WELCOME, EVERYONE.
AND THANKS FOR JOINING US TODAY
FOR THE VIRTUAL WEBINAR AND
LISTENING SESSION ON ENGAGING
THE PUBLIC AS PARTNERS IN
CLINICAL RESEARCH I'M ARE LYRIC
JORGENSON AND GRATEFUL TO BE
JOINED BY KEN GETZ
CLINICAL RESEARCH PARTICIPATION
CENTER FOR INFORMATION AND STUDY
ON CLINICAL RESEARCH
PARTICIPATION AND SEVERAL
COLLEAGUES FROM COLUMBIA
UNIVERSITY, CHRIS VEASLEY FROM
THE RESEARCH ALLIANCE WHO WILL
ALSO BE SPEAKING A BIT LATER IN
TODAY'S SESSION.
FOR AWARENESS TODAY'S WEBINAR IS
CO-HOSTED BY NIH WITH THE BIG
PICTURE SHARED GOAL VISION OF
ENGAGING PUBLIC VISION FOR
CLINICAL RESEARCH.
THIS IS PART OF AN INITIATIVE TO
DEVELOP CONCRETE STRATEGIES TO
ENSURE THOUGHTS AND PREFERENCES
ARE INTEGRATED INTO CLINICAL
RESEARCH.
I'D LIKE TO EMPHASIZE THAT
MEANINGFULLY ENGAGING PEOPLE
CANNOT BE A ONE SIZE FITS ALL
APPROACH.
WE BELIEVE ENGAGEMENT CAN BE A
PERSONAL EXPERIENCE OR SHARED
AND WE NEED TO THINK HOW TO
TAILOR EFFORTS TO THE NEEDS AND
EXPERIENCES OF PEOPLE AND THEIR
COMMUNITIES.
SECOND, IT IS IMPORTANT TO LEVEL
SET THE FACT THAT HISTORICALLY
COMMUNITIES THAT COULD BENEFIT
THE MOST FROM OUTCOMES OF
CLINICAL RESEARCH STUDIES CAN
OFTEN BE LEAST LIKELY WILL IN
THE RESEARCH.
THE GOAL IS TO THINK HOW TO FLIP
THE SCRIPT ON THIS AND BLAZE A
NEW PARADIGM BOTH FOR BETTER
SCIENCE AND IMPROVING OUTCOMES
FOR PEOPLE.
FINALLY, ORGANIZATIONS AND
COMMUNITIES ACROSS THE GLOBE ARE
ENGAGING COMMUNITIES IN CLINICAL
RESEARCH.
WE'RE NOT ALONE AND IN NIH THE
27 INSTITUTES AND CENTERS ARE
WORKING TO PIONEER APPROACHES TO
FULFILL THE MISSIONS.
THE GOAL OF THIS SPECIFIC
INITIATIVE IS TO PROVIDE NIH
WITH THE NORTH STAR FOR
PARTICIPANT ENGAGEMENT WITH A
TOOLKIT THAT CAN BE USED BY
PATIENTS, RESEARCH PARTICIPANTS,
RESEARCHERS, CLINICIANS AND MORE
TO ACHIEVE THIS COLLECTIVE
VISION.
ALL OF THAT SAID, TO GET THERE,
NIH IS BRINGING TOGETHER LEADERS
AND CONVENING AND TRANSLATING
PATIENT NEEDS AND THE PUBLIC AND
RESEARCHERS TO PROVIDE INPUT
ALONG THE WAY ON THE VISION AND
OF COURSE DEVELOP THE APPROACH.
I'M PLEASED TO SAY THE EFFORT IS
LED ABLY BY THE ENGAGE WORKING
GROUP AND YOU'LL HEAR DIRECTLY
FROM THE LEADERS OF THAT TEAM IN
A BIT.
THIS GROUP IS IDENTIFIED TO WILL
TARGET WHAT MATTERS MOST IN
CLINICAL RESEARCH AND THE
ANSWERS WILL SERVE AS A
CORNERSTONE OF THE WORK THIS
GROUP CONTINUES.
IN RECOGNITION OF THE IMPORTANCE
OF THE ANSWERS TO THESE
QUESTIONS ARE OPPORTUNITIES FOR
WRITTEN AND VERBAL COMMENT AND
MAKE IT CLEAR THERE WILL BE MANY
OPPORTUNITIES NOW AND ALONG THE
WAY AND IN THE FUTURE TO MAKE
YOUR VOICE HEARD.
THAT'S THE WHOLE POINT OF WHAT
WE'RE TRYING TO DO.
TODAY'S WEBINAR IS ONE OF THOSE
OPPORTUNITIES.
ANOTHER OPPORTUNITY OUT NOW IS
THE REQUEST FOR INFORMATION NIH
HAS RECENTLY ISSUED AND ANYONE
AND EVERYONE SHOULD TAKE TIME TO
THINK OF COMMENTING.
VISIT THE ENGAGE WEBSITE AT
PARTICIPANT -- SORRY, PARTNERS
IN RESEARCH AT NIH.gov TO LEARN
HOW TO SUBMIT A WRITTEN COMMENT
BY THE AUGUST 14 CLOSING DATE.
ULTIMATELY YOUR OPINIONS AND
PERSPECTIVE MATTER.
THEY'LL SHAPE THE WORK OF THE
EFFORT AND PUBLIC ENGAGE
THE IN NIH-SUPPORTED CLINICAL
RESEARCH NOW AND FOR THE YEARS
TO COME.
WE'RE COMMITTED TO THIS TOPIC.
IN ADDITION TO BEING THE FOUNDER
AND BOARD CHAIR, KEN GETZ IS
ALSO A PROFESSOR AND DIRECTOR OF
THE CENTER FOR THE STUDY OF DRUG
DEVELOPMENT AT TUFTS UNIVERSITY
SCHOOL OF MEDICINE.
AMONG KEN'S MANY MANY
ACCOMPLISHMENTS WE DON'T HAVE
TIME TO COVER HERE TODAY, HE'S
THE AUTHOR OF TWO NATIONALLY
RECOGNIZED BOOKS FOR PATIENTS
AND ADVOCATES ALONG WITH OTHER
SCHOLARLY PUBLICATIONS.
I'M NOW GOING TO TURN IT OVER TO
KEN, THE REAL EXPERT ON THE
TOPIC WE'RE ABOUT TO TALK ABOUT
TODAY TO SHARE HIS PERSPECTIVE
ON EFFORTS FOR UNDERTAKING AND
HOW TO COLLECTIVELY MOVE
FORWARD.
KEN IS MY ABSOLUTE PLEASURE
YOU'RE HERE WITH US TODAY AND
WOULD LOVE TO TURN IT OVER TO
YOU.
>> THANK YOU SO MUCH FOR THAT
KIND INTRODUCTION, LYRIC.
IT'S MY PLEASURE TO BE HERE
TODAY AND ON BEHALF OF WE'RE
PLEASED TO ON THE INITIATIVE.
THE RESEARCH COMMUNITY IS TRUE
PARTNERS IN THE PROCESS TO
DISCOVER AND DEVELOP NEW MEDICAL
THERAPIES.
BEFORE THAT TIME ENGAGEMENT WAS
LARGELY ONE SIDED.
IT WAS DRIVEN BY HIGHLY
MOTIVATED COMMUNITY ACTIVISTS.
THINK OF PATIENTS AND FAMILIES
AND THE HIV COMMUNITY AND
PARKINSON'S AND CYSTIC FIBROSIS
DISEASE COMMUNITIES.
THESE INDIVIDUALS LED MOVEMENTS
TO PRESSURE THE RESEARCH
COMMUNITY TO DEVELOP NEW
THERAPIES, TO ACCELERATE
REGULATORY REVIEW AND MAKE
CERTAIN TREATMENTS MORE
ACCESSIBLE.
WELL, OCCURRING THE PAST 15
YEARS AS LYRIC WAS MENTIONING,
THE ENTIRE PHILOSOPHY AND
CONCEPT OF ENGAGEMENT IN
CLINICAL RESEARCH HAS SHIFTED
REMARKABLY TO EMPHASIZE
TWO-SIDED PARTNERSHIP AND
COLLABORATION.
GOVERNMENT AGENCIES AROUND THE
WORLD HAVE FORMALIZED ELEMENTS
OF ENGAGEMENT TO RECOMMENDED
PRACTICES AND LAW, PUBLIC AND
PATIENT COMMUNITIES ARM IN ARM
WITH CLINICAL RESEARCH
PROFESSIONALS ARE SHARING THEIR
VOICES, THEIR PERSPECTIVES AND
INSIGHTS ON THE BURDEN OF LIVING
WITH A GIVEN DISEASE ON
PREFERRED TREATMENT OUTCOMES
AROUND HOW TO BEST EVALUATE THE
SAFETY AND EFFICACY OF NEW
INVESTIGATIONAL TREATMENTS.
JUST A QUICK WORD ABOUT CISCRP,
IT WAS FOUNDED IN 2003.
THE CENTER FOR INFORMATION AND
STUDY ON CLINICAL RESEARCH
PARTICIPATION HAS CONTRIBUTED TO
THIS REMARKABLE SHIFT IN A
NUMBER OF WAYS.
CISCRP IS VERY PASSIONATE ABOUT
ITS MISSION AS LYRIC NOTED.
IT IS DEDICATED TO PUBLIC AND
PATIENT ADVOCACY AND ENGAGEMENT
ON A VARIETY OF LEVELS.
RAISING PUBLIC AWARENESS AND
OVER ALL CLINICAL RESEARCH
LITERACY AROUND INFORMING
PATIENTS AND FAMILIES HOW BEST
TO NAVIGATE AND PARTICIPATE IN
CLINICAL RESEARCH, GATHERING
FEEDBACK FROM PATIENT
COMMUNITIES TO INFORM BETTER
PROTOCOL DESIGN AND RETURNING
NON-TECHNICAL, EASY TO
UNDERSTAND TRIAL RESULTS AND
INFORMATION TO STUDY VOLUNTEERS
AND THEIR FAMILIES.
CISCRP IS ALSO COMMITTED TO
ENHANCING THE PARTICIPATION
EXPERIENCE DURING AND AFTER
CLINICAL TRIALS.
IMPROVING PATIENT DIVERSITY,
INCLUSION, ACCESSIBILITY AND
CONVENIENCE.
EMPOWERMENT AND THE ENGAGEMENT
OF PATIENTS AND THE PUBLIC AS
PARTNERS IN CLINICAL RESEARCH
HAS SO MANY BENEFITS AND IT'S A
WIN-WIN FOR EVERYONE.
TO NAME A FEW OF THE BENEFITS
THROUGH COLLABORATION AND
PARTNERSHIP, CLINICAL RESEARCH
CAN FOCUS ON THE MOST RELEVANT
END POINTS AND IT CAN GATHER THE
MOST CLINICALLY MEANINGFUL AND
USEFUL INFORMATION.
