GOOD AFTERNOON, EVERYONE.
THANK YOU TODAY FOR JOINING US
FOR THIS VERY TIMELY AND
IMPORTANT MEETING.
I'D LIKE TO THANK ALL OF YOU AS
WELL AS THE CO-CHAIRS, DR.
CHRISTINA REDWIG AND DR. SUSAN
RAMAN AND WORKING GROUP MEMBERS
FOR THEIR PARTICIPATION IN THIS
ESSENTIAL WORK.
ONE OF MY MISSIONS AND AREAS OF
FOCUS AS DIRECTOR OF NICHD HAS
BEEN TO PROTECT PREGNANT WOMEN
THROUGH RESEARCH INSTEAD OF FROM
RESEARCH.
PREGNANT AND LACTATING PEOPLE
AND CLINICIANS ARE FORCED TO
MAKE DECISIONS WHETHER TO TREAT
PREEXISTING OR EMERGING MILLION
CONDITIONS, DESPITE THE LACK OF
ADEQUATE SCIENTIFIC KNOWLEDGE
REGARDING SAFETY AND EFFICACY OF
TREATMENTS IN PREGNANT PEOPLE.
NICHD WAS PROUD TO LEAD THE
ORIGINAL TASK FORCE ON RESEARCH
SPECIFIC TO PREGNANT WOMEN AND
LACTATING WOMEN OR PRGLAC,
COMMITTED TO ENSURING PREGNANT
AND LACTATING PEOPLE ARE
INCLUDED IN RESEARCH AND HAVE
THE INFORMATION THAT THEY NEED
TO MAKE DECISIONS ABOUT THEIR
OWN CARE.
IN 2018 THE ORIGINAL PRGLAC TASK
FORCE RELEASED A SET OF
RECOMMENDATIONS AND THEN IN 2020
THEY RELEASED AN IMPLEMENTATION
PLAN.
IN THE THREE YEARS SINCE PRGLAC
ISSUED ITS IMPLEMENTATION PLAN,
NICHD AND OTHER NUMEROUS FEDERAL
AGENCIES HAVE BEEN HARD AT WORK
IMPLEMENTING THESE
RECOMMENDATIONS.
FOR EXAMPLE, NICHD CREATED THE
MATERNAL AND PEDIATRIC PRECISION
IN THERAPEUTICS HUB, OTHERWISE
KNOWN AS MPRINT, TO COORDINATE,
PRESENT, AND EXPAND THE
AVAILABLE KNOWLEDGE, TOOLS AND
EXPERTISE IN MATERNAL AND
PEDIATRIC THERAPEUTICS.
IT SERVES AS A NATIONAL RESOURCE
FOR CONDUCTING AND FOSTERING
THERAPEUTICS FOCUSED RESEARCH
INCLUDING TRIALS IN OBSTETRICS,
LACTATION, AND PEDIATRICS.
YOU'RE GOING TO HEAR MORE ABOUT
THESE EFFORTS IN FUTURE
MEETINGS.
ONE OF THE ORIGINAL PRGLAC
RECOMMENDATIONS WAS ESTABLISH
AND ADVISORY COMMITTEE TO
MONITOR AND REPORT ON
IMPLEMENTATION OF THE
RECOMMENDATIONS, UPDATING
REGULATIONS AND GUIDANCE, AS
APPLICABLE, REGARDING THE
INCLUSION OF PREGNANT WOMEN AND
LACTATING WOMEN IN CLINICAL
RESEARCH.
THE MOST RECENT PRGLAC
RECOMMENDATIONS STATED THAT ONCE
A CHARTER EXPIRES IN 2021,
ANOTHER COMMITTEE WITH A SIMILAR
RANGE OF EXPERTISE SHOULD BE
ESTABLISHED TO ENSURE THAT THE
STEPS RECOMMENDED BY PRGLAC ARE
IMPLEMENTED AND PROGRESS IS
MONITORED.
THIS PARTICULAR RECOMMENDATION
IS WHY WE'RE ALL HERE TODAY.
BY SERVING ON THIS WORKING GROUP
OF THE NATIONAL ADVISORY CHILD
HEALTH AND HUMAN DEVELOPMENT
COUNCIL, YOU ARE FULFILLING THIS
RECOMMENDATION.
AND ARE HELPING TO MONITOR
IMPLEMENTATION EFFORTS, AND YOU
WILL REPORT ON PROGRESS TOWARDS
PRGLAC'S VISION.
I WANT TO BE CLEAR WHILE THIS
GROUP CAME OUT OF THE ORIGINAL
PRGLAC, WE ARE NOT HERE NOW TO
EXTEND THEIR WORK.
WE ARE UNIQUELY FOCUSED ON
TRACKING IMPLEMENTATION ON THE
ORIGINAL 15 RECOMMENDATIONS.
THE IMPLEMENTATION WORKING GROUP
WILL HEAR FROM A RANGE OF
AGENCIES AND NON-FEDERAL
PARTNERS OVER THE SERIES OF YOUR
MEETINGS.
AS YOU HEAR ABOUT THEIR EFFORTS,
I URGE YOU TO CRITICALLY EXAMINE
THE IMPLEMENTATION PLAN AND HOW
THIS IS REFLECTED IN FEDERAL
EFFORTS.
I HOPE THAT YOU LEARN ABOUT THE
NUMEROUS SUCCESSFUL INITIATIVES
UNDERWAY, AND THAT YOU UNCOVER
BARRIERS TO IMPLEMENTATION, AS
WELL AS PUTTING FORWARD
RECOMMENDATIONS TO FACILITATE
CONTINUED IMPLEMENTATION OF
PRGLAC.
TODAY'S MEETING WILL FOCUS ON
TWO OF THE RECOMMENDATIONS
SPECIFICALLY.
THESE ARE RECOMMENDATIONS 12 AND
13.
RECOMMENDATION 12 WAS TO UTILIZE
AND IMPROVE EXISTING RESOURCES
FOR DATA TO INFORM THE EVIDENCE
AND PROVIDE A FOUNDATION FOR
RESEARCH ON PREGNANT WOMEN AND
LACTATING WOMEN.
RECOMMENDATION 13 WAS TO
OPTIMIZE REGISTRIES FOR
PREGNANCY AND LACTATION.
I'LL BE POPPING IN AND OUT TODAY
BECAUSE I'M IN PARALLEL MEETINGS
THIS AFTERNOON BUT I VERY MUCH
LOOK FORWARD TO YOUR FINAL
REPORT AND TO YOUR FINDINGS.
I WANT TO THANK YOU ALL
SINCERELY FOR YOUR TIME AND
SERVICE TO THIS VERY IMPORTANT
WORKING GROUP.
I'LL NOW HAND THE VIRTUAL FLOOR
OVER TO EMMA CARPENTER, WHO WILL
GUIDE US THROUGH THE SUBSEQUENT
SPEAKERS.
THANK YOU ALL VERY MUCH.
>> I'M EMMA CARPENTER, THE STAFF
COORDINATOR, LOOKING FORWARD TO
DIVING INTO THE TASK.
BEFORE I INTRODUCE THE
CO-CHAIRS, I'D LIKE TO GO OVER A
COUPLE HOUSEKEEPING ITEMS.
>> EMMA, I CAN'T HEAR YOU
EITHER, CAN YOU TURN UP YOUR
VOLUME PLEASE.
>> YES, UH-HUH.
IS THAT A LITTLE BIT BETTER?
>> A LITTLE, YES.
>> IT'S UP ALL THE WAY, I'M SO
SORRY.
I'M HOPEFUL THAT IS AS GOOD AS I
CAN DO, AS LOUD AS IT CAN GET.
I'D LIKE TO GO OVER HOUSEKEEPING
ITEMS.
SO FIRST OF ALL, FOR THE
DURATION OF THE MEETING KEEP
YOUR CAMERA ON, MICROPHONE ON
MUTE UNLESS YOU'RE PRESENTING OR
SPEAKING.
IN THE QUESTION-AND-ANSWER
SESSIONS FEEL FREE TO COME OFF
AND USE THE CHAT FUNCTION OR
CAMERA AND COME OFF MUTE.
JUST A REMINDER THIS IS A PUBLIC
MEETING, WE'RE BROADCASTING VIA
NIH VIDEO CARS, SO I JUST WANT
YOU TO BE AWARE OF THAT.
AND THAT IS PART OF WHY WE'VE
ASKED YOU TO KEEP YOUR CAMERAS
OFF, SO FOLKS LIVE ARE NOT
JUMPING BETWEEN CAMERAS.
FINALLY I WANT TO NOTE A COUPLE
OF MEMBERS HAVE DISCLOSED
POTENTIAL CONFLICTS OF INTEREST.
GIVEN THE SCOPE OF THE WORKING
GROUP AND SPECIFIC TOPICS WE'RE
DISCUSSING TODAY WE DO NOT
BELIEVE THEY WILL NEED TO RECUSE
THEMSELVES FROM THIS
CONVERSATION.
WITH THAT, I WILL HAND THE
VIRTUAL FLOOR OVER TO THE
CO-CHAIRS OF THIS WORKING GROUP.
THANK YOU FOR YOUR LEADERSHIP.
OVER TO YOU.
>> THANK YOU, EMMA.
AND I'LL GET STARTED.
AND I'LL TRANSITION OVER TO YOU.
I WORK FOR NOVARTIS
PHARMACEUTICALS, GLOBAL HEAD OF
PEDIATRIC AND MATERNAL HEALTH
POLICY.
I'M ONE OF THE CO-CHAIRS FOR
THIS IMPLEMENTATION WORKING
GROUP OF NICCHD.
I'M HONORED TO BE HERE TODAY AND
HUMBLED TO REPRESENT MEMBERS OF
THE ORIGINAL PRGLAC, TO EVALUATE
IMPLEMENTATION TO DATE OF 15
RECOMMENDATIONS.
SO IF WE CAN GO TO THE NEXT
SLIDE PLEASE.
I WILL WALK US THROUGH SOME SAME
INFORMATION THAT DR. BIANCHI
JUST DISCUSSED, JUST TO
REEMPHASIZE SOME CRITICAL
FACTORS FOR WHAT OUR SCOPE OF
WORK WILL BE OVER THE COURSE OF
THE NEXT FEW MONTHS.
SO, AS WAS LAID OUT, THIS WORK
COMES AND WAS ESTABLISHED IN THE
114th CONGRESS, THROUGH THE
21ST CENTURY CURES ACT WHERE AT
WHEN THE 21ST CENTURY CURES WAS
SIGNED INTO LAW IT WAS DESIGNED
TO ACCELERATE MEDICAL PRODUCT
DEVELOPMENT AND BRING NEW
INNOVATION AND ADVANCES TO
PATIENTS WHO NEED THEM.
CLEARLY, ONE OF THE COMPONENTS
OF THE 21ST CENTURY CURES ACT
INCLUDED ENSURING THAT WE
IDENTIFY AND ADDRESS GAPS IN
KNOWLEDGE, REGARDING SAFE AND
EFFECTIVE THERAPIES OF VACCINES
FOR PREGNANT WOMEN AND LACTATING
WOMEN.
IN THE ORIGINAL ORGANIZATION OF
THE PRGLAC, MULTIPLE SECTORS
WERE REPRESENTED, INCLUDING
MULTIPLE AGENCIES, SOCIETIES,
THE INDUSTRY, ACADEMIA,
NON-PROFIT ORGANIZATIONS, AND WE
WERE VERY WELL ORGANIZED AND LED
BY THE NICHD.
IN 2018, THE DELIVERABLE WAS
PROVIDED TO CONGRESS, WHICH
INCLUDED A REPORT THAT HAD 15
RECOMMENDATIONS TO PROMOTE THE
INCLUSION OF PREGNANT WOMEN AND
LACTATING WOMEN IN CLINICAL
TRIALS.
A COMPONENT OF THE
RECOMMENDATIONS WAS REQUEST TO
EXTEND THE PRGLAC CHARTER SO WE
COULD CONTINUE OUR WORK TO
DEVELOP IMPLEMENTATION GUIDANCE.
AND THEN IN 2020, THE
IMPLEMENTATION PLAN WAS ALSO
PRESENTED.
NEXT SLIDE PLEASE.
SO DR. BIANCHI LAID OUT THERE
WERE 15 RECOMMENDATIONS THAT
CAME THROUGH THE PRGLAC.
THIS PICTOGRAM INCLUDES ALL 15
OF THE RECOMMENDATIONS, PART OF
THAT ORIGINAL WORK THAT WAS
DELIVERED BY THE PRGLAC.
OF THESE 15 RECOMMENDATIONS,
THERE WAS A CENTRAL THEME, THE
CENTRAL THEME OF ALL
RECOMMENDATIONS WAS NEED TO
REALLY ALTER THE SCIENTIFIC
CULTURISM SHOWING SIGNIFICANTLY
LIMITED ASCERTAINMENT OF
KNOWLEDGE OF THERAPEUTIC SAFETY
EFFECTIVENESS FOR PREGNANT WOMEN
AND LACTATING WOMEN.
IF YOU LOOK ACROSS THE 15
RECOMMENDATIONS THERE WERE SOME
THEMES, APPROXIMATELY NINE
THEMES YOU COULD FIND INTERWOVEN
AMIDST THESE RECOMMENDATIONS.
THESE INCLUDED LEVERAGING
EXPANDED EXISTING FEDERAL
PROGRAMS, OR NETWORKS;
DEVELOPING SYSTEMATIC PLAN TO
DIRECT DATA IN PREGNANT WOMEN OR
LACTATING WOMEN; DEVELOP
RESEARCH TOOLS AND STRATEGIES;
CONSIDER TRIAL DESIGNS OPTIMAL
FOR PREGNANT WOMEN AND LACTATING
WOMEN; UTILIZE REGISTRIES AND
DATA SOURCES; ESTABLISH
PRIORITIZATION PROCESS FOR
THERAPEUTICS IN PREGNANCY AND
LACTATION; TO ADDRESS
INCENTIVES.
FOSTER NEED TO INCLUDE IN
RESEARCH; AND TO CREATE
PARTNERSHIPS.
WHAT WE'LL BE DOING IS GOING
FURTHER IN DETAIL TO EVALUATE
THEN HOW THE IMPLEMENTATION
PLANS SUPPORTING THESE
RECOMMENDATIONS ARE PROGRESSING
TO DATE.
IF WE CAN GO TO THE NEXT SLIDE
PLEASE.
NEXT SLIDE PLEASE.
SO, DR. BIANCHI NOTED, THE
CREATION OF THIS WORKING GROUP
IS THE RESULT OF ONE OF THE
RECOMMENDATIONS IN THE ORIGINAL
PRGLAC PLAN.
AND THIS IS THE CONGRESSIONAL
LANGUAGE THAT SUPPORTED THE
FORMATION OF THIS PARTICULAR
GROUP, AND WHAT YOU SEE IN THE
TEXT OF THE SLIDE IS A COUPLE
KEY THINGS I'D LIKE TO HIGHLIGHT
FOR YOU AND WAYS TO MONITOR AND
REPORT ON IMPLEMENTING
RECOMMENDATIONS, UPDATING
REGULATIONS, AND GUIDANCE,
SPECIFICALLY TO THE POPULATION
OF PREGNANT WOMEN AND LACTATING
WOMEN.
AND OUR COMMITTEE WILL DIRECT
THE SECRETARY TO SUBMIT A REPORT
TO CONGRESS OUTLINING THE
PROGRESS TO DATE.
SO, WE ARE -- IF WE CAN GO TO
THE NEXT SLIDE -- SERVING AS A
WORKING GROUP THAT AGREED TO
DRAFT ULTIMATELY THE REPORT ON
PROGRESS, THAT WILL BE REPORTED
TO THE NICCHD COUNCIL, THE
COUNCIL THEN PROVIDES UNDER THE
GUIDANCE UNDER THE DIRECTOR,
FROM THERE THIS REPORT WILL BE
PROVIDED TO CONGRESS.
NEXT SLIDE PLEASE.
WE DO HAVE A KEY SET OF
OBJECTIVES.
AS NOTED, WE WERE FORMED UNDER
RECOMMENDATION 15 OF THE PRGLAC
REPORT.
AND OUR WORKING GROUP WILL DO A
NUMEROUS SET OF REVIEWS.
WE'RE GOING TO REVIEW LARGELY
PUBLICLY AVAILABLE MATERIALS
PERTAINING TO IMPLEMENTATION
PROGRESS, SPEAKERS FROM RELEVANT
FEDERAL AGENCIES AND/OR
NON-FEDERAL ENTITIES WILL BE
INVITED TO COME AND DISCUSS ANY
PROGRESS TO DATE ON
IMPLEMENTATION PLAN.
THEY CAN ALSO OUTLINE BARRIERS
THAT THEY ARE FACED WITH, OR
THEY CAN OUTLINE EXISTING
PROGRAMS THAT ARE IN PLACE THAT
CAN BE UTILIZED TO ADDRESS SOME
OF THESE RECOMMENDATIONS.
WHAT WE WILL DO THEN IS REPORT
THE FINDINGS TO THE NICHD
COUNCIL AS OUTLINED IN THE
PREVIOUS SLIDE, AND THE REPORT
WILL BE SUBMITTED TO CONGRESS.
THE REPORT WILL INCLUDE OR WILL
OUTLINE IMPLEMENTATION PROGRESS,
INCLUDING RECOMMENDATIONS TO
FACILITATE THE IMPLEMENTATION,
WHERE IT'S NECESSARY FOR US TO
PROVIDE THAT GUIDANCE.
AND/OR WE COULD ALSO BE
INCLUDING SOME RECOMMENDATIONS
FOR RECONSIDERATION OF ELEMENTS
OF SPECIFIC RECOMMENDATIONS OR
RECOMMENDATIONS THEMSELVES.
NEXT SLIDE PLEASE.
WE HAVE AN AMBITIOUS TIMELINE.
WE'RE HERE IN THE FIRST
LEFT-HAND SIDE OF THE SLIDE
SECTION, WHERE WE'RE DOING OUR
INFORMATION GATHERING
DISCUSSIONS, AND BECAUSE TWO
MEETINGS ARE VIRTUAL WE'LL HAVE
QUITE A BIT OF OUR PREP WORK
DONE OFFLINE, PREPARING SO WE'RE
ABLE TO REALLY PROCESS THE
INFORMATION BEING PRESENTED TO
US, BY THE INVITED SPEAKERS.
WE'LL HAVE OUR THIRD MEETING IN
PERSON IN MARCH.
IN MARCH AND APRIL OF NEXT YEAR
THE REPORT WILL BE DRAFTED, AND
ALL OF US IN THE WORKING GROUP
WILL BE REVIEWING, PROVIDING
RECOMMENDATIONS FOR EDITING,
ADDITIONS, AND THAT REPORT WILL
BE FINALIZED, PRESENTED TO THE
NICHD COUNCIL, THE REPORT
FINALIZED IN JULY, AND PROVIDED
TO CONGRESS.
SO IT'S A VERY, VERY AMBITIOUS
TIMELINE.
NEXT SLIDE PLEASE.
SO, SUE AND I HAVE BEEN MEETING
OFFLINE WITH THE EXCELLENT NICHD
STAFF TO TRY AND ORGANIZE THIS
QUITE SIGNIFICANT SCOPE OF WORK
FOR OUR GROUP TO TAKE ON, AND TO
SUCCESSFULLY DELIVER ON.
WE THOUGHT THE BEST WAY TO
HANDLE ALL OF THE INFORMATION
THAT WILL BE REPORTED TO US
WOULD BE TO CLUSTER SOME OF THE
COMMON THEMES TOGETHER INTO FIVE
OVERARCHING TOPICS.
SO, WE AS A WORKING GROUP
DISCUSSED EACH OF THESE FIVE
TOPICS, FOLLOWING PROVISION OF
INSIGHTS FROM THE RELEVANT
INVITED SPEAKERS REPORTING ON
PROGRESS TO DATE.
THE FIVE CLUSTERS INCLUDE
CLUSTER A ON CONDUCT OF CLINICAL
RESEARCH AND TRIALS; CLUSTER B
ON EDUCATION, OUTREACH, TRAINING
AND CAREER DEVELOPMENT; CLUSTER
C ON POLICY, REGULATORY ISSUES
AND LIABILITY; CLUSTER D
REGISTRIES AND REAL WORLD DATA;
AND CLUSTER E, NOVEL DRUG
DISCOVERY AND DEVELOPMENT.
NEXT SLIDE PLEASE.
AND THEN THIS IS OUR WORK PLAN
WHERE WE WILL WORK THROUGH EACH
OF THE DIFFERENT CLUSTERS.
TODAY AS YOU'RE WELL PREPARED
FOR, WE WILL BE -- AFTER WE'VE
COMPLETED OUR OVERVIEW OF PRGLAC
VERSION 1.70 WE'LL MOVE TO D,
REGISTRIES AND REAL WORLD DATA.
IN JANUARY MEETING 2 WE'LL
DISCUSS CLUSTERS A AND E AND
CLUSTER C.
AND IN OUR FACE-TO-FACE MEETING
IN MARCH WE'LL BE DISCUSSING
PROGRESS TO DATE ON CLUSTER B.
AND SO I THINK THIS TAKES US TO
TODAY'S AGENDA.
I'LL TURN THINGS OVER TO SUE.
>> THANK YOU, CHRISTINA.
SO, AS CHRISTINA MENTIONED, OUR
FIRST MEETING IS CLUSTER D,
BOTH RECOMMENDATIONS CENTER ON
THE COLLECTION, ORGANIZATION,
AND UTILIZATION OF REAL WORLD
DATA.
OUR PLANNING TEAM DISCUSSED THE
LIKELY OWNERS OF THESE
ACTIVITIES, AND WE IDENTIFIED
THE OFFICE OF THE NATIONAL
COORDINATOR IN CENTER FOR
MEDICARE AND MEDICAID SERVICES,
THE FDA, AND THE NIH.
AND SO WE'RE FORTUNATE ENOUGH TO
HAVE STEPHANIE GARCIA FROM ONC
JOINING US TODAY, ALONG WITH
DOCTORS TRISH BRIGHT AND LEILA
TAHEEN AND DR. VANCE AND CHIN
FROM NICHD.
WHERE WE'D LIKE TO LAND AT THE
END OF THE TIME TOGETHER IN
MARCHING IS AN UNDERSTANDING
WHICH RECOMMENDATIONS HAVE BEEN
FULFILLED, WE'LL CODE AS GREEN;
WHICH RECOMMENDATIONS ARE IN
PROGRESS OR PLANNED, BUT HAVE A
CLEARLY DEFINED OWNER OR OWNERS
AROUND SUFFICIENT EVIDENCE
POINTING TO A TIMELINE FOR THEIR
EXECUTION, AND THOSE WILL BE
CODED IN YELLOW.
AND FINALLY WHICH
RECOMMENDATIONS HAVEN'T SEEN ANY
REAL GAINS.
AND THIS CATEGORY COULD INCLUDE
ACTIVITIES THAT HAVE BEEN
OUTSOURCED OR COMPLETED EYE
OTHER GROUPS OR PERHAPS NO
LONGER MAKE SENSE TO PURSUE.
THIS DIAGRAM WILL SERVE AS THE
FRAMEWORK ON WHICH WE'LL
CONSTRUCT OUR REPORT.
THERE IS ONE MORE COLOR THAT WE
HOPE NOT TO NEED, BUT IS
AVAILABLE TO US, AND THAT IS
WHITE.
AND THAT WOULD MEAN THAT WE
HAVEN'T ASSEMBLED THE ADEQUATE
INFORMATION TO MAKE A
DETERMINATION ABOUT THAT
RECOMMENDATION STATUS.
THAT ALSO MEANS THAT OUR GROUP
WILL NEED TO DO ADDITIONAL WORK
OFFLINE TO IDENTIFY THE CORRECT
DATA SOURCES AND REVIEW THE
MATERIALS THEY PROVIDE US SO
THAT WE CAN MOVE THAT INTO A
DEFINITIVE DETERMINATION.
NEXT SLIDE PLEASE.
SO, HOW WE PLAN TO ATTACK THE
CHALLENGES BY WORKING THROUGH
OUR ASSESSMENT OF PROGRESS MADE.
THE SUBRECOMMENDATIONS, SO YOU
CAN SEE ON THIS PICTOGRAPH WE'VE
BROKEN OUT RECOMMENDATION 1 INTO
FIVE MAIN SUBRECOMMENDATIONS.
IF YOU DO THE MATH IN YOUR HEAD,
WE'RE TALKING ABOUT 40
SUBRECOMMENDATIONS OVER THE
COURSE OF FOUR HALF DAYS THAT
WE'RE TOGETHER, WHICH IS A LOT
OF GROUND TO COVER, IN A
RELATIVELY SMALL PERIOD OF TIME.
AND BECAUSE OF THE DOMAINS THAT
ARE RELEVANT TO EACH GUEST
SPEAKER WILL VARY, WE ALSO DON'T
HAVE THE LUXURY OF HAVING THEM
PRESENT IN THE ORDER THAT WE
FIND THE RECOMMENDATIONS AND
IMPLEMENTATION PLAN DOCUMENT.
SO, IT WILL YOUR RESPONSIBILITY
AS WORKING GROUP MEMBERS TO
FAMILIARIZE YOURSELF WITH
RECOMMENDATIONS WE'RE COVERING
IN ANY GIVEN MEETING AHEAD OF
TIME AND RECORD YOUR THOUGHTS
ACROSS THE RELEVANT
RECOMMENDATIONS AS WE HEAR FROM
OUR SPEAKERS.
I'M I'VE GOT A MATRIX IN FRONT
OF ME TO TAKE NOTES AS WE MOVE
THROUGH OUR SPEAKERS TODAY.
RECOMMENDATION 12, WE'LL BE
CONSIDERING PROGRESS MADE IN THE
AREA OF EHR SYSTEMS, COMMON DATA
ELEMENTS, DATABASE AND REGISTRY
INFRASTRUCTURE, AND REAL WORLD
DATA ANALYTICS.
NEXT SLIDE PLEASE.
FOR RECOMMENDATION 13, WE'LL
DRILL DEEPER INTO THE REGISTRY
SPACE AND FOCUS ON PROGRESS MADE
AS RELATED TO STANDARDS,
TRANSPARENCY, CONSTRUCTION, AND
ACCESS.
SO THE OPERATIVE PHRASE TO KEEP
IN MIND AS WE WORK THROUGH THE
RECOMMENDATIONS IS
IMPLEMENTATION PROGRESS, DR.
BIANCHI MENTIONED WE'RE NOT
REFRAMING OR REVISING THE
RECOMMENDATIONS.
WE'RE SIMPLY EVALUATING WHETHER
AND TO WHAT EXTENT THEY HAVE
BEEN ADDRESSED.
SO, AS YOU LISTEN TO SPEAKERS,
START CATALOGING THE ACTIVITIES
IN THEIR RESPECTIVE
SUBRECOMMENDATION CATEGORIES, I
WOULD ALSO ENCOURAGE YOU TO JOT
DOWN ANY THOUGHTS OR QUESTIONS
THAT YOU HAVE FOR THE SPEAKERS,
AND PREPARE TO POST THEM IN THE
CHAT, IF YOU FIND THEY HAVE NOT
BEEN RESOLVED AT THE END OF THE
DISCUSSION.
SUGGESTING THAT WE RELY HEAVILY
ON THE CHAT FEATURE, NOT ONLY TO
FACILITATE EFFICIENCY DURING THE
MEETING BUT ALSO TO KEEP A
WORKING RECORD OF THE
INFORMATION THE COMMITTEE WANTS
TO SEE, IN THE EVENT OUR TIME
RUNS SHORT AND ADDITIONAL
OFFLINE REVIEW OR DELIBERATIONS
WILL BE REQUIRED.
AS WE GO ALONG YOU MIGHT
IDENTIFY OTHER ENTITIES
ADDRESSING THESE
RECOMMENDATIONS, AND WE WANT TO
CAPTURE THOSE OBSERVATIONS AS
WELL BECAUSE WE MAY NEED TO
REACH OUT TO THOSE ENTITIES IF
WE FEEL MORE OR ADDITIONAL
INFORMATION IS NEEDED.
FINALLY, EVEN THOUGH WE'RE NOT
TASKED WITH MAKING
RECOMMENDATIONS WE MAY HAVE
KNOWLEDGE OF OR CONCERN ABOUT
MAJOR BARRIERS THAT WOULD
PREVENT A RECOMMENDATION FROM
BEING REALIZED, WE WANT TO
CAPTURE THAT DISCUSSION AS WELL.
SO I'M GOING TO STOP HERE AND
OPEN THE FLOOR TO QUESTIONS THAT
YOU MAY HAVE FOR CHRISTINA OR
MYSELF ABOUT OUR ROLE OR THE
PROGRESS, BEFORE WE ACTUALLY GET
READY AND GET UNDERWAY.
>> I JUST WANTED TO SAY I THINK
IT'S GREAT THAT YOU CLARIFIED
THAT WE'RE NOT GOING TO CHANGE
ANY OF THE ALREADY ESTABLISHED
RECOMMENDATIONS.
>> THANK YOU, ALLISON.
>> ANY OTHER QUESTIONS FOR
CHRISTINA OR MYSELF?
THEY CAN ALWAYS GO IN THE CHAT
AS WELL.
BOTH CHRISTINA AND I WILL BE
MONITORING THE CHAT THROUGHOUT
THE AFTERNOON AS WE'RE
MODERATING THESE SESSIONS.
ALL RIGHT.
HEARING NONE, CHRISTINA, I'LL
ASK YOU DO WE NEED TO TAKE A
QUICK STRETCH BREAK OR GET
STARTED?
>> MY RECOMMENDATION WOULD BE TO
JUMP IN.
>> OKAY.
LET'S GO.
HOPEFULLY EVERYBODY HAS ENOUGH
ENERGY AND NUTRITION ON BOARD TO
GET US THROUGH THE FIRST ROUND
OF SPEAKERS.
WITH A HEAVY LIFTING BEGINNING
NOW, STAY ALERT, BE PREPARED,
PLEASE STAY WITH US.
THIS FIRST SESSION WE'LL BE
HEARING PRIMARILY FROM
REPRESENTATIVES OF NICHD, BOTH
SPEAKERS WILL BE TOUCHING ON
ELEMENTS OF RECOMMENDATIONS 12
AND 13, SO I WOULD ENCOURAGE YOU
TO HAVE SUBRECOMMENDATIONS CLOSE
AT HAND WHICH WOULD HELP YOU
ORGANIZE YOUR THOUGHTS AND
QUESTIONS.
AGAIN, HAVE THEM IN FRONT OF
YOU, START TAKING NOTES.
LET'S FIGURE OUT WHAT WE'RE
HEARING FROM OUR SPEAKERS.
PLEASE, PLEASE, PLEASE MAKE
LIBERAL USE OF THE CHAT FEATURE
FOR QUESTIONS.
IF THEY REMAIN UNADDRESSED AFTER
THE SPEAKERS CONCLUDE.
AS THOUGHTS COME TO MIND LET'S
HEAR THAT SPEAKER THROUGH
COMPLETELY, THEN POST ADDITIONAL
QUESTIONS IN THE CHAT.
RIGHT NOW LEADING OFF WILL BE
KATIE VANCE.
TAKE IT AWAY.
>> I'M GOING TO SHARE MY SCREEN.
GIVE ME A SECOND.
I'M GOING TO PRESENT WORK TO
LEVERAGE LARGE DATASETS,
INCLUDING REAL WORLD EVIDENCE,
I'M KATIE VANCE, PROGRAM OFFICER
IN OBSTETRIC AND PEDIATRIC
FARMOLOGY AND THERAPEUTICS
BRANCH.
RESEARCH FOR PREGNANT AND
LACTATING AND POSTPARTUM
POPULATIONS CONTINUES TO LAG.
THIS SUMMER NICHD SURVEYED
PROGRAM OFFICERS AND KEY NIH
STAKEHOLDERS IN MATERNAL AND
PEDIATRIC PHARMACOLOGY AND
THERAPEUTICS.
ONE OF THE QUESTIONS WE ASKED
WAS WHAT THEY PERCEIVE TO BE
MAJOR CHALLENGES FOR PROGRESS
FOR THESE PATIENT POPULATIONS.
