I THANK YOU FOR JOINING OUR
VIDEOCAST THIS AFTERNOON.
I AM PLEASED TO SERVE AS YOUR
VIDEOCAST MODERATOR TODAY.
I OVERSEE OUTREACH
COMMUNICATIONS TO THE EXTRAMURAL
RESEARCH COMMUNITY FOR THE
NATIONAL CENTER FOR
COMPLEMENTARY AND INTEGRATIVE
HEALTH IN THE DIVISION OF
EXTRAMURAL RESEARCH.
THIS TECHNICAL ASSISTANCE
VIDEOCAST IS SPONSORED BY NCCIH,
AND THE NATIONAL CENTER FOR
ADVANCING TRANSLATIONAL SCIENCE,
THAT'S CALLED NCATS FOR SHORT,
AND SIX OTHER PARTNER
INSTITUTES, CENTERS, AND ONE
OFFICE THAT HAVE A VESTED
INTEREST IN THIS IMPORTANT AREA
OF SICKLE CELL RESEARCH.
DURING THIS VIDEOCAST, YOU WILL
HAVE THE OPPORTUNITY TO HEAR
MORE ABOUT HELPING TO END
ADDICTION LONG TERM OR THE HEAL
FUNDING OPPORTUNITY RELATED TO
SICKLE CELL DISEASE AND PAIN
RESEARCH.
AND DURING THE LATTER PART OF
THIS VIDEOCAST, YOU WILL HAVE
YOUR QUESTIONS ANSWERED BY
PROGRAM AND REVIEW STAFF.
BUT PLEASE NOTE YOUR ATTENDANCE
HERE TODAY IS IN NO WAY A
REQUIREMENT TO COMPETE FOR THIS
PARTICULAR OPPORTUNITY.
THE TWO HEAL FUNDING
ANNOUNCEMENTS RELATED TO SICKLE
CELL DISEASE AND PAIN RESEARCH,
WE WILL DISCUSS TODAY ARE: THE
ONE RELATED TO PRAGMATIC AND
IMPLEMENTATION STUDIES FOR THE
MANAGEMENT OF SICKLE CELL
DISEASE AND PAIN, AND THAT IS A
UG3/UH3 CLINICAL TRIALS OPTIONAL
FUNDING MECHANISM, AND THE
SECOND ONE IS SICKLE CELL AND
PAIN MANAGEMENT TRIALS UTILIZING
THE PAIN MANAGEMENT
EFFECTIVENESS RESEARCH NETWORK.
AND THAT ALSO IS A UG3/UH3
FUNDING MECHANISM.
THE RECEIPT DATE FOR BOTH IS
NOVEMBER THE 21ST, 2022.
THIS TECHNICAL ASSISTANCE
VIDEOCAST IS ONE HOUR IN LENGTH
AND WILL CONCLUDE AT 3:00 P.M.
DURING THE FIRST HALF-HOUR OF
THE VIDEO QAA C VIDEOCAST YOU WR
PRESENTATIONS FROM NCCIH AND
NCATS PROGRAM STAFF AND A MEMBER
OF NCCIH'S REVIEW TEAM.
THE LAST HALF OF THE VIDEOCAST
IS ENTIRELY DEVOTED TO ANSWERING
QUESTIONS FROM OUR VIEWING
AUDIENCE.
QUESTIONS CAN BE SUBMITTED ANY
TIME THROUGHOUT THIS VIDEOCAST
USING THE Q & A FEATURE, WHICH
IS A TAB AT THE BOTTOM OF YOUR
SCREEN.
SO AT THIS TIME, I WOULD REALLY
LIKE TO INTRODUCE OUR THREE
VIDEOCAST SPEAKERS.
OUR FIRST SPEAKER TO YOUR FAR
LEFT IS DR. SEKAI CHIDEYA,
PROGRAM DIRECTOR, CLINICAL
RESEARCH BRANCH AT NCCIH.
FOLLOWING IS DR. JANE ATKINSON,
OVER TO THE FAR RIGHT, UP TO THE
RIGHT.
SHE IS A SENIOR SCIENTIFIC
PROGRAM MANAGER FOR CLINICAL AND
TRANSLATIONAL SI SCIENCE AWARDSD
THE TRIAL INNOVATION NETWORK AT
NCATS.
AT THE LOWER LEFT IS DR. SONIA
NANESCU, SCIENTIFIC REVIEW
OFFICER IN THE OFFICE OF
SCIENTIFIC REVIEW AT NCCIH.
SO I'M VERY PLEASED AT THIS TIME
TO PASS IT OVER TO DR. SEKAI
CHIDEYA.
>>THANK YOU, ANITA.
GOOD AFTERNOON, EVERYONE.
THANK YOU FOR JOINING US.
WE'RE VERY GLAD TO HAVE YOU.
BEFORE I DIVE INTO THE WEBINAR,
I WANT TO JUST PROVIDE A BRIEF
OVERVIEW OF THE AGENDA OF
TODAY'S WEBINAR.
FIRST I WILL DISCUSS THE
ELIGIBILITY CRITERIA OF THE
RFAs, THEN DR. ATKINSON AND I
WILL GO OVER THE GOALS AND
OBJECTIVES OF THE TWO RFAs
WITH A PARTICULAR FOCUS ON THE
NIH PRISSMM HEALTHCARE SYSTEMS
RESEARCH COLLABORATORY, AND THE
EFFECTIVENESS RESEARCH NETWORK.
