WELCOME EVERYONE TO SESSION 4 OF
ETHICAL AND REGULATORY ASPECTS
OF CLINICAL RESEARCH.
IT'S HARD TO BELIEVE WE ARE
HALFWAY THROUGH THE COURSE.
TODAY WE HAVE TWO GUEST
SPEAKERS.
OUR FIRST GUEST SPEAKER IS FROM
OUR DEPARTMENT HERE AT THE NIH
THE DEPARTMENT OF BIOETHICS,
YUKIKO ASADA.
SHE JOINED RELATIVELY RECENTLY
IN 2002 AND HER EXPERTISE IS IN
POPULATION HEALTH AND
SPECIFICALLY TO MAKE EXPLICIT
THE IMPLICIT ASSUMPTIONS
UNDERLYING THE QUANTITATIVE
METHODS SHE USES AND OTHERS USE
IN POPULATION HEALTH RESEARCH.
AND JUST A QUICK REMINDER, ALL
THE FULL BIOS OF THE DEPARTMENT
FACULTY ARE ONLINE AND BIOS FOR
ALL GUESTS ARE POSTED WITH EACH
MODULE.
WITH THAT I'LL HAND IT OVER TO
YUKIKO.
>> OKAY.
GOOD MORNING.
AND THANK YOU VERY MUCH .
MY TALK IS THE USUAL DISCLAIMER.
I PRESENT MY VIEW AND NO ONE
ELSE.
SO THIS TALK, THE FOCUS IS IN
EQUITY AND DESIGN AND CONDUCT OF
CLINICAL RESEARCH.
SO, HERE WHEN I SAY CLINICAL
RESEARCH I USE THE TERM BROADLY.
SO ANYTHING TO DO WITH HUMAN
HEALTH.
I GIVE A LOT OF EXAMPLE OF THE
INTERVENTION STUDIES AND
CLINICAL TRIALS.
WHAT I TALK ABOUT TODAY REALLY
APPLIES TO ANY OTHER KIND OF
OBSERVATIONAL STUDIES AND OTHER
DESIGNS TOO.
AND IT'S NOT JUST THAT MEDICINE
PER SE IT COULD BE -- YOU CAN
EXTEND THE DISCUSSION TO SOCIAL
BEHAVIORAL RESEARCH TOO.
AND THEN I WANT TO MAKE TWO
POINTS.
FIRST IS THE EQUITY
CONSIDERATIONS ARE NOT A CHECK
BOX.
THEY'RE WOVEN INTO PRINCIPLES
FOR ETHICAL CLINICAL RESEARCH.
I SUPPOSE YOU'RE QUITE FAMILIAR
WITHIN THE EIGHT PRINCIPLES FOR
ETHICAL, CLINICAL RESEARCH.
SO WHEN I SAY EQUITY, IT'S NOT
LIKE I WANT TO ADD ONE MORE
CONSTELLATION TO THE EIGHT.
IT'S MORE LIKE FOR EVERYONE ONE
OF THEM YOU HAVE ETHICAL
CONSIDERATIONS.
THE INTERESTING THING IS IT'S
NOT A CHECK BOX, WHICH MEANS
IT'S NOT LIKE OKAY FOR THIS ONE
PRINCIPLE.
THERE'S AN ETHICS CONSIDERATION,
CHECK, ANOTHER ONE, CHECK.
IT'S NOT THAT SIMPLE.
SO IF YOU THINK ABOUT ETHICAL
CONSIDERATIONS IN ONE, THAT
MIGHT LEAD TO THE OTHER
PRINCIPLE.
SO IT'S KIND OF WOVEN IN.
AND TODAY BECAUSE OF THE
CONSIDERATIONS AND I FOCUSSED ON
THESE THREE.
AND SECOND POINT I WANT TO MAKE
IS THE BOTTOM ONE TO MAKE EQUITY
CONSIDERATIONS EXPLICIT AND
MEANINGFUL.
IT'S IMPORTANT TO THINK
CAREFULLY ABOUT WHEN HEALTH
INEQUALITIES ARE UNFAIR.
SO WHAT TO I MEAN?
I HOPE IT BECOMES CLEAR AS I
TALK.
SO TODAY, THIS TALK IS GUIDED BY
THREE QUESTIONS.
FIRST, WHO SHOULD BE IN THE
STUDY AND WHY.
SECOND, WHICH INEQUALITIES ARE
UNFAIR AND ALIVE AND FINALLY HOW
DO EQUITY CONSIDERATIONS
INFLUENCE THE STUDY DESIGN AND
ANALYSIS PLAN AND REPORTING?
IT'S A QUESTION IT'S NOT LIKE A
CLEAR ANSWER AND YOU CAN
MINIMALIZE IT AND ANSWER MANY
AND YOU HAVE TO PICK.
IT'S NOT LIKE AN EASY BUT I HOPE
BY THE END OF THIS TALK I CAN
CONVINCE YOU IT'S IMPORTANT TO
EXAMINE THE QUESTIONS.
SO, LET'S START.
WHO SHOULD BE IN THE STUDY AND
THE REASON I THINK THERE ARE
THREE WE CAN THINK ABOUT.
PARTICIPATION, BIOLOGY AND
SOCIETAL CONCERN.
AND I'LL GO ONE BY ONE.
THE FIRST, PARTICIPATION IS
PROBABLY FAMILIAR TO YOU FROM
PREVIOUS LECTURES.
SO CONSIDERATION HERE IS THE
FAIR DISTRIBUTION OF BENEFITS
AND BURDEN.
SO, AS YOU PROBABLY ALREADY
HEARD WHAT IT MEANS TO
PARTICIPATE IN STUDIES HAS
CHANGED FROM BEARING THE BURDEN
TO ACCESSING TO INNOVATIONS.
IT USED TO BE THE PARTICIPATION
IN THE CLINICAL TRIALS IS A
SPECIAL THING THAT AND NOW IT
SHIFTED THE DEFAULT IS
EVERYTHING SHOULD BE ABLE TO
PARTICIPATE AND IF YOU EXCLUDE
THEM YOU NEED JUSTIFICATION.
IT'S QUITE INTERESTING HISTORY
OF HOW AND THAT COULD BE ONE
REASON WHY YOU WANT TO INVOLVE
DIVERSE POPULATION IN YOUR STUDY
AND DISTRIBUTION OF BURD SKREN.
THAT'S NOT THE ONLY REASON WHY
YOU MAY WANT TO THINK OF OTHER
PEOPLE IN YOUR STUDY.
HERE I GIVE YOU BIOLOGY AND
SOCIETAL CONCERN.
FOR BIOLOGY, YOU ARE INTERESTED
IN YOUR STUDY, SOME CAUSAL
RELATIONSHIP X CAUSES Y AND YOU
MIGHT BELIEVE FOR WHATEVER
REASON THE CAUSALITY MAY WORK
DIFFERENTLY IN DIFFERENT GROUPS
OF HUMAN BEINGS BECAUSE OF
BIOLOGICAL DIFFERENCES.
HERE I WANT TO GIVE AN EXAMPLE
OF THE CARDIOVASCULAR DISEASE BY
SEX.
THESE ARE INFO GRAPHICS FROM THE
AMERICAN HEART ASSOCIATION.
AND HEART ATTACK SYMPTOMS
BETWEEN MEN AND WOMEN.
THIS IS NOW MEN AND WOMEN HAVE A
QUITE DIFFERENT SYMPTOMS OF
HEART ATTACK.
YOU CAN SEE I DON'T GO OVER
DETAILS AND YOU CAN MEASURE IF
YOU JUST STUDY MEN YOU MISS
WHAT'S HAPPENING IN WOMEN.
BIOLOGICAL MECHANISMS CAN BE
DIFFERENT AND THESE ARE STUDIES
I WON'T GO INTO THE DETAILS
BECAUSE IT'S NOT THE MEDICAL
TALK BUT SHOWS PROBABLY THERE'S
AND WE'RE TALKING ABOUT EXACTLY
THE SAME DISEASE.
HOW THAT MANIFESTS IN THE BODY
IS BIO LOGICALLY DIFFERENT
BETWEEN MEN AND WOMEN.
SO THAT IS A GOOD REASON TO
SUSPECT THAT WE CANNOT JUST
STUDY MEN, WHICH WE
TRADITIONALLY DID.
WE MIGHT MISS A LOT OF THINGS
AND WE CANNOT SAY THAT CAUSAL
RELATIONSHIP GENERALIZED TO
WOMEN.
SO THERE'S A GOOD REASON YOU
SHOULD STUDY BOTH OF THESE
GROUPS.
IT'S JUST ONE OF THE EXAMPLES OF
BIOLOGY DRIVES YOUR INTEREST TO
HAVE DIFFERENT PEOPLE IN YOUR
STUDY.
ANOTHER ONE IS THE SOCIETAL
CONCERN.
HERE WE MAY BE INTERESTED IN THE
CAUSAL RELATIONSHIP.
YOU MIGHT EXPECT WITHIN THAT
RELATIONSHIP WORKS DIFFERENTLY
FOR DIFFERENT KINDS OF PEOPLE
BECAUSE HOW WE ORGANIZE OUR
SOCIETY.
ONE WAY TO THINK ABOUT THIS IS
ANOTHER MIGHT BE DIFFERENTIAL
INTERVENTION AFFECTS BY SOCIAL
GROUP CHARACTERISTICS.
SO HERE EXAMPLE IS THE EFFECTS
OF WOMEN'S GROUP PARTICIPATION
ON NEONATAL MORTALITY RATE BY
MARGINALIZATION.
LET ME EXPLAIN MORE.
THIS IS TAKEN FROM META-ANALYSIS
AND MANY COUNTRIES FOCUSSED AND
I'M JUST FOCUSSING ON ONE
COUNTRY.
SO INTERVENTION IS PREGNANT
WOMEN IN NEPAL PARTICIPATED AND
THE COMPARISON IS WITH AND
WITHOUT THE INTERVENTION.
OUTCOME WE'RE INTERESTED IS THE
NEONATAL MORTALITY FROM THE
BABIES OF THE WOMEN WHO
PARTICIPATED OR NOT PARTICIPATED
IN THE INTERVENTION.
AND HERE THE INVESTIGATOR FELT
THAT MAYBE THIS INTERVENTION
HAVE A DIFFERENT EFFECT
DEPENDING ON THE DEGREE OF
MARGINALIZATION.
HERE IN THIS STUDY,
MARGINALIZATION IS DEFINED WITH
THE LITERACY.
SO MOST ARE WOMEN MANY
ILLITERATE AND POOR.
SO THE RIGHT-HAND SIDE -- AND
YOU SEE ON THE VERTICAL LINE THE
NEONATAL MORTALITY RATE.
GOING UP HIGHER IS THE MORTALITY
RATE WHICH IS NOT GOOD.
YOU WANT TO BE LOWER.
AND YOU SEE YEAR ONE AND THEN
TWO.
SO HERE WE SEE FOR THE CONTROL
GROUP THE INTERVENTION WORKS FOR
THE YEAR 1 AND 2 BECAUSE THE
SOLID LINE IS LOWER THAN THE
DOTTED LINE.
INTERESTINGLY FOR THE
MARGINALIZED GROUP IF YOU LOOK
AT JUST THE FIRST YEAR THERE
DOESN'T SEEM TO BE INTERVENTION
EFFECT BUT YEAR TWO IS A BIG
DIFFERENCE.
YOU WOULDN'T DESIGN THE STUDY
AND WOULD TOTALLY MISS THAT.
THAT'S ONE WAY TO KIND OF THINK,
OKAY, WHEN I DESIGN THE STUDY,
MAYBE I NEED TO INCLUDE
DIFFERENT KINDS OF WOMEN BASED
ON THE MARGINALIZATION BECAUSE I
EXPECT THIS.
RIGHT, SO THAT'S ONE WAY.
THE OTHER IS THE BOTTOM ONE.
SO YOU MIGHT EXPECT THE
DIFFERENTIAL EFFECTS WITHIN THE
TRADITIONALLY EXCLUDED GROUPS.
SO HERE I WANT TO GIVE AN
EXAMPLE OF THE EFFECTS OF THE
HIGH INTENSITY LIFESTYLE-BASED
PROGRAM FOR OBESITY TREATMENT UP
PRIMARY CARE CLINICS IN
LOW-INCOME NEIGHBORHOODS.
NOW WE'RE JUST FOCUSSING ON
TRADITIONALLY EXCLUDED GROUPS
WHICH IS THE LOW INCOME
NEIGHBORHOOD.
AND LOW INCOME NEIGHBORHOOD AND
THE INTERVENTION IS THE
HIGH-INCOME CITY.
LIFESTYLE BASED FOR OBESITY AND
THINGS THAT INCLUDE DIET,
NUTRITION, ADVICE AND PHYSICAL
EXERCISE PROGRAMS AND ALL THOSE
THINGS COMBINED.
COMPARISON IS THE INTENSIVE
PROGRAM AND USUAL CARE.
USUAL CARE COULD BE DOCTOR'S
ADVICE.
THEY'RE NOT IN AN INTERVENTION
PROGRAM.
OUTCOME IS THE EVALUATE.
MAJOR FINDINGS IS IN TWO YEARS
HOW MUCH BODY WEIGHT CHANGE.
SO HERE YOU SEE THE INTENSIVE
LIFESTYLE GROUP HAD THE BIGGEST
AMOUNT OF WEIGHT LOSS.
IT SEEMS TO BE WORKING.
AND THESE ARE GOOD RESULTS.
THEN YOU MIGHT IMAGINE LOW
INCOME NEIGHBORHOODS SHARE ON
ONIST -- SHARE LOW INCOME.
THE STUDY AUTHORS ASK HOW ABOUT
BY RACE.
IN THIS NEIGHBORHOOD THERE'S
BLACK AND NON-BLACK PEOPLE AND
ARE THERE DIFFERENCES?
YES, THEY FIND A DIFFERENCE.
HERE YOU SEE THE SOLID LINE IN
THIS GRAPH AND DOTTED LINE AND
FOR BOTH INTERVENTION GROUPS IT
WORKS.
INTERESTINGLY AND UNFORTUNATELY
THE EFFECT OF INTERVENTION IS A
BIT LESS FOR BLACK POPULATION
THAN THE OTHER RACE.
SO IF YOU DESIGN THIS WAY YOU
COULD TEASE OUT THE
INTERVENTION.
FOR SOCIETAL CONCERN ONE COULD
BE THE EFFECTS OF SOCIAL GROUP
CHARACTERISTIC.
THE NEPAL STUDY AND CAN FOCUS ON
THE TRADITIONALLY EXCLUDED GROUP
THE INTERVENTION STUDY.
PRIMARY INTEREST HERE IS WHY
WE'RE INTERESTED IN SOCIETAL
CONCERN IS IT'S DRIVEN FOR THE
CONCERN FOR UNFAIRNESS OR
INEQUITY.
SO WHEN WE THINK ABOUT THEM
THERE'S SOMETHING WRONG ABOUT
THEM ETHICALLY AND MORALLY
SHOULD BE THE REASON WHY WE WANT
TO STUDY.
SO HERE'S A GOOD TIME TO TALK
ABOUT TERMINOLOGY.
I'VE BEEN SAYING EQUITY,
INEQUALITY AND DIFFERENT TERMS
AND IT'S SUPER CONFUSING BECAUSE
THERE'S MANY SIMILAR TERMS AND
UNFORTUNATELY RESEARCHERS DON'T
USE CONSISTENTLY AND ALSO WHEN
YOU TALK TO PHILOSOPHERS, PUBLIC
HEALTH PEOPLE, IT'S DIFFERENT.
I WOULD CLAIM THIS IS THE WAY
PEOPLE SHOULD USE BUT THIS IS
HOW I MAKE SENSE OF IT.
AND I HOPE IT MAKES SENSE TO
YOU.
AND MY ADVICE IS TO UNDERSTAND
THIS NOW AND WHEN YOU TALK TO
PEOPLE ABOUT EQUITY, YOU SHOULD
HAVE A CONVERSATION WHAT DO YOU
MEAN, EQUITY AND MAKE IT CLEAR
WHAT YOU'RE TALKING ABOUT.
IT'S SUPER CONFUSING IN THE
FIELD.
I'VE BEEN WORKING IN THIS FIELD
FOR 20 YEARS AND IT'S
UNFORTUNATELY STILL LIKE THAT.
SO THE WAY IT MAKES SENSE TO ME
IS THE HEALTH INEQUALITIES.
THESE ARE HEALTH DIFFERENCES
BETWEEN GROUPS OR INDIVIDUALS.
THEN AMONG THEM HEALTH
INEQUITIES.
AND WHEN I SAY HEALTH
DIFFERENCES ACROSS GROUPS OR
INDIVIDUALS.
AND YOU CAN IMAGINE FAIR YOU CAN
DEFINE DIFFERENTLY AND MAYBE
DEPENDS ON HOW YOU FEEL BUT THE
DIFFERENCE IS HOUSING
INEQUALITIES ARE NOT ETHICAL OR
MORAL IT'S A DIFFERENT CATEGORY
OF DIFFERENCES AND WHEN YOU
START TO THINK ABOUT FAIRNESS,
ETHICALLY, PROBLEMATIC, THEN
IT'S INEQUITY.
AND THAT OFTEN YOU HAVE
DISPARITIES AND THE TERM USED A
LOT IN THE UNITED STATES AND
THIS IS HOW I UNDERSTAND IT.
IT'S ONE WAY TO TODAY FINE WHAT
IS UNFAIR.
-- TO DEFINE WHAT IS UNFAIR AND
MEANINGFUL CHARACTERISTICS OFTEN
INDICATIVE OF SOCIAL
DISADVANTAGE.
FOR EXAMPLE, HEALTH DISPARITIES
OR HEALTH DIFFERENCES BY RACE,
INCOME, EDUCATION, DISABILITY
STATUS AND THOSE GROUPS KIND OF
INDICATE SOCIAL DISADVANTAGE.
AND THEN HEALTH EQUITY WHICH I
USE AS THE ABSENCE OF HEALTH
INEQUITIES.
IF YOU FORGET EVERYTHING ABOUT
WHAT I SAY TODAY, I HOPE THIS IS
THE ONE THAT SHOWS UP IN YOUR
DREAM SOME TIME.
SO I'LL STOP HERE WITH THIS
DEFINITION BECAUSE I THINK IT'S
ONE OF THE KEY POINTS TODAY.
DO YOU HAVE ANY QUESTIONS HERE?
DID I CONVINCE YOU AND IT'S
CLEAR NOW?
>> SO, WE TALKED ABOUT THIS BUT
I WANTED TO RAISE THE FACT THAT
HEALTH INEQUITIES THAT'S OFTEN
THE TERM USED IN
NON-U.S. CONTEXT AND DISPARITIES
USED IN THE U.S. CONTEXT.
DO DIFFERENCE IN THE DEFINITIONS
REFLECT HOW THE U.S. SEES HEALTH
DISPARITIES COMPARED TO THE REST
OF THE WORLD?
>> THIS IS CONSISTENT WITH THE
TERMS USED IN THE UNITED STATES.
THE PAST DECADES PEOPLE STARTED
TO USE IN THE UNITED STATES
INEQUITIES ARE USED AND THEN SO
ETHICAL PART IS MORE EXPLICIT.
I THINK PEOPLE, SCIENTISTS,
PUBLIC HEALTH RESEARCHERS FELT
WHEN YOU START TO SAY INEQUITY
IT STANDS FOR SCIENCE BECAUSE
YOU'RE TALKING ABOUT MORALITY
AND ETHICS.
THAT'S NOT SCIENCE.
SOW PEOPLE FELT IT'S LIKE, WELL,
I'M A SCIENTIST.
I WANT TO TALK ABOUT NUMBERS AND
SO MAYBE DISPARITIES SOUNDS
BETTER.
BECAUSE IT'S A BIT AMBIGUOUS.
THAT'S HOW IT STARTED AND THE
DISPARITIES WERE TOSSED AROUND
BETWEEN INEQUALITY AND INEQUITY
FOR A LONG TIME AND NOW I THINK
PEOPLE ARE MORE COMFORTABLE TO
SAY WHEN WE SAY HEALTH
DISPARITIES, IT'S SOCIAL
DISADVANTAGE.
SO ETHICS IS FRONT AND CENTER.
SO IT'S AN INTERESTING HISTORY.
>> THANKS.
>> THANK YOU.
OKAY.
CAN I MOVE ON.
>> NO QUESTIONS FROM VIDEO LAND.
>> I WILL FEEL GOOD IF THIS IS
CLEAR SO LET'S MOVE ON.
SO I KIND OF MADE A BIG THING
ABOUT THE SOCIETAL CONCERN AND
TALK ABOUT INEQUITY,
DISPARITIES, DIFFERENCE AND SO I
CARRY ON THAT.
AND NOW IT COMES TO WHICH
HOUSING EQUALITIES IS FAIR AND
WHY AND INEQUITY IS FAIR AND
EQUALITY IS WHAT DO YOU MEAN BY
FAIR.
JUST STEPPING BACK, INCLUDING
DIVERSE STUDY SUBJECTS FOR
SOCIETAL CONCERN.
THAT KIND OF STUDY IS OFTEN
OPERATIONALIZED TO FOCUS ON
HISTORICALLY OVERLOOKED SOCIAL
GROUPS.
SO, AS I ALREADY MENTIONED IN
THE HEALTH DISPARITY GROUPS
LOOKING AT SOCIAL DISADVANTAGE
OR POWER IMBALANCE.
SO WHAT ARE THE GROUPS?
I ALREADY HINTED.
NIH GUIDELINES SAYS THE MINORITY
GROUP IS READILY IDENTIFIABLE
SUBSET OF THE U.S. POPULATION
WHICH IS DISTINGUISHED BY EITHER
RACIAL, ETHNIC AND/OR CULTURAL
HERITAGE.
SO THAT'S THEIR DEFINITION.
AND ALSO THERE'S THIS THING
CALLED PROGRESS PLUS.