THEY IDENTIFY A NUMBER OF
CHALLENGES, INCLUDING ETHICAL
CONCERNS, LACK OF PATIENT
PARTICIPATION IN RESEARCH,
SAMPLE COLLECTION METHODOLOGIES,
NEED FOR NOVEL STUDY DESIGNS,
SHORTAGE IN RESEARCH WORK FORCE,
LACK OF APPROPRIATE PRE-CLINICAL
MODELS.
THE MAJOR TAKEHOME MESSAGE FROM
THE SURVEY OF OUR NIH
STAKEHOLDERS IS THAT WE NEED
NOVEL METHODOLOGIES INCLUDING
UTILIZATION OF EXISTING LARGE
DATASETS TO PROMOTE INNOVATION
AND RESEARCH FOR PREGNANT AND
LACTATING AND POSTPARTUM
PERSONS.
THERE'S BEEN A LOT OF GROWING
MOMENTUM AND REAL WORLD DATA AND
REAL WORLD EVIDENCE ACROSS
SCIENCE AND MEDICINE.
THAT'S DRIVEN BY A NUMBER OF
FACTORS.
THERE ARE EMERGING AI/ML AND
OTHER TECHNOLOGIES THAT
FACILITATE THE EXTRACTION OF
DATA AND ANALYSES OF THESE DATA.
RECENT LEGISLATION INCLUDING
21ST CENTURY CURES ACT OF 2016
WHICH HAS BEEN ENACTED, THE 21ST
CENTURY CURES ACT WAS DESIGNED
ACCELERATE MEDICAL PRODUCT
DEVELOPMENT AND BRING INNOVATION
FASTER AND MORE EFFICIENTLY.
THE FDA HAS A REAL WORLD
EVIDENCE PROGRAM AND NUMBER OF
GUIDANCE DOCUMENTS SURROUNDING
THE USE OF REAL WORLD DATA AND
REAL WORLD EVIDENCE TO GUIDE
REGULATORY DECISION MAKING FOR
DRUGS AND OTHER BIOLOGICAL
PRODUCTS.
THE 2023 DATA MANAGEMENT AND
SHARING POLICY IS GOING TO BE
VERY IMPORTANT TO THE
GENERATIONS OF LARGE DATASETS AS
WELL AS SECONDARY USE OF LARGE
DATASETS.
WE'LL SEE A LOT OF DATA
AVAILABLE COMING UP IN THE NEXT
FEW YEARS FOR THE RESEARCH
COMMUNITY TO USE AND LEVERAGE TO
FIND NEW DISCOVERIES, NEW
TREATMENTS, NEW CURES.
AND THEN THERE'S BEEN A RECENT
DEMONSTRATION OF THE UTILITY OF
REAL WORLD EVIDENCE, IN 2021EN
APPROVED FOR USE, USING REAL
WORLD EVIDENCE, DATA CAN BE USED
TO IDENTIFY TREATMENTS FOR
PATIENTS.
IN THE LAST FEW YEARS NICHD DATA
SCIENCE PORTFOLIO AND REAL WORLD
EVIDENCE PORTFOLIO HAVE BEEN
GROWING.
THIS IS A SNAPSHOT OF SOME OF
THE AWARDED COMPETING GRANTS
INVOLVING DATA SCIENCE OR REAL
WORLD EVIDENCE STUDIES IN
PREGNANT, LACTATING, POSTPARTUM
PERSONS SINCE 2013.
YOU CAN SEE A BIG UPTICK IN THE
NUMBER OF AWARDS NICHD HAS MADE,
AND DATA SCIENCE AND REAL WORLD
EVIDENCE PORTFOLIO.
WE WANT TO CONTINUE THIS
MOMENTUM AND ENCOURAGE
EXTRAMURAL COMMUNITY TO LEVERAGE
LARGE DATASETS AND WE'RE DOING
THAT IN A NUMBER OF DIFFERENT
WAYS.
WE ARE ISSUES FUNDING
ANNOUNCEMENTS, RECRUITING NEW
PROGRAMS, WORKING WITH EXISTING
PROGRAMS, WORKING WITH OTHER NIH
PARTNERS TO HAVE TRANS-NIH
COLLABORATION TO ENCOURAGE
EXTRAMURAL COMMUNITIES TO
LEVERAGE DATASETS, AND WE'RE
ALSO RELYING ON OUR NICHD
RESOURCES.
SO TODAY I'M GOING TO SHARE A
FEW OF THESE EFFORTS NICHD HAS
USED TO PROMOTE USE MUCH REAL
WORLD DATA AND EVIDENCE FOR
PREGNANT, LACTATING, POSTPARTUM
PERSONS.
FIRST IS TRANSLATIONAL RESEARCH
IN MATERNAL AND PEDIATRIC
PHARMACOLOGY AND THEY ARE --
THERAPEUTIC OPPORTUNITIES,
STARTED IN 2009, REVISED IN 2023
TO FOCUS ON PRGLAC
RECOMMENDATIONS, INCLUDING
ENCOURAGEMENT TO SUBMIT FOR
FUNDING ANNOUNCEMENTS FOCUS ON
DEVELOPMENT OF NOVEL
GENERALIZABLE TOOLS, MODELS,
OTHER TECHNOLOGIES, AND THE
SPECIFIC REQUEST THAT WE HAD
WITH THESE FUNDING ANNOUNCEMENTS
WAS ENCOURAGING INVESTIGATORS TO
SUBMIT APPLICATIONS RELATED TO
THINGS LIKE MACHINE LEARNING
MODELS THAT INCORPORATE LARGE
DATASETS LIKE MULTI-OMICS OR
CLINICAL DATA, TO SUBMIT
APPLICATIONS FOR MODELS THAT
UTILIZE REAL WORLD DATA.
TOOLS AND OTHER RESOURCES THAT
UTILIZE PHARMACO EPIDATA, AND
OTHER METHODOLOGIES SUCH AS
AI/ML OR NLP POOLS TO FACILITATE
DATA EXTRACTION, HARMONIZATION,
AND INTEROPERABILITY,
INCREASINGLY MORE USED IN THE
RESEARCH COMMUNITY AND WE WOULD
LIKE TO LEVERAGE TECHNOLOGIES
AND CAPABILITIES FOR OUR PATIENT
POPULATIONS OF INTEREST.
THERE ARE THREE APPLICATIONS
THAT I WOULD LIKE TO TALK ABOUT.
THREE AWARDS THAT WE HAVE FUNDED
THROUGH OUR TRANSLATIONAL
RESEARCH PARS THAT SPECIFICALLY
DEAL WITH LEVERAGING HR, CLAIMS,
OTHER REAL WORLD DATA AND REAL
WORLD EVIDENCE IN PREGNANT,
LACTATING, AND POSTPARTUM
PERSONS, FIRST IS THE BOOST-HP
STUDY.
IT WAS AWARDED TO DR. JUDITH
MARO, AND THIS PARTICULAR AWARD
USES PRIVATE AND PUBLIC CLAIMS
DATA TO EVALUATE THE ASSOCIATION
BETWEEN PREGNANCY LOSS AND
TERATOGENIC RISK, THREAT
EXPOSURE, EVALUATING EXPOSURES
AND OUTCOMES SIMULTANEOUSLY.
AND THE LONG-TERM GOAL OF THE
AWARD IS TO BUILD A REUSABLE
SCALABLE APPROACH AND
INFRASTRUCTURE TO ACCELERATE
EVIDENCE GENERATION ON THE
SAFETY AND EFFECTIVENESS OF
MEDICATION USE DURING PREGNANCY.
THE NEXT AWARD THAT WAS GIVEN
OUT THIS SUMMER WAS DR. BEJAN,
AND IT'S THE LEVERAGE ARTIFICIAL
INTELLIGENCE METHODS AND
ELECTRONIC HEALTH RECORDS FOR
PEDIATRIC PHARMACOVIGILANCE.
A MAJOR PART OF THIS AWARD IS TO
EVALUATE THE IMPACT OF DRUG
EXPOSURE BEFORE AND DURING
PREGNANCY ON PEDIATRIC OUTCOMES.
SO THIS PARTICULAR AWARD HAS A
VERY LARGE COMPONENT ABOUT THE
IMPACT OF DRUGS ON PREGNANCY.
FINALLY THE MATERNAL COVID-19
VACCINATION AND LACTATION
OUTSOME STUDY BY DR. KRISTIN
PALMER, THE INVESTIGATORS WILL
USE EHR RECORDS LINKED WITH
STATE IMMUNIZATION RECORDS
ACROSS MULTIPLE HEALTH SYSTEMS,
AND THEY ARE GOING TO LOOK AT
HOW MATERNAL VACCINATION IMPACTS
INFANT GROWTH, INFANT CARE,
OTHER PREGNANCY AND POSTNATAL
THINGS, MASTITIS, BREASTFEEDING
STATUS, AND THE GOAL IS TO
COLLECT DATA AND INFORMATION
BOTH TO SUPPORT VACCINATION
DURING PREGNANCY AS WELL AS TO
MITIGATE SOME FEAR RELATED TO
VACCINATION DURING PREGNANCY.
THESE ARE SOME EXAMPLES OF SOME
INVESTIGATOR-INITIATED
APPLICATIONS THAT WERE SUBMITTED
TO A FUNDING ANNOUNCEMENT AT
NICHD UTILIZING REAL WORLD DATA
AND REAL WORLD EVIDENCE.
NEXT I'D LIKE TO TALK ABOUT SOME
EXISTING PROGRAMS, DR. BIANCHI
ALREADY MENTIONED THE MPRINT
HUB.
I'D LIKE TO COVER A LITTLE BIT
OF THE WORK THE MPRINT HUB IS
DOING.
SO, IT WAS ESTABLISHED TO
CATALYZE RESEARCH IN MATERNAL
AND PEDIATRIC PRECISION
THERAPEUTICS.
IT'S COMPRISED OF DATA MODEL
KNOWLEDGE AND RESEARCH
COORDINATION CENTER, AS WELL AS
VANDERBILT AND UCSD CENTERS OF
EXCELLENCE.
REAL WORLD EVIDENCE IS A
CROSS-CUTTING CONCERN ACROSS ALL
OF OUR THREE CENTERS.
FOR THE SAKE OF TIME, I'M JUST
GOING TO FOCUS ON THE WORK THAT
THE CARE C.C. IS DOING IN REAL
WORLD EVIDENCE.
THE FIRST CORE FOR THE KRCC IS
OUR REAL WORLD EVIDENCE CORE.
THE REAL WORLD EVIDENCE CORE
USES REAL WORLD DATA RESOURCES
TO CHARACTERIZE, STUDY, ADDRESS
RESEARCH QUESTIONS RELATED TO
MATERNAL AND PEDIATRIC
PHYSIOLOGY, PHARMACOLOGY,
CLINICAL OUTCOMES, THE ULTIMATE
GOAL IS TO ENHANCE DRUG SAFETY
AND EFFICACY.
NOW, OFTEN MOTHERS AND INFANTS
ARE TREATED AT MORE THAN ONE
HOSPITAL, EVEN MORE THAN ONE
HOSPITAL SYSTEM.
AND SO WE KNOW THAT IT'S VERY
DIFFICULT TO TRACK MATERNAL AND
CHILD DYADS FROM PREGNANCY
THROUGHOUT ADULTHOOD.
THE CORE IS DEVELOPING A LINKAGE
ALGORITHM FOR MATERNAL INFANT
RECORDS THAT WILL FACILITATE
RESEARCHERS IN EVALUATION OF
ASSOCIATION BETWEEN MATERNAL
EXPOSURE AND LONG-TERM PEDIATRIC
OUTCOMES, EVEN WHEN THE MOTHER
AND CHILD ARE TREATED ACROSS
DIFFERENT HEALTH SYSTEMS.
THE ULTIMATE GOAL OF THE SCORE
TO CREATE A CURATED
MATERNAL-PEDIATRIC DATA MART.
DATA WILL INCLUDE INFORMATION
RELEVANT TO UNDERSTAND DRUG
DISPOSITION AND RESPONSE, AND AS
WELL AS SUPPORT DRUG DEVELOPMENT
AND THERAPEUTICS AND MATERNAL
AND PEDIATRIC POPULATIONS.
ANOTHER CORE OF THE KRCC IS
KNOWLEDGE BASE AND PORTAL CORE
LED BY DR. LI.
ONE THING WE HEAR IS WE KNOW THE
DATA ARE OUT THERE BUT WE JUST
DON'T KNOW WHERE TO FIND IT.
AND ONE OF THE GOALS FOR THIS
PARTICULAR CORE IS TO DEVELOP A
KNOWLEDGE BASE OF DATA AND
RESOURCES, RELATED TO MATERNAL
AND PEDIATRIC THERAPEUTICS,
INCLUDING PHARMACOKINETICS,
PHARMACODYNAMICS, PEDIATRIC
ONTOGENY WITH PREGNANCY AND
LACTATION.
WHAT THE CORE IS GOING TO DO IS
INTEGRATE DATA SOURCES PUBLICLY
AVAILABLE AND IT'S GOING TO HELP
OUR RESEARCH COMMUNITY ASSESS
THE QUALITY, RELIABILITY, AS
WELL AS GAPS IN EVIDENCE,
SUPPORT TRANSLATIONAL RESEARCH.
I THINK THIS IS GOING TO GO A
LONG WAY TO SHOWING RESEARCH
COMMUNITY WHAT'S OUT THERE, AND
WHAT ELSE WE NEED TO FIND OUT.
NOW I'D LIKE TO TALK ABOUT A NEW
PROGRAM, SO THE IMPROVE PROGRAM
MATERNAL HEALTH RESEARCH CENTERS
OF EXCELLENCE INITIATED THIS
YEAR.
THESE ARE TEN RESEARCH CENTERS,
DATA INNOVATION AND COORDINATION
HUB.
AND IMPLEMENTATION SCIENCE HUB.
TOGETHER THESE INSTITUTIONS WILL
WORK TOGETHER TO DESIGN AND
IMPLEMENT RESEARCH PROJECTS TO
ADDRESS BIOLOGICAL BEHAVIORAL,
ENVIRONMENTAL, SOCIOCULTURAL AND
STRUCTURAL FACTORS THAT AFFECT
PREGNANCY-RELATED COMPLICATIONS
AND DEATH.
WE'LL FOCUS ON POPULATIONS THAT
EXPERIENCE HEALTH DISPARITIES
INCLUDING RACIAL AND ETHNIC
MINORITIES, ECONOMICALLY
CHALLENGED DISADVANTAGED
POPULATIONS, THOSE LIVING IN
UNDERSERVED RURAL AREAS, SEXUAL
AND GENDER MINORITY POPULATIONS,
AND PEOPLE WITH DISABILITIES.
AND THE CENTER I'D LIKE TO FOCUS
ON TODAY IS THE DATA INNOVATION
AND COORDINATION CENTER.
THE DATA HUB WILL DO A LOT OF
WORK IN THE REAL WORLD EVIDENCE
AND LARGE DATASET SPACE.
SO THEY WILL FACILITATE
HARMONIZATION WITH EXISTING
LARGE SCALE RESEARCH EFFORTS.
AND DATA TYPES THAT THESE
CENTERS AND DATA COORDINATION
HUB WILL WORK WITH INCLUDE REAL
WORLD DATA SUCH AS ELECTRONIC
HEALTH RECORDS, CLAIMS DATA,
PATIENT REGISTRIES, VITAL
STATISTICS AND SURVEILLANCE,
HOUSEHOLD SURVEYS, CENSUS DATA
AND SO FORTH.
THE INNOVATION AND COORDINATION
HUB WILL UTILIZE EXISTING
STANDARDS, AND FACILITATE
EXTRACTION AND TRANSFORMATION OF
DATA AS WELL AS DEVELOP METHODS
TO EXTRACT REAL WORLD DATA FROM
EHR RECORDS, PREDICTION AND RISK
ASSESSMENT, AS WELL AS DEVELOP
OTHER METHODOLOGIES USING AI/ML
AND DATA SCIENCE APPROACHES,
WITH EMPHASIS ON APPROACHES THAT
HAVE BALANCED ETHICAL CONCERNS
FOR THESE TOOLS SO WE DON'T
EXACERBATE ALREADY EXISTING
HEALTHCARE DISPARITIES.
AND WE'RE ALSO GOING TO PROVIDE
EXPERTISE AND INFRASTRUCTURE
NEEDED FOR DATA MANAGEMENT
INCLUDING STANDARDIZED
ACQUISITION, HARMONIZATION,
QUALITY ROLE, TIMELY
DISSEMINATION AND PUBLIC
ACCESSIBILITY TO THESE DATA,
IMPORTANT FOR US TO BE ABLE TO
COLLECT THE DATA IN A WAY THAT
MAKES IT REASONABLE AS WELL AS
TO SHARE THE DATA FOR FUTURE
USE.
I'D NEXT LIKE TO TOUCH ON
TRANS-NIH COLLABORATIONS THAT
NICHD IS WORKING ON RIGHT NOW
THAT PROMOTE THE USE OF LARGE
DATASETS.
THE FIRST I'D LIKE TO SPEAK
ABOUT IS HUMAN GENETICS
AMPLIFIER.
THIS IS A SOFTWARE PLATFORM AND
INFRASTRUCTURE THAT AGGREGATES,
INTEGRATES, ANALYZES LARGE HUMAN
GENETIC AND GENOMIC DATASETS.
IT'S A SERIES OF KNOWLEDGE
PORTALS THAT ALLOW THE PUBLIC TO
IDENTIFY NEW DRUG TARGETS,
BIOMARKERS, OTHER BIOLOGICAL
PARADIGMS, AND RECENTLY THE
REPRODUCTIVE SYSTEM KNOWLEDGE
PORTAL BECAME AVAILABLE AND THE
GOAL OF THESE PORTALS IS TO HELP
RESEARCHERS ANSWER THE QUESTION,
THE HUMAN GENETIC AND GENOMIC
RESULTS PROVIDE EVIDENCE ABOUT
THE INVOLVEMENT OF THE GENE OF
INTEREST IN A DISEASE TRAIT, SO
THIS IS A COLLABORATION THAT WE
HAVE WORKED WITH, IT'S A
PUBLIC/PRIVATE PARTNERSHIP
COLLABORATION, OTHER INSTITUTES
FNIH, AND OTHER INDUSTRY
PARTNERS HAVE WORKED TOGETHER
AND VERY EXCITED ABOUT THE
RECENT RELEASE OF THE
REPRODUCTIVE SYSTEM KNOWLEDGE
PORTAL.
ANOTHER PROGRAM THAT I'D LIKE TO
MAKE YOU AWARE OF IS THE
COMPLEMENT ANIMAL RESEARCH AND
EXPERIMENTATION, COMPLEMENTARY
PROGRAM.
RIGHT NOW THE NIH IS CONDUCTING
PLANNING ACTIVITIES TO INFORM A
POTENTIAL COMMON FUND PROGRAM
CALLED COMPLEMENT-ARIE TO
CATALYZE DEVELOPMENT
STANDARDIZATION VALIDATION AND
USE OF NEW APPROACH METHODS.
SOMETIMES ALSO CALLED NOVEL
ALTERNATIVE METHODOLOGIES,
NAMs.
AND ONE OF THE METHODOLOGIES
THEY ARE PROMOTING IS IN SILICO
MODELS, SO COMPUTATIONAL MODELS
BUILT WITH REAL WORLD EVIDENCE
OR OTHER COMPLEX DATASETS.
NICHD HAS REPRESENTATION ON THE
WORKING GROUP, AND HAS MADE SURE
THAT PREGNANT PERSONS AND
REPRODUCTIVE HEALTH ARE
REPRESENTED.
THEY LAUNCHED A CHALLENGE IN
EARLY NOVEMBER THAT ENDS IN
JANUARY, SELECTING UP TO 20
PRIZE WINNERS TO DEMONSTRATE
WAYS TO CONDUCT BASIC RESEARCH
UNCOVER DISEASE MECHANISM, INTO
DISEASE METHODS AND PRACTICE.
THE LAST TRANS-NIH COLLABORATION
IS THE CONSORTIUM N-PERC TO
IMPROVE CHILD HEALTH, RESEARCH
COLLABORATION.
BUT RECENTLY APPROVED THE
ESTABLISHMENT OF A SUBGROUP
FOCUSING ON PEDIATRIC AND
MATERNAL PHARMACOLOGY, OFTEN
VERY MUCH LINKED.
LEVERAGING DATASETS,
REPOSITORIES, AND DATA SCIENCE,
MAKING A NICE TRANS-NIH EFFORT,
A SPACE TO COMMUNICATE AND
COLLABORATION, COME UP WITH
IDEAS TO HELP IMPROVE THE HEALTH
OF PREGNANT, LACTATING, AND
POSTPARTUM PERSONS.
FINALLY I'D LIKE TO TALK ABOUT A
RESOURCE WE HAVE HERE AT NICHD,
DASH.
I'M SURE MANY IF NOT ALL OF YOU
ARE FAMILIAR WITH DASH.
THIS IS OUR CENTRALIZED
REPOSITORY FOR SHARING
DE-IDENTIFIED HUMAN DATA AND
BIOSPECIMENS FOR STUDIES FUNDED
FROM NICHD.
AT THE MOMENT THE DASH CONTAINS
MORE THAN 210 STUDIES, MORE THAN
50 STUDY TOPICS, HAS APPROVED
MORE THAN 600 DATA REUSE
REQUESTS FROM 16 COUNTRIES
RESULTING IN NEARLY 100
PUBLICATIONS, AND WE CONTINUE TO
IMPROVE DASH TO MODERNIZE, MAKE
SURE WE MAXIMIZE THE FAIRNESS OF
OUR DATA SO THE FUNDABILITY,
ACCESSIBILITY, INTEROPERABILITY
AND REUSABILITY OF DATA IN DASH.
THE ULTIMATE GOAL OF NICHD'S
EFFORTS AND THE REAL WORLD DATA
AND REAL WORLD EVIDENCE BASE ARE
MANY-FOLD.
WE WOULD LIKE TO EXPAND ACCESS
TO DATA AND GROW OUR DATA
ECOSYSTEM, AND BY DOING SO WE
CAN IDENTIFY NOVEL THERAPEUTIC
TARGETS, NOVEL BIOMARKERS,
DEVELOP TOOLS, ALGORITHMS,
SOFTWARE, AND ULTIMATELY INFORM
LEARNING HEALTH SYSTEMS AND
IMPROVE REPRODUCTIVE HEALTH
OUTCOMES FOR OUR PATIENT
POPULATIONS.
THANK YOU FOR YOUR TIME AND
OPPORTUNITY TO PRESENT NICHD'S
EFFORTS, AND LEVERAGING LARGE
DATASETS AND REAL WORLD DATA.
THANK YOU SO MUCH.
>> KATIE, THANK YOU VERY MUCH.
WE WILL HOLD QUESTIONS UNTIL WE
GET THROUGH OUR NEXT
PRESENTATION.
SO I'D LIKE TO INVITE DR. CHEN.
>> THERE ARE SOME CLARIFICATION
QUESTIONS ASKED, WONDERING IF IT
MAKES SENSE TO DO THOSE NOW.
>> I THINK WE CAN HOLD THOSE AND
MAKE THOSE BROADER BY WAY OF
WHAT THEY ARE ASKING, AND USE
THOSE TO STIMULATE DISCUSSION.
>> A COUPLE WERE SPECIFIC TO
STUDIES MENTIONED, BE AWARE.
>> DR. CHINN?
>> GOOD AFTERNOON.
I'M TALKING TODAY ABOUT THE
PATIENT CENTERS OUTCOMES
RESEARCH PROJECT TRUST FUND
PROJECT PROPOSAL, THE MORBIDITY
AND MORTALITY ELECTRONIC HEALTH
RECORD DATA INFRASTRUCTURE
PROJECT CONDUCTED HERE AT NICHD
WITH LEADS THAT I'M PRESENTING
FOR TODAY, AND ALLISONER IS
ALISON CERNICH.
THIS SPEAK TO RECOMMENDATION 12,
DESIGN HEALTH RECORD SYSTEMS TO
LINK MOTHER AND INFANT RECORDS.
IN THIS PRESENTATION I'LL TALK
ABOUT THE PROJECT AND STANDARDS
OVERVIEW AND ADDITIONAL
COMPONENT THAT WE SEE CALLED
MATERNAL HEALTH LINK, GOING INTO
DETAIL WITH THAT.
NEXT SLIDE PLEASE.
IN COLLABORATION WITH THE CDC,
NLM, NATIONAL COORDINATOR
OFFICE, WE DECIDED TO PROPOSE TO
CREATE NEW DATA LINKAGES THAT
ALLOW FOR RESEARCH WITH THE
EFFECT OF PREGNANCY RISK FACTORS
ON PREGNANCY-RELATED HEALTH
OUTCOMES AND EFFECTS,
COMPLICATIONS DURING PREGNANCY,
LONGER-TERM POST PREGNANCY
HEALTH OUTCOMES.
WAYS TO COLLECT AND SHARE DATA
NEEDED TO ANALYZE HOW A WOMAN OR
BIRTHING PERSON OR PREGNANT AND
POSTPARTUM PERSON'S LONGITUDINAL
HISTORY, SOCIOECONOMIC STATUS,
DEMOGRAPHIC CHARACTERISTICS
AFFECT OUTCOMES FOR BIRTHING
PERSON OR THE POSTPARTUM AND
PREGNANT INDIVIDUAL OR INFANT OR
INFANTS.
WE DEVELOPED A WAY TO
STANDARDIZE AND APPROACH TO LINK
ELECTRONIC HEALTH RECORDS AND
ELECTRONIC HEALTH DATA ON
MATERNAL AND INFANT HEALTH USE
FOR STUDYING IMPACTS OF THEIR
OUTCOMES OR MEDICAL CONDITIONS
AND INTERVENTIONS.
AND OUT OF THIS PROJECT WE
PRODUCED AN IMPLEMENTATION
GUIDE, A FINAL HL7 OR A HEALTH
LEVEL 7 PUBLISHED STANDARD AND
DISTRIBUTED TO PARTNERS,
PUBLICLY AVAILABLE, AND WE
PILOTED THE STANDARD OR
IMPLEMENT GUIDE USING THE OPEN
SOURCE TOOL WHICH IS THAT
MATERNAL HEALTH THAT I MENTIONED
IN THE PREVIOUS SLIDE.
NEXT SLIDE PLEASE.
SO, THE LONGITUDINAL MATERNAL
AND INFANT HEALTH INFORMATION
FOR RESEARCH FHIR OR LET ME GET
THAT ACRONYM FOR YOU.
THE HEALTH CARE INTEROPERABILITY
RESOURCES, THE STANDARD FOR
EXCHANGING HEALTH CARE
INFORMATION AND HL7, FOR HEALTH
LEVEL 7, THE INTERNATIONAL
STANDARD FOR COMMUNICATING
ACROSS THE ELECTRONIC HEALTH
RECORDS AND MEDICAL RECORDS.
WE DECIDED TO CREATE THIS
FRAMEWORK AND THIS
IMPLEMENTATION GUIDE TO LINK THE
RECORDS TOGETHER, AND CREATE
THIS TOOL FOR RESEARCHERS, WE
USE TWO SPECIFIC USE CASES TO DO
THAT.
ONE IS ON HYPERTENSIVE DISORDERS
OF PREGNANCY, AND THE OTHER IS
PREGNANCY-ASSOCIATED MATERNAL
DEATHS, BECAUSE WE WANTED TO
LOOK AT SEVERE MATERNAL
MORBIDITY AS WELL AS MATERNAL
MORTALITY.
NEXT SLIDE PLEASE.
THIS PROJECT TOOK PLACE OVER A
2-YEAR PERIOD WHICH SOUNDS LIKE
A LONG TIME BUT FROM START TO
FINISH IT WAS AMAZINGLY RAPID.
SO WE STARTED IN 2021,
SOCIALIZING IMPLEMENTATION GUIDE
THAT WAS DEVELOPED AT HL7
WORKING GROUP MEETINGS AND WE
HAD A PHENOMENAL CONTRACTOR WITH
THIS PROCESS, THE CONSULTANT, WE
STARTED WITH THE PROJECT
PROPOSAL, PROJECT SCOPE,
SOCIALIZING, INTRODUCED IT,
LOOKING FOR A RESPONSIBLE TORE.
WE WERE SPONSORED IN THE PUBLIC
HEALTH WORKING GROUP.
AND THEN THE NEXT CAME, THE
ITERATIVE PROCESS OF THE
IMPLEMENTATION GUIDE.
SO WE RECEIVED FEEDBACK,
ENVIRONMENTAL SCAN, SAW WHAT
OTHER IMPLEMENTATION GUIDES WHY
AVAILABLE THAT WERE SIMILAR, HOW
WE OVERLAP, WHAT ARE WE ADDING,
THOSE SORTS OF THINGS,
STAKEHOLDER ENGAGEMENT,
TECHNICAL EXPERT PANEL WHICH
CONSISTED OF FEDERAL EXPERTS AS
WELL AS NON-FEDERAL EXPERTS AND
FEEDBACK FROM CONNECT-A-THONS,
VALIDATED COMMENTS, ANOTHER WAY
OF GETTING INPUT AND FEEDBACK
FROM THE EXPERTS IN THIS HL7
GUIDANCE, AND NON-VALID
COMMENTS, WHICH IS INFORMATION
AND FEEDBACK FROM PEERS, AS WELL
AS REPRESENTATIVES OF OTHER
SOURCES OF EXPERTISE.
SO WE GATHERED THAT FEEDBACK TO
INFORM IMPLEMENTATION GUIDE.
LIKE I SAID, WE VALIDATE THIS
PROCESS, WE USE THAT INFORMATION
TO FULLY DEVELOP IMPLEMENTATION
GUIDE IN JANUARY 2023 WE WERE
ABLE TO SEEK HL7 APPROVALS FOR
THE PUBLICATION OF THE
IMPLEMENTATION GUIDE WHICH IS IN
THE PUBLIC DOMAIN.
NEXT SLIDE PLEASE.
SO, FOR PILOTING ON THE ORIGINAL
START OF THE PROJECT WE THOUGHT
WE WOULD BE ABLE TO PILOT
THROUGH SEVERAL USE CASES LIKE I
SAID WE HAD TWO BUT I THINK WE
DEVELOPED A TOTAL OF EIGHT.
THAT CAME NOT FEASIBLE FOR WHAT
WE WERE DOING FOR THIS PROJECT
SO WE ROUNDED DOWN TO TWO USE
CASES.
AND I WANT TO EMPHASIZE THAT
THIS WAS A SIGNIFICANT
MILESTONE, THAT'S THE EXACT
LANGUAGE ON THE SLIDE BUT IT WAS
TRULY SIGNIFICANT, FIRST
LONGITUDINAL INFORMATION FOR
RESEARCH IMPLEMENTATION GUIDE.
WE WERE LINKING THE MATERNAL
RECORD WITH THE INFANT RECORD,
LINKING THE MATERNAL RECORD WITH
THE MATERNAL RECORDS FROM
PREVIOUS AND CONTINUOUS,
CREATING A LONGITUDINAL HISTORY
OF THE BIRTHING PERSON AND THE
PREGNANT AND POSTPARTUM PERSON
AND LINKING TO THE INFANT
OUTCOMES.
HOWEVER, WE CREATED THIS
DOCUMENT, PUT IT IN THE PUBLIC
DOMAIN BUT IT'S ONLY AS GOOD AS
ADOPTION RATE.
YOU CAN HAVE A DOCUMENT THAT
JUST SITS OUT THERE AND GOES
UNUSED, THAT'S NOT SOMETHING WE
WANTED FOR THIS PROJECT SO WE
HAD TO IDENTIFY TOOLS AND
STRATEGIES TO CREATE A PROJECT
THAT WOULD BE USED BROADLY AND
AS ACCESSIBLE.
SO IN THE ADOPTION, WITH OUR
CONTRACT PARTNERS, WE PILOTED AN
AUTOMATION AND STANDARD TOOL
USING MATERNAL HEALTH LINK, AND
WE'LL GO INTO THAT IN THE NEXT
COUPLE SLIDES.
THIS IS ALSO A UNIQUE PRODUCT
THAT WAS PRODUCED OUT OF THIS
PROJECT FOR RESEARCH DATA
ACQUISITION.
AND THIS IS AN OPEN SOURCE
MEASURE BASED APPLICATION,
MATERNAL HEALTH LINK PROVIDES
DATA ACCESS AND FLEXIBILITY TO
ACCOMMODATE RESEARCHERS' NEEDS
OVER TIME.
SO THIS HELPS THE RESEARCHER USE
THE IMPLEMENTATION GUIDE AND
MAKES IT EASIER.