THEN WE'LL HAVE A SUMMARY OF THE
APPLICATION AND REVIEW PROCESS,
FOLLOWED BY PLENTY OF TIME FOR
OUR QUESTION AND ANSWER PERIOD.
PLEASE NOTE THAT DUE TO TIME
CONSTRAINTS, WE ARE NOT GOING TO
BE ABLE TO GO OVER THE
PRIORITIES OF THE PARTICIPATING
INSTITUTES AND CENTERS, HOWEVER,
ALL OF THE INFORMATION FOR THOSE
CENTERS AND INSTITUTES,
INCLUDING THE CONTACT
INFORMATION FOR THE PROGRAM
DIRECTORS AT THOSE CENTERS AND
INSTITUTES, WILL BE INCLUDED IN
THE SLIDE DECK THAT WILL BE
POSTED ONLINE FOR YOUR
REFERENCE.
BECAUSE SICKLE CELL DISEASE
PRIMARILY IMPACTS PEOPLE OF
AFRICAN, INDIAN AN MEDITERRANEAN
DESCENT WE HAVE RECEIVED A
NUMBER OF INQUIRIES FROM FOREIGN
INSTITUTIONS AND INVESTIGATORS
ASKING IF THEY ARE ELIGIBLE TO
APPLY FOR THIS FUNDING
OPPORTUNITY.
TO CLARIFY, NON-U.S. ENTITIES
SUCH AS FOREIGN INSTITUTIONS AND
COMPANIES AND FOREIGN COMPONENTS
OF U.S. ORGANIZATIONS ARE NOT
ELIGIBLE TO APPLY AS PRIMARY
GRANT RECIPIENTS.
HOWEVER, FOREIGN COMPONENTS AS
DEFINED IN THE NIH GRANTS POLICY
STATEMENT MAY BE INCLUDED IN AN
APPLICATION AND THE PROPOSED
STUDY TEAM SO LONG AS THEY ARE
NOT THE PRIMARY GRANT RECIPIENT.
IF THIS IS THE CASE, APPLICANTS
MUST INCLUDE A FOREIGN
JUSTIFICATION ATTACHMENT
DESCRIBING WHY A FOREIGN SITE IS
MORE APPROPRIATE THAN A U.S.
ONE.
PLEASE CAREFULLY REVIEW SECTION
3 OF THE RFAs TO DETERMINE
YOUR ELIGIBILITY BEFORE
APPLYING.
NOW LET'S TALK ABOUT THE HEAL
INITIATIVE, OR HELPING TO END
ADDICTION LONG-TERM INITIATIVE.
THIS INITIATIVE'S MISSION IS TO
IDENTIFY EVIDENCE-BASED
SOLUTIONS TO THE U.S. OPIOID
CRISIS BY IMPROVING PREVENTION
AND TREATMENT OF OPIOID MISUSE
AND ADDICTION AND UNDERSTANDING,
MANAGING AND TREATING PAIN.
HEAL RESEARCH PRIORITIES INCLUDE
BUT ARE NOT LIMITED TO:
ACCELERATING THE DISCOVERY,
PRE-CLINICAL DEVELOPMENT AND
CLINICAL TRIAL CONDUCT OF
NON-ADDICTIVE TREATMENTS FOR
PAIN.
ESTABLISHING BEST PAIN
MANAGEMENT STRATEGIES FOR ACUTE
AND CHRONIC PAIN.
EXPANDING THERAPIES FOR
ADDICTION, OVERDOSE PREVENTION
AND REVERSAL.
OPTIMIZING CURRENT AND
DEVELOPING NEW PREVENTION AND
TREATMENT STRATEGIES.
AND UNDERSTANDING THE
NEUROBIOLOGICAL UNDERPINNINGS OF
CHRONIC PAIN.
I TO WANT TO EMPHASIZE, THOUGH,
THAT THE HEAL INITIATIVES ARE
DISTINCT FROM ONGOING RESEARCH
INCLUDING ON SICKLE CELL PAIN
MANAGEMENT.
TO AVOID SUBMITTING A SICKLE
CELL PAIN MANAGEMENT TRIAL THAT
OVERLAPSE SIGNIFICANTLY WITH
OTHER ONGOING TRIALS, APPLICANTS
SHOULD CAREFULLY REVIEW THE
WEBSITES LISTED HERE.
THAT WILL HELP ENSURE THAT THEIR
APPLICATIONS ARE NOT DUPLICATIVE
WITH CURRENTLY FUNDED RESEARCH.
THIS SLIDE GRAPHICALLY SHOWS THE
TWO OBJECTIVES OF THE HEAL
INITIATIVE, ENHANCING PAIN
MANAGEMENT AND IMPROVING
TREATMENTS FOR MISUSE AND
ADDICTION.
IN THE AREA OF ENHANCING PAIN
MANAGEMENT, CLINICAL RESEARCH IN
PAIN MANAGEMENT IS A PRIMARY
FOCUS, AND THERE ARE MULTIPLE
PROGRAMS AND ACTIVITY IN THIS
AREA.
SOME OF WHICH ARE LISTED HERE.
