WELCOME TO SESSION 4.
TODAY IS EQUITY AND INCLUSION
DAY AND OUR SPEAKERS ARE GOING
TO PICK UP ON SOME OF THE
THEMES THAT DOCTOR WENT
WENDLER AND I MENTIONED AND
PROFESSOR SHAH FROM LAST WEEK.
WE HAVE THREE QUICK
ADMINISTRATORS OR
QUIZ-RELATED.
THE FIRST IS THE WORD OF THE
DAY IS EQUITY.
SO I WILL MENTION THAT AGAIN A
COUPLE OF TIMES TODAY.
THANK YOU TO THE 192 OF YOU
WHO ALREADY COMPLETED THE
MONKEY SURVEY THAT I SENT
AROUND ABOUT HOW YOU HEARD
ABOUT THE COURSE.
I AM GOING TO SEND THAT LINK
AROUND AGAIN TODAY AFTER
CLASS.
IF YOU HAVE ALREADY FILLED IT
OUT, AGAIN, YOU CAN DISREGARD.
THANK YOU.
BUT WE WOULD LIKE A COUPLE
MORE PEOPLE TO FILL THAT OUT.
THE OTHER THING I WANT TO
MENTION TODAY IS WE ARE GOING
TO BE USING SLIDO AND IT IS A
PROGRAM YOU CAN LOG IN
DIRECTLY TO YOUR LAPTOP OR
DESKTOP AT SLIDO.COM OR YOU
CAN LOAD IT ON YOUR SMART
PHONE OR LOOK IT UP ON THE WEB
FOR YOUR SMART PHONE.
AND FOR Dr. LA NGFORD'S
PRESENTATION AND FOR MINE AT
THE END OF THE DAY, WHAT WILL
HAPPEN IS I WILL ASK QUESTIONS
AND YOU WILL BE ABLE TO EITHER
PICK ANSWERS OR PUT IN SOME
ANSWERS SO WE CAN GET SOME
AUDIENCE PARTICIPATION.
THE CODE FOR THAT, I PUT BOTH
IN THE ANNOUNCEMENTS AND
E-MAIL.
I AM GOING TO MENTION IT NOW
IN CASE FOLKS HAVE A PENCIL OR
A PEN.
IT IS 9,847,744.
AND YOU DON'T NEED TO DO
ANYTHING.
YOU DON'T NEED TO CREATE AN
ACCOUNT, DON'T NEED TO LOG IN.
WHEN YOU GO THERE, IT WILL SAY
WHAT IS YOUR PARTICIPANT CODE
TO PUT IN AND I WILL MENTION
THAT AGAIN BEFORE Dr.
LANGFORD TALKS.
SO WITH WHAT, IT IS MY
PLEASURE TO INTRODUCE YOU ALL
TO OUR FIRST SPEAKER.
U.K. IKO AS A DA IS A NEW
FACULTY MEMBER HERE IN OUR
DEPARTMENT OF BIOETHICS.
SHE WAS MOST RECENTLY A
PROFESSOR AT THE COMMUNITY
HEALTH AND EPIDEMIOLOGY AT
HALIFAX UNIVERSITY IN HALIFAX,
CANADA AND IS AN EXPERT ON
ISSUES RELATED TO EQUITY
RESEARCH AND SHE IS GOING TO
TALK WITH US ABOUT WHEN OUR
HEALTH INEQUALITY IS UNFAIR.
AND I ALSO WANT TO MENTION
THAT WE'RE GOING TO TAKE TWO
BRIEF RESTS IN HER LECTURE
WHERE WE CAN ASK SOME
CLARIFYING QUESTIONS SO THOSE
OF YOU OUT THERE, REMEMBER YOU
CAN GO TO THE DISCUSSION BOARD
FOR SESSION 4 AND PUT IN
QUESTIONS OR SEND BY E-MAIL TO
THE BIOETHICS INQUIRY E-MAIL
AND WE ALSO HAVE FOLKS HERE IN
THE AUDITORIUM WHO WILL ASK
QUESTIONS.
SO WITH THAT, I WILL HAND IT
OVER TO DOCTOR ASADA WHO IS
JOINING US BY ZOOM TODAY.
>> THANK YOU VERY MUCH, CAN
YOU HEAR ME OKAY?
>>YES, WE CAN HEAR YOU JUST
FINE.
>>SO THANK YOU FOR THAT
INTRODUCTION.
HERE IS MY DISCLAIMER, THE
VIEWS EXPRESSED IN THIS TALK
ARE MY OWN AND DO NOT
REPRESENT THE POSITION OF THE
NIH, DHHS OR U.S. GOVERNMENT
AND I HAVE NO CONFLICTS OF
INTEREST TO DECLARE.
SO MY TALK TODAY WILL BE ABOUT
HEALTH INEQUITY AND BEFORE I
GIVE THIS TALK, IT WILL APPLY
TO OTHER FOCUSES ON HEALTH,
FOR EXAMPLE --
[INDISCERNIBLE]
THERE ARE A COUPLE OF THINGS I
WISH TO MENTION IN THIS TALK.
HERE IS THE LIST OF EIGHT
TOPICS FOR ETHICAL CLINICAL
RESEARCH WITH WHICH YOU ARE
PROBABLY ALREADY FAMILIAR AND
WE TALKED ABOUT IN THE FIRST S.
ETHICAL PRINCIPLES ARE NOT TO
ADD AND ARE NOT IN THE
TEXTBOOK BUT THEY ARE EQUITY
CONSIDERATIONS MADE.
I BELIEVE AT THE END OF THIS
TALK THAT EQUITY
CONSIDERATIONS ENTER INTO EACH
OF THE EIGHT PRINCIPLES BUT
WITH LIMITED TIME TODAY, I
WILL FOCUS ON THE THREE I HAVE
HIGHLIGHTED ON THE SLIDE.
SO THE FIRST ONE IS TO MAKE
THE EQUITY CONSIDERATION
MEANINGFUL.
I WILL START BY ASKING THREE
QUESTIONS, WHO SHOULD BE IN
THE STUDY AND WHY, HOW IS THE
STUDY FAIR AND WHY AND HOW DO
EQUITY DECISIONS INFLUENCE THE
STUDY DESIGN, ANALYSIS PLAN
AND REPORTING.
THE OTHER THING IS WE ARE NOT
GOING TO GIVE YOU ANSWERS TO
ANY OF THESE QUESTIONS BUT I
HOPE YOU AGREE WITH ME BY THE
END OF THIS TALK BY EXAMINING
THESE QUESTIONS AND THINK
DEEPLY ABOUT ETHICAL
CONSIDERATION.
SO LET ME DIG INTO THE FIRST
QUESTION WHICH IS WHO SHOULD
BE IN THE STUDY AND WHY.
THERE IS A CHANGE IN NORMS
FROM EXCLUSION TO INCLUSION.
THE STUDY USED TO BE FROM
HOMOGENEOUS GROUPS OF PEOPLE
THAT WERE MOSTLY WHITE MIDDLE
AGED MEN.
AND NOW CAN INCLUDE ANYONE AND
EXCLUSION REQUIRES
JUSTIFICATION.
AND FOR EXAMPLE, NIH
GUIDELINES ON INCLUSION OF
WOMEN AND MOTORS AS SUBJECTS
IN CLINICAL RESEARCH AND WE
WILL TALK MORE ABOUT THIS.
THERE IS A FEW DIFFERENT WAYS
TO THINK ABOUT THE QUESTION OF
WHO WILL BE IN THE STUDY,
PARTICIPATION, BIOLOGY AND
SOCIETAL AND I WILL TALK ABOUT
EACH.
THE FIRST IS PARTICIPATION.
THE AUTHORS SEARCHED FOR ALL
CLINICAL TRIALS IN GENERAL ON
RACE AND SEX REPRESENTATION IN
RANDOMIZED CLINICAL TRIALS
BETWEEN 2015 AND 2019.
ABOUT 50 PERCENT OF THESE
STUDIES HAD LESS THAN
15 PERCENT RECORDED AND MORE
THAN 98 PERCENT RECORDED.
THE GRAPH HERE IS A BOX
SHOWING THE LONGEST STUDY
REPORT, RIGHT, AND THE EFFECTS
ON THE RIGHTHAND SIDE.
WHAT IS THE PERSON WHO
PARTICIPATED IN EACH TRIAL.
SO WHEN RACE WAS REPORTED IN
TRIALS, THE RELATION IS --
[INDISCERNIBLE]
IN THIS COUNTRY AND POINTS OF
CONCERN.
THE OTHER THING TO NOTICE IS
THERE WERE STILL SURPRISINGLY
MORE MALE THAN FEMALE
PARTICIPANTS.
SO THE CONSIDERATION HERE IS
THE FAIR DISTRIBUTION OF
BENEFITS AND BURDEN AND WE
USED TO BE MORE FOCUSING ON
THE BURDEN SIDE AND IT IS
CHANGING TO BENEFITS.
SO WHAT IT MEANS TO
PARTICIPATE IN A STUDY HAS
CHANGED FROM BEARING THE
BURDEN TO ACCEPTING INNOVATION
SO THAT MEANS THAT WE DON'T
WANT TO RESTRICT THE BURDEN
DISTRIBUTION BECAUSE THAT WILL
DENY ACCESS TO INNOVATION.
THE OTHER THING IS THINKING
ABOUT WHO SHOULD BE IN THE
STUDY.
NOW BIOLOGY HAS BEEN TALKED
ABOUT AND PARTICIPATION.
NOW I WILL TALK ABOUT SOCIETAL
CONCERN.
IN THIS EXAMPLE, THE BASICS OF
INTERVENTION STUDIES, X AND Y.
SO FOR EXAMPLE, WE MIGHT
HYPOTHESIZE THAT INCREASED
ACTIVITY LEADS TO INCREASED
BENEFIT.
BUT MAYBE THAT IS NOT TRUE
BECAUSE SAY PHYSICALLY ACTIVE
PEOPLE MAY SMOKE LESS.
SO WE WANT TO INCLUDE TWO
THINGS, WE WANT TO CONTROL
THROUGH THE DESIGN AND
STATISTICALLY RANDOMIZE TO
REDUCE BIAS.
SO THE MORE CHALLENGING
GREATER THE DISTURBANCE IS,
THE MORE CHALLENGING IT IS TO
ESTABLISH CAUSALITY.
AND SIMILAR STUDY SUBJECTS
BRING LESS DISTURBANCE SO THE
ASSUMPTION IS CASS SALT IN
QUESTION X TO Y APPLIES TO ALL
HUMAN BEINGS AND AS AN
EXAMPLE, I WANT TO LOOK AT
CASS ASSAULT IN THE QUESTION X
LEADS TO Y.
THIS IS REPORTED QUITE A BIT
NOW BUT SURPRISINGLY IT IS
DIFFICULT BETWEEN MEN AND
WOMEN.
SO IF WE STUDY ONLY MEN FOR
HEART ATTACK SYMPTOMS, WE GET
X AND THIS ILLUSTRATION SHOWS
THAT THE FEATURES IN CARDIAC
ON DISORDERS MAKES IT CLEAR
THAT MEN AND WOMEN HAVE A
DIFFERENT MECHANISM FOR
CARDIOVASCULAR DISEASE SO THEN
IT IS IMPORTANT TO STUDY OTHER
SUBJECT WOMEN OTHERWISE WE
DON'T KNOW ABOUT IT.
WE COULD ALSO THINK THE
CAUSALITY QUESTION X TO Y MAY
WORK DIFFERENTLY IN DIFFERENT
HUMAN GROUPS BECAUSE -- I AM
SORRY, I SHOULD HAVE SAID, IN
THIS ONE, THERE ARE STILL
BIOLOGICAL DIFFERENCES SO THE
PRIMARY FOCUS HERE IS THE
POTENTIAL DIFFERENTIAL IMPACTS
BETWEEN MEN AND WOMEN AND THEY
ARE STUDIED SEPARATELY.
SO NOW WE LOOK AT X TO Y AND
HOW IT MAY WORK DIFFERENT IN
GROUPS BECAUSE OF HOW WE
ORGANIZE SOCIETY.
AND DIFFERENCE INTERVENTION
EFFECTS BY SOCIAL GROUP
CHARACTERISTICS.
AN EXAMPLE IS THIS STUDY, THE
METAANALYSIS OF TRIALS IN
INDIA, BANGLADESH AND NEPAL
WITH THE COMPARISONS AND
OUTCOMES THAT THEY MAY BE
DIFFERENT THAN THE ORIGINAL
STUDY GROUP.
SO I AM SHOWING YOU THE
POPULATION FROM NEPAL AND THE
INTERVENTION IN WOMEN'S GROUPS
AND COMPARISON WITH OR WITHOUT
THE INTERVENTION AND THE
OUTCOME OF NEONATAL MORTALITY.
MOST WOMEN WERE ILLITERATE AND
POOR FOR MOST MARGINALIZED.
AT THE BEGINNING, THE MOST
MARGINALIZED WOMEN WERE IN
NUMBER 1 AND IN THIS SECTION,
THERE IS A DIFFERENTIAL EFFECT
AND LOOKS LIKE IT WAS ACTUALLY
A GOOD STORY THAT IT WORKED
MORE FOR THE MOST MARGINALIZED
GROUP.
THE NEXT THING TO STUDY IS TO
FOCUS ON THE EXCLUDED GROUP
AND HOW INNOVATION WORKS IN
THE EXCLUDED GROUP.
HERE IS THE EXAMPLE FOCUSING
ON PRIMARY CARE IN PATIENTS
WHERE INTERVENTION IS NOT
PREVALENT IN THEIR LIFESTYLES.
SO THE POPULATION IS THOSE
LOW-INCOME NEIGHBORHOODS,
INTERVENTION IS THE LIFE-STYLE
BASED PROGRAM FOR OBESITY
TREATMENT AND COMPARISON IS
INTENSIVE LIFESTYLE PROGRAM
VERSUS USUAL CARE AND OUTCOME
IS PERCENT IN CHANGE IN BODY
WEIGHT SO YOU HAVE THE
INTENSIVE LIFESTYLE GROUP, THE
USUAL CARE GROUP AND THE
DIFFERENCE IS CLINICALLY
SIGNIFICANT WITH THIS
DIFFERENCE SO THIS STUDY IS
VERY GOOD BECAUSE IT LOOKS AT
THE TRADITIONALLY EXCLUDED
GROUP AND THEY WENT FURTHER
SHOWING THE INTERVENTION WHICH
LED TO GREATER CHANGE IN
WEIGHT SO THEN YOU HAVE THE
SOLID LINE AND THE DOTTED LINE
BUT THE INTERVENTION IS
BROADER IN BLACKS THAN OTHER
RACE.
SO THE PRIMARY INTEREST HERE
IS THE EFFECTS OF THE PROGRAM
FOR INTERVENTION.
NOW, I HAVE BEEN WORKING IN
THE FIELD QUITE A BIT, QUITE
LONG TIME BUT THE TERMINOLOGY
IS OFTEN CONFUSING.
PEOPLE USED TO THINK OF THEM
DIFFERENTLY AND IT IS GOOD
IDEA TO BE CLEAR ABOUT WHAT
WE'RE TALKING ABOUT.
AND HERE IS THE DEFINITION OF
GENERALLY WHAT IS SUPPORTED IN
THE FIELD.
SO WHEN WE SAY HEALTH
INEQUALITY, WE MEAN THE
DIFFERENCES OR VARIATIONS IN
HEALTH ACROSS INDIVIDUALS OR
GROUPS AND THERE IS NO ETHICAL
JUDGMENT.
BUT WHEN WE SAY HEALTH
INEQUITY, THAT MEANS
INEQUALITIES IN HEALTH ACROSS
INDIVIDUALS AND/OR GROUPS THAT
WE JUDGE ETHICALLY PROBLEMATIC
AND UNFAIR.
THERE ARE DIFFERENT STUDIES ON
HEALTH INEQUALITY THAT WE WILL
TALK ABOUT.
AND HERE IS ANOTHER TERM,
HEALTH DISPARITY WHICH IS USED
QUITE A LOT IN THE UNITED
STATES.
NOT SO MUCH OUTSIDE THE UNITED
STATES.
AND FOR A LONG TIME, THE
HEALTH DISPARITY IS UNDERSTOOD
AS HEALTH INEQUALITY BUT AS WE
THINK ABOUT IT MORE, PEOPLE
START TO THINK OF IT
DIFFERENTLY.
SO WE HAVE THE SAME WAYS TO
THINK ABOUT WHO SHOULD BE IN A
STUDY AND THE PRIME BIOLOGY
AND SOCIETAL CONCERN.
SO WE POSE THE QUESTION WHO
SHOULD BE IN THE STUDY AND
WHY.
I WILL PAUSE HERE AND HOLLY IF
YOU COULD HELP ME FIELD THE
QUESTIONS.
>>ANY QUESTIONS FROM THE
ROOM?
NO QUESTIONS FROM THE ROOM.
NOW I WILL CHECK AND SEE IF WE
HAVE ANY FROM THE STUDENTS.
AS A REMINDER, YOU CAN PUT
YOUR QUESTIONS ON THE SECTION
FOR SUBSTANTIVE QUESTIONS
DISCUSSION BOARD OR SEND AN
E-MAIL TO BIOETHICSINQUIRY.
THERE IS SOMETIMES A BIT OF A
DELAY IN GETTING QUESTIONS SO
I DON'T SEE ANY NOW BUT
EVERYONE IS NOW REMINDED THAT
THEY CAN BE PUTTING QUESTIONS
IN AS YOU GO AND WE CAN
PERHAPS DO SOMETHING FOR
CLARITY LATER.
>>OKAY, CORRECT, NOW I WILL
MOVE ON TO THE SECOND
QUESTION, WHO SHOULD BE IN THE
STUDY AND WHY. WHICH HEALTH
INEQUITIES AND WHY.
SO LET'S THINK FURTHER TO
INCLUDE DIVERSE STUDY SUBJECTS
FOR SOCIETAL CONCERN.
THERE ARE MANY GROUPS
SUGGESTED AND HERE ARE SOME
EXAMPLES.
SO AS I ALREADY MENTIONED, NIH
GUIDELINES ON INCLUSION OF
WOMEN AND MINORITIES AS
SUBJECTS IN CLINICAL RESEARCH.
THERE A MINORITY GROUP IS
DEFINED AS A READY
IDENTIFIABLE SUBSET OF THE
U.S. POPULATION WHICH IS
DISTINGUISHED BY EITHER
RACIAL, ETHNIC AND/OR CULTURAL
HERITAGE.
THE OTHER WAY MANY PEOPLE
THINK IS PROGRESS-PLUS WHICH
IS THE ACRONYM OF PLACE OF
RESIDENTS, RACE AND ETHNICITY,
CULTURE, LANGUAGE, OCCUPATION,
GENDER OR SEX, RELIGION,
EDUCATION, SOCIOECONOMIC
STATUS, SOCIAL CAPITAL AND
ADDITIONAL CONTEXT-SPECIFIC
PERSONAL OR SETTING
CHARACTERISTICS.
THIS PROGRAM WAS LOOKED AT IN
2017 AND THEY MADE SOME
CHANGES TO THE FRAMEWORK FOR
PARITY IN HEALTH EQUITY.