NEXT SLIDE PLEASE.
SO MATERNAL HEALTH WAS ADOPTED
FROM AN EXISTING TOOL THAT ALSO
USED OPEN FHIR APPLICATION FOR
PUBLIC HEALTH, AND THIS WAS DONE
UNDER A CDC CONTRACT, AND THIS
CONNECTS SECURELY TO ELECTRONIC
HEALTH RECORDS, WHAT WE WERE
TRYING TO DO VIA STANDARD OPEN
APPLICATION PROGRAMMING
INTERFACE API, FULL DISCLOSURE
THAT PART IS OUT OF MIGHT
H AVE -- OUT OF MY EXPERTISE AND
DOMAIN SO I CAN'T ANSWER
QUESTIONS ON THE TECHNICAL
ASPECT, BUT THE APPLICATION
EXTRACTS DATA, EVALUATES DATA
USING PRE-DEFINED AND SUBMITS
DATA TO THIS NETWORK.
NEXT SLIDE PLEASE.
SO WHAT WE DO WITH CONTRACTORS,
CUSTOMIZE THIS EXISTING TOOL FOR
THE TOOL CALLED MATERNAL HEALTH
LINK.
WE PROPOSE PILOTING WITH A
HEALTH INFORMATION EXCHANGE TO
AUTOMATE DATA COLLECTION.
THIS PROCESS TOOK A BIT OF TIME
BECAUSE WE HAD TO FIND DATA THAT
FIT THE PARTICULAR CRITERIA FOR
THE USE CASES THAT HAD THE
APPROPRIATE INFORMATION IN IT
AND THAT COULD -- THAT WE COULD
HAVE ACCESS TO.
THIS IS SOMETHING THAT TOOK
QUITE A BIT OF TIME AND
PERSISTENCE TO FIND THE VIABLE
DATASET WE COULD USE.
WE WERE VERY GRATEFUL TO USE
THIS HIE, AND WE DEVELOPED
MEASURES TO SUPPORT DATA
COLLECTION FOR COHORT POPULATION
SO WE USED SIMPLISTIC
PARAMETERS, TWO USE CASES, ONE
ON MATERNAL MORTALITY SO DEATH
WITHIN ONE YEAR OR 365 DAYS OF
END OF A PREGNANCY, AND THEN
ALSO THE HYPERTENSIVE DISORDERS
OF PREGNANCY, SO PREGNANT PERSON
AND PROBABLY POSTPARTUM PERSON
WITH DIAGNOSED HYPERTENSIVE
DISORDERS OF PREGNANCY.
NEXT SLIDE PLEASE.
THIS IS A GRAPHIC DEVELOPED TO
MAKE VISUAL AND TANGIBLE KIND OF
HOW THE MATERNAL HEALTH LINK
COMMUNICATES WITH THE DATABASE
AND WITH THE RESEARCHERS AND
THINGS.
YOU CAN SEE WE HAVE THIS HEALTH
INFORMATION EXCHANGE.
WE HAVE A USER INTERFACE IN THE
BLUE BOX ON THE LEFT, WHERE YOUR
RESEARCHERS ARE SITTING, THEY
USE THIS INTERFACE, WE HAVE
IMPLEMENTATION GUIDES, THIS
MEASURE LOGIC, WE PRESCRIBE FROM
THE RESEARCHER THE PARAMETERS
LIKE 365 DAYS EXPERIENCE OF
MATERNAL DEALT AND THEN, YOU
KNOW, THEY PUT IN THEIR
INFORMATION, THEY HIT SUBMIT,
THAT INFORMATION TO THE HEALTH
INFORMATION EXCHANGE DATABASE,
AUTHENTICATED, BACK TO THE MA
TERRIBLE HEALTH LINK WHICH
PRODUCES THE REPORT WHICH YOU
SEE FOR THE RESEARCHERSER, THEN
YOU SEE THE DOTTED LIKE IN BOX
4, RESEARCHERS AND PARTNERS AS
THEY BEGIN.
WE USE THIS INFORMATION TO MAKE
ASSESSMENTS WHAT WE NEED TO KNOW
AND HOW WE CAN MOVE FORWARD AS
WE MAKE NEW DISCOVERIES FOR
INTERVENTIONS AND PREVENTION FOR
SEVERE MATERNAL MORBIDITY AND
MORTALITY.
NEXT SLIDE PLEASE.
THIS IS PART OF THE PILOTING
THAT WE TALKED ABOUT WITH THE
MATERNAL HEALTH LINK, SO LIKE I
SAID WE DEFINED CRITERIA, FOUND
THAT HIE, THANKS TO DILIGENCE OF
DR. SHAKTURA, THAT'S A BIT OF
BUSINESS ASPECT OF PILOTING THIS
PROJECT.
AND THEN GOING DOWN A LITTLE
BIT, THERE'S A PILOT REPORT,
TECHNICAL ASSISTANCE, THINGS
LIKE THAT.
NEXT SLIDE PLEASE.
ON THE SUCCESS OF THE PROJECT.
WE FOUND THAT A SUCCESSFUL
HANDSHAKE, MEANING THE
PARAMETERS WERE ABLE TO BE USED
PROPERLY, THEY COMMUNICATED
PROPERLY, WE WERE ABLE TO
SUCCESSFULLY PRESENT THE DATA WE
NEED-- LINK THE DATA WE NEEDED
TO LINK, ACCOMMODATING
RESEARCHERS, AUTOMATING THE
QUERIES AND SETTING UP ALL THESE
THINGS AND CREATING THE RESULTS
THAT CAN BE EASILY INTERPRETED.
NEXT SLIDE PLEASE.
SO AGAIN THIS IS THE LITTLE BIT
OF THAT PROCESS.
NOW, WHEN THIS WAS PRESENTED
BEFORE THEY HAD AN AUTOMATED
DATA VISUALIZATION TO SHOW THAT
WAS TOO LONG TO DEMONSTRATE FOR
THIS GROUP IN THIS PRESENTATION.
BUT THERE IS A RECORDED
DEMONSTRATION THAT IF THIS GROUP
WOULD LIKE TO SEE IT, PROBABLY
COULD BE MADE AVAILABLE.
NEXT SLIDE PLEASE.
SO FUTURE RECOMMENDATIONS, NEXT
SLIDE.
ONE IS NOT ON THIS PAGE BUT I
WOULD LIKE TO EMPHASIZE WE USE
THIS FOR TWO USE CASES, AND WE
WOULD LIKE TO MAKE SURE THAT THE
IMPLEMENTATION GUIDE AND TOOLING
CAN BE MADE SO THAT IT IS USE
CASE AGNOSTIC.
SO THAT IT'S NOT SPECIFIC TO
HYPERTENSION, THAT IT'S NOT
SPECIFIC TO MATERNAL MORTALITY,
BUT THAT WE MAKE SOMETHING THAT
CAN BE USED FOR DUAL INCIDENTS
AND I THINK RIGHT NOW THE
GUIDANCE IS THERE BUT WE NEED TO
MAKE SURE THAT THEY CAN BE
TESTED IN ALL OF THOSE DOMAINS.
ALSO, TO USE A REAL RESEARCH
STUDY IS A GOAL OF THIS, TEST
THE SCALABILITY, LARGER VOLUME
DATA.
I'M NOT SURE WITH THE VOLUME OF
THE NEW YORK HIE WE CAN'T TO
SCALE THAT UP.
WE'RE LOOKING AT NATIONAL LEVEL
DATA, HOSPITAL LEVEL DATA, AND
SO IF WE NEED TO MAKE SURE THIS
IS APPROPRIATE FOR ALL DATA.
AND DATA FROM MULTIPLE SOURCES,
THIS IS ONE HIE BUT WE WANT TO
MAKE SURE THAT EPIC IN NEW YORK
CAN TALK TO A DIFFERENT SYSTEM
IN CALIFORNIA.
AND THAT WORKERS CAN BE LINKED
TOGETHER FOR LONGITUDINAL
HISTORY AND TO LINK TO INFANT
AND INFANTS BORN IN DIFFERENT
LOCATIONS.
AND WE WANT TO ENHANCE THIS
SECURITY.
EXACTLY.
SOMEONE PUT IN THE CHAT EPIC
ANDER IS AND SERNA DON'T TALK
TO EACH OTHER.
THEY ALL WANT TO SEE THESE
THINGS, IMPROVEMENTS IN MATERNAL
HEALTH.
SO WE WERE SURPRISED AND
FORTUNATE AND BENEFITED FROM
HAVING THEM PRESENT ON THE SAME
DAY, IN OUR WORKING GROUP.
WE ALSO WANT TO MAKE SURE THIS
IS SOMETHING THAT STAYS UP TO
DATE SO WE WANT TO MAKE SURE
IT'S CONTINUALLY USED AND ALSO
DEVELOP THIS MATERNAL TOOLKIT
EVEN FURTHER.
NEXT SLIDE.
AND SO WITH THAT I WILL TURN IT
BACK OVER TO OUR -- TO SUE AND
THANK YOU, EMMA.
I WANT TO ACKNOWLEDGE OUR ONC
TEAM, THE CDC, NLM, NATIONAL
LIBRARY OF MEDICINE, CENTERS FOR
DISEASE CONTROL AND PREVENTION,
THE OFFICE OF THE NATIONAL
COORDINATOR, OUR PROLIFIC
PROGRAM OFFICER, AND THE
LEADERSHIP OF NIKITA SHAKTURA
AND ALISON CERNICH.
>> WE'LL TAKE QUESTIONS FOR
KATIE AND JUANITA NOW.
I WANT TO BROADEN, A PROFESSOR
IS ASKING ABOUT DATA SOURCES AND
WHETHER THE SCOPE IS U.S. OR
INTERNATIONAL, CAN YOU SPEAK TO
THAT?
>> SURE.
FOR THE AWARDS I SPOKE ABOUT
EARLIER TODAY THOSE R01s AND
R21s ARE UNITED STATES DATA
SOURCES.
WE DO HAVE WITHIN OUR PORTFOLIO
APPLICATIONS THAT UTILIZE REAL
WORLD DATA FROM INTERNATIONAL
DATA SOURCES.
THEY JUST HAPPEN TO BE WITH
PEDIATRICS AT THE MOMENT.
CERTAINLY NEED TO BROADEN OUR
SCOPE THERE TO INCLUDE PREGNANT
AND LACTATING PERSONS AS WELL.
YES, THE ONES THAT I SPOKE ABOUT
TODAY ARE UNITED STATES DATA
SOURCES.
>> THANKS, KATIE.
AND A QUESTION ABOUT COVID
STUDDIES SPECIFICALLY BUT I'LL
BROADEN AND THINK IN THE CONTEXT
OF ARE WE TRACKING PREGNANCY
EXCLUSIONS IN FEDERALLY FUNDED
STUDIES?
>> THERE'S PROBABLY SOMEBODY WHO
CAN SPEAK TO THAT BETTER BUT I
THINK THAT'S SOMETHING THAT WE
AS AN INSTITUTE HAVE LOOKED AT
TO SEE IF PREGNANCY IS USED AS
EXCLUSION CRITERIA.
BUT I'M PROBABLY NOT THE EXPERT.
THAT'S A BROADER QUESTION THAN
JUST UTILIZATION OF REAL WORLD
DATA AND REAL WORLD EVIDENCE.
YES, IT'S A VERY IMPORTANT TOPIC
FOR THE INSTITUTE.
WE DO LARGELY SEE THAT AS
INCLUSION CRITERIA FOR THESE
STUDIES.
THEY ARE OFT EVERYBODY EXCLUDED
FROM STUDIES.
>> THANKS.
AGAIN, WE'LL TAKE OTHER
QUESTIONS IN THE CHAT OR IF YOU
WANT TO COME OFF CAMERA, RACHEL?
>> HI, QUESTION FOR DR. CHINN.
I WANT TO SAY IT'S AMAZING HOW
FAR WE'VE COME WITH ELECTRONIC
MEDICAL RECORDS.
MY QUESTION THAT REALLY HAS BEEN
ON MY MIND WE'VE MET WITH OCR
BUT A LOT OF CONCERNS ABOUT THE
SAFETY AND SECURITY OF
INFORMATION SHARED IN THE
MEDICAL RECORD AND MOST
CONVERSATIONS HAVE BEEN MORE
SPECIFIC TO -- IN THE CLINICAL
SETTINGS BUT I'M CURIOUS ABOUT
IF THIS HAS COME UP IN THE
RESEARCH STEPS WHAT STEPS HAVE
BEEN TOGETHER, IF THAT'S
SOMETHING WE SHOULD THINK ABOUT
TO MAKE SURE WE'RE ABLE TO GET
THE DATA BUT IT NOT BE MISUSED.
THANK YOU.
>> THANK YOU.
YES, THAT HAS COME UP MULTIPLE
TIMES.
AS WE MENTIONED, REAL WORLD
TECHNICAL PANELS, I BELIEVE
THERE WAS ACOG REPRESENTATION ON
THE PANEL, THAT QUESTION HAS
COME UP -- PRE-DOBBS, SO MANY
THINGS HAPPENED, THINGS CHANGE
QUICKLY BUT THAT'S SOMETHING
THAT WE ARE GENERALLY HAVE ON
OUR RADAR IN THE DATA SPACE.
OUR WORK IN THE POPULATION
DYNAMICS BRANCH AT NICHD, A LOT
OF DATA COLLECTIONS AS WELL,
THAT'S CERTAINLY SOMETHING DATA
PRIVACY THAT'S COME UP.
DOBBS-RELATED AND NOT.
THE OTHER THING IS THAT HAS COME
UP MULTIPLE TIMES IS DATA
SECURITY.
YOU CAN HAVE TWO PUBLIC USE
DATASETS AND WHEN YOU LINK THEM
TOGETHER, YOU NOW HAVE ENOUGH
INFORMATION FOR DISCLOSURE,
THAT'S ANOTHER WAY THE DATA
PRIVACY COULD COMPROMISE DATA.
THESE THINGS HAVE COME UP
INDEPENDENT OF THE TECHNICAL
EXPERT PANEL BUT ALSO HAVE COME
UP IN DISCUSSION WITH THE
TECHNICAL EXPERT PANEL.
SOLUTIONS ARE NOT AS PLENTIFUL
AS ACKNOWLEDGMENT THESE THINGS
WILL EXIST.
I'M NOT SURE WHAT THE DIRECTION
OF THE POLICIES ARE GOING FOR
THAT.
I CAN SAY WE'VE DEFINITELY
ACKNOWLEDGED, WE'VE DISCUSSED
PUTTING DISCLAIMERS, WHICH IS
CERTAINLY NOT ENOUGH, BUT IT IS
MAKING PEOPLE AWARE THAT THESE
RISKS ARE AVAILABLE WHEN YOU
LINK DATA.
AS FAR AS OTHER HEALTH
INFORMATION RELATED TO WOMEN AND
POSTPARTUM AND PREGNANCY, IT'S
ON OUR RADAR, BUT I'M NOT SURE
THAT A SOLUTION TO KIND OF THAT
DATA PRIVACY BECAUSE THE
INFORMATION IS CHANGING AS WE
HAVE THESE DISCUSSIONS.
>> THANK YOU, JUANITA.
JANET?
>> THANK YOU.
THANK YOU FOR SUCH WONDERFUL
PRESENTATIONS, VERY THOUGHT
PROVOKING.
I'M GOING DIRECT MY QUESTION TO
DR. VANCE, REGARDING THE IMPROVE
STUDY.
YOU MENTIONED YOU WANT TO
PROMOTE MATERNAL HEALTH EQUITY
AND YOU'RE STUDYING EHR AND
CLAIMS DATA, EQUITY VARIABLES
CAN BE CHALLENGING AND LARGE
DATA SOURCES POORLY RECORDED
AND/OR LARGELY MISSING.
HOW ARE YOU APPROACHING THAT?
I'D BE INTERESTED IN YOUR
THOUGHTS SINCE THIS IS A BIG
ISSUE WITH LARGE DATA.
THANK YOU.
>> ABSOLUTELY.
IT IS A LARGE ISSUE.
THE IMPROV PORTFOLIO IS NOT IN
MY PORTFOLIO, THERE ARE PROBABLY
OTHERS WHO CAN SPEAKER TO THIS A
LITTLE BIT BETTER.
I DO KNOW THE DATA HUB, THERE
ARE -- IT'S A PROBLEM.
IT'S A PROBLEM BOTH IN PATIENT
ACCESS TO CARE AND WHEN THEY
HAVE LIMITATIONS TO ACCESS TO
CARE AND BIAS WAS CARE, THERE'S
ALSO BIASES RELATED TO THE DATA
THAT ARE AVAILABLE AND THE DATA
THAT WE CAN GENERATE FROM REAL
WORLD DATA.
WHAT IS A CONCERN?
HOPKINS IS THE AWARDEE FOR THIS
PARTICULAR DATA HUB, THE DATA
INNOVATION HUB FOR CENTERS OF
EXCELLENCE.
SO, THEY DO HAVE A PLAN TO
ADDRESS THESE CONCERNS AND TRY
TO MITIGATE THEM USING
COMPUTATIONAL AND OTHER
METHODOLOGIES, BUT I CAN'T SPEAK
TO THE SPECIFICS, BECAUSE I'M
NOT THE PROGRAM OFFICER FOR THE
AWARD, THERE WILL BE BIASES WITH
UTILIZATION OF REAL WORLD DATA.
>> THANK YOU VERY MUCH.
>> THANK YOU, KATIE.
JUANITA, WE'VE GOT A FAIR AMOUNT
OF CONVERSATION IN THE CHAT
THAT'S ASKING ABOUT NON-HIE
RELATED DATABASES, SO PRIVATE
PAYER DATABASES, OTHER
GOVERNMENT-RELATED DATABASES.
CAN YOU SPEAK TO THAT?
>> THE U.S. DEPARTMENT OF HEALTH
AND HUMAN SERVICES OFFICE FOR
WOMEN'S HEALTH HAS PUBLISHED AN
ARTICLE ON MATERNAL HEALTH USING
THE PREMIER DATA, I THINK THAT
INCLUDES DATA LINKAGES, NOT SURE
HOW IT FITS WITH OUR PROJECT.
WE'VE HAD SOME CONVERSATIONS,
REGARDING KAISER I'M NOT SURE
THAT WE HAD KAISER COME IN AND
SEE ABOUT THE DATA LINKAGE.
THAT ONE I CAN'T REMEMBER.
AND THEN THE OTHER -- I'M NOT
FAMILIAR WITH TRINET, THAT ONE
I'M NOT FAMILIAR WITH.
BUT THERE'S SOME PUBLICATIONS IN
THE PUBLIC DOMAIN ON PREMIER
DATA, PARTICULARLY AROUND THE
HYPERTENSION LINKAGES.
SO, YEAH, I'M NOT FAMILIAR
ENOUGH.
BUT WE CAN TAKE THOSE QUESTIONS
DOWN AND HOPEFULLY GET SOME
SUFFICIENT ANSWERS FOR YOU.
>> MAYBE TO EXTEND THAT
QUESTION, JUANITA, HAVE THERE
BEEN ENOUGH CONVERSATION WAS
VARIOUS HIEs THAT YOU HAVE A
SENSE OF LOGISTICAL OR
CONTRACTUAL CHALLENGES TRYING TO
EXPAND THIS INITIATIVE?
>> YES.
SO, IN THE PRESENTATION I
MENTIONED KIND OF PERSISTENCE OF
DR. SHAKTUR IN SECURING THE
HEALTH INFORMATION EXCHANGE DATA
AND ACCESS, AND I BREEZED
THROUGH A SLIDE THAT HAD SOME OF
THAT CONTRACTUAL NEGOTIATIONS.
THIS IS SOMETHING THAT WE SHOULD
HAVE ANSWERED A LITTLE BIT
BETTER, SOME OF THE CHALLENGES
THAT ARISE WITH THAT IN
ACCESSING THESE DATA, I THINK WE
THOUGHT IT WOULD BE EASIER THAN
WHAT IT WAS.
AND SO I DO THINK THAT IS
SOMETHING THAT CAN BE EXPANDED
UPON FOR HOW WE DEVELOP THIS,
SCALE THIS UP, FOR A LARGER
SCALE IN OUR FUTURE DIRECTIONS,
BECAUSE THAT IS SOMETHING WE
WANT TO DO.
SO I THINK YOU RAISE AN
EXCELLENT POINT THERE, AND
THAT'S DEFINITELY SOMETHING THAT
WE'VE HAD CONVERSATIONS ABOUT
BECAUSE THERE WERE CHALLENGES
THAT WERE UNANTICIPATED IN
ACCESSING THESE DATA BECAUSE WE
CONTACTED MULTIPLE HIEs.
>> THANK YOU.
MAYBE ONE MORE QUESTION FOR
KATIE.
THE FACT THERE ARE A NUMBER OF
FUNDING OPPORTUNITIES THAT FALL
UNDER THE HEADING OF MATERNAL
AND PEDIATRIC, CAN YOU GIVE US A
SENSE HOW MANY APPLICATIONS AND
WHAT PERCENT OF FUNDING IS GOING
MATERNAL ROUTE VERSUS PEDIATRIC
ROUTE?
ARE WE GETTING UPTAKE BY OUR
MATERNAL RESEARCH PARTNERS?
>> WE ARE.
YEAH, WE ARE.
MY GENERAL IMPRESSION IS THAT WE
PROBABLY DO A LITTLE BIT BETTER
IN THE PEDIATRIC SPACE.
OUR BRANCH, OPPT IN PARTICULAR,
DID A DETAILED ANALYSIS OF OUR
PORTFOLIO LAST YEAR AND WE DID
SEE PROBABLY MORE IN THE
PEDIATRIC SPACE.
I FEEL LIKE IN THE LAST TWO
YEARS OF THE INTEREST IN
MATERNAL SPACE HAS GROWN.
WE'RE GETTING MORE APPLICATIONS
THAT ARE TRULY PREGNANCY
RELATED, OR THEY ARE DYADS.
MATERNAL-CHILD OUTCOME, MATERNAL
FETAL OUTCOME.
I THINK THERE'S MOVEMENT IN THE
SPACE, GROWING INTEREST,
PROBABLY LARGELY DUE TO THE
PRGLAC WORK FORCE.
I THINK THERE NEEDS TO BE MORE
OUTREACH FOR OUR INVESTIGATORS
TO SORT OF INCREASE THE NUMBER
OF APPLICATIONS THAT WE GET.
WE'RE WORKING ON IT.
>> DO WE HAVE OTHER QUESTIONS
RELATED PROGRESS MADE TOWARD
SOME OF THESE RECOMMENDATIONS?
WE'VE GOT ANOTHER QUESTION HERE,
WHAT EFFORTS ARE MADE TO ENSURE
THE AVAILABLE LINKED DATA IS
REPRESENTATIVE NATIONALLY?
MAYBE THIS IS TO JUANITA?
>> SO IT'S HARD TO LINK
NATIONALLY REPRESENTATIVE DATA
WHEN PULLING OUT OF THESE DATA
SOURCES.
TYPICALLY VITAL STATISTICS,
THINGS LIKE THAT ARE USED FOR
NATIONALLY REPRESENTATIVE DATA,
ON OUR -- SO THIS IS KIND OF ONE
OF THOSE, LARGE AMOUNT DATA, BUT
I CAN SAY THAT I WAS A LITTLE
BIT SURPRISED SOME OF THE
INFORMATION MISSING IN THE
ELECTRONIC HEALTH RECORDS AT THE
RATE WHICH THEY WERE SO
SOMETIMES REPRESENTATION IS HARD
TO ASCERTAIN.
FOR INSTANCE RACE AND ETHNICITY
WAS NOT ALWAYS INDICATED IN THE
ELECTRONIC HEALTH RECORDS, AS
WELL AS IT WAS DIFFICULT TO GET
SOME OF THE DEMOGRAPHIC DATA
THAT WE HAD ANTICIPATED WHEN WE
FIRST PROPOSED THIS PROJECT, BUT
EVEN DOWN TO GESTATIONAL AGE, WE
FOUND SOME MISSINGNESS THAT WAS
UNEXPECTED.
SO IT'S SOMETHING ON THE RADAR.
WE'VE HAD REPRESENTATIVES FROM
THE NATIONAL CENTER FOR HEALTH
STATISTICS, AS WELL AS CDC.
AND SO THIS IS A PART OF THEIR
RADAR, ON THEIR RADAR FOR
WORKING ON THIS PROJECT.
BUT IT IS SOMETHING THAT IS TOP
OF MIND.
LET ME SEE.
YES, THAT'S A PART OF ONE OF THE
THINGS THAT WE'RE TRYING TO
FIGURE OUT AS WELL SO WE HAD A
PRESENTATION ON KIND OF THE DATA
LINKAGES TO ELECTRONIC HEALTH
RECORDS TO THE CENSUS DATA AND
THINGS LIKE THAT SO WE COULD TRY
TO PUT IN SOME OF THIS TYPE OF
INFORMATION AND THERE'S A
WONDERFUL PAPER OUT THERE BY
BARBARA ATLAS, WE HAD HER COME
IN AND GIVE A TALK AS WELL.
AND SOME OF THE CHALLENGES AND
SUCCESSES WITH THOSE TYPES OF
DATA LINKAGE.
>> KATIE, THIS IS A FAIR
QUESTION TO YOU AS WELL, WHEN WE
LOOK THROUGH YOUR PORTFOLIO, HOW
MUCH OF WHAT WE'RE SEEING IS
FOCUSED ON UNDERREPRESENTED
POPULATIONS, UNDERREPRESENTED
GEOGRAPHIC REGIONS?
ARE THEY REPRESENTED EFFECTIVELY
IN THE FUNDING THAT'S GOING OUT
THE DOOR?
>> SO I THINK WE CAN ALWAYS DO
BETTER.
YOU KNOW, YOU DO SEE OFTEN THE
MAJOR PLAYERS ARE THE ONES
SUBMITTING THESE APPLICATIONS
AND GETTING FUNDED.
THEY ARE WHO YOU'RE EXPECTED TO
BE.
I THINK WE'RE GETTING BETTER IN
TERMS OF OF MAKING SURE THAT WE
RECRUIT PATIENT POPULATIONS AS
WELL AS INVESTIGATORS FROM
UNDERSERVED COMMUNITIES.
I KNOW THAT'S ONE OF THE THINGS
WE TRACK FOR THE TRANSITIONAL
RESEARCH PAR FOR EXAMPLE.
AND SO I DO THINK IT IS A
CONCERN.
I THINK WE AS A COMMUNITY CAN DO
A BETTER JOB MAKING SURE THAT WE
ACCESS UNDERSERVE AND
UNDERPRIVILEGED PATIENTS AS WELL
AS THE SCIENTISTS AN CLINICIANS
WHO CARE FOR THEM BUT I DO THINK
THAT WE'RE IMPROVING.
>> THANK YOU BOTH FOR TWO
WONDERFUL PRESENTATIONS,
CHRISTINA, ANYTHING ELSE WE WANT
TO TOUCH ON IN THE FIRST
SESSION?
>> IT'S A RELATIVELY MINOR
CLARIFICATION QUESTION, JUANITA.
THE LAST SLIDE FUTURE
RECOMMENDATIONS, TRYING TO
UNPACK THE WORD
"RECOMMENDATION."
ARE THESE ON A WISH LIST OR
THESE ARE INTENTIONAL AND
PLANNED ACTIVITIES THAT WILL BE
MOVING FORWARD?
>> I WAS TRYING TO LOOK AT THE
LAST SLIDE.
PROBABLY SHOULD SAY FUTURE WISH
LIST INSTEAD OF RECOMMENDATIONS.
I WOULD SAY MORE OF A WISH LIST,
AND AS FUNDING BECOMES AVAILABLE
WE'LL CHECK THESE THINGS OFF.
SCALABILITY IS DEFINITELY ONE,
WE HAVE ANOTHER CONNECT-A-THON
THAT WE'RE WORKING ON, I'M NOT A
HUGE PLAYER SO, YES, TO BOTH.
THESE ARE RECOMMENDATIONS, THESE
ARE WISH LISTS, AND THESE ARE
THINGS WE'RE ACTIVELY WORKING ON
TO MOVE FORWARD ON.
>> AND MY ONLY OTHER QUESTION,
IT'S FOR BOTH OF YOU, WE'VE
LIMITED CAPACITY TO INVITE
SPEAKERS, ALL THE THINGS
HAPPENING WITHIN THE UNITED
STATES.
ARE THERE OTHER AGENCIES YOU
FEEL WE SHOULD HAVE SIMILAR
CONVERSATIONS WITH TO UNDERSTAND
SIMILAR ACTIVITIES THAT ARE
TAKING PLACE?
OR DO YOU FEEL THIS IS A
REPRESENTATIVE EXAMPLE OF THE
TYPES OF ACTIVITIES TAKING PLACE
TO ADDRESS RECOMMENDATIONS LAID
OUT, THE DIFFERENCE SUBPARTS OF
THE RECOMMENDATION 12?
>> I THINK THE OFFICE OF
NATIONAL COORDINATOR AND THE --
BECAUSE THEY HAVE -- KATIE
MENTIONED THEM AS WELL.
THEY ARE VERY INTEGRAL IN THIS
SPACE BECAUSE THEY SET THE
STANDARDS.
AND THEN GUIDANCE, I APOLOGIZE,
BUT I ALSO WOULD SAY THE PATIENT
CENTERS OUTCOME RESEARCH TRUST
FUND BECAUSE THEY FUNDED OUR
PROJECT BUT THEY FUND MULTIPLE
PROJECTS IN THIS SPACE.
>> THANK YOU.
KATIE?
>> I THINK THOSE ARE EXCELLENT
SUGGESTION, THE ONLY OTHER TO
ADD IS THE CDC, IMPORTANT THINGS
TO SHARE.
>> WE'LL HEAR FROM SOME OF THEM
IN THE NEXT SESSION, A PERFECT
SETUP TO THE NEXT SESSION OF
SPEAKERS AS WELL.
BACK TO YOU.
>> IF WE'VE GOT NO OTHER
QUESTIONS IN THE CHAT WE'LL TAKE
THIS OPPORTUNITY TO TAKE A QUICK
BREAK, A QUICK TEN-MINUTE BREAK.
I'D LIKE TO THANK KATIE AND
JUANITA FOR TWO EXCELLENT
PRESENTATIONS.
AND WE WILL BE BACK AT -- I'M
SORRY 12:30 CENTRAL TIME, 1:30
EASTERN TIME AND KATIE AND
JUANITA WILL JOIN US LATER.
WE'LL SEE EVERYBODY IN TEN MINUTES.
FOR THE SECOND SESSION WE'RE
GOING TO FOLLOW THE SAME
CONSTRUCT IN THE PREVIOUS
SESSION.
WE'LL THRILLED TO HAVE SPEAK TO
PROVIDE THEIR INSIGHTS ON
PROGRESS TO DATE FOR OUR CLUSTER
DAY TOPICS FOR TODAY.
WE'LL START WITH STEFFI GARCIA
FROM OFFICE OF THE NATIONAL
COORDINATOR FOR HEALTH
INFORMATION TECHNOLOGY.
THANKS SO MUCH FOR BEING WITH US
TODAY.
>> THANK YOU FOR THE INVITATION.
I'M EXCITED TO PRESENT TO THIS
GROUP AND HOPE YOU'LL FIND THE
MATERIAL USEFUL AND INTERESTING.
AND I'LL JUMP RIGHT IN, ASSUMING
EVERYONE CAN HEAR ME OKAY.
SO-- GREAT, THANK YOU.
SO MY NAME IS STEPHANIE GARCIA,
A BRANCH BRIEF IN THE OFFICE OF
THE NATIONAL COORDINATOR FOR
HEALTH I.T.
TODAY I'M GOING OVER USCDI+ FOR
MATERNAL HEALTH IN PARTNERSHIP
WITH NICHD, AND AIM TO
DEMONSTRATE THOUSAND THIS CAN
SUPPORT IMPLEMENTATIONS OF 12
AND 13, AS MADE BY THE TASK
FORCE.
SO, HERE IS THE AGENDA.
A BRIEF OVERVIEW OF ONC AND OUR
ROLE WITHIN HHS AND MOVE TO
USCDI, PROVIDING THE FRAMEWORK
FOR UNDERSTANDING USCDI+.