I'D LIKE TO BRING YOUR ATTENTION
TO THE LAST TWO, THE PRAGMATIC
AND IMPLEMENTATION STUDIES FOR
THE MANAGEMENT OF PAIN, OR
PRISSMM, AND THE PAIN MANAGEMENT
EFFECTIVENESS RESEARCH NETWORK
OR ERN, BECAUSE THESE TWO ARE
RELEVANT TO THE RFAs BEING
DISCUSSED TODAY.
SO LET'S DISCUSS THE RFAs.
FIRST, I'LL GO OVER THE GOALS
AND OBJECTIVES OF RF RFA-AT-23-.
SOME HELPFUL DEFINITIONS.
EMBEDDED PRAGMATIC CLINICAL
TRIALS ARE THOSE THAT ARE
CONDUCTED WITHIN THE HEALTHCARE
DELIVER RESETTING AND ARE
PRIMARILY DESIGNED TO DETERMINED
EFFECTS OF AN EVIDENCE-BASED
INTERVENTION UNDER THE USUAL
CONDITIONS IN WHICH IT WILL BE
APPLIED.
THIS IS IN CONTRAST TO
EXPLANATORY TRIALS THAT ARE
PRIMARILY DESIGNED TO DETERMINE
THE EFFECTS OF AN INTERVENTION
UNDER IDEAL CIRCUMSTANCES.
IMPLEMENTATION RESEARCH SEEKS TO
UNDERSTAND THE BEHAVIOR OF
PRACTITIONERS, SUPPORT STAFF AND
OTHER STAKEHOLDERS ASCII
INFLUENCES ON THE ADOPTION,
IMPLEMENTATION AND
SUSTAINABILITY OF EVIDENCE-BASED
HEALTH INTERVENTIONS AND
GUIDELINES.
IMPLEMENTATION RESEARCH STUDIES
SHOULD NOT ASSUME THAT EFFECTIVE
INTERVENTIONS CAN BE INTEGRATE
NEIGHBORHOOD A SERVICE SETTING
WITHOUT ATTENTION TO THE LOCAL
CONTEXT.
THE PRAGMATIC AND IMPLEMENTATION
MECHANISM IS CROSS DISCIPLINARY
AND TRANS-NIH.
IT IS NOT SPECIFIC TO THE HEAL
INITIATIVE ALONE.
THIS MECHANISM SUPPORTS A
RESOURCE COORDINATING CENTER
THAT LEVERAGES THE HEALTHCARE
SYSTEM'S RESEARCH COLLABORATORY.
ITS COLLABORATORY COORDINATING
CENTER PROVIDES TECHNICAL
EXPERTISE ON RESEARCH WITH
HEALTHCARE SYSTEMS AND IS A
CENTRAL RESOURCE FOR
COLLABORATORY PRAGMATIC OR
IMPLEMENTATION TRIALS.
IT ASSISTS WITH BIOSTATISTICS
AND STUDY DESIGN, ELECTRONIC
HEALTH RECORDS, HEALTHCARE
SYSTEM INTERACTIONS,
PATIENT-CENTERED OUTCOMES AND
ETHICS AND REGULATORY AFFAIRS.
VERY IMPORTANTLY, THOUGH, IT
DOES NOT PROVIDE DATA
COORDINATION SUPPORT FOR
INDIVIDUAL PROJECTS.
SO SPEAKING SPECIFICALLY ABOUT
THIS RFA, THE PRAGMATIC AND
IMPLEMENTATION STUDIES FOR THE
MANAGEMENT OF SICKLE CELL
DISEASE PAIN, RFA 182-3001, THIS
SUPPORTS MULTISITE EMBEDDED OR
PRAGMATIC IMPLEMENTATION TRIALS
TO PERFORM THE UPTAKE OF
EVIDENCE-BASED PHARMACOLOGIC,
NON-PHARMACOLOGIC AND/OR
MULTICOMPONENT APPROACHES FOR
ACUTE AND/OR CHRONIC SICKLE CELL
PAIN MANAGEMENT.
GRANTS ARE MILESTONE-DRIVEN
PHASED COOPERATIVE AGREEMENTS.
THIS MEANS THAT YOU ARE NOT ABLE
TO MOVE TO THE SECOND PHASE OF
THE STUDY UNLESS YOU HAVE
SUCCESSFULLY MET ALL OF THE
MILESTONES OF THE PREVIOUS
PHASE.
A SINGLE APPLICATION PROVIDES UP
TO FIVE YEARS OF FUNDING.
ONE TO TWO YEARS FOR THE
PLANNING STAGE OR THE UG3 WITH
DIRECT COST CAP OF $500,000 PER
YEAR, AND TWO TO FOUR YEARS FOR
THE STUDY CONDUCTION PHASE, OR
THE UH3, WITH A DIRECT COST CAP
OF $1 MILLION PER YEAR.
APPLICATIONS MUST HAVE AT LEAST
THREE PARTNERING HEALTHCARE
SYSTEMS PER PROJECT UNLESS A
STRONG JUSTIFICATION FOR FEWER
IS PROVIDED, AND THEY SHOULD
INCLUDE A DIVERSE PATIENT
POPULATION THAT AAPPROXIMATES
THE U.S. POPULATION OF PATIENTS
WITH THE CONDITION BEING
STUDIED.
IN THIS CASE, SICKLE CELL
DISEASE.
NOW I'M GOING TO PASS THIS ON TO
DR. ATKINSON WHO WILL DISCUSS
THE SECOND RFA, AT-23-002.
>>THANK YOU.