THIS IS JUST ACRONYM SO YOU CAN
SEE WHAT THE PROGRESS STANDS FOR
HERE.
SO THIS IS DEVELOPED BY SOME
RESEARCHERS, 2003 AND A SYSTEM
FOR THE SYSTEMATIC REVIEW AND
ANALYSIS.
THERE'S MANY VERY DIFFERENT
SINGLE STUDIES BUT WE NEED TO
LOOK AT THE EVIDENCE TOGETHER
AND WHAT WE CAN SAY AND HOW TO
DO IT.
THAT'S THE KIND OF GROUPS AND
THEN THEY TOOK ON TO MAYBE
EQUITY CONSIDERATIONS ARE
IMPORTANT AND PROMOTE THE
PROGRESS PLUS.
IF WE'RE INTERESTED IN CERTAIN
GROUPS FOR SOCIETAL CONCERN,
THESE ARE THE GROUPS TO LOOK AT
THEN.
AND HERE, WHATEVER WAY YOU LOOK
AT IN THE LITERATURE, THE COMMON
THREAD IS WHAT I CALL BIVARIATE
APPROACH.
THIS IS HOW WE THINK.
THERE'S LEATH WHATEVER, HEALTH
OUTCOME YOU LOOK UP.
IT COULD BE LIFE EXPECTANCY,
MORTALITY, RP QUALITY OF LIFE,
CANCER PREVALENCE, WHATEVER, YOU
CAN TAKE A LOOK.
IT'S HEALTH YOU CAN MEASURE AND
GOING UP IS HEALTHY AND DOWN IS
LESS HEALTHY AND THEN YOU HAVE
THE SOCIAL GROUPS YOU'RE
INTERESTED IN AND I CALL
ATTRIBUTE BY INCOME, RACE,
ETHNICITY, SEXUAL AND DIFFERENT
GROUPS.
THIS IS HOW PEOPLE TYPICALLY
THINK ABOUT IT.
IT'S OKAY BUT I THINK THERE'S
CHALLENGES IN THIS WAY OF
THINKING.
THESE ARE GROUPS THAT INDICATE
SOCIAL DISADVANTAGE.
IT'S GROWING LONGER AND LONGER
EVERY YEAR.
WHICH IN ITSELF IS NOT A BAD
THING AND WE ARE MORE SENSITIVE
ABOUT THE ISSUES BUT IT'S
GETTING LONGER MEANING THERE'S
MANY GROUPS EVERY YEAR.
AND ALSO IN THAT PICTURE LOOKS
LIKE IF YOU'RE IN THIS GROUP
YOU'RE HEALTHIER AND IT'S NOT
ALWAYS TRUE AND IN THE OBESITY
STUDY YOU WENT TO THE LOWER
INCOME NEIGHBORHOOD BUT THERE'S
RACIAL DIFFERENCES.
SO THERE'S SOME DIFFERENCES
BETWEEN THEM.
BUT THIS WAY OF LOOKING AT IS
THE INTERSECTIONALITY ARE OFTEN
OVERLOOKED.
AND IF YOU START TO PAY
ATTENTION TO INTERSECTIONALITY,
FOR EXAMPLE, THE INCOME THEN YOU
HAVE MORE NUMBER OF PEOPLE TO
LOOK INTO.
THE GROUP IS GETTING MORE AND
MORE AND INTERESTINGLY THE GROUP
DEFINITION ITSELF COULD CHANGE.
WE CAN THINK ABOUT SEX.
WHEN I WENT TO GRADUATE SCHOOL,
YEAH, SEX IS A BINARY VARIABLE
AND MAYBE NOT, IT'S CONTINUOUS.
YOU HAVE TO MEASURE DIFFERENTLY.
SO, THAT GROUP DEFINITION ITSELF
COULD CHANGE AND THEN OFTEN
THOSE REASONS WHY THE SELECTED
GROUP CHARACTERISTICS SIGNIFIES
CONCERNS FOR FAIRNESS AND
INEQUITY ARE OFTEN JUST A SOCIAL
DISADVANTAGE AND YOU DON'T GO
ANYTHING BEYOND.
SO THEN WHAT'S HAPPENING IS
THERE'S SO MANY DIFFERENT GROUPS
WE THINK IT'S IMPORTANT AND THEN
WE DESCRIBE INEQUALITY.
THIS WAY AND MULTIPLE WAYS AND
LOTS OF INFORMATION.
THEN A SIMPLE QUESTION LIKE ARE
WITH MAKING ANY PROGRESS TO
REDUCE THOSE INEQUALITIES?
WE DON'T KNOW BECAUSE THERE'S SO
MANY AND HOW CAN WE SYNTHESIZE
THE RESULTS?
WE DON'T KNOW.
SO I THINK A DEEPER DISCUSSION
IS NEEDED TO INCLUDE THE DIVERSE
SUBJECT FOR SOCIETAL CONCERN.
AS I MENTIONED EXAMPLES OF THE
SOCIAL GROUPS OF CONCERN, RACIAL
ETHNIC MINORITIES, SEXUAL GENDER
MINORITIES, PEOPLE WITH LOW
INCOME AND DISABILITIES ARE
EXAMPLES.
THEN YOU HAVE TO ASK WHICH
GROUPS TO CHOOSE AND RIGHT NOW
RESEARCHERS JUST PICK BUT MAYBE
WE CAN DO DEEPER AND PHILOSOPHY
AND WHY ONE IS CONCERNED ABOUT
THE SOCIAL GROUPS.
SO HERE ONE EXAMPLE OF THE WORK.
MAYBE YOU'RE CONCERNED ABOUT
RECOGNITION OF PEOPLE.
THEN IT'S A GOOD REASON TO PICK
RACIAL, ETHNIC OR SEXUAL GENDER
MINORITY.
SOMETHING TO DO WITH
DISCRIMINATION.
YOU MIGHT PICK THOSE.
OR MAYBE YOU'RE CONCERNED ABOUT
RESOURCES.
HOW RESOURCES ARE DISTRIBUTED.
SO YOU MIGHT GO TO A GROUP LIKE
PEOPLE WITH LOW INCOME
MEDICATION OR MAYBE A POLITICAL
REPRESENTATION.
THAT'S YOUR REASON THEN PEOPLE
WITH DISABILITY.
THEY'RE EXAMPLES BUT YOU CAN GO
DEEPER AND THAT MAY GIVE YOU
SOME REASON WHY YOU PICK THOSE
GROUPS.
OR I ADD THE RESTORATION.
I'M FROM CANADA SO I FEEL MORE
COMFORTABLE TO GIVE YOU AN
EXAMPLE HERE, CANADIAN EXAMPLE
WHICH IS INDIGENOUS POPULATION.
IN CANADA THE PAST 10 YEARS
INDIGENOUS POPULATIONS AND WHAT
CANADA DID TO THEM BECAME SO
IMPORTANT AND NOW IT'S LIKE
THEIR RICH INDIGENOUS PEOPLE,
HIGHLY EDUCATED, POLITICALLY
STRONGLY INFLUENTIAL INDIGENOUS
PEOPLE BUT IT DOESN'T MATTER.
IF YOU HAVE INDIGENOUS HERITAGE,
WE HAVE TO BE WORRIED BECAUSE OF
THE HISTORICAL REASON OF WHAT WE
DID AS A COUNTRY.
THAT COULD BE ONE GOOD REASON.
I WANT TO HAVE THAT CONVERSATION
GOING A LITTLE BIT FOR THE
EMPIRICAL RESEARCHERS TO SHOW
THESE KINDS OF RESULTS.
THAT'S MY HOPE AND PEOPLE START
TO TALK ABOUT IT MORE.
SO THE FINAL QUESTION.
NOW I HOPE YOU KIND OF HAVE
IDEAS OF WHAT THIS EQUITY
CONSIDERATIONS ARE.
BUT THEN HOW DO EQUITY
CONSIDERATIONS INFLUENCE THE
STUDY DESIGN ANALYSIS AND
REPORTING?
WHY YOU WANT TO LOOK AT SOCIETAL
CONCERNS AND BIOLOGY.
I WANT TO WALK YOU THROUGH IT
BUT HERE'S STEPPING BACK THE
TRADITIONAL STUDY IS YOU HAVE A
POPULATION AND YOU PICK THE
STUDY SUBJECT INTERVENTION GROUP
TO KNOWN INTERVENTION GROUP AND
YOU WANT TO SEE THE OUTCOME AND
HOW IT'S DIFFERENT.
THIS IS THE TYPICAL WAY TO DO
IT.
THE EXAMPLE, HYPOTHETICAL
EXAMPLE I ASSIGNED IN THE WORK
SO I WANT TO WALK YOU THROUGH
THE EXAMPLE.
POPULATIONS OF LOW INCOME
COUNTRY.
INTERVENTION IS AN DIETARY
INDICATION AND SUPPLEMENTATION
PROGRAM MUCH LIKE PREGNANT
WOMEN.
THE INTERVENTION STUDY AND IT'S
BABIES WHOSE MOTHERS DID NOT
RECEIVE THE INTERVENTION.
SO TRADITIONAL STUDY IS
UNUSUALLY WE LOOK AT THE AVERAGE
TREATMENT EFFECT.
SO HERE YOU SEE THE DENSITY LIKE
THE BIRTH WEIGHT AND HERE'S THE
BIRTH WEIGHT GOING THAT WAY.
THEN IT'S THE DISTRIBUTION OF IT
AND CONTROL AND TREATED IS A
DIFFERENT COLOR.
ON THE DOTTED LINE IS THE
AVERAGE.
SO YOU ANALYZE THE DIFFERENCE
BETWEEN THE MEANS AND YOU REPORT
WHAT'S THE DIFFERENCE BETWEEN
THEM.
THAT'S THE TRADITIONAL WAY THE
TYPICAL INTERVENTION STUDIES WE
DO.
SO HOW DOES IT LOOK IF YOU HAVE
EQUITY CONSIDERATIONS?
SO THE REASON WHY YOU'RE
INTERESTED IN INCLUDING DIVERSE
POPULATION IS THE PARTICIPATION.
WE ALREADY TALKED ABOUT THIS,
RIGHT?
AND THEN FAIR SUBJECT SELECTION
IS A PRIMARY CONCERN AND IF
THERE'S NO REASON TO SUSPECT OR
BE INTERESTED IN POTENTIALLY
DIFFERENTIAL INTERVENTION
EFFECTS DUE TO BIOLOGY OR
SOCIETAL CONCERNS, NO ADDITIONAL
CONSIDERATIONS FOR THE STUDY
DESIGN AND REPORTING MAY BE
NECESSARY.
ALL YOU HAVE TO WORRY ABOUT IS
YOU GO TO THE DIVERSE POPULATION
AND YOU MAKE SURE THAT THE STUDY
SUBJECT SELECTION IS FAIR.
AND YOU DO BUSINESS AS USUAL.
BUT IF IT'S BIOLOGY, REMEMBER
WITHIN AN CARDIOVASCULAR DISEASE
MEN AND WOMEN ARE DIFFERENT.
THEN IT HAS A BIG IMPLICATION
FOR STUDY DESIGN AND REPORTING.
YOU NEED TO MAKE SURE YOU
INCLUDE BOTH GROUPS MEN AND
WOMEN IN THAT EXAMPLE.
YOU HAVE TO RUN THE STUDY AMONG
THEM INTERVENTION WORK AND THEN
YOU HAVE TO DO THE SEPARATE
ANALYSIS IF YOU'RE A
QUANTITATIVE PERSON THE
STRATIFIED ANALYSIS WE SAY AND
YOU HAVE TO REPORT SEPARATELY
OTHERWISE YOU DON'T KNOW IF MEN
AND WOMEN HAVE A DIFFERENT
EFFECT.
SOCIETAL CONCERN YOU HAVE TO DO
DIFFERENTLY AND PEOPLE START TO
USE DIFFERENT TERMS LIKE HEALTH
EQUITY RELEVANT RANDOMIZED
TRIALS OR EQUITY INFORMATIVE
METHODS.
AND THERE'S TWO APPROACHES.
ONE IS FOCUSSING ON AN EXCLUDED
GROUP AND THE OTHER IS ASSESSING
DIFFERENCES FOR SOCIAL GROUPS.
FOCUSSING ON TRADITIONALLY
EXCLUDED GROUP IS NOT THAT
DIFFERENT IN TERMS OF THE STUDY
DESIGN YOU HAVE TO GO TO THOSE
FRS
TRADITIONALLY EXCLUDED GROUPS.
THE RESEARCHERS WENT TO THE LOW
INCOME NEIGHBORHOOD AND SELECTED
PEOPLE.
AND THEN THE REST IS BUSINESS AS
USUAL.
SO, NOW THE DISTRIBUTIONS CAME
FROM THAT PARTICULAR GROUP AND
THEN YOU SEE INTERVENTION EFFECT
LIKE TRADITIONAL STUDY.
IT'S JUST THE POPULATION IS
DIFFERENT HERE.
BUT A BIT MORE COMPLEX IS
DIFFERENCES FOR SOCIAL GROUPS.
YOU HAVE TO GO TO THE POPULATION
REPRESENTING THE SOCIAL
CHARACTERISTIC OF INTEREST.
IF WE'RE INTERESTED IN INCOME,
YOU NEED LOW INCOME PEOPLE AND
HIGH-INCOME PEOPLE.
YOU CANNOT JUST HAVE A CERTAIN
INCOME PEOPLE.
AND WHEN YOU RUN THE STUDY MAKE
SURE YOU MEASURE IT.
YOU HAVE TO MEASURE INCOME IF
IT'S YOUR INTEREST, RACE, IF
RACE IS THE INTEREST.
EXAMINE THE CHARACTERISTICS AND
THE STUDY WOULD LOOK LIKE THIS.
THIS IS THE STUDY NOW IT'S
ADDED.
THE LOWER INCOME TO HIGHER
INCOME.
THEN WHAT'S THE FIRST.
HERE YOU CAN SEE FOR THE LOW
BIRTH WEIGHT WHAT'S THE
DIFFERENCE BETWEEN INTERVENTION
AND NON-INTERVENTION GROUP.
AND IN THE MIDDLE AND HIGH
INCOME.
SO YOU CAN AT THE DIFFERENT
LEVEL OF INCOME, HOW THE
INTERVENTION EFFECT IS DIFFERENT
AND YOU CAN REPORT THAT.
SO FOR THIS HYPOTHETICAL STUDY
IS A WONDERFUL STUDY BECAUSE THE
LOWER THE INCOME IS THE GREATER
THE INTERVENTION EFFECT IS.
IF YOU DIDN'T MEASURE INCOME YOU
CAN'T DO THIS.
AND SO YOU NEED TO PLAN IN
ADVANCE OF WHAT YOU WANT TO LOOK
FOR AND HOW TO ANALYZE IT AND
HOW TO REPORT.
SO THERE'S SOME CHALLENGES FOR
EQUITY RELEVANT AND INFORMATIVE
STUDIES.
ONE IS SAMPLE SIZE.
BECAUSE IT'S INDICATING A SOCIAL
DISADVANTAGE ARE USUALLY SMALL.
LARGE SAMPLE SIZE IS NEEDED FOR
TYPICALLY SMALL GROUPS.
WE ARE INTERESTED IN SEXUAL
MINORITY GROUPS AND RACIAL
MINORITY GROUPS AND BY
DEFINITION MINORITY OF SMALL
GROUP AND YOU HAVE TO THE
NUMBER.
AS LONG AS SOCIAL
CHARACTERISTICS ARE REPORTED
STATUS CAN BE REPORTED RELEVANT
INFORMATIVE POST HOC.
MEANING IF YOU MEASURE AND
REPORT IT AND IF YOU PUBLISH THE
STUDY, LATER PEOPLE CAN GO BACK
AND CHECK IT AGAIN.
AND THERE'S QUITE EXCITING
QUANTITATIVE METHODS HOW TO DO
IT.
COMBINING DATA FROM MANY STUDIES
PLUS MEGA ANALYSIS.
YOUR STUDY MAY BE VERY SMALL BUT
YOU COULD COMBINE LATER.
ALSO THERE'S BAYESIAN METHODS
OVERCOMING THOSE ISSUES.
IT'S WONDERFUL IF YOU CAN DESIGN
VERY LARGE STUDY THAT'S ENOUGH
POWER TO DETECT THOSE SMALL
DIFFERENCES OF THE SMALL GROUPS.
IF YOU CANNOT, STILL MEASURE
THOSE CHARACTERISTICS THEN YOU
CAN HELP OTHER RESEARCHERS TO
KIND OF COMBINE THE POWER LATER.
COST COULD BE THE ISSUE BECAUSE
YOU HAVE TO GO TO INVITED AND
WILLING TO PARTICIPATE BUT HIP
GUIDELINES AND RESEARCHERS WRITE
THE GRANTS AND JUSTIFY WE WANT
TO DO THIS STUDY AND IT'S MORE
EXPENSIVE AND THEY WANT TO GO
INTO THOSE DIFFICULT TO REACH
POPULATION FOR THE SOCIETAL
CONCERNS.
NIH POLICY IS SURE, WE'LL DO IT
BECAUSE IT'S IMPORTANT.
SO COST SHOULD NOT BE THE
REASON.
I THINK THE IDEAL IS GOOD TO
THINK ABOUT AND YOU CAN SEE IN
MY DIAGRAM THE EQUITY RELEVANT
STUDIES GET FAIRLY COMPLEX HOW
YOU DESIGN IT.
SO, THE SUMMARY.
WE ASK THREE GUIDING QUESTIONS,
WHO SHOULD BE IN THE STUDY AND
WHY.
DIFFERENT REASONS.
AND WHICH HOUSING EQUALITIES ARE
UNFAIR AND HOW DO THEY INFLUENCE
THE ANALYSIS PLAN AND REPORTING.
I HOPE THIS KEY POINTS I WANTED
TO MAKE ARE NOW CLEAR.
EQUITY CONSIDERATIONS ARE NOT
THE CHECK BOX AND THEY'RE WOVEN
INTO THE PRINCIPLES FOR ETHICAL,
CLINICAL RESEARCH AND TO MAKE
EQUITY CONTRIBUTIONS EXPLICIT
AND MEANINGFUL IT'S IMPORTANT TO
THINK CAREFULLY ABOUT WHEN
HOUSING INEQUALITIES ARE THERE.
>> THANK YOU VERY MUCH.
WE HAVE 10 MINUTES FOR
QUESTIONS.
AS A REMINDER FOR THOSE IN THE
ROOM, PLEASE HEAD TO THE
MICROPHONES.
WE HAVE A QUESTION FROM VIDEO
LAND WE CAN START WITH.
SO, THIS IS BACK TO YOUR
DEFINITIONS.
AND SO HERE'S THE QUESTION FROM
JAKE.
COULD YOU GIVE AN EXAMPLE OF A
HEALTH INEQUITY THAT IS NOT A
HEALTH DISPARITY?
SO, HE'S ASKING YOU HAVE A GREEN
AND THEN AN OLIVE.
ARE THERE -- WHAT'S IN THE GREEN
CIRCLE VERSUS WHAT'S IN THE
OLIVE CIRCLE?
>> THAT'S AN INTERESTING
QUESTION.
THERE ARE DIFFERENT
PHILOSOPHICAL PERSPECTIVES TO
DEFINE HEALTH INEQUITY.
I GIVE YOU ONE OR TWO.
SO ONE IS THAT EQUAL OPPORTUNITY
FOR HEALTH AND FOR PHILOSOPHERS
IN THE ROOM AND WHAT'S WRONG
ABOUT IT IS THOSE FACTORS BEYOND
INDIVIDUAL CONTROL.
THOSE ARE INEQUITY AS SOMETHING
WITHIN YOUR CONTROL AND
SOMETHING THAT HAPPENS.
TYPICAL EXAMPLE I GIVE IS YOU
DON'T NEED TO BUT YOU INSISTED
AND YOU DID BUNGIE JUMPING
WITHOUT SAFETY PRECAUTION AND
DIDN'T NEED TO.
IT'S YOUR CHOICE.
AND YOU HAPPEN TO JUST BREAK
YOUR LEG THEN TOO BAD, I'M SORRY
THAT HAPPENED BUT MAYBE
SOCIETY'S NOT RESPONSIBLE FOR
WHAT YOU DID.
BUT THAT HEALTH IS OKAY.
SOMETHING LIKE THAT.
YOU COULD THINK ABOUT IT.
IN THAT VIEW, THE DISTINCTION IS
NOT SO MUCH WHICH GROUP.
SO YOU CAN IMAGINE EVEN LOWER
INCOME PEOPLE WITHIN THEM, THE
PEOPLE WHO DID BUNGIE AND NOT
BUNGIE JUMPING THERE'S
DIFFERENCES.
IT DOESN'T UNIQUELY FIT INTO THE
GROUPS.
AND THAT'S THE CORE PART.
>> SO JAKE LET US KNOW IF YOU
HAVE A FOLLOW-UP.
AND REMA.
>> THANK YOU FOR YOUR TALK.
I HAVE A QUESTION ABOUT
INTERSECTIONALITY BECAUSE IT
SEEMS THE PAST 10, 20 YEARS WE
STARTED TO TALK ABOUT HOW PEOPLE
CAN BE A PART OF MORE THAN ONE
GROUP.
WHEN RESEARCHERS ARE DOING A
STUDY ABOUT THE EFFECTS OF
INCOME ON SOME OTHER THING IT
SEEMS LIKE IN ADDITION TO IN
ADDITION TO GROUPING BY LOW
INCOME AND MIDDLE INCOME AND
HIGH INCOME THERE SHOULD BE
UNDERSTANDING OF THE GENDER
INFLUENCES INCOME OR MAYBE
DISABILITY INFLUENCES INCOME.
HOW ARE RESEARCHERS TEASING
APART THOSE ISSUES AND HOW ARE
THEY MAPPING ON MAYBE LIKE
LOOKING BACK AT THE COMPLEX
INTERACTS BETWEEN GROUPS?