AND THEN I'LL SPEAK ABOUT THE
DRAFT DATA LIST HOW THIS WORK
SERVES AS A STARTING POINT TO
MEET PARTS OF RECOMMENDATION 12
AND 13 AND WRAP UP WITH NEXT
STEPS.
ONC WAS FOUNDED IN 2004 BY
EXECUTIVE O, TO ADVANCE NATIONAL
GOALS FOR BETTER AND SAFER
HEALTH CARE THROUGH
INTRAPROBABLY NATIONWIDE HEALTH
I.T. INFRASTRUCTURE.
IN 2009 CONGRESS PASSED THE ACT,
PROMOTED ADOPTION AND USE OF
HEALTH I.T.
THIS IS FOUNDATION FOR
PROLIFERATION ACROSS THE HEALTH
CARE INDUSTRY.
I'M GOING TO PAUSE AND ASK CAN
YOU SEE THE SLIDES OR ARE YOU
SEEING MY NOTES?
>> WE CAN SEE YOUR SLIDES.
THANK YOU.
>> OKAY.
THANK YOU.
SO, IN 2016, CONGRESS THEN
PASSED THE 21ST CENTURY CURES
ACT.
WHICH WE'RE FAMILIAR WITH, AIMS
TO ENCOURAGE, PROMOTE, LEVERAGE
EXISTING HEALTH I.T. AND EHRs
ACROSS THE HEALTH CARE INDUSTRY;
VALUE RESEARCH AND BETTER CARE.
HITECH IN 2009 PROVIDED THE
FOUNDATION THROUGH ADOPTION AND
NOW WITH THE CURES ACT ONC'S
POSITION TO LEVERAGE THE
FOUNDATION.
OVER TIME, ONC IDENTIFIED
SEVERAL MECHANISMS WHICH ARE IN
THE BULLETED LIST BELOW, THAT
DEPEND ON STANDARDIZED DATA TO
CREATE THAT INTEROPEARABLE
HEALTH I.T. INFRASTRUCTURE.
NOW JUMPING INTO USCDI, THE U.S.
CORE FOR DATA INTEROPERABILITY
SHOULD BE AVAILABLE
ELECTRONICALLY.
THIS BASELINE ALONG WITH
GUIDANCE REGARDING APPLICABLE
VOCABULARY STANDARDS FOR A
VARIETY OF USE CASES INCLUDING
TREATMENT, PAYMENT, POST MARKET
SURVEILLANCE, RESEARCH AND
PUBLIC HEALTH.
THERE'S AN ANNUAL WELL-DEFINED
PROCESS FOR INCORPORATION OF NEW
DATA ELEMENTS AND CLASSES INTO
USCDI, AND THIS PROCESS IS
BASICALLY A WAY FOR ONC TO
SIGNAL TO INDUSTRY WHERE THE
HEALTH I.T. CERTIFICATION
REQUIREMENTS ARE LIKELY TO GO IN
THE FUTURE.
THIS ALSO HELPS WITH
PRIORITIZING STANDARDS
DEVELOPMENT.
POLICY PERSPECTIVE THE ABILITY
TO ADD NEW DATA ELEMENTS ON
ANNUAL EXPECTED BASIS HAS
INCREDIBLE IMPACT BECAUSE WE'RE
ABLE TO RESPOND TO OUR
CONSTANTLY DEVELOPING AREAS OF
HEALTH WITH EMPHASIS ON HEALTH
EQUITY OUTSIDE REGULATORY
CYCLES.
SO, FOR EXAMPLE, THE FIRST
VERSION OF USCDI IS ADOPTED AS A
STANDARD IN THE ONC CURES FINAL
ACT RULES, THE RULE WAS
PUBLISHED IN 2020 AND
CERTIFICATION REQUIREMENTS WERE
EXPECTED TO BE ADHERED TO IN
2022.
HOWEVER, ALTHOUGH THAT TOOK TWO
YEARS TO HAVE IT RECOGNIZED A
STANDARD IN ALL, WE HAVE
CONTINUED TO EVOLVE USCDI WITH
VERSION 4 CLOSING COMMENT PERIOD
IN SEPTEMBER OF THIS YEAR.
THE UPDATES REQUIRE ONLY MODEST
DEVELOPMENT BURDEN ON HEALTH
I.T. MODULES, CREATE MODEST
IMPLEMENTATION BURDEN, AND
RESULT IN MODEST AND AGGREGATE
LIFT FOR ALL NEW DATA ELEMENTS
COMBINED.
AS COORDINATING OFFICE CHARGED
WITH PROMOTING NATIONWIDE
INFORMATION EXCHANGE WE'VE BEEN
WORKING WITH HHS COLLEAGUES
ACROSS OPERATING DIVISIONS TO
SUPPORT ADOPTION AT USCDI BY ALL
HHS PROGRAMS AS WELL.
SITTING IN THE OFFICE OF THE
SECRETARY, THIS IS A REALLY NICE
PURVIEW AND ABILITY TO WORK
ACROSS THE OPERATING DIVISIONS.
AGAIN, ALL OF THIS IS WITH THE
INTENT OF CREATING THAT
INTRAOPERABLE FOUNDATION FOR
HEALTH INFORMATION.
THE FIRST THREE VERSIONS, YOU'RE
MORE THAN WELCOME TO GOOGLE
USCDI AND FIND MORE INFORMATION
AS WELL AS THE VERSION 4.
JUST TO SUM UP, USCDI
ESTABLISHED CONSISTENT BASELINE
OF HARMONIZED DATA ELEMENTS THAT
CAN BE BROADLY REUSED ACROSS USE
CASES, INCLUDING THOSE OUTSIDE
OF PATIENT CARE AND PATIENT
ACCESS, SO AS WE'RE DISCUSSING
TODAY FOR RESEARCH PURPOSES.
UPDATE BASED ON ANNUAL PROCESS
WITH MULTIPLE CRITERIA INCLUDING
MATURITY OF THE STANDARD, AS
WELL AS PUBLIC AND INDUSTRY
PRIORITIES.
AND JUST TO REITERATE, USCDI
ASSURANCE ONLY THE MOST
IMPORTANT DATA ELEMENTS AND
DIRECTLY TIED TO MEASURABLE
IMPROVEMENTS ARE ADDED ON AN
ANNUAL BASIS.
NOW WE'LL DISCUSS THE USCDI+ FOR
MATERNAL HEALTH DATASET.
BUILDING OFF OF THAT USCDI
FRAMEWORK, USCDI+ ESTABLISHES
DATA FACTS AND IMPLEMENT
GUIDANCE TO HARMONIZE AND ALIGN
DATA NEEDS FOR AGENCY PARTNERS.
USCDI+ IS AN EXTENSION AND
COMPLEMENT TO USCDI, AND WE'VE
BEEN WORKING WITH HHS PARTNERS
TO IDENTIFY DATA NEEDS ACROSS
AND OUTSIDE OF HHS SPECIFIED
AREAS.
TODAY DISCUSSING MATERNAL
HEALTH, FOR EXAMPLE.
THIS WILL GIVE PARTNERS ABILITY
TO POINT TO GUIDANCE AS THEY
LOOK FOR INFORMATION ON HOW TO
BEST COLLECT OR EXCHANGE DATA.
AND WHEN IMPLEMENTING DATA
STANDARDS FOR THOSE ACTIVITIES.
THE USCDI PLUS LAUNCHED IN FALL
OF 2021 AND SINCE THEN THERE'S
BEEN INCREASING INTEREST IN THE
MODEL IN A FEW AREAS SO WE
WORKED WITH CDC, CMS, HRSA, NIH
TO ADVANCE DIFFERENT
PROGRAMMATIC AREAS, LISTED HERE.
AND THE MATERNAL HEALTH DOMAIN
WAS IDENTIFIED AS AN AREA OF
FOCUS WITHIN THE CONTEXT OF THE
DISCUSSION REGARDING PUBLIC
HEALTH DATASETS WITH CDC AND TO
SUPPORT ONC PARTNERED WITH NICHD
TO BEGIN ESTABLISHING THE DATA
LIFT, AND STAKEHOLDERS AND PILOT
PARTNERS TO ENSURE THAT IS
DEVELOPED OVER TIME WITH USER
FEEDBACK.
JUST A FEW INCREMENTAL OVER
TIME, THE TRANSPARENT ESTABLISH
COLLABORATIVE PROCESS, WEIGHING
BOTH ANTICIPATED BENEFITS AND
INDUSTRY IMPACTS, USCDI+ WILL
MERIT A SIMILAR PROCESS
ESTABLISH DATA ELEMENTS AND
IMPLEMENTATION GUIDANCE TO
HARMONIZE AND ALIGN DATA NEEDS
FOR PARTNERS.
THE U.S. CDI+ MATERNAL SET
FOCUSED ON ESTABLISH CORE
DATASET, AS NECESSARY FOR HIGH
QUALITY EQUITABLE OUTCOMES
SUPPORTING PUBLIC HEALTH
INITIATIVES AND MATERNAL HEALTH
RESEARCH, THE INTENT TO EXPAND
AS NEED, CONDUCT PILOT TESTING,
AND EVENTUALLY SEEING ADOPTION
BY RELEVANT STAKEHOLDERS.
THE GOAL TO DEVELOP SOMETHING
THAT HHS PROGRAM OFFICES CAN USE
AND POINT TO, AS THIS IS THE
DATA THAT SHOULD BE
ELECTRONICALLY AVAILABLE WHEN
PROVIDING CARE OR INSTITUTING
PUBLIC HEALTH INITIATIVES OR
CONDUCTING RESEARCH WITHIN THE
POPULATION.
WE WERE INITIALLY THINKING ABOUT
OUR INCLUSION AND EXCLUSION
CRITERIA FOR THIS CURRENT DRAFT
DATASET, IN THREE AREAS.
WE LOOKED AT IMPORTANCE FOR
PROMOTING HIGH QUALITY CARE AND
ADDRESSING CARE GAPS, LIKELIHOOD
OF DATA AVAILABILITY THROUGH
DOCUMENTATION, AND POTENTIAL
IMPLEMENTATION BURDEN.
SO YOU'LL SEE THAT ALIGNS
CLOSELY WITH THE USCDI CRITERIA
AS WELL.
OUR INITIAL REVIEW INCLUDED
INPUTS AND RESOURCE LISTED HERE.
WE SCOPED DIFFERENT RESOURCES
BOTH ACROSS HHS AND OUTSIDE THE
DEPARTMENT AS WELL.
AND THE RESULTING DRAFT DATASET
REFLECTS DATA ELEMENTS
IDENTIFIED THROUGH THESE INPUTS,
MANY OF WHICH ARE TIED TO
FEDERAL PROGRAMS AND OTHER
NATIONAL INITIATIVES.
ALSO, GIVEN ONC ROLE AS
COORDINATOR WE'VE MET WITH
VARIOUS FEDERAL PARTNERS AND
WE'RE HELD TWO PUBLIC LISTENING
SESSIONS WITH INVITED EXTERNAL
PARTNERS TO GATHER ADDITIONAL
FEEDBACK FROM CERTAIN SPECIFIC
MATTER AREAS, WE'VE ALSO
PARTNERED WITH THREE PILOT SITES
TO GATHER ON THE GROUND
FEEDBACK, MOSTLY AROUND
FEASIBILITY, HAD THEM LOOK AT
DATA LIFT AND TELL US WHAT DATA
ON THE LIST WAS CURRENTLY
AVAILABLE TO THEM, AND EVEN WHAT
IT LOOKED LIKE, WHAT THE GENERAL
PERCENTAGES OR ESTIMATES THE
DATA WAS AVAILABLE FROM THE
VARIOUS SOURCES THAT THEY MAY
HAVE HAD ACCESS TO.
DURING THE FEEDBACK SESSIONS WE
ASKED THE SAME QUESTIONS, SO ARE
THESE THE RIGHT DATA CLASSES AND
ELEMENTS, ARE WE MISSING
ANYTHING, IS THE DATA ELEMENT
LIKELY TO CONTRIBUTE THE GOALS
WE HAD SET FORWARD IN TERMS OF
HIGH QUALITY CARE, AND EQUITABLE
CARE, THEY ASKED ABOUT
IMPLEMENTATION BURDEN AND DATA
AVAILABILITY.
AND ALSO WHETHER THERE WAS ANY
PARTICULAR ISSUES WITH
ELECTRONICALLY EXTRACTING THE
DATA AND ABOUT HOW MUCH
DEVELOPER TIME WOULD BE NEEDED.
AGAIN, I PUT THIS SLIDE IN SO
YOU CAN ALSO SEE SOME OF THE
GROUPS OF PARTNERS THAT WE'VE
MET WITH, SO HHS PROGRAMS,
HEALTH CARE PROVIDERS, VARIOUS
TYPES, I.T. DEVELOPERS, PUBLIC
HEALTH EXPERTS AND RESEARCHERS.
WE RECENTLY MOVED TO AN ONLINE
PLATFORM TO HOUSE THIS AND OTHER
USCDI+ SETS, LAUNCHING IN A FEW
WEEKS, IT WILL BE ANNOUNCED ON
HEALTHIT.GOV WITH A COMMENT
PERIOD FOR THIS DATA LIST THAT
WILL OPEN AT A LATER DATE, AND
AS I MENTIONED IT WILL BE PART
OF THE REFINEMENT OF THE
DATASET.
SINCE WE CAN'T LOOK AT IT TODAY
I'LL GIVE AN OVERVIEW AND A HIGH
LEVEL PREVIEW OF WHAT THE DATA
ELEMENT -- WHAT THE DATA LIST
CONSISTS OF.
THERE ARE ABOUT 153 DATA
ELEMENTS, AS YOU CAN SEE A BIG
PORTION OF THEM ARE ACTUALLY
FROM THE USCDI DATASET WHICH IS
GREAT BECAUSE THAT MEANS THAT
DATA IS LIKELY ALREADY AVAILABLE
AND SHOULD BE ELECTRONICALLY
ABLE TO BE ELECTRONICALLY
EXCHANGED.
WE ALSO FOUND THAT IN THE
CREATION OF THE VARIOUS DOMAINS
WITHIN USCDI PLUS THERE WAS
OVERLAP.
SO NAMELY THERE WAS OVERLAP WITH
THE PUBLIC HEALTH DOMAIN, CANCER
DOMAIN, QUALITY DOMAIN.
THIS LETS US KNOW A COUPLE
THINGS, THAT THERE ARE VARIOUS
DATA ELEMENTS AND CLASSES WITHIN
THE DATA LIST THAT SHOULD BE OF
SUBSTANTIAL MATURITY LEVEL.
IT CAN ALSO TELL US THAT THEY
MAY NOT BE AT A SUBSTANTIAL
MATURITY LEVEL BUT THERE'S A
NEED ACROSS MULTIPLE DOMAINS AND
AREAS TO STANDARDIZE SOMETHING
SO THERE'S A GAP THERE IN MORE
THAN JUST MATERNAL HEALTH.
AND THEN I DID ALSO WANT TO
HIGHLIGHT THAT FOR MATERNAL
HEALTH DATASET THERE ARE UNIQUE
ELEMENTS THAT ARE OBVIOUSLY NOT
IN USCDI OR IN OTHER DOMAINS,
AND SOME EXAMPLES I'VE INCLUDED
HERE ARE THINGS LIKE DATA CLASS
AND ELEMENT FOR DEPRESSION,
ANXIETY, HEMORRHAGIC RISK
SCREEN, ALSO LOOKING AT THINGS
THAT MAY INDICATE HIGH RISK FOR
PERINATAL REFERRAL, HYPERTENSIVE
DISORDERS SPECIFIC TO PREGNANCY,
METHOD OF CONTRACEPTION AND SOME
OTHER PREGNANCY-RELATED
INFORMATION.
BECAUSE OF THE FOCUS AREA OF THE
GROUP I DID TAKE A LOOK AT THE
DATASET AND PROVIDED SOME
ADDITIONAL EXAMPLES OF OTHER
DATA ELEMENTS THAT WE CURRENTLY
HAVE IN THE DATASET, AND NAMELY
THERE WERE -- I INCLUDED SOME
SAMPLES OF THE TYPE OF DATA
ELEMENTS LISTED FOR MEDICATION
INFORMATION GATHERING, RELATED
TO PHARMACY NOTE IN THE
RECOMMENDATION, BIRTH OUTCOME, I
INCLUDED SOME DATA ELEMENTS
RELATED TO -- THAT WOULD BE
COLLECTED IN THAT, YOU KNOW,
PERIOD RIGHT AFTER DELIVERY, AND
THEN IN TERMS OF TRYING TO
IDENTIFY POTENTIAL EQUITY TYPE
DATA, I'VE INCLUDED THINGS LIKE
ETHNICITY, TRIBAL AFFILIATION,
AND RACE.
I WILL NOTE CURRENTLY WE DON'T
HAVE LACTATION SPECIFIC ELEMENTS
BUT I'LL HIGHLIGHT THAT'S, FOR
EXAMPLE, ONE PLACE I WOULD
WELCOME SUBJECT MATTER EXPERTISE
FROM THIS GROUP TO PROVIDE
DURING THE COMMENT PERIOD SO WE
CAN CONTINUE TO EXPAND AND
REFINE THE DATASETS.
THE LAST TOPIC I'M GOING TO
TOUCH ON ARE MOTHER AND INFANT
LINKAGES.
THROUGH A VARIETY OF ACTIVITIES
ONC HAS BEEN LOOKING AT MOM AND
INFANT LINKAGES FOR A LITTLE BIT
OF TIME NOW.
AND WE FOUND THE APPROACH VARIES
SIGNIFICANTLY ACCORDING TO
TECHNOLOGY DEVELOPER AND ALSO
DATA HOLDER.
SO SOME MAINTAIN PERSISTENT
LINKS BETWEEN MOM AND BABY
WITHIN THEIR SYSTEM AND THAT
LINK IS THEN ONLY BROKEN ONCE
THE DATA IS SHARED OUTSIDE OF
THE SYSTEM.
OTHERS DO NOT LINK RECORDS AT
ALL.
AND STILL OTHERS TAKE A
DIFFERENT APPROACH BY CREATING A
SEPARATE ENCOUNTER THAT'S JUST
SPECIFIC TO THE BIRTH, AND THEN
THEY ONLY HAVE MOM'S MAIDEN NAME
NOTED ON THE BABY RECORD.
IN TERMS OF LINKING RECORDS, IT
DEPENDS ON THE ENTITY BUT THERE
ARE THREE GENERAL APPROACHES
THAT WE HAVE FOUND.
SO, FIRST USING SOME SORT OF AN
ALGORITHM OR MANUALLY LOOKING AT
DATA TO INDICATE WHETHER RECORDS
SHOULD BE LINKED.
AND OFTEN TAKE APPROACHING USED
IN PATIENT MATCHING TO IDENTIFY
POTENTIAL LINKS, AND DATA THAT
ARE USED TYPICALLY TO DO THIS
INCLUDE INFANT DATA, SORRY,
INFANT DATA AT BIRTH, NEXT OF
KIN INFORMATION, MOTHER'S
DEMOGRAPHIC.
ANOTHER WAY TO LINK IS
IDENTIFIED AS A SYSTEM TRIGGER,
SO IT WILL GENERATE A FAMILY
HISTORY FOR THE BABY WHEN THERE
IS SOME SORT OF REQUEST FOR THE
BABY'S INFORMATION AND THEN MOM
WILL INEVITABLY SHOW UP IN THE
FAMILY HISTORY.
AND THEN THE LAST TWO THAT I'VE
INCLUDED HERE ARE WAYS TO LINK
RECORDS BY USING PORTIONS OF AN
EXCHANGE MESSAGE.
SO THE FIRST ONE IS USING HL7
FHIR, AND THERE ARE THREE
OPTIONS WHICH SHOULD DEPEND ON
THE SPECIFIC USE CASE.
ABOUT THERE IS SOMETHING CALLED
RELATED PERSON, WHICH WILL LINK
MOM AND BABY PRETTY
PERSISTENTLY.
THERE'S ANOTHER CHOICE WHICH IS,
AGAIN, USING AN ENCOUNTER SUCH
AS LINKING MOM AND BABY THROUGH
THE SPECIFIC ENCOUNTER OF THE
BIRTH, AND THEN AS I MENTIONED
EARLIER USING THE FHIR RESOURCE
FAMILY MEMBER HISTORY WHICH
WOULD BE USED IN AN INSTANCE
AGAIN WHEN BABY'S INFORMATION IS
BEING PULLED UP AND THE MOTHER'S
INFORMATION COMES UP IN THE
FAMILY MEMBER HISTORY.
THEN WE ALSO FOUND THAT THERE IS
AN OPPORTUNITY TO USE THE HL7 V2
PATIENT IDENTIFICATION SEGMENT.
AT THIS TIME I UNFORTUNATELY
DON'T HAVE A LOT OF INSIGHT
INTO, YOU KNOW, HOW OFTEN EACH
OF THESE ARE USED.
BUT I CAN SAY THAT THEY DID COME
UP DURING OUR STAKEHOLDER
HEARINGS AND PARTNER FEEDBACK
SESSIONS, AND HL7 ONES IN
PARTICULAR ARE IDENTIFIED AS
CANDIDATES, VIABLE CANDIDATES
FOR USE IN MOM AND BABY LINKING.
TO WRAP UP, I WANT TO CLOSE BY
SAYING THAT THE WORK THAT WE'RE
DOING IN USCDI+ FOR MATERNAL
FALLS WITHIN THE LARGER
WHEELHOUSE OF ONC EFFORTS IN
USHERING TOWARD HEALTH I.T.
ALIGNMENT ACROSS DEPARTMENT OF
HHS.
THERE ARE A SERIES OF MECHANISMS
THAT ONC HAS BEEN ESTABLISHENING
THAT ARE WORKING TO BRING
ALIGNMENT IN HOW THE DEPARTMENT
PURCHASES AND USES HEALTH I.T.
SO THAT WE'RE ALL USING A
STANDARDS-BASED APPROACH TO
COLLECTING AND USING THE DATA
WHICH IS THAT FOUNDATION OF AN
INTEROPERABLE INFRASTRUCTURE.
YOU MAY HAVE SEEN THE LANGUAGE
ONC IS WORKING TO INCORPORATE
INTO HHS PROGRAMS.
AND OTHER WAYS WE ARE, AGAIN,
TRYING TO MAXIMIZE THE USE OF
ONC-APPROVED STANDARDS AND
AUTHORITIES, AND ALSO ALWAYS
LOOKING FOR PARTNERS WHO ARE
READY TO TAKE ON, YOU KNOW,
IMPLEMENTING DATASET, LETTING US
KNOW IF WE'RE MISSING ANYTHING
IN THERE, AND, YOU KNOW, AGAIN
THAT FEASIBILITY QUESTION IS A
REALLY IMPORTANT ONE FOR US.
SO THAT WE ARE BUILDING AN
ON-RAMP TO MAKE SURE THAT WE
EVENTUALLY GET THERE WITHOUT
MAKING PEOPLE FEEL LIKE THEY ARE
PUSHED BEFORE THEY ARE READY.
SO I THINK THAT THE ONLY OTHER
THING I WANT TO MENTION IS THAT,
AGAIN, THAT WINDOW OF FEEDBACK
ON THE DATASET WILL BE OPEN,
HOPEFULLY SOMETIME NEXT YEAR.
IF YOU HAVEN'T SIGNED UP FOR THE
ONC NEWSLETTER, NOW WOULD BE A
GREAT TIME.
YOU CAN CHECK OUT OUR WEBSITE
FOR RELEVANT UPDATES AND
INFORMATION.
THANK YOU.
>> THANK YOU, STEPHANIE.
VERY WISE TO REMIND EVERYONE
ABOUT THE PUBLIC CONSULTATION
OPPORTUNITY, SO SIGN UP FOR THE
NEWSLETTER, I COULDN'T AGREE
MORE WITH THAT APPROACH.
WE HAVE TIME, I WANT TO SEE ARE
THERE ANY CLARIFICATION
QUESTIONS THAT ANYONE HAS FOR
STEPHANIE.
WE'LL GET INTO A BROADER
QUESTION-AND-ANSWER AT THE END
OF THE SESSION BUT I WANT TO
MAKE SURE WE DON'T MISS
CLARIFICATION QUESTIONS BASED ON
WHAT WAS PRESENTED.
SEEING NO HANDS COMING UP, I
THINK WHAT WE CAN DO, TRISH AND
LEILA, MOVE TO YOU.
>> I'LL GO AHEAD AND I WILL
SHARE MY SCREEN.
>> I CAN HEAR YOU CLEARLY.
>> GOOD.
ALL RIGHT.
AND LET ME GO HERE.
>> PERFECT.
VERY NICE.
>> THANK YOU I'M TRISH BRIGHT
WITH THE FDA'S CENTER FOR DRUG
EVALUATION AND RESEARCH.
I WORK WITH THE SENTINEL SYSTEM
IN PARTICULAR.
SO I WAS ASKED TO SPEAK TO USE
OF NOVEL DATA RESOURCES AND
WE'LL JUMP INTO THAT.
FIRST I WANT TO JUST EXPLAIN
WHAT THE SENTINEL SYSTEM IN IN
CASE PEOPLE HAVE LESS
FAMILIARARITY.
CDER'S SYSTEM, ARI,
CONGRESSIONALLY MANDATED TO HAVE
THIS STOOD UP.
IT INVOLVES ELECTRONIC HEALTH
CARE DATA, TYPICALLY INSURANCE
CLAIMS, SOME INTEGRATED WITH
EHR.
WE HAVE A COMMON DATA MODEL,
DISTRIBUTED NETWORK OF DATA
PARTNERS.
AND PRE-DEFINED PARAMETERIZE
REUSABLE QUERYING TOOLS, OFF THE
SHELF PROGRAMMING SO WE HAVE
PROGRAMS THAT ARE DONE THAT
ADDRESS SOME BASE QUESTIONS THAT
WE LIKE TO ASK, PULL THEM AND
REUSE THEM.
AND QUALITY ASSURANCE PROCESS.
I JUMPED AHEAD A LITTLE BIT.
OKAY, SO, WE'LL LOOK AT THE
MIDDLE COMMON FIRST, COMMON DATA
FORMAT.
WE GATHER INFORMATION ON
ENROLLMENT, DEMOGRAPHICS,
ENCOUNTER, DISPENSING, LAB
TESTS, VITAL SIGNS, ACROSS
DIFFERENT DATA PARTNERS.
IF WE JUMP TO THE RIGHT-HAND
SIDE HERE IF WE HAVE A QUESTION
AT FDA WE CAN DESIGN A STUDY TO
USE DATABASES.
WE HAVE A SENTINEL CENTER THAT
DROPS IN PROGRAMMING FORMAT WITH
PARAMETERS, QUERIES ARE
DISTRIBUTED TO EACH APPLICABLE
DATA PARTNER, AND YOU'LL SEE
THAT DONE HERE, REPRESENTING
DIFFERENT DATA PARTNERS IN OUR
NETWORK.
WE HAVE 14 AND DO HAVE SOME
KAISERS IN HERE, THAT WAS A
PRIOR QUESTION.
SO THE DATA PARTNERS MAINTAIN
PHYSICAL AND OPERATIONAL CONTROL
OVER THEIR DATA, STAYS BEHIND
THEIR FIRE WALL.
DATA PARTNERS EXECUTE
STANDARDIZED QUERIES AGAINST
THEIR OWN DATA FORMATTED AND
RETURN RESULTS TO THE CENTER
OPERATIONS, SENTINEL OPERATIONS
CENTER.
THE SENTINEL CENTER GIVES
AGGREGATED RESULTS,
DE-IDENTIFIED, PRESERVING
PRIVACY.
AND IN THE MOTHER-INFANT LINKAGE
TABLE WAS ADDED TO THE DATA
MODEL IN 2018.
AND I HAVE UP HERE NEAR THE TOP
JUST A LINK IN CASE ANYBODY IS
INTERESTED, YOU CAN GO THERE AND
SEE AND GET THEM YOURSELF.
WE DO HAVE A SAS PACKAGING
AVAILABLE.
IT HAS TO BE IN THE FORM OF THE
SENTINEL COMMON DATA MODEL BUT
THEN YOU CAN USE IT.
SO THERE'S 10.8 MILLION LINKED
DELIVERIES IN OUR DATA.
AND WE SHOW THAT DELIVERIES HERE
OVER TIME, AND THIS GREEN
SECTION IS WHEN WE UPLOAD
INCLUDED MEDICAID DATA, I'LL
TALK MORE ABOUT THAT LATER, BUT
IT'S A RICH RESOURCE THAT ADDS A
LOT OF PREGNANCY AND INFANT
DATA.
THIS IS JUST ANOTHER LINK FOR
YOU IN CASE PEOPLE HAVE AN
INTEREST WHERE THERE'S TRAINING
ON USING THE SENTINEL SYSTEM.
SO YOU CAN PUT IN THE LINK OR
FDA AND 2023 SENTINEL PUBLIC
TRAINING AND IT WILL POP UP IN
THE SEARCH ENGINE.
THE QUESTION I WAS ASKED TO
SPEAK TO IS USING NOVEL DATA
RESOURCES TO SUPPORT LARGE POST
MARKETING OBSERVATIONAL STUDIES
TO EVALUATE THE SAFETY OF
MEDICATION CLASSES DURING
PREGNANCY.
I CROSSED OUT SECTIONSES BECAUSE
WE SHALL NOT USING IN THE
CONTEXT OF PREGNANCIES, WE'RE
NOT USING DATABASE STUDIES TO
STUDY EFFECTIVENESS.
IN DATABASE STUDIES WE'RE NOT
CURRENTLY LOOKING AT LACTATION.
SO WE'RE USING IT THOUGH.
SO HERE IS AN EXAMPLE OF
ASSESSMENT FOR PRE-MARKET
REVIEW.
IF WE JUMP TO THE LEFT-HAND SIDE
HERE, THE CONCERN WAS THAT
EMBRYO FETAL MALFORMATIONS WERE
IN ANIMAL STUDIES.
FDA WAS THINKING RISK EVALUATION
AND MITIGATION STRATEGY, A REMS
PROGRAM SHOULD BE REQUIRED, WE
ESTIMATED HEART FAILURE IN
REPRODUCTIVE AGE WOMEN AND
CHARACTERIZE MEDICATION USE
AMONG PREGNANCIES WITH HEART
FAILURE.
WE COULDN'T STUDY THE ACTUAL USE
OF THIS MEDICATION BECAUSE IT
WAS STILL PRE-MARKET.
SO WE FOUND HEART FAILURE WAS
RARE AMONG WOMEN OF REPRODUCTIVE
AGE.
AND THE POTENTIAL EMBRYO TOXIC
HEART FAILURE MEDICATION USE
DURING PREGNANCY WAS RARE.
THIS INFORMATION CONTRIBUTED TO
FDA DETERMINATION THAT LABELING
WOULD PROVIDE SUFFICIENT
INFORMATION TO ASSURE BENEFITS
OUTWEIGHED THE RISK.
HERE'S ANOTHER STUDY THAT WAS
DONE, RISK OF CONGENITAL CARDIAC
MALFORMATION FOLLOWING DISCERN
USE.
YOU CAN FIND IT ON THE SENTINEL
SITE, CLICK ON THESE THINGS IF
YOU WANT TO SEE IT.
WE'RE ACTIVELY USING IT BUT
THERE'S A LOT MORE THAT COULD BE
DONE AND ALL OF THIS IS AN
EVOLUTION.
SO, WHAT I'M GOING TO SHOW YOU
NEXT IS THAT SOME OF THE
LIMITATIONS AROUND IT.
ONE OF THE ISSUES IS RIGHT NOW
WE ARE ANCHORING ON LIVE BIRTHS.
STUDYING MATERNAL EXPOSURE WE
ALSO WANT TO KNOW ABOUT OUTCOMES
THAT WEREN'T LIFE BIRTHS AND
SAFETY, BECAUSE WE'RE STILL
WORKING ON THAT PROGRAMMING AND
TOOLS DON'T HAVE THEM AVAILABLE
RIGHT NOW BUT WE'RE ABOUT TO
HAVE THEM DONE.
WHEN WE WENT AND LOOKED AT THE
SENTINEL SYSTEM WE WOULD LIKE
WHEN THERE'S A MARKET
APPLICATION BEING APPROVED, NO,
THE SYSTEM ISN'T GOING TO
CAPTURE THAT BECAUSE IT DOESN'T
CAPTURE THE ENTIRETY OF THE
OUTCOMES WE'RE INTERESTED IN.
