COORDINATING CENTER TO
MAKE SURE THAT THIS ALL GOES
SMOOTHLY SO WE CAN LEARN WHAT AS
WORKS AND HOPEFULLY HAVE SOME --
NOFOs AS WE'RE NOW CALLING
THEM.
WE WERE ALSO VERY IMPRESSED WITH
WHAT THE NIH-WIDE BRAIN
INITIATIVE DID IN WHAT'S CALLED
THE DEVELOPMENT OF PLANS TO
ENHANCE DIVERSE PERSPECTIVES.
THEY WERE LOOKING AT WHO WERE
THE PEOPLE IN THEIR CLINICAL
STUDIES, WHO WERE THE PEOPLE IN
THEIR AUTOPSY STUDIES, AND THEY
FOUND THEY WERE PRETTY
HOMOGENEOUS.
AND THEY STEPPED BACK AND THEY
LOOKED AT IT AND THEY FELT THAT
THAT'S BECAUSE THEIR SCIENTISTS
WERE PRETTY HOMOGENEOUS.
SO THEY WANTED TO DO SOMETHING
TO ENHANCE THE DIVERSITY OF
THEIR SCIENTISTS WHO ARE
INVOLVED IN THE BRAIN INITIATIVE
AND CAME UP WITH PLANS TO
ENHANCE DIVERSE PERSPECTIVES AS
AN EXPECTATION WHEN PEOPLE WERE
APPLYING FOR GRANTS THROUGH THE
BRAIN INITIATIVE.
THE OFFICE OF GENERAL COUNSEL,
WE'RE CLOSELY WITH THEM, AND
WHEN THEY TALK ABOUT DIVERSE
PERSPECTIVES, THEY'RE TALKING
ABOUT DIVERSITY BY GEOGRAPHY, BY
DISCIPLINE, YES AND KEEPING WITH
THE NOTICE OF SPECIAL INTEREST
FROM NIH THAT INCLUDES GENDER,
RACE, ETHNICITY, DISABILITY,
COMING FROM A DISADVANTAGED
BACKGROUND.
AND THIS -- THE BRAIN INITIATIVE
IS USED IN SCORING THE GRANTS.
YOU ALL DO HUMAN SUBJECT
RESEARCH, YOU KNOW WITH HUMAN
SUBJECT RESEARCH YOU REVIEW,
SCORE SEPARATELY IS INCLUSION
ACCEPTABLE OR NOT.
THE DIVERSITY OF THE TEAM, THE
DIVERSE PERSPECTIVES OF THE TEAM
ARE CONSIDERED AT EVERY PHASE OF
THE EVALUATION AND PART OF THE
SCORING.
UNITE IS ADVOCATING FOR ALL THE
INSTITUTES AND CENTERS TO
INCLUDE THIS IN THEIR NOFOS AND
I KNOW THERE ARE A COUPLE OF
ICs VERY AGGRESSIVELY GOING
ABOUT THAT.
WE ALSO HAVE EXPANDED WHAT'S
CALLED THE SCIENCE EDUCATION
PARTNERSHIP AWARDS, THE SEPA
AUTOIMMUNE AWARDS, NOW THERE AR7
INSTITUTES AND CENTERS THAT ARE
DOING THIS.
RECOGNIZING THAT SCIENCE
IDENTITY IS OFTEN DEVELOPED AS
EARLY AS MIDDLE SCHOOL, AND
THERE'S QUITE A BIT OF DIVERSITY
AMONG BID EL SCHMIDDLE SCHOOLER.
IT'S IMPORTANT TO GET THEM
ENERGIZED AS THIS IS ONE MEANS
OF DOING THAT.
WE'VE ALSO WITHIN THE LAST 10
DAYS HAVE THIS NEWLY RELEASED
NOFO FOR RESEARCH ACTIVITIES
RELATED TO DIVERSITY.
AN OPPORTUNITY FOR SCIENTISTS
WHO DON'T HAVE NIH FUNDING TO
GET FUNDED AND RECOGNIZE THE
WORK IN DIVERSITY.
SO THIS IS A REAL OPPORTUNITY
FOR HBCUs, TRIBAL COLLEGES AND
UNIVERSITY, IT'S A GREAT PARTNER
TO AN ADMINISTRATIVE SUPPLEMENT
THAT MY TEAM HAS BEEN GIVING,
AND YES, THIS WILL HELP TO
SUPPORT THE MENTORING THAT'S
REALLY ESSENTIAL FOR SUCCESS
BECAUSE MENTORING IS NOT USUALLY
COMPENSATED.
ADDITIONALLY, JUST IN THE LAST
10 DAYS, THERE'S A NOTICE OF
FUNDING OPPORTUNITY FOR
INSTRUMENTATION GRANTS FOR
RESOURCE LIMITED INSTITUTIONS.