IT CAN HELP SPEED UP THE PACE OF
TRIALS AND DRIVE HIGHER SUCCESS
RATES AND ULTIMATELY AND PERHAPS
MOST IMPORTANTLY ENGAGEMENT
DELIVERS BETTER MEDICAL
TREATMENTS TO PATIENTS AND THEIR
FAMILIES WAITING FOR THEM.
WE'RE EXCITING TO BE CO-HOSTING
TODAY'S IMPORTANT WEBINAR WITH
THE NIH AND VERY EXCITED TO BE
PART OF THIS LISTENING SESSION.
LYRIC, I'LL TURN THE MEETING
BACK OVER TO YOU AND THANK YOU
AGAIN FOR THE OPPORTUNITY TO
COLLABORATE WITH YOU.
WE'RE EXCITED TO PARTNER WITH
YOU AND BE HERE TODAY.
I'D LIKE TO GET OUR PROGRAM
STARTED TO GET OUR DISCUSSION
GOING AND HEAR FROM THE PUBLIC
WHICH IS WHAT WE'RE TRYING TO DO
HERE TODAY.
AS I MENTIONED, WE HAVE OUR
ENGAGED LEADERSHIP HERE TODAY,
SUE BAKKEN AND CHRIS VEASLEY
WORKING ON A PLAN TO IMPROVE
PUBLIC ENGAGEMENT AND RESEARCH
AND WE'LL DIVE TOO THE WORK
THEY'VE BEEN DOING.
SUE BAKKEN IS A PROFESSOR OF
NURSING IN BIO INFORMATICS AT
COLUMBIA UNIVERSITY AND PROMOTES
HEALTH AND REDUCES HEALTH
DISPARITIES IN UNDER SERVED
POPULATIONS.
CHRIS VEASLEY IS CO-FOUNDER AND
DIRECTOR OF THE CP -- CHRONIC
PAIN RESEARCH ALLIANCE AND HOLDS
POSITIONS AT THE NIH, CDC AND
FOOD AND DRUG ADMINISTRATION.
SHE HAS BEEN A PASSIONATE AND
SUCCESSFUL ADVOCATE FOR PEOPLE
LEAVING WITH PAIN AND PATIENT IS
PERSPECTIVES IN RESEARCH.
IT'S AN HONOR TO BE SHARING THE
STAGE -- THE VIRTUAL STAGE WITH
THESE LADIES WHO HAVE BEEN
TREMENDOUSLY INSPIRATIONAL AND
WORK REALLY HARD TO MAKE VOICES
HEARD IN WAYS THAT ARE
MEANINGFUL AND IMPACTFUL FOR
ALL.
I WILL TURN IT OVER TO YOU
LADIES TO KICK OFF OUR PROGRAM
FOR TODAY.
>> THANKS, IT'S GREAT TO HEAR
FROM YOU, LYRIC, AS WELL AS KEN
AND SETTING US UP.
CHRIS AND I ARE GOING TO
CONTINUE WITH A BRIEF BACKGROUND
BECAUSE TODAY IS REALLY A
LISTENING SESSION.
WE'RE REALLY HERE MORE TO LISTEN
THAN TO TALK.
BUT WE'LL START OUT WITH A FEW
DEFINITIONS AND LET YOU KNOW
WHAT WE'VE BEEN UP TO BEFORE WE
OPEN THE FLOOR FOR YOUR
COMMENTS.
SO, JUST A LITTLE BIT OF
BACKGROUND.
THE NIH INFORMATION'S MEDICAL
RESEARCH AGENCY, THE NIH FUNDS
RESEARCH ACROSS THE U.S. TO MAKE
IMPORTANT DISCOVERIES THAT
IMPROVE HEALTH AND SAVE LIVES.
IN TERMS OF FUNDING, NIH
INVESTED NEARLY $18 BILLION IN
CLINICAL RESEARCH IN 2022.
THIS IS THE LARGEST AMOUNT IN
THE U.S.
IN TERMS OF SOME NEXTS, IT'S
IMPORTANT WE THINK BROADLY ABOUT
WHAT CLINICAL RESEARCH IS SO YOU
HAVE A SENSE OF THE ENGAGEMENT
ACTIVITIES IN CONJUNCTION WITH
THE RESEARCH LIFE CYCLE.
AND IT'S MEDICAL RESEARCH THAT
IMPROVES PEOPLE AND LEARN MORE
ABOUT DISEASE AND IMPROVE
HEALTH.
THIS INCLUDES MULTIPLE STAGES
FROM CONCEPT DEVELOPMENT TO
DESIGN AND PLANNING A STUDY,
CONDUCTING THE STUDY AND
ANALYZING THE RESULTS AROUND
SHARING THE RESULTS.
THE IDEA OF THE WORK IN THE BIG
PICTURE IS PUBLIC ENGAGEMENT IS
NECESSARY THROUGHOUT THE CYCLE.
AND IMPORTANTLY, WHEN WE'RE
THINKING ABOUT THAT RESEARCH
ENGAGEMENT, IT HAPPENS WHEN
INDIVIDUALS SUCH AS PATIENTS AND
GROUPS OF PEOPLE AND COMMUNITIES
AND ORGANIZATIONS PARTNER WITH
RESEARCHERS TO PLAN, BEING
CONDUCTING IN RESEARCH OR DESIGN
AND WHEN PEOPLE THINK OF
RESEARCH DESIGN AND ENGAGEMENT
THEY MAY THINK PRIMARILY ABOUT
CLINICAL TRIALS BUT IT'S VERY
IMPORTANT FOR THIS WORK THAT
WE'RE CONDUCTING TO NOT JUST
THINK ABOUT CLINICAL TRIALS BUT
BROADLY THINK OF OTHER TYPES OF
RESEARCH THAT ARE BEING
CONDUCTED.
AND SOME DIFFERENT WAYS WE THINK
ABOUT INCLUDING PUBLIC
ENGAGEMENT IN RESEARCH, REALLY
HIGHLIGHTING THE POINT THAT
PATIENTS, COMMUNITIES AND OTHER
MEMBERS ARE ESSENTIAL PARTNERS
TO THE SUCCESS OF THE RESEARCH.
SO THIS IS NOT ABOUT ONLY
RESEARCH PARTICIPANTS AND MAKING
SURE THEY'RE ADEQUATE
PARTICIPANTS IN RESEARCH STUDIES
IT'S BROADER THAN THAT IN TERMS
OF RESEARCH ENGAGEMENT AND
IMPORTANT TO THINK ABOUT THE
FACT THAT ENGAGEMENT SHOULD BE
TAILORED TO THE NEEDS AND
EXPERIENCE OF PEOPLE IN
COMMUNITIES AND THESE GROUPS
SHOULD GUIDE THE RESEARCH
IMPACTFUL TO THEM.
IT'S NOT A ONE-SIZE FITS ALL
APPROACH AND WHICH COMMUNITIES
AND WHICH STAGE OF THE LIFE
CYCLE WE NEED APPROPRIATE
APPROACHES TO WORK WITH THEM.
TO ACCOMPLISH THIS NIH HAS
DEVELOPED A VISION AND FRAMEWORK
FOR INCORPORATING PUBLIC VOICES
IN ALL PHASES AND TYPES OF
CLINICAL RESEARCH.
THIS IS THE ENGAGE WORKING GROUP
LYRIC HAS MENTIONED.
AND CHRIS AND I ARE DELIGHTED TO
BE LEADING THE ENGAGE WORKING
GROUP AND NOW I'M FOG TO TURN IT
OVER TO CHRIS TO TALK A LITTLE
BIT MORE ABOUT WHAT THE ENGAGE
WORKING GROUP IS DOING BEFORE WE
HEAR BACK FROM YOU.
CHRIS.
>> THANKS, SUE AND LYRIC AND
KEN.
IT'S A PLEASURE TO BE HERE.
THE NIH BROUGHT TOGETHER A GROUP
OF PATIENTS, ADVOCATES,
RESEARCHERS, CLINICIANS AND
NON-PROFIT REPRESENTATIVES WHO
ARE EACH EXPERTS IN CLINICAL
RESEARCH AND ENGAGEMENT.
AND MEMBERS OF OUR WORKING GROUP
ARE SHOWN HERE ON THE SCREEN.
THIS GROUP AS SUE JUST MENTIONED
IS COLLECTIVELY REFERRED TO AS
THE ENGAGE WORKING GROUP.
AND WE ARE DEVELOPING A VISION
AND FRAMEWORK FOR ENGAGEMENT IN
CLINICAL RESEARCH.
SO WE'VE BEEN HARD AT WORK SINCE
LAST YEAR AND HAVE BEEN
DEVELOPING A VISION AND GOAL
STATEMENT TO GUIDE OR WORK.
OUR VISION SHOWN HERE ON THE
SCREEN IS THAT IF WE ARE
SUCCESSFUL IN THE WORK WE'RE
DOING, ENGAGEMENT IN CLINICAL
RESEARCH WILL BECOME A STANDARD
PRACTICE THAT WILL PROMOTE
RECE
RESPONSIVENESS TO COMMUNITY
NEEDS AND TRANSPARENCY WHILE
MEETING THE NIH MISSION OF
HELPING TURN DISCOVERIES TO
IMPROVED LEATH OF ALL PEOPLE.
IN SIMILAR TERMS IS PEOPLE IN
COMMUNITIES HAVE A SAY IN THE
AGENDA IN RESEARCH THAT'S
IMPACTFUL TO THEM.
BOTH STATEMENTS ARE STILL IN
DRAFT FORM AND WE PLAN TO
CONTINUE TO UPDATE AND SEEK
PUBLIC INPUT ON THEM.
IF YOU HAVE FEED BACK, PLEASE
LET US HEAR FROM YOU.
THE GROUP IS ALSO WORKING ON
OTHER DRAFT PRODUCTS GUIDED BY
THE COMMENTS YOU'LL HEAR IN
TODAY'S SESSION AND IN RESPONSE
TO OTHER CALLS THAT WE HAVE TO
HEAR FROM THE COMMUNITY.
SO I'M SUPER EXCITED TO
HIGHLIGHT THE NIH RECENTLY
RELEASED A NEW WEBSITE LYRIC
MENTIONED EARLIER AND IT'S GOING
TO SERVE AS A CENTRAL RESEARCH
FOR OUR EFFORT AND PARTNERS IN
RESEARCH.NIH .GOV AND ENCOURAGE
YOU TO LEARN MORE ABOUT THE
EFFORT.
WE'RE LOOKING FORWARD TODAY TO
ALL THE COMMENTS THAT WE'LL HEAR
FROM YOU BUT ALSO WANT TO
EMPHASIZE THIS IS JUST ONE OF
MANY OPPORTUNITIES TO PROVIDE
INPUT.