AND YOU MIGHT WONDER WHAT IS
THE LAST THING, AND THAT IS
LIKE DISABILITY OR SEXUAL
ORIENTATION OR MIGRATION FOR
REFUGEE STATUS, THE BIVARIATE
APPROACH TO THE STUDY.
SO THERE ARE DIFFERENT WAYS OF
SUGGESTING PEOPLE BE SUBJECTS
AND WHEN I THINK OF
DIFFERENCES, I THINK OF WHAT
WE ARE TYPICALLY THINKING SO
THERE IS HEALTH AND THEN THERE
IS OTHER ATTRIBUTES OR THINGS
WE'RE WORRIED ABOUT, LIKE
INCOME AND EDUCATION AND THEN
WE HAVE SEPARATE AND
INTERESTED IN WHAT ARE
DIFFERENT DIFFERENT LEVELS OF
HEALTH.
SO THIS IS THE WAY WE OFTEN
THINK BUT THERE ARE SOME
CHALLENGES FOR THIS APPROACH.
FIRST AN INCREASING NUMBER OF
GROUPS IDENTIFY AS IMPORTANT.
NOTHING WRONG ABOUT IT BUT THE
NUMBER HAS BEEN MORE AND MORE.
AND THEN OFTENTIMES WITHIN
GROUP VARIATION AND
INTERSECTIONALITY ARE OFTEN
OVERLOOKED.
SO IN THE GRAPH I SHOWED YOU,
EVERYBODY HAS THE SAME HEALTH
BUT THE DATA SHOWS WITHIN THE
GROUP THERE IS SOME UNDERLYING
OBSERVATION.
AND CONCERNS FOR INTERSECTIONA
LITY, WE WANT TO LOOK AT
VARIATION AND WE SAY WELL, IT
IS NOT ENOUGH SO WE WANT TO
INCREASE THE NUMBER OF GROUPS.
AND ANOTHER INTERESTING ISSUE
IS THE GROUP DEFINITION ITSELF
CAN CHANGE.
A GOOD EXAMPLE IS SEX.
IT USED TO BE THAT WE LOOKED
AT BINARY SEX BUT NOW WE ARE
LOOKING AT OTHER VARIABLES.
AND THEN I THINK A REALLY
IMPORTANT POINT IS THE REASONS
WHY THE SELECTED GROUP
CHARACTERISTIC SIGNIFY
CONCERNS FOR UNFAIRNESS AND
INEQUALITY ARE OFTEN INTUITIVE
AND IMPLICIT.
SO THERE IS NO ARTICULATION OF
UNFAIRNESS, IT IS JUST A THING
WHERE WE THINK IT IS WRONG SO
IT IS WRONG AND WE DON'T NEED
TO EXPLAIN BECAUSE IT IS
WRONG.
AND DOING THAT, WE EXCLUDE
MANY BITS OF INFORMATION TO
LACK A COHERENT PICTURE.
SO FOR EXAMPLE, IF SOMEBODY
ASKS, WHICH WE ASK A LOT, HOW
WE CAN DO BETTER WITH HEALTH
EQUITY AND IT IS DIFFICULT TO
EXPLAIN BECAUSE WE MISS MANY
BITS OF INFORMATION AND THEN
MISS OUT ON A WAY TO HAVE A
MORE COHERENT PICTURE.
SO WHAT IS THE CHALLENGES OF
THE BIVARIATE APPROACH?
YOU CAN SEE WE HAVE ON THE
LEFT, THE ATTRIBUTE BIVARIATE
GROUP.
YOU CAN SEE THE HORIZONTAL IS
HEALTHY AND NOT HEALTHY AND
THEN THE VERTICAL IS THE
DISTRIBUTION AND INTERESTINGLY
INDIVIDUAL EFFORTS IS OFTEN
HERE IN THE PUBLIC HEALTH WAY
OF THINKING, AND BETWEEN THE
HEALTH AND AT ATTRIBUTE, THEY
DON'T OFTEN TALK TO EACH
OTHER.
SO THE INTERESTING QUESTION IS
ARE WE GIVING ACCESS TO THE
BIVARIATE GROUP AND IS IT
UNFAIR?
SOME PEOPLE SAY YES.
BUT MANY SAY NO, THAT ONLY
PART OF INEQUALITY IS UNFAIR.
SO THERE IS A PHILOSOPHY AND
DIFFERENT VIEWS, OF COURSE AND
I JUST SELECTED ONE.
SO EQUAL OPPORTUNITY FOR
HEALTH AND INEQUALITIES ARE
DUE TO FACTORS BEYOND THE
INDIVIDUAL CONTROL THAT ARE
UNFAIR.
SO POLICY AMENABILITY, THAT
HEALTH INEQUALITIES DUE TO
FACTORS AMENABLE TO POLICY
INTERVENTIONS ARE UNFAIR.
REIMMEDIATEABILITY AND
COMPENSABILITY HEALTH
INEQUITIES ARE UNFAIR.
AND THEN FAIR DISTRIBUTION OF
SOCIAL DETERMINANTS OF HEALTH,
FOR EXAMPLE, EDUCATION.
AND IF HEALTH EFFICIENCY IS
ADDRESSED, THIS COULD MAKE A
DIFFERENCE AND THEN THERE IS
GETTING EXTRA INCOME BY
COMPENSATION WHEN HEALTH
INEQUALITIES ARE UNFAIR.
SO THERE IS A MEDICINE WE
COULD HAVE DONE BUT THEN WE
DIDN'T AND THIS HEALTH
EFFICIENCY, THERE IS NO WAY WE
CAN COMPENSATE BY OTHER
GROUPS, LIKE GIVING A LOT OF
INCOME DOESN'T HELP FOR
EXAMPLE.
REALLY EXCRUCIATING PAIN, SAY.
SO THE SOCIAL DETERMINANTS OF
HEALTH ARE DISTRIBUTING
UNFAIRLY BECAUSE THE HEALTH
INEQUALITIES ARE UNFAIR.
SO THESE ARE THE VIEWS AND
THERE ARE MANY MORE AND THERE
IS ALWAYS DISAGREEMENT BETWEEN
THESE HERE.
SO THEN WHAT'S THE POINT?
THEY DON'T AGREE, THEY DON'T
HELP US, AND IN THE STUDY THE
VITAL CONCERN HAS GONE BY FROM
THE UNETHICAL NATURE.
SO IT IS IMPORTANT TO INCLUDE
TWERS STUDY SUBJECTS FOR
SOCIETAL CONCERN INFORMED BY
PHILOSOPHICAL LITERATURE AND
HERE IS A GRAPHIC DEFINITION.
SO WE HAVE SOCIAL GROUPS WE
CONSIDER AND JUST FOCUS ON
THAT BUT ACTUALLY THERE IS AN
UNDERLYING THEORY WHY IT IS
IMPORTANT.
THERE IS A REASON WHY WE WANT
TO FOCUS ON SOCIAL GROUPS AND
IF WE ARE CLEAR AND KNOW A BIT
ABOUT THE UNDERLYING THEORY,
THEN WE CAN SAY MORE ABOUT
WHICH ONE MIGHT BE MORE
IMPORTANT, HOW THEY RELATE TO
EACH OTHER AND FOR THOSE
QUESTIONS WE HAVE BETTER
KNOWLEDGE AND UNDERSTANDING.
SO THIS IS THE END OF THE
SECOND QUESTION AND I DID NOT
PROVIDE THE ANSWER TO THE
QUESTION OF WHAT IS UNFAIR,
ACTUALLY, I GAVE MANY ANSWERS
BUT HOPE I CONVEYED THE
TECHNICAL GOOD.
SO HERE IS ANOTHER PLACE TO
PAUSE FOR A QUESTION.
>>AND I ACTUALLY HAVE A
QUESTION FROM BRENDA.
SO ON A PREVIOUS SLIDE YOU
TALKED ABOUT EQUITY AND
EQUALITY AND NOT SURPRISING,
PERHAPS, SHE WOULD LIKE YOU TO
EXPLAIN THE DIFFERENCE AT
LEAST ONE MORE TIME, WHAT IS
THE DIFFERENCE BETWEEN THE
QUALITY AND EQUITY OR, I THINK
THE TERMS YOU USED WERE
INEQUALITY AND INEQUITY.
>>OKAY, SO I WILL SPEND A BIT
MORE TIME BECAUSE I DIDN'T
TALK ABOUT INEQUALITY AND
INEQUITY --
>>RIGHT, INTENTIONALLY.
>>INTENTIONALLY.
SO NOT ALL EQUALITY IS
EQUITABLE.
THE REASON IS IF YOU THINK WE
ARE JUST FOCUSING ON HEALTH,
IF A GENOCIDE HAPPENS,
EVERYBODY IS DEAD AND IF YOU
ARE CONSIDERED DEAD AS A
HEALTH INCOME, THERE IS
EQUALITY.
BUT YOU WOULDN'T SAY THAT'S A
GOOD OUTCOME.
THAT IS NOT EQUITY, RIGHT?
>>YEP.
>>SO THAT IS WHY I
DISTINGUISH BETWEEN EQUITY AND
INEQUALITY.
BUT YOU MIGHT SAY HEALTH
INEQUALITY INCLUDES
DIFFERENCES IN VARIATIONS IN
HEALTH ACROSS INDIVIDUALS OR
GROUPS.
LIKE HOWE TALL THE TREES ARE,
IF THEY HAVE MOUNTAINS AND
YOU ARE STILL NOT MAKING ANY
ETHICAL JUDGMENT, THEN YOU SAY
WHICH ONE IS NO GOOD AND THE
REASON WE SAY IT IS NO GOOD IS
BECAUSE OF ETHICAL CONCERNS.
AND WHEN WE IDENTIFY THIS
PARTICULAR INEQUALITY IS WRONG
BECAUSE OF THE ETHICAL
CONSIDERATION, THEN YOU ARE
TALKING ABOUT INEQUALITY.
>>GREAT, AND I ALSO WANT TO
REITERATE A POINT THAT YOU
MADE EARLIER THAT HEALTH
INEQUITIES ARE A SUBJECT OF
HEALTH INEQUALITIES.
SO IF YOU THINK OF, YOU KNOW,
A LARGE CIRCLE, YOU MIGHT BE
ABLE TO IDENTIFY, RIGHT, ALL
THE MOUNTAINS THAT ARE
DIFFERENT OR ALL THE TREES
THAT ARE DIFFERENT.
BUT THEN YOU MIGHT HAVE A
SMALLER CIRCLE OF THE
DIFFERENCES THAT ARE
INEQUITABLE.
SO FOR EXAMPLE, HERE IN THE
UNITED STATES IN WEST
VIRGINIA, THEY BLOW OFF THE
TOPS OF MOUNTAINS TO MINE FOR
COAL.
[LAUGHTER]
SO WE MIGHT SAY IT WAS UNFAIR
TO BLOW THE STOPS OFF THAT
SUBSET OF MOUNTAINS IN WEST
VIRGINIA BECAUSE THEY ARE NO
LONGER, YOU KNOW, THE SAME AS
THEY WERE BEFORE, FOR EXAMPLE.
AND YOU COULD HAVE LEFT THEM
THAT WAY SO IT IS PROBLEMATIC
IN THAT WE, MAN, HUMANKIND,
TOOK AN ACTION THAT LED TO AN
INEQUITY AMONG THE MOUNTAINS.
>> YES, THAT IS AN EXCELLENT
EXAMPLE.
AND THEN MAYBE I WILL ADD THAT
NOT ALL INEQUALITY IS MORALLY
BAD, RIGHT?
>>RIGHT.
>>SO SOME PEOPLE SAY IT'S
GOING BEYOND HEALTH BUT
INEQUALITY THEY SAY IS BAD BUT
THEN SOME PEOPLE SAY WE MIGHT
WANT TO HAVE A REWARD FOR HARD
WORK SO IF SOMEBODY WORKS
REALLY HARD AND THEN MAYBE IT
IS OKAY TO GIVE MORE MONEY.
AND THEN ALSO IF WE UNDERSTAND
INEQUALITY AS DIFFERENCES,
BIODIVERSITY, THE DIFFERENCES
BETWEEN THE SPECIES ARE NOT.
AND WE OFTEN SAY THAT THE
HEALTH INOOH QUALITY IS NOT
GOOD OR BAD SO THAT IS THE WAY
WE START TO CAPTURE THAT.
>>AND AGAIN IF YOU SAY THERE
IS NO ETHICAL JUDGMENT ABOUT
INEQUALITY, IT IS ONLY WHEN WE
LABEL IT AS AN INEQUITY THAT
WE WANT TO HAVE A ADJUSTMENT
AND NOW WE WILL HAVE A
QUESTION FROM HERE.
>>SORRY, I HAVE A QUESTION
ABOUT THE POINT ON THE LAST
SLIDE YOU WERE LOOKING AT WITH
HAUSAM'S IDEA ABOUT
INEQUALITY.
WE KNOW PEOPLE ARE LOW INCOME
HAVE HIGHER STRESS LEVELS THAN
PEOPLE WITH HIGHER OR MIDDLE
INCOME AND THAT CAUSES CERTAIN
HEALTH INEQUALITIES AS PEOPLE
WITH HIGHER STRESS MIGHT HAVE
HIGHER BLOOD PRESSURE, HIGHER
CHOLESTEROL, LOTS OF OTHER
THINGS.
THAT IS SOMETHING THAT YOU CAN
ADDRESS MEDICALLY WITH PILLS
AND THERAPY AND SO IT IS
REIMMEDIATABLE BUT IT IS ALSO
COME PENSABLE IN THAT IF
PEOPLE MADE MORE MONEY, THEY
WOULD BE LESS STRESSED OUT.
AND YET EVEN THOUGH IT IS
COMPENSALBE, IT IS
STRAIGHTFORWARD FOR ME TO SAY
IT IS STILL AN UNFAIR
INEQUALITY.
SO AM I WRONG IN SAYING THAT
IS A COMPENSABLE INEQUALITY OR
AM I BEING UNFAIR?
>>THERE IS NO FAMILY HEALTH
INEQUALITY THAT WE COMPARE
BECAUSE AS YOU SAY, WE CAN
COMPENSATE.
AND IT IS NOT JUST ABOUT
HEALTH, WE NEED TO THINK ABOUT
OVERALL AND HEALTH IS JUST ONE
OF THE IMPORTANT WAYS TO LOOK
AT THE OVERALL HEALTH ROLE.
SO WE CANNOT JUST TALK TOO
MUCH ABOUT HEALTH.
WE CANNOT FORGET ABOUT THE
BIGGER PICTURE.
>>OKAY, SO WOULD IT BE FAIR
TO SAY FROM HAUSMAN THAT THE
EXAMPLE I GAVE IS AN INEQUITY
BUT NOT A HEALTH INEQUITY?
>>YES, SO WE NEED TO
COMPENSATE.
>>THANK YOU.
>>GREAT, SO WHY DON'T YOU
CONTINUE ON.
I HAVE ANOTHER QUESTION BUT I
THINK WE CAN ASK IT IN THE
DISCUSSION SESSION.
>>THAT'S GREAT.
SO IN THE LAST SECTION, I
WOULD LIKE TO ASK HOW EQUITY
ADMINISTRATION ADDRESSES THE
STUDY DESIGN.
WE TALKED ABOUT REASONS WHY
THE STUDY DESIGN SHOULD BE
DIVERSE AND THE ANALYSIS PLAN
AND REPORTING.
SO THE FIRST ONE WE TALKED
ABOUT WAS PARTICIPATION.
THE PRIMARY CONCERN HERE IS
THE FAIR SUBJECT SELECTION.
AND IF THAT IS THE CONCERN AND
THAT'S IT AND IF YOU DO NOT
CONSIDER POTENTIALLY
DIFFERENTIAL INTERVENTION
EFFORTS DUE TO BIOLOGY OR
SOCIETAL CONCERN, YOU ARE
MISSING OUT ON A STUDY OR
ANALYSIS PLAN THAT WE SHOULD
BE DOING.
AND IF THE EMPHASIS IS
BIOLOGY, EXAMINATION
POTENTIALLY DIFFERENTIAL
CAUSAL PATHWAYS IN DIFFERENT
GROUPS, THEN THERE WILL BE
REPORTING.
WE TALKED ABOUT THE PROGRAM
WHERE YOU DO NOT INCLUDE WOMEN
AND THAT WILL DECREASE THE
SAMPLE SIZE AND YOU WOULD
DESIGN FOR THAT WHEN YOU PUT
THE STUDY TOGETHER ON WHICH IS
TRUE.
AND FINALLY FOR THE SOCIAL
CONCERN, WE CAN SAY EQUITY
CONSIDERATION, THE STUDY
DESIGN, ANALYSIS PLAN AND
REPORTING SHOULD MEET THE
OBJECTIVE OF IDENTIFYING
DIFFERENCES ACROSS GROUPS THAT
INDICATE UNFAIRNESS OR
INEQUITY.
SO THE TWO STUDIES WE LOOK AT
TODAY BY JULL AND COOKSON,
THEY LOOK AT HEALTH EQUITY
REEL VANITY RANDOMIZED TRIALS
AND EQUITY INFORMATIVE
METHODS.
SO FOR EXAMPLE IN COOKSON'S
ARTICLE, THE POPULATION IS LOW
INCOME COUNTRY, THE
INTERVENTION IS ANTENATAL
DIETARY EDUCATION AND
SUPPLEMENTATION PROGRAM AND
THE COMPARISON OF BABIES WHOSE
MOTHERS RECEIVED INTERVENTION
VERSUS BABE LEASE WHOSE
MOTHERS DID NOT RECEIVE THE
INTERVENTION AND THE OUTCOME
IS THE BIRTH WEIGHT.
SO LEFTHAND SIDE, THE PANEL
SHOWS THE DISTRIBUTION OF
BIRTH WEIGHT FOR CULTURAL, THE
BASELINE SHOWS NEEDS FOR EACH
GROUP, THE CONTROL AND TREATED
AND THEN FARTHER LEFT WITH
VERY LOW BIRTH WEIGHT.
AND THEN THE RIGHT GRAPH SHOWS
THE AVERAGE TREATMENT EFFECT.
SO THIS IS THE CONTROL VERSUS
THE TREATMENT AS AN ABSTRACTED
NUMBER AND THEN THE TREATMENT
AVAILABLE.
WHAT I LIKE IS THE
DISTRIBUTION FOR THE CONTROL
AND TREATED GROUP EVEN THOUGH
NOT EVERYBODY HAD THE SAME
FACTORS.
SO IF WE FOCUS ON A PARTICULAR
GROUP, TRADITIONALLY EXCLUDED
GROUP, THEN WE COULD SAY THAT
IT IS NONEQUITY INFORMATIVE,
NONEQUITY RELEVANT.
SO HERE IS ONE WAY TO DO THE
EQUITY STUDY.
IT IS OFTEN CALLED THE
CONDITIONAL OUTCOMES AND THE
AVERAGE TREATMENT EFFECT.
SO THE LIGHT BLUE WHICH IS
CONTROLS AND TREATED IS THE
DARKER BLUE SO THE LINES SHOW
THE AVERAGE BIRTH WEIGHT
CONDITIONAL FOR EACH TREATMENT
IN TREATED AND CONTROL GROUP.
THE VERTICAL DIFFERENCE
BETWEEN THESE LINES ARE THE
CONDITIONAL AVERAGE TREATMENT
EFFECTS.