SO WHAT I'M GOING TO SHOW HERE
AT THE TOP THERE'S INFORMATION
ON ANOTHER ARTICLE THAT TALKS
ABOUT USE OF THE SENTINEL SYSTEM
AND THEY HAVE ABOUT A PARAGRAPH
OR TWO ABOUT PREGNANCY.
THERE IS THIS TABLE, IT SHOWS
THE DISTRIBUTION OF THE SAFETY
CONCERNS, BUT DECIDED THE THERE
ARE TOOLS IN THE SENTINEL SYSTEM
NOT SUFFICIENT TO ADDRESS THE
OUTCOME OF INTEREST, STILL
CAPTURE THE HEALTH OUTCOME.
THERE COULD BE OTHER REASONS WHY
WE COULDN'T USE SENTINEL,
CO-VARIATES OR POPULATION WE
COULDN'T CAPTURE BUT THIS IS
FOCUSED ON HEALTH OUTCOMES, AND
I'M SHARING BECAUSE THE TOP ROW
IS PREGNANCY.
WE WANT TO LOOK AT THE GAMUT OF
POTENTIAL SAFETY OUTCOMES
ASSOCIATED WITH MEDICAL EXPOSURE
TO MOM ON THE MOM AND THE BABY.
IT'S INSUFFICIENT BUT THAT COULD
BE EVOLVING AND CHANGING BECAUSE
WE DO HAVE NEW PROGRAMMING
THAT'S BECOMING AVAILABLE TO US.
IN ADDITION, WE HAVE
PRESCRIPTION DRUG USER FEES,
KNOWN AS PDUFA FEES, TO SUPPORT
THE FDA.
THERE'S A COMMITMENT LETTER.
ON THE RIGHT-HAND SIDE IS A
SECTION, BUT PART OF THE PDUFA
7, OUR MOST RECENT COMMITMENT,
FOCUSED ON PREGNANCY SAFETY.
WE SAID WE COULD CONDUCT FIVE
DEMONSTRATION PROJECTS TO
ADDRESS GAPS IN KNOWLEDGE ABOUT
PERFORMANCE CHARACTERISTICS OF
DIFFERENT STUDY DESIGNS.
WE NEEDED TO HAVE THIS COMPLETED
BY 2027 TO HELP INFORM A
FRAMEWORK THE FDA WILL USE
AROUND POST-MARKETING SAFETY.
AND THIS IS JUST SHOWING WHAT
THREE OF THOSE DEMONSTRATION
PROJECTS INVOLVE.
COMPARING PREGNANCY REGISTRY
STUDIES, VERSUS ELECTRONIC
HEALTH RECORD STUDIES AND
LOOKING AT SIGNAL DETECTION AND
SIGNAL EVALUATION.
BOTTOM ONE HERE IS LOOKING AT
SINGLE ARM SAFETY STUDIES VERSUS
ELECTRONIC HEALTH CARE DATABASE
TO UNDERSTAND WHAT COMPLEMENT
APPROACHES AND HOW TO USE THEM
IS BEST IN THE POST MARKET SPACE
ABOUT PREGNANCY SAFETY.
SO WE'VE RECENTLY HAD A WORKSHOP
ON SEPTEMBER 18 AND 19 ABOUT
OPTIMIZING THE USE OF PREGNANCY
SAFETY STUDIES.
AND YOU'LL FIND THE LINK TO THAT
INFORMATION DOWN HERE AT THE
BOTTOM, MATERIALS ARE LOCATED
HERE.
YOU CAN GO IN AND LISTEN TO THE
ENTIRE WORKSHOP IF YOU WANT SO
THAT'S AVAILABLE TO YOU.
SO, THE SECOND QUESTION, SUBPART
QUESTION POSED, NOVEL DATA
SOURCES TO SUPPORT STUDIES
ACROSS MULTIPLE DRUGS USING THE
SAME INFRASTRUCTURE TO CONSERVE
RESOURCES AND YES WE DO THAT.
WE USE OUR COMMON DATA MODEL TO
LOOK AT STUDY CLASS EFFECTS.
I PUT AN EXAMPLE, THE LINK AT
THE BOTTOM FOR PEOPLE
INTERESTED.
AND WE HAVEN'T DONE THIS IN THE
CONTEXT OF PREGNANCY SAFETY BUT
WE DO USE THE SENTINEL SYSTEM
IN GENERAL.
I WANTED TO TALK ABOUT MEDICAID
DATA BECAUSE THIS IS MORE RECENT
WORK.
WITHIN THE U.S. FDA'S SENTINEL
SYSTEM, THE LINKAGE OF MOTHER
AND INFANT DATA IS CRITICAL FOR
ASSESSMENT OF MEDICATION SAFETY
DURING PREGNANCY.
AND MEDICAID DATA IS THE NEW
TRANSFORMED MEDICAID STATISTICAL
INFORMATION SYSTEM, T-MSIS,
CONVERTED INTO THE SENTINEL
COMMON DATA MODEL, INITIAL
LINKAGE WAS PERFORMED, OBJECTIVE
TO HAVE THE MOST ACCURATE
LINKAGE, BOTH ASSOCIATED WITH
THE SAME JURISDICTION, BUT
DELIVERY RECORD AND INFANT
RECORD MUST HAVE THE SAME CASE
NUMBER IDENTIFIER, A
STATE-ASSIGNED NUMBER OFTEN A
PROXY FOR FAMILY IDENTIFIER,
CLOSE TO DELIVERY DATE.
I'M GOING THROUGH THIS QUICKLY.
YOU CAN SEE A DEPICTION OF
LINKAGE.
61% OF MOTHER DELIVERY RECORDS
IN THE MEDICAID AND CHIP DATA
COULD BE LINKED BUT THEY HIDE
VARIABILITY.
FOR EXAMPLE, 34 OF THE
JURISDICTIONS LINKAGE RATE WAS
OVER 75%, SEVEN WERE UNDER 15%.
I'M GOING TO SHOW MORE
GRANULARITY ABOUT THE DATA.
I'M NOT THE ONE WHO DID THE
LINKAGE AND WORKED ON THIS
PROJECT.
THIS WORK IS LED BY DR. JUDY
MARO, ONE OF THE NICHD WINNERS
PRESENTED EARLIER, IN AN EARLIER
PRESENTATION.
SO THE TOP ROW HERE IS ALASKA.
SO YOU'LL SEE ALASKA HAS THE
GREEN CHECKS, SIGNIFY THE TEAM
WENT THROUGH AND FOUND IT WAS
REALLY COMPLETE AND SOLID DATA
ACROSS ALL YEARS.
BUT YOU HAVE TO BE CAREFUL ABOUT
WHAT YOU'RE GETTING BECAUSE THE
RED INDICATE WHERE THE TEAM
IDENTIFIED A PROBLEM AND THE
NUMBERS WE DON'T HAVE TO FOCUS
ON TOO MUCH, THE LETTERS, THESE
ARE SIGNIFYING THE TEAM CODE OF
WHAT TYPE OF PROBLEM IT WAS.
IN ALABAMA THEY LOOKED AND SAID
NO, THIS DATA IS NOT COMPLETE.
WE CAN'T USE IT.
SO WE'RE NOT USING ANY OF THAT.
BUT THERE IS A LOT OF
VARIABILITY.
WE HAVE ARKANSAS, THE FIRST TWO
YEARS, 2004, 2015, A YEAR WHERE
THEY WERE ONBOARDING THE SYSTEM
SO STATES YOU'LL SEE SOME
ONBOARDED EARLIER THAN OTHERS.
STARTING IN 2016, IT WASN'T THAT
GOOD BUT THEN IN THE OTHER YEARS
IT WAS ACCEPTABLE.
BUT NOT FOR THIS CMC,
COMPREHENSIVE MANAGED CARE IN
ONE PARTICULAR YEAR.
SO I THINK THE MORAL, YOU HAVE
TO BE CAREFUL AND WORK WITH
PEOPLE WHO KNOW THE DATA AND
HAVE LOOKED AT IT CAREFULLY AND
DONE THESE KIND OF QUALITY
CHECKS.
BECAUSE IF YOU JUST TOOK THE
DATA AT FACE VALUE, SORT OF
GARBAGE IN, GARBAGE OUT, SO
MOVING ON, THE JURISDICTIONS
WITH GREATER THAN FIVE YEARS OF
INCLUSION MEDICAID DATA WERE 33.
WITH LESS THAN FOUR YEARS WERE
16.
JURISDICTIONS WITH ANY INCLUSION
WERE 4.
AND THIS IS WHERE IF YOU WANT TO
GO TO THE LINK THAT DESCRIBES
THE PROJECT, IT DOESN'T HAVE THE
RESULTS THAT I SHOWED YOU BUT
DOES DESCRIBE THE PROJECT.
SO, FROM FDA'S CENTER FOR DRUG
EVALUATION AND RESEARCH
EXPERIENCE WHAT HAS BEEN DONE IN
FDA'S SENTINEL SYSTEM THAT MIGHT
ALIGN WITH RECOMMENDATION 12,
10.8 MOTHER AND INFANT LINKED.
LACTATION IS NOT ADDRESSED
THROUGH DATABASE STUDIES.
WE'RE SORTING THROUGH THE BEST
PRACTICES FOR USING
COMPLEMENTARY DATA SOURCES FOR
POST-MARKET SAFETY ASSESSMENT
AND THE PROGRAMMING TOOLS ARE
STILL EVOLVING AND DEVELOPING.
THE MEDICATE DATA IS RICH,
QUALITY AND CAPTURE DIFFERS BY
STATE
WHAT RESOURCES, POLICY CHANGE,
REGULATIONS ARE NEEDED?
I INCLUDED THE LINK TO THE
WORKSHOP BECAUSE WE SPENT TWO
DAYS TALKING, IF ANYBODY WANT A
DEEP DIVE INTO FDA CURRENT
THINKING THEY CAN GO AND WATCH
THAT.
AND SO WITH THAT I'LL END.
>> THANKS SO MUCH, TRISH.
I THINK OUR WORK GROUP MEMBERS
SHOULD HAVE RECEIVED THOSE LINKS
AS PART OF THEIR PRE-READ, SO
ANYTHING THAT'S IN THESE SLIDES
YOU WILL RECEIVE SOME OF THE
SLIDES AT THE COMPLETION OF THE
MEETING BUT YOU SHOULD AT LEAST
HAVE THESE LINKS AVAILABLE FROM
THE PREVIOUS MEETING.
I DO WANT TO MAKE SURE BEFORE WE
MOVE TO LEILA, ARE THERE
QUESTIONS FOR CLARIFICATION FOR
TRISH BASED ON HER PRESENTATION
TODAY?
NOT SEEING ANYONE, I'M ASKING --
WAIT, THERE IS A QUESTION.
DR. CHARO?
>> THAT WAS TERRIFIC.
THANK YOU SO VERY MUCH.
I JUST WONDER IF YOU COULD SAY A
FEW WORDS ABOUT THE STATES SLOW
TO IMPLEMENT OR DIDN'T IMPLEMENT
AT ALL FROM YOUR LAST SLIDE,
WHAT WERE THE REASONS OR THE
OBSTACLES AND IS THERE SOME
REASON TO THINK IT'S GOING TO
IMPROVE IN THE FUTURE?
>> YEAH, IT'S HARD TO SAY
BECAUSE I WASN'T THE ONE WHO DID
IT.
WITH THE ONES SLOW, I WOULDN'T
BE TOO WORRIED BECAUSE THEY WERE
GIVEN TWO YEARS TO TRANSITION,
IT MAY HAVE BEEN HOW THEY
PRIORITIZED OR FUNDED FOR THAT
YEARS.
MORE CONCERNING IS WHEN YOU HIT
THE BLIPS LATER ON SEEING THE
RED LETTERS LATER BECAUSE THAT'S
SYSTEMS UP AND GOING AND
SOMETHING WENT WRONG.
SOMETIMES THE REASONS ARE REALLY
KIND OF STRANGE, LIKE, FOR
EXAMPLE, THERE'S SOME STATES
WHERE THEY FOUND THEY HAVE THE
UNIQUE FAMILY IDENTIFIER,
THERE'S SOME STATES, SOME
JURISDICTIONS WHERE THEY START
REISSUING THAT TO DIFFERENT
FAMILIES, WHICH THROWS OFF THE
LINKAGE.
SOMETIMES THE ISSUES WERE
ELIGIBILITY, SOMETIMES GETTING
STRANGE TEMPORAL SEQUENCE OF
PEOPLE GETTING MEDICATIONS
BEFORE THEY WERE FORMALLY
ENROLLED, A FEW STRANGE THINGS
LIKE THAT, THOSE WERE SORT OF
THE REASONS THE TEAM WOULD SAY
THIS DOESN'T MAKE LOGICAL SENSE,
THIS ISN'T DATA WE CAN USE.
WILL THEY GET BETTER?
I WOULD HOPE SO.
AND I THINK WITH TIME THEY
PROBABLY WOULD BUT, AGAIN, WE
DID SEE SOME THAT SEEM SOLID AND
THEN THEY HAD ERRORS JUMP IN.
>> THANKS VERY MUCH.
>> UH-HUH.
>> AND REBECCA, YOUR HAND IS UP
FOR A CLARIFICATION QUESTION AS
WELL.
>> SORRY.
MY COMPUTER WAS SLOW.
THIS IS PROBABLY AN IGNORANT
QUESTION.
ONCE YOU ALL DO THE STUDIES WITH
SENTINEL, WHAT'S THE NEXT STEP
THERE, DOES THAT GO BACK TO
LABELING OR DO YOU PUT OUT
RESEARCH STUDIES, KIND OF HOW
DOES THAT INFORMATION THEN GET
TO CLINICIANS, PATIENTS?
YEAH.
>> IT'S A GOOD QUESTION.
ALL OF OUR STUDIES THAT WE DO
ARE POSTED ON OUR WEBSITE SO
PEOPLE CAN SEE THEM.
TYPICALLY THE REASON WE'RE DOING
A STUDY IS BECAUSE WE'RE TRYING
TO ANSWER A REGULATORY QUESTION
POSED WITHIN THE FDA.
SO MAYBE A REVIEW TEAM THAT HAS
A QUESTION AND THEY WANT US TO
ADDRESS SOMETHING OR A SAFETY
QUESTION, MAYBE IDENTIFIED IN
LITERATURE, PEOPLE WANT TO SEE
IF THIS IS REALLY DONE.
WE DO THE STUDY AND FEED IT BACK
TO THERAPEUTIC DIVISION
RESPONSIBLE FOR THAT.
AND THEN THEY MAKE A DECISION,
DO THEY WANT TO TAKE REGULATORY
ACTION, SOMETIMES IT COULD BE A
COMMUNICATION TO THE PUBLIC,
SOMETIMES IT COULD BE A LABELING
CHANGE.
WE HAVE ABOUT 12 LABELING
CHANGES AT THIS POINT THAT
INCLUDE SENTINEL DATA.
SOMETIMES IT'S CONSIDERING FOR
APPROVAL OF A NEW MEDICATION.
WE DID STUDIES RELATED TO
PAXLOVID BEFORE IT WAS APPROVED,
OR OFTEN OVERLOOKED MOST OF THE
TIME WE GET REASSURING SAFETY
INFORMATION, SO THE TEAM DECIDES
NO REGULATORY ACTION IS NEEDED.
>> HELPFUL.
THANK YOU.
>> THANK YOU.
>> THANK YOU VERY MUCH FOR THE
PRESENTATION.
WE'LL BRING YOU BACK FOR THE
QUESTION-AND-ANSWER ONCE LEILA
COMPLETED HER PRESENTATION.
>> SOUNDS GOOD, THANK YOU.
>> NEXT WE'LL INVITE DR. SAHIM.
>> I'M IN THE DIVISION OF
PEDIATRICS AND MATERNAL HEALTH,
OFFICE OF NEW DRUGS IN CDER.
SLIGHTLY DIFFERENT DIVISION THAN
TRISH BUT WE COLLABORATE ON A
LOT OF PROJECTS TOGETHER.
SO THANK YOU SO MUCH FOR THE
OPPORTUNITY TO PRESENT TODAY.
NEXT SLIDE PLEASE.
I'LL FDA SPEAKERS HAVE TO
PRESENT THIS DISCLAIMER AS PARTS
OF OUR PRESENTATION, SO IT'S
IMPORTANT FOR ME TO NOTE THAT
THIS PRESENTATION TODAY REFLECTS
MY PERSONAL VIEWS AND NOT THE
OFFICIAL POSITION OF THE FDA.
NEXT SLIDE PLEASE.
SO, THE OBJECTIVES OF MY TALK
ARE TO PROVIDE A LITTLE BIT OF
BACKGROUND INFORMATION ON KIND
OF THE REGULATORY PATHWAY FOR
DRUG APPROVALS, AND HOW WE HAVE
CERTAIN AUTHORITIES REGARDING
PREGNANCY REGISTRIES IN
POST-APPROVAL SETTING, AND THEN
I'M GOING TO TALK A LITTLE BIT
ABOUT FDA EFFORTS SUPPORTING
PRGLAC RECOMMENDATION 13.
NEXT SLIDE PLEASE.
SO, IN TERMS OF BACKGROUND
INFORMATION, OF COURSE THIS IS
ALL INFORMATION THAT YOU'RE
AWARE OF.
THERE ARE APPROXIMATELY 5.5
APPROXIMATELY PREGNANCIES IN THE
U.S. EVERY YEAR.
AND OF COURSE, THE REASON WE'RE
ALL HERE FOR THIS MEETING IS
BECAUSE PREGNANT INDIVIDUALS MAY
NEED TREATMENT FOR CHRONIC OR
ACUTE CONDITIONS, AND SO IT'S
ALSO UNDERSTOOD THAT PREGNANT
INDIVIDUALS HAVE HISTORICALLY
BEEN LEFT OUT OF DRUG
DEVELOPMENT TRIALS FOR VARIOUS
REASONS.
THERE ARE CURRENTLY SOME EFFORTS
THAT WE'RE INVOLVED IN TO
ADDRESS THIS, BUT I THINK THAT'S
STILL A HUGE EFFORT THAT'S GOING
TO TAKE A LONG TIME.
SO, WHAT HAPPENS IS THAT
PHARMACEUTICAL COMPANIES SUBMIT
DRUG APPLICATIONS TO THE FDA,
AND THEN WHEN DRUGS ARE APPROVED
THEY ARE ONLY APPROVED WITH
CLINICAL REPRODUCTIVE DATA TO
INFORM SAFETY AND PREGNANCY.
SO THE CURRENT PARADIGM IS THAT
HUMAN DATA ARE THEN NEEDED TO
INFORM THE PRESCRIPTION DRUG
LABELING, TO INFORM CLINICAL
CARE, AND THESE DATA ARE
COLLECTED IN THE POST-APPROVAL
SETTING.
AT THE TIME OF NEW DRUG APPROVAL
FDA COULD ISSUE POST-MARKETING
REQUIREMENTS TO CONDUCT
PREGNANCY SAFETY STUDIES.
NEXT SLIDE PLEASE.
SO, I WANTED TO TALK A LITTLE
BIT ABOUT FDA'S AUTHORITIES
BECAUSE THIS SETS THE STAGE FOR
DISCUSSION LATER ON IN TERMS OF
SOME OF PRGLAC RECOMMENDATIONS
FOR THE COMMITTEE TO UNDERSTAND
WHAT ARE WITHIN FDA'S
AUTHORITIES TO KIND OF, YOU
KNOW, TO IMPLEMENT SOME OF THESE
RECOMMENDATIONS.
PREGNANCY SAFETY STUDIES CAN BE
REQUIRED UNDER SESSION 505O 3 OF
THE FD & C ACT.
IN CBER THEY ISSUE AS
POST-MARKETING COMMITMENTS,
PMCs.
FDA HAS BEEN ISSUING TWO TYPES
OF PREGNANCY REQUIREMENTS, A
PREGNANCY REGISTRY AND
COMPLEMENTARY DATABASE STUDY,
AND THIS IS HAPPENING IN CDER.
NEXT SLIDE PLEASE.
SO, I'M GOING TO MOVE ON TO TALK
ABOUT FDA EFFORTS SUPPORTING
PRGLAC RECOMMENDATION 13
SPECIFICALLY.
NEXT SLIDE PLEASE.
SO PRGLAC RECOMMENDATION 13A IS
RECOMMENDATION TO CREATE USER
FRIENDLY PREGNANCY REGISTRY FOR
REGISTRY LISTING.
AND THEN UNDER THIS
RECOMMENDATION SUBPART, A IS
TO -- RECOMMENDATION TO IDENTIFY
ELEMENTS NEEDED FOR REGISTRY
LISTING AND THEN B TO DEVELOP A
PUBLIC/PRIVATE PARTNERSHIP TO
HOST A AND LACTATION REGISTRY
LISTING WEB PAGE.
IN TERMS OF WHAT FDA IS DOING
MAINTAINING A FDA REGISTRY
WEBSITE ONLY LIMITED TO PRODUCTS
APPROVED BY FDA.
AND SO THERE IS AN EXISTING
PROCESS THAT FDA IMPLEMENTS IN
TERMS OF STANDARD ELEMENTS TO
LIST THE PREGNANCY REGISTRY, SO
WHEN SPONSORS SUBMIT THEIR STUDY
PROTOCOLS FOR PREGNANCY
REGISTRIES TO FDA THEY ARE
REVIEWED BY FDA, AND THEN WE
SEND BACK RECOMMENDATIONS TO THE
COMPANY, ADVISING THE COMPANY TO
LIST THEIR PREGNANCY REGISTRY ON
THIS PREGNANCY WEB PAGE.
SO IN TERMS OF RECOMMENDATION B
DEVELOPING A PUBLIC/PRIVATE
PARTNERSHIP TO HOST THIS
PREGNANCY REGISTRY LISTING WEB
PAGE, FOR US IT'S, YOU KNOW,
FROM OUR PERSPECTIVE THIS
PREGNANCY REGISTRY WEB PAGE IS
SERVING OUR NEEDS IN TERMS OF
PRODUCTS THAT ARE APPROVED BY
FDA, AND SO I GUESS A QUESTION
FOR THE COMMITTEE IS, YOU KNOW,
ARE THERE OTHER NEEDS THAT CAN
BE ADDRESSED BY A PUBLIC/PRIVATE
PARTNERSHIP FOR OTHER TYPES OF
REGISTRY LISTINGS THAT MAY BE
OUTSIDE OF FDA'S PURVIEW.
AND WE CAN TALK ABOUT THESE
QUESTIONS OR THESE ISSUES IN THE
THE QUESTION-AND-ANSWER PERIOD
OR IN DISCUSSION.
WE CAN MOVE TO THE NEXT SLIDE
PLEASE.
RECOMMENDATION 13B DEVELOP
REGISTRY STANDARDS AND COMMON
DATA ELEMENTS AND FACILITATE
INPUT WITH TRANSPARENT ACCESS TO
OBTAIN INFORMATION IN REAL TIME.
FDA PUBLISHED A GUIDANCE ON
SAFETY STUDIES FOR, AGAIN,
FDA-APPROVED MEDICAL PRODUCTS.
AND SO IN THIS GUIDANCE,
REGISTRY STANDARDS IN THE
DISCUSSION OF THE COMMON DATA
ELEMENTS ARE DESCRIBED.
THERE IS A TABLE AT THE END OF
THE GUIDANCE THAT DESCRIBES ALL
OF THE COMMON DATA ELEMENTS THAT
ARE REQUESTED AS PART OF A
PREGNANCY REGISTRY STUDY.
THIS GUIDANCE IS CURRENTLY BEING
UPDATED BASED ON PUBLIC
COMMENTS.
AND THEN THE ISSUE RELATED TO
REALTIME DATA COLLECTION, SO
DATA IS COLLECTED FROM PREGNANT
INDIVIDUALS IN REAL TIME THROUGH
THE USE OF APPS.
AND SO AGAIN FROM OUR
PERSPECTIVE WE FEEL THAT I GUESS
A QUESTION IS THAT ARE THERE
OTHER REGISTRIES OUTSIDE OF
FDA'S PURVIEW THAT NEED TO
ADDRESS COMMON DATA ELEMENTS.
NEXT SLIDE PLEASE.
AND THIS IS THE GUIDANCE THAT I
MENTIONED THAT'S CURRENTLY
UNDERGOING REVISION.
NEXT SLIDE PLEASE.
RECOMMENDATION 13C FACILITATE
ACCESS TO DATA AND TRANSPARENCY
OF INFORMATION AND REGISTRIES
USE ANTIRETROVIRAL AS A MODEL.
FDA SUPPORTS THIS
RECOMMENDATION.
WE AT THE PUBLIC WORKSHOP THAT
WE HELD IN SEPTEMBER, THIS ISSUE
CAME UP AS WELL AND WAS A TOPIC
FOR DISCUSSION.
AND SO THE ANTIRETROVIRAL
PREGNANCY REGISTRY HAS DONE THIS
VERY SUCCESSFULLY AND IS A GREAT
MODEL BECAUSE IT INVOLVES 24
DIFFERENT MANUFACTURERS AND THAT
INCLUDES 61 BRAND NAME DRUGS,
THIS IS NOT A PREGNANCY REGISTRY
THAT IS ISSUED AS A
POST-MARKETING REQUIREMENT, SO
ALL OF THESE COMPANIES
COLLABORATE TOGETHER AND THIS
PREGNANCY REGISTRY PUBLISHES
THEIR RESULTS ON A PUBLIC-FACING
WEBSITE, EVERY SIX MONTHS.
AND SO THIS IS A SUCCESSFUL
MODEL, AND THEN I GUESS THE
QUESTION THAT WE HAVE AGAIN FOR
THE COMMITTEE IS THAT FROM OUR
PERSPECTIVE, THE DATA BELONG TO
THE MANUFACTURER THAT
MANUFACTURES THE INDIVIDUAL
DRUG, AND SO, YOU KNOW, WHERE
DOES THE AUTHORITY LIE TO
OPERATIONALIZE THIS
RECOMMENDATION?
I THINK WE ALL SUPPORT THIS.
BUT I GUESS WE NEED TO HAVE
FURTHER DISCUSSION AS TO HOW
THIS CAN BE IMPLEMENTED ACROSS
THE BOARD.
NEXT SLIDE PLEASE.
THE NEXT RECOMMENDATION IS
RECOMMENDATION 13D, DEVELOPING
DISEASE AND CONDITION FOCUSED
REGISTRIES, MOVING TOWARDS
SINGLE REGISTRY FOR ALL
THERAPEUTIC PRODUCTS WITH INPUT
FROM STAKEHOLDERS, BUILD
COLLABORATION BETWEEN THE
PUBLIC/PRIVATE PARTNERSHIP AND
OTHER INDUSTRY REPRESENTATIVES
TO WORK TOWARDS SINGLE REGISTRY
FOR THERAPEUTIC PRODUCTS USED BY
PREGNANT WOMEN AND LACTATING
WOMEN AND B, EXPAND USE OF
DISEASE OR CONDITION
POST-MARKETING STUDIES.
IN TERMS OF STATUS UPDATE, THIS
IS ANOTHER RECOMMENDATION THAT
FDA STRONGLY SUPPORTS.
WE KNOW FROM PRIOR EXPERIENCE
THAT DISEASE-BASED REGISTRIES
HAVE A TRACK RECORD IN TERMS OF
DATA COLLECTION COMPARED TO
SINGLE DRUG, SINGLE COMPANY
PREGNANCY REGISTRIES THAT
TYPICALLY TAKE 10 TO 15 YEARS TO
COLLECT DATA.
AND SO THIS IS WHERE WE ALL
ASPIRE TO, AND WE CONSISTENTLY
PROVIDE RECOMMENDATIONS TO
INDUSTRY WHEN WE RECEIVE
PREGNANCY REGISTRY PROTOCOLS, WE
CONSISTENTLY SEND BACK
RECOMMENDATIONS FOR SPONSORS TO
CONSIDER ALIGNING AND
COLLABORATING WITH OTHER
MANUFACTURERS TO CONDUCT A
DISEASE-BASED PREGNANCY
REGISTRY.
SO AT THE PUBLIC WORKSHOP THAT
WE HELD IN SEPTEMBER, THIS TOPIC
WAS ALSO DISCUSSED.
THERE WAS A PRESENTATION BY
JESSICA ALBANO WHO OVERSEES THE
ANTIRETROVIRAL PREGNANCY
REGISTRY, AND SO SHE DESCRIBED
HOW COMPLEX IT IS, HOW -- BUT
THEY ARE SUCCESSFUL IN
DEVELOPING CONFIDENTIALITY
AGREEMENTS, DATA SHARING
AGREEMENTS, ET CETERA.
AND THIS IS ALSO DONE WITHOUT
ANY KIND OF PUBLIC FUNDING.
SO JUST WANTED TO BRING THAT TO
EVERYBODY'S ATTENTION THAT THIS
IS A GREAT MODEL, BUT HOW DO WE
OPERATIONALIZE THESE
RECOMMENDATIONS?
I WANT TO RECOGNIZE TWO
COMMITTEE MEMBERS, TINA CHAMBERS
AND JANET HARDY, WERE
PARTICIPANTS AT THE FDA PUBLIC
WORKSHOP IN SEPTEMBER, SO THEY
WERE SPEAKERS AND THEY WERE
PANEL MEMBERS, AND SO THIS --
THESE RECOMMENDATIONS ARE VERY,
VERY COMPLEX, AND, YOU KNOW,
THEY ARE KIND OF MORE RELATED TO
POLICY ISSUES AND AUTHORITY
ISSUES, AND SO FORTH.
SO, IT'S A LITTLE BIT DIFFICULT
FOR, YOU KNOW, FOR US TO
DIRECTLY RESPOND TO SOME OF
THESE AND MAYBE THESE ARE SOME
OF THE RECOMMENDATIONS THAT MAY
END UP BEING RED DOT WHERE THERE
NEEDS FURTHER CONSIDERATION BY
THE COMMITTEE.
NEXT SLIDE PLEASE.
AND THAT'S THE END OF MY
PRESENTATION.
SO THANK YOU FOR YOUR ATTENTION
AND THANK YOU FOR THE
OPPORTUNITY.
>> THANK YOU, LEYLA.
DOES ANYONE HAVE CLARIFICATION
FOR LEYLA BEFORE WE GO INTO THE
OPEN QUESTION-AND-ANSWER?
NOT SEEING ANY HANDS I'LL JUMP
INTO LEYLA'S LAST COMMENT.
THANK YOU VERY MUCH, STEPHANIE
AND TRISH, FOR COMING UP ON
SCREEN.
YOU PREEMPTED MY NEXT COMMENT.
LEYLA RAISES AN IMPORTANT
COMMENT IN THE PRESENTATION, ONE
THAT'S FUNDAMENTAL TO SUE LAID
OUT HOW WE INTEND TO WORK WITH
YOU IN THINKING ABOUT THESE
RECOMMENDATIONS, WHERE WE MIGHT
NEED TO BE, SOME ADDITIONAL WORK
DONE FOR SOME RECOMMENDATIONS TO
ULTIMATELY BE PUT INTO PRACTICE.
SO I THINK THERE'S A REALLY
IMPORTANT COMMENT THAT'S RAISED
BY LEYLA THAT WE NEED TO THINK
ABOUT IN TERMS OF THE
STAKEHOLDERS ENGAGED, THE CALL
TO ACTION, WHERE TO DIRECTION
COMES FROM.
SUE, THERE ARE QUITE A HANDFUL
OF QUESTIONS IN THE Q&A.
I DO INVITE YOU TO COME ON
SCREEN TO ASK YOUR QUESTION.
I DO SEE WE HAVE DR. CHARO WHO
IS READY WITH THE FIRST ONE.
>> THANKS AGAIN, BOTH TERRIFIC.
FOLLOWING UP ON THE POINT ABOUT
PROPRIETARY DATA AND DIFFICULTY
IN IMPLEMENTING SOMEBODY'S
RECOMMENDATIONS ON, YOU KNOW,
TRANSPARENCY BECAUSE OF THAT.
CAN YOU GIVE US ANY EXAMPLES OF
OTHER SITUATIONS IN WHICH THERE
WAS SOME KIND OF DEAL OR
ARRANGEMENT THAT RESULTED IN
COMPANIES ALLOWING FOR
TRANSPARENCY OF PROPRIETARY
DATA?
WONDERING IF THERE ARE LESSONS
TO BE LEARNED THERE TO EXTRACT
THAT INFORMATION FOR PUBLIC
SCRUTINY.