>> THAT'S A VERY GOOD QUESTION.
THERE'S DIFFERENT WAYS TO ANSWER
IT.
WHO ARE THE RESEARCHERS WE'RE
TALKING ABOUT?
SO THOSE WE'RE INTERESTED IN
EMPIRICAL WORK LIKE TRIALS, AS I
SAID, THE CHOICE OF GROUPS ARE
OFTEN JUST INTUITIVE.
SO THEY'RE NOT VERY INTERESTED
IN GENDER.
I'M INTERESTED IN RACE AND LET'S
DO THAT.
NOTHING WRONG ABOUT IT BUT
THERE'S ALL THINGS YOU CAN
CONSIDER AND SIT DOWN AND COME
UP WITH A THEORY AND PICK THE
IMPORTANT ONE AND ALSO AND EVEN
NOW MEASURING SEX IS GETTING
VERY COMPLEX HOW TO MEASURE.
SO DO WE HAVE THE DATA OR DO WE
KNOW HOW TO MEASURE.
THAT BECOMES THE CONSIDERATION.
ALSO TYPICALLY HAVE THEIR
OWN-ISM.
I'M INTERESTED IN SEXISM.
I'M INTERESTED IN RACISM.
I'M INTERESTED IN CAPITALISM.
THEY'RE JUST GOING TO ONE.
AND THEN IT'S VERY DIFFICULT TO
SAY EVERYTHING IS IMPORTANT AND
WHICH DO YOU CHOOSE AND THAT'S
NOT THE WAY THE EMPIRICAL WORK
GOES.
I'D LIKE TO HAVE THE
CONVERSATION GOING MORE.
BUT THERE'S A GAP IN HOW TO HAVE
THE DISCUSSION.
>> THANK YOU.
>> THANK YOU AGAIN FOR YOUR
TALK.
MY QUESTION IS THE REASONS WHY
YOU CONDUCT THE STUDY, RIGHT.
SO IT'S LIKE IN TERMS OF
PARTICIPATION OR BIOLOGICAL OR
SOCIAL DIFFERENCES.
MY QUESTION IS HOI YOU STUDY
CONFLATING BIOLOGY AND SOCIAL
ISSUES.
WE THINK OF THE HISTORY OF
SCIENCE AND COMPLETING BETWEEN
BIOLOGY AND SOCIAL HISTORY FOR
EXAMPLE.
SO TO GO FURTHER IN DEPTH, A LOT
OF WAYS LIKE RACE AND GENDER IS
ONE PRIMARY CONSEQUENCE OF
COMPLETING THESE TWO REASONS WHY
WE STUDY.
FOR EXAMPLE, WE HAVE A HISTORY
OF CONTRIBUTING INTELLIGENCE FOR
EXAMPLE TO RACE OR GENDER AND
THE CONSEQUENCES YOU COULD BE AS
SIMPLE AS STEREOTYPING TO
SOMETHING SEVERE LIKE EUGENICS
MOVEMENT BASED OFF THE SCIENCE
OF THINKING THERE'S BIOLOGICAL
DIFFERENCES BETWEEN THESE
GROUPS.
AND IS THERE KNOWING THERE'S A
BIOLOGICAL OR HISTORICAL
DIFFERENCE AND HOW CAN WE
COMMUNICATE THE RESULTS IN A WAY
THAT'S UPLIFTING RATHER THAN
DEGRADING AND MAKING SURE WE'RE
CONSCIENCE OF THE DIFFERENCES?
>> THAT'S A REALLY GOOD
QUESTION.
WE JUST HAVE TO BE CRITICAL AND
CAREFUL.
IF IT IS YOU CAN ALWAYS SAY THE
INTELLIGENCE IS THE BIOLOGY AND
YOU CAN THINK THAT WAY BUT I
COULD BE WRONG.
THERE'S DIFFERENT WAYS AND IF IT
DOESN'T GIVE THE LICENSE, YOU
CAN DO IT AND IF IT'S A GOOD
QUESTION AND MAKES SENSE, I
AGREE WITH YOU AT THE SAME TIME,
RIGHT NOW WE TRY TO INCLUDE
DIVERSE POPULATIONS AND DO A
LITTLE BIT MORE CAREFUL
EXAMINATION AND WE DIDN'T BEFORE
AND THAT'S A PROBLEM TOO AND AT
THE SAME TIME IF YOU HAVE AN
ASSUMPTION AND START TO PROVE
THAT AND I KNOW I'M NOT
ANSWERING BUT I HAVE TO AGREE
WITH YOU AND YOU HAVE TO BE
CAREFUL.
>> TWO QUICK THINGS, RIGHT.
I THINK TRANSPARENCY AND AS YOU
SAID, CRITICAL.
IF YOU'RE LOOKING AT LITERATURE
IT'S IMPORTANT FOR YOU TO BE
ABLE TO SAY, OKAY, LET ME THINK
ABOUT WHAT THEY WERE INTERESTED
WHEN THEY WERE DESIGNING THE
STUDY.
AND LET ME CRITICALLY LOOK AT
WHETHER OR NOT THEY'RE BASING
THEIR HYPOTHESIS ON A VERY OLD
AND INCORRECT ASSUMPTIONS.
IF YOU DO META-ANALYSIS OR
SOMETHING, YOU SAY, THAT'S
GARBAGE TO BE HYPERBOLIC.
I'M NOT GOING TO INCLUDE THAT IN
MY META-ANALYSIS BECAUSE THEY
WEREN'T ASKING AN APPROPRIATE
QUESTION MAYBE OR SOMETHING LIKE
THAT.
>> YEAH.
SO I THINK IT'S HELPFUL TO GO
BACK IN PRINCIPLE.
ONE IS THE VARIABLE SCIENTIFIC
QUESTION.
>> YEAH.
>> AND HERE THE REASON WHY I
SAID EQUITY CONSIDERATION IS NOT
A CHECK BOX IT'S WOVEN IN AND IS
A GOOD EXAMPLE LIKE IF YOU DO
THIS IT'S FINE.
YOU HAVE TO THINK WHERE DOES THE
QUESTION COME FROM?
IS IT REALLY VARIABLE, SOLID,
MEANINGFUL QUESTION AND THAT
ALWAYS NEEDS TO BE EXAMINED.
>> I'M TAKING THE MODERATOR'S
PRIVILEGE AND WE HAVE ONE MORE
QUESTION FROM VIDEO AND THEN
WE'LL TRANSFER OVER TO ME.
THIS IS ANOTHER QUESTION FROM
JAKE.
CAN EQUITY CONSIDERATIONS
JUSTIFY NOT CARRYING OUT A STUDY
DUE TO LIMITED RESOURCES OR
OTHER FEASIBILITY CONSTRAINTS?
A STUDY THAT LACKS NECESSARY
RESOURCES TO SUFFICIENTLY
MITIGATE RISK OF HARM OR OBTAIN
ADEQUATE INFORMED CONSENT FROM
PARTICIPANTS SHOULD NOT BE
CONDUCTED BUT SHOULD WE EVER
STOP A STUDY FROM MOVING FORWARD
DUE TO EQUITY CONCERNS?
SAY YOU THOUGHT ABOUT WHAT
GROUPS YOU'LL SAMPLE FROM BUT
THE SAMPLE SIZE WOULD BE SO
LARGE YOU CAN'T GET FUNDING TO
DO THAT LARGE A STUDY SO YOU
MIGHT HAVE TO COMPROMISE.
>> AND IS IT OKAY?
>> YEAH.
I'M TRYING TO GO BACK TO MY
SLIDE.
SO THAT'S HAPPENING.
IT'S AGAIN ONE -- SORRY, IT'S
NOT LIKE A BOOK.
SO BEFORE I THINK IT'S
IMPOSSIBLE BECAUSE IT'S SO
EXPENSIVE NOT FEASIBLE AND ALSO
AS I INDICATED, TYPICALLY IT'S
NOT A SMALL SAMPLE SIZE BUT
THESE ARE THE POPULATIONS OFTEN
FOR HISTORICAL AND GOOD REASON,
THEY DONT WANT TO PARTICIPATE IN
THIS STUDY BECAUSE THEY'RE
SUSPICIOUS AND WHO ARE WE TO
BLAME BECAUSE WE DID SO WRONG.
SO JUST TO GET THAT NECESSARY
SAMPLE IT JUST COSTS MORE.
YOU NEED MORE EFFORT AND MORE
PEOPLE TO GO IN AND TALK AND
IT'S ALL THAT.
SO WE SAID WE DON'T DO IT
BECAUSE IT'S SO EXPENSIVE.
SO I THINK THAT'S NOT RIGHT.
SO WE HAVE TO PUSH IT.
IT'S VERY NICE THE NIH SAID IT'S
NOT A CONCERN THEN YOU CAN WRITE
THE GRANT AND YOU JUSTIFY WE
NEED THESE PEOPLE BECAUSE WE
HAVE THIS CONCERN AND WE NEED
THIS MUCH MONEY AND GIVE US
MONEY AND THEY SHOULD GET THE
MONEY SO THAT'S GOOD BUT AT THE
SAME TIME, THERE ARE MANY
METHODOLOGIES YOU CAN PRODUCE.
I TALK ABOUT META-ANALYSIS AND
BAYESIAN METHODS SO THOSE ARE
THINGS THE RESEARCHER TRIED BUT
STILL NOT SUFFICIENT BUT MAYBE
COLLECTIVELY WE COULD STILL MAKE
SOME DIFFERENCE.
IT'S NOT EITHER/OR.
I THINK WE HAVE TO DO EVERYTHING
WE COULD DO.
>> YEAH.
A
AND COST CAN'T BE AN ISSUE BUT
THERE ARE FINITE RESOURCES AND
SAY WE DESIGN A STUDY THAT IS
GOING TO COST $5 MILLION AND
FIVE OTHER STUDIES THAT COST $1
MILLION TO REINFORCE IT'S NOT AN
EASY ANSWER.
GREAT, THANK YOU VERY MUCH.
>> THANK YOU.
>> NOW YOU'LL GET TO HEAR FROM
ME AND YOU'LL HEAR FROM ME AND
BEING TRANSPARENT I WAS EXCITED
ABOUT TODAY'S LECTURES AN I'M
GOING TO TRY TO WEAVE THE IDEAS
TOGETHER AND YUKIKO WILL GIVE US
BACKGROUND.
DR. LANGFORD WILL TALK ABOUT
PARTICIPATION.
I'LL TRY TO WEAVE THOSE TOGETHER
A BIT BY TALKING A LITTLE BIT
MORE ABOUT ETHICS AND A LITTLE
MORE ABOUT POLICY.
AND WE'RE ALSO TODAY GOING TO DO
SOME SLIDO.
SO HERE'S MY DISCLAIMER.
YOU ALWAYS GET TO SEE THERE IS A
PLACE IN MY LECTURE WHERE WE'RE
GOING TO DO A SLIDO QUIZ.
IT'S EASY FROM YOUR END.
GO TO SLIDO.COM ON YOUR PHONE OR
COMPUTER DEPENDING ON WHERE YOU
ARE AND IT WILL POP UP AND SAY
WHAT'S YOUR NUMBER, WHAT'S YOUR
CODE.
AND THIS IS THE CODE YOU'RE
GOING TO PUT IN 2997361.
SO WHEN WE GET TO THAT PART OF
MY LECTURE I'M GOING TO ENGAGE A
QUIZ AND GET YOUR RESPONSES.
SO I'M GOING TO TRY TO DO THIS
AND TRY TO MULTI TASK.
AS I SAID I'M GOING TO TALK MORE
ABOUT FAIR PARTICIPANT SELECTION
FROM A BROADER ETHICAL CONTEXT
THAN INEQUITIES AND DISPARITIES
AND THEN TALK A BIT MORE ABOUT
POLICY THE BACKGROUND POLICIES
THAT YUKIKO HAS MENTIONED AND
FROM LANGFORD WILL ALSO MENTION.
SOME REPETITION BUT ALSO WITH
THE GOAL OF GIVING YOU A NICE
PACKAGE OF CONTENT TODAY.
SO, BACK TO THE FIRST DAY WE
TALKED ABOUT THE BELMONT REPORT.
AND THE BELMONT REPORT HAS THREE
ETHICAL PRINCIPLES AS YOU MIGHT
REMEMBER.
THE THIRD BEING JUSTICE.
AND ACCORDING TO THE BELMONT
REPORT THERE ARE AT LEAST TWO
THINGS THAT RESEARCHERS SHOULD
HAVE IN MIND WHEN EXHIBITING
FAIRNESS AND JUST A SIDE NOTE,
WHEN YOU'RE READING TERMS LIKE
FAIRNESS, JUSTICE, IT'S ALWAYS
IMPORTANT TO THINK ABOUT, WELL,
WHAT TRADITION ARE THEY COMING
FROM OR WHAT PERSPECTIVE ARE
THEY COMING FROM AND THAT MAY
INFLUENCE HOW THEY'RE SETTING
THINGS UP JUST A QUICK SIDE
NOTE.
SO, INDIVIDUAL JUSTICE IS ONE
THING THEY MENTIONED.
AND THAT'S ABOUT HOW A
RESEARCHER EXHIBITS HIS OR HER
FAIRNESS.
AND A QUICK WAY TO SAY THAT IS
SOMETHING LIKE, IF I'M A P.I., I
DON'T OFFER THE RISKY TRIALS TO
PEOPLE I DON'T LIKE AND THE
POTENTIALLY BENEFICIAL TRIALS TO
THE PEOPLE I DO LIKE, RIGHT?
I SHOULDN'T BE MAKING INDIVIDUAL
DECISIONS ON MORALLY IRRELEVANT
CONCERNS WHETHER I LIKE SOMEONE
OR NOT IS NOT A MORALLY RELEVANT
CONCERN I SHOULD HAVE IN MIND
WHEN I'M RECRUITING PEOPLE TO
JOIN MY STUDY.
THE OTHER IS THE DISTINCTION
BETWEEN CLASSES AND WE TALKED
ABOUT THIS LAST WEEK WITH
PROFESSOR SHAW'S LECTURE WHERE
THERE CAN BE A DISTINCTION DRAWN
BETWEEN CLASSES OF SUBJECTS.
AND SO GOOD EXAMPLE HERE IS WHEN
WE THINK OF ENROLL BEING
CHILDREN IN RESEARCH, ONE QUICK
RESPONSE IS, WELL, MAYBE WE
SHOULD DO THE RESEARCH IN ADULTS
BEFORE CHILDREN?
THERE MAY BE REASONS WHY WE CAN
EXPOSE A COMPETENT ADULT TO A
LEVEL OF RISK THAT HE OR SHE IS
ABLE TO MAKE AN INFORMED
DECISION AND WE OUGHT TO DO THAT
FIRST BEFORE WE ASK A CHILD WHO
CAN'T MAKE AN INFORMED DECISION
AND CLASSES OF INDIVIDUALS.
AND WE COME THEN TO THE
PRINCIPLES THAT DR. GRADY
MENTIONS ON THE FIRST DAY TO
FAIR PARTICIPANT SELECTION.
AND IT TURNS OUT THAT WE HAVE
TALKED ABOUT THE FOUR MIDDLE
CONCEPTS LAST WEEK AND I'M GOING
TO SPEND A LITTLE BIT OF TIME ON
THE FIRST AND LAST.
YUKIKO TALKED ABOUT DISTRIBUTING
BURDENS AND BENEFITS FAIRLY.
WHEN THE BELMONT REPORT WAS
BEING DRAFTED, ONE PHENOMENON
THEY ARE WERE RESPONDING TO IS
SOMETHING LIKE THIS, WHILE AT
THE TIME THIS IS IN THE EARLY
1970s AND LONG BEFORE, THERE
WERE PUBLIC AND PRIVATE
HOSPITALS.
I'M SURE YOU CAN IMAGINE EVEN
FROM WATCHING TELEVISION, PUBLIC
HOSPITAL TEEMING WITH PEOPLE
LIKELY IN AN URBAN SETTING.
PRIVATE HOSPITAL MAY ALSO BE IN
AN URBAN SETTING BUT FANCIER
ROOMS.
BASICALLY THE WHO DON'T HAVE THE
FUNDS GO TO THE PUBLIC.
THOSE WHO DO HAVE THE FUNDS GO
TO THE PRIVATE.
IT USED TO BE THAT A LOT OF
RESEARCH WAS CONDUCTED IN THE
PUBLIC HOSPITAL AND THE RESULTS
MOST QUICKLY MIGHT RUN OVER TO
THE PUBLIC, MOST QUICKLY WENT TO
THE PRIVATE PATIENTS IN THE
PRIVATE HOSPITAL.
ONE WE THIS WAS THOUGHT ABOUT
AND THIS IS A BIT OF
RETROSPECTIVE MORAL ANALYSIS.
THE IDEA WAS FROM THE PUBLIC
HOSPITAL PERSPECTIVE WE ARE
PROVIDING CARE TO THESE PEOPLE
WHO MIGHT NOT OTHERWISE HAVE
ACCESS TO CARE.
SO, INCLUDING THEM IN RESEARCH
IS THE WAY THEY CAN PAY BACK THE
ALTRUISM.
WE CAN HAVE A LONG DISCUSSION
ABOUT THE PROBLEMS WITH THAT AND
THE AUTHORS OF BELMONT CLEARLY
TOOK NOTE AND SAID THAT'S NOT AN
APPROPRIATE WAY TO THINK ABOUT
THIS.
WE OUGHT NOT TO PUT ALL THE
BURDENS ON ONE GROUP AND HAVE
ALL THE BENEFITS TRANSFER TO
ANOTHER.
WE OUGHT TO BE DOING RESEARCH IN
ALL PATIENTS EXPOSING ALL OF
THEM TO THE RISKS AND INCLUDING
ALL PATIENTS IN THE BENEFITS OF
THAT RESEARCH.
NOW, YOU ALL KNOW AT LEAST THOSE
WHO LIVE IN THE UNITED STATES
AND ARE FAMILIAR WITH OUR HEALTH
CARE SYSTEM KNOW THIS WHILE THIS
IS I THINK TRUE AND WE HAVE MADE
EFFORTS AND I'LL TALK A LITTLE
BIT MORE ABOUT THEM, HOW WE HAVE
INCLUDED MORE PEOPLE IN CLINICAL
TRIALS, A MORE DIVERSE GROUP AND
THOSE WHO ARE IN THE TRIAL ARE
MUCH LIKE ALL THE PATIENTS WHO
MIGHT THEN BENEFIT, WE HAVE AN
UNFAIR SYSTEM SO IT'S NOT ALWAYS
THE CASE THAT ALL PATIENTS
RECEIVE THE BENEFITS OF
RESEARCH.
THAT'S JUST HOW OUR SYSTEM IS.
BUT WE CAN AT LEAST AGREE THAT
IN THINKING ABOUT THE BURDENS
AND BENEFITS OF RESEARCH, THEY
OUGHT TO BE DISTRIBUTED FAIRLY.
NOW, LET'S THINK A LITTLE MORE
ABOUT BURDENS AND BENEFITS.
THIS GOES BACK TO YUKIKO'S
PRESENTATION.
THE SCIENTIFIC GOALS OF THE
STUDY SHOULD BE THE PRIMARY
CONSIDERATION IN DETERMINING WHO
IS ELIGIBLE TO ENROLL RIGHT.
SO SETTING ALL THOSE OTHER
THINGS ASIDE, ONE IMPORTANT
THING IS YOU SHOULD BE
RECRUITING INDIVIDUALS HE WELIG
FOR THE STUDY YOU'VE DESIGN AND
THIS IS A MORE SCIENTIFIC
PERSPECTIVE AS YUKIKO MENTIONED,
YOU PLAY HAVE STATISTICAL
CONSIDERATIONS YOU WANT TO
ADDRESS AND THINK OF THOSE IN
THE DESIGN OF YOUR STUDY BECAUSE
YOU WANT TO DISTRIBUTE THE
BENEFITS AND BURDENS FAIRLY.
SO THE GENERALIZABILITY RIGHT.
THE BROADER THE POPULATION OF
PARTICIPANTS YOU ENROLL, THE
MORE LIKELY THE RESULTS OF THAT
STUDY IS GOING TO BE
GENERALIZABLE TO THE LARGER
POPULATION.
SO THERE'S A GOAL OF ENROLLING A
BROAD RANGE OF SUBJECTS TO HAVE
THE FINDINGS OF THE RESEARCH
APPLY TO AS MANY PEOPLE AS
POSSIBLE.
AGAIN, WHAT I'M NOW GOING TO DO
IS SHIFT A LITTLE BIT AND TALK
ABOUT PROTECT OF THE VULNERABLE.
AS I MENTIONED FROM BELMONT WE
GET THE IDEA THERE'S AN ORDER OF
PREFERENCE IN SELECTING SUBJECTS
AND FROM SIOMS WE TALKED ABOUT
IN THE FIRST DAY AND THE RELATED
READING IN THE MODULE 1, THAT WE
SHOULD EXCLUDE VULNERABLE
SUBJECTS UNLESS THEY'RE
PARTICIPATION IS NEEDED FOR
SCIENTIFIC REASONS.
THIS IS SAYING THIS IN A
SLIGHTLY DIFFERENT WAY.
YOU SHOULD ALWAYS HAVE AN ORDER
UNLESS THERE IS A SCIENTIFIC
REASON FOR INCLUDING SOMEONE WHO
WE MIGHT THINK ABOUT AS
VULNERABLE.
AND IN GENERAL WHEN WE TALK
ABOUT VULNERABLE SUBJECTS
THEY'RE LESS ABLE TO PROTECT
THEIR OWN INTERESTS.
THAT'S THE STARTING LINE.
WHEN WE TALK ABOUT CLINICAL
RESEARCH, THE VULNERABLE
SUBJECTS TYPICALLY ARE THOSE WHO
ARE UNABLE TO GIVE INFORMED
CONSENT.