SO IN THE LEFT LINE, SHOULD
THIS CONTINUE, YOU CAN DRAW
THIS, AND SUMMARIZE THE
CONDITIONAL EARNING TREATMENT
FOR THE POOREST, MIDDLE AND
RICHEST POPULATION AND THEN
AGAIN, I LIKE THAT THE EXAMPLE
SHOWS THE ENTIRE DISTRIBUTION
OF INCOME RATHER THAN JUST THE
GROUPS AND THAT IS MORE
INFORMATIVE, I THINK, AND THIS
IS A HYPOTHETICAL EXAMPLE THAT
MAY SHOW THAT INTERVENTION HAS
MORE IMPACT FOR THE LOWER
SOCIOECONOMIC GROUP AND NOT
ONLY BY DESIGN BUT AN
INFORMATIVE STUDY WITH A GOOD
RESULT IN TERMS OF HEALTH
EQUITY.
AND THIS IS NOT THE ONLY WAY
TO DO THE EQUITY INFORMED
STUDY BUT THE MOST OBVIOUS ONE
AND WE SEE THAT, YOU KNOW,
ALMOST LIKE THE SAME AS THE
ONE I SHOWED YOU HERE, A STUDY
OF PREGNANT WOMEN AND THIS IS
THE CONTROL AND TREATED WAY TO
SHOW THE HEALTH INEQUITY.
BUT THIS IS NOT THE ONLY WAY
TO DO THE INFORMATIVE STUDY.
A LARGER SAMPLE SIZE IS NEEDED
FROM TYPICALLY SMALLER GROUPS
AND IT IS OFTEN HARD TO REACH
SO IT IS DIFFICULT.
SO YOU MIGHT NOT BE ABLE TO
ENLARGE THE STUDY BUT AS LONG
AS DIVERSE SOCIODEMOGRAPHIC
CHARACTERISTICS ARE REPORTED,
STUDIES CAN BE EQUITY-RELEVANT
AND INFORMATIVE POST-HOC.
COMBINING DATA FROM MANY
STUDIES WITH THE METAANALYSIS
CAN BE HELPFUL.
METHODOLOGICALLY, THERE IS A
RECORDED DIFFERENCE OUTSIDE OF
THAT STUDY TO OVERCOME SMALL
SAMPLES.
ALSO ANOTHER CHALLENGE IS
COST.
THE HARDER TO REACH
POPULATION, MIGHT BE ETHICS
BUT ALTERNATIVELY, THE NIH
GUIDELINES SAY COST IS NO
REASON FOR EXCLUSION SO IF YOU
REQUIRE FUNDING FOR THE STUDY,
JUST ASK FOR IT.
THE FINAL CHALLENGE IS
COMPLEXITY AND IN HERE I WANT
TO GO BACK TO THE PRINCIPLES
FOR ETHICAL CLINICAL RESEARCH.
BECAUSE OF THE TIME
CONSTRAINT, I ONLY FOCUSED ON
THREE IN THIS PRESENTATION BUT
THERE ARE OTHERS IN RED HERE.
I THINK THIS EQUITY
CONSIDERATION COMES IN.
SO COLLABORATIVE PARTNERSHIP.
NOW WE ARE TALKING ABOUT FOR
EXAMPLE WORKING WITH A
COMMUNITY GROUP.
FAVORABLE RISK-BENEFIT MIGHT
BE CONSIDERED AND INDEPENDENT
REVIEW.
SO HERE WE ARE THINKING ABOUT
DIVERSIFYING AND THINKING
ABOUT THE DISTRIBUTION THAT
SOME OF THESE SUBJECTS ARE
GIVING INFORMED CONSENT AND
THEN RESPECT FOR ENROLLED
SUBJECTS.
SO THERE ARE OTHER
CONSIDERATIONS TO MAKE.
INFORMED CONSENT AND RESPECT
FOR ENROLLED SUBJECTS MIGHT
REQUIRE EXTRA CARE, JUST BY
THE NATURE OF WHO ARE NOW
INVITED IN THIS STUDY.
SO THIS IS THE SUMMARY OF THE
TALK.
I COVERED THREE QUESTIONS, WHO
SHOULD BE INCLUDED AND WHY,
HOW IS IT FAIR & OR UNFAIR AND
WHY AND HOW DO EQUITY
CONSIDERATIONS INFLUENCE STUDY
DESIGN ANALYSIS PLAN AND
REPORTING.
SO I HOPE BY NOW I WANTED TO
MAKE IT CLEAR TO YOU THAT
EQUITY CONSIDERATIONS ARE NOT
A CHECK BOX, THAT THEY ARE
WOVEN IN PRINCIPLES FOR
ETHICAL CLINIC RESEARCH AND WE
NEED TO MAKE EQUITY
CONSIDERATIONS EXPLICIT AND
MEANINGFUL.
IT IS IMPORTANT TO THINK
CAREFULLY ABOUT WHEN HEALTH
INEQUALITIES ARE UNFAIR.
SO THAT IS THE END OF IT.
SHOULD I STOP SHARING MY
SCREEN?
>>SURE, THAT WOULD BE GREAT.
WE'RE GOING TO GIVE YOU A BIG
GIANT ROUND OF APPLAUSE FROM
ALL OF US HERE IN THE
AUDITORIUM.
I WANT TO SEE IF ANYONE IN THE
ROOM HAS A QUESTION.
DOESN'T LOOK LIKE ANYBODY IS
JUMPING UP TO THE MIC.
I HAVE ONE QUESTION FROM A
LEARNER OUT IN THE WORLD.
LET ME JUST SCROLL -- AND I
WILL ALSO MENTION THAT YOUR
LECTURE HAS SPARKED A VERY
LOVELY CONVERSATION ONLINE
ABOUT EQUITY AND INEQUITY AND'
QUALITY SO THERE IS FURTHER
TEACHING GOING ON IN THE
DISCUSSION BOARD WHICH IS
LOVELY.
SO THIS QUESTION IS NOT
DIRECTLY ON POINT BUT YOU MAY
HAVE SOMETHING TO SAY.
THIS IS FROM FERNANDO.
HE SAYS WE HAVE SEEN A
MOVEMENT TO INCLUDE PREGNANT
WOMEN IN CLINICAL TRIALS WHO
ARE GENERALLY EXCLUDED TO
PROTECT THEM.
WHEN THE OBJECT OF THE STUDY
IS NOT PREGNANCY, WOULD IT BE
JUSTIFIED TO INCLUDE THIS
CATEGORY OF CLINICAL TRIALS OF
UNTESTED DRUGS.
I GUESS ANOTHER WAY TO SAY
THIS IS LIKE PREGNANT WOMEN
ARE OFTEN THE GROUP THAT ARE
EXCLUDED AND SHOULD WE WORRY
ABOUT THAT, AND/OR HOW SHOULD
WE BE MAKING PROGRESS IN
INCLUDING THEM MORE OFTEN?
>>YEAH, SO I THINK THERE ARE
OTHER PEOPLE PERHAPS WHO CAN
HAPPENS BETTER THAN ME BUT
WHAT I CAN OFFER, AND RECENTLY
I READ SOME RECOMMENDATIONS I
THINK IN --
[INDISCERNIBLE]
>>OH YEAH, WE DISCUSSED THAT
THE OTHER DAY.
>>SO THE QUESTION IS ARE THEY
VULNERABLE.
THERE ARE TWO PRINCIPLES.
ONE IS THEY ARE INHERENTLY
VULNERABLE BECAUSE OF THE
NATURE OF THE PEOPLE, LIKE
CHILDREN, THE DECISION-MAKING
CAPACITY IS STILL DEVELOPING.
AND PREGNANT WOMEN PREFERABLY
GO INTO THAT CATEGORY BECAUSE
OF THE FACT THEY ARE PREGNANT.
BUT THEN THERE ARE OTHER KIND
OF VULNERABILITIES WHICH IS
SOCIALLY CONSTRUCTED
VULNERABILITY.
SO THERE IS NO REASON THAT THE
LOW INCOME PEOPLE SHOULD BE
NOT CONSIDERED IF IT IS NOT
INCOME YOU ARE STUDYING.
SO I THOUGHT THAT WAS VERY
HELPFUL AND MAYBE APPLIES
HERE.
>> YEAH, GREAT AND WE TALKED
A LITTLE ABOUT THE INCLUSION
OF PREGNANT WOMEN, I GUESS
LAST WEEK, AND I CAN TOUCH ON
THAT AGAIN IN MY -- I HAVE A
LITTLE BRIEF LECTURE HERE TO
ORIENT FOLKS TO DIFFERENT
POLICIES.
SO WITH THAT, WE WILL THANK
YOU FOR JOINING US HERE ONLINE
AND LOOK FORWARD TO SEEING YOU
IN PERSON AGAIN NEXT WEEK.
>>THANK YOU.
THANK YOU VERY MUCH.
[LAUGHTER]
>>SEE YOU LATER.
>>THANK YOU.
>>SO AS I SAID, YOU GUYS GET
A BRIEF LECTURE FROM ME NOW,
REMINDER THAT TODAY'S WORD IS
EQUITY.
AND FOR THOSE WHO ARE JUST
JOINING, WE ARE GOING TO BE
USING SLIDO LATER AND I WILL
REMIND YOU AGAIN OF THE NUMBER
BEFORE Dr. LANGFORD'S TALK
SO WE CAN GET YOUR FEEDBACK.
SO IF I COULD GET MY SLIDES
UP, THAT WOULD BE GREAT.
I THINK IT IS TAILOR POLICY OR
SOMETHING, AWESOME.
OOH, INTERESTING.
OKAY, SO WE HAD A CRAZY COLOR
THERE FOR A MINUTE.
SO AS I SAID, WE HAVE BEEN
ALLUDING TO INCLUSION POLICIES
LAST WEEK AND AGAIN TODAY AND
I THOUGHT IT WOULD BE HELPFUL
TO GIVE FOLKS A BIT OF
BACKGROUND ON THE POLICY IN
THE BACKGROUND THAT IS
MOTIVATING INVESTIGATORS TO
INCLUDE MORE DIVERSE
POPULATIONS IN THEIR RESEARCH.
HERE IS MY DISCLAIMER THAT YOU
ARE ALL FAMILIAR WITH NOW.
SO A REALLY QUICK PRIMER FOR
EVERYONE, ESPECIALLY THOSE NOT
FAMILIAR WITH HOW THE U.S.
DEPARTMENT OF HEALTH AND HUMAN
SERVICES WORKS, BUT THERE ARE
SIX KEY AGENCIES RELATED TO
DHHS.
YOU WILL PROBABLY RECOGNIZE
SOME OF THEM, SOME OF THEM
MAYBE NOT SO MUCH BUT I AM
GOING TO FOCUS ON THE FDA AND
THE NATIONAL INSTITUTES OF
HEALTH.
WE ARE HERE AT THE NATIONAL
INSTITUTES OF HEALTH AND WE DO
A LOT OF RESEARCH IN HOUSE AS
WELL AS FUND A LOT OF RESEARCH
AND AS YOU KNOW, THE FDA IS IN
CHARGE OF THE REGULATION OF
DRUGS AND ALL SORTS OF OTHER
BIOLOGICS THAT ARE HEADED TO
MARKET.
SO JUST TO GIVE YOU A CONTEXT
AS HOW DEEP THE NIH GOES IN
TERMS OF HOW POLICY THAT THE
NIH DEVELOPED CAN AFFECT THE
CONDUCT OF HUMAN SUBJECT
RESEARCH, THE NIH BUDGET FOR
THE LAST FISCAL YEAR WAS
$45 BILLION.
THAT IS A LOT.
84PERCENT OF THAT $45 BILLION
WENT TO EXTRAMURAL
RESEARCHERS, SO RESEARCHERS
THAT ARE ALL OVER THE UNITED
STATES, SOME INTERNATIONALLY,
THAT HAVE APPLIED FOR AND
RECEIVED COMPETITIVE GRANTS.
THIS IS JUST ONE YEAR, MIND
YOU.
I JUST FIND THESE NUMBERS SO
BIG.
50,000 COMPETITIVE GRANTS TO
MORE THAN 300,000 RESEARCHERS
AT MORE THAN 2500
UNIVERSITIES, RIGHT?
SO AGAIN, THE NIH HAS A LONG
REACH AS IT RELATES TO
RESEARCH BECAUSE WE, THE ROYAL
WE, HOLD THE PURSE STRINGS.
SO WE CAN PLACE DEMANDS ON
INVESTIGATORS AND THEY REALLY
HAVE TO DO WHAT WE SAY BECAUSE
IF THEY DON'T, THEY MAY NOT BE
COMPETITIVE FOR GRANTS.
AND JUST AS AN ASIDE,
10 PERCENT OF THE FUNDING
STAYS HERE AND FUNDS 6000
INVESTIGATORS, MOST OF THOSE
LABS ARE HERE IN BETHESDA.
THERE IS A PRESENTATION IN
MONTANA AS WELL AS A COUPLE OF
OTHER STATES.
SO I WILL NOT TALK A LOT ABOUT
THESE BUT I WANT YOU TO BE
AWARE OF THEM AND AWARE OF THE
TIMELINE.
SO IT IS NOW MANY YEARS AGO
THAT THE NIH FIRST DEVELOPED
POLICY THAT SUGGESTED TO
INVESTIGATORS WHEN YOU ARE
DOING YOUR RESEARCH, IT IS A
REALLY GREAT IDEA IF YOU
EXPAND THE POPULATION OF WOMEN
AND MINORITIES IN YOUR
RESEARCH.
IT WAS OPTIONAL BUT THE NIH
WAS, RIGHT, SETTING OUT THE
EXPECTATION AND THE STANDARD.
IN 1994 AND UPDATED IN 2001,
THE SO I WANT, THE CONGRESS OF
THE UNITED STATES SAID NIH,
YOU HAVE TO COME UP WITH A
POLICY THAT YOU ARE GOING TO
ENFORCE AS IT RELATES TO THE
INCLUSION OF WOMEN AND
MINORITIES AS SUBJECTS IN
CLINICAL RESEARCH.
SO THAT MEANS THAT NIH HAS TO
SAY TO INVESTIGATORS TELL US
HOW YOU ARE GOING TO RECRUIT
DIVERSE POPULATIONS AND WE
TALKED A LITTLE ABOUT HOW ONE
MIGHT DO THAT.
NIH IS GOING TO TALK A LOT
ABOUT WHAT THE PRACTICAL
IMPLICATIONS OF -- SORRY,
Dr. LANGFORD WILL TALK ABOUT
HOW ONE MIGHT VIEW THAT.
AND IT BECAME A RULES RATHER
THAN A SUGGESTION.
IN THAT SAME -- UNDER THAT
SAME UMBRELLA A COUPLE OF
YEARS LATER, ADVOCATES SAID,
YOU KNOW, THOSE POLICIES THAT
YOU HAVE IN PLACE FOR WOMEN
AND MINORITIES WOULD ALSO BE
REALLY IMPORTANT AS IT RELATES
TO KIDS BECAUSE AS WE
DISCUSSED WITH Dr. SHAH LAST
WEEK, CHILDREN WERE
TRADITIONALLY EXCLUDED FROM
RESEARCH BECAUSE OF THEIR
VULNERABILITY AND BECAUSE OF
THE PRIORITIES OF
PHARMACEUTICAL COMPANIES.
SO THE NIH PUT OUT A SIMILAR
REQUIREMENT THAT INVESTIGATORS
OUGHT TO CONSIDER THE
INCLUSION OF CHILDREN AND IF
THEY AREN'T GOING TO INCLUDE
THEM, THEY HAVE TO JUSTIFY IT
IN THEIR APPLICATION.
SO AGAIN PUSHING, LIKE YOU
HAVE GOT TO DO IT, IF YOU
CAN'T, TELL US WHY.
AND AS DOCTOR ASADA MENTIONED
ON WOMEN AND MINORITIES, COST
CAN'T BE A REASON WHY.
YOU CAN'T SAY I CAN'T AFFORD
THAT.
YOU BUILD THAT INTO YOUR GRANT
PROPOSAL.
AND THEN FINALLY AS IT RELATES
TO THE NIH, THERE WAS AN
UPDATE TO THE CHILDREN'S
GUIDELINE IN 2017 THAT SAID,
YOU KNOW WHAT, THERE ARE ALSO
OLDER PEOPLE WHO ARE GENERALLY
EXCLUDED FROM RESEARCH.
NOW THOSE WHO ARE OLDER ARE
GENERALLY EXCLUDED BECAUSE
THEY OFTEN HAVE COMORBIDITIES.
THE OLDER YOU GET, YOU MIGHT
HAVE ONE OR MORE CONDITIONS
THAT YOU ARE TAKING MEDICATION
OR HAVE SOME INTERVENTION FOR.
AND AS WE MENTIONED BEFORE,
THE BEST CLINICAL TRIAL MIGHT
HAVE VERY HEALTHY HOMOGENOUS
PEOPLE.
ONCE YOU INTRODUCE SOMETHING
LIKE UNDERLYING HEALTH
CONDITIONS, IT MAKES IT A
LITTLE MORE COMPLICATED.
THE NIH SAID IT MIGHT BE A
LITTLE MORE COMPLICATED BUT
REMEMBER IF YOU ARE DEVELOPING
DRUGS FOR PEOPLE WHO ARE OLDER
AND DON'T INCLUDE OLDER PEOPLE
WHO HAVE COMORBIDITIES, YOU
WILL NOT KNOW WHETHER YOUR NEW
TREATMENT WILL WORK IN THAT
GROUP.
SO AN EFFORT TO THEN SAY YOU
HAVE GOT TO INCLUDE PEOPLE
ACROSS THE LIFESPAN.
SO THAT'S THE NIH IN TERMS OF
THE INCLUSION GUIDELINES.
THERE IS AN ADDITIONAL POLICY
THAT WAS INTRODUCED IN 2016
THAT SAID IF YOU ARE DOING
EARLY-STAGE RESEARCH, YOU
OUGHT TO ALSO BE TALKING
ABOUT, THINKING ABOUT SEX AS A
BIOLOGICAL BARRIER ALTHOUGH I
DON'T THINK THAT IS THE RIGHT
WORD BUT A BIOLOGICAL MARKER.
BUT THE IDEA THERE IS AND WE
HAVE TALKED BRIEFLY ABOUT
THIS, ONE OUGHT TO BE THINKING
ABOUT GENDER AS AN EXAMPLE
WHEN YOU ARE DOING YOUR
RESEARCH IN THE PETRI DISH OR
WITH ANIMALS, RIGHT?
IF YOU ANTICIPATE THE DRUG YOU
ARE DEVELOPING, SO BACK TO
Dr. ASADA'S EXAMPLE FOR
HEART DISEASE, IF YOU ARE
DEVELOPING A NEW TREATMENT FOR
HEART DISEASE, MAYBE YOU OUGHT
TO BE INCLUDING MALE AND
FEMALE MICE IN YOUR RESEARCH.
SO AGAIN, PUSHING FURTHER DOWN
IN THE STAGES OF DEVELOPMENT.