SO THE NIH HEAL PAIN MANAGEMENT
EFFECTIVENESS RESEARCH NETWORK
IS -- THE GOAL OF THE PROGRAM IS
TO SUPPORT CLINICAL TRIALS TO
TEST THE EFFICACY OR
EFFECTIVENESS OF INTERVENTIONS
FOR PREVENTION OR MANAGEMENT OF
PAIN WHILE REDUCING RELIANCE ON
OPIOIDS.
SPECIFIC TO THIS RFA, THE
OVERALL GOAL IS TO INFORM
CLINICIANS ABOUT THE EFFICACY OR
EFFECTIVENESS OF INTERVENTIONS
SUCH AS COORDINATED,
MULTIDISCIPLINARY MANAGEMENT
STRATEGIES THAT REDUCE ACUTE
AND/OR CHRONIC SICKLE CELL
DISEASE PAIN AND THAT CONTINUE
TO PROVIDE ACCESS TO OPIOID PAIN
MANAGEMENT AS NEEDED.
CLINICAL TRIALS WILL BE
CONDUCTED WITHIN THE
INFRASTRUCTURE OF THE HEAL PAIN
MANAGEMENT EFFECTIVENESS
RESEARCH NETWORK, WHICH WE CALL
HEAL ERN, WHICH WAS ESTABLISHED
THROUGH EXISTING INFRASTRUCTURE
IN THE NCATS TRIAL INNOVATION
NETWORK, AND YOU CAN LEARN MORE
ABOUT THE NETWORK BY GOING TO
THAT URL LINK IN THIS SLIDE.
NOW THIS FOA CANNOT BE USED FOR
APPLICATIONS THAT PROPOSE
TESTING OF INTERVENTIONS TO
ESTABLISH INITIAL EFFICACY OF
DRUGS, DEVICES OR BIOLOGICS FOR
APPROVAL BY THE FOOD AND DRUG
ADMINISTRATION.
SO TRIALS WILL BE IMPLEMENTED AT
THE CTSA PROGRAM HUB, WHICH ARE
THE CLINICAL AND TRANSLATIONAL
SCIENCE AWARD PUBS, THERE ARE 60
ACROSS THE UNITED STATES, BUT
WITHIN EACH HUB, YOU MAY HAVE
MULTIPLE CLINICAL SITES AT
DIFFERENT INSTITUTIONS THAT ARE
AFFILIATES.
AND PRINCIPAL INVESTIGATORS ARE
FREE TO CHOOSE ANY OTHER
CLINICAL SITE THAT THEY WISH TO
INCLUDE IN THEIR STUDY TEAM.
AWARDS WILL BE MADE AS A
MILESTONE-DRIVEN PLANNING PHASE,
JUST LIKE WITH THE PRISSMM
APPLICATIONS FOR ONE OR TWO
YEARS, WITH THE POSSIBILITY
TRANSITION TO A CLINICAL TRIAL
CONDUCT PHASE FOR UP TO FOUR
ADDITIONAL YEARS.
ONLY UG3 PROJECTS WITH A PLANNED
VANGUARD PILOT STUDY MAY REQUEST
TWO YEARS FOR THE PLANNING PHASE
WITH UP TO THREE YEARS FOR THE
IMPLEMENTATION PHASE.
ALL OTHER PROJECTS MAY REQUEST
ONE YEAR FOR THE UG3 PHASE WITH
UP TO FOUR YEARS FOR THE UH3
PHASE BUT THE TOTAL AWARD
DURATION CANNOT EXCEED FIVE
YEARS.
JUST LIKE WITH THE OTHER PRISM
FOA, PROJECTS THAT MEET THE
SCIENTIFIC MILESTONES AND
FEASIBILITY REQUIREMENTS WILL
TRANSITION TO THE UH3 PHASE AND
BOTH PHASES ARE INCLUDED AS ONE
APPLICATION.
NEXT SLIDE?
OH.
SO THE BUDGET IS A LITTLE MORE
COMPLICATED THAN PRISSMM.
THE TRIAL INNOVATION NETWORK
WHICH IS PROVIDING A LOT OF
INFRASTRUCTURE WILL PROVIDE
THESE RESOURCES TO ALL AWARDEES.
SINGLE IRB SERVICES FOR THE
UNITED STATES SITES IF THE
APPLICATION WISHES ASSISTANCE
WITH THE EXECUTION OF A MASTER
CLINICAL TRIAL AGREEMENT WITH
THE U.S. CLINICAL SITE,
DEVELOPING THE FINAL STUDY
PROTOCOL WITH THE STUDY TEAM,
FINALIZING RECRUITMENT AND
RETENTION PLANS WITH
INVESTIGATORS BEFORE TRIAL
INITIATION, PROVIDING SUPPORT
FOR STUDY DESIGN, THEY WILL DO
THE FINAL STATISTICAL ANALYSES
INDEPENDENTLY, AND HELP WITH
INTERPRETATION OF RESULT FOR
MANUSCRIPTS AND PUBLICATIONS.
AND THEY DEVELOP THE ASSOCIATED
TRIAL DOCUMENTS THAT YOU NEED
FOR IMPLEMENTATION SUCH AS A
MANUAL OF PROCEDURES.
YOU DO NOT NEED LETTERS OF
SUPPORT FROM THE TRIAL
INNOVATION NETWORK FOR YOUR
APPLICATION.