WE'LL TALK MORE ABOUT
INDIVIDUALS VERSES GROUPS.
FROM INFORMED CONSENT
PERSPECTIVE THEY LACK CAPACITY
OR THEY HAVE CAPACITY BUT ARE
NOT FREE FROM INFLUENCE.
TRADITIONALLY OR FROM A
REGULATORY PERSPECTIVE, THESE
ARE THE THREE POPULATIONS WHO
ARE OFFICIALLY VULNERABLE.
WHAT I MEAN BY OFFICIALLY IS IF
A SUBJECT WERE A POPULATION OF
INDIVIDUALS YOU'RE PLANNING TO
RECRUIT ARE ONE OF THESE THREE
GROUPS, YOU HAVE EXTRA STEPS IN
TERMS OF HOW YOU DO THE
RESEARCH, WHAT TYPE OF RESEARCH
YOU CAN DO, WHEN YOU HAVE TO
HAVE ONE PARENT, VERSUS TWO
PARENT CONSENT.
THERE'S ADDITIONAL SAFEGUARDS,
QUOTE, UNQUOTE, WHEN CONDUCTING
RESEARCH WITH THESE POPULATIONS.
AND WE TALKED QUITE A BIT ABOUT
CHILDREN AND PRISONERS ARE AN
EXAMPLE OF THOSE WHO AGAIN AT
THE TIME WHEN BELMONT WAS
WRITTEN AND THEN TRANSLATED INTO
FEDERAL REGULATIONS, PRISONERS
WERE CONSIDERED TO HAVE
CAPACITY.
LET'S ASSUME THE AVERAGE PERSON
WHO IS INCARCERATED HAS THE FULL
CAPACITY TO MAKE A FULLY
INFORMED DECISION OR AT LEAST A
GOOD DECISION.
THEY MAY BE SITUATED IN A WAY
THAT THEY CAN'T MAKE A DECISION
FREE FROM INFLUENCE.
THEY HAVE A LOT OF THEIR CIVIL
RIGHTS WITHHELD.
SO WE WANT TO ASK THE QUESTION,
DOES THE LIMIT ON THEIR CIVIL
RIGHTS MEAN THAT THEY ARE ARE IN
A SITUATION WHERE IT WOULD BE
CHALLENGING TO MAKE AN INFORMED
DECISION.
HOW PRISONERS OR THOSE
INCARCERATED HAVE BEEN
CONSIDERED AS POTENTIAL RESEARCH
SUBJECTS HAVE CHANGED OVER TIME
THERE HAVE BEEN EFFORTS TO
EXPAND HOUN WE THINK OF
CONDUCTING RESEARCH WITH
PRISONERS BUT KEY TO THAT IS
THERE HAS TO BE SOME REVISION TO
THE CURRENT FEDERAL REGULATIONS
AND IT TAKES A LONG TIME TO DO
THAT BUT THE MIND SET HAS
CHANGED IN SOME WAYS BUT THE
REGULATORY SIFE GUARDS,
GUIDELINES HAVE NOT.
SO -- SAFEGUARDS, GUIDELINES
HAVE NOT.
LET'S TALK MORE ABOUT
VULNERABILITY.
THERE'S SOME CASES WHERE IT'S
POSSIBLE TO ADDRESS
VULNERABILITY WITHOUT EXCLUDING
THEM.
LET ME QUICKLY GO BACK TO THE
SLIDE.
I SAID THERE'S AT LEAST TWO WAYS
TO THINK ABOUT VULNERABLE
SUBJECTS.
THEY LACK CAPACITY OR HAVE
CAPACITY BUT FREE FROM
INFLUENCE.
GIVEN YUKIKO'S TALK AND WHAT WE
KNOW FROM LIFE, RIGHT, ALL OF US
ARE VULNERABLE.
EVERYONE HAS VULNERABILITIES.
THAT'S NOT HELPFUL PER SE BUT
IT'S HELPFUL TO THINK ABOUT
PEOPLE AND WHERE THEY ARE AND IF
THERE IS A POTENTIAL
VULNERABILITY IF THERE'S A WAY
THAT WE CAN ADDRESS IT.
SO, INDIVIDUALS WHO DON'T
UNDERSTAND ENGLISH ARE
VULNERABLE IF THEY'RE HERE IN
THE UNITED STATES FOR THOSE IN
SOUTH AMERICA, OBVIOUSLY THE
REVERSE WOULD BE TRUE.
BUT WE CAN ADDRESS THIS
VULNERABILITY.
WE CAN TRANSLATE S AND HAVE A
CONSISTENT WAY THAT THOSE WHO
DON'T SPEAK ENGLISH HAVE ACCESS
TO SOMEONE WHO CAN PROVIDE THEM
WITH GUIDANCE AND ANSWER
QUESTIONS, ETCETERA.
IF WE PROTECT THE VULNERABLE BY
EXCLUDING ALL INDIVIDUALS WHO
ARE UNABLE TO CONSENT, WHAT DO
WE DO ABOUT ALZHEIMER'S?
ESPECIALLY LATE STAGE
ALZHEIMER'S FOR EXAMPLE.
WE SHOULD ENROLL PEOPLE ONLY WHO
HAVE EARLY STAGE DEMENTIA
BECAUSE SOME OF THEM HAVE THE
CAPACITY TO MAKE A FULLY
INFORMED DECISION.
PUT WHAT IF THERE ARE RESEARCH
QUESTIONS WE NEED TO ASK AMONG
THOSE WHO HAVE LATER STAGE
ALZHEIMER'S AND A QUICK ASIDE, I
DON'T KNOW WE REALLY HAVE A GOOD
WAY TO DIAGNOSIS EARLY VERSUS
LATE.
MAYBE SOME DAY WE'LL HAVE A
BIOMARKER OR HAVE IDEAS WE'LL
HAVE A BIOMARKER TO DIAGNOSIS
THIS, BUT IN SOME CASES THERE'S
A JUSTIFICATION OR NEEDS TO BE A
JUSTIFICATION TO ENROLL THOSE
WHO CAN'T CONSENT ON THEIR OWN.
AND IN THOSE CASES, WE CAN
IMAGINE OR IMPLEMENT ADDITIONAL
SAFEGUARDS.
FOR EXAMPLE, SAY WE'RE GOING TO
DESIGN A STUDY OF PATIENTS WHO
HAVE LATE STAGE ALZHEIMER'S, THE
WAY RESEARCH WITH THAT GROUP IS
DONE TODAY IS THAT THERE IS
SOMEONE WHO SERVES BOTH AS THE
LEGALLY AUTHORIZED
REPRESENTATIVE.
THAT PERSON DESIGNATED AS HAVING
DECISION MAKING POWER FOR THAT
PERSON.
AND A STUDY PARTNER.
I MAKE THIS DISTINCTION BECAUSE
LEGALLY AUTHORIZED
REPRESENTATIVE BASICALLY MEANS
THERE'S AN ADULT WHO CAN PROVIDE
CONSENT ON BEHALF OF THIS
PERSON.
WHERE STUDY PARTNER REALLY
IMPLIES THERE'S SOMEONE WHO IS
GOING TO BE AVAILABLE AND
HELPING THAT PERSON ENROLL,
CONTINUE TO BE ENROLLED, GET
THEM TO THE CLINIC, ASSESS
WHETHER THIS IS A GOOD OR BAD
DAY TO TAKE THEM TO THE CLINIC,
ETCETERA.
SO THERE'S AN ADDITIONAL
PROTECTION WHEN THE GROUP OR THE
INDIVIDUAL IN THAT GROUP IS
VULNERABLE MAY NOT BE ABLE TO
PROVIDE THEIR OWN CONCEPT.
-- CONCEPT.
-- CONSENT.
SO NOW WE'RE GOING TO TALK MORE
BROADLY ABOUT THE PHENOMENON
YUKIKO MENTIONED THE SHIFT FROM
PROTECT
PROTECTING PARTICIPANTS.
LOOKING BACK TO THE 1970s THEY
WERE CONCERNED WITH PROTECTING
VULNERABLE POPULATIONS.
THIS IS IN THE WAKE OF JEWISH
STUDY AND THE STUDIES SHARED
WITH US THAT LED US TO SAY, OH,
MY GOSH, WE REALLY NEED TO
PROTECT THESE VULNERABLE
INDIVIDUALS AND YOU CAN'T UNDULY
TARGET PRISONERS,
INSTITUTIONALIZED PEOPLE, POOR
DURB -- LOOKING AT THE HISTORY
THEY ARE SAID WE HAVE TO BE
DIRECTIVE WITH EVERYBODY ON WHO
THROUGH CAN AND CAN'T ENROLL.
SHIFT 20 PLUS YEARS WE'RE BEYOND
THE 1990s BUT IT BEGAN IN THE
'90s WHERE THERE WAS A PUSH TO
HAVE DISADVANTAGED GROUPS TO
HAVE ACCESS TO WHAT CAN BE
LEARNED THROUGH RESEARCH DURING
RESEARCH.
AND WE MUST ASSURE ACCESS IN A
FAIR WAY.
I'M GOING TO SWITCH GEARS AND
TALK A LITTLE BIT ABOUT THE FOOD
AND DRUG ADMINISTRATION AND TALK
ABOUT THE NATIONAL INSTITUTES OF
HEALTH.
THE FOOD AND DRUG ADMINISTRATION
HAS TWO COMPETING GOALS.
ONE IS TO ASSURE SAFETY-BACK TO
A TALK ABOUT A LONG HISTORY OF
LET'S LOOK AT WHAT HAPPENS
BEFORE.
PEOPLE WERE SELLING THINGS
POISON.
PEOPLE WERE SELLING THINGS WITH
COCAINE WE HAVE TO ADOPT LAWS
AND POLICY TO PREVENT THOSE BAD
THINGS FROM HAPPEN.
THE LAST TWO OWN HERE WERE
TRIALS THAT LED TO HARM IN
FETUS.
PREGNANT WOMEN INGESTED THE
COMPOUNDS.
THE HARM WAS TO THEIR INFANTS.
KNOWN WERE CLINICAL TRIALS.
THEY'RE LOOKING AT HISTORY AND
IN NEITHER OF THOSE CASES WAS
THERE A CLINICAL TRIAL THAT
DISCOVERED THIS.
IT WAS THIS COMPOUND NOT YET
WELL RESTRICTED FOR A LACK OF A
BETTER THERM AND THALIDOMIDE WAS
GIVEN AND THIGH THEIR GOAL IS
ASSURING SAFETY.
SO IN THE WAKE WITH OF THOSE
EXAMPLES THE FDA JUST CLOSED THE
DOOR FOR LACK OF A BETTER TERM,
FOR THE INCLUSION OF WOMEN IN
PARTICULAR CLINICAL TRIALS.
SO IN 1977, THE FDA SAID, AND
AGAIN THEY'RE MARCHING DOWN THIS
PATH OF BEING VERY DIRECTIVE
ABOUT WHO SHOULD BE IN A TRIAL
AND HOW THE TRIAL SHOULD BE
DESIGN, WHAT TYPE OF MARKETING
IS ACCEPTABLE, ETCETERA.
ONE IS INFANTS ARE AT HIGH RISK
AN WHEN WE SAY WOMEN, WE SAY
WOMEN OF CHILDBEARING POTENTIAL.
AND THAT MEANS THIS
PREMENOPAUSAL AND CAPABLE OF
BEING PREGNANT AND WOMEN WHOSE
HUSBANDS HAVE HAD VASECTOMIES.
SO LET ME GO TO SLIDO AND OPEN
THE FIRST QUESTION.
HOW COULD THE EXCLUSION OF WOMEN
BE PROBLEMATIC SCIENTIFICALLY?
YOU CAN FILL IN YOUR ANSWER AND
THEY'LL APPEAR ON MY SCREEN.
WE'RE THEN GOING TO TALK ABOUT
THEM.
I'M HOPING SOME OF YOU WILL BE
ABLE TO TYPE IN SOME ANSWERS
HERE.
THIS IS THE FIRST TIME WE'RE
USING SLIDO TODAY.
WE HAVE NINE PARTICIPANTS
TYPING.
THAT'S GOOD.
HOPING IT WILL COME UP IN A
SECOND.
THESE ARE NOT QUESTIONS ABOUT --
LOOKS LIKE FOLKS ARE USING IT
FOR ASKING ME QUESTIONS.
HERE WE GO.
SO HERE'S EXAMPLES OF WHAT YOU
THINK ARE SCIENTIFICALLY
PROBLEMATIC.
BIOLOGICAL DIFFERENCES.
WE HEARD THAT IN YUKIKO'S
PRESENTATION.
THERE'S A DISEASE EFFECTS MEN
AND WOMEN DIFFERENTLY.
YOU WERE ALL LISTENING.
I APPRECIATE THAT.
LEADS TO AN IMBALANCE ON HEALTH
DISEASES THAT AFFECT WOMEN AND
MEN OR UNIQUELY WOMEN.
BIOLOGICAL DIFFERENCES CAN BE
ASSESSED.
IT CAN SKEW THE DATA.
THE RESULTS MIGHT NOT APPLY TO
WOMEN.
THERE'S REPRESENTATION AND
GENERALIZABILITY.
GREAT.
THANK YOU ALL FOR THAT.
LET ME SAY A COUPLE WORDS YES,
YOU'VE GOT THE RIGHT ANSWERS.
I WANT TO COME TO THIS ONE ABOUT
GENERALIZABILITY SOMETHING
THERE'S A HISTORY OF EXCLUDING
WOMEN AND YOU'RE AN OB-GYN AND A
WOMAN COMES IN YOUR OFFICE FOR A
VISIT AND CURRENTLY TAKING A
DRUG BECAUSE SHE HAS SEVERE
EPILEPSY OR ASTHMA OR
DEPRESSION.
I'M GOING TO SAY, OH, I'M GOING
TO LOOK THIS UP AND SAY WHAT THE
PHYSICIAN'S DRUG REFERENCE SAYS
ABOUT TREATING WOMEN AND LOOK AT
THE BOTTLE AND IT SAYS NO WOMEN
WERE INCLUDED IN CLINICAL TRIALS
AND YOU'LL HAVE TO MAKE A
CLINICAL DECISION BASED ON
RESULTS WE KNOW FROM MEN.
MEN, WOMEN, HUMAN, ETCETERA.
IT'S NOT LIKE YOU HAVE NO BUT IT
MEANS THE RESULT OF THAT
EXCLUSION SCIENTIFICALLY PUTS
THE CLINICIAN IN A BAD SPOT
BECAUSE HE OR SHE CAN'T LOOK AT
THE LITERATURE AND MAKE A
THOUGHTFUL CLINICAL DECISION
ABOUT THE PERSON IN FRONT OF
THEM.
AND I'M EXAGGERATING THAT A BIT
FOR EFFECT BUT IT'S NOT TOO FAR
OFF.
OKAY.
NEXT QUESTION, HOW IS EXCLUSION
OF WOMEN PROBLEMATIC ETHICALLY?
GO.
YOU'RE THE SAME NUMBER AND I
JUST OPENED THE POLL.
THIS IS FUN FOR ME IF IT'S NOT
FUN FOR YOU.
GOOD, WE HAVE UNFAIR
DISTRIBUTION.
GOOD.
INCLUDED FROM THE POTENTIAL
BENEFITS AND UNJUST,
DISCRIMINATORY.
WE DON'T KNOW HOW TO TREAT
WOMEN.
THAT'S SCIENTIFIC AND ETHICAL
IMPLY CALLINGS.
IT CAN BLOCK ACCESS TO BENEFITS.
SO WE'RE TALKING ABOUT THE SHIFT
IN MIND SET IF BACK IN THE 1970s
WE EXCLUDED ALL WOMEN NOW WE'RE
IN 2024 AND KNOW THERE'S
POTENTIAL BENEFIT WE'RE
EXCLUDING HER FROM.
GREAT, YOU'RE ALL COMING IN WITH
GREAT QUESTIONS AND MISSED
OPPORTUNITY.
INTERESTING THE PRODUCT OF
GESTATION IS A NEW INDIVIDUAL.
WE COULD TALK ABOUT THAT.
SO AGAIN, I DON'T WANT TO
DIMINISH THE HARM THAT AN
UNIMPORTANT FETUS DIMINISH THE
HARM A FETUS MAY BE EXPOSED TO
BUT MY READ OF THAT POLICY WAS
SOMETHING LIKE THE FOLLOWING, WE
DON'T TRUST WOMEN TO BE GOOD
STEWARDS OF THEIR REPRODUCTIVE
POTENTIAL.
LIKE WE DON'T TRUST YOU.
YOU CAN TELL US YOUR SINGLE OR
TELLING US YOU USE CONTRACEPTION
OR YOUR PARTNER IS A WOMAN OR A
MAN THAT HAS HAD A VASECTOMY.
WE DON'T CARE.
WE'RE GOING TO CLOSE THE DOOR.
WE DON'T THINK YOU CAN MAKE A
THOUGHTFUL DECISION.
I WOULD SWITCH AND SAY SOMETHING
LIKE THE FOLLOWING, ONE OF THE
REASONS WHY WE MIGHT WANT TO
PROTECT AND I'LL PUT THAT IN AIR
QUOTES, PREGNANT WOMEN IS FOR
THE FOLLOWING DIFFERENT REASON.
PREGNANT WOMEN AS A GROUP, I'M
SURE YOU'VE MET SOME IN YOUR
TIME, WILL LIKELY DO ANYTHING
FOR THE BENEFIT OF THEIR FETUS.
SO THEY MAY DIMINISH THE RISK OF
THEMSELVES AND TAKE ON MORE RISK
OTHERWISE BECAUSE THEY WANT TO
PROTECT THEIR FETUS.
SO IN WE REFRAME IT AND SAY WE
HAVE TO BE CAREFUL IN DOING
RESEARCH WITH PREGNANT WOMEN
ONLY OR WITH EVERYONE AND SOME
FOLKS MAY BE PREGNANT OR BECOME
PREGNANT, THERE ARE DIFFERENT
WAYS TO THINK ABOUT
VULNERABILITY.
THANK YOU FOR PLAYING AND YOU'LL
HAVE ANOTHER CHANCE TO USE SLIDO
WITH DR. LANGFORD'S TALK.
SO WE'LL CONTINUE ON HERE.
SO NOW I WANT TO TELL YOU ABOUT
THE OTHER GOAL OF FDA, ASSURING
ACCESS.
THEY HAVE TO PROTECT AND ENSURE
ACCESS.
THEY HAVE TWO THINGS RUNNING.
AND OUR PERSPECTIVE -- I'M USING
OUR IN THE SENSE OF SCIENTIST,
POLITICIANS, MEMBERS OF THE
U.S., CITIZENS HAVE SHIFTED FOR
THREE REASONS BACK IN THE 1980s
AND '90s.
I'M SURE MANY WEREN'T ALIVE, I
WAS.
WHEN THERE WAS NO TREATMENT FOR
HIV, MANY PEOPLE WERE DYING OF
AIDS.
HIV IS THE VIRUS, AIDS ARE THE
OPPORTUNISTIC INFECTION AND
CANCERS AND OTHER DISEASES THAT
ATTACK INDIVIDUALS WITH HIV
BECAUSE THEIR IMMUNE SYSTEM IS
SEVERELY COMPROMISED.
SO AIDS ACTIVISTS STARTED
PROTESTING HERE AT TO THE NIH
AND THIS PICTURE IS FROM THE FDA
AND AIDS ACTIVISTS WERE INVITED
TO THE TABLE AT THE NIH ALSO AT
THE FDA AND THEY MADE THEIR
INTERESTS KNOWN SAYING SOMETHING
LIKE THE FOLLOWING, LOOK, YOU
DON'T UNDERSTAND, WE HAVE NO
TREATMENT OPTIONS.
YOU'VE GOT TO GET THESE DRUGS
OUT THERE AND IN US ASAP.
WE DIDN'T ALLOW INDIVIDUAL TO
TAKE ON CRIAZY LEVEL OF RISK.
WE STILL SENT TRIALS THROUGH
SYSTEMATIC AND IRB REVIEW BUT
THERE WAS MOVEMENT TOWARDS
ACCESS TO CLINICAL TRIALS.
THE TERM I THINK IT'S NOT ON
HERE BUT SOME OF THE PROTEST
SIGNS SAY ACCESS TO CLINICAL
TRIALS IS ACCESS TO HEALTH CARE.
NOW, THAT'S A WHOLE OTHER
CONVERSATION WE COULD HAVE BUT
THE IDEA IS WE HAVE NO OPTIONS.
YOU HAVE TO GET THE CLINICAL
TRIALS UP AND RUNNING AND ONE
POLICY RESPONSE IS AIDS ACTIVISM
WAS PARALLEL TRACT BACK IN 1989
WHERE YOU HAVE ONE TRAIN GOING
THROUGH THE REGULAR PHASE I, II
AND III TRACK AND THE PARALLEL
TRACT IS LET'S EXPAND ACCESS TO
PEOPLE WHO HAVE HIV WHO WERE
UNABLE TOE ENROLL IN ANY OF THE
TRIALS ON THE MAIN TRACT.
THEY LIVE FAR AWAY.
THERE WAS AN INITIATIVE TO ALLOW
INDIVIDUALS TO EXPERIMENT AL
TRACK AND THERE WERE
EXPECTATIONS ABOUT GATHERING
DATA.
YOU HAD TO HAVE A CLINICIAN
WILLING TO MONITOR YOU AND IT
WASN'T A FREE-FOR-ALL BUT A
DIRECT RESPONSE TO YOU HAVE TO
GET THIS TO US SOON.
AND INDIVIDUALS DOING
METAANALYSIS SAID HEY, LO AND
BEHOLD WE WERE WORRIED ABOUT THE
RISKY RESEARCH AND HARM THAT MAY
COME TO INDIVIDUALS.
IT TURNS OUT THE ACTUAL LEVEL OF
HARM TO THOSE ENROLLED IS REALLY
NOT THAT HIGH.