AND RECENTLY WE DON'T YET HAVE
ANY POLICY FOR THE NIH BUT
THERE HAS BEEN ATTENTION TO
INCLUSION OF ADDITIONAL GROUPS
SO LESBIAN, GAY, BISEXUAL AND
TRANSGENDER PEOPLE AND PEOPLE
WITH DISABILITIES WHICH WE
TALKED ABOUT THE OTHER DAY IN
TERMS OF ARE WE PUTTING
RESTRICTIONS ON CLINICAL
TRIALS THAT NOT INTENTIONALLY
EXCLUDE PEOPLE WITH
DISABILITIES.
REALLY BASIC EXAMPLE, RIGHT?
YOUR CLINIC IS NOT ACCESSIBLE
OR NOT ACCESSIBLE TO
PARTICULAR GROUPS OF DISABLED
PEOPLE, MAYBE YOU SHOULD THINK
ABOUT WAYS YOU COULD MAKE IT
MORE ACCESSIBLE.
SO I AM GOING TO QUICKLY
TRANSITION OVER TO THE FDA.
THE FDA, YOU WILL REMEMBER, IS
REGULATING THE MARKETING OF
NEW PRODUCTS, SO A LOT OF THAT
PRELIMINARY RESEARCH IS GOING
ON IN THE EXTRAMURAL SETTING
WITH THOSE NIH DOLLARS.
PHARMACEUTICAL COMPANIES THEN
BUY, PROCURE, GET THOSE
PRODUCTS AND PUSH THEM FORWARD
THROUGH THEIR SYSTEMATIC SET
OF TRIALS.
WE KNOW FOR EXAMPLE THAT A LOT
OF PHASE 1 AND PHASE 2
RESEARCH HAPPENS HERE AT THE
CLINICAL CENTER.
BEFORE IT GOES TO PHASE 3,
THERE MIGHT BE SOMETHING THAT
THERE IS A TRANSFER BETWEEN
THE DEPARTMENT OF HEALTH AND
PHARMACEUTICAL COMPANY TO TAKE
IT INTO PHASE 3 TRIALS.
SO AGAIN, ANOTHER BIG PLAYER
IN ENFORCING OR SUGGESTING
INCLUSION.
IF SO AGAIN, NOT GOING TO GO
THROUGH ALL OF THESE.
I MENTIONED THE FIRST ONE IN
MY LECTURE LAST WEEK ABOUT THE
GENERAL CONSIDERATIONS IN 1977
THAT SAID CHILD-BEARING WOMEN
SHOULD NOT BE INCLUDED IN
EARLY PHASE TRIALS.
THAT WAS WITHDRAWN IN 1993
AND SINCE, YOU WILL SEE I HAVE
ON THE SLIDE HERE, THERE HAVE
BEEN LOTS OF EFFORTS FROM THE
FDA TO ENCOURAGE
PHARMACEUTICAL COMPANIES TO
THINK ABOUT DIVERSE
POPULATIONS SO YOU KNOW
CHANGES TO THE NEW DRUG
APPLICATIONS, DRUGS LIKELY TO
BE USED IN ELDERLY, LOOKING
FOR GENDER DIFFERENCES,
DEMOGRAPHICS, PREGNANT WOMEN,
ENHANCING COLLECTION OF
DEMOGRAPHIC SUBGROUP DATA,
LOOKING AT RACE AND ETHNICITY
WITH RELATION TO MEDICAL
DEVICES.
AGAIN, LOTS OF ACTION AS
RECENTLY AS 2020 IN
ENCOURAGING PHARMACEUTICAL
COMPANIES TO DIVERSIFY THEIR
POPULATION.
AND I AM JUST GOING TO SHOW
YOU THIS REALLY COOL SNAPSHOT
THAT I DISORDER WHEN I WAS
DOING SOME RESEARCH FOR THIS
LECTURE.
IT TURNS OUT THAT SINCE AN ACT
OF CONGRESS IN 2015 OR I GUESS
2014 IMPLEMENTED IN 2015, THE
FDA PRODUCES THIS DRUG TRIAL
SNAPSHOT EVERY YEAR.
THIS GRAPHIC I AM SHARING HERE
IS FROM THE 2019 REPORT
BECAUSE UNFORTUNATELY THIS
LOVELY GRAPHIC IS NOT IN THE
2021 REPORT BUT YOU WILL SEE
THAT EVERY YEAR THEY ARE
REPORTING ON Y AXIS KEY
THERAPEUTIC AREAS AND THE ON
THE X AXIS, THE NUMBER OF MEN
AND WOMEN ENROLLING IN THOSE
TRIALS.
AND THE FDA CAN DO THAT
BECAUSE ALL THE RESEARCH THAT
WAS CONDUCTED IN ORDER TO ASK
THE FDA TO APPROVE SOMETHING
FOR MARKETING IS PULLED INTO
THE APPLICATION SYSTEM AND
THEY CAN THEN LITERALLY COUNT
UP THE NUMBER OF MEN AND
NUMBER OF WOMEN INCLUDED IN
ANY SET OF CLINICAL TRIALS.
AND SO YOU WILL SEE HERE,
RIGHT, THERE ARE SOME, SO
CARDIOVASCULAR DISEASE, RIGHT,
YOU KNOW, IT IS NOT EQUAL,
RIGHT?
WE HAVE MAYBE A THIRD, SO
20,000 UP TO 60,000, YOU HAVE
MAYBE A THIRD WOMEN IN THE
CARDIOVASCULAR DISEASE AREA
BUT FRANKLY THAT IS A LOT OF
PROGRESS.
IT TOOK THE SCIENTIST
COMMUNITY A WHILE TO GET TO
THE POINT Dr. ASADA
MENTIONED WHERE WE HAVE
ACKNOWLEDGED AND NOW ARE
FOCUSING ON BIOLOGICAL
DIFFERENCES IN GROUPS OF WOMEN
AND MEN WITH CARDIOVASCULAR
DISEASE AND HOW THEY RESPOND
DIFFERENTLY.
SO I SEE THIS AS GOOD NEWS
THAT THERE IS ACTUALLY A THIRD
OF THE WOMEN, A THIRD OF THOSE
WHO ARE BEING STUDIED ARE
WOMEN. NO SURPRISE, FINE
COLLING IS ALL BLUE AND IT
LOOKS PRETTY GOOD --
GYNECOLOGY.
SOME OF THESE INFECTIOUS
DISEASES ARE EQUAL TO BE
CONSIDERED AND ONE COULD SAY,
SPEAKING OF CAUSALITY, BACK TO
Dr. ASADA' S LECTURE, I AM
NOT CERTAIN I CAN SAY THE
REASON THIS SLIDE LOOKS THIS
WAY IS BECAUSE ALL THE WORK
THE NIH AND FDA HAVE DONE TO
ENCOURAGE DIVERSITY, BUT I AM
PRETTY SURE IT HAS PLAYED A
ROLE IN THE FACT THAT WE CAN
PORTRAY THE DATA IN THIS WAY
AND SEE THAT IT'S RELATIVELY
EQUAL.
SO I AM GOING TO MENTION A
COUPLE OF OTHER PLAYERS AS IT
WERE IN THIS SPACE AND THEN WE
CAN -- YOU KNOW WE'LL HAVE A
COUPLE MORE MINUTES FOR
QUESTIONS IF ANYBODY HAS THEM.
SO THE OTHER TWO KEY PLAYERS
IN THIS SPACE ARE THE
GOVERNMENT ACCOUNTING OFFICE
AND NATIONAL ACADEMY OF
DESIGNS.
THE GOVERNMENT ACCOUNTING
OFFICE IS A NONPARTISAN ARM OF
OUR GOVERNMENT THAT THE
CONGRESS CAN DIRECT TO DO
PROJECTS LIKE HEY GAO, WE'RE
GOING TO APPROPRIATE FUNDS FOR
YOU TO LOOK AND SEE HOW WELL
INVESTIGATORS ARE ACTUALLY
FOLLOWING THE INCLUSION
GUIDELINES, EITHER RELATED TO
THE NIH GUIDELINES OR THE FDA
GUIDELINES.
AND BACK TO THAT EARLIER SLIDE
WHERE I HAD LIKE 1977 TO
1994, WHATEVER, IF YOU LOOK
BACK AT THAT HISTORY, THE GAO
IS A BIG PLAYER.
SO THE ONE EXAMPLE I WILL GIVE
YOU, I MENTIONED IN 1996, THE
NIH HAD BASICALLY AN
ENCOURAGEMENT FOR
INVESTIGATORS TO INCLUDE WOMEN
AND MINORITIES IN TRIALS.
THE GAO SAID THAT DID NOT
WORK.
JUST ENCOURAGING WAS NOT
ENOUGH.
THEY NEEDED MAYBE NOT JUST A
CARROT BUT A STICK.
AND WITH THAT STICK, FURTHER
INVESTIGATIONS BY GAO HAVE
BEEN CONDUCTED, STILL NOT
DOING A STELLAR JOB BUT YOU
CAN SORT OF PLOT IMPROVEMENT.
SO IF YOU ARE INTERESTED IN
POLICY IMPLEMENTATION AT THE
NATIONAL LEVEL, THE GAO IS
OFTEN A REALLY GREAT PLACE TO
LOOK FOR NATIONAL EVALUATIONS.
THE OTHER GROUP THAT PLAYS AN
IMPORTANT ROLE IS THE NATIONAL
ACADEMY OF SCIENCES AND THIS
IS WHAT I WILL CALL A QUASI
GOVERNMENT BODY IN THAT THE
SAME WAY CONGRESS CAN ASK THE
GOVERNMENT ACCOUNTING OFFICE,
CONGRESS CAN ALSO ASK THE
NATIONAL ACADEMY OF SCIENCES.
THE NATIONAL ACADEMY IS MADE
UP OF EXTRAMURAL INVESTIGATORS
WHO ARE AT THE TOP OF THEIR
FIELD.
THEY HAVE ALL SORTS OF
COMMITTEES AND SUBCOMMITTEES
AND THEY -- THE CONGRESS MIGHT
SAY, OKAY, NATIONAL ACADEMY OF
SCIENCES, HOW ARE WE DOING
WITH THE INCLUSION OF WOMEN IN
CLINICAL TRIALS AS AN UNDER
REPRESENTED GROUP.
THEY DO AN INDEPTH
INVESTIGATION WITH THE HELP OF
THE STAFF AT THE NATIONAL
ACADEMY.
THEY HAVE A GROUP, A
EMPLOYMENT OF COMMITTEE OF
EXPERTS IN THE FIELD AND WILL
OFTEN THEIR RESULTS CAN DRIVE
POLICY CHANGE THE SAME WAY THE
GAO MIGHT DRIVE POLICY CHANGE.
SO I WANTED TO GIVE FOLKS WHO
MIGHT BE INTERESTED A QUICK
TOUR OF THAT.
WE HAVE ABOUT TWO MINUTES FOR
A QUESTION.
I ACTUALLY DIDN'T BUILD ANY
QUESTION TIME IN FOR MYSELF
BUT I DON'T SEE ANYONE LEAPING
UP FOR A QUESTION.
LET ME JUST CHECK THE -- I AM
GOING TO MULTITASK AND CHECK
THE DISCUSSION BOARD AND I
DON'T SEE ANYTHING THERE.
SO WHAT WE'RE GOING TO DO NOW
IS TAKE OUR 15-MINUTE BREAK A
LITTLE EARLIER THAN USUAL.
WHEN WE COME BACK, WE'RE GOING
TO WELL COME IETHA LANGFORD
FROM NIU AND WILL TALK ABOUT
WHAT DOES IT PRACTICALLY MEAN
TO U SECOLLUSION USE
INCLUSION IN YOUR STUDY.
SO I HAVE PUT UP THE NUMBER
HERE AND MAYBE YOU CAN FIGURE
OUT HOW TO PARTICIPATE.
SO WE WILL HAVE A BREAK AND BE
BACK AT 10:00 A.M. WHICH IS 15
MINUTES FROM NOW.
THANK YOU.
WELCOME BACK
EVERYBODY.
REALLY QUICKLY, I AM GOING TO
REMIND YOU THAT DURING Dr.
LANGFORD'S TALK, WE WILL BE
USING SLIDO.
THE NUMBER IS IN ANNOUNCEMENTS
AND E-MAIL AND WITH THAT I
WILL INTRODUCE Dr.
AISHA LANGFORD.
SHE IS ZOOMING IN TODAY FROM
NIU WHERE SHE IS PROFESSOR OF
DECISION HEALTH AND SIGNS AND
IMPORTANTLY IT IS IMPORTANT
FOR THE TALK TODAY, ALSO
DIRECTS THE RECRUITMENT CORE
WHICH IS AN INSTITUTION-WIDE
EFFORT TO IMPROVE EQUITY AND
INCLUSION AMONG OTHER THINGS
AND ADVOCATES IN HER WORK THAT
ALL PATIENTS ARE INVITED TO
PARTICIPATE IN CLINICAL TRIALS
AND THAT UNDER REPRESENTED
POPULATIONS HAVE EQUAL ACCESS
WHICH OFTEN MEANS ADDRESSING
COMMUNICATION BARRIERS.
SO I THINK Dr. LANGFORD IS A
PERFECT PERSON TO PICK UP FROM
WHERE Dr.ASADA AND I AND
Dr. WENDLER KICKED OFF LAST
WEEK.
SO I WILL TURN IT OVER TO YOU.
>>THANK YOU ALL FOR THAT
WONDERFUL INTRODUCTION.
I AM EXCITED TO BE BEFORE YOU
TODAY AND BEFORE WE GET
STARTED, IT IS IMPORTANT TO
SAY THAT CLINICAL TRIALS ARE
NOT ONE PARTICULAR THING.
SOMETIMES IN THE COMMUNITY,
THEY JUMP TO DRUG TRIALS AND
THINK CLINICAL TRIALS ARE ONLY
ON DRUGS BUT THERE ARE MANY
TRIALS THAT FOCUS ON SURGERY
OR SOME ASPECT OF METICS OR
SOME ARE FAMILY-FOCUSED SO IT
MAY BE A MOM OR A DAD AND A
CHILD OR SIGNIFICANT OTHERS
AND ALL OF THOSE THINGS MAY
CHANGE OUR APPROACH TO
RECRUITMENT AND CONSIDERATION
FOR RETENTION.
IN ADDITION TO DIFFERENT TYPES
OF CHILD AND DIFFERENT
POPULATIONS, THERE'S ALSO
DIFFERENT PHASES OF TRIALS.
YOU ALL KNOW PHASE 1, 2 AND 3
AND AGAIN AGAIN, ALL OF THAT
MAY IMPACT YOUR PESK SPECIFIC
APPROACH TO RECRUITMENT AND
RETENTION AND BEING PICKED FOR
TRIALS.
IN JUNE 2020, I HAD THE
PRIVILEGE OF WRITING A BLOG
WITH MY PEER HERE AT NIU AND A
TRUE FRIEND AND WE WROTE THIS
BLOG ON FAIRNESS AND INCLUSION
IN COVID-19 TRIALS BECAUSE
THERE WAS A LOT OF TALK ABOUT
MAKING SURE THERE WAS ENOUGH
DIVERSITY IN THE TRIALS AND
ALSO HOW THE VULNERABLE
POPULATION SHOULD BE PROTECTED
IN THE TRIALS.
A FEW OF THE TAKEAWAYS OR
SUGGESTIONS WE PRESENTED IN
THAT BLOG POST OR PERSPECTIVE
PIECE WAS REALLY ABOUT PAYING
CAREFUL ATTENTION TO INCLUSION
AND EXCLUSION CRITERIA.
SO BY NATURE OF HOW
RESEARCHERS ARE ACTUALLY
DESIGNING THEIR PROTOCOL, THEY
MAY BE INADVERTENTLY AND
SYSTEMATICALLY EXCLUDING WHOLE
GROUPS OF PEOPLE SO WHILE IT
IS VERY IMPORTANT TO PROTECT
EXPLOITATION OF ALL THE
POPULATIONS, WE DON'T WANT TO
BE OVERLY RESTRICTIVE SO THAT
PEOPLE ARE EXCLUDED
UNNECESSARILY.
IT IS ALSO IMPORTANT TO MAKE
SURE PEOPLE KNOW ABOUT
CLINICAL TRIALS AND ARE
CLEARLY AND EXPLICITLY INVITED
TO PARTICIPATE WHEN ELIGIBLE.
SOME OF THE CONVERSATION
HISTORICALLY, ESPECIALLY WHEN
IT COMES TO RACIAL AND ETHIC
POPULATIONS BUT NOT
EXCLUSIVELY, HAS BEEN THAT
ETHNIC GROUPS WON'T
PARTICIPATE BECAUSE OF
EXPERIMENTS LIKE TUSKOGEE
EXPERIMENTS.
HOWEVER, POTENTIALLY A BIGGER
ISSUE IS THAT A LOT OF
AMERICANS ARE NOT AWARE OF
CLINICAL TRIALS AT ALL AND
MANY TIMES AS WE BECOME MORE
INCLUSIVE AND THOUGHTFUL, WE
MAY NEED TO BE MORE THOUGHTFUL
ABOUT PARTNERING WITH
COMMUNITY HOSPITALS AND
QUALIFIED HEALTH CENTERS OR
EVEN PRISON FOR MEDICAL
PRACTICES TO EXPAND
OPPORTUNITIES FOR PEOPLE IN
THE COMMUNITY TO PARTICIPATE.
AND THEN FINALLY IT IS
OBVIOUSLY REALLY IMPORTANT TO
MINIMIZE PARTICIPATION BURDENS
AND THAT MIGHT BE THINKING
ABOUT CONSIDERATIONS WITH
REGARD TO TRAVEL REIMBURSEMENT
OR HOW PEOPLE WILL -- WHAT
THEY WILL NEED TO FULLLY
PARTICIPATE.
SO FOR EXAMPLE IF YOU ARE
DOING A STUDY ON MILD TO
MODERATE COGNITIVE DECLINE OR
ALZHEIMER'S, NOT ONLY DO YOU
HAVE TO ACCOUNT FOR THE
PARTICIPANT THEMSELVES TO BE
IN THE STUDY BUT YOU NEED TO
MAKE PROVISIONS OR SHOULD MAKE
PROVISIONS FOR THEIR CARETAKER
OR THE PERSON WHO WOULD HAVE
TO ACCOMPANY THEM BOTH
REGARDING ATTENDANTS AND ALSO
TRANSPORTATION SUPPORT.
THIS PAPER ON THE SCREEN IS
ANOTHER COMMENTARY I HAD
PUBLISHED DURING THE PANDEMIC,
SO THIS WAS PUBLISHED IN MARCH
2021 AND IS FOCUSED ON VACCINE
CLINICAL TRIALS ALTHOUGH THERE
ARE IDEAS PRESENTED THAT
REALLY ARE APPLICABLE ACROSS
CLINICAL TRIALS BUT IN THIS
PARTICULAR PAPER, I WAS
FOCUSSED ON HEALTH
COMMUNICATION AND
DECISION-MAKING ABOUT VACCINE
CLINICAL TRIALS FOR PEOPLE.
I ACTUALLY DID PARTICIPATE IN
A PHASE 1 CLINICAL TRIAL
DURING THE PANDEMIC.
I WAS ACTUALLY ONE OF 48
PEOPLE AT NIU TO PARTICIPATE
IN PFIZER'S PHASE 1 CLINICAL
TRIAL AND IT WAS QUITE
INTERESTING, BEING A
PARTICIPANT FOR THE FIRST TIME
IN A PHASE 1 TRIAL AND I CAN
TALK MORE ABOUT THAT LATER.