AGAIN, SOME OF THE INSTITUTIONS
WE'RE TALKING ABOUT, HBCUs,
TRIBAL COLLEGES AND
UNIVERSITIES, AND THEN WE HAVE A
PRIZE COMPETITION FOR
INSTITUTIONAL EXCELLENCE IN
DIVERSITY, EQUITY AND INCLUSION
AND ACCESSIBILITY AND WE HOPE TO
BE ANNOUNCING IF THE VERY NEAR
FUTURE, SO THAT'S A SPACE TO
WATCH.
THERE ARE SOME CONCEPTS THAT
HAVE BEEN APPROVED BY THE NIGMS
AND BY THE NIMHD COUNCIL, AND
ONCE A CONCEPT HAS BEEN APPROVED
BY AN ADVISORY COUNCIL, THE VAST
MAJORITY OF CASES IT ENDS UP
BEING A NOTICE OF FUNDING
OPPORTUNITY.
ONE IS AN INSTITUTIONAL CLIMATE
GRANT LIKE THE FIRST INITIATIVE
THAT WAS MENTIONED, JUST NOT
WITH FUNDS FOR GROUPS BUT IT
HELPS TO LOOK AT THE CLIMATE AND
MAKE IT RECEPTIVE FOR A NUMBER
OF SCIENTISTS.
RESEARCH CAPACITY BUILDING
PROGRAM TO ENHANCE WORKFORCE
DIVERSITY JUST APPROVED BY THE
NIGMS COUNCIL IN FEBRUARY TO
TARGET LOW RESOURCE INSTITUTIONS
FROM WHAT I UNDERSTAND.
AND AN INSTITUTIONAL RESEARCH
CAPACITY BUILDING NEEDS
ASSESSMENT AND ACTION PLAN
DEVELOPMENT GRANTS, VERY
SPECIFICALLY MEANT TO ADDRESS
THE NEEDS OF, AGAIN, LOWER
RESOURCE INSTITUTIONS THAT NEED
ADDITIONAL -- WE TALKED EARLIER
ABOUT INFRASTRUCTURE RESOURCES,
THIS IS TARGETED TOWARDS THOSE
INSTITUTIONS.
THERE'S A LOT THAT'S GOING ON.
I WOULD REALLY ENCOURAGE YOU TO
JUST GOOGLE NIH UNITE.
TAKE A LOOK AT THE PROGRESS
REPORT.
IT'S AN ECK SA S EXCITING TIME,A
LOT GOING ON, AND I THINK IT
WILL HELP AS WAS NOTED DURING
THE CONVERSATION, THINGS DON'T
TURN ON A DIME.
IT WILL TAKE A WHILE TO SEE THE
FULL IMPACT OF ALL OF THIS.
BUT I THINK IT GOING TO BE
REALLY SUPPORTIVE TO ALL THINGS
THAT WERE DISCUSSED HERE AND
REALLY I'M LOOKING FORWARD TO
SEEING THE OUTCOMES.
THANK YOU.
>> OH, THANK YOU.
THANK YOU SO MUCH, DR. BERNARD,
FOR YOUR GRATEFUL COMMENTS AND
GREAT PRESENTATION.
>> YEAH.
>> AND SO WE WANT TO CLOSE BY
THANKING ALL OF THE INDIVIDUALS
THAT HELPED MAKE THIS WORKSHOP A
SUCCESS.
FIRST AND FOREMOST.
THANK YOU TO ALL THE
PARTICIPANTS FOR ATTENDING THIS
TWO-DAY WORKSHOP.
WE WOULD ALSO LIKE TO THANK THE
MODERATORS, THE SPEAKERS AND THE
PANELISTS.
>> YES.
AND IN ADDITION, THERE IS A HUGE
HOST OF PEOPLE WHO HELPED TO
PLAN, ORGANIZE, AND COORDINATE
THIS WORKSHOP, SO WE'D LIKE TO
THANK OUR PLANNING COMMITTEE
MEMBERS, NIMHD COMMUNICATIONS
AND ADMINISTRATIVE STAFFS, NIH
EVENTS MANAGEMENT STAFF WHO
COORDINATED THE VIDEOCAST LIVE
STREAM, OUR CONTRACTOR SUPPORT
THROUGH SIDEM, AND OUR ASL
INTERPRETERS.
AND LASTLY, WE WANTED TO
ACKNOWLEDGE THE ART AND THE
ARTIST FEATURED ON THE WORKSHOP
MATERIALS.
SHYAMA KUVER SUBMITTED THIS
ARTWORK TO THE NIMHD ENVISIONING
HEALTH EQUITY ART CHALLENGE.
IN THE PIECE ENTITLED "TOGETHER
WE THRIVE," THE MOON ORBITS
REPRESENT PERSISTENCE AND
RESILIENCE, AND THE HANDS
REPRESENT CONNECTEDNESS.
SO WE LEAVE YOU WITH THE
REMINDER THAT WHEN WE WORK
TOGETHER, OUR COMMUNITIES
THRIVE.
THANK YOU SO, SO MUCH FOR COMING
TO THIS WORKSHOP.
YES, THANK YOU.
IT'S BEEN GREAT.
THANK YOU.