>> YEAH, THANKS FOR THAT
QUESTION.
SO I THINK THAT THE ONE EXAMPLE
WE'RE ALL FAMILIAR WITH IS IN
THE ANTIRETROVIRAL PREGNANCY
REGISTRY, I'M NOT FAMILIAR WITH
OTHER PREGNANCY REGISTRIES THAT
USE A SIMILAR MODEL WHERE THEY
SHARE THEIR DATA.
SO IT IS A VERY, VERY
COMPLICATED PROCESS BUT THE
ANTIRETROVIRAL PREGNANCY
REGISTRY FIGURED OUT A WAY TO DO
THIS, SO, YOU KNOW, MAYBE THAT'S
SOMETHING FOR THE COMMITTEE TO
CONSIDER, MAYBE HAVE THAT, THE
PERSON WHO RUNS THAT PREGNANCY
REGISTRY COME TALK TO THE
COMMITTEE TO PROVIDE MAYBE SOME
RECOMMENDATIONS OR POTENTIAL
SOLUTIONS ON HOW THIS CAN BE
DONE.
HAPPY TO HEAR FROM OTHERS AS
WELL, OTHERS ON THE COMMITTEE
WHO HAVE EXPERIENCE WITH
PREGNANCY REGISTRIES, AND FROM
OUR INDUSTRY REPRESENTATIVES AS
WELL.
>> JANET, YOUR HAND IS UP.
>> HI.
I WOULD LIKE TO RAISE THE POINT
FOLLOWING UP TO THE DISCUSSION
THAT THE ANTIRETROVIRAL
RETROVIRAL EXAM STELLAR, WITH 20
YEARS OF DATA, VAST AMOUNT OF
DATA PROVIDING FOR MORE PRIVACY
AND IN TERMS OF TRANSPARENCY IF
YOU'RE RELEASING RESULTS EVERY
SIX MONTHS THERE'S SOME SAMPLE
SIZE TO ACTUALLY HAVE SOME
CONFIDENCE IN THOSE RESULTS.
AND THERE ARE NOT AT THIS TIME
TOO MANY OTHER REGISTRIES THAT
CAN SAFELY DO THAT, SO I THINK
THAT'S A GRAY AREA THAT WE
SHOULD BE CAREFUL ABOUT IN TERMS
OF MAKING RECOMMENDATIONS
BECAUSE WE SHOULDN'T EXPECT THAT
THOSE OTHER REGISTRIES ARE GOING
TO BE READY TO PROVIDE DATA
AND/OR RESULTS, GIVEN THEIR SIZE
AND STAGE.
>> GOOD AFTERNOON.
THESE HAVE BEEN OUTSTANDING
TALKS.
AS SOMEONE WHO DEALS WITH ARV
SIDE I CAN TELL YOU WE'RE ALWAYS
ENTERING OUR PATIENTS INTO THE
ANTIRETROVIRAL REGISTRY, SO I
HAD A FEW QUESTIONS.
FIRST IS DO WE THINK ALLOWING
PHARMA TO DO THESE REGISTRIES
GIVE THEM A PASS TO DOING STUDY
ON THE POPULATION?
THAT WAS SORT OF MIGHT HAVE, YOU
KNOW, THINK/WORRY KIND OF THING.
THE OTHER IS FOR DISEASE-BASED
REGISTRIES, AND DEVELOPING ONE,
HOW IS THAT WHOLE COLLABORATION
BETWEEN PHARMA FOR THEIR PATENT
OR OFF-PATENT OR GENERIC DRUGS
SORT WHO HAVE IS GOING TO BE,
YOU KNOW, RESPONSIBLE, COLLATE
DATA, IT'S NOT MY DRUG ANYMORE,
I DON'T HAVE TO WORRY ABOUT IT.
ARV REGISTRY WE CAPTURE IN REAL
TIME NEW DRUGS BEING ADDED ALL
THE TIME BUT FOR THE CARDIOLOGY
TYPE OR NEUROTYPE REGISTRIES
THOSE ARE GENERIC DRUGS, HOW DO
WE GET OUR HANDS NDS AROUND
THAT?
>> SHARON IS ASKING A GREAT
QUESTION, SHOULD BE ASKING OTHER
INDUSTRY RENTS --
REPRESENTATIVES IF THEY WOULD
LIKE TO SPEAK.
>> IT'S QUIET OUT THERE.
>> I'M GOING TO STEP OUTSIDE TO
THE CONVERSATION.
I THINK SHARON, YOU'RE ASKING
THE QUESTION THAT IS A VERY
APPROPRIATE QUESTION TO FOLLOW
FROM LEYLA'S COMMENT.
THE REALITY, IT'S NOT A SINGLE
STAKEHOLDER WHO NEEDS TO DO
THIS.
THIS IS A TRUE PUBLIC/PRIVATE
PARTNERSHIP OF RELEVANT
STAKEHOLDERS TO UNDERSTAND WHAT
THE NEED IS FOR THE DATA
COLLECTION, TO UNDERSTAND WHERE
THE PRIORITIES LIE, AND THEN TO
ENSURE JUST AS YOU'VE SAID WHAT
IS THE SAFE HARBOR FOR DATA
COLLECTION, DATA ANALYSIS, AND
THE SUSTAINABILITY INTO THE
FUTURE, SO I THINK IT'S A REALLY
IMPORTANT QUESTION, A VERY
RELEVANT SET OF QUESTIONS, AND I
THINK THIS IS PART OF THE
DISCUSSION THAT WE NEED TO THINK
ABOUT HOW DO WE WRITE THAT TO
CONGRESS WHAT'S NEEDED TO ENSURE
THAT WE CAN PROPERLY IMPLEMENT
THIS RECOMMENDATION.
>> I WAS THINKING THAT YOU WERE
GOING TO GO BACK TO THE EARLIER
TODAY DIALOGUES ABOUT IF WE'RE
LOOKING AT THIS LARGE DATABASES
AND WE CAN CRITIQUE IT ON DRUGS
USED, OR CONDITIONS FOR DRUGS
USED, THAT WOULD BE KIND OF THE
NEXT LOW-HANGING FRUIT BIG STEP.
YOU KNOW, IF IT'S CARDIOLOGY
DRUGS OR NEURO-SEIZURE DRUGS,
AND THOSE ARE THE BIG BUCKET OF
DRUGS GIVEN TO PREGNANT
POPULATIONS, IS THAT THE NEXT
REGISTRY THAT WE WANT TO DO?
AND AMONGST THAT REGISTRY WHAT
ARE THE DRUGS, PATENT OR
OFF-PATENT THAT WE NEED TO
INVESTIGATE?
I DON'T THINK WE CAN DO THIS FOR
ALL THINGS.
I THINK THERE ARE ORPHAN
DISEASES, NOT ORPHAN DISEASES, I
DON'T WANT TO SAY HIV IS AN
ORPHAN DISEASE OR NOT BUT THERE
ARE FROM THE DATABASES THAT YOU
GUYS TALKED ABOUT EARLIER BIGGER
DISEASE CATEGORIES OR BIGGER
DRUGS/DISEASE CATEGORIES.
WHY IS IT WE CAN'T DO ANOTHER
PILOT PROJECT SIMILAR TO WHAT
YOU HAVE BEEN TALKING ABOUT, TO
SAY WHAT'S THE BIG DISEASE
CATEGORY, WHAT ARE THE DRUGS
INCLUDED IN THAT DISEASE
CATEGORY, THAT'S OUR NEXT STEP
ON THESE DATABASES.
YOU KNOW, PERHAPS I'M NOT IN THE
RIGHT SPACE.
>> SO THIS IS TRISH.
I CAN JUMP IN ON A FEW POINTS.
I THINK ONE OF THE QUESTIONS YOU
HAD ASKED WAS ABOUT SORT OF IF
COMPANIES DOING REGISTRY-BASED
STUDIES PASS ON A POPULATION
BASED STUDY AND I THINK LEYLA
CAN CORRECT ME, IN GUIDANCE THEY
RECOMMEND TWO TYPES, ONE BEING
REGISTRY, ONE BEING POPULATION
BASED.
I THINK THAT'S HAPPENING IN
PARALLEL.
ANOTHER QUESTION YOU HAD ABOUT
THE GENERICS, WE CAN AND DO DO
THAT IN SENTINEL.
I DON'T THINK WE'VE DONE IT IN
PREGNANCY SAFETY BUT WE LOOK AT
GENERICS, IT DEPENDS ON THE
QUESTION BECAUSE IF WE LOOK AT
CLASS, WE'LL TAKE ALL THE DRUGS
AND FIND OUT WHAT THEY ARE.
SO DISEASE-BASED, THAT'S ONE OF
THE THINGS WE'VE BEEN THINKING
ABOUT DOING.
WE HAVE A COUPLE SORT OF AREAS
THAT WE LOOK AT IN DATABASES,
BUT BECAUSE OUR --
WHAT WE'VE BEEN LOOKING AT IS
THERE'S A SPECIFIC REGULATORY
QUESTION WE'RE BEING ASKED
ABOUT, OFTEN NECESSARILY CUT IN
THE CATEGORY OF THE DISEASE, BUT
DEPENDING WHAT THE QUESTION IS
WE MAY OR MAY NOT BE ABLE TO DO
THAT.
>> THANK YOU, TRISH.
SO, WHAT ABOUT LACTATION, IN THE
CHAT?
FROM THE THREE OF YOUR
PRESENTATIONS ARE YOU ABLE TO
GIVE SOME INSIGHTS INTO SIMILAR
QUESTIONS THAT COME REGARDING
HOW TO GENERATE THAT INFORMATION
FOR LACTATION?
>> THIS IS EMMA.
I ALSO CAN'T FIGURE OUT HOW TO
GET THE VIDEO WORKING SO I
APOLOGIZE FOR THAT.
WHEN I WAS LISTENING TO THESE
CONDITION DATABASE THINGS, THE
ONE THAT STRUCK ME AS BEING A
VERY COMMON PROBLEM WOULD BE NEW
DISORDERS IN THE POSTPARTUM
PERIOD AND SAFETY OF USING THOSE
MEDICATIONS, A COMMON CLINICAL
CONCERN.
I WAS CURIOUS SPECIFIC TO
LACTATION.
THANK YOU.
>> NO WORRIES.
>> I WANT TO CHIME IN TO SAY
WHEN I MET WITH SUE AND EMMA,
THE FACT WE HADN'T INCLUDED
LACTATION IN THE DATASET WAS
APPARENT.
SO, WE HAVEN'T PUT -- THAT WAS
JUST A FEW WEEKS AGO.
WE HAVEN'T PUT ANY NEW DATA
ELEMENTS IN USCDI YET BUT ARE
HAPPY TO WORK WITH SUBJECT
MATTER EXPERTS ON WORKING THAT
IN.
AS FAR AS FHIR GOES, AS EXCHANGE
AND STANDARD, THERE ARE WAYS OF
INCLUDING LACTATION DATA FOR
EXCHANGE, SO THE CAPABILITIES
ARE PROFILED IN THE FHIR
RESOURCES.
>> THANK YOU, STEPHANIE.
TRISH OR LEYLA, ANYTHING TO ADD?
>> SURE.
FDA ALSO HAS AUTHORITIES TO
ISSUE POSTPARTUM REQUIREMENTS
FOR LACTATION STUDIES, SO THAT'S
AN ACTIVE AREA FDA IS INVOLVED
IN TRYING TO FURTHER ADVANCE.
FDA'S PREGNANCY REGISTRY WEBSITE
WILL ALSO SOON BE LAUNCHING AN
ADDITIONAL WEBSITE THAT WILL BE
LISTING ALL LACTATION STUDIES
THAT FDA ISSUED AS
POST-MARKETING REQUIREMENTS, SO
THAT CONSUMERS, HEALTHCARE
PROVIDERS AND PATIENTS ARE AWARE
OF LACTATION STUDIES THAT ARE
ACTIVE AND ENROLLING PATIENTS
INTO THEIR STUDY.
>> THANK YOU, LEYLA.
TRISH, ANYTHING TO ADD?
>> NO, I WOULD SAY LARGE
DATABASES IN GENERAL WHERE WE'RE
USING DATA FROM INSURANCE CLAIMS
DON'T CAPTURE LACTATION DATA
WELL.
ONE MIGHT BE ABLE TO LOOK FOR A
WHERE SOMEBODY GOT A PUMP, IN
THEORY, LET'S NARROW DOWN TO THE
SUBSET WHERE THEY USED CLAIMS
INSURANCE IN PUMPING BUT MY
CONCERN, AS AN EPIDEMIOLOGIST,
WHAT ARE YOU MISSING?
I DON'T THINK IT'S THE BEST
RESOURCE OR BEST APPROACH WITH
LACTATION STUDIES.
>> THANK YOU.
AND THERE'S A QUESTION IN THE
CHAT REGARDING FDA ENGAGEMENT,
IF YOU WANT TO EXPAND ON YOUR
COMMENT OR QUESTION.
>> YES, THANK YOU TO THE
SPEAKERS.
I JUST HAD THE RECOMMENDATION
13, TO FACILITATE ACCESS TO DATA
AND TRANSPARENCY OF REGISTRIES,
THE SUGGESTION FROM THE ORIGINAL
PRGLAC IS TO USE THE ART
REGISTRY BUT I FEEL CLINICALLY
WHAT'S MOST COMMON PEOPLE ARE
USING INFORMATION TO GUIDE
MEDICATION USE IN PREGNANCY, THE
NON-PROFIT HAS EMERGED AS
EMERGED AS PRINCIPAL SOURCE.
IT SEEMS LIKE I WAS EXCITED TO
SEE THIS, RECOMMENDATION 13,
CURIOUS TO HAVE SPEAKERS COMMENT
ON POTENTIAL PARTNERSHIP OR IF
ONE ALREADY EXISTS.
THANK YOU.
>> I CAN START.
SO, WE ARE VERY AWARE BUT WE
DON'T ACTIVELY ENGAGE IN
DISCUSSIONS.
I MEAN, WE ATTEND ALL THE PDRP
MEETINGS AND HAVE INTERACTIONS
WITH THE REPERTOX STAFF AND
MEMBERS.
THE DATA, YOU KNOW, THE DATA
OWNED BY THE MANUFACTURERS SO
MAYBE THAT'S A CONSIDERATION TO
ENGAGE WITH MANUFACTURERS AS
WELL, BUT HAPPY TO ALSO CONSIDER
THE IDEA OF FURTHER ENGAGEMENT
AND DISCUSSION WITH REPERTOX.
>> ANYTHING TO ADD?
>> NOTHING TO ADD.
>> TINA, YOU HAVE A HAND UP?
>> THANK YOU.
TO AGREE WITH TRISH, I'M NOT
SURE HOW USEFUL LARGE DATA WOULD
BE FOR LACTATION STUDIES, OR HOW
MEANINGFUL THE DATA WOULD BE
GIVEN THE LARGE VARIABILITY ONE
WOMAN MAY HAVE IN OTHER
LACTATION PRACTICES OVER A SHORT
PERIOD OF TIME WOULD BE HARD TO
CAPTURE, OVER TO LEYLA YOU
MENTION ED FDA HAS AUTHORITY FOR
LACTATION STUDIES, COULD THAT BE
TIED INTO REGISTRIES FOR
EXPOSURE, MORE LACTATION
CAPTURED DATA?
THANK YOU.
>> YES, THANK YOU FOR THAT
SUGGESTION, JANET.
YES, WE'RE LOOKING INTO THAT.
YES, ALL OF THESE DISCUSSIONS GO
ON DURING THE REVIEW OF THE NDA
AND SO THAT'S SOMETHING THAT
WE'RE DISCUSSING.
THANKS.
>> THANK YOU.
AND A QUESTION IN THE CHAT, IF
YOU WANT TO COME OFF CAMERA AND
ASK.
>> I WANTED TO KNOW, I THINK
I'VE PROBABLY ASKED THIS BEFORE,
BUT ONE OF THE CHALLENGES WE
FOUND MANY YEARS AGO NOW,
PROBABLY TEN YEARS AGO, ACCESS
TO GOOD DATA FROM THE
REGISTRIES.
SO JUST THINKING ABOUT HOW TO
MAKE THAT AS EASY AS POSSIBLE
FOR CLINICIANS AND PATIENTS WHO
MIGHT NEED TO ENGAGE IN SHARED
DECISION MAKING.
IT'S GREAT TO HAVE THE
INFORMATION IN ONE PLACE, I
STILL THINK I HAVE SOME CONCERNS
ABOUT HOW EASY IT IS TO ACCESS
SOME OF THAT DATA JUST GIVEN
IT'S NOT NECESSARILY OWNED, YOU
KNOW, BY FDA OR IS PUBLICLY
AVAILABLE NECESSARILY, IT'S
REALLY UP TO THE DRUG SPONSORS.
>> I THINK IT'S PROBABLY MORE OF
A COMMENT THAN A QUESTION,
KATIE.
>> SURE IS.
>> ONE WE SHOULD CONTINUE TO
DISCUSS WITHIN THE WORKING
GROUP, THE ISSUE THAT COULD
POTENTIALLY BE ADDRESSED BACK TO
CONGRESS ABOUT THE ACCESSIBILITY
OF THAT INFORMATION, YES.
VERY GOOD.
I SHARON, ATHINK WE ADDRESSED
YOUR QUESTION IN THE CHAT.
AND JULIE HAD A COMMENT
REGARDING COUNSELING PROGRAMS AS
A DATA POINT FOR LACTATION.
DO YOU WANT TO EXPAND ON THAT?
>> SURE.
LET ME GET MYSELF ON CAMERA TOO.
ACTUALLY, I ADDED A THOUGHT TO
THAT, JUST AS EVERYONE KEEPS
TALKING ABOUT HOW DIFFICULT IT
IS TO GET LACTATION DATA POINTS,
THE PEER COUNSELING PROGRAM, IF
WE'RE TALKING ABOUT MEDICATION,
THE DIETITIAN OR NURSE
PRACTITIONER ON STAFF OR DOCTOR,
BUT WIC, THE NETWORK IS NOT
NECESSARILY AS INTEGRATED AS
LET'S SAY A HOSPITAL SYSTEM
WOULD BE OR MAYBE LIKE A LARGE
SYSTEM, MORE INTEGRATED, EXCUSE
ME, OR LIKE A LARGE SYSTEM LIKE
KAISER.
ANOTHER THOUGHT I HAD AS WELL IS
POSSIBLY USING LactMed AS A
WAY TO GATHER DATA.
IN OTHER WORDS, IF THE ISSUE IS
TRYING TO FIGURE OUT THE
LACTATION, WHO IS LACTATING, AND
WHEN, YOU MIGHT NOT BE ABLE TO
GATHER ALL OF THAT DATA BUT
COULD POSSIBLY GATHER DATA ON
HITS ON IT, IF THERE WAS LIKE A
LINK OR SOMETHING LIKE THAT, IF
A PRACTITIONER CLICKED THE LINK
TO REGISTER THEY LOOKED AT THIS
DRUG FOR A PATIENT.
I'M NOT A TECH PERSON.
MIGHT BE SOMETHING THAT INVOLVED
SOMETHING VERY TECHY, THE NIH IS
JUST ABOUT WORK, BUT IT IS A
THOUGHT BECAUSE IN LACTATION
CIRCUMSTANCES ALSO WE USE
LACTOBACILLUS -- LactMed
THIS WEEK.
IF YOU LOOKED UP THIS DRUG CAN
YOU CLICK THIS AND PUT IN A FORM
HOW OLD IS THE BABY, IT MIGHT BE
ONE WAY TO GATHER INFORMATION.
>> THANK YOU, JULIE.
WE CAN PROBABLY HAVE MORE
DISCUSSION AROUND JULIE'S
COMMENT WHEN WE HAVE THE OPEN
SESSION FOLLOWING.
AND I SEE ONE MORE COMMENT IN
THE CHAT.
WOULD YOU LIKE TO COMMENT OFF
CAMERA AND ASK YOUR QUESTION?
IF NOT I'LL READ IT.
IS THERE A VALUE SUGGESTING
OTHER RESOURCES TO INVESTIGATE
DATA HARMONIZATION FOR DATA
PREGNANCY RESEARCH.
THERE YOU ARE.
>> I'M GETTING TO MY BUTTONS NOT
QUICKLY ENOUGH.
I THINK I WAS REFERRING TO ONE
OF THE EARLIER SPEAKERS THAT WAS
JUST TALKING ABOUT THE WHOLE
DATA HARMONIZATION PROCESS.
AND JUST WONDERING IF THERE IS A
VALUE TO CONNECTING WITH SOME
OTHER DATA HARMONIZATION WORK
THAT'S HAPPENED IN THE PREGNANCY
SPACE, PREGNANCY RESEARCH
SPECIFICALLY.
I'M PART OF A GLOBAL CONSORTIUM
THAT DEVELOPED A COMMON DATA
DICTIONARY FOR PREGNANCY
RESEARCH, STARTED OFF
SPECIFICALLY TO PREECLAMPSIA BUT
EXPANDED TO COVER OTHER
PREGNANCY THINGS AND THAT MAKES
ME THINK ABOUT THE MULTITUDE OF
PATIENT-DRIVEN REGISTRIES.
WE USE THE WORD REGISTRY TO
IMPLY IT IS OFTEN ONE THAT IS
HOSTED BY, LET'S SAY, A DRUG
MANUFACTURER OR SOMEBODY TO
CAPTURE POST MARKET DATA BUT
THERE ARE A HOST OF PATIENT
REGISTRIES AND I'M WONDERING IF
THERE'S ANY VALUE IN SORT OF
THINKING ABOUT WHAT ROLE THEY
COULD PLAY IN ALL OF THIS DATA
HARMONIZATION WORK.
SO JUST KIND OF SOME OPEN-ENDED
QUESTIONS ABOUT HOW MUCH FURTHER
WE MIGHT BE ABLE TO GO EXPANDING
INTO SOME OTHER SOURCES, DATA
SOURCES.
AND INITIATIVES LIKE DATA
HARMONIZATION.
>> THANK YOU
>> YEAH, I WOULD SAY WE'RE
DEFINITELY IN THE BEGINNING
PHASES OF ESTABLISHING USCDI+
MATERNAL HEALTH DATASET, WE'RE
DEFINITELY OPEN TO ANY
ADDITIONAL RESOURCES THAT COULD
HELP BUILD OUT THAT LIST.
>> EXCELLENT.
AND WE CAN TALK MORE ABOUT THIS
TOPIC TOO IN THE UPCOMING OPEN
SESSION.
I THINK MAYBE BEFORE WE GO TO
BREAK, SINCE WE ARE PROBABLY
EARLY, SINCE WE STARTED EARLY, I
WANT TO MAKE SURE, SUE, ANY
ADDITIONAL CLARIFYING QUESTIONS,
COMMENTS?
>> NOT FROM ME BUT CHRISTINA, I
WONDER IF MAYBE YOU'LL INDULGE
ME AND WE CAN GET OUR
TEMPERATURE-TAKING EXERCISE
STARTED BEFORE THE BREAK.
TO GET PEOPLE'S BRAINS MOVING
AND THINKING ABOUT WHERE WE'RE
HEADED AFTER THE BREAK IF THAT'S
OKAY?
>> ABSOLUTELY.
>> GREAT.
SO, IF EMMA, COULD YOU PULL UP
OUR SLIDES FOR 12 AND HAVE 13
CUED UP?
>> YES.
>> ONE OF THE THINGS CHRISTINA
AND I TALKED ABOUT AS WE HEAD
INTO THE LARGER DISCUSSION IS
CAN WE STREAMLINE THE SESSION
AND IDENTIFY RECOMMENDATIONS
THAT THE GROUP BY CONSENSUS
FEELS DON'T REQUIRE ANY
ADDITIONAL DISCUSSION, SO ARE
THERE ANY ELEMENTS OF
RECOMMENDATIONS 12 AND 13 THAT
YOU PROPOSE HAVE EITHER BEEN
FULFILLED AS OUTLINED IN THE
IMPLEMENTATION PLAN THAT WE
COULD CODE AS GREEN, OR HAVE
SUFFICIENT PLANNING AND MOMENTUM
BEHIND THEM THAT WE CAN CONSIDER
THEM IN PROCESS, SO CODED AS
YELLOW?
AND AT THIS POINT I'LL OPEN IT
UP TO THE COMMITTEE TO SEE IF
ANYBODY'S GOT ANY THOUGHTS OR
RECOMMENDATIONS ON ELEMENTS THAT
WE FEEL WE MAY HAVE ENOUGH
INFORMATION ON AND WE KNOW ARE
FAR ENOUGH ALONG THAT WE CAN
TRIAGE THEM AND GIVE US A LITTLE
BIT MORE DISCUSSION TIME FOR THE
OTHER ELEMENTS.
>> YEAH, AND I WOULD SAY LET'S
HOLD THAT PART UNTIL AFTER THE
BREAK.
>> OKAY.
>> LET'S KICK OFF WITH PROPOSALS
FROM OUR WORKING GROUP, THOSE
THEY THINK HAVE BEEN ADDRESSED,
SO THAT WE CAN MOVE ON AND FOCUS
ON THE ONES WHERE WE NEED
ADDITIONAL DISCUSSION, SINCE
WE'RE JUST AT 2:50.
>> THAT WORKS.
I'D LIKE FOLKS TO THINK ABOUT
THIS AND READY TO PROPOSE SOME
ITEMS WHEN WE GET BACK.
>> THANK YOU VERY MUCH, TO THE
SPEAKERS FROM THIS SESSION.
THANK YOU ON BEHALF OF ALL OF US
HERE.
WE CERTAINLY APPRECIATE YOUR
PARTICIPATION AND THE WORK YOU
PUT INTO THE PRESENTATIONS.
WE'LL SEE YOU IN TEN MINUTES,
EVERYONE, AT 3 P.M., EASTERN.
>> WE'LL GET STARTED.
I KNOW BEFORE WE TURN THINGS
OVER TO SUE TO LEAD THE
DISCUSSION, I WANTED TO MAKE
SURE WE SEE REBECCA, YOU HAD A
COUPLE CLARIFYING QUESTIONS TO
RAISE.
>> THANK YOU SO MUCH.
JUST AS WE THINK ABOUT THE FINAL
REPORT, WE'RE GOING TO COLOR
CODE THESE.
AND THEN WILL WE HAVE FURTHER
DISCUSSION ABOUT LIKE WHAT WE
THINK WE NEED TO PRIORITIZE AND
REPORT BACK TO CONGRESS, YOU
KNOW, FDA AND ONC ARE DOING
THIS, WE STILL NEED TO DO XYZ,
AS WE'RE THINKING ABOUT -- YES,
THAT'S MY QUESTION.
>> YES, MA'AMA, - EMMY, DO YOU
WANT TO SPEAK ABOUT THAT?
>> SURE.
CAN YOU HEAR ME?
>> YES.
>> OKAY.
GREAT.
FIRST, YES, WE'LL HAVE MORE TIME
TO DISCUSS THAN JUST THIS
AFTERNOON.
I WANT TO MAKE SURE, WAS THAT
PART OF YOUR QUESTION?
>> I GUESS, YOU KNOW, FOR MANY
OF THESE, YEAH, SOME OF THE WORK
STARTED, THERE'S A LOT MORE WORK
TO DO.
IS THERE MORE THAN JUST A COLOR
CODING THAT WE CAN USE THAN TO
LIKE SEND OUR RECOMMENDATIONS
OVER AND SAY THIS IS WHAT WE
THINK IS THE NEXT STEP HERE?
>> MAYBE I CAN STEP IN.
THE REPORT WILL BE FARM MORE --
FAR MORE DETAILED THAN COLOR
CODING.
WHAT WILL GO BACK AS PART OF THE
REPORT IS A STATUS UPDATE WHERE
EVERYTHING IS, WHERE WE FEEL
ADDITIONAL COMMUNICATIONS
INITIATIVES NEED TO TAKE PLACE,
PUT THOSE RECOMMENDATIONS IN ON
BEHALF OF THE COMMITTEE, IF
THERE ARE ELEMENTS THAT WE FEEL
NEED TO BE PULLED OUT WE'LL MAKE
THOSE RECOMMENDATIONS AS WELL.
WE'RE JUST USING THE COLOR
CODING AS A FRAMEWORK FOR US TO
VISUALLY IDENTIFY WHERE WE ARE
TO START THE COMMUNICATION.
>> IT'S MORE OF A CHEAT SHEET TO
FOCUS IN A SHORT TIME FRAME TO
GO TO ENSURING WE'RE HAVING
BROADER DISCUSSION AROUND THOSE
ELEMENTS THAT CLEARLY NEED MORE
CONSIDERATION.
>> THANK YOU.
>> YOU'RE WELCOME.
>> WE HAVE ONE MORE
CLARIFICATION QUESTION.
>> I WAS CURIOUS, MANY SPEAKERS
ARE STILL HERE WITH US NOW, SO
FOR THIS PORTION OF THE OPEN
DISCUSSION --
>> WE'VE LOST YOU.
PUT YOUR QUESTION IN THE CHAT.
>> CAN WE ENGAGE THE SPEAKERS
AND GET SOME ADDITIONAL
CLARIFICATION AND GO BACK AND
FORTH, WE MOST CERTAINLY CAN.
I MAY HAVE MISINTERPRETED.
DO WE HAVE HER BACK?
ALL THESE PICTURES ARE BOUNCING
ALL OVER THE PLACE.
>> THAT'S OKAY.
WE'LL MAKE SURE WHEN SHE COMES
BACK -- CLARIFICATION.
IT'S A GREAT TIME FOR US TO
TRANSITION THINGS OVER TO YOU,
SUE, TO LEAD US THROUGH THIS
EXERCISE TO FOCUS.
>> I'LL KICK US OFF AND WE'LL
TAG TEAM WE'VE GOT TWO SLIDES,
THIS AND THE NEXT SLIDE, IF YOU
COULD TOGGLE BACK AND FORTH.
I WOULD LIKE TO TAKE PROPOSALS
FROM THE GROUP AS TO WHETHER OR
NOT WE BELIEVE ANY OF THESE HAVE
EITHER BEEN FULFILLED OR ARE FAR
ENOUGH ALONG WE REALLY
UNDERSTAND WHERE THE TRAJECTORY
IS THAT WE MAY NOT NEED A LOT OF
DISCUSSION AROUND THEM.
>> PROFESSOR CHARO?
>> A 12A BASED ON WHAT I WAS
HEARING IT SOUNDS LIKE THE
DESIGNING OF SYSTEMS IS WELL
UNDERWAY.
THE COORDINATION AND CONVERGENCE
OF SYSTEMS IS NOT NECESSARILY
VERY WELL UNDERWAY, AND I DON'T
KNOW IF THAT'S DIFFERENT THAN
DESIGN BUT THAT SEEMS TON -- TO
BE PART OF THE PROBLEM, THEY ARE
NOT ABLE TO TALK TO ONE ANOTHER
OR SHARE INFORMATION ACROSS
SYSTEMS.
>> YOU'RE SUGGESTING THAT THIS
IS PERHAPS PARTIALLY -- HAS BEEN
PARTIALLY ADDRESSED WITH STILL
SOME OUTSTANDING ISSUES?
>> YES, ONLY WORKING ON HEALTH
RECORDS SYSTEMS IN THE UNITED
STATES, I WENT CRAZY TALKING
ABOUT WHY WE SHOULD PAY
ATTENTION TO OTHER COUNTRIES.
IF WE'RE FOCUS ON THE UNITED
STATES THERE HAVE BEEN A LOT OF
TOOLS DEVELOPED TO CREATE
LINKAGES BUT THEY ARE NOT ALL
THE SAME TOOLS, DIFFERENT TOOL
MAKERS CAME UP WITH DIFFERENT
SYSTEMS NOT ABLE TO THEN BE
AGGREGATED THE WAY WE WANT,
SLIGHTLY DIFFERENT THAN THE
DESIGN QUESTION, IT'S WHAT DO DO
YOU WITH DIFFERENT DESIGNS.
>> TO PARAPHRASE AND PULL IN THE
CONVERSATION WITH ONC
COLLEAGUES, THE DESIGN IS THERE,
WELL UNDERWAY, LINK IS IMPERFECT
IN ALL SYSTEMS.
SOUNDS LIKE CONVERSATIONS ARE
BEING HAD AROUND THIS, SO YOU'RE
PROPOSING THIS MIGHT BE ONE THAT
WOULD GET COLOR CODED THAT IS
WHERE, ONGOING AND PLANNED?