THERE'S CURRENTLY AN OPEN
OPPORTUNITY TO SUBMIT WRITTEN
COMMENTS TO THE NIH AS WELL AND
I'LL SPEAK MORE ABOUT THAT IN A
MOMENT.
THE UPCOMING FALL AND WINTER
WE'RE ENTHUSIASTIC TO START
HOSTING A SERIES OF COMMUNITY
CONVERSATIONS ACROSS THE UNITED
STATES TO SEEK INPUT AND
FEEDBACK FROM PEOPLE LIKE YOU.
SO PLEASE STAY TUNED FOR MORE
MOTIVATION HOW TO JOIN A
SESSION.
WE'RE ALSO PLANNING ADDITIONAL
MEETINGS AND WE RECEIVED A HIGH
LEVEL OF INTEREST AND YOU CAN
EMAILING THE SCIENCE POLICY
ADDRESS LISTED ON THE SLIDE.
OUR FINAL REPORT WILL BE
RELEASED IN SUMMER 2025 SO CHECK
BACK REGULARLY FOR UPDATES.
AS I MENTIONED, THE NIH IS
CURREN
CURRENTLY SEEKING INFORMATION
VIA RFI, REQUEST FOR
INFORMATION.
VISIT THE ADDRESS ON THE SCREEN
OR SCAN THE QR CODE TO LEARN HOW
TO RESPOND TO THIS OR SIMPLY
VISIT THE WEBSITE WE JUST
MENTIONED, PARTNERS IN
RESEARCH.NIH.gov AND YOU'LL FIND
MORE THERE.
IT PROVIDES A SERIES OF PROMPTS
YOU CAN EASILY RESPOND TO
ONLINE.
PLEASE SEND IN YOUR COMMENTS BY
AUGUST 14, THAT'S THE DEADLINE
FOR THIS FIRST RFI TO MAKE JUR
VOICE HEARD.
-- YOUR VOICE HEARD.
SUE, THE ENTIRE WORKING GROUP
AND I ARE EXTREMELY EXCITED TO
HEAR YOUR THOUGHTS ON THIS TOPIC
AND THANK EVERYONE WHO SIGNED UP
TO PROVIDE COMMENTS TODAY.
WITH THAT I'LL OPEN IT BACK UP
TO LYRIC FOR THE COMMENT PERIOD.
>> THANK YOU, SUE AND CHRIS.
WITH ALL OF THAT IN MIND, WE ARE
REALLY EXCITED TO OPEN MORE TO
HEAR FROM INDIVIDUALS WHO SIGNED
UP TO SPEAK PRIOR TO THE
WEBINAR.
WE'RE EXCITED.
WE HAVE A LOT OF PEOPLE WHO WANT
TO TALK SO I'M GOING TO DO MY
BEST ON REFRAIN ON ENTERING INTO
DISCUSSION TO HEAR ALL THE
PERSPECTIVES THOUGH I THINK IT
WILL BE HARD FOR US NOT WANT TO
ENGAGE GIVEN THE GOALS OF
ENGAGEMENT.
WITH THAT, RYAN, THE DIRECTOR OF
ADMINISTRATION ENGAGEMENT WILL
OPEN AND MODERATE THIS PORTION
OF THE SESSION.
PLEASE TAKE OVER.
>> THANKS, LYRIC.
I'M LETTING IN OUR FIRST
PARTICIPANT, BILLY HANDLIN.
HE SHOULD BE JOINING US IN ONE
MOMENT.
FOR BILLY, I THINK YOU MAY HAVE
YOUR VIDEOCAST ON IN A DIFFERENT
WINDOW IF YOU COULD MUTE THAT SO
WE CAN HEAR YOUR COMMENTS.
I'M GOING TO PUT UP A TIMER TO
HELP GUIDE YOUR COMMENTS AND
WHENEVER YOU ARE READY, YOU MAY
START.
>> THANK YOU FOR THAT, RYAN.
CAN YOU HEAR ME?
OKAY.
WONDERFUL.
I JUST FIRST WANTED TO THANK NIH
OSP FOR HOSTING THE PUBLIC
FORUM.
I THINK THE WORK IS IMPORTANT
AND IT'S SO IMPORTANT.
THE FOLLOWING IS MY PUBLIC
COMMENT AND DO MY BEST TO STAY
BRIEF AND THE RECOVER INITIATIVE
STUDYING LONG COVID HAS BEEN
REPORTED IN THE PRESS AT LENG
MANY.
ONE CENTRAL CONCERN HAS BEEN THE
LACK OF PATIENT INCLUSION IN A
MEANINGFUL WAY WITH RESPECT TO
THE CLINICAL TRIAL DESIGN
DESPITE PUBLIC'S PLEASE THEY'VE
FORGED LEAD ON WHAT SEEMS TO BE
THEIR OWN INTENTIONS.
THIS IS REFLECTED IN THE
CLINICAL TRIALS SO FAR HAVE BEEN
RATHER UNAMBITIOUS AND
DISCONNECT WITH THE COMMUNITY.
MOST INTERVENTIONS DIDN'T AIM AT
THE POSSIBLE BIOLOGICAL UNDER
PROCESSES UNDERLYING THE ILLNESS
WHILE THE APPRECIATION PUBLIC
FUNDS HAVE BEEN SUPPORTING THE
WORK.
THE FRUSTRATIONS HAVE MIRRORED
ME/CFS.
IT'S AN INFECTIOUS ASSOCIATED
DISEASE IT MEETING THE
DIAGNOSTIC CRITERIA.
OSP I'M URGING NIH AND
LEADERSHIP TO LOOK TO THE
CLINICAL TRIAL RECOMMENDATIONS
FOR LONG COVID IN ME/CFS.
DR. NATH CAMPAIGNED FOR
INTERVENTIONS AND THE NEW
DIRECTOR BERTAGNOLLI SAID THE
FUNDS WOULD GO TO THE NEXT ROUND
OF THE NIH MEETING IN JUNE.
HEEDING THIS ADVICE WOULD BE
WELCOME AND ALIGN WITH THEIR
LEADER JUST HONORED FOR THEIR
INFLUENCE AS A TRUSTED MENTAL
HEALTH LEADING.
FUNDING ME-CFS FOR RESEARCH AND
SPEARHEADING PROMISING CLINICAL
TRIALS WOULD BE AN APT STARTING
POINT FOR THE BRIGHTER FUTURE
AND MAKE IT MORE LIKELY TO
AUTHENTICALLY ENGAGE WITH NIH
AND NEW INSTITUTIONAL LEADERSHIP
RECOGNIZED THE WOUNDS AND
BLEMISHES.
NOW IT'S TIME TO SUBSEQUENT
ACTIONS TO INDICATE CHANGE IS
INDEED UNDERWAY.
THANK YOU AGAIN FOR HOSTING THIS
TODAY AND THANK YOU FOR YOUR
TIME.
>> THANK YOU.
I'M LETTING IN BRIAN DINGER NEXT
FROM THE WAITING ROOM.
ARE YOU ABLE TO HEAR US?
>> BRIAN, YOU MAY HAVE YOUR
VIDEOCAST ON IN ANOTHER WINDOW.
IF YOU CAN MUTE THAT WHILE
YOU'RE GIVING YOUR COMMENTS
HERE.
>> THANK YOU.
I CLOSED THAT WINDOW.
YOU CAN HEAR ME WELL?
>> YEAH, TELL ME WHEN YOU WANT
ME TO ARE THE START THE
COUNTDOWN.
>> I'M PART OF THE DUCHENNE'S
MUSCULAR CAN CAN DYSTROPHY AND
MY COMMENTS ARE ACCESSING MORE
INDIVIDUALS BROADLY TO THE
CONVERSATIONS.
IN MANY YEARS INVOLVED WITH RARE
DISEASE ADVOCACY ORGANIZATIONS
I'VE HAD NUMEROUS OPPORTUNITIES
TO PARTICIPATE IN NIH AND ATTEND
SCIENTIFIC MEETINGS AND
WORKSHOPS AND HAVE BEEN INVOLVED
WITH LISTENING SESSIONS WITH
COMPANIES SEEKING MY OPINION
ABOUT POTENTIAL AND ONGOING
RESEARCH AND HAVE ALSO MADE AN
EFFORT TO REACH OUT TO LOCAL
SCIENTISTS AT THE JACKSON
LABORATORIES IN MAINE AND MET
REGULARLY FOR 20 YEARS.
THERE ARE MANY PEOPLE IN THE
DISEASE COMMUNITY.
WE'RE A BIASSED SAMPLE AND I
RECOGNIZE THAT'S PARTS OF THE
ISSUE.
WE NEED TO REACH OUT TO MORE
INDIVIDUALS.
SOLICITING PARTICIPATION THROUGH
ADVOCACY ORGANIZATIONS IS AN
IMPORTANT ELEMENT IN FINDING
ADDITIONAL PARTICIPANTS.
FAMILIES CONNECTED TO THESE
ORGANIZATIONS ARE GENERALLY
INFORMED AND MOTIVATED TO HELP.
GENERALLY LEADERSHIP OF THESE
ORGANIZATIONS KNOW MANY WITHIN
THE COMMUNITY AND SPONSOR
REGISTRIES AND DATABASES WHICH
MAY BE HELPFUL IN IDENTIFYING
ADDITIONAL TARGETS OF A SUBSET
OF A POPULATION OF INTEREST TO
AN OUTSIDE GROUP.
ADVOCACY ORGANIZATIONS ALSO HOST
REGULAR CONFERENCES AND MEETINGS
WHICH MAY BE HELPFUL IN
ENGAGEMENT WITH RESEARCH AND
MEMBERS OF THE PATIENT
COMMUNITY.
THE PROCESS MAKES THESE GROUPS
GATE KEEPERS FOR INTERESTED
PARTICIPANTS AND LIMITS THE TO
THOSE WHO WILL BE PARTICIPATING
IN THE ORGANIZATION'S ACTIVITIES
AND THE NEED FOR MORE INFORMED
PARTICIPANTS DOES COME AT THE
COST OF BEING SELECTED BY THE
LEADERSHIP OF THESE
ORGANIZATIONS.
AS IS TRUE IN THE RARE AND MORE
COMMON DISEASE COMMUNITIES,
PATIENT AGE, CURRENT DISEASE
STATE AND OTHER FACTORS SUCH AS
DEMOGRAPHICS AND ABILITY TO
ACCESS APPROPRIATE CARE INFORMS
THEIR OPINION.
THESE PEOPLE'S OPINIONS ARE
EQUALLY AS IMPORTANT YET SOME
WITHIN THE COMMUNITY ARE MORE
DIFFICULT TO REACH.