SO THAT INCENTIVE TO KEEP PEOPLE
OUT TO PROTECT THEM FROM HARM
WAS LESSENED FROM A BIO
STATISTICAL PERSPECTIVE.
AND FINALLY, THE PICTURE I LOVE
THE CONGRESSIONAL WOMEN'S CAUCUS
BEGAN AN INTEREST IN THE
EXCLUSION OF WOMEN IN CLINICAL
TRIALS.
WHY IS THIS THE CASE?
THIS WAS AT THIS TIME WAS SORT
OF THE HIGH POINT IN THE NUMBER
OF WOMEN WHO WERE IN CONGRESS.
THIS WAS LIKE A TON COMPARED TO
WHAT WAS USUAL.
THEY WERE A BIG ENOUGH BODY TO
HAVE SOME WAY AND TALK BRIEFLY
TO GIVE YOU A BIT OF THE POLICY
ENVIRONMENT IN WHICH
INVESTIGATORS ARE NAVIGATING,
QUOTE, UNQUOTE, THE FUNDING THEY
AND WHO THEY HAVE TO THINK ABOUT
IN TERMS OF INCLUDING.
THAT'S IN THEIR RESEARCH.
SO YUKIKO TALKED ABOUT THE
SCIENTIFIC REASONS WHY YOU
SHOULD THINK ABOUT BIOLOGY,
INCLUSION, CAN'T REMEMBER HER
THIRD, SOCIAL CONCERNS.
IN ORDER TO ENFORCE SOME OF THE
THINGS THAT CONGRESS THAT OTHERS
THOUGHT OUGHT TO BE IN PLACE,
CONGRESS TOLD THE NIH, TOLD THE
FDA TO START PASSING,
IMPLEMENTING POLICIES THAT WOULD
QUOTE, UNQUOTE ENFORCE A SOCIAL
NORM.
RIGHT?
WE ALL -- LET'S ALL PRETEND THAT
WE THINK WOMEN SHOULD BE
INCLUDED IN RESEARCH.
LET'S MAKE THAT HAPPEN BY
PUTTING IT INTO LAW IN TERMS OF
GUIDANCE.
ONE POINT WITH THE SLIDE, NIH IS
RESPONSIBLE FOR A LOT OF FUNDING
IN THE EXTRAMURAL COMMUNITY.
WE'RE PHYSICALLY HERE IN THE
CLINICAL CENTER WHICH IS PART OF
THE INTRAMURAL RESEARCH PROGRAM.
ABOUT 10% OF NIH FUNDING COMES
HERE AND THERE'S 6,000
INVESTIGATORS AROUND THIS AREA
DOING RESEARCH.
BUT 84% OF $48 BILLION GOES OUT
IN THE EXTRAMURAL WORLD.
SO IN 2023, 50,000 COMPETITIVE
GRANTS TO MORE THAN 3,000
RESEARCHERS, RIGHT.
SO NIH HAS A BIG SWAY IN HOW
RESEARCH IS DONE BECAUSE THEY
ARE FUNDING A TON OF RESEARCH.
NOW, YOU MIGHT ASK WHAT ABOUT
PHARMA?
HOW DO WE THINK ABOUT PHARMA AND
HOW THEY'RE DOING?
LET'S SET ASIDE SOME NIH FUNDING
RESEARCH BECOMES A PRODUCT
PHARMACEUTICAL COMPANIES ADOPT
AND THEN MARKET.
IN ORDER TO GET YOUR DRUG
APPROVED YOU HAVE TO FOLLOW THE
RULES FDA TELLS YOU TO FOLLOW.
WHEN WE THINK OF THE CLINICAL
RESEARCH THAT HAPPENS IN THE
UNITED STATES AND THAT'S MY VIEW
SO SORRY FOR THOSE NOT FROM THE
U.S. IN OUR AUDIENCE, THE NIH
AND FDA HAVE A HUGE AMOUNT OF
POWER IN TELLING INVESTIGATORS
WHAT TO DO OR WHAT NOT TO DO.
SO, I JUST WANT TO -- I'M NOT
GOING TO GO THROUGH ALL THESE
POLICIES.
I JUST WANT YOU TO PAY ATTENTION
TO SOME OF THE WORDS I'VE
HIGHLIGHTED.
OVER THE LAST 40 YEARS THE NIH
HAS IMPLEMENTED A NUMBER OF
POLICIES THAT TELL RESEARCHERS
THEY MUST INCLUDE WOMEN,
MINORITIES, CHILDREN AND THEN WE
DECIDED RELATIVELY RECENTLY WE
SHOULD BE THINKING ABOUT
CHILDREN AND SHOULD THINK ABOUT
OLDER ADULTS.
SO KIDS AND OLDER ADULTS ARE NOW
IN THIS POLICY CALLED INCLUSION
OF INDIVIDUALS CROSS THE LIFE
SPAN.
THAT MEANS IF YOU'RE AN
INVESTIGATOR YOU HAVE TO KEEP
TRACK OF ALL THE POLICIES AND
HOW THEY INFLUENCE THE
SCIENTIFIC DECISIONS YOU'RE
MAKING ABOUT YOUR WORK.
AND I WANT TO TOUCH ON TWO OTHER
POPULATIONS THAT YUKIKO
MENTIONED.
THE FIRST IS THOSE WITH
DISABILITIES.
NOW, THE NATIONAL KANSAS ON
DISABILITIES RECENTLY PUT OUT A
REPORT CALLING OUT THE EXCLUSION
OF PEOPLE WITH DISABILITY IN
CLINICAL TRIALS.
AND THEY HAVE SOME
RECOMMENDATIONS FOR THE HHS AND
FDA AND NIH AND THEY'RE BOTH
PARTS OF HHS.
AGAIN, THESE ARE THE SAME
REASONS WHY THERE WERE EFFORTS
TO INCLUDE WOMEN AND CHILDREN.
WE HAVE TO AVOID UNNECESSARY
INCLUSION RECOMMEND ALL
INCLUSION CRITERIA BY
SCIENTIFICALLY JUSTIFIED.
VERY SIMILAR THEMES.
AND THE NIH HAS COME OUT WITH A
POLICY IT'S NOT YET AT THE LEVEL
OF GUIDELINE THAT SAYS
INVESTIGATORS, YOU OUGHT TO HAVE
THIS ON YOUR PLATE IN ADDITION
TO OTHER THINGS YOU SHOULD BE
THINKING ABOUT THIS AS WELL.
THE OTHER GROUP IS SEX AND
GENDER MINORITIES.
SO THE SECRETARY'S ADVISORY
COMMITTEE ON HUMAN RESEARCH
PROTECTIONS I'LL JUST TELL YOU
IT'S AN IMPORTANT ADVISORY GROUP
ON ISSUES RELATED TO CLINICAL
RESEARCH.
THEY JUST CAME OUT WITH A POLICY
AND CONSIDERATIONS DIRECTED TO
THE SECRETARY OF HEALTH AND
HUMAN SERVICES FOR ALL
INVESTIGATORS TO THINK ABOUT
ANOTHER SET OF CONSIDERATIONS
FOR THE DESIGN, REVIEW AND
CONDUCT OF AND RESEARCH WITH
THOSE WHO ARE SEX AND GENDER
MINORITIES.
AND I MENTION THIS IN THE SENSE
OF INCREMENTAL PROGRESS WITH THE
TOPICS.
I DON'T KNOW WHERE IT WILL GO
NEXT.
IT ALSO PUTS INVESTIGATORS IN
THE POSITION OF HAVING TO
NAVIGATE A LOT OF WHEN THINKING
ABOUT APPLYING TO THE NIH.
NOW I'LL TELL YOU A SIMILAR
STORY FROM FRAD.
-- FROM NIH.
FIRST THING THEY DID WAS
WITHDRAW THE POLICY I MENTIONED
ABOUT EXCLUDING WOMEN BUT IT
WASN'T WITHDRAWN UNTIL 1993.
AGAIN SOME WERE BORN AFTER THAT
BUT THAT'S IN MY LIFE TIME
CERTAINLY.
YOU CAN SEE INCREMENTAL CHANGES
FDA IS MAKING IN GUIDELINES
DIRECTED AT PHARMACEUTICAL
COMPANIES BECAUSE THAT'S THEIR
CONSTITUENCY.
NOW IMAGINE YOU'RE AN
INVESTIGATOR WHO IS FUNDED BY
THE NIH AND PLANNING TO PURSUE
MARKETING.
THERE'S A WHOLE LOT TO KEEP
TRACK OF.
BUT AGAIN THE IDEA HERE IS THAT
WAVE ALL AGREED THERE'S A
DIVERSE POPULATIONS IN SAMPLES
WE USE FOR CLINICAL RESEARCH.
AGAIN A WHOLE LONG LIST YOU'LL
HAVE IN THE SLIDES IF YOU'RE
INTERESTED.
RELATIVELY RECENTLY THE FDA PUT
OUT THIS DOCUMENT CALLED
ENHANCING THE DIVERSITY OF
CLINICAL TRIAL POPULATIONS.
ELIGIBILITY CRITERIA, ENROLLMENT
PRACTICE AND GUIDANCE FOR
INDUSTRY.
ATTENTION TO SEX AND GENDER
MINORITIES AND THE NEW DRAFT
CAME OUT IN SEPTEMBER AND WE
HAVE THE THEMES NIH HAS BEEN
TALKING ABOUT AND FDA IS ALSO
TALKING ABOUT GENDER IDENTITY,
SEXUAL ORIENTATION AND PHYSICAL
AND MENTAL DISABILITIES SO
PILING IT ON.
ANOTHER QUICK ASIDE IS THERE ARE
LOTS OF PLAYERS IN THIS POLICY
DEBATE.
SO THE NATIONAL ACADEMY OF
SCIENCES HAS A WHOLE SET OF
BOOKS ABOUT THIS.
THE GOVERNMENT ACCOUNTING
OFFICE, THEY'RE THE ONES WHO DID
THE TALLYING UP OF HOW WE'RE
DOING ON THE POLICIES.
THE BOTTOM LINE IS WE'VE BEEN
THINKING ABOUT THIS SINCE THE
1980s.
WE'RE STILL REALLY FAR FROM
SAYING, OH, GOSH, IT WORKED.
ALL THE SAMPLES ARE DIVERSE.
ALL THE SAMPLES HAVE LOTS OF
MEMBERS AND MINORITY
COMMUNITIES.
IT'S ONE THING TO SAY IT'S A
SOCIAL NORM AND HERE'S OUR
POLICY.
IT'S ANOTHER TO THINK ABOUT WHAT
THIS MEANS IN PRACTICE AND THAT
IS WHAT DR. LANGFORD IS GOING TO
TALK ABOUT IN A COUPLE MINUTES.
SO, I AM NOW OPEN FOR QUESTIONS
AND FOR THOSE IN THE ROOM,
PLEASE HEAD TO THE MICROPHONES
AND I'M GOING TO OPEN MY
COMPUTER AND SEE IF THERE ARE
ANY QUESTIONS OUT IN VIDEO LAND.
A REMINDER TO THOSE OF YOU WHO
ARE OUT IN VIDEO LAND, I'M NOT
LOOKING AT SLIDO FOR QUESTIONS,
I'M LOOKING AT THE DISCUSSION
BOARD AND THE EMAIL OR ALEX IS
FORWARDING THE EMAIL IF HE GETS
ANY AND LOOK AT THE SLIDO
QUESTIONS LATER.
MIRA.
>> YEAH, SO I WAS CURIOUS ABOUT
THE SITUATION WITH THE AIDS
ACTIVISM AND THE RISK
CALCULATION FOR THE
PARTICIPANTS.
SO YOU SAID THAT THEY REVISED
THEIR INITIAL ASSESSMENT, RIGHT,
THAT THE RISKS WERE TOO HIGH.
WHAT FACTORS WENT INTO THAT
REVISION?
>> SO, WHAT I WAS SAYING WAS
LET'S HAVE ACCESS EARLY AND
ENROLL EARLY.
THE RESPONSE WAS WE HEAR YOU BUT
ARE NOT GOING TO SAY IT'S
PERFECTLY FINE FOR THIS GROUP TO
MAKE A DECISION TO EXPOSE
YOURSELF TO A HIGH LEVEL OF RISK
THAT WE THE SCIENTIFIC COMMUNITY
DON'T THINK IS SCIENTIFICALLY OR
ETHICALLY APPROPRIATE.
A WAY TO SAY THAT IS IT THIS
WALL OVER HERE OF THIS IS HOW WE
DO TRIALS, PHASE I, II, III,
THAT CAN TAKE UP TO 10 YEARS AND
YOU HAVE A GROUP OF PEOPLE OVER
HERE DYING OF AIDS.
THERE WAS PUSH AGAINST THIS WALL
AND THE RESPONSE WAS WE HEAR YOU
AND WE'LL CREATE A WAY WITH YOUR
HE
HELP AND ALLOW FOR ACCESS
EARLIER THAN WE USE TO.
IT DOESN'T MINE WE'LL EXPOSE YOU
TO A LOT MORE RISK, BUT WE'LL
PUT THIS THROUGH IN THE USUAL
WAY BUT PROVIDE ACCESS EARLIER.
SO, ONE WAY TO THINK ABOUT THAT
WOULD BE TO SAY HEY, HOLLY, YOU
SAID IT HAD TO GO THROUGH PHASE
I BEFORE ON PARALLEL TRACK.
YES, PHASE I IS JUST ABOUT
SAFETY AND YOU MAY SAY WHAT'S
THAT MEAN IN TERMS OF THEIR
EXPOSURE TO RISK AND I WOULD SAY
EVEN PHASE I RESEARCH IS
REVIEWED BY AN INSTITUTIONAL
REVIEW BOARD.
EVEN IF SOMEONE WAS WILLING AS
AN INDIVIDUAL TO MAKE A CHOICE
TO EXPOSE THEMSELVES TO A LEVEL
OF RISK THAT YOU AND I WOULD
THINK IS UNACCEPTABLE, THEY
CAN'T BECAUSE THE IRB IS STILL
IN PLACE.
SO THEY DIDN'T COMPROMISE ON THE
LEVEL OF RISK UP WITH BEING
EXPOSED TO IN A CLINICAL TRIAL
BUT MADE A CALCULATION THAT
SAID, AND THIS PARALLEL TRACK I
SHOULD MENTION IS BEYOND HIV.
IT ALSO APPLIED TO OTHER
TERMINAL DISEASES AND THERE'S
COMPASSIONATE USE AND AS THE
TIMES INDIVIDUALS CAN REQUEST
ACCESS TO A COMPOUND BEFORE IT'S
GONE THROUGH ALL OF THE LIKE AT
LEAST IN PHASE 1,IF NOT PHASE 2.
THERE CAN BE A REQUEST FOR
COMPASSIONATE USE.
THE PERSON HAS NO OTHER OPTIONS
AND THIS DRUG LOOKS LIKE IT
MIGHT BE HELPFUL.
WE DON'T KNOW.
WE CAN'T MAKE ANY GUARANTEE BUT
WE THINK THE RISK BENEFIT IS
ACCEPTABLE AND SO WE'RE GOING TO
ALLOW THEM TO HAVE EARLY ACCESS.
AND JUST AS AN ASIDE, THAT HAS
SHIFTED TO 2024 OF LIKE I DON'T
CARE WHAT ANY OF YOU SAY, STATES
HAVE IMPLEMENTED LAWS THAT SAY
YOU PATIENTS SHOULD HAVE ACCESS
TO ANYTHING YOU WANT THAT A
PHARMACEUTICAL COMPANY IS
DEVELOPING.
THE TRICK IS THE PHARMACEUTICAL
COMPANY ISN'T GOING TO SAY SURE,
YOU CAN HAVE IT.
IT'S ON THE BOOKS IT HASN'T HAD
MUCH OF AN IMPACT ON INDIVIDUAL
ACCESS TO THINGS THAT THEY THINK
MIGHT BE HELPFUL TO THEM THAT
HAVEN'T GONE THROUGH THE
APPROPRIATE SET OF CLINICAL
TRIALS.
>> THANKS.
>> IT'S A LONG ANSWER TO YOUR
QUESTION.
SO LET ME CHECK AND SEE ANYMORE
QUESTIONS FROM THE GROUP?
GREAT, DR. LANGFORD HAS EA
QUESTION.
>> MY QUESTION IS ABOUT
VULNERABLE POPULATIONS.
HISTORICALLY IT'S BEEN PREGNANT
WOMEN, CHILDREN AND PRISONERS
AND DURING COVID BUT NOT
EXCLUSIVELY WE TALKED ABOUT A
LOT OF PEOPLE BEING VULNERABLE
IN SOME WAYS THAT SUBJECTIVE
THAT WHO NEEDS PROTECTION BY
SCIENTISTS VERSUS WHO SHOULD
HAVE THE RIGHT TO BE INVITED AND
MAKE THEIR OWN DECISIONS.
TALK ABOUT THE EVOLUTION AND HOW
WE USE THE TERM APPROPRIATELY
AND SOMETIMES IN MY OPINION
INAPPROPRIATELY.
>> YES, SO I THINK WE AGREE.
SO, BEEN AS A REMINDER, THERE
ARE THREE GROUPS THAT ARE
OFFICIALLY DESIGNATED, PREGNANT
WOMEN, PRISONERS AND CHILDREN.
AND THERE ARE ALL SORTS OF WAYS
WE COULD SAY, EVERYONE IS
VULNERABLE WHICH IS NOT HELPFUL
AND THEN WE MIGHT BE TEMPTED TO
IDENTIFY GROUPS THAT ARE
VULNERABLE.
LET'S SAY I'M ABOUT TO DO MY
CLINICAL TRIAL AND I SAY YOU'RE
VULNERABLE BECAUSE YOU ARE MY
STUDENTS AND I CAN MAKE YOU DO
WHATEVER I WANT IN ORDER TO PASS
MY CLASS THERE'S A POWER
IMBALANCE.
ONE COULD SAY HOLLY COULD TAKE
ADVANTAGE OF HER POWER IMBALANCE
AND COULD EXPLOIT THE GROUP.
ANOTHER WAY OF SAYING IT IS
PEOPLE CAN BENEFIT FROM THE
RESEARCH AND IF THERE'S THE
POWER IMBALANCE WHY NOT TAKE
HOLLY OUT OF THE PICTURE AND
HAVE SOMEONE OTHER THAN HOLLY
INTRODUCE THE TRIAL.
AND IF YOU DON'T WANT TO DO IT
THEY ARE WON'T REPORT TO ME WHO
DID AND DIDN'T DO IT.
WHILE YOU'RE VULNERABLE AND
YOU'RE A CLASS OF PEOPLE
VULNERABLE, WE CAN TAKE ACTIONS
TO MAKE YOU AND TAKE OUT THE
THING THAT MIGHT EXPLOIT YOU.
THAT'S ONE WAY TO THINK ABOUT IT
AND OTHER WAY I WAS REFERRING TO
WE TALKED ABOUT THE TUSKEGEE
STUDY AND I'M AN INVESTIGATOR
AND I KNOW PEOPLE WHO ARE NOT
WHITE ARE AFRAID OF RESEARCH AND
I DON'T WANT TO SHARE THEM SO
I'M NOT GOING TO OFFER
ENROLLMENT TO THEM.
I'M MAKING HUGE ASSUMPTIONS AND
I PULLED IT FROM THE AIR AND
APPLIED IT TO EVERYBODY AND SAID
THEREFORE ALL OF YOU ARE
VULNERABLE.
I'M NOT EVEN GOING TO APPROACH.
I HOPE YOU SEE THAT'S
INAPPROPRIATE.
THAT'S ACONTRIBUTING SOMETHING
AND THAT'S NOT THE CASE BUT WE
ARE ALL VULNERABLE TO USE IN A
PUN.
WE'RE ALL VULNERABLE TO MAKING
ASSUMPTIONS.
IT'S RICKY WHEN WE MAKE
ASSUMPTIONS ABOUT WHO IS
VULNERABLE AND WHO ISN'T.
COLLOQUIALLY IT'S IMPORTANT AS
WAS IT IN ABOUT WHAT DR. ASADA
WAS SAYING.
IT'S REALLY IMPORTANT TO SAY
WHAT DO YOU MEAN BY VULNERABLE.
YOU SAID EVERYBODY IN THE ROOM
IS VULNERABLE.
WHY ARE THEY VULNERABLE?
I WOULD SAY WELL, THERE'S A
POWER IMBALANCE.
GOOD.
NOW WE'VE DEFINED WHAT IS IT
BEHIND THE VULNERABILITY.
VERSUS, I READ IN THE NEWSPAPER
PEOPLE WHITE OR AFRAID OF
CLINICAL TRIALS.
THAT'S WHY I THINK THEY'RE
VULNERABLE.
THAT WOULD BE SOMETHING TO
CRITIQUE, TO CHALLENGE.
LET ME SEE IF THERE ARE LET'S
SEE IF THERE'S A QUESTION IN
VIDEO LAND.
ARE EMPLOYEES OF ANY INSTITUTE
CONSIDERED VULNERABLE AS STUDY
PARTICIPANTS?
IF SO, HOW DO YOU MITIGATE THE
EFFECT OF VULNERABILITY.
QUITE ON TARGET.
I'LL TELL YOU A LITTLE BIT ABOUT
HOW THE CLINICAL CENTER HANDLES
THIS.
AS I REMINDER WE ARE IN A VERY
LARGE HOSPITAL AND THERE ARE
CLINICAL TRIALS GOING ON ALL THE
TIME.
AND WE AS EMPLOYEES OF THE
CLINICAL CENTER CAN JOIN LISTS
OF IF YOU WANT TO VOLUNTEER FOR
A STUDY, PUT YOUR NAME HERE ON
THIS REGISTER.
SO WE RECEIVE ALL SORTS OF
E-MAIL THAT SAY COME JOIN MY
STUDY.