THEY WILL ALSO PROVIDE TRAINING
SUPPORT, DEVELOPING AND
MAINTAINING THE DATA SYSTEM FOR
DATA COLLECTION STORAGE AND
ADVERSE EVENT REPORTING,
PROVIDING RANDOMIZATION SUPPORT,
PROVIDING SUPPORT FOR CLINICAL
OPERATIONS AND MONITORING OF
U.S. SITES, PROJECT MANAGEMENT
AND TRIAL IMPLEMENTATION IN THE
UNITED STATES.
AND THIS INCLUDES FINDING
ADDITIONAL SITES IF YOU NEED
THEM, NOT ONLY DURING THE
PLANNING PHASE BUT DURING
IMPLEMENTATION PHASES TWO MEET
ENROLLMENT GOALS.
IN FACT, WE'RE CURRENTLY
SUPPORTING FIVE TRIALS AND I
THINK THREE OF THE FIVE HAVE
GONE BACK TO FIND ADDITIONAL
SITES.
THEY WILL MANAGE THE DATA AND
SAFETY MONITORING BOARDS AND
PROVIDE LOGISTICS FOR
FACE-TO-FACE MEETINGS.
DO NOT INCLUDE MANAGEMENT COSTS
IN YOUR INDIVIDUAL BUDGET.
LIKE THE OTHER FOA, BUDGETS WILL
NOT EXCEED MORE THAN $5 $500,00N
DIRECT COSTS FOR THE UG3 YEARS
AND $1 MILLION IN DIRECT COSTS
FOR THE UH3 YEARS.
STUDY COSTS FOR STUDY TEAM AND A
TRIAL STATISTICIAN WHO WILL WORK
WITH THE TIN STA TISHES SHOULD
BE INCLUDED.
COSTS TO CLINICAL SITES FOR
ENROLLMENT AND EVALUATION OF
PARTICIPANTS OR COSTS SUCH AS
CORE LABORATORY COSTS,
BIOSPECIMEN SHIPPING COST OR
COST FOR ACQUIRING AND SHIPPING
STUDY AGENTS SHOULD BE INCLUDED
AS STUDY COSTS.
COSTS AT THE CLINICAL SITES
SHOULD BE BUDGETED ON A
PER-SUBJECT OR PER-PROCEDURE
BASIS.
SPESPECIMENS COLLECTED BEYOND TE
NEEDED WILL BE SHIPPED AND
STORED IN THE NIH HEAL COMMON
REPOSITORY.
PLEASE INCLUDE COSTS FOR
SHIPPING TO THE REPOSITORY.
AND TRAVEL COSTS SHOULD INCLUDE
ONE INVESTIGATOR TEAM TO ATTEND
THE NIH HEAL MEETING AS WELL AS
AN ANNUAL ONE-DAY, IN-PERSON ERN
STUDY INVESTIGATOR MEETING.
THIS IS JUST A TABLE I'VE
INCLUDED, I'M NOT GOING TO GO
OVER EVERYTHING, I'VE ALREADY
INCLUDED IT, SO IT MAKES IT
EASIER TO FIGURE OUT THE BUDGET
FOR YOUR APPLICATION.
OTHER FACTORS TO NOTE.
IT'S EXPECTED THAT EACH TRIAL
WILL BE OVERSEEN BY A DATA AND
SAFETY MONITORING BOARD, WHICH
THE TIN WILL SET UP AND MANAGE
AND THEY'LL PROVIDE THE REPORTS
FOR THE MEETINGS.
PLEASE READ THE RFA CAREFULLY,
INCLUDING REVIEW CRITERIA.
AND NOTICE THE GOVERNANCE
STRUCTURE THAT'S OUTLINED IN
TERMS AND CONDITIONS.
SO THAT'S IT FOR ME.
I'M GOING TO TURN IT BACK TO DR.
>>THANK YOU SO MUCH,
DR. ATKINSON.
SO WHICH FUNDING OPPORTUNITIES
SHOULD YOU APPLY TO?
YOU PROBABLY ALREADY HAVE SOME
THOUGHTS IN YOUR MIND, BUT
HOPEFULLY THIS TABLE AND
DISCUSSION WILL HELP SOLIDIFY
THAT FOR YOU.
APPROPRIATE TYPES OF STUDIES
SUPPORTED BY RFA AT23001 INCLUDE
EMBEDDED PRAGMATIC TRIALS OR
IMPLEMENTATION TRIALS OF
EVIDENCE HIGH PRESSURE BASED
INTERVENTIONS WITH ESTABLISHED
EFFECTIVENESS.
IT ALSO INCLUDES INTERVENTIONS
EMBEDDED IN HEALTHCARE SYSTEMS
IN REAL WORLD SETTINGS.
PRAGMATIC TRIALS THAT COLLECT
MOST OF THE REQUIRED RESEARCH
DATA AS PART OF ROUTINE CLINICAL
CAROL, DATA THAT WOULD BE
OBTAINED PRIMARILY THROUGH
ELECTRONIC HEALTH RECORDS.
AND IMPLEMENTATION TRIALS THAT
HAVE IMPLEMENTATION FOCUSED MAIN
OUTCOMES, MOST LIKELY AT A
SYSTEM OR INDIVIDUAL PROVIDER
LEVEL.
APPROPRIATE TYPES OF STUDIES FOR
THE OTHER RFA, AT-23-002,
INCLUDE EFFICACY OR
EFFECTIVENESS RESEARCH TRIALS.