EFFORTS TO REACH A LARGER SAMPLE
OF THE DISEASE COMMUNITY WILL
TAKE CREATIVE MEASURES INCLUDING
IDENTIFYING THOSE UNABLE TO MEET
THE COMMUNITY TARGETING CLINICS
AND HOSPITALS FOR THE GROUP OF
INTEREST ARE LIKELY OUR BEST
OPPORTUNITIES AND ANOTHER WAY OF
REACHING OUT TO THESE PATIENT
COMMUNITIES WHETHER IT'S THROUGH
POLLING, DIRECT CONTACT, ALL OF
THESE ARE MEASURES TO INCREASE
THE VOICE OF THOSE WHO ARE LEFT
OUTSIDE THE LARGER COMMUNITY.
THANK YOU.
>> THANK YOU, BRIAN.
THERE'S NO ONE CURRENTLY IN THE
WAITING ROOM OUR NEXT SPEAKER
HAS NOT SHOWED UP IF YOU HAVE
ANOTHER POINT YOU WANTED TO MAKE
FEEL FREE.
>> THANK YOU, I WAS RUSHING
THROUGH MY LAST COMMENT.
SO FOLLOWING UP WITH REGULAR
VIRTUAL MEETINGS IS IMPORTANT TO
SCREEN INDIVIDUALS BY PHONE OR
BY COMPUTER ACCESS.
THAT'S IMPORTANT IN IDENTIFYING
PEOPLE OUTSIDE THE TYPICAL
SELECTION GROUP WHO ARE
PARTICIPANTS WITH THESE ADVOCACY
ORGANIZATIONS.
ANOTHER OPPORTUNITY IS ENSURING
THAT THERE ARE REGULAR FOLLOW-UP
MEETINGS WITH THESE INDIVIDUALS
TO DETERMINE WHO WOULD BE MOST
APPROPRIATE FOR YOUR ENGAGEMENT.
THE OTHER ASPECT IS TIMING OF
THE MEETS WILL NEED TO BE
FLEXIBLE.
WHILE EVENING MEETINGS MAY WORK
FOR CARETAKERS IT LATE NIGHT MAY
BE MORE SUITABLE WHO CANNOT
COMMIT EARLIER IN THE DAY.
SPREADING A LARGER NET NEEDS TO
ACCOUNT FOR IF CONFLICTS IN
REGULAR ATTENDANCE OR LIMITS FOR
THOSE WHO WANT TO CONNECT AND
FINDING THE MOST INTERESTED
PARTICIPANTS.
AS A CORE OF INTERESTED
PARTICIPANTS IS IDENTIFIED,
FURTHER POLLING MAY BE HELPFUL
IN ENSURING SCHEDULING
APPROPRIATE MEETING TIME FOR
THOSE THAT WORK.
ADDITIONAL STARTING POINTS
INCLUDE DETERMINING WHETHER A
PARTICULAR COMMUNITY HAS A
CONNECTED GROUP OF PATIENT
AND/OR CAREGIVERS WHETHER
THROUGH SOCIAL MEDIA OR ADVOCACY
ORGANIZATION.
THERE MAY BE GROUPS UNABLE TO
MEET IN PERSON OR BROADER IN
CONNECTED AGAIN BY SOCIAL MEDIA.
WHEN LED BY A MEMBER OF AN
ADVOCACY ORGANIZATION, OR A
METHOD TO ENSURE MEMBERS ARE
PART OF A COMMUNITY, THAT CAN BE
A SOURCE FOR NEW VOICES NEEDED
TO INTERACT WITH RESEARCHERS.
THANK YOU.
>> THANK YOU.
OUR NEXT SPEAKER IS GOING TO BE
C. DANIEL MULLENS.
CAN YOU HEAR ME?
>> YES, THANK YOU VERY MUCH.
THANK YOU FOR THE OPPORTUNITY TO
PROVIDE COMMENTS.
TRUSTWORTHY COMMUNITY ACADEMIC
PARTNERSHIPS ARE CO-DEVELOPED
AND SUSTAINABLE.
OTHERWISE EFFORTS TO IMPROVE
PUBLIC ENGAGEMENT IN CLINICAL
RESEARCH ARE TRANSACTIONAL NOT
AUTHENTIC.
HELICOPTER RESEARCH IS WHEN
RESEARCHERS SCOOP INTO
COMMUNITIES TO OBTAIN DATA OR
BIO SPECIMENS LEAVE BEHIND GIFT
CARDS FOR PARTICIPANTS THEN
SWOOP BACK OUT WITHOUT
MEANINGFUL COLLABORATION WITH
COMMUNITY STAKEHOLDERS.
THANK YOU FOR ALLOWING ME THE
OPPORTUNITY TO COMMENT.
I, DANIEL MULLINS HAVE HAD THE
PLEASURE OF WORKING WITH SEVERAL
COMMUNITY LEADERS IN WEST
BALTIMORE TO BUILD AN ACADEMIC
COMMUNITY CALLED THE PATIENTS
PROGRAM.
STARTED BY AN AGENCY R24
INFRASTRUCTURE GRANT IN 2012.
OUR GOVERNANCE STRUCTURE
REQUIRES THE MAJORITY OF OUR
STEERING COMMUNITY MEMBERS ARE
PATIENTS AND COMMUNITY LEADERS
NOT PART OF UNIVERSITY OF
MARYLAND-BALTIMORE.
THEY CAN HOST COMMUNITY MEMBERS
INTEREST THE UNIVERSITY.
INFRASTRUCTURE AND GOVERNANCE
STRUCTURE HAS A HUGE IMPACT ON
PUBLIC ENGAGEMENT AND CLINICAL
RESEARCH AND TRUST IN
TRANSLATIONAL SCIENCE.
THE PATIENTS PROGRAM HAS BEEN
FUNDED BY SEVERAL NIH INSTITUTES
AND OTHERS SUCH AS THE U.S. FOOD
AND DRUG ADMINISTRATION AND THE
OUTCOMES RESEARCH.
OUR DIVERSIFIED FUNDING STREAM
SUPPORTS SUSTAINABILITY YET MANY
COMMUNITY ACADEMIC PARTNERSHIPS
DISSOLVE AT THE END OF A SINGLE
GRANT BECAUSE THERE ARE NO FUNDS
TO SUPPORT CONTINUATION.
IN MANY INSTANCES COMMUNITY
MEMBERS FEEL ABANDONED, PATIENTS
FEEL USED AND THE PUBLIC ONCE
AGAIN FEELS THEY'RE TREATED LIKE
GUINEA PIGS RATHER THAN
PARTNERS.
MY SECOND POINT, NIH FUNDING
SHOULD EXIST BEYOND A SINGLE
PROJECT AND RETURN RESULTS TO
PATIENTS WHO VOLUNTEER IN
CLINICAL RESEARCH STUDIES YET
OFTEN IS THE RETURN OF RESULTS
IS WITHOUT MEANINGFUL
TRANSLATION AND BROADER
DISSEMINATION WOULD LEAD TO
FASTER AND TRANSLATION OF
RESEARCH FIND TO ROUTINE
CLINICAL PRACTICE.
MY THIRD AND FINAL POINT.
WE CAN DO A BETTER JOB IF WE
EXPLAIN HOW RESEARCH FINDINGS
ARE SOLUTIONS TO THE HEALTH
PROBLEMS PATIENTS FACE.
WE CAN AND MUST DO BETTER AT
DISSEMINATING HEALTH SOLUTIONS
AND THAT SHOULD OCCURRED BEYOND
THE END OF A SINGLE RESEARCH
GRANT.
IN SUMMARY, NIH FUNDING SHOULD
SUPPORT AND DEMAND CONTINUOUS
ENGAGEMENT IN CLINICAL RESEARCH
BOTH SHORT-TERM INNOVATION AND
SCIENTIFIC DISCOVERY AND
LONG-TERM COMMUNITY ACADEMIC
PARTNERSHIPS FOR ENGAGEMENT IN
CLINICAL RESEARCH.
THANK YOU.
>> THANK YOU.
THE NEXT SPEAKER IS TRACY
MUELLER.
JOINING US MOMENTARILY.
HEL
HELLO.
>> MY NAME IS TRACY WHEELER WITH
A NON-PROFIT THAT FUNDS RESEARCH
AND PROGRAMS IN SPINAL CORD
INJURY.
I WAS SO EXCITED TO SEE THAT THE
THOUGHT OF CREATING A WEBINAR
LIKE THIS.
I'M PLEASED TO HAVE THE
OPPORTUNITY TO ACTUALLY
CONTRIBUTE TO IT.
AS A PROGRAM OFFICER I MANAGE
SOME OF THE RESEARCH THAT THE
FOUNDATION SUPPORTS AND I'M
MOSTLY CONCERNED ABOUT BANDWIDTH
BOTTLENECKS AND EFFECTIVENESS
WHEN PARTNERING.
THE CLINICAL TRIALS I'M
SUPPORTING CAN REACH OUT TO
SEVERAL GREAT COMMUNITY
ORGANIZATIONS THAT WE HAVE IN
THE FINAL CORT INJURY FIELD TO
BUILD THE PARTNERSHIPS.
WHAT I SEE IS THAT EFFECTIVE
PARTNERING REALLY REQUIRES HIGH
TOUCH.
FINDING THE RIGHT PERSON TO WORK
WITH THE RIGHT GROUP AND HOW
THAT ALL WORKS OUT RIGHT NOW IS
BEING DONE AGAIN PHENOMENALLY
BUT WHAT HAPPENS WHEN THIS
SCALES?
THAT'S WHAT I ENVISION FOR THE
FUTURE.
SO MY COMMENT IS, IF THERE'S ANY
WAY AN ORGANIZATION THAT'S LARGE
AND WELL KNOWN SUCH AS THE NIH
COULD HELP THESE ORGANIZATIONS
OR HELP PARTNER WITH THEM SO
THEY'RE EFFECTIVENESS AND THE
SMALLER SCALE CAN HANDLE THE
GROWTH I ANTICIPATE THEY
EXPERIENCE AND IF YOU PULL
SOMEONE OFF THE STREETS AND ASK
THEM IF THEY KNOW OF THE
NATIONAL INSTITUTES OF HEALTH
WILL THEY SAY THE SAME WITH THE
SPINAL CORD INJURY CORNER
CONSORTIUM?
I DON'T THINK SO.
I THINK AS YOU THINK ABOUT THIS
PROBLEM, I ENCOURAGE YOU TO
SPEND TIME THINK ABOUT THE
SUPPORT AND INFORMATION SHARING
THAT CAN HAPPEN WITH THE
GRASSROOTS AND ORGANIZATIONS TO
REMAIN EFFECTIVE.
THANK YOU.
>> BEFORE YOU MOVE TO THE NEXT
ONE I WANT TO MAKE IT CLEAR TO
THOSE ON THE WEBINAR I CAN SEE
ALL MY FELLOW LEADS FURIOUSLY
WRITING THINGS DOWN AND SEE YOUR
HEADS CONTINUOUSLY GOING LIKE
THIS BECAUSE WE'RE TAKING NOTES.