NOW, WE'RE ALL ALLOWED AS
CLINICAL CENTER EMPLOYEES TO
PICK AND CHOOSE WHICH TRIALS WE
WANT TO BE IN.
THE FOLLOWING HAPPENS WHEN IT'S
MY TRIAL AND BRITNEY WORKS IN MY
LAB AND I SUPERVISE HERE AND THE
WORRY IS THE POWER IMBALANCE.
IF I SAY YOU KNOW TRIAL IS
OPENING TODAY AND PLEASE GO DOWN
AND RECALL OR RESPOND TO THE
RECRUITMENT E-MAIL OR WHATEVER,
BRITTANY MIGHT WORRY, OH, NO, IF
I DON'T ENROLL I MAY BE IN
TROUBLE FROM HOLLY.
I WAS GOING TO GO TO THE
CONFERENCE, MAYBE SHE'LL RESCIND
THE PERMISSION AND CLINICAL
CENTER IS AWARE OF THE POWER
IMBALANCE AND THIS IS A DIRECT
ROLE, THEY CONTACT THE BIOETHICS
SERVICE AND THEY SAY YOU HAVE AN
EMPLOYEE IN YOUR DIRECT
SUPERVISORY LINE WHO WANTS TO
ENROLL, WE CAN COME AND TALK
WITH THEM TO MAKE SURE THEY
UNDERSTAND WHAT THEY'RE GETTING
INTO AND APPRECIATE THEY DON'T
FEEL ADDITIONAL PRESSURE,
ETCETERA.
THE POLICY IS ACKNOWLEDGING THE
POWER IMBALANCE AND THE
MECHANISM TO ALLOW FOR A
CONVERSATION FOR THE PERSON TO
BOTH APPRECIATE WHAT THAT MEANS
AND SHE SHOULD FEEL FREE OF
PRESSURE AND TELL US THAT.
THE TRICKY PART IS THE
FOLLOWING.
HERE AT THE CLINICAL CENTER WE
HAVE AN ELECTRONIC HEALTH
RECORD.
EVERYBODY IS IN RESEARCH.
THERE AREN'T PATIENTS AND
RESEARCH POPULATIONS.
THERE'S JUST ONE ELECTRONIC
HEALTH RECORD FOR EVERYONE IN
RESEARCH.
BRITTANY NEEDS TO KNOW WE NEED
ACCESS TO ONLY DE-IDENTIFIED
DATA BUT SAY I CAN LOOK AT
EVERYONE WHO CONSENTED TO MY
TRIAL.
YOU CAN SEARCH ON THAT AND
BRITT
BRITTANY'S NAME IS GOING TO POP
UP OR NOT.
I SHOULDN'T BE CHECKING THAT TO
SEE WHETHER OR NOT PEOPLE IN MY
LAB HAVE DONE IT.
BUT IT'S A RISK I WANT BRITTANY
TO KNOW.
I NEED HER TO KNOW HER
INFORMATION WILL BE IN THE
ELECTRONIC HEALTH RECORD.
IT MAY ALSO BE AVAILABLE TO
OTHERS ON THE STUDY TEAM AND
THAT'S IMPORTANT TO KEEP IN
MIND.
YOU MIGHT HAVE SENSITIVE
INFORMATION ABOUT YOURSELF YOU
WANT TO KEEP PRIVATE YOU
WOULDN'T WANT EVERYONE TO KNOW
OR MAYBE YOU'D ANSWER MORE
VAGUELY AND THEN YOU THINK, WAIT
A SECOND, IF I'M ACTUALLY
WILLING TO ANSWER A QUESTION
VAGUELY OR INCORRECTLY WHEN THEY
ARE ASK ME, THAT HAS SOMETHING
TO DO WITH THE INTEGRITY OF THE
STUDY.
I SHOULDN'T ENROLL.
ALL TO SAY IT'S NOT EASY BUT
THERE'S A MECHANISM IN PLACE
HERE AT THE CLINICAL CENTER TO
HOPEFULLY PROVIDE AN OPPORTUNITY
FOR THE DISCUSSION ABOUT WHAT IT
MEANS TO BE AN EMPLOYEE
ENROLLING IN A STUDY THAT IS RUN
BY YOUR OWN LAB.
OKAY.
THANK YOU ALL, WITH THAT WE'LL
TAKE OUR BREAK.
IT'S 10:20.
WE'LL RETURN AT 10:35, 15
MINUTES FROM NOW AND WE'LL THEN
HAVE OUR LAST AND FINAL LECTURE
FOR TODAY.
THANK YOU ALL.
WELCOME BACK TO OUR FINAL
LECTURE WE HAVE A GUEST, AISHA
LANGFORD VISITING FROM WAYNE
STATE AN ASSOCIATE PROFESSOR IN
THE DEPARTMENT OF FAMILY
MEDICINE AND PUBLIC HEALTH
SCIENCES.
HER RESEARCH PRIMARILY FOCUSES
ON THE WAY IN WHICH HEALTH
COMMUNICATIONS CAN ENHANCE
INDIVIDUAL DECISION MAKING AND
REDUCE HEALTH DISPARITIES ALONG
THE THEME AND SPECIFICALLY IS
GOING TO TALK TO US ABOUT
RECRUITMENT AND RETENTION.
TAKE IT AWAY.
THANKS GOOD, DR. TAYLOR AND WANT
TO YOU CAN TO TALK ABOUT
RECRUITMENT AND RETENTION IN
HEALTH RESEARCH STUDIES.
I DON'T HAVE CONFLICTS OF
INTEREST.
YOU ALL PROBABLY NOTICED
CLINICAL TRIALS ARE DIVERSE IN
TOPIC.
THERE'S BEHAVIORAL STUDIES,
GENETIC STUDIES, PEOPLE WHO
CHOOSE TO PARTICIPATE IN SURGERY
STUDIES OR DRUG TRIALS OR
VACCINE TRIALS.
OR TRIALS THAT ARE FOCUSSED ON
SOCIAL SUPPORT OR LIKE SYMPTOM
MANAGEMENT.
THERE'S ALSO DIFFERENT PHASES OF
CLINICAL TRIALS, PHASE I AND II
AND III AND I'VE BEEN IN A TRIAL
AND THE TARGET POPULATION CAN
DIFFER.
IN SOME POPULATIONS WE FOCUS ON
CHILDREN.
IN SOME SITUATIONS WE MAY FOCUS
ON OLDER ADULT OR FAMILIES AND
IN SOME SITUATIONS WE MAY
ACTUALLY BE FOCUSSING
EXCLUSIVELY OR PRIMARILY ON
PREGNANT WOMEN.
SO, BEFORE WE ACTUALLY GET
STARTED JUST IMAGINE YOU HAVE A
NEIGHBOR.
HER NAME IS LINDA AND SHE KNOWS
YOU EITHER WORK AT NIH OR ARE
VERY INTERESTED IN CLINICAL
TRIALS AND HEALTH RESEARCH AND
SHE'S TRYING TO FIND A CLINICAL
TRIAL FOR PEOPLE LIVING WITH
TYPE II DIABETES AND IF SHE CAME
TO YOUR DOOR TONIGHT AND ASKED
FOR YOUR HELP, WHERE WOULD YOU
START IF YOU WANTED TO HELP HER
FIND A CLINICAL TRIAL FOR TYPE
II DIABETES OF ALL PLACES WHERE
WOULD YOU START?
I BELIEVE WE HAVE A SLIDO.
>> FOR THOSE WHO NEED THE NUMBER
IT'S 2997631.
SLIDO.COM IS WHERE YOU'LL GO AND
PUT IN THE NUMBER.
THE SAME USED FOR THE PREVIOUS
QUESTIONS UP WITH OF YOU HAS
RESPONDED SO I NEED MORE OF YOU.
NOW AMERICAN DIABETES
ASSOCIATION IS COMING UP AND
THERE'S A HAND UP.
THE CODE IS 2997361.
ACADEMIC CENTER AND DIABETES
ASSOCIATION ARE NECK AND NECK.
CLINICAL TRIALS IS WINNING AT
79%.
WE HAVE A COUPLE VOTES FOR NIDDK
BUT CLINICAL TRIALS DOT-GOV IS
THE CLEAR WINNER.
MOST PEOPLE CHOSE CLINICAL
TRIALS.gov AND WE'LL TALK MORE
ABOUT THAT LATER.
SO BEFORE WE GET IN DEPTH INTO
STRATEGIES AND WAYS OF
RECRUITMENT AND RETENTION I WANT
TO HIGHLIGHT EXAMPLE MODELS.
SO THIS MODEL BY FORD AND
COLLEAGUES IS ONE OF THE FIRST
THE CLINICAL TRIALS CONCEPTUAL
FRAMEWORKS AND POSIT THAT
BARRIERS CAN BE CATEGORIZED AS
AWARENESS BARRIERS OR PROMOTERS
OR OPPORTUNITY BARRIERS OR
PROMOTERS AND ACCEPTANCE OR
REFUSAL.
SO AWARENESS, OPPORTUNITIES AND
THINGS THAT CAN POTENTIALLY
IMPACT PEOPLE'S DECISION TO
PARTICIPATE.
THIS IS ONE OF THE EARLIEST
FRAME WORKS I'VE BEEN INVOLVED
IN THOUGH I'M SURE THERE'S MANY.
KEEP THAT IN THE BACK OF YOUR
MIND.
AND THEN MORE -- WELL,
RELATIVELY MORE RECENT ONE THE
PRIOR ONE WAS PUSH ESTABLISHED
IN 2007 AND IN PRINT IN 2008 AND
IN 2021, WILKENS AND COLLEAGUES
PARTS OF THEIR INVOLVEMENT WITH
THE RECRUITMENT INNOVATION
CENTER, THE RECRUITMENT
INNOVATION CENTER IS PART OF THE
TRIAL INNOVATION NETWORK WHICH
IS FUNDED BY THE NATIONAL CENTER
FOR ADVANCING TRANSLATIONAL
SCIENCES AND THAT'SED PART OF
NIH.
SO THEY PUT FORTH THIS
CONCEPTUAL MODEL OF PARTICIPANT
RECRUITMENT EFFORTS AND MOST ARE
PRETTY EXPLANATORY.
THERE'S AWARENESS, HOW THEY
CONCEPTUALIZE FEASIBILITY IS
MORE FROM THE CONCEPT OF MAKING
SURE YOU HAVE INELIGIBLE
POPULATIONS AND MAY BE ACCESS
FEASIBILITY THROUGH THINGS LI
LILIKE
ELECTRONIC HEALTH RECORDS AND DO
THEY KNOW TOOLS ARE AVAILABLE
AND SCREENING, INVITATIONS TO
PARTICIPATE AND IT'S GREAT TO
HAVE CLINICAL TRIALS BUT YOU
HAVE TO HAVE WAYS TO INVITE AND
CONSENT AND IF PEOPLE THINK THIS
THROUGH THEY'LL GO ON TO ENROLL
IN THE TRIAL AND THEN ENGAGEMENT
AND RETENTION THROUGHOUT THE
TRIAL.
IT'S REALLY ABOUT COMMUNICATION
AND MAKING PEOPLE FEEL LIKE THEY
HAVE SOME SENSE OF CONNECTEDNESS
AND THIN THEY TALK ABOUT RETURN
OF VALUE AND HOW THEY
CONCEPTUALIZE RETURN OF VALUE IS
THE IDEA OF GETTING OR GIVING
BACK INDIVIDUAL RESULTS AND ALSO
STUDY RESULTS TO PARTICIPANTS
EVEN IF IT'S NOT CLINICALLY
MEANINGFUL BUT THEY TALK ABOUT
REALLY THE RETURN OF INFORMATION
AS THE RESPECT FOR PERSONS.
THEN FINALLY, THIS IS ACTUALLY
MY CONCEPTUAL MODEL WHICH
IRONICALLY I PUBLISHED IN A
SPECIAL SUPPLEMENT FOCUSSED ON
VACCINE CLINICAL TRIALS.
SO THIS WAS IN THE JOURNAL OF
HEALTH COMMUNICATION AND SO THIS
IS A GENERAL MODEL OF CLINICAL
TRIAL PARTICIPATION DEVELOPING
FOR MANY YEARS AND FINALLY GOT
IT PUBLISHED DURING COVID.
I'M NOT GOING TO GO OVER EVERY
SINGLE BULLET POINT BUT I JUST
WANT US TO APPRECIATE THAT A LOT
OF THINGS HAPPEN BETWEEN US AS
RESEARCHERS CREATING A CLINICAL
TRIAL IDEA AND PEOPLE AND
ENROLLING OR ARE GETTING TO THE
END OF THE TRIAL AND I LIKE TO
PAY ATTENTION TO CLINICAL TRIAL
CHARACTERISTICS.
THE DECISIONS WE MAKE OFTEN AS
STUDY TEAMS IN TERMS OF THE
INTERVENTION AND HOW MANY
PROCEDURES AND THINGS LIKE
NUMBER OF STUDY VISITS AND
INCENTIVES, ALL THESE CLINICAL
TRIAL CHARACTERISTICS IMPACT
PEOPLE'S WILLINGNESS OR
AVAILABILITY OR ACCESS TO DO THE
THINGS WE'RE ASKING THEM TO DO
AND ALSO EYE LIKE TO HIGHLIGHT
THE COMMUNICATION THROUGHOUT THE
TRIAL IS IMPORTANT.
HOW TO REACH PEOPLE, WHOSE THE
AUDIENCE AND CONTEXT AND
MESSAGING AND AT THE END THE
THINGS WE THINK ABOUT AS
RESEARCHERS ARE DO PEOPLE
DECLINE OR ENROLL, HOW MUCH
RETENTION DID WE HAVE AND AS
SOMEONE WHO STUDIES MEDICAL
DECISION MAKING I'M OFTEN
INTERESTED IN DO PEOPLE HAVE
DECISIONAL REGRET.
SO IF YOU'RE IN A TRIAL AND
EVERYTHING WENT WELL, YOU'RE
PROBABLY OKAY.
IF THINGS DIDN'T GO SO WELL YOU
MAYBE HAVE REGRET BUT WITH A
WELL INFORMED CONSENT PROCESS
THINGS MAY NOT TO PERFECTLY WELL
BUT THE EXPECTATIONS SHOULD BE
PLANKED.
MANAGED.
AS PART OF THAT SAME PAPER THAT
I HAD PUBLISHED OF MY GENERAL
MODEL OF CLINICAL TRIAL
PARTICIPATE I ALSO PUTS FORTH
THE ASK APPROACH FOR ENHANCING
CLINICAL TRIAL PARTICIPATION.
AS SOME OF YOU KNOW, MORE
CONTEMPORARY RESEARCH HAS BEEN
SHOWING THAT PARTICULARLY FOR
MINORITIZED FROUP AND THE
NARRATIVE HAS BEEN PEOPLE ARE
AFRAID AND HAVE MISTRUST AND
THERE'S THAT COMPONENT BUT
PEOPLE ARE OFTEN LITERALLY NOT
ASKED TO PARTICIPATE OR GIVEN
THE OPPORTUNITY.
A STANDS FOR ASSUME ALL PATIENTS
WANT TO KNOW THEIR OPENINGS EVEN
IF ONE IS A CLINICAL TRIAL AND
WE CAN HAVE FAITH THEY'RE ABLE
TO MAKE A DECISION ABOUT THEIR
OWN HEALTH CARE PLAN INCLUDING
POTENTIALLY OPTION OF A TRIAL.
WE ALSO WANT TO SEEK THE COUNCIL
OF STAKEHOLDERS AND K STANDS FOR
KNOW YOUR NUMBERS AND GET YOUR
GENERAL CHECK UP AND IN A STUDY
AND WHAT IS YOUR THEORETICAL
PULL SO IF YOU WORK WITH A BIO
STATISTICIAN AND THEY SAY IF
THEY LIVE IN BETHESDA, MARYLAND
AND HAVE SEEN 50 PEOPLE IN THE
LAST THREE YEARS YOU'LL HAVE A
PROBLEM BEFORE YOU START BECAUSE
YOU DIDN'T REALLY THINK ABOUT
WHAT YOUR THEORETICAL POOL OF
PEOPLE IS GOING TO BE.
CLEARLY YOU NEED TO HAVE A
SAMPLE SIZE OF WHAT YOU BELIEVE
IS SUFFICIENT.
STAKEHOLDERS ANY INCLUDE BUT NOT
LIMITED TO ALL OF THESE BULLET
POINTS.
EACH TIME I GIVE THIS TALK
SOMEONE COMES UP WITH ANOTHER
STAKEHOLDER GROUP I SHOULD THINK
OF BUT ONE OF THE LAST TALKS I
GAVE ONE OF MY COMMUNITY
PARTNERS SAID I SHOULD INCLUDE
COMMUNITIES HEALTH WORKERS.
DEPENDING ON YOUR RESEARCH
STUDY, YOU PLAY NOT NEED TO
INCLUDE ALL THESE PEOPLE BUT I
WOULD INVOLVED WITH A LOT OF
CONSULTATIONS, PARTICULARLY FOR
SOME OF THE COVID CLINICAL
TRIALS AND IN ADDITION TO
PATIENTS AND RESEARCHERS, WE
WORKED A LOT WITH OUR
COMMUNICATIONS AND MARKETING
FOLKS BECAUSE WE DID A LOT OF
PUBLIC ADVERTISEMENT.
IF YOU'RE GOING TO BE QUERYING
YOUR ELECTRONIC HEALTH RECORD
YOU NEED TO CONNECT WITH HEALTH
PEOPLE AND ALMOST EVERYONE WILL
INTERACT WITH THE IRB BUT SOME
IRBs -- SOME OF MY COLLEAGUES IN
THE LAST FIVE TO 10 YEARS HAVE
BEEN SPECIFICALLY WORKING WITH
IRBs TO EXPAND THEIR KNOWLEDGE
OF DOING COMMUNITY-BASED
RESEARCH AND SOME STRATEGIES ARE
DIFFERENT THAN THE MORE CLEAN
CUT DOING DRUG TRIALS.
DEPENDING ON WHAT YOU WANT TO DO
AND IF YOU'RE USING NOVEL
METHODS OF RECRUITMENT AND
RETENTION YOU MAY NEED TO GO
BACK AND FORTH WITH YOUR IRB
TEAM.
THIS CONCENTRIC CIRCLE MODEL IS
FROM WCG CLINICAL DOT -COM.
THE IDEA IS MOST THE TIME
ESPECIALLY WORKING IN A HEALTH
CARE SETTING THE INNER CIRCLE
AND PATIENTS CLOSEST TO WHERE
YOU ARE AND HAVE A RELATIONSHIP
WITH YOU OR HEALTH CARE AGENCY
OR GROUP, YOU ARE TYPICALLY
GOING TO HAVE MAYBE NOT AN EASY
TIME BUT YOU MAY HAVE BETTER
ACCESS AND A BETTER OPTION OF
CONNECTING AN OFFERING TRIALS TO
PATIENTS THAN MAYBE STARTING
WITH LIKE A MASS MEDIA CAMPAIGN.
I'M AT WAYNE STATE IN DETROIT.
I USED TO BE AT NYU HEALTH
SYSTEM IN NEW YORK AND
ESPECIALLY FOR COVID FOR A LOT
OF THE TRIALS RESEARCHERS WANTED
ADVERTISEMENTS IN THE SUBWAYS OR
BILLBOARDS.
WELL, NOT A LOT OF PEOPLE WERE
RIDING THE SUBWAYS DURING COVID
BUT THAT'S REALLY EXPENSIVE.
AND HOW MANY HAVE BEEN ON THE
METRO HERE IN THE D.C. AREA AND
SAW AN ADVERTISEMENT FOR A
CLINICAL TRIAL AND CALLED AND
ENROLLED?
I'M NOT SAYING IT'S NOT
IMPOSSIBLE BUT YOU DON'T WANT TO
DO THE BIGGEST, MOST EXPENSIVE
THING FIRST SO HERE ACTIVE
CLINIC PATIENTS EVEN INACTIVE
CLINIC PATIENTS.
THINK IF YOU'RE AT THE NIH
CLINICAL CENTER.
MAYBE PEOPLE WHO LAD A HISTORY
IN THE PAST MAY BE MORE OPEN TO
OPPORTUNITIES AND REFERRING
CLINICIANS AND PATIENTS AND
COMMUNITY OUTREACH WAS IMPORTANT
AND I'M NOT SAYING MEDIA
OUTREACH NEVER WORKS BUT YOU
DON'T WANT TO DO THE MOST
EXPENSIVE THING FOR PEOPLE IN
THE WORLD WHO HAVE NO IDEA WHO
YOU ARE AND THE RELATIONSHIP.
AND MAY INCLUDE SOCIAL MEDIA ARE
OTHER STRATEGIES, E-MAIL,
E.H.R.-RECORDS BASED METHODS.
I'VE USED THAT AT SOME OF MY
PRIOR INSTITUTIONS.
THEY HAVE EPIC AND MY CHART AND
WITHIN EPIC THE HEALTH I.T. TEAM
CAN ACTIVATE THE RESEARCH AND
WITH IB APPROVAL AND IN
PARTNERSHIP WITH YOUR I.T. TEAM
CAN PUSH OUT DIRECT TO PATIENT
INVITATIONS VIA THE PORTAL AND
IF PATIENTS ARE INTERESTED THE
CAN CLICK YES, I'M INTERESTED.
ONCE THE PEOPLE IDENTIFIED AS
INTERESTED ARE ABLE TO RESPOND
VIA THE PATIENT PORTAL WITH THE
INTERESTED PATIENT.
I'VE DONE RESEARCH WITH ONLINE
SURVEY PANELS THOSE WORK BETTER
FOR MORE SURVEY RESEARCH BROADER
THINGS BUT IT IS AN OPTION.
YOU CAN DO PAID DIGITAL
ADVERTISEMENT AND POSTING ON YEB
SIGHT.
SOMETIMES PEOPLE WILL HEAR ABOUT
SOMETHING AND FORWARD IT TO
THEIR FRIENDS.