>> .
>> I'M NOT SURE, I'LL HAVE TO
LISTEN HOW PEOPLE DISTINGUISH
BETWEEN RED AND YELLOW, SOME
WHERE IN BETWEEN THERE.
ONE LAST THING AND I'LL STOP.
THERE WAS A QUESTION I ASKED IN
THE CHAT, I DON'T THINK IT GOT
ANY ATTENTION, ABOUT WHETHER
THERE'S ANY ABILITY TO ACCESS
NEWBORN BLOOD SPOTS AT THE STATE
HYGIENE LABS BECAUSE I DIDN'T
HEAR -- I COULD HAVE MISSED IT,
I DON'T THINK I HEARD ANYBODY
TALK ABOUT THE USE OF THAT
SOURCE OF MATERIAL FOR CREATING
LINKAGE BUT ALL CAN BE DNA TYPED
BUT I UNDERSTAND MAYBE PRIVACY
CEREBRAL CORTEXES OR -- PRIVACY
CONCERNS, BUT THAT'S A
RECONSIDERATION, A RED LIGHT ON
THAT ONE ASPECT.
>> WE DON'T HAVE A CLEAR
RECOMMENDATION OF SOMETHING WE
WANT TO TRIAGE, SOUNDS LIKE YOU
WANT ADDITIONAL DISCUSSION.
IS THERE ANY ADDITIONAL COMMENT
THAT HAS TO BE HAD ABOUT THE
STATEWIDE DRIED BLOODSPOT?
>> I'M FROM CDC.
WE'RE STILL OFF FROM GETTING
BLOODSPOT SAMPLES IN ANY
CENTRALIZED SYSTEM.
SO, I WOULD -- THAT WOULD BE
YEARS IN THE FUTURE FROM MY
PERSPECTIVE.
>> THANK YOU VERY MUCH.
>> I'LL JUMP IN REAL QUICK.
MY COLLEAGUE FROM CDC, WE HAVE
WORKED WITH THE SAFETY UTAH,
PROBABLY THE FURTHEST ALONG IN
TRYING TO GET THAT INFORMATION
ELECTRONICALLY AVAILABLE, AND
THERE'S STILL A WAYS TO GO.
>> THANK YOU.
>> REMEMBER, EVERYONE, FOCUS ON
THE SUBCOMPONENTS, SO
RECOMMENDATION 12A HAD THREE
SUBCOMPONENTS.
WE SHOULD BE LOOKING AT BASED ON
WHAT WE HEARD TOGETHER, THESE
PARTICULAR PIECES DON'T HAVE TO
BE COMPLETE, HAVE THEY BEEN
ACTIONED AND HAS WORK BEEN MADE
TOWARD IT, IT'S RELEVANT FOR US
TO RAISE ADDITIONAL PIECES ABOUT
IT'S BEING ACTIONED BUT THE
INTEROPERABILITY, THE ABILITY TO
SPEAK BETWEEN MAY STILL REQUIRE
ADDITIONAL FOCUS SO I THINK THAT
WOULD BE A PART OF WHAT WE WOULD
THINK ABOUT BUT GO BACK TO THE
TOOLS THAT WE PROVIDED AS
PREVIOUS, THEY ARE GOING TO BE
HELPFUL IN UNDERSTANDING
INDIVIDUAL ELEMENTS OF THE
RECOMMENDATIONS.
>> GREAT RECOMMENDATION.
I WOULD RECOMMEND EVERYBODY OPEN
THAT DOCUMENTS UP, HAVE IT SIDE
BY SIDE NEXT TO THE ZOOM.
THERE ARE HANDS UP FOR
CLARIFICATION QUESTIONS.
I DON'T WANT TO ADDRESS THOSE
NOW.
I WANT TO SEE IF WE'RE ABLE TO
TRIAGE ANY OF THESE
RECOMMENDATIONS BEFORE WE GET
INTO MUCH BROADER DISCUSSION
ABOUT ALL OF THEM.
SHARON, I'M TRUSTING YOU'RE
PROPOSING ONE TO BE TRIAGED.
>> I WAS LOOKING AT 12C NOVEL
DATA RESOURCES.
WHEN I THINK ABOUT GRANTS,
CONTRACTS OUT THERE, WHAT'S
HAPPENING WITH THOSE, THOSE ARE
NOVEL DATA RESOURCES, SO I WANT
TO SAY THEY MAY NOT HAVE THE
RIGHT ANSWERS BUT SOUNDS LIKE
THAT PATHWAY IS WORKING.
YOU'VE GIVEN PEOPLE DOLLARS TO
DO THE WORK.
THEY HAVE OUTLINED CREATIVE
SOLUTIONS HOW THEY ARE GOING TO
DO THE WORK.
I DON'T WANT TO SAY THEY ARE THE
RIGHT ANSWERS BUT AT LEAST WHEN
I THINK ABOUT USING NOVEL DATA
RESOURCES IT SOUNDS LIKE YOU'RE
IN THE RIGHT PLACE SO I DON'T
WANT TO SAY IT'S FULFILLED.
I THINK IT'S MORE OF A YELLOW
THAN A GREEN.
BUT IT'S NOT A RED.
YOU HAVE A PLAN.
SOUNDS LIKE IT'S ROLLING ALONG.
>> SHARON IS PROPOSING TRIAGING
12C.
I'M TURNING TO CHRISTINA FOR A
HIGH LEVEL VIEW OF THE
SUPPLEMENTS FOR 12C AND LET'S
SEE IF WE GET ENDORSEMENT FROM
THE WORKING GROUP.
>> FOR 12C TWO SUBCOMPONENTS,
LARGE OBSERVATIONAL STUDIES,
MEDICATIONS CLASSES IN PREGNANCY
AND LACTATION, AND SUPPORT
STUDIES ACROSS MULTIPLE DRUGS
USING THE SAME INFRASTRUCTURE TO
CONSERVE RESOURCES.
>> IS THERE A GENERAL
ENDORSEMENT FROM THE WORKING
GROUP THAT THAT'S UNDERWAY?
>> I WOULD AGREE THAT'S ONGOING.
IN YELLOW.
WITH THE EXCEPTION OF EFFICACY.
I DIDN'T HEAR A LOT ABOUT
EFFICACY.
I HEARD A LOT ABOUT SAFETY.
THAT'S JUST MY OPINION.
>> I AGREE.
I THINK THE CHALLENGE CREATING
BUCKETS THE YELLOW AND RED CAN
BLEND A LITTLE BIT.
>> SURE.
>> AND THERE'S SOME HESITATION
WITH SAYING IT'S ONGOING,
WHETHER WE NEED TO BE CLEAR IT'S
ONGOING BUT WE MAY NOT BE WHERE
WE NEED TO BE AND NEED TO ALIGN
ON THE FACT THAT'S WHAT WE ALL
AGREE ON.
BECAUSE THAT'S MY CONCERN WITH
SAYING IT'S ONGOING.
IT'S PLANNED.
AND THEN WE'RE NOT REALLY
GETTING TO THAT POINT OF SOME OF
THE THINGS IN THE
RECOMMENDATION.
SUCH AS EFFECTIVENESS AND THEN
REPORT STUDIES ACROSS MULTIPLE
DRUGS USING THE SAME
INFRASTRUCTURE.
>> AND THAT'S A GREAT EXAMPLE
THAT REQUIRES MORE DISCUSSION
FROM THIS GROUP AND SO THAT WILL
COME BACK INTO DISCUSSION.
LET ME JUST THROW ONE OUT THERE.
DOES ANYBODY BELIEVE THAT 12E IS
FAR ENOUGH ALONG THAT IT
REQUIRES NO SIGNIFICANT INITIAL
DISCUSSION IN TERMS OF WHAT IS
FULFILLED OR WHAT IS PLANNED?
>> FULFILLED AND PLANNED AROUND
THE SAME THING, FROM MY SIDE.
I KEEP THINKING WE'LL HAVE
ANOTHER COLOR LIKE ORANGE THAT'S
BETWEEN STUFF.
YES, 12E IS BEING PLANNED.
IS IT FULFILLED?
NO.
>> CORRECT, BUT IS IT ONGOING
AND PLANNED AND IS THERE ENOUGH
MOMENTUM THAT'S BEEN DESCRIBED
IN THAT TOPIC AREA THAT IT'S NOT
ANYTHING WE HAVE TO PROVIDE
ADDITIONAL DISCUSSION OR
RECOMMENDATIONS AROUND?
>> ARE YOU ASKING US TO LOOK
AGAIN IN 12 MONTHS AND SEE WHAT
THEY HAVE ACCOMPLISHED?
>> WE'RE TRYING TO MAKE
ASSESSMENT WHERE WE ARE NOW.
>> WHEN I HEAR YOUR LANGUAGE,
I'M TRYING TO UNDERSTAND DOES
THAT MEAN I'M HANDS UP NOW OR,
OKAY, I'M HAPPY, COME BACK IN 12
MONTHS AND SHOW ME THAT YOU'VE
GOT TO THOSE STEPS.
I GUESS I'M HAVING A HARD TIME
BEING AS SO CONCRETE AS, OKAY,
HANDS UP, I'M DONE, VERSUS NO,
YOU'RE ON THE PATH BUT I DON'T
KNOW THAT YOU'RE DONE.
>> WE'RE NOT MAKING A
DETERMINATION EVERYTHING HAS TO
BE COMPLETED.
WHAT I'M TRYING TO GET AT IS
THERE ELEMENTS THAT CAN BE
TRIAGED, IS THERE ANY MEANINGFUL
CONVERSATION THAT NEEDS TO TAKE
PLACE ABOUT COMMON DATA
ELEMENTS, OR IS THERE ENOUGH
DIRECTION THAT'S CURRENTLY
ONGOING THAT ADDITIONAL
DELIBERATION OR CONVERSATION
FROM THIS COMMITTEE WOULDN'T BE
NECESSARY?
>> YEAH, I'LL ADD JUST THINK
ABOUT IT DIFFERENTLY AS WELL,
ALL POLICY TAKES YEARS TO
IMPLEMENT.
ALL POLICY TAKES YEARS TO
IMPLEMENT, OKAY?
SO, THERE IS NO EXPECTATION I
THINK FROM ANYONE THAT WOULD
HAVE EXPECTED ALL OF THESE
RECOMMENDATIONS AND
SUBRECOMMENDATIONS TO BE
ACTIONED BY THE TIME WE MAKE THE
REPORT TO CONGRESS.
BECAUSE THERE ARE SO MANY THINGS
THAT GO INTO THE SUPPORT
PLANNING RESOURCING, BRINGING
TOGETHER STAKEHOLDERS, AND I
THINK WHAT WE NEED TO DO NEAR
THIS EXERCISE IS SOMETHING IS
TRULY DONE, IT'S DONE.
WHY 14 AND 15 WE'RE NOT GOING TO
EVER DISCUSS AGAIN BECAUSE THEY
ARE DONE.
THEY ARE SIMPLE AND THEY ARE
DONE.
MANY OTHER RECOMMENDATIONS ARE
VERY COMPLEX.
SO THE LIKELIHOOD IS MOST OF
THESE ARE EITHER GOING TO BE
ONGOING OR PLANNED, OR THEY
REQUIRE ADDITIONAL ATTENTION OR
RECONSIDERATION.
AND THAT'S NOT A PROBLEM FOR
THAT COULD BE THE CASE.
SO I WANTED TO THINK ABOUT THAT
IN YOUR MIND AS YOU'RE THINKING
ABOUT THIS.
FOR SOMETHING TO BE TRULY
FULFILLED IT MEANS ALL THE
ACTIONS GOING INTO SEEING IT
COME TO LIGHT ARE DONE.
>> THAT'S A GREAT WAY TO
DESCRIBE IT, THE FOUNDATION HAS
BEEN LAID ALREADY.
SO I'M NOT HEARING ENDORSEMENT
FOR ANY OF THESE WHICH MEANS I
THINK WE NEED TO NEED TO MORE OF
A MODERATED DISCUSSION AROUND
THEM.
DO YOU HAVE A CLARIFICATION
QUESTION OR PROPOSEAL
>> .
>> NEITHER.
WHERE I'M HAVING TROUBLE
ANSWERING YOUR QUESTIONS
DIRECTLY WE'RE THINKING ABOUT
ANSWERING DIRECTLY, WE'VE HEARD
FROM SOME CORE STAKEHOLDER
FEDERAL GROUPS, BUT I THINK WHAT
I'M HAVING TROUBLE TRANSLATING
HOW WE ARE IF FDA IS DEALING
WITH IT, FDA OF COURSE IS THE
CENTRAL STAKEHOLDERS AND
COMPONENT, AND NICHD IS DEALING
WITH IT, AND, YOU KNOW, THE
ORGANIZING CENTER, RIGHT?
BUT THERE ARE OTHER ENTITIES,
WHETHER PUBLIC/PRIVATE
PARTNERSHIP, WHETHER AHRQ, OTHER
ENTITIES NAMED IN THE DOCUMENT
SO IT'S HARD TO SAY HOW FAR ARE
WE IF WE TALKING ABOUT A FEW
ENTITIES ANDS SOAR -- AND
OTHERS WE HAVEN'T TOUCHED.
WE'VE HEARD FROM ONLY A FEW
FEDERAL STAKEHOLDERS TODAY.
>> YOU'RE RAISING A VERY
IMPORTANT QUESTION.
WE HAVE TO -- THE CRUX OF THE
REPORT, WE'VE INVITED SPEAKERS
FROM DIFFERENT AGENCIES ACROSS
THE GOVERNMENT, AND THEY ARE
PROVIDING US WITH INSIGHTS INTO
THE WORK THEY ARE DOING THERE.
THESE ARE EXAMPLES OF ACTIVITIES
THAT ARE ONGOING.
IT DOESN'T MEAN WE HAVE
ENCOMPASSED EVERYTHING BUT AGAIN
OVERLAY WHAT YOU HEARD TODAY
WITH THE SPECIFIC
RECOMMENDATIONS THAT ARE THERE.
AND I THINK THAT WE CAN ALSO IN
OUR REPORT THE WAY THE REPORT IS
PUT TOGETHER WE CAN MAKE SURE WE
TAILOR THE LANGUAGE TO SAY IN
THE AGENCIES THAT WE'RE ABLE TO
PRESENT TO US, HERE'S THE
PROGRESS WE'VE SEEN THAT'S BEEN
MADE.
OUR REPORT IS A REFLECTION OF
THE REQUISITE ACTIVITIES OR
ACTIONS TAKEN WITHIN THESE
AGENCIES.
DOES THAT SEEM ACCEPTABLE?
>> THAT'S HELPFUL, YES, THANK
YOU.
>> AND THAT TOUCHES ON WHAT
WE'RE SEEING, A COMMENT BY
PROFESSOR CHARO AS WELL THAT
SAYS IT NEEDS TO BE SEPARATED
FOR PREGNANCY AND LACTATION.
WE CAN HAVE CAVEATS, THIS IS
WHAT WE HEARD AND INTERPRET IT
AS BEING AT THIS PARTICULAR
POINT IN TIME HERE FOR PREGNANCY
BUT NOT LACTATION, VICE VERSA.
>> I'M GOING TO LEAVE MY VIDEO
OFF, LAST TIME IT CRASHED MY
ZOOM.
I WAS GOING TO JUST OFFER, FOR
ME IN RESPONSE TO DR. CHARO'S
COMMENT, IF ELEMENT OR
SUPPLEMENT DOES NOT MEET
SUFFICIENT FEELINGS AROUND
EITHER PREGNANCY OR LACTATION,
THAT WOULD MEAN IT GOES DOWN IN
COLOR CODING TO USE THAT
FRAMEWORK, AND THEN WE COULD
COMMENT LACTATION SHOULD BE
FURTHER BOLSTERED IN THE REPORT.
I WAS GOING TO SAY IN TERMS OF
TRIAGING FOR ME PERSONALLY NONE
OF THESE ARE GREEN.
AND I HAD A COMMENT THAT LIKE I
CAN TELL YOU WHICH I HAD AS
YELLOW AND RED BUT TWO I HAD AS
WHITE.
I UNDERSTAND WE DON'T HAVE THE
OPPORTUNITY TO GET TO SCORCHED
EARTH BUT THERE'S A KEY ELEMENT
THAT WAS MISSING TO THIS
PARTICULAR CONVERSATION ABOUT
REGISTRIES, THE ISSUE OF
ARTIFICIAL INTELLIGENCE WHEN WE
THINK ABOUT LARGE DATA
MANIPULATION OR MODELING, A LOT
OF THESE COMMENTS HAVE TO DO,
THE REPORT FROM PRGLAC, NOVEL
DATA METHODS AND RESOURCES AND
LEVERAGING, I FEEL LIKE I'M AN
OB/GYN RESEARCHER WITH CLINICAL
EXPERTISE, NOT A COMPUTER
SCIENTIST.
I ALMOST WISH THAT -- MAYBE WE
DO HAVE A COMPUTER SCIENTIST IN
THE VIRTUAL ROOM AND I WOULD BE
GLAD TO HEAR FROM THAT PERSON TO
UNDERSTAND SOME OF THESE
COMMENTS IN RESPECT TO THE LIKE
RAPIDLY ADVANCING COMPUTER
SCIENCE WORLD.
>> THAT'S HELPFUL.
SOUNDS LIKE THERE'S NOTHING WE
CAN TRIAGE AND WE PROBABLY NOW
OUGHT TO SYSTEMATICALLY GO
THROUGH THESE AND GET THE FEEL
OF THE COMMITTEE AS TO WHETHER
OR NOT WE'VE SEEN ENOUGH
INFORMATION THAT WE HAVE A SENSE
OF WHETHER OR NOT IT'S BEEN
ADDRESSED OR ON TRACK OR WHETHER
WE NEED MORE INFORMATION TO
REVIEW.
CHRISTINA, DO YOU WANT TO GO
STRAIGHT DOWN?
>> I WOULD SUGGEST DOING THAT
SEPARATELY THEN FOR PREGNANCY
AND LACTATION BECAUSE -- FOR
LACTATION I THINK IT WILL BE A
LOT MORE RED ORIENTED THAN IT
WILL BE FOR PREGNANCY.
>> AGREED.
LET'S START WITH THE DESIGN TO
LINK MOTHER AND INFANT DATA.
TAKE A QUICK LOOK OR REFRESH
YOUR VIEW OF THE SUBCATEGORIES
ESTABLISH ONGOING WORKING GROUPS
WITH HHS AND DATA HEALTH RECORD
EXPERTISE, EXISTING RESOURCES
AND REGISTRIES.
DEVELOP VARIABLES FOR
MOTHER-INFANT RECORDS.
GENERAL SENSE OF THE GROUP, DO
YOU FEEL THERE'S BEEN SOME
MOVEMENT IN THIS SPACE?
>> YES.
>> SOME NODDING HEADS.
WE'VE GOT SOME YELLOW, YES.
AND LET'S TALK A LITTLE BIT THEN
ABOUT ELEMENTS WE FEEL REQUIRE
OUR GROUP TO CALL OUT A SPECIFIC
PIECE OF INFORMATION THAT MIGHT
BE MISSING, SOMETHING THAT MAY
NOT HAVE BEEN ADDRESSED, SO WE
CAN ACKNOWLEDGE THAT 12A IS
SEARCH ONGOING OR PLANNED AND
THERE'S BEEN MOVEMENT IN THIS
SPACE.
AND THE QUESTION BECOMES WHAT
ARE THE CONCERNS WE HAVE ABOUT
THESE ELEMENTS MOVING FORWARD
ULTIMATELY TO THAT GREEN LEVEL
OF IMPLEMENTATION, A LONG WAY TO
GO LOOKING THROUGH THE COMMENTS
HERE, LACK OF PATIENT-REPORTED
OUTCOMES.
WE'VE GOT ONE COMMENT WE CAN
WATCH AND WAIT.
DOES ANYBODY WANT TO REGISTER
SPECIFIC ITEMS TO PULL OUT HERE
THAT WE WANT TO BE REPRESENTED
IN OUR REPORT?
>> MIGHT I MAKE A SUGGESTION?
>> YES PLEASE.
>> THERE'S QUITE A HANDFUL OF
OUR WORKING GROUP WHO BELIEVES
THERE'S A LONG WAY TO GO BUT
THERE'S WORK THAT HAS PROGRESSED
IN PREGNANCY.
IS THERE ANYONE WHO DISAGREES
WITH THAT?
IT WOULD BE USEFUL TO HAVE I
SHARE WHY YOU DISAGREE.
>> I'M TRYING TO TRACK WHAT
WE'RE SEEING IN THE MEETING
CHAT.
IT LOOKS LIKE WE'VE GOT GENERAL
CONSENSUS.
>> YES.
PREGNANCY.
>> IN PREGNANCY.
>> I JUST WANT TO ADD I AGREE
WITH THAT, AND I THINK THERE MAY
BE A COMMENT THAT ALLUDES TO
THIS.
WHAT I WAS STRUCK WITH WAS SOME
OF THE PRESENTATIONS REGARDING
DATABASES AND LINKAGES.
THERE'S BEEN WORK DONE IN THE
PHARMACO EPIDEMIOLOGICAL WORLD
FOR SEVERAL DECADES THAT IT
SEEMS LIKE ONE HAND IS NOT
NECESSARILY TALKING TO THE OTHER
AND THEY COULD BENEFIT FROM
SHARING METHODS.
>> THAT'S A GREAT COMMENT THAT
WILL GET CAPTURED IN THE REPORT.
ARE THERE ANY ADDITIONAL
COMMENTS THAT SHOULD BE CAPTURED
ABOUT THE ELEMENTS IN 12A?
>> THERE WILL NEED TO BE
DISCUSSION REGARDING LACTATION,
MOST LIKELY FOR ALL OF THESE.
>> YES.
>> SO I WOULD ACTUALLY MAKE A
RECOMMENDATION THAT WE JUST --
WE OPERATE UNDER THE ASSUMPTION
THAT LACTATION WILL BE
IDENTIFIED AS DEFICIENT UNLESS
WE IDENTIFY IT OTHERWISE HERE
WITH THE GROUP.
ARE YOU FEELING DATA ARE
LIMITED, THERE MAY -- INTENT TO
COLLECT DATA -- DO WE HAVE ONE
MORE LINK WITH MOM OR SEVERAL
BIRTHS?
I LIKE WHAT IS HAPPENING HERE IN
THE CHAT WHICH IS WE'VE GOT
ADDITIONAL COMMENTS AND
CONSIDERATIONS BEING POPULATED.
SO THIS SEEMS TO BE A VERY
EFFECTIVE USE OF OUR TIME IS TO
MAYBE GO AHEAD AND USE THE CHAT
FEATURE TO POPULATE THOSE
ADDITIONAL ELEMENTS THAT SHOULD
BE ADDRESSED IN THE REPORT.
AND LET'S MOVE DOWN TO 12B.
LEVERAGING LARGE STUDIES AND
DATABASES, EMRs, REGISTRIES.
IS THERE A GENERAL FEELING FROM
THE GROUP THIS IS ALSO ONGOING?
YEP, ONE THUMBS UP.
A COUPLE NODDING HEADS, ANOTHER
THUMBS UP.
FANTASTIC.
ANY SPECIFIC CAVEATS THAT NEED
TO BE ACKNOWLEDGED BASED ON WHAT
WE'VE HEARD TODAY?
>> I THINK -- I DON'T KNOW IF
THEY WANT TO SPEAK UP,
MR. HERTZ, YOUR POINT IS WELL
TAKEN, A PIECE WE PERHAPS NEED
TO PARKING LOT TO DISCUSS, YES?
>> AND WHERE IS THAT?
THIS IS MOVING FASTER.
I'M GOING TO TRUST YOU TO TAKE
THE CHAT --
>> BARRIERS BEING FULFILLED AS A
WHOLE ON A FULL SCALE BY ALL
IMPLEMENTERS AND STAKEHOLDERS, I
THINK THAT'S A VERY IMPORTANT
PART OF WHAT WE IDENTIFIED, NEED
TO DISCUSS IF THERE ARE IN FACT
SOME SPECIFIC BARRIERS.
>> AGREED.
>> YEAH, THIS IS K J AT MARCH OF
DIMES.
YOU JUST EXPLAINED MY COMMENT
BUT WHAT I GUESS I WAS GETTING
AT IS THAT IF THERE HAD BEEN
SOME PROGRESS MADE WE COULD
DOCUMENT THAT BUT I THINK WE
NEED TO BE VERY CLEAR CUT
SHOWING WHERE BARRIERS ARE FOR
MORE WHOLESALE HOLISTIC FULL
SCALE ADOPTION, IN THE SYSTEM,
AS FAR AS EHRs, YOU KNOW, BY
HOSPITAL SYSTEMS AND WHERE THE
DATA ARE.
>> ABSOLUTELY.
EVEN OUR COLLEAGUES AT FDA LAID
OUT SOME OF THAT NICELY FOR US
WHERE THE CHALLENGES ARE
W ITHRESPECT TO WHO OWNS DATA,
WHO TAKES THE LEAD, THINGS WE
COULD IDENTIFY AS BARRIERS TO BE
COGNIZANT OF AND PERHAPS MAKE
RECOMMENDATIONS ABOUT PROMOTING
ADDITIONAL DISCUSSION OR
SOMETHING ELSE TO HELP US
ACKNOWLEDGE THE BARRIERS AND GET
PAST THEM.
>> PROFESSOR CHARO?
>> IT WAS INTERESTING HOW
DIFFERENT DATA SOURCES HAD
DIFFERENT AREAS OF BIAS.
THERE WAS A COMMENT IN CHAT
SOMEBODY MADE ABOUT RURAL VERSUS
URBAN CENTERS AND EFFECT OF
COLLECTING DATA.
THERE WAS A PRESENTATION THAT
FOCUSED ON MEDICAID DATA WHICH
PICKS UP UNDERPRIVILEGED
POPULATION BUT I DON'T KNOW THAT
I WAS ABLE TO CAPTURE SOMETHING
THAT TOLD ME OVERALL WHAT'S THE
MIX OF BIASES AND ARE WE AT THE
POINT WHICH THEY ARE CANCELING
EACH OTHER OUT OR IS THERE A
KIND OF OVERSAMPLING OR
UNDERSAMPLING OF SPECIFIC
POPULATIONS?
IT DID SEEM HERE ONE NUANCE IS
THAT THERE BE AN EVALUATION OF
SOURCES OF DATA TO LOOK AT
WHETHER OR NOT IT'S GIVEN AS AC
ACCURATE SNAPSHOT.
>> THERE REMAIN UNKNOWN ELEMENTS
IN TERMS OF SCOPE OF THESE
RESOURCES SO I THINK THAT'S A
GREAT POINT TO CAVEAT THIS AS
WELL.
12B, DELINEATION, INCREDIBLY
IMPORTANT, I AGREE WE NEED TO
DELINEATE CHALLENGES AND COULD
CERTAINLY DO THAT BUT, AGAIN,
ARE WE -- SOUNDS AS IF WE'RE IN
GENERAL AGREEMENT THAT AT LEAST
THERE'S INITIATIVE THIS IS
ONGOING AND WE'VE NOW STARTED TO
CAPTURE SOME OF THE LIMITATIONS
AND CONCERNS.
>> THERE'S A QUESTION FOR
CLARIFICATION, WOULD THESE
RESOURCES BE LISTED ON THE DASH
WEBSITE?
I'M GOING ASK OUR COLLEAGUES IF
KATIE IS ON IF SHE COULD SPEAK
TO THAT.
>> OKAY.
SO THE QUESTION IS, IS THERE A
WEBSITE THAT PROVIDES US WITH A
LIST OF REGISTRIES AND ANY
OTHER -- WHAT OTHER RESOURCES,
I'M SORRY, I DID MISS THAT.
>> YEAH, ALLISON, DO YOU WANT TO
CLARIFY WHICH RESOURCES YOU'RE
THINKING ABOUT BECAUSE DASH IS
REALLY THAT RESULTS DATA.
SO WHAT ARE YOU THINKING ABOUT
THERE WITH THAT QUESTION?
>> MY QUESTION, WHAT DOES DASH
OFFER US AS FAR AS IMPACTING
THIS CONVERSATION.
SOMEONE ELSE HAD ASKED WHERE DO
WE FIND THESE RESOURCES, IS
THERE A DATABASE FOR MANUSCRIPT,
I RESPONDED WITH A QUESTION
WHICH WAS, DOES DASH HELP US
HONE IN ON SOME OF THAT
INFORMATION?
>> OKAY, GREAT QUESTION.
YEAH, SO AT THE MOMENT, DASH
WILL POINT -- WHAT DASH CAN
POINT YOU TO IS DATA STORED
WITHIN DASH, DATA THAT HAS BEEN
SUBMITTED, DE-IDENTIFIED DATA
SUBMITTED INTO THE DASH
REPOSITORY ITSELF.
I THINK THERE ARE -- THERE'S
SOME MOVEMENT TO MODERNIZE DASH
AND MAKE IT -- TO DEVELOP SOME
TOOLS THAT CAN HELP POINT
INVESTIGATORS TO OTHER DATA THAT
ARE OUT THERE PARTICULARLY IN A
REPRODUCTIVE HEALTH SPACE BUT
THOSE ARE STILL YOU UNDER
DISCUSSION AT THIS POINT.
THEY HAVEN'T BEEN DEVELOPED OR
IMPLEMENTED BUT THAT'S THE
DISCUSSION THAT THE DASH TEAM IS
HAVING.
HOW TO FACILITATE IDENTIFYING
DATA ACROSS REPOSITORIES, NOT
JUST WITHIN DASH.
I DO WANT TO MENTION THE IMPRINT
KNOWLEDGE PORTAL.
SO THAT WILL -- THAT IS
COLLECTING DATA PRIMARILY
RELATED TO PUBLICATIONS BUT ALSO
FROM OTHER DATA SOURCES.
AND IT WILL POINT INVESTIGATORS
TO THE LOCATION OF DATA, SO
WHETHER THAT IS A MODEL OR A
DATASET, I THINK EVENTUALLY THE
GOAL IS TO HAVE THAT KNOWLEDGE
PORTAL ABLE TO POINT
INVESTIGATORS TO WHERE THE DATA
ACTUALLY ARE.
BECAUSE THAT'S DEFINITELY A NEED
IN THIS SPACE, JUST FIGURING OUT
WHERE ARE THE DATA BECAUSE THERE
ARE SO MANY DIFFERENT PLACES
WHERE IT IS SHARED AND STORED.
THAT WAS A GREAT QUESTION.
>> SO, IT SOUNDS LIKE THE
CONVERSATION AROUND 12B RELATES
TO THE FACT THAT THIS IS
ONGOING, AGAIN IT'S VERY
SPECIFIC WHERE IT IS OCCURRING,
WHERE IT'S TAKING PLACE.
THERE MAY BE SOME ACCESSIBILITY
ISSUES, ALTHOUGH THIS IS
REALLY -- THIS PARTICULAR
RECOMMENDATION IS FOCUSING MORE
ON THE EXPLORATION OF THIS.
SO, THERE'S CLEAR EVIDENCE
THAT'S TAKING PLACE BUT IT'S
HIGHLY SPECIFIC AND TRANSPARENCY
MAY BE AN ISSUE TO DISCUSS.
>> AND I WOULD SUGGEST AGAIN,
JUST TO ADD BEFORE WE MOVE TO
12C, PUT YOUR COMMENTS IN THE
CHAT.
THE CHAT IS BEING COLLECTED AND
RECORDED SO THIS HELPS US TO
KEEP A REMINDER OF POINTS RAISED
SO PLEASE DO CONTINUE TO USE THE
CHAT FEATURE.
>> AND, AGAIN, --
>> WE CAN'T SEE THEM LIVE BUT
WITH KEEP THE INFORMATION IN THE
CHAT FEATURE.
>> THIS COMMITTEE WILL BE
REVIEWING THE REPORT AND MAKING
CHANGES SO WHAT WE'RE TRYING TO
DO RIGHT NOW IS CAPTURE A
FRAMEWORK AND WE CAN EXPAND OUT
ANY OF THESE COMMENTS, ONCE
WE'RE ACTUALLY AT THE WRITING
STAGE.
>> 12C, THE USE OF DATA, NOVEL
DATA RESOURCES, THAT SUPPORT
LARGE POST-MARKETING
OBSERVATIONAL STUDIES, SUPPORTS
STUDIES ACROSS MULTIPLE DRUGS,
USING THE SAME INFRASTRUCTURE, I
THINK THERE'S CLEAR EVIDENCE
THAT'S TAKING PLACE.