THANK YOU SO MUCH.
>> OUR NEXT SPEAKER COMING IN IS
ANNA POLLA.
SHE SHOULD BE JOINING
MOMENTARILY.
YOU MAY HAVE A VIDEOCAST ON IN A
SEPARATE WINDOW.
YOU MAY NEED TO MUTE THAT SO YOU
DON'T GET THE FEEDBACK.
>> HELLO.
>> WE CAN HEAR YOU.
>> HELLO.
I WILL START MY NAME IS ANNA
POLEA -- SORRY, SOME KIND OF LAG
IN COMMUNICATION.
I'LL START.
I'M RESEARCHER ONE A UNIVERSITY
AND WE'RE TRYING TO DEVELOP
TECHNICAL SOLUTION FOR
ENGAGEMENT OF THE PUBLIC NAMELY
PARTLIES IN CLINICAL TRIALS IN
DATA SHARING.
-- PARTICIPANTS IN CLINICAL
TRIALS IN DATA SHARING AND
TRYING TO COMBINE EXPERIENCES IN
THE U.S. AND EUROPEAN UNION TO
BUILD A PROPER FRAMEWORK.
MY CONCERN AND MY COMMENT
RELATED TO THE DISABILITY OF THE
WORLD WIDE PUBLIC ACCESS TO THE
MEDICAL DATA AND DATA SHARING
FACILITIES AS WELL AS WORLD WIDE
ENGAGEMENT OF THE PARTICIPANTS
CLINICAL TRIAL PARTICIPANTS AND
OTHER ORGANIZATIONS AND SO ON.
SO WHAT I WANTED TO DISCUSS WITH
YOU IS MAYBE NIH COULD WE COULD
INCLUDE SOME INFORMATION AND
PROVISIONS INTO THIS PUBLIC
ACCESS DOCUMENT AND PUBLIC
ACCESS IN ORDER TO MAKE THIS
WORLDWIDE AND CONNECTION
POSSIBLE AND WE COULD SHARE
INFORMATION WORLDWIDE.
I'M SORRY, FOR MY SPEECH BECAUSE
IT'S SOME KIND OF LAG IN
COMMUNICATION I MEAN IN
CONNECTION.
THANK YOU VERY MUCH FOR GIVING
ME THIS OPPORTUNITY TO MAKE MY
COMMENTS.
I'LL PROBABLY DO WRITTEN
COMMENTS LATER AND PROBABLY WE
COULD COLLABORATE WITH SOME OF
THE COMMENTERS AND FORUMS.
IT WOULD BE BENEFICIAL FOR ALL
THE PARTS.
THANK YOU VERY MUCH ONE MORE
TIME.
>> THANK YOU VERY MUCH.
YOU CAME THROUGH LOUD AND CLEAR.
THANK YOU, WE APPRECIATE THAT.
CURRENTLY THERE IS NO ONE IN THE
WAITING ROOM.
WE HAVE OTHER SPEAKERS THAT ARE
GOING TO BE COMING ONLINE.
WE'RE A LITTLE BIT AHEAD OF
SCHEDULE.
WE DO EXPECT TO HAVE ANOTHER
SPEAKER IN THE NEXT SEVERAL
MOMENTS HOPEFULLY.
>> THANK YOU FOR THE COMMENTS.
IT WAS INTERESTING TO TALK ABOUT
THE GROUP AND I KNOW THE ENGAGE
GROUP HAS BEEN THINKING ABOUT
THE SCIENCE AND ENGAGEMENT
GLOBAL SO THOSE WERE HELPFUL
COMMENTS.
>> THE COMMITTEE FOR THIS
PARTICULAR ENGAGED GROUP IS
EXCEPTIONAL TECHNOLOGIES IN
RESEARCH ADVISORY COMMITTEE.
WE ARE THINKING VERY MUCH ABOUT
EXCEPTIONAL TECHNOLOGIES AS WELL
AS TRADITIONAL RESEARCH METHODS.
HAD THERE'S POTENTIAL ISSUES AND
IN TERMS OF POTENTIAL SOLUTIONS.
TO THE NEXT COMMENTER HAS JOINED
CAROLINE CASEY JOINING US NOW.
CAN YOU HEAR ME?
HELLO, CAROLINE.
SHE'S HAVING MICROPHONE ISSUES
AS WE SPEAK.
SHE MAY BE TRYING TO GET THE AV
CHALLENGES UNDER CONTROL DESPITE
US USING THIS AS THE NEW NORM
HERE STILL ESCAPES ME SOMETIMES.
>> I'M SURE SHE'LL HAVE IT
FIGURED OUT MOMENTARILY.
I CAN UPDATE YOU ONCE SHE COMES
BACK IN.
WE HAD SOME DROP OFF LEADING TO
GAPS IN COMMENTS.
HOPE ANY SOME PEOPLE WILL BE
TUNING IN EARLIER TO -- I HAVE
ONE THERE'S SOMEONE ELSE
AVAILABLE.
THAT WILL BE ADOLF CHICCON.
HELLO, ADOLF?
>> CAN YOU HEAR ME?
>> YES, WHEN YOU'RE HAPPY TO
START.
>> I THOUGHT I'D COME EARLY.
>> THANK YOU FOR DOING THAT.
WE HAD SOME DEAD AIR SO YOU'RE
OUR M.V.P. SO FAR.
>> THANK YOU FOR THE OPPORTUNITY
TO PROVIDE COMMENTS TODAY.
MY NAME IS ADOLPH FOR THE
ALLIANCE WITH HISPANIC HEALTH A
COMMUNITY DRIVEN ORGANIZATION
THAT FOCUSES ON THE BEST HEALTH
FOR ALL.
OUR WORK IS TO ENSURE HEALTH
INCORPORATES CULTURE IN SCIENCE.
SCIENCE HAS ALWAYS 2K3W5GUIDE E
AND SUPPORTED HHS AND THE
DEVELOPMENT OF THE FIRST
HISPANIC HEALTH SURVEYS TO TODAY
LEADING OUTREACH FOR THE ALL OF
US PROGRAM AND THE HEALTHY
AMERICAS FOUNDATION.
NOT ONLY A CONSORTIUM OF 27
RESEARCH TEAMS AND RESEARCHERS
CONDUCTING GROUNDBREAKING
RESEARCH IN HISPANIC HEALTH AND
WELL BEING.
HFK HISPANICS ARE WILLING TO
PARTICIPATE AND A SURVEY SHOWED
6% WERE IN CLINICAL RESEARCH.
WE JUST COMPLETED ACROSS THE
NATION IN HISPANIC COMMUNITIES
PARTICIPANTS WERE WILLING TO
ENROLL IN RESEARCH AND THE
LARGEST MOTIVATOR WAS TO IMPROVE
THE HEALTH FOR THEIR 2367 AND
FAMILY AND COMMUNITY.
THESE ARE PERSONAL DECISIONS TO
IT ENTER IN CLINICAL RESEARCH.
DESPITE THE DATA SHOWING THE
CENTRAL ROLE OF A PERSON ASKING
TO JOIN CLINICAL RESEARCH THE
MOST IS UNIVERSITY BASED AND
DOES NOT WORK AND INVOLVE
COMMUNITY LOOKING AT BREAST
CANCER TREATMENT EXPERIENCES WE
FOUND THE LARGEST REASON PEOPLE
DIDN'T JOIN CLINICAL RESEARCH
WERE THEY WEREN'T ASKED.
REFORM IS NEEDED.
AND MANDATES HAVE NOT WORKED.
WE SHOULD BE IMPLEMENTING
PRINCIPLES OF COMMUNITY-BASED
RESEARCH.
NIH SHOULD NOT BE FUNDING
RESEARCH THAT SHOULD NOT BE
FUNDED IF NOT VATE -- SEPARATING
DATA.
HISPANICS ARE 16.2% OF
PARTICIPATION.
SO ON A LARGE SCALE WE KNOW IT
CAN BE DONE IF IT'S DONE THE
RIGHT WAY.
THANK YOU SO MUCH.
>> THANK YOU.
WE DON'T WANT TO CUT YOU SHORT
IF THERE'S ANOTHER POINT YOU
WANTED TO HIT UPON.
THERE'S NO ONE IN THE WAITING
ROOM.
WE'VE HAD DECADES OF ASKING FOR
INCLUSION AND IT NEEDS TO BE
STRUCTURAL.
IT NEEDS TO FOLLOW THE MONEY.
WHAT ARE THE IMPLEMENTS?
ONE IS ADEQUATE FUNDING OF
TRUSTED COMMUNITY PARTNERS, TWO
IS THE CO-DESIGN WITH COMMUNITY
PARTNERS AND FEEDBACK AND THEY
WANT TO KNOW THE PARTICIPATION
IS MAKING A DIFFERENCE AND THREE
IS THE ONE TO ONE INFORMATION IN
A MOMENT AND SUPPORT AND
FOLLOW-UP.
I CANNOT EMPHASIZE THAT ENOUGH
WE HAVE MANY DIGITAL APPROACHES
BUT THE HIGH TOUCH IS THE
DIFFERENCE IN INCLUSION.
I CANNOT EMPHASIZE IT'S THE
CRITICAL DIFFERENCE IN SUCCESS.
FULL INCLUSION OF UNDER
REPRESENTED POPULATION SHOULD BE
A METRIC FOR SUCCESS AND WE
SHOULD BE REQUIRING RESEARCH TO
CONDUCT ONGOING TRACTING OF
THEIR INCLUSION -- TRACKING AND
THEIR INCLUSION AND REPORT TO
THE FUNDER SHOULD BE OPPORTUNITY
FOR MID COURSE CORRECTION IF THE
METRICS AREN'T BEING MET.
AND FINALLY I WANT TO SAY THE
PAYOFF FOR DOING THIS RIGHT IS
TREMENDOUS.
FOR EXAMPLE, HISPANICS
REPRESENTED LESS THAN 1% OF
GENOME-WIDE ASSOCIATION STUDIES.
WHAT DOES THAT MEAN?
IT MEANS STRUCTURALLY HISPANIC
COMMUNITIES WILL NOT BENEFIT
FROM DISCOVERIES USING THE
GENOMIC DATABASE OR FROM
PERSONALIZED MEDICINE.
BUT IN THE ALL OF US RESEARCH
PROGRAM, DOING IT THE RIGHT WAY
AND GETTING 16.2% OF THE
DATABASE WITH HISPANIC
PARTICIPANTS HAS DRAMATICALLY
CHANGED THE AMOUNT OF GENETIC
DATA AVAILABLE AND IT'S VERY
ROBUST BECAUSE IT INCLUDES
ELECTRONIC HEALTH RECORDS AND
OTHER DATABASES.