IN THIS CASE, MOST OF THE
STUDIES WILL RANDOMIZE
INDIVIDUAL PARTICIPANTS, COLLECT
DATA POINTS FOR RESEARCH
DIRECTLY FROM PARTICIPANTS, AND
DELIVER AN INTERVENTION IN A
STANDARDIZED FASHION.
IN TERMS OF INFRASTRUCTURE, RFA
AT23001 TRIALS ARE CONDUCTED
WITHIN THE INFRASTRUCTURE OF THE
HEAL INITIATIVE COORDINATING
CENTER.
AWARDEES WORK WITH THE PRISM
PRAGMATIC TRIALS COLLABORATORY
COORDINATING CENTER TO PLAN AND
REFINE THE TRIBAL IN PARTNERSHIP
WITH THE HEALTHCARE SYSTEMS N
CONTRAST, RFA AT23002, CLINICAL
TRIALS ARE CONDUCTED WITHIN THE
INFRASTRUCTURE OF THE HEAL ERN,
AND AWARDEES WORK WITH THE
NATIONAL CENTER FOR ADVANCING
TRANSLATIONAL SCIENCES TRIAL
INOINNOVATION NETWORK FOR CLINI,
BIOSTATISTICAL AND RECRUITMENT
SUPPORT.
SO NOW HOPEFULLY YOU HAVE SOME
IDEAS IN YOUR MIND ABOUT WHICH
ONE YOU'RE GOING TO APPLY FOR.
I'M GOING TO PASS THIS ON TO GO
OVER THE APPLICATION REVIEW
PROCESS.
>>DR. NANESCU, BEFORE YOU
START, I WANT TO REMIND THE
AUDIENCE YOU CAN SUBMIT YOUR
QUESTIONS AT ANY TIME DURING THE
PRESENTATIONS SO THAT WE CAN
DELVE RIGHT INTO THEM WHEN THE
PRESENTATIONS END.
SO WE'D APPRECIATE THAT VERY
MUCH.
>>THANK YOU SO MUCH FOR YOUR
ATTENTION SO FAR TO THIS
WEBINAR, AND THANK YOU FOR
PRESENTING THE PROGRAM
PERSPECTIVE.
WE WILL NOW GO THROUGH THE
REVIEW PERSPECTIVE.
THE FACTORS THAT IMPACT THE
REVIEW OF APPLICATIONS ARE
RESPONSIVENESS, COMPLIANCE, AND
COMPLETENESS.
IF NOT FOLLOWED COULD RESULT IN
YOUR APPLICATION BEING WITHDRAWN
AND I'LL COVER THIS IN THE NEXT
FEW SLIDES SO YOU CAN MAKE SURE
THIS DOESN'T HAPPEN.
THE REVIEW CRITERIA AND THE
REVIEW PANEL COMPOSITION -- WE
WILL ALSO HAVE -- TIMELINE
TOWARDS THE END OF MY
PRESENTATION.
THIS IS A REMINDER TO PLEASE PAY
ATTENTION TO RESPONSIVENESS
CRITERIA SINCE BOTH STATE
APPLICATIONS THAT ARE
NONRESPONSIVE WILL NOT MOVE
FORWARD TO REVIEW.
YOU CAN SEE EXAMPLES THAT ARE
NOT RESPONSIVE IN THE RFAs OP
THIS SLIDE.
WHILE THE FINAL DECISION ON
RESPONSIVENESS IS MADE BY
PROGRAM STAFF IN COLLABORATION
WITH -- STAFF, IN ORDER TO MAKE
SURE THAT YOUR APPLICATION IS
RESPONSIVE, PLEASE PAY CRITICAL
ATTENTION TO ALL STATEMENTS LIKE
MUST, REQUIRE, NEED, AND
NONRESPONSIVE.
YOU CAN SEE EXAMPLES HERE AS
WELL.
YOU CAN SEE IN THESE EXAMPLES
THAT BOTH RFAs HAVE HEAL
CLINICAL PAIN CORE COMMON DATA
ELEMENTS REQUIREMENTS.
BOTH RFAs ALSO HAVE SLIGHTLY
DIFFERENT RESPONSIVENESS
REQUIREMENTS.
THE BUDGET AND DURATION FOR THE
UG3 WERE COVERED PREVIOUSLY.
I WILL DRAW YOUR ATTENTION THIS
SLIDE IS ON TRAVEL BUDGET
REQUIREMENTS.
THOSE RFAs REQUIRE FOR
ALLOCATING BUDGET FOR TRAVEL FOR
PRINCIPAL INVESTIGATORS TO
ATTEND THE INVESTIGATORS'
MEETING IN WASHINGTON, D.C.
SINCE THE AWARDED APPLICATIONS
FROM THE RFA AT-23-001 WILL BE
CONDUCTED WITH INFRASTRUCTURE OF
PRISM AND WILL ALSO WORK WITH
THE HEALTHCARE SYSTEM'S RESEARCH
COLLABORATORY CENTER, PRINCIPAL
INVESTIGATORS FOR THESE
APPLICATIONS MUST ALSO BUDGET TO
ATTEND THE PRISM CLINIC.
I WILL REMIND YOU THAT FOREIGN
INSTITUTIONS ARE NOT ELIGIBLE TO
APPLY BUT FOREIGN COMPONENTS ARE
ALLOWED.