SO IN THAT COMMENTARY, I
PRESENTED A GENERAL MODEL OF
CLINICAL TRIAL PARTICIPATION
AND AS YOU CAN SEE, THERE ARE
LOTS OF BULLETS ON THE SCREEN.
I AM NOT GOING TO GO THROUGH
EVERY SINGLE BOX AND EVERY
SINGLE BULLET BUT I THINK THE
TAKEHOME HERE IS THAT THERE
ARE SO MANY CONSIDERATIONS WE
SHOULD BE THINKING ABOUT AS
STUDY TEAMS AND PIS WHEN WE
ARE DESIGNING CLINICAL TRIALS
AND SPEAKING ABOUT WHO CAN
PARTICIPATE AND HOW TO MAKE
PARTICIPATION EASIER.
ONE OF THE BOXES I LIKE TO
HIGHLIGHT IS THE CLINICAL
TRIALS CHARACTERISTICS BOX AT
THE VERY TOP.
SO EVEN BEFORE WE EVER
INTRODUCE A CLINICAL TRIAL TO
A COMMUNITY MEMBER OR PATIENT,
THE DECISIONS WE MAKE
SOMETIMES MONTHS OR YEARS IN
ADVANCE IN THINKING ABOUT THE
PROTOCOL HAS REAL IMPLICATIONS
FOR PEOPLE WHO PARTICIPATE SO
THINGS LIKE THE NUMBER OF
PROCEDURES AND ASSESSMENTS,
THE LOCATION OF THE RESEARCH
SITE, TRAVEL TIME, HOW LONG
THE TRIAL WILL LAST AND ALSO
WHAT TYPES OF INCENTIVES YOU
OFFER AND THE FREQUENCY OF
THOSE INCENTIVES THEMSELVES
THAT CAN HAVE A BIG IMPACT ON
PARTICIPATION OR PERSPECTIVES
ABOUT WHETHER PEOPLE THINK IT
IS WORTH THEIR TIME.
AND THEN THE THOUGHT HERE, A
LOT OF TIMES IN OUR
CONSULTATION GUIDE IN
CONSULTATION WITH OTHER TEAMS,
WE'RE TALKING EARLY ON ABOUT
WHAT DEMOGRAPHIC GROUPS YOU
ARE WANTING TO TARGET FOR YOUR
INTERVENTION BUT ALSO
LANGUAGE, THE LANGUAGE SPOKEN
BY THE TARGET POPULATION,
HEALTH LITERACY LEVELS,
CUSTOMS, ALL OF THOSE THINGS
ARE IMPORTANT TO THINK ABOUT
EARLY ON AND WHAT I SEE IN MY
WORK DOING CLINICAL TRIALS IN
GENERAL AND DOING
CONSULTATIONS IS THAT
SOMETIMES THOSE THINGS ARE
BROUGHT TO PEOPLE'S ATTENTION
LATE AND YOU ARE ALREADY DOWN
THE ROAD AND ALREADY HAVE A
PROBLEM WITH RECRUITMENT.
IN THAT SAME COMMENTARY, I
ACTUALLY PRESENT THE ASK
APPROACH TO CLINICAL TRIAL
PARTICIPATION AND THAT IS JUST
TO REMIND US WE NEED TO ASK
PEOPLE TO PARTICIPATE.
AND ASK MEANS ASSUME THAT ALL
PATIENTS WILL WANT TO KNOW
THEIR OPTIONS.
SOMETIMES PEOPLE ARE
UNCOMFORTABLE OR DON'T WANT TO
HEAR ABOUT IT AND ASSUME A
MORE NEGATIVE PERSPECTIVE BUT
JUST ASSUME EVERYONE WANTS TO
KNOW WHAT THEIR HEALTHCARE
OPTIONS ARE.
S TALKS TO SEEK THE COUNCIL
SELL OF STAKE HOLDERS AND THEN
K IS KNOW YOUR NUMBERS.
SO STAKEHOLDERS MAY INCLUDE
BUT ARE NOT LIMITED TO A LOT
OF THESE GROUPS IN BULLETS
HERE.
MANY OF US WHO DO RESEARCH ARE
ALWAYS THINKING THE
RESTAKEHOLDERS ARE
RESEARCHERS, PATIENTS AND
CAREGIVERS BUT THERE ARE MANY
MORE AND EVERY TIME I GIVE
THIS TALK, SOMEONE WILL ADD A
BULLET OR BRING UP A GROUP WE
SHOULD BE THINKING ABOUT.
SO FOR EXAMPLE, IN THE
ORIGINAL PAPER, WE HAD SOME
COMMUNITY-BASED ORGANIZATIONS
BUT DIDN'T HAVE COMMUNITY
HEALTH WORKERS SO ONE OF MY
HEALTH EDUCATORS SAID PEOPLE
SHOULD THINK ABOUT THAT EARLY
ON AS WELL.
SO REALLY THE IDEA IS THROUGH
EITHER PATIENT ADVOCATES OR
ADVISORY COUNCILS, MECHANISMS
TO GET FEEDBACK EARLY ON IN
THE PROTOCOL OF THE
DEVELOPMENT PHASE TO MAKE SURE
WHAT YOU ARE HOPING TO DO IS
PALATABLE TO YOUR TARGET
AUDIENCE AND AS MUCH AS
POSSIBLE, YOU CAN ANTICIPATE
RECRUITMENT AND RETENTION
CHALLENGES.
KNOW YOUR NUMBERS DOES NOT
REFER TO BLOOD PRESSURE
ALTHOUGH IT IS GOOD TO KNOW
YOUR BLOOD PRESSURE NUMBERS
BUT REALLY ABOUT THINKING
HOLISTICALLY ON HOW WE TRACK
NUMBERS ON CLINICAL TRIALS.
OFTENTIMES IT IS THE ABSOLUTE
NUMBER OF PATIENTS ENROLLED IN
A STUDY BUT IT IS IMPORTANT TO
THINK ABOUT BEFORE YOU GET
STARTED WHAT IS THE POTENTIAL
OF ELIGIBLE PATIENTS.
SO FOR EXAMPLE IF YOU DO A
POWER ANALYSIS WITH A
STATUTEISTICIAN AND THEY SAY
USE THE NUMBER 500 FOR
STATISTICAL VARIANCE.
SO IT IS GOOD TO KNOW AT LEAST
IN THEORY WHO COULD
PARTICIPATE.
AND THE FIRST STEP, NOW THE
PROTOCOL DESIGN IMPACTS
WHETHER THOSE POTENTIALLY
ELIGIBLE PEOPLE TO WANT DO
YOUR STUDY BUT YOU HAVE TO AT
LEAST KNOW YOU HAVE ENOUGH
PEOPLE TO BEGIN WITH.
WE HAVE ALSO BEEN THINKING
MORE INDEPTH ABOUT THE NUMBER
OF PEOPLE INVITED BY DIFFERENT
METHODS SO SOME PEOPLE USE
PATIENT PORTALS, SOCIAL MEDIA,
REACHING OUT VIA TEXT MESSAGE
AND TELEPHONE BUT REALLY
REACHING OUT TO THE DIFFERENT
CHANNELS FOR A DIFFERENT
RESPONSE RATE AND THEN
THINKING ABOUT THE NUMBER OF
INTERESTED PEOPLE BUT NOT
ELIGIBLE.
SO IF YOU HAVE A THOUSAND
PEOPLE INTERESTED IN YOUR
STUDY BUT ONLY 50 OF THOSE ARE
ACTUALLY ELIGIBLE, THEN YOU
MAY WANT TO FORM YOUR STUDY
FROM THAT INFORMATION.
AND AT WHAT COULD YOU TELL TO
CLINICAL TRIAL ENROLLMENT,
THIS IS FROM UNIVERSITY OF
CALIFORNIA AT SAN FRANCISCO
AND THEY WERE LOOKING AT THE
TRAVEL BURDEN IN A VARIETY OF
THEIR CLINICAL TRIALS THAT
WERE OFFERED.
AND THE PATIENT POPULATION
WERE PATIENTS WHO WERE WITHIN
THE UC-SAN FRANCISCO CLINICAL
TRIAL MANAGEMENT DATABASE AND
THEY SPECIFICALLY LOOKED AT
PEOPLE WHO WERE ENROLLED IN A
BREAST, GENITOURINARY OR
GASTROINTESTINAL CANCER
CLINICAL TRIAL OVER A DECADE,
1993 TO 2014.
THEY ALSO EVALUATED A
HOUSEHOLD ZIP CODE, ETHNICITY,
STUDY SPONSOR AND THE YEAR THE
CONSENT FORM WAS SIGNED.
SO THEIR MAIN OUTCOME OF
INTEREST WAS THE DISTANCE
TRAVELED FROM THEIR HOME TO
THE MEDICAL CENTER AND THEY
USED THAT USING GOOGLE MAPS
AND REALLY THE MAIN FOCUS WAS
THE RELATIONSHIP OF DISTANCE
WITH THESE THINGS I MENTIONED
BEFORE, PHASE OF TRIAL,
HOUSEHOLD INCOME AND RACE AND
ETHNICITY SPECIFICALLY.
SO THE GENERAL RESULTS WERE
THAT ABOUT 1600 PATIENTS WERE
ENROLLED IN THESE TYPES OF
CLINICAL TRIALS OVER THAT TIME
PERIOD, THE MOST BEING IN A
BREAST CANCER CLINICAL TRIAL.
AND THE OVERALL MEDIAN ONE-WAY
DISTANCE TRAVELED FROM HOME TO
STUDY SITE WAS ABOUT 26 MILES
AND FOR THOSE OF WHO YOU ARE
FAMILIAR OR NOT WITH THE SAN
FRANCISCO BAY AREA, THERE IS
PUBLIC TRANSPORTATION BUT ONLY
MOST HELPFUL IF YOU LIVE IN A
PARTICULAR AREA OF THE SAN
FRANCISCO BAY AREA AND ARE
ACTUALLY FROM THAT AREA.
A LOT OF PEOPLE DO HAVE CARS
AND HAVE TO DRIVE BECAUSE OF
HOW SPREAD OUT IT IS.
ADDITIONAL RESULTS WERE THAT
THE LONGEST DISTANCE TRAVELED
WERE FOR NIH SPONSORED TRIALS
SO THOSE HAD THE MEDIAN TRAVEL
BURDEN OF ABOUT 39 MILES AND
THEN FOR PEOPLE ENROLLED IN
PHASE 1 HEALTH, THOSE STUDIES
ACTUALLY HAD THE LONGEST
DISTANCE TRAVELED OF ABOUT
41 MILES.
AND ADDITIONALLY, PATIENTS WHO
CAME FROM LOWER INCOME AREAS
ACTUALLY REPORTED OR IT WAS
ESTABLISHED THEY TRAVELED
LONGER DISTANCES COMPARED TO
PATIENTS FROM HIGHER INCOME
AREAS AND THAT WAS A
DIFFERENT, PRETTY SIGNIFICANT
DIFFERENCE OF ABOUT 58 MILES
VERSUS 18 MILES.
SO IF YOU THINK ABOUT
PARTICULARLY ALL PATIENTS
COMING TO PHASE 1 WHERE YOU
MAY HAVE MORE VISITS, MAY BE
SICK OR NOT, THAT IS
DEFINITELY NOTE WORTHY TO IF
GIVE OUT.
SO IN SUMMARY THEY FOUND IN
THIS PARTICULAR STUDY THE
HIGHER TRAVEL BURDEN WAS
RELATED TO PEOPLE WHO WERE IN
PHASE 1 STUDIES, NIH-SPONSORED
STUDIES AND THAT PEOPLE FROM
LOWER INCOME AREAS HAVE THE
GREATEST TRAVEL BURDEN.
NOW I WANT TO FLASH FORWARD TO
ANOTHER STUDY I HAVE FOUND
QUITE INTERESTING.
ONE OF MY COLLEAGUES IS A
COAUTHOR ON THIS PAPER BUT
THIS WAS PUBLISHED EARLIER
THIS YEAR IN FEBRUARY AND THEY
COMPARED THE RACIAL, ETHNIC
AND GEOGRAPHIC DIVERSITY TO
THOSE INVOLVED IN A TRAVEL
BASED COVID-19 CLINICAL TRIAL
AND A IN-HOUSE COVID-19 TRIAL.
SO THIS WAS FOR 1410
PARTICIPANTS --
>> HEY, AISHA, I THOUGHT THAT
QUESTION WAS FOR THE GROUP.
>>OH, I AM SORRY.
>>I PUT IT IN AS A QUESTION,
YOU KNOW, JUST TO GET THE
FOLKS' RESPONSE OF WHETHER OR
NOT THEY THOUGHT THAT HAVING A
REMOTE SITE WOULD INCREASE
DIVERSITY.
SO I OPENED THE POLL.
>> OKAY, I AM SORRY, I MISSED
THAT E-MAIL BUT IT IS A GOOD
QUESTION AND WHEN YOU GET THE
RESULTS, I WOULD BE CURIOUS TO
SEE WHAT PEOPLE --
>>THAT'S OKAY, WHAT THEIR
INSTITUTIONS ARE. --
INTUITIONS WERE.
SO WE ARE GETTING VOTES IN AND
MY GUESS IS IF THEY ARE PAYING
ATTENTION, THEY WILL GET THE
ANSWER YOU ARE LIKELY TO
PRESENT.
I HAVE YOUR LATEST QUESTIONS
BUILT IN AS WELL.
>>OKAY, YEAH, NO PROBLEM.
I ACTUALLY SOMETIMES HAVE A
DIFFERENT LIKE DIFFERENT
QUESTIONS I TAKE IN AND OUT SO
I THOUGHT I HAD LEFT IN A
DIDN'T QUESTION BUT WILL BE
INTERESTING TO SEE WHAT PEOPLE
SAY.
>>NO PROBLEM.
SO HERE IS THE ANSWER, QUOTE
UNQUOTE, 97 PERCENT SAID YES
INCLUDING REMOTE TRIALS IS
LIKELY TO INCREASE DIVERSITY
AND 3 PERCENT SAID NO.
SO LET'S SEE WHAT THE REAL
ANSWER IS.
[LAUGHTER]
>>YES, SO IT WAS A COHORT
STUDY AND THEY DID SECONDARY
ANALYSIS OF ABOUT 1400 PEOPLE
ENROLLED IN ONE OF THREE
COVID-19 STUDIES CONDUCTED
EARLY ON IN THE PANDEMIC.
AND ALL OF YOU CAN NOW BE PAID
CONSULTANTS FOR THESE TRIALS
BECAUSE THEY FOUND REMOTE
CLINICAL TRIALS THAT IT HAD AN
ELEMENT OF ONLINE RECRUITMENT
HAD SIGNIFICANTLY BETTER AND
INCREASED RACIAL, ETHNIC AND
GEOGRAPHICAL DIVERSITY AND ONE
OF THEIR CONCLUSIONS WERE THAT
THE FINDINGS SUGGEST THAT
CLINICAL TRIALS WITH ONLINE
ADVERTISING MAY BE CONSIDERED
AS A STRATEGY TO INCLUDE
DIVERSITY AMONG PARTICIPANTS.
SO THEY DID SOME
ADVERTISEMENT SPECIFICALLY ON
SOCIAL MEDIA PLATFORMS SO YOU
ALL GET THE GRADE.
>>AND THEY PROVED THE PROOF
OF CONCEPT SO FOLKS HAVE
DOWNLOADED SLIDO AND ARE
ENGAGING SO THAT IS GOOD FOR
OUR NEXT QUESTION AS WELL.
>>OH, GREAT.
SO I WILL KIND OF PUT A CAVEAT
IN HERE BUT WE HAVE HAD VERY
INTERESTING CONVERSATIONS OVER
THE LAST COUPLE OF YEARS
SPECIFICALLY WITH COVID BUT
JUST IN GENERAL ABOUT HOW,
WHEN IF AT ALL YOU SHOULD USE
SOCIAL MEDIA ADVERTISEMENT AND
PAID ADVERTISEMENT BECAUSE
DIFFERENT STUDY TEAMS
SOMETIMES WANT TO GO TO THE
SUBWAY OR DOING A FACEBOOK AD
AND DEPENDING ON THE STUDY OF
THE CONTEXT, SOMETIMES WE FIND
IT HAS NOT YIELDED NECESSARILY
ABOVE AND BEYOND AND CAN COST
A LOT OF MONEY.
SO I THINK IT IS A NUANCED
CONVERSATION AND REALLY
DEPENDS ON THE SCOPE AND WHAT
YOU ARE TRYING TO DO AND WHAT
OTHER THINGS YOU TRIED.
SO NOW I WANT TO TALK A LITTLE
BIT ABOUT FINDINGS THAT ARE
KEY IN RESEARCH AND I GOT THIS
SCREEN SHOT FROM A STUDY AND
MANY FOLKS SAY WE NEED
DIVERSITY BUT DEPENDING ON
CONTEXT, YOU MAY WANT
DIVERSITY ON ABILITY LEVELS.
OR AGE, OR SOCIOECONOMIC
STATUS OR GEOGRAPHY OR
DIVERSITY IN EXPERIENCE OR
JUST LIVED EXPERIENCE, PERIOD,
OR DIVERSITY IN THE ACTUALLY
DISEASE MANIFESTATION ITSELF.
SO I AM ALWAYS ASKING STUDY
TEAMS WHEN THEY SAY WE NEED
DIVERSITY, I SAY WHAT TYPE AND
WHY AND WHY DO YOU THINK THAT
PARTICULAR DIVERSITY WILL DO
FOR YOUR STUDY?
AND AGAIN THIS WHOLE ISSUE OF
RACIAL AND ETHIC DIVERSITY IS
REALLY IMPORTANT BUT YOU KNOW
DEPENDING ON WHO YOU TALK TO,
PEOPLE WILL SAY WELL, RACE AND
ETHNICITY, THOSE ARE SOCIAL
CONSTRUCTS AND YOU DON'T WANT
TO PROMOTE THIS IDEA OF
INFERIORITY.
SO THERE IS I WILL SAY OVER
THE YEARS IN TALKING TO MY
COLLEAGUES A RANGE IN HOW WE
SHOULD BE THINKING ABOUT
ETHNICI ITY IN TRIALS.
SO I SAW THIS FROM A STUDY
THAT HAD THE DEFINITION OF
EQUITY, THE REMOVAL OF
SYSTEMIC BARRIERS AND BIASES
ENABLING ALL STEROIDS HAVE
EQUAL OPPORTUNITY TO ACCESS
AND BENEFIT FROM THE PROGRAM.
AND THEN I ALSO LIKED THAT
THIS GROUP FROM CANADA, THEIR
DEFINITION OF INCLUSION IS THE
PRACTICE OF ENSURING THAT ALL
INDIVIDUALS ARE VALUED AND
RESPECTED FOR THEIR
CONTRIBUTIONS AND ARE EQUALLY
SUPPORTED.
AND AGAIN THESE DEFINITIONS
WERE FROM A BROADER CONTEXT OF
WORKFORCE DEVELOPMENT BUT IF
YOU THINK OF THAT IN THE
CONTEXT OF CLINICAL TRIALS,
WHAT BUILD AN INDIVIDUAL NEED
TO FEEL RESPECTED AND VALID
FOR THEIR CONTRIBUTIONS AND
SUPPORTED TO THEY CAN BE
SUCCESSFUL AT COMPLETING A
CLINICAL TRIAL?