THAT CHANGE MEANS THE STRUCTURAL
BARRIER IS GETTING REMOVED AND
DRAMATICALLY GOING TO CHANGE THE
FUTURE FOR HISPANICS BENEFITING
FROM PERSONALIZED MEDICINE.
AGAIN, THANK YOU SO MUCH.
>> THANK YOU FOR THOSE
INSIGHTFUL COMMENTS.
WE VERY MUCH APPRECIATE IT.
OUR NEXT SPEAKER IS HERE.
I'M LETTING HER IN RIGHT NOW.
HELLO?
>> CAN YOU HEAR ME?
>> THE FLOOR IS YOURS.
LET ME KNOW WHEN YOU WANT TO
START AND I'LL START THE
COUNTDOWN FOR YOU.
>> I'M ALL SET.
FIRST, THANK YOU FOR THE
OPPORTUNITY TO SPEAK THIS
MORNING AND FOR HOSTING THIS
PUBLIC COMMENT SESSION.
THANK YOU FOR FOCUSSING ON HOW
THE RESEARCH ENTERPRISE CAN WORK
TOWARDS BECOMING MORE
TRUSTWORTHY.
MY NAME IS RANA BARAR FOR THE
COMMUNITY ENGAGEMENT PROGRAM AT
THE CLINICAL SCIENCE INSTITUTE
AT THE UNIVERSITY OF CALIFORNIA
SAN FRANCISCO.
SINCE SO MUCH OF RESEARCH
PRACTICE TRICKLES DOWN FROM
POLICY AND FUNDING STRUCTURES
I'LL START MY COMMENTS AT THAT
LEX.
FUNDING AGENCIES NEED TO FULLY
EMBRACE THE IDEA THAT ENGAGEMENT
AND PARTNERSHIP ARE NOT
TRANSACTIONAL ENDEAVORS AND
ONGOING AND AS MANY HAVE SAID
ALREADY ON THE CALL
BI-DIRECTIONAL.
PARTNERSHIPS ARE BUILT ON TRUST
WHICH TAKES TIME AND MOST
IMPORTANTLY INVESTMENT.
HOW DOES AN EARLY CAREER
RESEARCHER BUILD TRUSTING
RELATIONSHIPS WITH COMMUNITY
PARTNERS WITHOUT THE TIME,
FUNDING AND INSTITUTIONAL
SUPPORT TO DO SO.
INVESTING IN COMMUNITY
ENGAGEMENT NETWORKS, PARTNERSHIP
DEVELOPMENT, DEVELOPMENT GRANTS
AND PARTNERSHIP SUSTAINABILITY
IS ESSENTIAL.
I KNOW THAT WE ALWAYS TEND TO
FOCUS ON RESOURCES BUT THIS IS
AN AREA WHERE RESOURCES CAN
REALLY MAKE A DIFFERENCE IN
ALLOWING RESEARCHERS TO
ESTABLISH ONGOING BI-DIRECTIONAL
TRUST IN PARTNERSHIPS.
FUNDERS CAN ALSO PLAY A
PROACTIVE ROLE IN DEVELOPING
TRAINING AND ORIENTATION FOR
COMMUNITIES ABOUT HOW RESEARCH
AND RESEARCH PARTICIPATION
HAPPENS.
SO MANY INSTITUTIONS INCLUDING
MY OWN END UP DEVELOPING THESE
KINDS OF RESOURCES THEMSELVES
AND HAVING THE NIH AND THE
WORKING GROUP PLAY A MORE ACTIVE
ROLE IN PROVIDING INFORMATION
AND TRAINING TO COMMUNITIES
WOULD PROVIDE AN ECONOMY OF
SCALE.
INSTITUTIONAL POLICY AS WE ALL
KNOW ALSO GOVERNANCES SO MUCH OF
HOW COMMUNITY ENGAGEMENT TAKES
PLACE AND POLICY MAKING AS IT
PERTAINS TO INTRAMURAL FUNDING
DECISIONS, IRB PRACTICES, A.I.
AND DATA SHARING PRACTICES AND
POLICIES IS REALLY IMPORTANT.
THIS IS PARTICULARLY CLEAR IN
THE AREA OF PARTICIPANT AND
COMMUNITY PARTNER REMUNERATION
WHICH ARE PRACTICES WHICH ARE
ALL OVER THE PLACE AND THE BANE
OF MOST RESEARCH MANAGER'S
EXPERIENCE AND NIH CAN EASE THIS
TENSION BY USING THE FAIR MARKET
CAL KWLATER.
-- CALCULATOR.
THERE'S NUMEROUS INTERVENTIONS
THAT MAKE A HUGE DIFFERENCE.
FIRST AND FOR MOST TREATING
PARTICIPANTS AND COMMUNITY
PARTNERS AS THE EXPERTS THEY AND
REMUNE RATING THEM AS
APPROPRIATE.
-- TO THEIR EXPERTISE.
REVIEW CRITERIA AT ALL LEVEL
SHOULD INCLUDE ADEQUACY OF
COMPENSATION AND NURTURING
DIVERSE TEAMS FOR BUDGET AND
TRANSLATION ARE ALSO ESSENTIAL
PARTS OF THIS.
LASTLY, I JUST WANT TO RECOMMEND
AND ENCOURAGE FOLKS TO LOOK AT
THE MANY EXCELLENT MATERIALS
THAT HAVE ALREADY BEEN DEVELOPED
IN THIS AREA.
THE AAMC PRINCIPLES OF
TRUSTWORTHINESS AND THE
RECOMMENDATIONS FOR
STRENGTHENING IN PARTNERSHIPS
AND THE BELONGING INSTITUTES
GUIDELINES ARE RECENT EXAMPLES
AND THERE ARE EXISTING WORKING
GROUPS IN NETWORKS ON COMMUNITY
ENGAGEMENT SUCH AS THE NCATS
WORKING GROUP ON CE AND THE CTSI
TASK FORCE ON DEIA BUILDING ON
EXPERTISE AND RESOURCES CAN BE
VERY FRUITFUL.
THANK YOU AND I'M SORRY FOR
GOING A COUPLE SECONDS OVER.
>> NOT A PROBLEM AT ALL.
THANK YOU VERY MUCH FOR THOSE
COMMENTS.
WE APPRECIATE YOU TAKING TIME
OUT OF YOUR DAY TO TALK WITH US.
OUR NEXT SPEAKER IS JACQUELINE
DALTON.
SHE'LL BE JOINING US FROM THE
WAITING ROOM VERY SOON.
HELLO, JACQUELINE.
>> HELLO.
>> HOW ARE YOU?
THE FLOOR IS YOURS.
YOU'RE NOW ON THE WEBINAR.
TELL ME WHENEVER YOU'D LIKE TO
START AND I'LL START THE TIMER
FOR YOU.
>> I'M READY.
>> GREAT.
HELLO, EVERYONE.
I'M JACQUELINE DALTON DIRECTOR
OF THE HEALTH EQUITY COMMUNITY
COLLABORATIVE AT THE NATIONAL
NONPROFIT HEALTH LEADS.
I'M JOINING FROM NASHVILLE,
TENNESSEE WHERE I CO-CHAIR THE
GREATER NASHVILLE HEALTH
DISPARITIES COALITION A
COLLABORATIVE STARTED OVER 25
YEARS AGO AND CONTINUES TO
MAINTAIN STRONG TIES AND
RELATIONSHIPS WITH OUR LOCAL
ACADEMIC INSTITUTIONS TODAY.
I WANT TO THANK THE NIH FOR THE
CISCRP TO COMMENT ON ENGAGEMENT
AND CLINICAL RESEARCH AND MY
RESEARCH HAS HAD PERSPECTIVES ON
THE LAST 10 OR 12 YEARS.
MY COMMENTS CENTERS AROUND A
QUOTE FROM ADRIAN MARIE BROWN
WHO LIKES TO SAY TREAT ME LIKE A
HUME AN.
PEOPLE ARE OFTEN TIMES SEEN AS
ONE DIMENSIONAL OR THE FOCUS OR
TARGET OF AN ISSUE OR
CIRCUMSTANCE OF WHICH THE
RESEARCH TYPICALLY FOCUSES ON.
AND THIS IS SIMILAR TO WHAT I'VE
SEEN WHEN IT COMES TO ENGAGING
PEOPLE IN CLINICAL RESEARCH.
EACH HUMAN BEING IS DYNAMIC.
THERE ARE MULTIPLE LIVED
EXPERIENCES AND AREAS OF
KNOWLEDGE AND INTERESTS THAT
GOES INTO HOW THEY MAY OR MAY
NOT SHOW UP WHEN IT COMES TO
BEING INVOLVED IN CLINICAL
RESEARCH.
SO WHEN SPEAK -- SEEKING TO
ENGAGE PEOPLE IN CLINICAL
RESEARCH I BELIEVE IT'S
IMPORTANT WE NOT ONLY TAKE
INFORMATION FROM THEM AND
UNDERSTAND THEY MAY NOT BE
WILLING TO RETURN IF WE JUST TO
THE INFORMATION AT THEM OR
INUNDATE THEM WITH INFORMATION
FROM A PROTE COOL.
WHEN IT COMES TO ENGAGING PEOPLE
IN RESEARCH THEY OFTEN WANT TO
BE RESPECTED AND TREATED AS
PARTNERS AND NOTE A CHECK BOX.
THEY WANT TO BE LISTENED AND SEE
THE VALUE OF THEIR INVOLVEMENT
REFLECTED IN THE RESEARCH YOU'RE
INVOLVING THEM.
NOT
>> UST -- NOT JUST THAT YOU
HEARD THEM BUT WHEN WILL THEY BE
ABLE TO SEE THE CHANGE IN THE
RESEARCH FOR OTHER INITIATIVES.
IF NOTHING ELSE MY COMMENT IS
WHEN YOU SEEK TO ENGAGE PEOPLE,
TREAT THEM AS HUMAN BEINGS WHO
ARE DYNAMIC AND HAVE A WORLD OF
VARYING KNOWLEDGE AND INTEREST
AND COMMUNITY TO BRING TO THE
TABLE WHEN IT COMES RESEARCH.
THEY WANT TO KNOW YOU CARE ABOUT
THEM AND OTHERS WHO THEY HAVE
SHARED CIRCUMSTANCE OR LIVED
EXPERIENCE LIKE THEY HAVE.
NOT JUST WHEN YOUR RESEARCH IS
FUNDED BUT BEYOND THE RESEARCH
OR GRANT.
THEY WANT TO KNOW YOU CARE ABOUT
THEM AND VALUE THEM AS HUMAN
BEINGS TO MAINTAIN CONNECTION
AND RELATIONSHIP EVEN WHEN THE
PROJECT IS OVER AND WHEN THERE'S
NO FUNDING THAT SAYS YOU NEED TO
CARE.
HUMAN BEINGS ARE CAPABLE OF
PROVIDING INVALUABLE INPUT AS
COLLABORATORS AND DECISION
MAKERS.