SOME RESEARCH PROJECTS I'M AWARE
OF THAT HAVEN'T BEEN DIRECTLY
INVOLVED IN HAVE GOTTEN
PERMISSION THROUGH THEIR IRB
PROTOCOL TO TEXT PATIENTS TO
CONSIDER PARTICIPATING IN A
RESEARCH TRIAL WHICH ALSO HAS
IMPLICATIONS FOR SUBJECT
SELECTION AND WHEN YOU THINK
ABOUT NOWADAYS A LOT OF PEOPLE
DO USE E-MAIL BUT A LOT OF
PEOPLE ARE VERY DEPENDENT ON
THEIR CELL PHONES AND TEXT
MESSAGING.
SO IF THAT'S A GOOD WAY TO REACH
YOUR AUDIENCE, YOU MAY WANT TO
CONSIDER THAT.
AND YOU MY WANT TO CONSIDER
RECRUITMENT REGISTRIES SUCH AS
RESEARCH MATCH DOT ORG.
HAS ANYONE EVER HEARD OF
RESEARCH MATCH DOT ORG OR USED
IT?
IT'S A PROGRAM FUNDED BY NIH AND
IT'S A NATIONAL REGISTRY THOUGH
PEOPLE DON'T HAVE TO PROACTIVELY
JOIN THE REGISTRY TO FIND
RESEARCH OPPORTUNITIES.
I ACTUALLY JOINED RESEARCH MATCH
DOT ORG YEARS AGO BECAUSE I WAS
CURIOUS HOW IT WORKED BUT
BECAUSE I'M A REGISTERED
PARTICIPANT I GET ALERTS EVERY
SO OFTEN ABOUT UNIVERSITY OF SAN
FRANCISCO HAS THIS STUDY ON X,
Y, Z.
BECAUSE IT'S A NATIONAL REGISTRY
YOU MAY GET INVITATIONS IF YOU
SIGN UP FROM UNIVERSITIES FROM
ACROSS THE COUNTRY.
AS OF TWO DAYS AGO THERE'S ABOUT
120,000 PEOPLE WHO REGISTERED ON
RESEARCH MATCH AND IT'S GROWING.
I THINK THERE'S 1500 ACADEMIC
MEDICAL CENTERS PART OF IT.
IT'S FAIRLY SIMPLE TO REGISTER
AND RESEARCH MATCH.org AND FOR
SURVEY RESEARCH AND WHERE PEOPLE
DON'T NEED TO NECESSARILY COME
INTO THE CLINICAL CENTER IT
COULD BE A GOOD RESOURCE TO
CONSIDER.
I WANT TO GIVE A FEW EXAMPLES.
I HAVE MORE RECENTLY WITHIN THE
LAST EIGHT YEARS BEEN DOING MORE
RESEARCH ON HYPERTENSION
MANAGEMENT AND CARDIOVASCULAR
DISEASE IN BLACK ADULTS.
HISTORICALLY MY EARLIER RESEARCH
WAS ON CLINICAL TRIAL
PARTICIPATION OF UNDER
REPRESENTED GROUPS.
FOR MY CAREER DEVELOPMENT AWARD
WHEN I WAS IN NEW YORK, I DID
FOCUS GROUPS WITH BLACK PATIENTS
AND MY PRIMARY STRATEGY FOR
RECRUITING PATIENTS WAS ACTUALLY
GOING THROUGH OUR HEALTH SYSTEM
ELECTRONIC MEDICAL RECORD AND
INVITING PEOPLE THROUGH THE
PATIENT PORTAL SO I ONLY NEEDED
40 PEOPLE BUT GOT 500.
I THINK MY DESCRIPTION WAS NOT
OVERLY WORDY AND GOT A QUICK
RESPONSE AND I DID INVITE PEOPLE
THROUGH THE PATIENT PORTAL FOR
THE FOCUS GROUPS.
I ALSO DID A SURVEY OF 200 BLACK
ADULTS WITH HYPERTENSION AND
WENT THROUGH OUR PATIENT PORTAL
AND UTILIZED RESEARCH MATCH.org
FOR THE BROADER SURVEY AND
WORKED WITH OUR I.T. PEOPLE
BECAUSE FOR THAT STUDY I ALSO
RECRUITED CLINICIANS.
THEY WERE ABLE TO HELP ME QUERY
PRIMARY CLAIR CLINICIANS WITHIN
OUR HEALTH SYSTEM AND THERE'S
ALL THESE CATEGORIES OF HOW
DOCTORS ARE LABELLED I GUESS
WITHIN THE HEALTH SYSTEM.
THEY MAY BE IN FAMILY MEDICINE
AND SOME ARE IN DIFFERENT GROUPS
THOUGH THEY SEE PATIENTS WITH
HYPERTENSION AND A WAY TO
POTENTIALLY IDENTIFY POSITIONS.
I PUT IN A GRANT APPLICATION A
COUPLE WEEKS AGO TO NHLBI WHERE
I'LL BE RECRUITING BLACK
PATIENTS IN THE DETROIT AREA
WITH HYPERTENSION BUT FOCUSSING
ON FEDERALLY QUALIFIED HEALTH
CENTERS.
SO WAYNE STREET DOES NOT HAVE
IT'S NOT CONNECTS TO A HEALTH
SYSTEM PER SE.
I'M WORKING I'LL BE WORKING WITH
AN INDEPENDENT FEDERALLY
QUALIFIED HEALTH CENTER AND THE
CLINICAL DIRECTOR I TALK TO
SEVERAL TIMES AND I SAY IS THERE
A WAY FOR ME TO WORK WITH YOUR
I.T. PERSON AND GET A LIST.
THEY SAID WE'RE NOT GIVING A
LIST OF OUR PATIENTS BUT BUT IF
THEY'RE OWN COLLISIONS BRING UP
TRIALS TO THEIR PATIENTS BECAUSE
IT'S A MEDICALLY UNDER SERVED
GROUP THEY TRUST THE DOCTORS SO
IF YOU GET FUNDED THE CLINICIANS
WILL BRING UP THE STUDY AND DO A
SOFT HAND OFF IF PATIENTS ARE
INTERESTED.
HE SUGGESTED I CREATE LIKE 3X5
CARDS AND PLAIN LANGUAGE OF THE
STUDY AND IF PATIENTS ARE
INTERESTED THEY'LL HAVE TO
CONTACT US.
YOU HAVE TO WORK WITH WHATEVER
GROUP YOU'RE WORKING WITH AND
SOMETIMES THE METHODOLOGY WILL
BE DEPENDENT ON WHO YOU ARE AND
WHO YOU WANT TO WORK WITH AND
COMFORT WITH DIFFERENT
METHODOLOGIES.
WE'LL SEE HOW THAT GOES.
NOW I WANT TO TALK A LITTLE BIT
ABOUT SOME HEALTH LITERACY
CONSIDERATIONS.
BOTH FOR CLINICAL TRIAL
COMMUNICATIONS AND INFORMED
CONSENT.
THROUGH THE YEARS THERE'S BEEN
DIFFERENT DEFINITIONS OF HEALTH
LITERACY.
I'M USING ONE FROM HEALTHY
PEOPLE 2030 AND THEY DEFINE
PERSONAL HEALTH LITERACY AS TO
THE DEGREE INDIVIDUALS HAVE THE
ABILITY TO FIND, UNDERSTAND AND
USE INFORMATION IN SERVICES TO
INFORM HEALTH-RELATED DECISIONS
AND ACTIONS FOR THEMSELVES AND
OTHERS.
WHEN YOU THINK OF THAT WITH OUR
CASE WITH LINDA EARLIER WITH
TYPE II TRYING TO FIND A TRIAL
FOR TYPE II DIABETES, PEOPLE
DIFFER WHERE THEY WOULD FIND IT
AND UNDERSTAND AND WHETHER THEY
PREFER PRINT OR AUDIO OR MORE
VISUAL INFORMATION THESE ARE
LOOKING AT THE ASSOCIATION AND
THIS WAS A QUALITATIVE STUDY OF
20 WOMEN WITH LOWER HEALTH
LITERACY WHO PARTICIPATED IN A
PHASE 2 TRIAL FOR BREAST CANCER
AND WHAT THEY ARE FOUND WAS
WOMEN WITH LOWER LITERACY WERE
LESS LIKELY TO RELY ON PROVIDE
RECOMMENDATION WHETHER THEY
SHOULD ENROLL IN A TRIAL WHICH
IS PROBABLY NOT THAT SURPRISING.
SO IF YOU HAVE TROUBLE WITH
HEALTH LITERACY YOU MAY RELY ON
OUR CLINICAL TEAM TO ADVISE YOU
TO CONSIDER IT OR NOT.
AND THIS AND THE STUDY OF 500
PATIENT GOT INFORMATION ABOUT
RANDOMIZATION IN PLAIN LANGUAGE
OR GIVEN A GAMBLING METAPHOR AND
BENIGN METAPHOR WHERE THEY
DESCRIBED RANDOMIZATION AS THE
CHANCE OF A PREGNANT WOMAN
HAVING A MALE OR FEMALE CHILD
AND AND CONTROLLED CONTINUE AND
PEOPLE WITH HIGHER HEALTH
LITERACY PREFERRED OR DID BETTER
UNDERSTANDING RANDOMIZATION WITH
THE GAMBLING METAPHOR.
AGAIN THE FLIP OF A COIN.
PEOPLE WITH LOWER LITERACY
SKILLS WERE UNDERSTOOD
RANDOMIZATION BETTER WHEN IT WAS
THE CHANCE OF A MALE OR FEMALE
CHILD.
INTERESTING STUDIES AND THINGS
TO CONSIDER.
FINALLY IN THE LAST STUDY BY KIM
AND KIM THEY THIGH RANDOMIZED
150 PEOPLE TO GET TO WITH ONE OF
TWO CONDITIONS.
A STANDARD CONSENT FORM OR MORE
SIMPLIFIED VERSION OF A CONSENT
FORM PEOPLE PREFER
SIMPLIFICATION AND THAT WAS
BETTER FOR EVERYBODY.
PROBABLY NOT A SURPRISING
FINDING IF YOU HAVE THE
OPPORTUNITY TO SIMPLIFY
INFORMATION IN A CONSENT FORM.
HAS ANYONE EVER BEEN IN A
CLINICAL TRIAL WHERE THEY HAD TO
READ A CONCEPT FORM?
-- CONSENT FORM?
OKAY, YOU HAVE AND I HAVE.
HOPEFULLY IT WAS STRAIGHTFORWARD
BUT SOMETIMES IT COULD BE
MULTIPLE PAGE AND SMALL FONT FOR
LEGAL AND ETHICAL REASONS AND
SOMETIMES CAN BE OVERWHELMING.
THIS PAPER I WORKED WITH
COLLEAGUES BROADLY IN THE
DECISION SCIENCE WORLD AND WE
PUBLISHED THIS PAPER DESCRIBING
A PROFESSION FOR DEVELOPING A
PLAIN LANGUAGE SUPPORT TOOL TO
HELP PEOPLE CONSIDER
PARTICIPATING IN CANCER CLINICAL
TRIALS AND WE LOOKED AT HEALTH
LITERACY AND BLENDING HEALTH
LITERACY, ACADEMIC RESEARCH AND
MINORITY PATIENT PERSPECTIVES.
THIS WAS A THREE-PHASE PROCESS
AND DID QUALITATIVE INTERVIEWS
WITH 45 BLACK AND HISPANIC
CANCER SURVIVORS TO UNDERSTAND
THEIR CHALLENGES AND I GUESS
OPPORTUNITIES RELATED TO
CLINICAL TRIALS.
THE SECOND PART WAS A SURVEY OF
1100 CANCER SURVIVORS AND THEN
LITERATURE REVIEW.
AND THEN PHASE II WAS CONSENT
GENERATION AND TAKING THE
INFORMATION LEARNED IN PHASE I
AND CREATE A FIRST PROTOTYPE OF
THE DECISION SUPPORT TOOL AND
PHASE III WAS USABILITY TESTING.
THIS PAPER DESCRIBES A PROCESS
FOR DEVELOPING A DECISION
SUPPORT TOOL.
AS PART OF THAT SAME PAPER, WE
PROPOSED OR TALKED ABOUT THE
MODEL FOR CANCER CLINICAL TRIAL
PARTICIPATION STANDING FOR
KNOWLEDGE, EMPOWERMENT AND
VALUES CLARIFICATION.
I WON'T GO OVER EVERY BOX
BECAUSE SOME WERE REPRESENTED IN
PAST MODELS BUT WITH DECISION
SUPPORT TOOLS, THE MIDDLE BOXES,
COMMUNICATION SKILLS DEVELOPMENT
AND COMMUNICATION IS AN
IMPORTANT PRINCIPLE IN DECISION
MAKING.
FOR DECISION MAKING AND THE
IDEAS OF VALUES CLARIFICATION
LIKE EXERCISES AND QUESTIONS TO
HELP PEOPLE THINK THROUGH WHAT
THEIR OWN PERSONAL VALUES ARE
AND WHAT THEY WOULD PERCEIVE AS
THE VALUE OF PARTICIPATING IN A
CANCER CLINICAL TRIAL.
NOW I WANT TO SHIFT TO BUILDING
AND MAINTAINING TRUST.
AND THIS IS A QUOTE FROM A PAPER
FROM MY COLLEAGUE DEREK GRIF
EDGE AN READ THIS OUTS, TRUST,
MISTRUST AND DISTRUST INFLUENCE
PEOPLE'S ABILITY TO UTILIZE
CRITICAL RESOURCES AND MAKE
DECISIONS BEST FOR THEIR HEALTH
AND WELL BEING.
TRUST IS NECESSARY FOR
OPTIMIZING HEALTH RESEARCH,
ELIMINATING HEALTH CARE
DISPARITIES AND ACHIEVING HEALTH
EQUITY BUT EFFORTS TO BUILD
TRUST TO INCREASE HEALTH CARE
UTILIZATION IN RESEARCH
PARTICIPATION MAY WILL LITTLE
EFFORT ON ATTITUDES AND
BEHAVIORS ROOTED IN DISTRUST AND
MISTRUST.
THIS PAPER IS NOT SUPER LONG BUT
THEY DO A GOOD JOB OF TALKING
ABOUT TRUST AND MISTRUST AND
SOMETIMES IN ACADEMIC SITUATIONS
LIKE THIS WE USE THE TERMS
INTERCHANGEABLY AND MISTRUST AND
DISTRUST AND BUILDING TRUST IN
PEOPLE WITH LOW TRUST THEY'RE
DISTINCT THINGS AND ARGUE IT'S
IMPORTANT WE'RE PRECISE IN WHAT
WE'RE TALKING ABOUT AND WHAT
WE'RE TRYING TO INTERVENE ON.
THIS IS A CONCEPTUAL MODEL FROM
A PAPER CONSUELA WILLIAMS
MENTIONED AND SHE POSITS THESE
ARE AREAS THAT ARE IMPORTANT.
NONE OF THESE SHOULD BE PRIZING
BUT I THINK IT'S GOOD TO RESIST
CONC
CONCEPTS.
TRUST IS IMPORTANT AND
COMMUNICATION AND CONFIDENCE.
THE BELIEF AND RELIABILITY OF
THE DIFFERENT PARTIES ENSURING
PEOPLE HAVE CONFIDENTIALITY AND
THEY'RE FAIRNESS AND FIDELITY
AND SAFETY AND SYSTEM TRUST.
THE SYSTEM TRUST HAS TO DO WITH
MRE
BELIEFS IN INSTITUTION AND THE
ENTERPRISE AND THE RIGHT UPPER
BOX TALKS ABOUT CHARACTERISTICS
OF TRUST WORTHY RESEARCHERS.
REALLY TRYING TO AS BEST WE CAN
BE ACCESSIBLE, APPROACHABLE,
TAEPTIVE TO THE NEEDS AND
CONCERNS OF COMMUNITIES,
EMPATHETIC, HONEST, HUMBLE.
RESPECTFUL.
IN THE BOTTOM RIGHT BOX IS
SUPPORTIVE OF PRINCIPLES OF
COMMUNITY ENGAGED RESEARCH AND
CBPR AND THINKING ABOUT POWER
DYNAMICS AND TRANSPARENCY.
HOW DO YOU CREATE INFRASTRUCTURE
AND POLICIES TO BOLSTER UP
INFRASTRUCTURE FOR PLACES LIKE
NOT THE NIH MEDICAL RESEARCH
CENTER FOR BIG RESEARCH CENTERS
HOW ARE RESOURCES EQUITABLY
DISTRIBUTED.
DO WE HAVE THE IDEA OF EFFECTIVE
COMMUNICATION AND ESTABLISHING
PATTERNS OF FULFILLING TRUST AND
ALSO THE NOTION OF SHARED
DECISION MAKING AND VALUING
DIFFERENT RESOURCES AND
SOMETIMES AS RESEARCH GROUPS WE
COME INTO COMMUNITIES OR INTO
PARTNERSHIPS FROM A PLACE OF THE
INFORMATION AND RESOURCES THAT
WE CAN IMPART THE COMMUNITY AND
COMMUNITY ALSO HAS RESEARCH
RESOURCES VALUABLE TO THE
RESEARCH ENTERPRISE WE SHOULD
HONOR.
I HAVE THE BENEFIT OF WORKING
WITH A LOT OF DIFFERENT
RESEARCHERS AND STACY LOBE IS A
UROLOGIST AT NYU HEALTH SYSTEM
AND WITH THE MANHATTAN V.A. AND
LED A PROJECT I WAS A PART OF
LOOKING AT PERCEIVED TRUST IN
ONLINE VIDEOS ABOUT PROSTATE
CANCER.
THIS WAS A RANDOMIZED CLINICAL
TRIAL.
WE DID THIS TRIAL THROUGH A
SURVEY SAMPLING INTERNATIONAL AN
ONLINE SURVEY PANEL AND HOW THIS
CLINICAL TRIAL WAS SET UP WERE
PARTICIPANTS WERE RANL DOMIZED
TO ONE.
FOUR GROUPS AND SAW CLINICAL
TRIALS WITH A BLACK PHYSICIAN OR
WHITE PATIENT OR OTHER AND TOOK
A QUESTIONNAIRE AND THIS IS
TRUST IN THE INFORMATION IN THE
VIDEOS.
WE USED A VALIDATED GROUP
MINORITY-BASED MISTRUST SCALE BY
HAILEY THOMPSON AND TO THE HIGH
POINT KEY FINDING BLACK ADULTS
WERE MORE LIKELY TO TRUST A
VIDEO WITH A BLACK PRESENTERS
BUT IN WHITE ADULT THE COLOR OF
THE PRESENTER WAS NOT AFFILIATED
WITH TRUST.
THE TAKE HOME IS THAT
REPRESENTATION MATTERS,
DIVERSITY MATTERS AND NOT JUST
ON RESEARCH TEAMS BUT IN HEALTH
COMMUNICATION AND PATIENT
EDUCATION MATERIALS.
SO, MY LAST FEW SLIDES ARE
REALLY ABOUT POINTS TO CONSIDER
WHEN YOU'RE THINKING OF DRAFTING
RECRUITMENT AND RETENTION PLAN
FOR CLINICAL RESEARCH.
THIS INFORMATION IS FROM A NICE
ARTICLE POSTED ON THE NATIONAL
INSTITUTE OF MENTAL HEALTH
WEBSITE AND THE LINK IS THERE.
THE FIRST KEY CONCEPT IS
COMMUNITY ENGAGEMENT AND
QUESTIONS TO ASK YOURSELF AND
HOW DO YOU IDENTIFY COMMUNITIES
THAT YOU WOULD LIKE TO ENGAGE?
SO, EXAMPLES COULD BE
PARTICIPANTS AND THEIR FAMILY
MEMBERS.
IF THEY'RE LOOKING AT SOMETHING
LIKE ALZHEIMER'S OR PARKINSON'S
SUPPORT OR COMMUNITY CENTERS.
YOU ALSO WANT TO THINK THROUGH
BARRIERS TO PARTICIPATION.
SO WHAT ARE THE BARRIERS AND HOW
DO YOU ADDRESS THEM AND IT COULD
BE THINGS LIKE TIME OFF WORK OR
TRANSPORTATION OR IF IT'S A DRUG
STUDY OR SOME KIND OF CHANGE IN
HOW PEOPLE WILL MANAGE THEIR
HEALTH CONDITIONS THEY MAY NOT
WANT TO CHANGE THEIR MEDICATION
PLAN.
THERE'S ALSO BENEFITS TO
PARTICIPATION AND THIS IS REALLY
NOT WHAT WE THINK AS RESEARCHERS
ARE THE BENEFITS BUT THE
PERCEIVED BENEFITS FROM
POTENTIAL PARTICIPANTS.
AN THING YOU WOULD DO IS WORK
WITH COMMUNITIES THROUGH FOCUS
GROUPS OR INTERVIEWS OR SURVEYS
TO GET THEIR SIX REPORTED LIST
OF WHAT THEY THINK ARE THE
POTENTIAL BENEFITS OF WHAT
WHENEVER PROJECT YOU ARE
PROPOSING.
THERE ARE ALSO INFORMATIONAL
MATERIALS.
WILL THEY ACCOUNT FOR DIFFERENT
LEVELS OF LITERACY AND COGNITIVE
ABILITIES AND SUGGESTIONS HERE
TO THE BEST YOU CAN USE CLEAR
AND SIMPLE LANGUAGE.
THERE'S PLANNING AND TIME LINE
AND YOU KNOW THE TIME LINE
SOMEHOW SEEMS TO BE LONGER THAN
WHAT WE INITIALLY THINK.
ASKING YOURSELF AND EXPERIENCED
RESEARCHER IS THIS A REALISTIC
RECRUITMENT TIME LINE AND TO
THINK ABOUT IF THERE'S OTHER
LOCAL STUDIES IN YOUR AREA
ESTIMATES AND RECRUITMENT
STRATEGIES AND WHAT MECHANISMS
YOU'LL USE TO ENCOURAGE
RECRUITMENT AND MAKE SURE ALL
STAFF THAT COMMUNICATE WITH
POTENTIAL PARTICIPANTS RECEIVE
PROPER TRAINING AND PRACTICE.