SO HE HOLLY, DO WE HAVE A
SLIDE OVER THERE ONE?
>>WE DO.
>>OKAY, THAT WAS WHAT I HAD
IN MY HEAD.
GREAT.
SO THIS QUESTION IS HOW WOULD
YOU ENSURE THAT POTENTIALLY
ALL ELIGIBLE PEOPLE ARE
INVITED TO CONSIDER CLINICAL
TRIALS.
>>AND THIS ONE IS A CHECK BOX
SO FEEL FREE TO BE CONCISE AS
THAT WOULD BE HELPFUL SO I CAN
READ OUT ALL THEIR LOVELY
RESPONSES.
OH, SO SOMEONE SAID HOW ABOUT
USING THE ASK PROTOCOL AND
UNFORTUNATELY CHIMED IN AS
ANONYMOUS SO WE CAN'T GIVE
THEM IT THE $20 THAT...
[LAUGHTER]
ANYMORE IDEAS OUT THERE FOLKS?
TRANSPARENCY?
OUTREACH IN MULTIPLE AVENUES.
HOW ABOUT INVITE LITERALLY
EVERYONE?
USE E-MAIL AND TEXT.
OH, GOSH, WE HAVE A LOT NOW,
CVS, GOOD MARKETING, AWARENESS
THROUGH VARIOUS SOCIAL MEDIA
PLATFORMS, LET'S SEE,
ADVERTISING USING A NUMBER OF
DIFFERENT METHODS, MAKE IT
VISIBLE, LOTS OF GOOD IDEAS
WHICH I WILL SHARE WITH YOU
LATER.
>>YES, THOSE ARE ALL
EXCELLENT IDEAS AND WHOEVER --
THESE ARE ALL WONDERFUL IDEAS.
I THINK THE IDEA, WHOEVER SAID
LITERALLY INVITING EVERYONE, I
WANT TO TALK NOW ABOUT OPT-OUT
VERSUS OPT-IN SYSTEMS AND SOME
OF YOU MAY BE FAMILIAR WITH
THOSE.
AN EXAMPLE OF AN OPT-OUT
SYSTEM WOULD BE A STRATEGY WE
USE AT NIU HEALTH.
SO IN JANUARY WE CHANGED OUR
PRACTICES TO INCLUDE THAT
INDIVIDUALS COULD BE DIRECTLY
CONTACTED FOR RESEARCH RELATED
OPPORTUNITIES AND THERE WAS A
LOT OF DISCUSSION, ANGST BACK
AND FORTH LEADING UP TO THAT
BUT WE DECIDED TO TAKE THE
STEP REALLY AND IT IS THE
PRINCIPLE THAT PATIENTS SHOULD
HAVE THE OPPORTUNITY TO HAVE
DIRECT TO PATIENT INVITATION.
AND ALSO BECAUSE WHEN YOU
THINK WITH -- ABOUT EQUITY IF
YOUR PATIENT NEVER KNOWS ABOUT
THE CLINICAL TRIAL, THAT CAN
CREATE BIAS.
AND HISTORICALLY ONE OF THE
MAIN WAYS PEOPLE LEARN ABOUT
CLINICAL TRIALS WOULD BE BASED
ON THE CLINICIAN OFFERING, IF
THE CLINICIAN KNOWS ALL THE
TRIALS AVAILABLE, WHETHER THEY
OFFER IT TO ALL PATIENTS AND
MAYBE THEY DON'T HAVE THE TIME
OR ARE NOT NECESSARILY AWARDED
FOR HAVING CONVERSATIONS FOR
CLINICAL TRIALS SO IF WE RELY
ON A GATEKEEPER SYSTEM, THERE
ARE OBVIOUSLY PROBLEMS WITH
THAT.
SO WE MOVED TO AN OPT-IN
SYSTEM AND THIS WAS A SCREEN
SHOT FROM MY OWN MEDICAL
RECORDS AND I AM FREELY
SHARING OBVIOUSLY WITH YOU
ALL.
IN THE PATIENT PORTAL, AT THE
TOP, WE HAVE A OPT-OUT SYSTEM.
PEOPLE ARE ABLE TO CHANGE
THEIR PARTICIPATION LEVEL IN
THE PATIENT PORTAL.
SO UP HERE, I SAID IT IS OKAY
TO CONTACT ME ABOUT RESEARCH
BUT IF I CHANGE MY MIND TODAY
OR TOMORROW, I CAN CHANGE THIS
TO DON'T CONTACT AND I WILL
NOT BE CONTACTED BY ANY
RESEARCHERS.
THIS ALSO HAS MY ACTIVE
STUDIES AND AS I MENTIONED TO
YOU BEFORE, IT IS TECHNICALLY
OVER AS OF LAST MONTH BUT I
WAS ON THE COVID-19 TRIAL FOR
PFIZER AND THEN THIS IS A
STUDY I WAS INVITED TO, I WANT
TO SAY, FOUR YEARS AGO AND I
THINK I WAS INVITED WITH OTHER
HUNDREDS OF WOMEN BECAUSE IT
WAS A STUDY ABOUT FACTORS
INFLUENCING REPRODUCTIVE
SUCCESS WITH TIMES PREGNANT
AND IF YOU PLANNED TO GET
PREGNANT WITHIN A YEAR, I DID
NOT QUALIFY AS THAT WAS NOT A
GOAL OF MINE AT THAT TIME AND
I SAID I WAS NOT INTERESTED SO
IT SAYS DON'T CONTACT PATIENT
FOR THAT STUDY AND THEN THERE
IS A WHOLE AREA WHERE PEOPLE
CAN LEARN ABOUT THE CLINICAL
TRIAL BROADLY.
ONE EXAMPLE OF AN OPT-OUT
SYSTEM -- SORRY, OPT-IN.
LET ME TAKE A STEP BACK.
SO OPT OUT IS USED BY DEFAULT,
ALL PATIENTS AND PARTICIPANTS
CAN BE CONTACTED AND THERE WAS
NOTHING I HAD TO DO ON MY END
TO POSSESSIONLY HAVE THE
OPPORTUNITY TO LEARN ABOUT
CLINICAL TRIALS WITHIN MY
HEALTH SYSTEM.
NOW THERE ARE MANY OPT IN
SYSTEMS AND THERE HAS BEEN A
LOT OF DEBATE WITHIN THE IRB
AND RESEARCH COMMUNITY IN
GENERAL ABOUT WHETHER YOU
SHOULD HAVE A STANDARD
OPT-OUT.
SOME PEOPLE FEEL STRONGLY
THERE SHOULD ONLY BE OPT IN
SYSTEMS BUT MY EDITORIAL
COMMENT, AN EXAMPLE OF OPT-IN,
A FEDERAL REGISTRY INSTITUTED
BY THE NATIONAL INSTITUTES OF
HEALTH AND OTHER MEDICAL
CENTERS PARTICIPATE.
BASICALLY AS OF YESTERDAY,
THERE WERE 143,000 PEOPLE WHO
HAVE REGISTERED IN RESEARCHNAT
AND YOU CAN SIGN UP -- WELL,
YOU DON'T HAVE TO SIGN UP FOR
RESEARCHNAT.
YOU CAN SEARCH FOR CLINICAL
TRIALS IN GENERAL BUT IF YOU
DECIDE TO JOIN THE REGISTRY,
FILL OUT THE PRO FILE ABOUT
YOUR HEALTH INTERESTS AND
HEALTH HISTORY AND BASED ON
THE PROFILE THAT SETS THAT UP,
YOU CAN BE SELECTED FOR OTHER
OPPORTUNITIES.
SO I JOINED RESEARCHNAT
SEVERAL WEEKS AGO I THINK WHEN
I WAS DOING MY RESEARCH ON
CLINICAL TRIAL SELECTION AND
JUST CURIOUS ABOUT HOW IT
WORKS.
SO NOW I HAVE A PROFILE AND I
SOMETIMES DID SURVEY STUDIES
OR OPPORTUNITY FROM PLAYS IN
CALIFORNIA, OHIO, ET CETERA,
SO THIS IS AN EXAMPLE OF WHAT
THE E-MAIL INVITATION WOULD
LOOK LIKE.
SO THIS ONE RIGHT HERE, SORRY
THE TEXT IS A LITTLE BIT SMALL
BUT IT WAS SENT TO MY E-MAIL
BECAUSE I AM A MEMBER OF OF
RESEARCHNAT, IT SAYS A
RESEARCHER AT UNIVERSITY OF
GEORGE WASHINGTON THINKS YOU
MAY BE A GOOD FIT SO BASICALLY
THIS STUDY IS TRYING TO
UNDERSTAND THE DIFFERENCES IN
HEALTH OF WOMEN ACROSS THE
UNITED STATES.
SO IT IS A SURVEY THAT TAKES
15 MINUTES, IT IS VOLUNTARY
AND YOU WON'T BE COMPENSATED
BUT I DID ADD HUMAN KIND IN
HOW ATTITUDES ABOUT WOMEN
IMPACT HEALTH AND SIMILAR TO
HOW OUR PATIENT PORTAL AT NYU
WORKS, PATIENTS CAN SAY YES I
AM INTERESTED OR NO I AM NOT
INTERESTED AND ONLY PATIENTS
WHO SAID YES I AM INTERESTED
WILL BE CONTACTED.
SO NOW I WANT TO TALK BROADLY
ABOUT THE SCIENTIFIC
WORKFORCE, BOTH BY CLINICAL,
MEDICAL BEHAVIORAL IN SOCIAL
SCIENCES AND RESEARCH, ONE
ASPECT SOMEBODY RACIAL
DIVERSITY WITH RACIAL AND
ETHNIC GROUPS BUT ALSO
CONVERSATION ON HOW YOU BUILD
INCLUSIVE ENVIRONMENTS AND
BUILD A WORKFORCE AMONG PEOPLE
WHO HAVE DISABILITIES SO
PHYSICAL, VISUAL, THINGS YOU
CAN SEE AND THINGS YOU CAN'T
SEE.
THERE IS ALSO CONVERSATIONS
ABOUT HOW TO EXPAND PEOPLE
FROM DISHAD A VANITY TAEUBLGD
BACKGROUNDS, SO THERE'S
DIFFERENT DIMENSIONS WITH
DISADVANTAGED AND ALSO MAKING
SURE THE ENVIRONMENTS ARE
DIVERSE AND INCLUSIVE OF
WOMEN.
SO ONE, WHEN I THINK ABOUT
PARTICULARLY WHEN IT RELATES
TO FACULTY MEMBERS, THE FIRST
CONVERSATION IS HOW YOU GET
PEOPLE IN THE DOOR, PERIOD.
SO HOW DO WE THINK ABOUT
RECRUITMENT PARTICULARLY OF
FACULTY MEMBERS OR RESEARCH
SCIENTISTS.
SO THE NIH HAS A REALLY NICE
TOOL KIT.
YOU ALL MAY HAVE SEEN IT OR
NOT BUT I WOULD ENCOURAGE YOU
TO CHECK IT OUT.
SO IT HAS REALLY LIKE FOUR
PILLARS OF HOW TO BUILD
DIVERSITY IN A SCIENTIFIC
WORKFORCE AND THAT FIRST RED
AREA IS DIVERSE CANDIDATE
POOL, GOLD IS UNBIASED TALENT
SEARCHES, PURPLE IS OUTREACH
AND NETWORKING AND FINE IS
MENTORING RELATIONSHIPS AND I
WILL TALK ABOUT A FEW OF
THESE.
SO SOME OF THE STRATEGIES WHEN
IT COMES TO RECRUITMENT AND
HIRING IS SYSTEMATICALLY
REVIEWING YOUR YOU PROCEDURES
AND POLICIES.
SOME DASHBOARDS HAVE HIRING
AND PROMOTION BY SEX AND
GENDER AND IT IS IMPORTANT TO
PROVIDE RESOURCES AND
DIVERSITY TOOLS TO DIVISIONS
AND DEPARTMENTS OR HOWEVER
YOUR ORGANIZATION KIND OF
CATEGORIZES THEIR GROUP'S
RESEARCH EFFORT AND THEN
EVALUATING THE STRATEGY
INCLUDED.
SO IT IS IMPORTANT TO HAVE
DIVERSITY PUT AS I MENTIONED
BEFORE, DIVERSITY IS A LOT OF
THINGS.
SO SAY OKAY WE HAVE 100 PEOPLE
AND ADDED 5 PEOPLE WHO ARE DOG
LOVERS AND WHAT HAS BEEN THE
IMPACT OF ADDING THE FIVE
PEOPLE WHO ARE DOG LOVERS TO
YOUR GROUP?
AND AGAIN AS MENTIONED BEFORE,
TO REALLY THINK ABOUT WHAT WE
WANT THE DIVERSITY TO ACTUALLY
DO AND HOW WILL WE KNOW IT IS
WORKING IF WE CREATE A DIVERSE
POPULATION WHICH YOU CAN DO IN
A LOT OF DIFFERENT WAYS, HOW
IS THAT REALLY GOING TO HAVE A
DIFFERENT IMPACT AND IF IT IS
NOT HAVING AN IMPACT OR THE
IMPACT YOU WANT FOR YOUR
CONTACT, ADJUSTING THE
STRATEGY.
IT IS ALSO IMPORTANT TO REVIEW
AND ENSURE EQUALITY WITH
RESOURCES AND ALSO THE SALARY
AND FINANCIAL ASPECT OF
RECRUITMENT AND PROMOTION ARE
VERY IMPORTANT AND HAVE
HISTORICALLY BEEN UNEQUAL,
PARTICULARLY AS IT RELATES TO
RACIAL AND ETHNIC MINORITIES
AND WOMEN.
ALSO ENSURING WIDTH,
BREADTHTH, FAIRNESS AND THEN
SPONSORING FACULTY PROMOTION
FOR AWARDS AND INCLUSION IN
PROFESSIONAL NETWORKS SO I
WILL TALK A LITTLE ABOUT
MENTORING AND SPONSORING IN A
COUPLE OF SLIDES.
AND REALLY JUST COMMITTING TO
WORKPLACE BALANCE FOR ALL
FACULTY AND CONDUCTING SURVEYS
TO GET A GUT CHECK ON THE
CLIMATE AND MAKE CHANGES AS
NECESSARY.
SO ONE OF THE THINGS WIFE BEEN
TALKING ABOUT IN MY
ORGANIZATION AND SOME OF THE
GROUPS I AM A PART OF AND EVEN
PROFESSIONAL SOCIETIES I AM A
PART OF AS IT RELATES TO
FINDING NEW PEOPLE TO BE ON
THE BOARD OR TO NOMINATE FOR
AWARDS, TO REALLY HAVE CLEAR
CRITERIA AND STANDARDS FOR THE
POSITION BEFORE ANYONE IS
RECRUITED AND CONTACTED WHICH
SEEMS OBVIOUS BUT DOESN'T
ALWAYS HAPPEN AND REALLY
HAVING A CLEAR EVALUATION AND
CREATING A GLOBAL SCORING.
AND THEN CONDUCTING ANONYMOUS
SCORING IF THE RESEARCH IS BIG
ENOUGH AND THEN HAVING DIVERSE
EFFORTS SO WITH NO SURPRISE
WITH REGARD TO IMPLICIT BIAS
AND JUST IN GENERAL, ALL
HUMANS DO IT?
A. WE TEND TO LIKE PEOPLE WHO
ARE LIKE US.
IT MAY BE THAT YOU LIKE DOG
PEOPLE OVER CAT PEOPLE OR CAT
PEOPLE OVER DOG PEOPLE, MAYBE
IF YOU ARE A PSYCHOLOGIST YOU
MIGHT HAVE A PREFERENCE TO
RECRUIT A PSYCHOLOGIST SO
TWAOE ALL HAVE OUR OWN BIASES
AND SO IF WE ENSURE THEY ARE
DIVERSE WE WILL HAVE HOPEFULLY
A GROUP OF WELL ROUNDED
CANDIDATES.
SO THIS IS A TWEET I SAW LAST
MARCH AND I DON'T KNOW THIS
PERSON, RYAN, BUT IT REALLY
STRUCK MY ATTENTION BECAUSE I
HAD THIS SOAPBOX ABOUT THE
UNPAID INTERNSHIPS AND HE SAID
IT IS A PERIOD OF TESTING YOUR
LIMITS.
THE INTERNSHIP CAN BE AN
ASSESSMENT OF HOW WILLING YOU
ARE TO ACCEPT FINANCIAL ABUSE.
PENNIES SOUNDS LIKE A LOT
AFTER WORKING FOR FREE.
THEN HE WENT ON TO SAY SEVERAL
OF MIGHT HAVE MENTORS SAW ME
UNGRATEFUL FOR OPPORTUNITIES
BUT IT WAS FINANCIALLY
IMPOSSIBLE FOR ME TO DEVOTE
HOURS TO FREE LABOR.
THESE SYSTEMS WERE DESIGNED
FOR PEOPLE WITH MONEY AND
PRESSURE TO PERFORM WEALTH CAN
PRODUCE COMPOUND FINANCIAL
OBSTACLES FOR WORKING CLASS
PEOPLE.
SO THAT REALLY STRUCK OUT TO
ME ESPECIALLY SINCE THERE ARE
THESE PLACES WITH PAY FOR
VOLUNTEERS AND THERE COULD BE
UNINTENDED EFFECTS OF
INTERNSHIPS THAT AREUNPAID.
SO THEN WE TALK ABOUT
SCIENTISTS AND KEEPING THEM IN
THE DOOR AND THIS ACTUALLY IS
FROM THE NATIONAL CENTER FOR
FACULTY DEVELOPMENT AND
DIVERSITY AND IF ANYONE IS
INTERESTED, I CAN E-MAIL IT TO
YOU, THE PDF FORM YOU CAN FILL
IN.
AND THE IDEA HERE IS THERE ARE
LOTS OF ASPECTS OF MENTORING
AND PROFESSIONAL DEVELOPMENT
THAT WE DON'T ALWAYS THINK
ABOUT AND WHILE IT IS
WONDERFUL TO HAVE TYPICALLY IN
UNIVERSITIES, THEY USUALLY
HAVE A PRIMARY MENTOR AND IN
SOME CASES, A MENTORING
COMMITTEE, I AM GUESSING IT IS
THE SAME FOR STAFF MEMBERS, ET
CETERA AND IT IS GREAT TO HAVE
A MENTOR BUT YOU NEED MORE
THAN ONE PERSON AND DIFFERENT
TYPES OF NORTH CAROLINA TO
HAVE WELL-ROUNDED AT ADVICE OR
INFORMATION AND SO THIS IS AN
ASPECT PEOPLE CAN BE THINKING
ABOUT FOR THEIR OWN MENTORING.
AND FROM THE SAME
ORGANIZATION, NATIONAL CENTER
FOR FACULTY DEVELOPMENT
ENDEAVORS, THIS WAS ACTUALLY
POSTED IN 2016 BUT USED IN
OTHER TALKS I LIKED AND KERRA
ANN IS AN INDIVIDUAL THAT
ADDRESSES MENTORSS AND THERE
IS THIS QUESTION.