I BELIEVE IT'S TIME TO MAKE THIS
SHIFT IN THE RESEARCH BROADLY
TODAY TO TREAT PEOPLE AS HUMAN
BEINGS.
THANK YOU SO MUCH.
>> THANK YOU, JACQUELINE AND FOR
THOSE THOUGHTS.
OUR NEXT SPEAKER IS AVAILABLE,
IT'S SCOTT JOINING US NOW.
WE'RE HAPPY TO HERE YOUR
COMMENTS.
>> I'M GOOD TO START.
SO MY NAME IS SCOTT DID --
DANISKA AND EXPERIENCED IT
THROUGH RESEARCH AND PARTICIPANT
AND HAVE SEEN HUNDREDS OF
DOCTORS AS A PATIENT AND SPOKEN
TO THOUSANDS OF OTHER PATIENTS
OVER THE COURSE OF EIGHT YEARS.
IN MY EXPERIENCE THE PATIENTS
KNOW MORE THAN THE DOCTORS.
THE DOCTORS RARELY READ NEW
PUBLICATION.
COORDINATION IS CRITICAL IF
WE'RE TO GET ANYWHERE IN TERMS
OF IMPROVING QUALITY OF HIVE AND
WE HAVE RESEARCHERS SO LOST IN
FIBROMYALGIA AND OTHERS AS IF
THEY'RE PSYCHOLOGICAL DISEASES.
JUST TALK TO ANY OF THESE
PATIENTS OUT THERE THAT HAVE THE
CONDITIONS AND YOU'LL FIND OUT
VERY QUICKLY THEY'RE NOT.
WE CANNOT AFFORD RESEARCH THAT
DOES NOT HAVE A CONSISTENT FOCUS
ON IMPROVING PATIENT QUALITY OF
LIFE ANYMORE.
IN ACADEMIA THAT'S FREQUENTLY
THE CASE OF LEARNING FOR THE
SAKE OF LEARNING AND WE'RE NEAR
THE BREAKING POINT OF SOCIETY IN
OUR ECONOMY IF WE DON'T
PRIORITIZE NOVEL TREATMENT
DEVELOPMENT AND PATIENT OUTCOMES
OUR SITUATION WILL SOON BECOME
CATASTROPHIC AS CHRONIC ILLNESS
CONTINUES TO RISE.
TO GET THE BEST REPRESENTATION
YOU NEED TO SPEAK TO A VARIETY
OF PATIENTS DIRECTLY.
I PROPOSE THERE'S TWO TYPES OF
PATIENTS, ONE A LAY GROUP THAT
REPRESENTS THE PATIENT
POPULATION AS A WHOLE AND THE
OTHER BEING PATIENTS WITH A
TECHNICAL BACKGROUND OR
UNDERSTANDING FOR GRANT
REVIEWING.
I PROPOSE FEEDBACK FROM THE
COMMUNITY AND WE HAVE A LIVE
CHAT SUCH AS DISCORD OR SLACK
WHERE PATIENTS CAN POST TO
RESEARCHERS FOR SOURCING IDEAS
AND BETTER UNDERSTANDING
SYMPTOMS AND HAVING A DIRECT
LINE OF COMMUNICATION RATHER
THAN TRYING TO BOMBARD RESEARCH
OFFICES AND EVERY LINKEDIN
PROFILE ON THE INTERNET.
THERE MUST BE STRATEGY FOR
INCLUDING SEVERE PATIENT
POPULATION WITHOUT THAT
RESEARCHERS DON'T UNDERSTAND HOW
SERIOUS IT IS AND DR. NATH MADE
A COMMENT ME/CFS PATIENTS AREN'T
SO SEVERE.
PATIENTS SACRIFICE A TREMENDOUS
AMOUNT OF TIME, ENERGY AND
LITERALLY BLOOD TO PROVIDE THE
SAMPLES AND NEED THE INFORMATION
TO UNDERSTAND THEIR OWN BODY
CHEMISTRY IN A WAY THAT DOESN'T
RACK UP FOR MEDICAL BILLS FOR
THOSE WHO HAVE NO INCOME.
THE CONSUMER REVIEWER PROGRAM
RAN BY THE DEPEND OF DEFENSE IS
GREAT.
I MADE A DRAMATIC IMPACT IN MY
EXPERIENCE WITH THE REST OFF THE
REVIEW BOARD AND THIS PROGRAM
SHOULD BE EXPANDED TO ALL OF
NIH.
HOWEVER, WE NEED TO LIMIT
PARTICIPATION TO PATIENTS WITH
SOME DEGREE OF SCIENTIFIC
LITERACY TO GET THE MOST
INFORMATIVE RESPONSES.
ONE CONSUMER WE VIEWER DIDN'T
HAVE A TECHNICAL BACKGROUND AND
COULDN'T SPEAK ON THE TOPIC.
PATIENTS ARE SO DESPERATE FOR
ANSWERS MANY WOULD RATHER DIE
LAN LIVE WITH THEIR CHRONIC
ILLNESS.
I KNOW OF OF AN INTERNET GROUP
EXPERIENCED IN THE TRIAL OF IT
AND PULL THEIR MONEY TOGETHER
NORTH OF $100,000 PER ORDER AND
HAVE EXPERIMENTAL DRUGS YOU
NEVER HEARD OF MANUFACTURED IN
CHINA, REPACKAGED IN SUPPLEMENT
BOTTLES DISTRIBUTED ACROSS THE
U.S.
PATIENTS WILL NOT WAIT FOR
ANSWERS TO COME AND SOME
CLINICAL TRIALS INCLUDING A
SLEEP TRIAL AND SUPPLEMENTS
WON'T CUT IT.
OUR RESEARCHERS NEED TO HEAR IT.
THAT'S IT.
THANK YOU.
THANK YOU FOR JOINING US, SCOTT.
WE APPRECIATE THE COMMENTS.
ADAM FAGAN IS JOINING US NEXT
FROM THE WAITING ROOM TO THE
WEBINAR.
>> WE'RE READY TO HEAR YOUR
COMMENTS WHEN YOU'RE READY TO
START.
>> I'M ADAM FAGAN FOR THE
ASSOCIATION OF SCIENCE AND
TECHNOLOGY CENTERS NONPROFIT
MEMBERSHIP ORGANIZATION FOR
SCIENCE CENTERS AN MUSEUMS AND
OTHERS WHO ENGAGE THE PUBLIC IN
SCIENCE AND PUBLIC.
OUR MEMBERS DIRECTLY ENGAGE OVER
100 MILLION INDIVIDUALS AND
PLAYERS IN THE INTERSECTION OF
SCIENCE AND SOCIETY IN EVERY
COMMUNITY ACROSS THE COUNTRY.
THANK YOU TO THE NIH OFFICE OF
SCIENCE POLICY AND CLINICAL
RESEARCH PARTICIPATION AND
SOLICITING PUBLIC INPUT.
WE'RE GLAD TO SEE NIH ENGAGE THE
PUBLIC IN RESEARCH AND THOUGH
IT'S KEY IN NIH PROGRAMS IT'S
NOT YET BEEN EMBRACED ACROSS THE
AGENCY.
ONE IMPORTANT WAY FOR PUBLIC TO
HAVE TRUST IN SCIENCE IS TO FEEL
AGENCY AND OWNERSHIP IN THE
PROCESS.
WHILE THE PACE OF SCIENCE HAS
ACCELERATED AND OUR
UNDERSTANDING OF WHAT MAKES FOR
ETHICAL RESEARCH HAS EVOLVED,
EFFORTS TO MORE FULLY ENGAGE THE
PUBLIC HAVE NOT KEPT PACE.
THE PUBLIC HAS GENERALLY NOT
BEEN BROUGHT INTO DISCUSSION OF
WHICH RESEARCH TO BE PURSUED,
HOW THE INVESTIGATIONS ARE TO BE
CONDUCTED AND WHO BENEFITS.
ABOUT THE ENGAGE INITIATIVE
INCLUDING THE WORKING GROUP IT'S
DEFINED THROUGH ADVOCATES AN FOR
THE PATIENT ADVOCACY COMMUNITY
ARE CRITICAL COMPONENTS AROUND
CLINICAL RESEARCH THERE'S A
WIDER UNIVERSE OF PEOPLE WHO
SHOULD BE ENGAGED.
PUBLIC ENGAGEMENT IS STRENGTHENS
IF IT INCORPORATES THE VOICES OF
THOSE NOT ONLY WITH A DIRECT
PERSONAL STAKE BUT THE PUBLIC.
THE MORE ENGAGED THE HIGHER
TRUST AND GREATER SUPPORT FOR
BIO MEDICAL RESEARCH.
MOREOVER, RESEARCH HAS SHOWN
SIXTY -- U.S. ADULTS HAVE AN
APPETITE FOR ENGAGING IN
RESEARCH AND CLINICAL TRIALS AND
A RANGE OF TOPICS RELEVANT TO OR
OF INTEREST TO A BROADER CROSS
SECTION OF PEOPLE INCLUDING MANY
WHO ARE NOT YET AWARE OF THE
FUTURE DIAGNOSIS.
THIS COMMITMENT TO BROAD PUBLIC
ENGAGEMENT ENSURES A VOICE FOR
ALL BACKGROUNDS AND RESEARCH,
PRIORITIES, PRACTICES AND
FINDINGS.
AS NIH CONTINUES TO REFINE ITS
PLANS WE URGE YOU TO BROADEN THE
REACH OF THE INITIATE AND TAP
INTO THOSE WITH EXPERIENCE IN
THE WORK.
AS AN ORGANIZATION WITH A VISION
OF INCREASING UNDERSTANDING OF
AND ENGAGEMENT WITH SCIENCE AND
TECHNOLOGY AMONG ALL PEOPLE, OUR
MEMBERS ARE AMONG THE
ORGANIZATIONS WELL POSITIONED TO
WORK WITH PARTNERS AT NIH AND
BEYOND TO ENGAGE THEIR
COMMUNITIES IN OPEN AND HONEST
DISCUSSIONS INCLUDING AROUND
CLINICAL RESEARCH AND THE
UNDERLYING SCIENCE.
AS HIGHLY TRUSTED INSTITUTIONS,
SCIENCE CENTERS AND MUSEUMS
TACKLE IMPORTANT CHALLENGES
INCLUDING THE MANY SUPPORTED BY
THE SCIENCE EDUCATION
PARTNERSHIP AWARD PROGRAM NOW
BASED NIGMS AND HAVE EXPERTISE
AND THOSE THAT TOUCH ON
SENSITIVE SOCIETAL ISSUES.
THANK YOU FOR THE COMMUNITY AND
WE LOOK FORWARD TO WORKING WITH
YOU.
>> THANK YOU, VERY MUCH, ADAM.