GET CELL PHONE, PHONE NUMBER OR
FA MANY -- FAMILY MEMBERS AND
FRIENDS AND IT'S GOOD TO HAVE
MULTIPLE PHONE NUMBERS TO
FOLLOW-UP AND SEND SMALL TOKENS
OF APPRECIATION TO REMIND THEM
OF YOUR STUDY ESPECIALLY IF IT'S
NOT A ONE-TIME THING.
FINALLY, WHEN THE STUDY IS OVER
HOW ARE YOU GOING TO THANK
PARTICIPANTS AND ACKNOWLEDGE
THEM AND HOW WILL YOU MAINTAIN
RELATIONSHIPS.
I HOPE I GET FUNDED BY THE DASH
STUDY AND PUTTING OUT VIBES YOU
GET FULLY FUNDED BUT AFTER THAT
YOU DON'T WANT TO BE A
HELICOPTER RESEARCHER AND SHOW
UP WHEN YOU NEED ISSUING AND
DISAPPEAR AND COME BACK 10 YEARS
LATER.
HOW WILL YOU PLANK THAT
RELATIONSHIP?
SEND THANK YOU NOTES TO THOSE
INVOLVED IN YOUR STUDY AND
REPORT TO THE COMMUNITIES
INVOLVED.
PARTICIPANTS, FAMILY MEMBERS OF
PARTICIPANTS AND ALSO MAYBE
REFERRING PRACTITIONERS OR
CLINICIANS.
I FOUND HAVING WORKED IN SEVERAL
HEALTH SYSTEMS BUSY CLINICIANS
DO NOT WANT LONG RECORDS.
A LOT OF TIMES THEY LIKE SHORT
MEMOS TO TRYING TO BE CONCISE.
AND I'LL TALK ABOUT MY
PARTICIPATION IN THE PHASE 1
CLINICAL TRIAL FOR THE PFIZER
COVID VACCINE.
I WAS A PARTICIPANT AND THERE
WERE 14 VISITS OVER TWO YEARS
BUT ON MY LAST STUDY VISIT
THOUGH WE GOT PAID FOR ALL OF
OUR TIME AND VISITS, THEY GAVE
US THIS GIFT BOX AND THAT'S A
PIN.
IT'S A LITTLE BLURRY BUT A
LITTLE GIFT BOX AND I THOUGHT IT
WAS COOL AND SENT IT TO OUR
MARKETING AND COMMUNICATIONS
PERSON IN NEW YORK.
THE NET SAID YOUR COURAGE WROTE
HISTORY IT'S CLEAR OUR SURVIVAL
DEPENDS ON ONE ANOTHER.
WHEN YOU BECAME A CLINICAL TRIAL
VOLUNTEER FOR THE FIRST COVID-19
VACCINE TO BE APPROVED YOU
JOINED TENS OF THOUSANDS TO
BRING LIGHT TO A DARKENED WORLD.
WE OFFER THIS KEEPSAKE AND IN
THE BACK IT SAID PURSUIT OF HOPE
AND YOU CAN WRITE YOUR NAME IN
THERE.
I WAS FEELING EXTRA CITIZEN AND
HAPPY BUT IT WAS A NICE NOTE WE
LIGHT TO A DARKENED WORLD.
ANYWAY, THAT'S ONE EXAMPLE.
I DON'T HAVE STOCKS OR BONDS IN
PFI
PFIZER.
IT WAS OUR FIRST CONSENT FORM
AND IT WAS 20 PAGES AND 10-POINT
FONT.
I DID READ IT ALL BUT IT WAS A
LOT AND BECAUSE THERE WERE MINOR
CHANGES THROUGHOUT THE STUDY I
WAS THINKING THERE WERE TWO OR
THREE UPDATES TO THE CONCEPT
FORM AND I LEARNED A LOT AND I'M
HAPPY TO TALK MORE ABOUT IT.
I WANTED TO BE IN THE CLINICAL
TRIAL FOR A LOT OF REASONS.
ONE, I BELIEVE IN VACCINES AND I
WAS KIND OF SELFISH LIKE IF
THERE'S GOING TO BE A GOOD
VACCINE OR EFFECTIVE VACCINE I
WANT TO BE ONE OF OF THE FIRST
TO GET IT.
EVEN THE IDEA OF ME KNOWING
WHERE TO GO TO SIGN UP HAD SOME
LEVEL OF PRIVILEGE BECAUSE IT
WASN'T OBVIOUS AT THE BEGINNING
BUT HAD FRIENDS WHO GOT REALLY
SICK FROM COVID AND HAD THE
TIME.
I WANTED TO CONTRIBUTE.
I ALSO LEARNED A LOT AS A
RESEARCHER WHO HAD DONE CLINICAL
RESEARCH, BEING A PARTICIPANT
AND GOING THROUGH ALL THE STEPS
IT WAS VERY EYE-OPENING.
I PERSONALLY HAD A GOOD
EXPERIENCE BUT IT'S A LOT TO DO
ALL OF THAT.
I'M HAPPY TO TALK ABOUT IT BUT
AS PART OF MY OWN PARTICIPATION
IN THE PFIZER PHASE I STUDY AND
AT THE TIME DOING CLINICAL
TRIALS AND EDUCATION ABOUT THE
NEED FOR CLINICAL TRIAL
PARTICIPATION FOR THE VACCINE
TRIALS AND ALSO AFTER IT WAS
APPROVED TALKING A LOT TO
COMMUNITIES ABOUT CONSIDERING
GETTING VACCINATED.
IT INFORMED A LINE OF RESEARCH
SO I HAVE ANOTHER GRANT
APPLICATION UNDER REVIEW ABOUT
ENHANCING OR REDUCING VACCINE
HESITANCY FOR FLU AND COVID
VACCINES.
AND HERE THIS IS REALLY JUST A
SIMPLIFIED GRAPH IN TERMS OF
VACCINE ACCEPTANCE THERE'S SOME
PEOPLE WHO REFUSE ALL VACCINES
AND SOME WHO WILL JUST DELAY
VACCINES.
YOU MAY ACCEPT VACCINATIONS BUT
HAVE CONCERNS.
IF YOU WORK FOR A HEALTH SYSTEM
THAT REQUIRES THE FLU SHOT YOU
MAY BE CONCERNED ABOUT THE FLU
SHOT BUT MAY NEED TO KEEP YOUR
JOB AND PAY YOUR BILLS AND HAVE
PEOPLE LIKE ME WHERE THERE'S A
MILLION THINGS TO BE WORRIED
ABOUT.
I PERSONALLY WOULDN'T BE
CONCERNED ABOUT VACCINE AND GET
ALL THE AGE APPROPRIATE VACCINES
I CAN GET BUT MAYBE I'M A WEIRD
BIRD OR WHATEVER.
MY LAST EXAMPLE HERE, THIS IS A
REAL STUDY OF LOOKING AT LOW
PATHOGENICITY FOR THIS INFLUENZA
VIRUS IN A HEALTHY HUMAN
CHALLENGE MODEL.
FOR THOSE NOT FAMILIAR WITH
HUMAN CHALLENGE TRIALS THEY'RE
PURPOSELY INFECTING PEOPLE WITH
THE VIRUS WHO ARE HEALTHY AND
LOOKING AT THE IMMUNE RESPONSE
IN THOSE PEOPLE.
THESE FOLKS HAVE TO BE WILLING
TO BE INFECTED WITH THE
VIRUS-LIKE FLU.
THIS RECRUITMENT IS WRAPPING UP
SOON BUT IT'S A TRIAL BEING
FUNDED AND DONE RIGHT HERE AT
NIH.
IF YOU ARE INTERESTED YOU CAN
LOOK AT THE QR CODE.
I'LL TELL YOU WHAT SOME OF THE
REQUIREMENTS ARE.
SO YOU HAVE TO BE A HEALTHY
PERSON BETWEEN 18 AND 50.
YOU ACTUALLY ALSO YOU'LL GET
COMPENSATED BUT IF YOU CHOOSE TO
TO THE HUMAN CHALLENGE TRIAL YOU
ACTUALLY HAVE TO DO A PRESCREEN
AND THEN HAVE TO COME TO THE
CLINICAL CENTER IN BETHESDA AND
HAVE TO STAY NINE DAYS IN
PATIENT HOSPITAL AND THERE'S
FOUR OUT PATIENT FOLLOW-UP
VISITS.
18 TO 50 AND NINE IN THE
HOSPITAL AND FOLLOW-UP.
THAT'S EVERYBODY.
YOU GUYS ARE IN RESEARCH.
I'M SURE YOU WOULD SIGN UP RIGHT
NOW BECAUSE YOU SUPPORT THE
MISSION OF NIH.
THE NEXT SLIDE IF YOU GO TO
CLINICALTRIALS.gov THEY GIVE
BACKGROUND ON THE FLU AND WHY
IT'S IMPORTANT.
THEY WANT TO FIND THE SMALLEST
DOSE OF THIS INFLUENZA VIRUS
THAT PLAY CAUSE UNCOMPLICATED TO
MILD FLU INFECTION IN HEALTHY
PEOPLE AND USED TO INFORM HOW
THE NEXT FLU VACCINES WILL WORK.
SO I THINK THIS IS OUR LAST
GROUP QUESTION IF YOU GO BACK TO
SLIDO, IF YOU WERE IN CHARGE OF
THE RECRUITMENT AND RETENTION
PLAN FOR THIS HUMAN CHALLENGE
STUDY, WHERE WOULD YOU RECRUIT
PEOPLE?
AGAIN, THEY HAVE TO BE 18 TO 50.
THEY HAVE TO BE WILLING TO STATE
IN THE NIH CLINICAL CENTER
HOSPITAL FOR NINE DAYS AND COME
BACK FOR FOUR VISITS.
THEY'RE COMPENSATED BUT THE
COMPENSATION AMOUNT WAS NOT ON
THE WEBSITE SO I DON'T KNOW HOW
MUCH THEY'RE COMPENSATED.
CAN YOU SEE THE SLIDO OPTIONS.
>> FOR THOSE WHO NEED A REMINDER
THE NUMBER IS 2997361.
WE HAVE SOME VOTES COMING IN.
>> I DON'T KNOW IT YOU SEE THEM
BACK TO BACK.
THE FIRST QUESTION IS WHERE
WOULD YOU RECRUIT PEOPLE AND
WHAT CHALLENGES, IF ANY, DO YOU
ANTICIPATE WITH TRYING TO
RECRUIT PEOPLE FOR THE HUMAN
CHALLENGE MODEL.
>> I'M HAVING THE FIRST ONE
OPEN AND RIGHT KNOW SOCIAL MEDIA
IS WINNING.
RESEARCH MATCH IS A STRONG
SECOND.
>> OKAY.
>> VERY FEW PEOPLE SAY
CLINICALTRIALS.gov.
A COUPLE PEOPLE AREN'T SURE.
>> OKAY.
IT I DON'T KNOW IF I WAS IN
CHARGE OF RECRUITMENT AND
RETENTION HOW FAR I'D GO.
WE NEED HEALTHY PEOPLE IN THE
WORLD WILLING TO BE INFECTED
WITH THE VIRUS.
IT'S JUST THE FLU.
EARLY ON IN THE FIRST YEAR OF
COVID THE MEDICAL ETHICS GROUP
WHERE I WAS AT NYU HAD A
SYMPOSIUM ON SHOULD THEY ARE
HAVE HUMAN CHALLENGE TRIALS FOR
COVID.
AND MOST PEOPLE SAID NO BECAUSE
WE HAVE NO EXPERIENCE OR FOR
MITIGATION BUT THERE WERE
PHILOSOPHICAL QUESTIONS WOULD IT
BE ETHICAL DURING 2020 TO INFECT
PEOPLE WITH COVID-19 TO INFORM
TREATMENT DEVELOPMENT.
>> THE CLEAR WINNER WAS SOCIAL
MEDIA AND VERY FEW FOR
CLINICALTRIALS.gov AND NOW I
HAVE OPENED THE QUESTION WHAT
CHALLENGE, IF ANY, DO YOU
ANTICIPATE.
FEEL FREE TO SEND IN YOUR
COMMENTS.
WE HAVE -- WHO'S GOING TO TAKE
OFF THE TIME FOR WORK?
COMMUNICATIONS.
NINE DAYS IN THE HOSPITAL WILL
BE A CHALLENGE.
>> WHY YOU'RE ALL INDEPENDENTLY
WEALTHY.
>> WHAT IF YOU GET SICK?
THAT MAY BE A REASON NOT TO
ENROLL.
A COUPLE MORE TIME OFF WORK.
WHO'S GOING TO HAVE THE TIME TO
DO THAT.
WHAT IF YOU HAVE FAMILIES OR A
DOG TO TAKE CARE OF?
AND MAYBE MISUNDERSTANDING ABOUT
THE STUDY IT SOUNDS
CONSPIRAT
CONSPIRATORIAL.
BETHESDA, IN THE EVERYBODY LIVES
IN THE AREA.
CHILDCARE, TRANSPORT.
BACKLASH FROM THE ANTI-VACCINE
PEOPLE.
>> THE ANTI-VAXERS THEY'LL SAY
SEE THEY WERE TRYING TO INFECT
ALL OF US THE WHOLE TIME.
>> I NEED TO KNOW HOW MUCH
YOU'RE GOING TO PAY ME.
>> INTERESTING.
>> HOW ARE WE GOING TO ATTRACT
FOLKS FROM LOWER SES, I'M
PUTTING WORDS IN THEIR MOUTH.
CAN YOU TAKE NINE DAYS OFF?
CAN YOU TRANSPORT YOURSELF TO
BETHESDA?
>> GREAT QUESTIONS.
THAT'S MY LAST SLIDE AND HAPPY
TO TAKE QUESTIONS BUT I THOUGHT
THAT WAS AN INTERESTING TRIAL TO
THINK ABOUT BECAUSE YOU HAVE TO
COME TO A PLACE AND BE INFECTED.
IT'S JUST THE FLU.
HAPPY TO TAKE QUESTIONS AND
THANKS FOR PARTICIPATING.
>> AND TO POINT OUT THE
DIFFERENCE.
ONE OF THE POINTS YOU WERE
CLEARLY MAKING IS HOW YOU'LL
THINK ABOUT RECRUITMENT AND
RETENTION DEPENDS ON ALL SORTS
OF THINGS INCLUDING THE TRIAL
YOU'LL ASK THEM.
FOR THE TRIAL MAYBE THERE'S A
GROUP OF PEOPLE THAT MAYBE THIS
GROUP WOULD BE AN IDEAL GROUP TO
RECRUIT FOR A CHALLENGE STUDY.
>> GREAT.
YOU GUYS ARE ALL RAISING YOUR
HANDS.
YOU'RE BOSSES WILL GIVE YOU TIME
OFF.
YOU WORK AT NIH, RIGHT?
>> TO SAY IF I WAS DEVISING THE
RECRUITMENT STRATEGY I MIGHT
WANT PEOPLE WHO KNOW ABOUT
SCIENCE AND LIVE IN BETHESDA AND
HAVE A RELATIVELY HIGH EDUCATION
LEVEL.
SO VERSUS SOME OF YOUR
CARDIOVASCULAR TRIALS IN THE
COMMUNITY YOU MIGHT HAVE A VERY
DIFFERENT PRIORITY IN TERMS OF
HOW YOU'RE THINKING ABOUT
RECRUITMENT AND RETENTION.
>> ABSOLUTELY.
ANY QUESTIONS?
I CAN'T SEE ANY FROM THE GROUP.
PLEASE COME UP TO THE MIKE.
I'LL GO BACK OVER TO VIDEO LAND
AND SEE IF THERE ARE SOME.
JONATHAN, GO AHEAD.
>> THANKS FOR THE TALK.
I HAD A QUESTION ABOUT THE
CHARACTERISTICS OF TRUSTWORTHY
RESEARCHERS.
YOU MENTIONED WILKENS.
JUST CURIOUS, DO YOU KNOW HOW
THEY DETERMINED WHAT THE
CHARACTERISTICS ARE OR HOW
RESEARCHERS MIGHT DO THAT IN
GENERAL.
WAS IT A BUNCH OF DATA AND TRIED
TO NOTICE CERTAIN PATTERNS OR
DID THEY HAVE A PARTICULAR
METHOD?
I DO NOT KNOW OFFHAND BUT I
ACTUALLY HAVE IT PRINTED OUT.
I KNOW FROM OTHER CONCEPTUAL
MODELS THEY'VE DONE FOCUS GROUPS
WITH COMMUNITY MEMBERS AND
SURVEYS ON WHAT PEOPLE PERCEIVE
AS WHAT WOULD BE A TRUSTWORTHY
RESEARCHER OR INSTITUTION AND
THEN AND INFORMED BY PRINCIPLES
OF COMMUNITY RESEARCH WHICH DOES
COME FROM THE COMMUNITY BUT ALSO
A LOT OF COMMUNITY-MINDED
RESEARCHERS SAYING IN AN IDEAL
WORLD THIS IS HOW WE CAN DO
RESEARCH BETTER.
GREAT QUESTION.
>> I HAVE A QUESTION ABOUT
RESEARCH MATCH.org.
I'M WONDERING HOW THEY'VE BEEN
PUBLICIZING.
100,000 PEOPLE SIGNED UP SOUNDS
LIKE A LOT.
>> IT'S LIKE 120 NOW AND EACH
TIME I'VE GIVEN THE TALK IT WAS
LIKE AT 93,000.
I'M NOT SURE.
I KNOW THEY WERE TRYING TO GET
THE WORD OUT THROUGH SOME
ACADEMIC PARTNERS THAT ARE
INVOLVED.
I THINK THERE'S CLOSE TO OVER
1,000 OR CLOSE TO 1500
INSTITUTIONS.
I HAVEN'T REALLY SEEN IT ON
BILLBOARDS AND THINGS AND IF
YOU'RE NOT LOOKING FOR IT, YOU
MAY NOT HAVE SEEN IT BUT AND
IT'S BEEN AROUND I THINK AT
LEAST A DECADE NOW.
MAYBE THERE WERE MORE EFFORTS AT
THE BEGINNING OR MORE OBVIOUS
EFFORTS.
I KNOW LIKE FOR ALL OF US, I
DON'T SEE A TON FOR ALL OF US
EITHER BUT BELIEVE WHEN IT FIRST
CAME OUT THROUGH ACADEMIC
MEDICAL CENTERS IT WAS A BIG
THING AND I SEE BILLBOARDS BUT
I'M ALSO AT NIH SO I EXPECT TO
SEE THINGS FOR ALL OF US.
I DON'T KNOW WHAT THEIR PARKING
PLAN IS RIGHT NOW.
-- MARKETING PLAN IS.
>> IS IT FOR HEALTHY VOLUNTEERS
OR CONDITION SPECIFIC?
>> BOTH.
YOU CAN ACTUALLY QUERY I THINK
IT'S LIKE THE ABOUT US SECTION
BUT SEE PERCENTAGES.
I DID SIGN UP FOR IT BUT CAN'T
REMEMBER ALL THE CONDITIONS BUT
THERE'S INFORMATION ABOUT PEOPLE
WITH DIABETES, HYPERTENSION,
MAYBE 150 OR 20 CONDITIONS AND
PEOPLE WHO ARE HEALTHY
VOLUNTEERS.
AND ALSO SURROGATES WHO WOULD BE
INTERESTED IN STUDIES FOR
CHILDREN.
IT'S A MIX OF HEALTHY VOLUNTEERS
AND PEOPLE WHO HAVE
SELF-REPORTED CONDITIONS AND
IT'S A REGISTRY WHERE PEOPLE
LIKE PROACTIVELY SIGN UP FOR IT.
BUT YOU DON'T HAVE TO -- YOU
HAVE TO BE SIGNED UP TO GET THE
ALERTS EVERY SO OFTEN BUT ANYONE
IN THE WORLD AT CLINICAL TRIALS
CAN GO ON RESEARCH MATCH.org WHO
DOESN'T WANT TO SIGN UP
OFFICIALLY AND SEE CLINICAL
TRIALS AVAILABLE.
IT'S A MIX OF BOTH.
>> THAT'S A GOOD POINT.
THOSE HUNDREDS OF THOUSANDS OF
PEOPLE REGISTERED BUT IF ATTACK
I WANTED TO LOOK UP CANCER
TRIALS IN BETHESDA, I DON'T HAVE
TO REGISTER.
>> AND THE ENGINE BEHIND
RESEARCH MATCH IS ACTUALLY
CLINICAL TRIALS.gov.
IT LOOKS NICER IN MY OPINION AND
MORE USER FRIENDLY TO SEE IT
THROUGH THE INTERFACE BUT PEOPLE
SEARCHING WHO HAVEN'T REGISTERED
WHAT IS FEEDING THAT IS CLINICAL
TRIALS IN THE BACKGROUND OR DOT
GOT BUT LOOKS MORE USER
FRIENDLY.
>> SO THEY LEARNED A LESSON
PERHAPS.
>> RESEARCH MATCH DOT GOV THE
PURPOSE IS TO BE A PUBLIC
LISTING OF TRIALS.
IT'S NOT THE MOST USER FRIENDLY
BECAUSE YOU HAVE TO PUT IN A LOT
OF WORDS AND HOW ITS COMES UP IS
FUNCTIONAL BUT WOULD BE MORE
USER FRIENDLY.
THANK YOU.
>> JOIN ME IN THANKING
DR. LANGFORD.
THANK YOU ALL.
THAT'S IT FOR US TODAY.
WE'LL BE BACK NEXT WEEK WITH A
GROUP OF FOLKS TALKING ABOUT
GENETICS.
IT'S GENETICS DAY NEXT WEEK.
THANK YOU.