I'D LIKE TO HEAR FROM FOLKS ON
THE WORKING GROUP AS TO WHERE
THEY THINK THIS IS IN PROCESS.
>> DO YOU WANT TO ADD ANYTHING
TO WHAT YOU SAID PREVIOUSLY?
>> YEAH, I MEAN, I THINK THIS IS
ONGOING.
IT'S TRICKY BECAUSE I THINK WE
CAN KIND OF GO -- WE CAN MAKE A
CASE FOR YELLOW OR RED IN MANY
OF THESE BUT I THINK FROM WHAT
WE SAW TODAY, THIS IS ONGOING,
IN MY PERSPECTIVE.
MORE SO IN THE SAFETY SPACE OF
IT AND NOT IN THE LACTATION
SPACE, BUT DEALING WITH
PREGNANCY.
LEYLA OR TRISH, DO YOU HAVE
ANYTHING MORE TO ADD?
>> THIS IS TRISH.
NOTHING TO ADD.
>> I DON'T HAVE ANYTHING TO ADD
EITHER, THANKS.
>> AND IT COULD RUMP TO RED --
BUMP TO RED IF THERE WAS NO
MOVEMENT, NOTHING HAPPENING.
HEARING WHAT YOU SAID
REGISTERING COMMENTS I THINK
WE'RE AT ONGOING PLAN AND I
WOULD ASK FOLKS TO USE THE CHAT
TO POPULATE ELEMENTS OR POINTS
OF CONSIDERATION THAT NEED TO BE
ADDRESSED WITH RESPECT TO
LIMITATIONS OR BARRIERS.
>> GO AHEAD, CHRISTINA.
>> ONE CAVEAT REGARDING
EFFECTIVENESS.
>> YES.
>> BECAUSE THAT'S THE ONE
COMPONENT THAT WE DO NEED TO
HAVE PERHAPS SOME DISCUSSION
WITHIN THE REPORT ON THE ABILITY
TO DO SO, WITH THE CURRENT TOOLS
OR IF THERE IS GOING TO BE
FUTURE CONSIDERATION OF
UTILIZATION OF TOOLS FOR
PURPOSES OF EFFECTIVENESS
ANALYSIS
>> SAMPLE OF BUILDING OUT AREAS
THAT NEED TO BE ADDRESSED.
THANK YOU VERY MUCH, CHRISTINA.
12D RELATES TO USE OF INNOVATIVE
METHODS OF DATA ANALYSIS.
SO THIS GETS BACK TO WHAT A
PREVIOUS SPEAKER HAD JUST
BROUGHT UP ABOUT ARTIFICIAL
INTELLIGENCE, BUT THE USE OF
METHODS AND DEANNELYTICS TO LINK
MULTIPLE DATA SOURCES TO
IDENTIFY METHODS OF DATA
ANALYTICS, CONSIDER ESTABLISHING
PUBLIC/PRIVATE PARTNERSHIPS TO
VERY MANY STRATEGIES FOR USING
INNOVATIVE METHODS, WE DEFEEL
THERE'S BEEN -- - DO WE FEEL
THERE'S MOVEMENT IN THIS AREA.
>> CAN YOU CLARIFY WHAT YOU MEAN
BY YOUR WORD "METHODS"?
>> I WOULD DRAW YOUR ATTENTION
TO THE IMPLEMENTATION PLAN IT
BREAKS IT DOWN A LITTLE BIT MORE
FOR YOU THERE.
SO IF YOU LOOK AT 12D SUBPART A,
PROBABILISTIC MATCH, UNIQUE
IDENTIFIERS, NATURAL LANGUAGE
PROCESSING, THAT TYPE OF THING.
>> THANKS.
SORRY ABOUT THAT, I DIDN'T HAVE
IT UP ON MY SCREEN.
>> NO PROBLEM.
PAMELA, THANK YOU.
YOU'RE SAYING YES THERE'S
MOVEMENT BUT WE AGREE BETTER
HEARING FROM SOMEONE WITH
EXPERTISE.
I THINK HOW I WOULD INTERPRET
THAT IS THAT THE CONVERSATION
RIGHT NOW THAT ACTIVITY RIGHT
NOW IS PROBABLY INCOMPLETE OR
PERHAPS OUR KNOWLEDGE IS
INCOMPLETE.
WITH RESPECT TO WHETHER OR NOT
THERE ARE OTHER SECTORS.
>> I WOULD AGREE.
>> IT'S NOT NECESSARILY
ALIGNMENT WITH THE WORKING
GROUP.
I'D LOVE TO HEAR FROM OTHERS.
>> I DON'T SEE HOW THE
PRESENTATION I HEARD FROM TODAY
AND I'M HAPPY TO BE CORRECTED ON
THIS, I FEEL LIKE I'M THE MEAN
ONE IN THIS MEETING, IS THAT
THEY SEEMED LIKE METHODS I HAVE
SEEN AND HEARD OF BEFORE, MANY
TIMES.
WHICH IS NOT TO SAY THAT'S BAD
BUT THAT'S GREAT.
I'M GLAD THEY ARE DOING THINGS
THAT WORK WELL IN THE PREGNANCY
AND LACTATION SPACE BUT THAT'S
NOT NOVEL TO ME.
SPECIFICALLY, THE OUTLINE OF THE
RECOMMENDATIONS POINTS TOWARDS
NOVEL COMPUTER SCIENCE-DRIVEN
METHODS SO I'M NOT AN EXPERT IN
THAT SPACE.
I'D BE GLAD TO HAVE AN EXPERT
TELL US IF PEOPLE THINK WE'RE
DOING A GOOD JOB OR THERE'S MORE
TO GO.
>> I AGREE.
I WAS THINKING THIS WAS -- I
WANT TO SAY JUST KINDERGARTEN AS
OPPOSED TO FIRST GRADE, SECOND
GRADE, EVEN HIGH SCHOOL.
IT JUST DIDN'T SOUND LIKE, OH,
THIS IS A JUMP IN AND IT'S
RUNNING, IT'S MORE, OH, WHY
DON'T WE TRY THIS.
SORRY.
>> NO, THAT'S HELPFUL.
I WOULD SAY LET'S, FOR EXAMPLE,
TAKE A LOOK AT 12D SUBPART B,
USING DATA ANALYTICS METHODS TO
LINK MULTIPLE DATA SOURCES.
AND SO I DO THINK THAT WE'VE GOT
SOME, AND WE'VE HEARD A LITTLE
EVIDENCE FOR THAT TODAY.
THERE'S CERTAINLY AT LEAST PILOT
DATA OUT THERE THAT DEMONSTRATES
THAT THERE'S SOME CAPABILITY.
BUT, AGAIN, I'M NOT TRYING TO
SWAY THE GROUP ONE WAY OR
ANOTHER.
I'M JUST SUGGESTING THERE ARE
SOME ELEMENTS OF THIS THAT WE'VE
HEARD AT LEAST IN PROCESS AND
ONGOING.
LYNN?
>> MY ATTENTION WAS DRAWN ALSO
TO 12D, PART C.
ESTABLISHING PUBLIC/PRIVATE
PARTNERSHIPS TO DEVELOP METHODS,
STRATEGIES USING METHODS.
I FEEL THERE MIGHT BE
PUBLIC/PRIVATE PARTNERSHIPS FOR
COLLECTION DATA I DID NOT FEEL
WE'RE AT ALL CLOSE WITH REGARD
TO PARTNERSHIPS FOR THE PURPOSE
OF INNOVATIVE METHODS.
SO I THINK THAT ALONG
CONTRIBUTES TO THE FEELING MORE
THIS IS A RED.
>> KATIE?
>> HI.
I APPRECIATE THESE COMMENTS.
DEFINITELY SOMETHING WE AS AN
INSTITUTE NEED TO CONSIDER.
I DO WANT TO REMIND YOU OF THE
TRANSLATIONAL RESEARCH PAR,
USING NOVEL ANALYTICS SUCH AS
AI/ML AND NATURAL LANGUAGE
PROFESSING VERY IMPORTANT WHEN
WE REISSUED THE PAR.
WE DID TRY TO INCORPORATE SOME
RECOMMENDATIONS FROM THE TASK
FORCE WHEN WE UPDATED THAT PAR
AND WE'RE HOPING WE SEE MORE OF
A HIT WITH THE RESEARCH
COMMUNITY AND GET MORE
APPLICATIONS IN THIS SPACE
BECAUSE WE RECOGNIZE IT AS BEING
VERY IMPORTANT AND WE'RE HOPING
TO DRIVE SOME INTEREST HERE
WITHIN THIS COMMUNITY.
>> THANK YOU, KATIE.
THE ONE THING I WOULD TAKE AWAY
FROM YOUR COMMENT THERE IS
YOU'VE GOT A PROCESS AND FUNDING
OPPORTUNITY THAT LAYS THE
FOUNDATION FOR REALIZING THIS
PARTICULAR RECOMMENDATION.
SO I THINK THAT'S ONE THING WE
WANT TO KEEP IN MIND AS WELL.
AGAIN AS CHRISTINA MENTIONED
THINGS MIGHT BE FIVE, TEN,
FIFTEEN YEARS OFF BUT IS THE
FOUNDATION THERE?
>> I HAPPENED TO SEE SARAH'S
HEAD PEAK OVER THE TOP OF MY
IMAGES, AND SHE REMINDS ME I
THINK ONE OF THE THINGS WE WANT
TO DO IS DON'T LET OUR
ENTHUSIASM FOR THE CONVERSATION
THAT TAKES PLACE THE FACT THAT
A.I. CAN SOLVE THE WORLD'S ILLS
WITH THE ACTUAL PLACE WE ARE
RIGHT NOW, BEING ABLE TO APPLY
SOME OF THESE TOOLS IN THE WORK
THAT WE'RE DOING.
SO, MAYBE ONE OF THE THINGS WE
MIGHT WANT TO THINK ABOUT DOING
IS TRULY HAVING A COLLEAGUE WITH
EXPERTISE IN INNOVATIVE SPACES
TO WEIGH IN ON THE ABILITY TO
APPLY OR BASED ON WHERE THESE
INNOVATIVE TOOLS QUANTITATIVE
METHODS ARE CURRENTLY FOR
PURPOSES OF SCIENTIFIC RESEARCH.
SO I DO WANT TO KEEP A LITTLE
BIT OF THAT TEMPER IN MIND TOO
BECAUSE THERE'S SO MUCH
ENTHUSIASM FOR THESE TOPICS AND
ABILITY TO PRACTICALLY APPLY IS
NOT NECESSARILY ALWAYS AT THE
SAME PLACE AS ENTHUSIASM LEVEL.
>> GOOD POINT.
>> I WANT TO ECHO WHAT CHRISTINA
SAID, ENTIRELY AGREE BECAUSE
IT'S LIKE WHAT SOMEBODY SAID
EARLIER TOO.
IT'S GARBAGE IN, GARBAGE OUT.
WE DO NOT HAVE LINKAGE BETWEEN
MOMS AND BABIES AT THIS POINT IN
TIME SO HOW CAN YOU UNLEASH A.I.
IF YOU DON'T KNOW WHICH MOM HAD
WHICH BABY?
YEAH, I HAVE CONCERNS.
>> SO THIS ONE IS PROBABLY THE
LEAST FAR ALONG, IF I'M HEARING
THE GROUP CORRECTLY.
I THINK WE'VE GOT A MIX OF
OPINIONS ABOUT MAYBE THERE'S A
LITTLE BIT OF FOUNDATION THERE.
SO WE WILL KEEP THAT, THE
RECOMMENDATIONS AS EITHER A VERY
LIGHT YELLOW OR RED, AS I'M
SEEING IN THE CHAT, AND THEN
WE'LL CLARIFY THROUGH OUR
COMMUNICATIONS AND ADDITIONAL
NOTES THAT WE MAKE AS WE MOVE
FORWARD.
BEFORE I TURN OVER TO CHRISTINA
FOR 13, LET'S HIT 12E.
COMMON DATA ELEMENTS TO
FACILITATE COLLABORATION.
WHERE DO PEOPLE FEEL WE ARE
BASED ON CONVERSATIONS TODAY
FROM ONC?
>> I THINK THAT'S THE GREENEST
OUT OF ALL OF THEM.
I DO THINK THAT THERE'S BEEN
SOME REAL PROGRESS THERE SO I
HOPE IT WILL GET IMPLEMENTED
EVERYWHERE SO THAT WE CAN REAP
THE BENEFITS OF THAT INVESTMENT.
BUT TO ME THAT IS DEFINITELY
KIND OF A YELLOWISH-GREEN.
>> OKAY.
SARAH?
>> I WOULD POINT OUT THOUGH PART
C ON THAT, WHERE IT'S BEING
PUSHED TO OR INCENTIVIZED,
COMMON DATA ELEMENTS ACROSS
EHRs, I STILL THINK THAT HAS A
LONG WAY TO GO.
I WASN'T JUST THINKING ABOUT EHR
BUT OTHER RESEARCH EFFORTS, I
DON'T THINK WE HAVE COMMON DATA
ELEMENTS AND DATA DICTIONARIES
ACROSS VERY MANY OF OUR STUDIES
YET AND SO I THINK THERE'S A
LONG WAY TO GO TO GET PEOPLE IN
AGREEMENT IN WHICH COMMON DATA
ELEMENT WE SHOULD BE USING.
>> THANK YOU, SARAH.
THAT'S IMPORTANT TO POINT OUT.
I SEE TALKING ABOUT NOT
SATISFACTORILY ANSWERING THE
PATIENT-REPORTED OUTCOMES.
SO THIS LOOKS LIKE ANOTHER
YELLOW WHERE WE HAVE THE MOST
PROGRESS BUT THERE'S STILL SOME
ELEMENTS THAT WE NEED TO
CONSIDER AS NEEDING ATTENTION.
FOR THE SAKE OF TIME I'M GOING
TO TRANSITION TO CHRISTINA TO
HIT 13 AND WE'LL THINK THROUGH
TIMING AND COALESCING
EVERYTHING.
>> THE PHONE RANG SO I
APOLOGIZE FOR NOISE IN THE
BACKGROUND.
I'M GOING TO SAY UP FRONT THE
PURPOSE OF THIS WORKING GROUP IS
NOT TO RUSH THROUGH TO MAKE A
REPORT.
SO, I HAVE NO LOFTY ASPIRATIONS
WE'RE GOING TO COMPLETE WHAT WE
NEED COMPLETE FOR RECOMMENDATION
13.
WE'LL GET STARTED.
AND WHAT WE DON'T COMPLETE
TODAY, WE WILL WORK OUT A
PROCESS TO BE ABLE TO FIND AT
LEAST A PLACE OF INITIAL
ALIGNMENT OFFLINE.
APOLOGIES IN ADVANCE WE DON'T
KNOW WHAT THAT'S GOING TO LOOK
LIKE YET BUT IT'S NOT GOING TO
BE POSSIBLE FOR US TO GET
THROUGH ALL OF THIS IN 15
MINUTES.
SO, WE'LL START WITH 13A.
WHICH WAS TO -- LET'S GO BACK TO
THE RECOMMENDATIONS.
THE RECOMMENDATION HAS A VERY
IMPORTANT WORD THAT IT STARTS
OFF WITH, "OPTIMIZE."
OPTIMIZE REGISTRIES FOR
PREGNANCY AND LACTATION, KEEP
THAT IN YOUR MIND WORKING
THROUGH THE SUPPLEMENTS OF THE
RECOMMENDATION.
13A WAS CREATE A USER-FRIENDLY
WEBSITE FOR REGISTRY LISTINGS.
WE DID HEAR THERE ARE SOME
REGISTRY LISTINGS.
DO THEY MEET THE NEED OF THE
USER-FRIENDLY WEBSITE LISTING
FOR PURPOSES OF ALL OF OUR NEEDS
IN PREGNANCY AND LACTATION SO
I'LL OPEN IT UP TO YOU.
>> I APPRECIATE THAT THERE ARE
MAYBE EFFORTS TO MOVE TOWARDS
THIS BUT I THINK SOME ISSUES
RAISED EARLIER I THINK BY KATIE
SCHUBERT, I THINK I'M LEANING
TOWARDS RED FOR MOST OF THESE.
THERE HAVE BEEN BARRIERS AND
REALLY WOULD -- AND MAY NEED
ADDITIONAL ACTIONS TO REALLY
COME UP TO WHERE WE WOULD LIKE
TO SEE MOST OF THESE BUT I GUESS
STARTING WITH A, I WOULD SAY RED
FOR THIS ONE, NOT TO THOUGHT
RECOGNIZE EFFORTS THERE BUT I
THINK THAT THERE ARE SOME
BARRIERS TO REALLY FULFILLING
THIS ONE THAT MAY NEED SOME
ADDITIONAL WORK.
I DON'T SEE THE KEY UNDERNEATH
SO I'M SORRY IF I'M GETTING IT
WRONG.
>> NO WORRIES.
THANK YOU.
I APPRECIATE YOUR COMMENTS.
KATIE, DID YOU WANT TO WEIGH IN
SINCE RACHEL DID MENTION YOU AND
I SEE YOUR COMMENT IN THE CHAT?
>> YEAH, SURE.
I HAVE TRANSITIONED TO THE PART
OF MY DAY WHERE I --
(INDISCERNIBLE) I'M OFF CAMERA
BUT I WOULD TOTALLY AGREE.
I THINK THE KEY WORD IS
"OPTIMIZE."
THERE ARE ELEMENTS THAT EXIST
BUT IT'S NOT OPTIMIZED, AND
BEING USER FRIENDLY, ACCESS, I
WOULD AGREE I THINK IT'S
PROBABLY RED.
AND NOT EVEN QUITE INTO THE LIKE
IT'S MOVING ALONG.
I THINK IT PROBABLY NEEDS A PUSH
AND MORE CONVERSATION HOW TO DO
THIS, TO BE ABLE TO OPTIMIZE IT.
>> THANK YOU VERY MUCH, KATIE.
THANK YOU FOR DOUBLE TASKS
CURRENTLY.
AND I ALSO SEE THAT MOST OF THE
COMMENTS IN THE CHAT ARE IN
AGREEMENT.
I WANT TO GO TO 13A, SMALL
LETTER B.
THERE IS A PIECE THAT CALLS FOR
DEVELOPMENT OF THE
PUBLIC/PRIVATE PARTNERSHIP TO
HOST A PREGNANCY OR LACTATION
REGISTRY.
SO I DO THINK THERE IS A CLEAR
DIRECTION HERE THAT THERE IS
ADDITIONAL WORK THAT NEEDS TO BE
DONE.
THERE'S GOING TO BE
CONSIDERATION OF RESOURCE, WHOSE
RESPONSIBILITY IT WOULD BE TO BE
THE THIRD PARTY CONVENER FOR
THIS PUBLIC/PRIVATE PARTNERSHIP.
SO I THINK THAT UNLESS THERE'S
ANYONE WHO DISAGREES WITH THE
DISCUSSION, I SEE A HAND RAISED.
>> YES, SO THOSE THERE FOR THE
ORIGINAL PRGLAC FOR A POINT OF
HISTORY OR CONTEXT, OFTEN TIMES
THE REGISTRY IS AN EXAMPLE OR
MODEL.
CURIOUS TO LEARN WHAT FACETS.
ERA-T REGISTRY MIGHT HAVE
PROMPTED THAT FEELING OR
DISCUSSION, IS IT THAT IT WAS
ONE OF THE FEW OR ONLY, WAS IT
SOME PARTICULAR ASPECT OF
ACCESSING THAT DATA THAT MIGHT
HELP ME THROUGH THROUGHOUT OUR
MANY MEETINGS.
>> YEAH, I'M NOT AN EXPERT ON
THE ART REGISTRY AND KNOW
THERE'S SOMEONE ON THE CALL WHO
PROBABLY IS MUCH MORE SO THAN I.
SHE MAY SPEAK IF SHE'D LIKE.
HAVING BEEN IN THOSE
CONVERSATIONS, ART WAS DISCUSSED
AS A FORM OF A MODEL REGISTRY, A
MODEL, BECAUSE IT HAS SUCH A
DEPTH OF HISTORY, A WEALTH OF
INFORMATION.
BECAUSE THERE'S SUCH A GREAT
EMBRACE IN A MULTI-STAKEHOLDER
PERSPECTIVE, IT'S A MODEL.
IF ANYONE WANTS TO SPEAK TO WHY
AND HOW THAT WOULD BE WELCOME.
>> THERE'S MORE OF AN EXPERT BUT
CORRECT ME IN I'M WRONG.
MY UNDERSTAND IT'S A
DISEASE-BASED REGISTRY, RIGHT?
SO WHERE A LOT OF REGISTRIES ON
OUR WEB PAGE ARE PMR FOR
SPECIFIC MEDICAL PRODUCTS.
THAT LISTS PMR BUT THINGS
MISSING ARE NOT ENCOMPASSED BY
RESOURCE FDA PROVIDES.
MY UNDERSTANDING FROM A.R.T.,
DISEASE, TO YOUR POINT,
CHRISTINA, ISN'T IT FUNDED BY
INDUSTRY FOR THOSE DRUGS THAT
ARE USED IN THAT?
MAYBE SOMEONE ELSE KNOWS THAT
SPECIFIC.
>> YES, TINA CHAMBERS HAS A HAND
UP.
>> YEAH, IT IS.
I THINK THE VALUE, UNIQUE VALUE
IS THAT IT'S DISEASE BASED, AND
IT'S A PARTNERSHIP WHERE
MULTIPLE PHARMACEUTICAL
COMPANIES WHO MAKE MEDICATIONS
IN THIS SPACE CAN JOIN THIS AS
AN EXISTING STANDING, YOU KNOW,
STANDARD GOVERNANCE ALREADY IN
PLACE, AND THAT THE METHODS FOR
COLLECTING THE DATA ARE WELL
ESTABLISHED.
AND IT'S, YOU KNOW, ABLE TO
COMPARE EXPOSURES EARLY IN
PREGNANCY TO THOSE ONLY LATER IN
PREGNANCY SO IT'S BEEN A HIGHLY
SUCCESSFUL MODEL IN THAT REGARD,
BOTH IN TERMS OF COLLABORATION
BUT IN TERMS OF MAKING IT
RELATIVELY SIMPLE AND
STRAIGHTFORWARD FOR PREGNANT
PERSONS TO PARTICIPATE.
>> I THINK --
>> I THINK IT'S IMPORTANT THAT
EVERYONE IS INVESTED IN PUTTING
EVERY PIECE OF DATA INTO THE
REGISTRY AND NO WE DON'T GET
PAID AT PROVIDERS, I THINK IT'S
THAT STRONG FEELINGS THAT WE'RE
NOT CAPTURING WITH OTHER
REGISTRIES THAT WE'RE TALKING
ABOUT HERE.
EVERY MATERNAL PROVIDER, OH MY
GOD, I HAVE TO REPORT IT, I
DON'T SEE THAT KIND OF
INVESTMENT HAPPENING ACROSS
OTHER DISEASES OR OTHER FOCI
WE'VE BEEN TALKING ABOUT.
AND I THINK THAT'S THE BIGGEST
PROBLEM THAT I SEE, WE'RE
DEVELOPING REGISTRIES, TALKING
ABOUT REGISTRIES, BUT THERE'S NO
SKIN IN THE GAME FOR PEOPLE TO
SUBMIT DATA TO THOSE REGISTRIES.
>> YES, THANK YOU
I HAD A FEELING YOU'D BE ABLE TO
OFFER THAT VALUABLE
CONTRIBUTION.
I ALSO WANT TO CALL UP ERIN, DO
YOU WANT TO SPEAK MORE TO YOUR
COMMENT BECAUSE I THINK IT'S A
VERY RELEVANT COMMENT FOR THIS
DISCUSSION AS WELL.
>> YOU MEAN WILL THE LactMed
DATABASE?
>> YES, THANKS, AARON.
>> YEAH, SURE.
A COUPLE YEARS AGO NATIONAL
LIBRARY OF MEDICINE, WHO
SUPPORTED A VARIETY OF THESE
TYPES OF KNOWLEDGE BASES, FOR
EXAMPLE LIVER TOX AND SOME OF
THOSE, THEY HAVE -- THEY ARE
SUPPORTING THE INFRASTRUCTURE
FOR THE WEBSITE FOR THE
DISSEMINATION, DATABASE, THEY
HAVE ASKED DIFFERENT GROUPS THAT
ARE MORE SUBJECT AREA EXPERTS TO
PICK UP CURATION, SO NICHD TWO
OR THREE YEARS AGO PICKED UP
CURATION OF LactMed,
ESSENTIALLY MAINTAINING THE SAME
OPERATING PROCEDURES THAT
NATIONAL LIBRARY OF MEDICINE DID
AND WE'RE IN DISCUSSIONS RIGHT
NOW ABOUT WHAT THE NEXT
ITERATION OF LactMed SHOULD
LOOK LIKE.
SO I THINK ANY THOUGHTS FROM
THIS WORKING GROUP THAT IN TERMS
OF RECOMMENDATIONS THAT GO TO
COUNCIL WOULD BE VERY WELCOME
RIGHT NOW.
>> THANK YOU, AARON.
AND THANK YOU TO THE COLLEAGUES
FOR THAT IMPORTANT AS WELL.
SO I THINK JUST PAYING ATTENTION
TO THE TIME, WE HAVE FIVE
MINUTES LEFT.
AND SO INSTEAD OF RUSHING
THROUGH AND NOT REALLY PAYING
DUE DIAL -- DUE DILIGENCE TO
THE REMAINING SUBCOMPONENTS,
WE'LL FIND AN OFFLINE WAY TO GET
AT LEAST SOME INITIAL ALIGNMENT
ON WHERE WE STAND.
WATCH YOUR IN-BOXES AS RELATED
TO 13B THROUGH D.
EMMA, I'M GOING TO HAVE YOU
COME UP, SUE AS WELL.
FOR THE REMAINDER OF OUR WORK I
SAW YOUR COMMENT, LEE, IN
REGARDS TO THE FLEXIBILITY OF
THE TIMELINE, AND SINCE I'M
MERELY THE CO-CHAIR I'D LIKE TO
HAVE EMMA ADDRESS THAT QUESTION
FOR YOU PLEASE.
>> YEAH, ABSOLUTELY.
I THINK I DON'T WANT TO SPEAK
OUT OF TURN ESPECIALLY IN THIS
MINUTE BUT I THINK IF THE
WORKING GROUP FEELS LIKE THERE'S
MORE NEED, WE COULD TALK ABOUT
THAT.
WE HAD SET OUT THIS PLAN, ONE,
WITH HOPES WE WOULD PRESENT TO
THE JUNE COUNCIL, SO BECAUSE WE
DO NEED TO PRESENT UP TO NICHD'S
COUNCIL WE ARE PULLED INTO THAT
TIMELINE SO WE CAN CHECK
CERTAINLY IF THAT'S SOMETHING
THE WORKING GROUP WOULD LIKE TO
ENTERTAIN, PRESENTING TO A
FUTURE COUNCIL INSTEAD.
THAT'S SOMETHING WE CAN TALK
ABOUT.
ALTHOUGH I DON'T WANT TO MAKE
PROMISES ABOUT THAT.
>> SO IT WILL BE DISCUSSION FOR
US TO HAVE.
THIS IS OUR FIRST CALL.
IT'S FULLY VIRTUAL AS WE'VE ALL
JUST EXPERIENCED, TRYING TO GET
THROUGH A LOT OF INFORMATION.
AND HONESTLY I THINK FOR OUR
FIRST MEETING, JUST BEGINNING TO
WORK WITH EACH OTHER, SOME OF
YOU MAYBE WORKING FOR THE FIRST
TIME TOGETHER, THIS IS A LOT TO
TRY AND ACCOMPLISH IN A SHORT
PERIOD OF TIME.
WE'LL SEE HOW THIS PROGRESSES.
SPEAKING FOR MYSELF, HAVING NOT
DISCUSSED THIS WITH SUE OR EMMA,
THE REST OF THE WONDERFUL NICHD
STAFF WHO HAVE BEEN SUPPORTING
US, WE SAID HOW ARE WE GOING TO
GET THROUGH ALL OF THIS AND WE
CHOSE A WAY WE THOUGHT WOULD AT
LEAST HELP US GET STARTED.
IF ANY OF YOU FEEL THAT THIS HAS
NOT BEEN CONSTRUCTIVE AND THERE
MIGHT BE A BETTER WAY TO DO THIS
DON'T HESITATE TO REACH OUT
OFFLINE.
WE'RE WILLING TO ENTERTAIN YOUR
THOUGHTS.
OUR NEXT MEETING IS GOING TO BE
LOOKING TO GET THROUGH A LOT OF
GROUND.
THERE'S GOING TO BE A LOT TO
DISCUSS.
AT LEAST THIS GIVES YOU A FLAVOR
OF HOW WE'D LIKE TO WORK IN THE
PREP LEADING UP TO THE MEETING
THAT WILL BE HELPFUL TO YOU.
WE WILL TRY TO ALWAYS MAKE SURE
PRE-READS ARE DIRECTING YOU TO
RECOMMENDATIONS TO PREP FOR,
BECAUSE IT IS A LOT AND WE KNOW
YOU'RE DOING THIS BECAUSE YOU'RE
PASSIONATE ABOUT IT.
WE DO APPRECIATE THAT.
BUT I DO ALSO WANT TO JUST
REMIND YOU THAT OUR NEXT WORKING
GROUP MEETING I THINK I HAD IT
IN THE SLIDES IS SCHEDULED FOR
JANUARY 19.
SO IT'S NOT TOO FAR INTO THE
FUTURE.
THERE'S A LOT OF HOLIDAYS IN THE
U.S. BETWEEN NOW AND THEN.
SO WE'LL MAKE SURE WE FIGURE OUT
HOW TO ADDRESS 13B THROUGH D, WE
THOUGHT OFFLINE IF THERE'S A
DIFFERENT WAY FOR US TO DO THIS
WORK, REVISIT THE PARKING LOT
WHERE WE PLACED ITEMS THAT MIGHT
NEED ADDITIONAL DISCUSSION AND I
WANT TO MAKE SURE, SUE, NICK YOU
FEEL YOU NEED TO ADD HERE AND
EMMA AND THE REST OF THE STAFF
PLEASE.
>> I FULLY ENDORSE WHAT
CHRISTINA IS SAYING.
WE'RE TRYING TO FIGURE OUT THE
BEST WAY THROUGH A PROCESS OF
GETTING A LOT OF INFORMATION
REVIEWED AND SO WE'RE OPEN TO
ANY RECOMMENDATIONS.
THERE'S ONE REQUEST THAT I WOULD
HAVE OF THIS COMMITTEE BEFORE
THE NEXT MEETING.
ACTUALLY PROBABLY WITHIN THE
NEXT FEW WEEKS IF YOU CAN TAKE A
LOOK AT RECOMMENDATIONS WE'RE
GOING TO BE DEALING WITH AND IF
YOU BELIEVE THERE MAY BE KEY
SPEAKERS, SPEAKERS THAT CAN
SPEAK TO SPECIFIC ELEMENTS, SEND
THAT LIST OUR WAY.
WE MAY HAVE THEM UNDER
CONSIDERATION.
WE MAY NOT.
WE'RE TRYING TO PLAN SPEAKERS
NOW.
BUT SOMEBODY MENTIONED THE A.I.
AS AN EXAMPLE.
IF YOU FEEL THERE'S SOMEBODY WE
NEED TO HEAR FROM PLEASE LET US
KNOW.
WE'LL DO WHAT WE CAN TO MAKE
SURE THEIR VOICE IS REPRESENTED.
>> AND EMMA?
ANY LAST SAGE WORDS?
>> NO, NOT AT ALL.
THANK YOU.
THANK YOU BOTH FOR YOUR
LEADERSHIP AND WORKING GROUP
MEMBERS, WE APPRECIATE YOUR
PARTICIPATION AND EFFORTS.
I'LL BE IN TOUCH WITH LOTS OF
YOU SOON.
THANK YOU ALL SO MUCH.
>> THANK YOU, EVERYONE.
HAVE A REALLY WONDERFUL AND
RESTFUL WEEKEND AND VERY HAPPY
THANKSGIVING.
>> THANK YOU VERY MUCH TO THE
SPEAKERS AS WELL.
TAKE CARE.
>> BYE-BYE.