CAN I MENTOR AFRICAN-AMERICAN
FACULTY EFFECTIVELY OR SHOULD
I TRY TO CONNECT WITH A
TENURED AFRICAN-AMERICAN
SCHOLAR IN ANOTHER DEPARTMENT
AND THEN HE PUTS IN
PARENTHESES, WE DON'T HAVE ANY
AND SIGNS IT UNSURE HOW TO
MENTOR.
I THINK THIS IS A REALLY GREAT
QUESTION AND IN RESPONSE TO
THAT SHE TALKS ABOUT LIMITING
BELIEFS DRIVING AWKWARD
FEELINGS AND SOME LIMITING
BELIEFS COULD BE ONLY PACK
CULT FACULTY OF COLOR COULD
ONLY MENTOR FACULTY OF COLOR
AND THAT IS NOT TRUE.
LIMITINGBELIEFS DRIVING YOUR
AWKWARD FEELINGS AND RACE IS
NOT THE ONLY THING THAT A
FACULTY OF COLOR COULD BE
MENTORING ON AND ANOTHER
LIMITING BELIEF IS THERE ARE
NO NEEDS THAT A FACULTY OF
COLOR COULD HAVE THAT DON'T
RELATE TO YOU.
I DON'T KNOW THE ETHIC
BREAKOUT OF THOSE LISTENING
BUT WE ALL HAVE INFORMATION
AND INSIGHTS THAT COULD BE
HELPFUL TO OTHER PEOPLE AND SO
THOSE OF YOU, I AM GUESSING,
YOU ARE SMART TO TAKE THIS
COURSE SO I AM SURE IF YOU
HAVE HELPFUL TOOLS AND STUFF
YOU CAN SHARE WITH OTHERS AND
ARE THEN THE LAST ONE OF
HUMIDITYING BELIEFS IS THERE
ARE NEEDS THAT FACULTY OF
COLOR CAN HAVE THAT CAN BE MET
BY YOU AND MENTORING MEANS
GIVING ADVICE TO MENTEES BASED
ON YOUR PERSONAL EXPERIENCE AS
OPPOSED TO SCIENCE AND TOOLS
AND PERSPECTIVES THAT COULD
HELP ANY MENTEE REGARDLESS
WHETHER THEY SHARE YOUR
PERSONAL EXPERIENCE OR NOT.
AND IN MY LAST COUPLE OF
SLIDES, I ACTUALLY WANT TO
FOCUS ON STUDY COORDINATORS
AND STAFF MEMBERS SINCE A LOT
OF TIMES THEY DON'T
NECESSARILY GET YOUR SIDE OR
ATTENTION, A LOT OF WHAT I
PRESENTED AS RESEARCH IS
ACTUALLY ON FACULTY MEMBERS
AND SCIENTISTS WHICH IS REALLY
IMPORTANT BUT ALSO VERY
IMPORTANT TO BE THINKING ABOUT
STAFF.
SO A FEW YEARS AGO, WE
CONDUCTED A STUDY LOOKING AT
KNOWLEDGE AND USE OF
RECRUITMENT SUPPORT TOOLS
AMONG STUDY COORDINATORS AT
NYU FOR NOVEL APPROACHES TO
RECRUITMENT PLANNING STUDY.
THERE IS NOT A LOT OF SPECIFIC
LITERATURE IN STUDIES THAT
HAVE SPECIFICALLY FOCUSED ON
THE SUPPORT THAT STUDY
COORDINATORS NEED TO
EFFECTIVELY RECRUIT AND
RETAIN STUDY PARTICIPANTS.
SO WE LOOKED AT A
CROSS-SECTIONAL SURVEY FROM
147 STUDY COORDINATORS, WE HAD
SOME FROM THE DEPARTMENT OF
HEALTH, SOME INVOLVED IN DRUG
STUDIES OR SURGERY STUDIES AND
WHAT HAVE YOU SO THERE WAS A
GOOD SAMPLING OF STUDY
COORDINATORS AND ARE IN THAT
PAPER, WE ACTUALLY ASKED ABOUT
A LOT OF THINGS AND IF YOU
WERE -- I DON'T KNOW IF ANYONE
TOOK THIS CLASS LAST YEAR BUT
I TALKED ABOUT OTHER RESULTS
FROM THIS PARTICULAR STUDY
LAST YEAR.
GIVING A TOPIC TO THE TALK, WE
HAD COORDINATORS GIVE THEIR
PERSPECTIVE ABOUT HOW
IMPORTANT IT WAS FOR A STUDY
COORDINATOR CONCORD A NCE, HOW
IMPORTANT THEY THOUGHT IT WAS
TO HAVE A CONCORDANCE TO THE
STUDY IN SOME WAY AND SOME OF
THE QUESTIONS ASKED ABOUT
RELATED TO AGE, GENDER, RACE
AND ETHNICITY AND LANGUAGE
SPOKEN.
AND I AM NOT SURE WHAT WE -- I
THINK I EXPECTED DIFFERENT
ANSWERS BUT THERE WAS ONLY --
IT WAS ON A SCALE OF 1 TO 5
AND IT RELATED TO THE
CONCORDANCE WAS VERY IMPORTANT
VERSUS NOT IMPORTANT AND
60 PERCENT OF THE PARTICIPANTS
LISTED LANGUAGE AS VERY
IMPORTANT WHICH I THINK IS
INTERESTING FOR A VARIETY OF
REASONS BUT IN PARTICULAR,
BECAUSE AT LEAST AT NYU, WE
HAVE BEEN TALKING A LOT MORE
ABOUT HAVING INTERPRETATION
AND TRANSLATION OPPORTUNITIES.
A LOT OF WHAT -- IF THERE IS
ANOTHER LANGUAGE BESIDES
ENGLISH, A LOT OF TIMES IT IS
SPANISH WHICH IS APPROPRIATE
BECAUSE A LOT OF PEOPLE LIVING
IN THE UNITED STATES SPEAK
SPANISH BUT IF YOU ARE IN A
CITY LIKE I AM, NEW YORK CITY
OR WASHINGTON D.C., A CITY
THAT HAS A LOT OF DIFFERENT
LANGUAGES IN THE FIELD,
SOMETIMES THE LACK OF LANGUAGE
OFFERINGS IN DIVERSITY CAN BE
A BARRIER FOR FULLY INCLUDING
AND DIVERSIFYING THE RESEARCH
POOL OR PARTICIPANT POOL IN
CLINICAL TRIALS.
ALL RIGHT, SO PROUD OF MYSELF,
ALMOST RIGHT ON TIME WHERE WE
NEEDED TO END.
SO THESE WERE A FEW MORE
EMERGING QUESTIONS IN GROUP
DISCUSSION THAT I WANTED TO
RAISE TO DIFFERENT GROUPS IS.
IT IN SLIDO?
>>YES, IT IS IN SLIDO SO I
WILL HOPE THE FIRST QUESTION
BUT FIRST I AM GOING TO ADD ON
YOUR LAST POINT, AISHA, I WAS
HELPING OUT WITH SOME STUDIES
OF NOVEL MEDICAL DEVICES TO
TEST FOR COVID.
AND ONE OF THE STUDY SITES WAS
IN CHICAGO AND THEY THE GIVEN
THE NEIGHBORHOODS IN WHICH
THEY WANTED TO RECRUIT, THEY
TRANSLATED ALL THE STUDY
INFORMATION INTO POLISH --
>>OH WOW.
>>-- BECAUSE THERE WAS A VERY
LARGE IMMIGRANT POLISH
COMMUNITY WHICH I GUESS IS TO
SAY IT GOES ALONG WITH KNOWING
YOUR NUMBERS AS YOU MENTIONED
EARLIER --
>>RIGHT.
>>-- BECAUSE THEY KNEW ENOUGH
TO KNOW THEY WOULD HAVE LOST
THE OPPORTUNITY TO ENROLL THAT
GROUP IF THEY HAD NOT
TRANSLATED THINGS INTO TOLL
POLISH.
>>THAT WAS A GREAT QUESTION.
>>SO WHAT ASPECT OF VARIETY
SHOULD BE IN CLINICAL TRIALS
AND THIS CAN BE A FIRST STEP
IN THE CONVERSATION WE WILL
CONTINUE.
I HAVE A CASE FOR DISCUSSION
FOR OUR LAST HALF HOUR WHERE
WE SORT OF EXPLORE A NUMBER OF
ISSUES AS IT RELATES TO NOW
THAT WE HAVE HAD ALL THESE
LECTURES, WHAT SHOULD BE OUR
PRIORITY?
INTO WE'LL GIVE THE STUDENTS A
CHANCE TO PUT IN SOME
SUGGESTIONS AND OF COURSE, YOU
KNOW, THIS CAN JUST BE --
THESE ARE ALL YOUR OPINIONS,
THERE IS NO RIGHT OR WRONG
ANSWER TO THIS QUESTION.
>>RIGHT.
>>OH, WE HAVE GOT A LOT OF
PARTICIPANTS TYPING.
REALLY DEPENDS ON WHAT YOU ARE
STUDYING, THAT IS A GOOD
ANSWER.
LANGUAGE, ENVIRONMENT, SEX,
DISEASE FACTORS, TRANSPARENCY
AND EQUALITY, SOCIOECONOMIC
FACTORS.
A LOT OF FOLKS HAVE MULTIPLE
THINGS IN THEIR ANSWERS SO NOT
JUST FOR RACE OR ETHNICITY PUT
SOCIAL DETERMINANTS OF HEALTH,
SOCIOECONOMIC STATUS, RACE AND
MINORITY GROUPS, SOCIAL
DIVERSITY I GUESS IS ANOTHER
WAY OF SAYING, YOU KNOW,
DIFFERENT SOCIAL DETERMINANTS.
COMORBIDITIES, HEALTH BELIEFS
AS YOU MENTIONED AND A COUPLE
MORE, WE HAVE A COUPLE MORE
FOR GENDER, RACE AND AGE.
THAT SEEMS TO BE A COMMON
RESPONSE FROM FOLKS AND I WILL
LET YOU TAKE IT AWAY.
>>OKAY, GREAT.
AND THE SECOND QUESTION, I
DON'T KNOW IF THAT IS IN SLIDO
AS WELL --
>>IT IS.
>>-- OKAY GREAT.
WITH THE CONSTRUCTION, THERE
IS A PI OR STUDY COORDINATOR
BUT IF YOU SAID OKAY WE'RE
GOING TO HAVE THE DREAM STUDY
AND WHAT TYPES OF PEOPLE
SHOULD BE ON THAT TEAM, SO IS
IT LIKE ROLES, SKILLS OF THAT
STUDY TEAM, WHAT, IF YOU HAD
TO CREATE THE PERFECT STUDY
TEAM, WHAT WOULD THAT LOOK
LIKE AND WHY SHOULD IT BE
INVOLVED?
>>SOME PEOPLE HAVE MENTIONED
I SHOULD MENTION THE WORD OF
THE DAY AGAIN WHICH I WILL DO,
IT IS EQUITY, OUR THEME AND
WORD OF THE DAY.
SO HERE IS MORE ENPOINTE
QUESTIONS.
SO MULTISTAKEHOLDER,
NONSCIENTIFIC FOLKS, THOSE
MORE FAMILIAR WITH COMMUNITY
AND AS YOU MENTIONED, LIKE
TRANSPORT MAPS, SOMEONE WHO
ACTUALLY IS MAYBE FRIENDLY TO
THE COMMUNITY AND FAMILIAR
WITH THAT.
AGAIN, IT DEPENDS ON THE
STUDY.
THIS IS A SMART GROUP WHO
KNOWS WE TAILOR CERTAIN
STUDIES.
A LOT OF VOTES ARE PEOPLE FROM
THE COMMUNITY.
AND AGAIN, I WILL EDITORIALIZE
THAT AND SAY THE COMMUNITY
FROM WHICH YOU ARE HOPING TO
IDENTIFY SO IF YOU ARE AT NYU
AND INTERESTED IN ENROLLING
WOMEN WHO ARE PRIMARILY
SPANISH SPEAKERS WHO LIVE IN
THE BRONX, THEN YOU MIGHT WANT
TO ASK SOMEONE WHO HAS THOSE
CHARACTERISTICS.
>>RIGHT.
HAS A OUTLY.
WELL GREAT, THOSE ARE GREAT
ANSWERS AND THAT FITS INTO MY
TALK SO I WILL STOP SHARING
BUT I REALLY APPRECIATE
HEARING ALL YOUR GREAT
FEEDBACK.
>>AND DO YOU HAVE ANY -- LIKE
IS THERE -- LIKE IF I PUT THE
QUESTION TO YOU, LIKE OF ALL
THE THINGS, AND THIS IS, I
KNOW, A REALLY HARD QUESTION
BECAUSE IT WILL ALWAYS DEPEND
ON THE STUDY, I WILL TAKE MY
MASK OFF SO PEOPLE CAN HEAR ME
A LITTLE BETTER, OF ALL THE
THINGS WE MIGHT SORT OF WANT
TO FOCUSES ON OR IF WE COULD
ONLY FOCUS ON ONE THING, AGAIN
PERHAPS THINKING ABOUT OUR
PAST IN TERMS OF HOW INCLUSIVE
WE HAVE BEEN, IS THERE A GROUP
OR IF I CAME TO YOU AND SAID I
CAN'T PRIORITIZE EVERYONE BUT
I REALLY WANT MY STUDY TO BE
DIVERSE, HOW SHOULD I FOCUS MY
ATTENTION AS IT RELATES TO
DIVERSITY?
>>YEAH, SO I WOULD SAY
THAT -- USUALLY IT DEPENDS BUT
I WOULD SAY I WOULD REALLY
FOCUS -- I OF LATE HAVE BEEN
INTERESTED IN AGE DIVERSITY IN
PART BECAUSE A LOT OF OUR
DRUGS AND DEVICES AND SENATOR
THINGS HAVE BEEN IN SOMEWHAT
YOUNGER, HEALTHIER POPULATIONS
AND SO I DO THINK MAYBE IT HAS
ALWAYS BEEN A CONVERSATION BUT
I THINK MORE RECENTLY THERE
HAS BEEN MORE CONVERSATION ON
DIVERSITY OF AGE AND REALLY
THINK ABOUT INTERVENTION
THROUGHOUT THE LIFESPAN.
SO I MEAN IF YOU GET LIKE
PREAGE, YOU WOULD SAY PREGNANT
WOMEN BUT ALSO LIKE CHILDREN
AND YOU COULD THINK ABOUT WHAT
COVID WAS, LIKE A REALLY GREAT
EXAMPLE REALLY EVALUATING
VACCINES TO AGES DIVERSITY
SORE THOSE OVER 65 OR MIDDLE
AGED AND YOUNGER PEOPLE.
NOT THAT I THINK IT IS OVERLY
IMPORTANT BUT NOT ENOUGH
ATTENTION HAS BEEN FOCUSED ON
A I AND IT IS A LITTLE
INTERESTING AND LITTLE SCARY
TO THINK ABOUT ALL THE DRUGS
AVAILABLE NOW THAT HAVEN'T
TRIED THE FULL AGE DIVERSITY
WHICH WOULD BE IDEAL AND WHAT
IS IT THAT MEAN, RIGHT?
HIKE IF YOU HAVE TROOPS OF
PEOPLE OVER AGE 65 OR 75,
WOULD BE MORE LIKELY TO HAVE
THESE CONDITIONS AND THESE
MEDICATIONS FOR THESE THINGS
AND NOT FULLY REPRESENTED IN
THE TRIALS.
SO A 75-YEAR-OLD WOULD NOT BE
CONSIDERED LIKE A 40-YEAR-OLD
AND IF THE SUBJECT IS A KID,
THEN THERE ARE OTHER
PSYCHOLOGICAL AND OTHER
THINGS.
>> RIGHT, WE TALKED ABOUT YOU
JOINED US ABOUT NIH
ORIENTATION OF GUIDELINES TO
BE KIDS AND THOSE AT THE
HIGHER END AND AS SOMEONE
AGING, THAT WILL BE REALLY
IMPORTANT TO ME.
>> YEAH, I WOULD SAY FOR THE
RECRUITMENT AND RETENTION PLAN
I DIRECT, THERE IS A
PEDIATRICIAN AND A
GERIATRICIAN AND WE MAKE THE
CASE THAT SOMETIMES THE
STUDIES SHOULD BE DONE IN
PARALLEL BECAUSE IT TAKES SO
LONG TO DO THE ADULT TRIALS
AND YOU WAIT FOR MANY MANY
YEARS FOR THE RESULTS.
SO SOMETHING LIKE A VACCINE
WHERE YOU HAVE TO WAIT FOR THE
ADULT STUFF, CHILDREN HAVE TO
WAIT.
>>AND WE HAVE THE SORT OF
PERFECT EXAMPLE OF THAT, LIKE
WITH THE COVID VACCINES, WE
GOT IT FOR ADULTS PRETTY
QUICKLY BUT THEN HAD TO WAIT
APPROPRIATELY PERHAPS FOR
KIDS.
THERE WILL ALWAYS BE A RISK
BENEFIT ASSESSMENT CLINICIANS
ARE IN EVERY DAY WHETHER THEY
WILL GIVE A KID THE TREATMENT
THAT WAS GIVEN TO ADULTS AND
DIDN'T HAVE TO HAVE A
PEDIATRIC TRIAL.
ANY QUESTIONS FROM THE GROUP?
SO MICHELLE WILL ASK A
QUESTION.
>>HI, THANK YOU SO MUCH FOR
THE TALK AND I KNOW THERE IS
THIS ROLE THAT A LOT OF
COMMUNITIES, LIKE THE BLACK
COMMUNITY WOULD HAVE A
MISTRUST OF PARTICIPATING IN
CLINICAL TRIALS BECAUSE OF
TUSKOGEE BUT THERE IS A
REVERSE TO THAT IDEA THAT IT
IS OVER SIMPLISTIC AND SO I AM
WONDERING HOW NOW THINKING
ABOUT INCLUSION, HOW YOU
INTEGRATE MISTRUST IF AT ALL?
>>RIGHT.
SO I DON'T GO TO MISTRUST
FIRST.
I WOULD SAY USUALLY WHEN I AM
DOING MY OWN STUDIES OR DOING
A CONSULTATION, I AM REALLY
FOCUSING ON WHEN DO PEOPLE
KNOW ABOUT IT, HOW ARE THEY
INVITED AND HOW ARE YOU MAKING
THE BURDEN AS MINIMIZED AS
POSSIBLE.
NOW, I THINK IF MISTRUST COMES
UP, THEN I THINK YOU COULD
TALK ABOUT IT BUT THERE'S
DIFFERING APPROACH OWES ES
AROUND ADDRESSING THE ELEPHANT
IN THE ROOM BUT YOU ARE
SUGGESTING THE ELEPHANT IS
WHETHER PEOPLE ARE
PARTICIPATING OR NOT BUT IT
MAY BE THAT THEY ARE HAPPY TO
PARTICIPATE AND YOUR STUDY IS
ONLY DOING SOMETHING FROM
10:00 A.M. TO 2:00 P.M. ON
THURSDAY AND WERE IT SATURDAY,
MORE PEOPLE MIGHT PARTICIPATE.