LIMITATIONS FOR THE RFA
AT-23-001, THE RESEARCH STRATEGY
SECTION IS LIMITED TO 30 PAGES.
PLEASE KEEP IN MIND, HOWEVER,
THAT BOTH RFAs HAVE THE SAME
REQUIREMENT FOR ONLY ONE PAGE
FOR THE SPECIFIC AIMS FOR BOTH
PHASES TOGETHER.
THERE IS ALSO A REQUIREMENT FOR
THE MINIMUM LEVEL OF EFFORT FROM
THE PRINCIPAL INVESTIGATOR OR
FOR MULTIPLE PRINCIPAL
INVESTIGATORS ON THE RFA
AT-23-001, FOR A COMBINED LEVEL
OF EFFORT MINIMUM OF 20%
ANNUALLY.
PLEASE KEEP AN EYE ON THE NIH
COVID-19 FLEXIBILITIES AND --
THE APPLICATIONS -- THE CURRENT
POLICY ON COVID-19 FLEXIBILITIES
FOR APPLICATIONS DUE WHEN
JANUARY COMES AROUND WHICH HAS
NOT BEEN EXTENDED YET BUT IT
COULD BE FOR THE MAY COUNCIL.
ONE PAGE UPDATE, TYPICAL
MATERIAL SUCH AS USE OF AN
ARTICLE ALSO APPLY.
THE RFAs ALLOW FOR MATERIAL
FOR AN UPDATED CLINICAL TRIAL
EXPERIENCE TABLE FOR THE RFA
001, CLINICAL EXPERIENCE TABLE
FOR CLINICAL TRIALS, AND BOTH
RFAs ALLOW FOR AN UPDATED
MILESTONE PLAN.
PLEASE REMEMBER THAT ALL
MATERIALS SHOULD BE SUBMITTED 30
DAYS BEFORE THE MEETING DATE.
IN ORDER FOR AN APPLICATION TO
BE COMPLETE IT NEEDS AT LEAST
ONE HUMAN SUBJECTS STUDY RECORD
IF HUMAN SUBJECTS ARE INVOLVED.
THE RFA 001 STATES -- PROPOSED
FOR EACH CLINICAL TRIAL SO IF
BOTH THE UG3 PHASE AND -- HAVE
CLINICAL TRIALS PROPOSED THE
RECORDS SHOW -- FOR EACH OF THE
PHASES.
IF THE APPLICATION SUBMITTED TO
THE RFA WITH A CLINICAL TRIAL
OPTION IS A CLINICAL TRIAL, THEN
THE REQUIRED CLINICAL TRIAL
ATTACHMENTS ARE THE CLINICAL
EXPERIENCE TABLE AND THE
MILESTONES PLAN.
SINCE THE RFA AT23002 IS A
CLINICAL TRIAL -- THE CLINICAL
TRIAL ATTACHMENTS MUST BE
INCLUDED ARE THE SCHEDULE OF
EVENTS AND MILESTONES PLAN.
IN ORDER FOR APPLICATION TO BE
COMPLETE AND TO COMPLY WITH THE
HEAL SHARING REQUIREMENTS, ALL
APPLICATIONS FOR BOTH RFAs
MUST INCLUDE THE DATA MANAGEMENT
AND SHARING PLAN HOW THE DATA
WILL BE MANAGED AND SHARED.
THE RFA AT23001 ALSO REQUIRES
LETTERS OF SUPPORT FROM EACH OF
THE HEALTHCARE SYSTEM PARTNERS.
BOTH RFAs -- AS WELL AS THE
ADDITIONAL CRITERIA SUCH AS
MILESTONES ARE ALL TAKEN INTO
CONSIDERATION BY REVIEWERS WHEN
THEY DETERMINE THE OVERALL
IMPACT SCORE.
SO PLEASE MAKE SURE THAT YOU
WOULD ALSO TAKE THESE INTO
ACCOUNT.
ALL APPLICATIONS WILL RECEIVE
ONE OVERALL IMPACT SCORE FOR
BOTH PHASES TOGETHER.
QUITE A BIT OF ADDITIONAL
LANGUAGE HAS BEEN -- AN EXAMPLE
OF THE LANGUAGE FOR SIGNIFICANCE
IN DARK BLUE FOR BOTH OF THE
RFAs HERE.
REVIEWERS WILL BE ASKED TO
ADDRESS LANGUAGE IF THE
APPLICATION IS A CLINICAL TRIAL
IN STANDARD LANGUAGE.
-- WILL MATCH WHAT YOU AS
APPLICANTS ARE ASKED TO ADDRESS
IN THE APPLICATION BUT IT MAY BE
HELPFUL FOR YOUR APPLICATIONS IF
YOU TAKE A LOOK AT THE REVIEW
CRITERIA AS WELL AND
PARTICULARLY TO THIS ADDED
LANGUAGE.
THIS IS AN EXAMPLE OF HOW THE
ASPECTS THAT -- WILL MATCH WHAT
APPLICANTS ARE ASKED TO ADDRESS
IN THE APPLICATION.
SO PLEASE MAKE SURE THAT YOU
READ SECTION 4 OF THE RFA.
SO FOR RFA AT23001, IF
APPLICANTS WERE ADVISED IN THE
RESEARCH PLAN TO PROVIDE
SUFFICIENT RATIONALE FOR THE
HEALTHCARE SYSTEM SELECTED, THIS
WILL BE ADDRESSED IN THE
ENVIRONMENT SECTION OF THE
CRITIQUES.