AT THIS POINT WE HAVE NO ONE IN
THE WAITING ROOM.
WE HAD A FEW PEOPLE
UNFORTUNATELY FOR ONE REASON OR
ANOTHER UNABLE TO JOIN US AND
AFTER THE MEETING WE'LL E-MAIL
THEM AND ENCOURAGE THEM TO
SUBMIT WHAT THE COMMENTS THEY
WERE GOING TO GIVE.
WE HAVE ONE MORE SPEAKER SIGNED
UP FOR 2:10 P.M.
THEY'RE NOT IN THE WAITING ROOM
YET SO I DON'T KNOW IF YOU AND
YOUR COLLEAGUES AND THE TO DO
WRAP-UP AND IF THAT PERSON JOINS
WE CAN ACCOMMODATE THEIR COMMENT
TO KEEP THE FLOW OF THE MEETING
GOING.
>> I WOULD LOVE TO HEAR FROM
CHRIS AND SUE DIRECTLY.
I KNOW WE STRUGGLED WITH HAVING
WE'RE NOT JUST TALKING ABOUT
PEOPLE JUST IN THE TIME OF NEED
AND I'D LOVE IT IF YOU WANTED TO
REFLECT ON THE COMMENT.
ADAM'S POINT WAS SPOT ON IF YOU
WANTED TO REFLECT ON THAT.
>> I WANT TO EXPRESS ON BEHALF
OF ALL OF US OUR APPRECIATION
FOR ALL THE COMMENTS THAT WE'VE
HEARD ESPECIALLY THE ONE YOU
JUST MENTIONED, LYRIC.
THIS IS SOMETHING OUR WORKING
GROUP HAS BEEN VERY PASSION NAL
ABOUT THE NEED TO EXPAND OUR
REACH.
IT CAN'T JUST BE A SPECIFIC
GROUP OF PEOPLE AND HARD TO
REACH POPULATIONS AND I AGREE
THE COMMENTS HAVE BEEN SPOT ON
AND MANY OF THE OTHERS WE HEARD
FROM THE OTHER SPEAKERS TODAY
OUR THEMES THAT HAVE COME UP
OVER AND OVER AGAIN.
ON ONE HAND NOT GREAT THAT WE
HAVE SO MANY ISSUES THAT WE IT
NEED TO TACKLE BUT ON THE OTHER
HAND WE LOOK AT THESE AS
OPPORTUNITIES TO BUILD AND GROW
FROM WHERE WE ARE SO AGAIN I
WANTED TO EXPRESS OUR
APPRECIATION.
SUE, I'M SURE YOU HAVE A FEW
THINGS YOU'D LIKE TO SAY ALSO.
>> I APPRECIATE IT SOME THINGS
THAT AND IT CAN'T BE STUDY BY
STUDY.
IT'S A PROCESS.
IT HAS TO BE ABOUT THE RETURN OF
VALUE AS WELL TO THE COMMUNITIES
AND THINKING ABOUT THEY ARE
PERHAPS BE DESIGN BY THE NIH TO
HELP WITH THAT AND INVOLVED IN
THE SCIENCE INSTITUTE IN
COLUMBIA FUNDED IN ROUND ONE A
LONG TIME AGO AND AS A RAPID
RADX OP INVESTIGATOR.
I THINK ABOUT THIS ALL THE TIME
BECAUSE I FEEL SO MUCH
INVESTMENTS GOES INTO
ESTABLISHING THESE NETWORKS
BUILT FOR PURPOSE.
I WONDER HOW DO WE KEEP THEM
WARM IN BETWEEN.
SO MANY EFFORT WENT TO RADX
AFTER COVID WITH AMAZING
COMMUNITY ENGAGEMENT AND HOW CAN
WE TAKE ADVANTAGE OF THOSE
IMPORTANT LESSONS.
I THINK PROBABLY SOME OF THE
THINGS THAT ARE OUR INITIATIVE
ARE INTERNAL TO THE NIH AND
CREATE IS PROBABLY TACKLING SOME
OF THOSE KINDS OF THINGS AS WELL
BUT WE HEAR THAT NOT
TRANSACTIONAL DOESN'T CREATE
TRUST.
YEAH.
>> I KNOW WE'RE SCHEDULED TO
WRAP UP TOGETHER BUT I WOULD
LOVE TO TURN TO YOU TO REFLECT
ON THE CONVERSATION AND I KNOW
IT'S SOMETHING YOU THINK ABOUT
DAILY.
>> FIRST, THANK YOU, LYRIC AND
SUZANNE.
I COULDN'T AGREE MORE WITH YOUR
COMMENTS AND ECHO SOME OF THE
RICH AND VALUABLE COMMENTS THAT
WERE MADE THAT I THINK HIGHLIGHT
HOW WE HAVE TO MOVE BEYOND JUST
THAT TRANSACTIONAL APPROACH WE
CONTINUE TO ENCOUNTER EVEN WHEN
WE'RE ALL WELL INTENTIONED AND
RECOGNIZE THE IMPORTANCE OF
REINFORCING AND BUILDING ENG
ENGAGE
ENGAGEMENT.
I FOUND SO MANY COMMENTS ON
RECONSIDERING THE SCOPE AND
QUALITY OF ENGAGEMENT.
THERE'S MORE WE CAN BE DOING.
THERE'S VALUABLE COMMENTS THAT
RELATED TO WAYS THAT NIH FUNDED
RESEARCH COULD BUILD ON THE
CURRENT FOUNDATION OF ENGAGEMENT
AND EXPAND THAT FURTHER.
AND WE NEED TO THINK ABOUT EACH
PERSON IN A CLINICAL TRIAL AND
THEIR UNIQUE SITUATION AND
NEEDS.
THAT'S A VALUABLE REMINDER FOR
US.
WE TEND TO THINK ABOUT ENG
ENGINEENGINE
-- ENGAGEMENT AND IT'S A BROAD
NUANCE AND HAS TO BE FOCUSSED AT
A LEVEL AND INTRODUCE ITSELF IN
GENE THERAPIES AND PERSONALIZED
AND PRECISION MEDICINE, ORPHAN
AND RARE DISEASES.
THERE'S A LOT WE CAN LEARN FROM
THESE COMMUNITY INITIATIVES TO
HELP US UNDERSTAND MORE BROADLY
THE VARIATION IN NEED BASED ON
DISEASE, BASED ON EACH PATIENT'S
UNIQUE SITUATION AND HEALTH
JOURNEY.
>> TO MAKE SURE WE DON'T HAVE
OTHER PEOPLE IN THE WAITING ROOM
AND TALK ABOUT WHAT WILL HAPPEN
AFTER TODAY BECAUSE OF THE
SUSTAINABILITY WE'RE GOING TO
TALK ABOUT IN LEAVING YOU SO
TALK ABOUT AND RYAN I WANT TO
MAKE SURE WE'RE NOT CUTTING
ANYONE OFF.
>> NO, THERE'S NO ONE CURRENT HI
IN THE WAITING ROOM.
>> THANK YOU SO MUCH.
I'D LIKE TO BEGIN BY THANK
EVERYONE WHO TOOK TIME TO
PROVIDE PUBLIC COMMENT.
HOW DO WE ENGAGE HUMAN BEINGS TO
ENGAGE AND YOU'RE TAKING TIME
FROM YOUR LIFE TO SPEND IT WITH
US AND WANT TO EMPHASIZE WE'RE
DOING THIS BECAUSE WE WANT TO
HEAR IT AND WE WANT TO LEARN
FROM IT AND WANT TO USE IT
MOVING FORWARD.
YOUR TIME HOPEFULLY YOU FEEL IS
WELL SPENT AND TALK ABOUT HOW WE
HOPE TO KEEP YOU ENGAGED MOVING
FORWARD.
SO COMMENTS LIKE WE HEARD TODAY
AND WE HOPE TO HEAR MORE AGAIN
THROUGH THE WRITTEN REQUEST FOR
INFORMATION RESPONSES WILL SERVE
AS AN IMPORTANT INPUT IN THE
BUILDING BLOCKS OF THE
ENGAGEMENT RECOMMENDATION.
YOU HEARD TEASER INTERNAL WORK
WITH THE PROGRAM FOLKS WHO HAVE
HAVE BEEN SMART IN PIONEERING
THAT AND HOPEFULLY HEAR MORE AT
THE NEXT WEBINAR.
SPECIFICALLY THE WORKING GROUP
WILL USE THE INFORMATION TO
DRAFT PRODUCTS WHICH THEY
CONTINUE TO SHARE PUBLICALLY AND
AS SUE AND CHRIS MENTIONED IN
OTHER WAYS OF ENGAGING YOU
MOVING FORWARD.
WE'LL STAY TUNED AND MONITOR OUR
WEBSITE AND OUR LIST SERVE IF
YOU'RE NOT A SUBSCRIBER FOR HOW
TO GET INVOLVED THERE.
I WANT TO EMPHASIZE THERE WILL
BE MULTIPLE OPPORTUNITIES FOR
MEMBERS OF THE PUBLIC TO SHARE
THEIR FEEDBACK.
WE'LL MAKE SURE TO BROADLY
ANNOUNCE THE OPPORTUNITIES.
BEFORE I FULLY CLOSE, KEN, AS
OUR GRACIOUS CO-SPONSOR WHO I
ALREADY LEARNED SO MUCH FROM IS
THERE ANY REMARKS YOU'D LIKE TO
SHARE BEFORE WE CLOSE TODAY IN
>> NO, YOU HIT IT OUT OF THE
PARK.
WHAT A PLEASURE TO BE HERE AND
LEARN FROM ALL OF YOU.
WE LOOK FORWARD TO MORE
OPPORTUNITIES LIKE THIS.
THANK YOU SO MUCH.
>> SUE AND CHRIS, ANY FINAL
WORDS YOU'D LIKE TO -- ANY WORDS
YOU'D LIKE TO SHARE.
>> WE'VE LISTENED.
WE'LL CONTINUE TO LISTEN.
>> I'LL ECHO SAY AND THIS IS THE
FIRST OF MANY ADDITIONAL
OPPORTUNITIES TO HEAR FROM THE
COMMUNITY SO WE ENCOURAGE YOU TO
CONTINUE TALKING WITH US AND
PLEASE SHARE THE WORD WITH YOUR
COMMUNITIES SO WE DO HAVE THAT
MORE BROAD AND DIVERSE
PARTICIPATION AND VOICES IN
ENGAGE.
THANK YOU.
>> AND OF COURSE, MY
CO-PRESENTERS HAVE ENDED THIS
PERFECTLY SO WITH THAT I WILL
LEAVE YOU ALL AND STAY TUNED FOR
MORE INFORMATION AND WE'LL
CONTINUE TO REACH OUT TO SOLICIT
INFORMATION AS WE MOVE FORWARD.
THANK YOU FOR SPENDING YOUR TIM