SO I TEND TO NOT FOCUS ON
MISTRUST AND NOT THAT I DON'T
THINK IT IS A REAL THING BUT A
LOT OF DISPARITIES IN CLINICAL
TRIALS MAY BE MORE FOCUS D ON
STATISTICAL ISSUES AND
INCLUSION AND EXCLUSION
CRITERIA AND EVEN THOUGH
MISTRUST IS IMPORTANT FOR SOME
PEOPLE, IT IS NOT THE
DOMINATING THING FOR ALL
PEOPLE SO I WOULD FOCUS ON THE
CHARACTERISTICS OF MAKING SURE
PEOPLE NOW ABOUT IT AND WERE
INVITED AS MY FIRST STEP.
>>YES, AND THIS IS HOLLY.
I THINK BY COVID THERE WAS
THIS SORT OF REORIENTATION OF
YES, THERE IS SOME MISTRUST
BUT DON'T USE THAT -- YOU
CAN'T LOOK AT DATA AND GO GEE,
THIS LOOKS LIKE MANY MORE WAIT
TO PEOPLE JOINED AND NOT MANY
OTHERS DID, IT MUST BE BECAUSE
THEY PROVIDES TRUST AND IN
FACT IT IS BECAUSE THE BUS
SYSTEM IS TERRIBLE OR WHATEVER
THE OTHER STRUCTURAL BARRIERS
ARE.
>>AND THE COVID-19 VACCINE
STUDIES, THEY WEREN'T PERFECT
BUT THERE WAS A PRETTY GOOD
POOL OF DIVERSITY AND I THINK
IN PART THERE WAS A
CONCENTRATED EFFORT TO WORK
WITH COMMUNITY GROUPS AND
CHURCHES AND COMMUNITY BASED
ORGANIZATIONS SO ACTUALLY LIKE
A REAL LIFE CASE STUDY THAT IT
IS POSSIBLE.
AGAIN, IT WASN'T PERFECT BUT
IT WAS PRETTY GOOD.
>>GREAT, THANK YOU SO MUCH
FOR JOINING US.
>>THANK YOU, I APPRECIATE IT.
>>AND HOPE YOU HAVE A LOVELY
REST OF YOUR DAY.
>>OKAY, TAKE CARE.
>>THANKS A LOT.
SO EVERYBODY IS NOW STUCK WITH
ME FOR THE LAST PART OF THE
SESSION AND I REALLY WANT TO
SORT OF FOCUS IN ON AT LEAST A
QUESTION I HAVE ASKED MYSELF
RED TORQUELY AND ART CHAPLAIN
WHO HAPPENS TO BE A COLLEAGUE
OF Dr. LANGFORD'S AT NYU,
WHEN WE WOULD TALK -- WHEN
THERE WAS DISCUSSION ABOUT
INCLUSION IN CLINICAL TRIALS
RECENTLY, AND THIS HAS BEEN
EARLIER THIS YEAR, HE PUT THIS
BLOG OUT AND I AM JUST
CAUGHTING AND PASTING THE PART
THAT I THOUGHT WAS MOST
INTERESTING AS A WAY TO SPARK
SOME CONVERSATION IN THIS LAST
HALF HOUR.
I ALSO HAVE SOME SLIDO
QUESTIONS FOR FOLKS SO KEEP
THAT OPEN ON YOUR COMPUTERS.
SO I AM JUST GOING TO READ
THIS FOR THOSE OF YOU WHO MAY
NOT HAVE IT IN FRONT OF YOU.
SO HE SAYS THERE IS YET
ANOTHER UNEXPLORED CHALLENGE
AMID ALL THE CALLS FOR
DIVERSITY -- THE CONTINUED USE
OF OUTDATED RACIAL CATEGORIES
TO MEASURE INCLUSIVITY.
IN THE AGE OF PRECISION
MEDICINE AND EXPLODING
KNOWLEDGE OF GENETICS, IT
HARDLY MAKES SENSE TO TALK
ABOUT ASIAN, BLACK, HISPANIC
AND WHITE AS MON LIT THEY CAN
BIOLOGICAL CLASSES.
THE NOTION THAT CATEGORIES
BASED ON GRIM HISTORICS OF
RACISM AND PREJUDICE OUGHT TO
GUIDE SUBJECT RECRUITMENT IN
AN ERA OF MULTIRACIAL IDENTITY
KNOWN GENETIC VARIABILITY
WITHIN GROUPS AND WIDE GENETIC
VARIATION IN THE SOCIAL
CATEGORIES BEING INVOKED IS
OUTDATED AND INACCURATE.
CLINICAL TRIALS IN THE U.S.
HAVE LONG SKUD TOWARD
RECRUITING MOSTLY WHITE
PEOPLE.
AND POINTING TOWARDS ACROSS --
ACCESS TO TRIALS AS A BENEFIT
TO JUSTIFY EFFORTS AT
DIVERSITY WHEN SO MANY
AMERICANS ARE UNINSURED OR
SADDLED WITH CRIPPLING MEDICAL
DEBT THAT MEAN THEY CANNOT
ACCESS THE BREAKTHROUGHS OF
RESEARCH MAKES EVEN LESS
SENSE.
SO I THINK WHAT HE IS SAYING
IS ARE WE ENCOURAGING THE
RIGHT OPTION WHEN EXPANDING
FOR INCLUSION AND I THINK THE
ONE THING HE IS SAYING IS
MAYBE GENETICS WOULD BE A
BETTER WAY TO ENSURE
DIVERSITY.
SO I WANT TO START THIS
CONVERSATION OFF WITH MY
QUESTION IN SLIDO WHICH I WILL
NOW OPEN WHICH IS IF RACE IS A
SOCIAL CONSTRUCT SHOULD WE
ABEEN A -- ABANDON IT IN THE
CONTEXT OF RACE IN STUDY AND
WHY OR WHY NOT.
I WILL GIVE FOLKS A LITTLE
TIME TO PUT THEIR ANSWERS IN.
A LITTLE LOPSIDED HERE AS I
MIGHT HAVE EXPECTED.
[LAUGHTER]
SO IT IS A PRETTY RESOUNDING
NO -- OH, WE HAVE A COUPLE OF
YESES.
NOW WE HAVE SOME LATE COMERS
WHO ARE SHIFTING A LITTLE
TOWARDS YES.
SO MY NEXT QUESTION WHICH I
WASN'T EXACTLY SURE HOW TO
OPEN IN SLIDO IS THIS SORT OF
WHY, WHY NOT.
IT SAYS WHY NOT BUT THINK OF
IT AS WHY, WHY NOT P-FPLT SO
WHY SHOULD WE NOT ABANDON THIS
SOCIAL CONSTRUCT AS A WAY TO
INFORM POLICY?
AND THOSE OF YOU IN THE ROOM
FEEL FREE TO EITHER SLIDO OR
GO TO THE MIC IN THE ROOM.
SO SOME OF THE RESPONSES HERE
ARE THAT IT HAS CLINICAL
RELEVANCE, THERE ARE ACTUAL
DIFFERENCES IN HEALTH
OUTCOMES, SOME DECISIONS THAT
AFFECT HEALTH MAY BE SOCIALLY
MOTIVATED, BECAUSE RACIAL
DIFFERENCES IN HEALTH ARE
REAL.
WE HAVE RACE IS A USEFUL PROXY
FOR OTHER DIMENSIONS IN WHICH
TO ENSURE DIVERSITY.
SADLY A MEANINGFUL GROUP,
ALTHOUGH WE MAY NEED TO DEFINE
IT AND THIS IS, I THINK, THE
POINT IN RESPONSE TO Dr.
KAPLAN'S COMMENTARY THAT WE
DON'T REALLY HAVE AN EASY
PRACTICAL WAY TO REPLACE IT.
IF ALL OF US HAD OUR GWOC
SCAN, IF SOMEONE HAD A RED
GENOME AND WE HAD A CHIP THAT
HAD OUR GENOME IN IT, IT WE
WERE ENROLLED IN A CLINICAL
TRIAL, IT MIGHT BE A WAY TO
DECIDE WHETHER WE ARE
ELIGIBLE.
SO WE NEED TO RESPOND TO THE
HISTORIC ARM.
NOTHING TO REPLACE IT WITH, A
LOT OF FOLKS THINKING ALONG
THE SAME LINE.
PRECISION MEDICINE IS EMERGING
AND NOT QUITE READY YET,
AGREED, BUT MAYBE SOMETHING WE
IN THIS ROOM AND THIS CLASS
SHOULD BE ANTICIPATING.
ARE THERE REASONS WHY WE MIGHT
WANT TO ADVOCATE FOR AN
ALTERNATIVE?
GREAT, SO THANK YOU ALL FOR
THAT RESPONSE.
I THINK THAT IS A GREAT WAY TO
START OUR CONVERSATION.
AND MY NEXT QUESTION WAS GOING
TO BE IS THERE A REASONABLE
ALTERNATIVE AND I THINK YOU
ALREADY ANTICIPATED THAT THERE
MAYBE ISN'T, RIGHT, AND THAT
MAY TO BE IN SURPRISE.
IT IS COMPLEX SO IT IS REALLY
HARD TO SAY AHA, LET'S USE
THIS INSTEAD.
BUT IN LISTENING TO Dr.
ASADA'S LECTURE, I THOUGHT
WHAT ABOUT THAT PROGRESS PLUS?
SO AS A REMINDER, PROGRESS IS
ABOUT PLACE MEANING WHERE YOU
LIVE, RACE, ETHNICITY, YOUR
JOB, YOUR GENDER, YOUR
RELIGION, EDUCATION,
SOCIOECONOMIC STATUS AND/OR
YOUR ACCESS TO SOCIAL CAPITAL.
SO IS THERE -- MAYBE ONE
CRITIQUE COULD BE USING THESE
PROXY MEASURES OF SKIN COLOR
MAY NOT ACTUALLY BE THE BEST
PROXY.
MAYBE WHAT WE NEED IS A
VARIABLE THAT HAS MULTIPLE
COMPONENTS THAT MIGHT BE A WAY
TO HAVE A DIVERSE POPULATION
ACROSS A WHOLE BUNCH OF
DIFFERENT AREAS.
SO LOOKS LIKE THERE'S SOME
ENTHUSIASM FOR USING PROGRESS.
GOT A COUPLE MORE FOLKS
WEIGHING IN THAT MAYBE MORE
TIME FOR TESTS, A GOOD IDEA.
SO TO ME IT SEEMS LIKE A
REALLY GOOD IDEA BECAUSE AT
LEAST ONE WORRY THAT THOSE OF
US IN THE ROOM ACTUALLY TALKED
ABOUT LAST WEEK AFTER LECTURES
IS IF WE, AND I WILL USE THE
ROYAL WE, IF WE, THE UNITED
STATES, CONTINUE TO ADVOCATE
FOR POLICIES LIKE THE ONE THAT
THE NIH HAD, WE OUGHT TO BE
ENCOURAGING INCLUSION OF
DIVERSE POPULATIONS AS IT
RELATES TO RACE AND ETHNICITY
STATUS.
THERE IS A RISK THAT WE ARE --
AND I THINK BOTH Dr. ASADA
AND I MENTIONED THIS THAT
THERE IS THIS NAME CALLING AND
WE THINK THERE ARE BIOLOGICAL
DIFFERENCES BETWEEN RACES THAT
WE THIS ARE IMPORTANT TO
STUDY.
SO LET'S SET ASIDE FOR THE
MOMENT THAT THERE MIGHT BE
SOME -- HERE IS HOW I THINK
ABOUT IT IN TERMS OF IS IT
REALLY ZERO THAT THERE IS --
IT REALLY IS A SOCIAL
CONSTRUCT AND THERE IS, YOU
KNOW, NO DIFFERENCE.
THERE ARE DIFFERENCES IN THE
FOLLOWING WAY SO YOU GUYS MAY
NOT BE FAMILIAR WITH THIS DRUG
CALLED BIVIL BUT IT WAS
BASICALLY A FAILED MEDICATION,
MEANING THAT THE CLINICAL
TRIAL FOR THIS STUDY SHOWED NO
DIFFERENCE WITH NO BETTER THAN
THE OLD MEDICATION, LET'S JUST
CALL IT FOR CARDIOVASCULAR
DISEASE.
BUT WHEN THEY DID SECONDARY
ANALYSIS OF THEIR DATA, IT
SHOWS THAT THE
AFRICAN-AMERICANS IN THE
POPULATION WERE MORE LIKELY TO
IMPROVE THAN OTHER GROUPS AND
THEN WENT FORWARD IN THE
MARKETING APPROVAL WITH THE
FDA FOR THIS DRUG TO BE A
SPECIFIC TREATMENT FOR AFRICAN
AMERICANS WHO HAD
CARDIOVASCULAR DISEASE.
NOW, IT TURNS OUT THAT THE
DIFFERENCE BEHIND THAT PROXY
WAS THAT ALL OF US, BECAUSE
WE'RE RELATED TO EVERYONE AND
HAVE GENETICS THAT ARE, YOU
KNOW, ALL OVER THE PLACE --
[LAUGHTER]
-- WHAT IT REALLY HAD TO DO
WAS WITH THE ALILS RELATED TO
A PARTICULAR GENETIC
COMPONENT.
ANOTHER WAY TO SAY THAT IS IT
HAPPENED TO BE THAT THOSE TWO
WHO DID BETTER, BOTH BLACKS
AND WHITES HAVE THIS
PARTICULAR ALIL THAT MADE THEM
MORE LIKELY TO POSITIVELY
RESPOND.
SO IT WASN'T NECESSARILY ABOUT
RACE BUT IT TURNED OUT THAT
THE DIFFERENCES IN THE NUMBER
OF ALILS THAT WAS NOT NORMALLY
DISTRIBUTED ACROSS THE
POPULATION LED TO SEEING A
DIFFERENCE, RIGHT?
SO ANOTHER WAY TO SAY THAT IS
THAT UNTIL WE HAVE SOMETHING
BETTER, AT LEAST WE CAN THINK
ABOUT HOW IN OUR OWN WORK THAT
WE'RE NOT DEFAULTING, QUOTE
UNQUOTE TO, SORT OF SIMPLISTIC
EXPLANATIONS, THAT WE'RE
THINKING ABOUT THE POPULATION
WE'RE INTERESTED IN, THAT
WE'RE THOUGHTFUL ABOUT ALL THE
THINGS THAT Dr. LANGFORD
MENTIONED AND HAVING AS
DIVERSE A POPULATION AS
POSSIBLE, I THINK THERE'S
VALUE IN DIVERSITY APART FROM
WHETHER OR NOT YOU ARE GOING
TO HAVE THE ABILITY TO
IDENTIFY STATISTICALLY
SIGNIFICANT DIFFERENCES
BETWEEN GROUPS.
HAVING A DIVERSE POPULATION
PUTTING EFFORT INTO MAKE SURE
EVERYONE WHO IS ELIGIBLE HAS
AN OPPORTUNITY MEANS THAT
ETHICALLY YOU ARE BETTER
SHARING THE BENEFITS AND
BURDENS OF OF RESEARCH.
SO WHILE MATHEMATICALLY IF WE
ACTUALLY USE PROGRESS, FOR
EXAMPLE, IT MIGHT BE REALLY EX
SENSIVE TO DO SUBGROUP
ANALYSIS BY ALL OF THOSE
VARIABLES BUT WE WOULD HAVE A
MORE DIVERSE POPULATION.
AND I AM GOING TO CHECK AND
SEE IF ANYBODY HAS ANY
QUESTIONS FOR ME OR WANTS TO
CHALLENGE ANY OF MY
ASSUMPTIONS BECAUSE THESE ARE
JUST MY OPINIONS, AS A
REMINDER.
THESE ARE MY OPINIONS, NOT THE
OPINIONS OF ANYBODY ELSE OR
ANY COMMENTS ABOUT DIVERSITY
MORE GENERALLY.
FOLKS ARE QUIET OUT THERE.
SO I WONDER, SO I KNOW THAT
MANY OF YOU, BECAUSE MANY OF
YOU HAVE INTRODUCED YOURSELVES
ONLINE ARE FROM ALL OVER THE
WORLD AND, SORRY, THIS IS A
PARTICULAR -- I THINK OF THIS
AS A PARTICULARLY AMERICAN
PHENOMENON BUT I WOULD LOVE TO
HEAR FROM THOSE OF YOU FROM
OTHER PLACES ABOUT CHALLENGES
YOU ENCOUNTER IN DEVELOPING
DIVERSE POPULATIONS.
I AM GOING TO ASSUME THAT FOR
SOME OF YOU WHO ARE ACTIVE
INVESTIGATORS, THERE ARE
PEOPLE THAT ARE ROUTINELY
EXCLUDED.
AND WHETHER YOU HAVE SPACE
CHALLENGES WITH THAT AND WHAT
SORT OF SOLUTIONS YOU MIGHT
HAVE BEEN COMING UP WITH.
WELL MAKE WE WILL JUST END
CLASS A LITTLE EARLY TODAY.
[LAUGHTER]
OH, MAYBE YOU ARE POSTING
THINGS IN SLIDO THAT I CAN'T
SEE.
I AM GOING TO BE BACK OVER
THERE, JUST FOR THE HECK OF
IT.
LET'S SEE.
I DON'T SEE -- OH, HERE IS
SOME.
OH, LET'S SEE.
LOOKS LIKE THERE ARE A LOT OF
PEOPLE CHATTING HERE BUT MAYBE
NOT ON THE -- BELOW EVERYONE.
YEAH, SO LOTS OF LOWS IN THE
SLIDO BUT I DON'T SEE -- LET
ME SEE IF I CAN FIND SOME
OTHERS.
OKAY SO I GUESS WE WILL END
EARLY TODAY.
I THOUGHT THIS WOULD BE MORE
THOUGHT-PROVOKING.
SO I WILL GIVE EVERYONE A
COUPLE MINUTES BACK TO THEIR
DAY.
I WILL MENTION THAT NEXT WEEK,
OUR TOPIC IS GOING TO BE
INFORMED CONSENT.
WE WILL START OFF WITH A
LECTURE FROM CHRISTINE GRADY
WHO IS AN EXPERT IN THE FIELD
AND ALSO HERE ON OUR FACULTY.
WE'LL ALSO HEAR FROM SCOTT KIM
WHO IS ALSO A FACULTY MEMBER
IN THE DEPARTMENT WHO HAS
EXPERTISE IN THOSE WHO HAVE
WHAT I WILL CALL COMPROMISED
DECISION-MAKING CAPACITY.
THEN WE ORIGINALLY WERE GOING
TO HOST KATIE TODDMAN WHO IS
PART OF A GROUP HERE THAT WE,
THE DEPARTMENT OF BY OH ETHICS
ARE A PART OF, ON HOW TO
ASSESS CAPACITY.
SO SHE IS ACTUALLY NOT GOING
TO BE ABLE TO JOIN US BUT HER
COLLEAGUE CAROL SQUIRE IS
GOING TO COME AND WE'RE GOING
TO TALK ABOUT HOW YOU DO THIS
HERE AT THE NIH THINKING THAT
MY THE OF SOME VALUE TO THOSE
OF YOU HAVE AT OTHER CENTERS.
AND THEN I WILL SPEND A COUPLE
OF MINUTES AT THE VERY END
GIVING YOU WHAT I THINK OF AND
HOPE ARE THE NUTS AND BOLTS OF
CONSENT THAT YOU MIGHT WANT TO
THINK ABOUT AS YOU DEVELOP
CONSENT FORMS.
AND WITH THAT, I WILL GIVE YOU
ALL BACK 11 1/2 MINUTES OF
YOUR DAY.
SO THANK YOU ALL.