IF THE RFA-AT-23-002 ASKS FOR
DISCUSSION OF HOW THE RESULTS OF
THE TRIAL WILL INFORM THE
GUIDELINES IN SECTION 4, THE
REVIEWERS WOULD ALSO ADDRESS
THIS IN THE ENVIRONMENT SECTION
OF THEIR CRITIQUES.
I WILL NOT GO OVER EACH OF THE
NEW CRITERIA FOR THE RFAs, AND
I WILL ONLY BRIEFLY ADDRESS
MILESTONES.
AS A REMINDER, MILESTONES DO
ENFLEUNS THE OVERALL IMPACT
SCORE, AND ADDITIONAL CRITERIA
SPECIFIC TO BOTH OF THE RFAs.
HEERY VIEWERS WILL ADDRESS THE
MILESTONES ACTUA, ARE THEY CLEAY
DEFINED, FEASIBLE, WELL
DEVELOPED AND QUANTIFIABLE WITH
REGARD TO THE GOALS OF THE
APPLICATION.
ARE ADEQUATE CRITERIA PROVIDED
IN EACH PHASE?
THE REVIEW OF THESE APPLICATIONS
WILL TAKE PLACE AT NCCIH AND
REVIEWERS WILL BE SELECTED BASED
ON THE SPECIFIC AREA OF
EXPERTISE IN THE TARGET AREAS
FROM THE RFAs AND THE SCIENCE
PROPOSED IN THE APPLICATIONS.
SO PLEASE KEEP THIS IN MIND TO
ADDRESS HOW YOUR APPLICATION
WILL BE IMPACTFUL CONSIDERING
THE GOALS OF THE RFA, AND SINCE
REVIEWERS -- THEIR ASSESSMENT OF
ADDITIONAL REVIEW LANGUAGE AND
ADDITIONAL REVIEW CRITERIA
SPECIFIC TO THE RFA.
WE ENCOURAGE AND APPRECIATE IF
YOU SUBMIT -- THIS ALLOWS US TO
BETTER PREPARE FOR THE REVIEW OF
THE APPLICATIONS.
BUT THIS IS NOT REQUIRED.
IF YOU WOULD LIKE TO SUBMIT A
LETTER OF INTENT, PLEASE ADDRESS
TO MARTINA SCHMIDT.
HER EMAIL ADDRESS IS LISTED ON
THE SLIDE AND THE APPLICATION
FOR THE RFAs.
THE APPLICATION IS DUE
NOVEMBER 21ST AND SCIENTIFIC
REVEUL AFTER THE APPLICATION DUE
DATE DURING WHICH NIH WOULD
CONSIDER ACCEPTING LATE
APPLICATIONS.
THE DECISION TO APPROVE LATE
APPLICATIONS WITHIN THIS
TWO-WEEK WINDOW WILL BE MADE
BY -- FROM CSR DOES NOT DEPEND
ON NCCIH AND COULD NOT BE GIVEN
IN ADVANCE.
AND WITH THIS, I WILL THANK YOU
AGAIN FOR THE PATIENCE AND
ATTENTION TO THE WEBINAR.
I WILL HAND OVER THE MICROPHONE
TO OUR MODERATOR FOR THE NEXT
SEBTION OFSECTION OF THE WEBINA.
>>THANK YOU, AND I ALSO WANT TO
THANK OUR THREE SPEAKERS, DID
SEKAI CHIDEYA, DR. ATKINSON, AND
THESE ARE OUR PARTNERS THAT HAVE
A VESTED INTEREST FROM THE
STANDPOINT OF THEIR INSTITUTES,
CENTER OR OFFICE OF SICKLE CELL
DISEASE RESEARCH AND PAIN.
FIRST BEFORE I INTRODUCE THEM,
I'D LIKE TO INTRODUCE DR. WENDY
WEBER, BRANCH CHIEF OF THE
CLINICAL BRANCH AT THE NATIONAL
CENTER FOR INTEGRATIVE MEDICINE,
DR. WEBER, WELCOME.
>>GOOD AFTERNOON, EVERYONE, OR
GOOD MORNING DEPENDING ON WHERE
YOU ARE.
ANITA, ONCE YOU DO
INTRODUCTIONS, WE CAN OPEN IT UP
TO JUST A COUPLE OF -- IF ANYONE
WANTS TO ADD ANY SORT OF
CLARIFICATIONS OR ADD ANY
ADDITIONAL COMMENTS, THAT WOULD
BE GREAT.
>>I THINK THAT'S GREAT.
I DON'T HAVE A FORMAL
INTRODUCTION.
ONCE I CALL YOUR FIRST NAME, IF
YOU CAN JUST INTRODUCE YOURSELF,
YOUR IC AND IF YOU HAVE ANYTHING
ELSE TO ADD TO YOUR AREA OF
SPECIAL INTEREST.
AND LET ME JUST START WITH
KAREN.
>>GOOD MORNING OR AFTERNOON.
MY NAME IS KAREN KAYLE FROM THE
NATIONAL INSTITUTE OF NURSING
RESEARCH.
>>NEXT UP IS SUSAN.
>>HI.
I AM SUE SHERRO FROM THE
NATIONAL HEART, LUNG AND BLOOD
INSTITUTE AND I'M IN THE CENTER
FOR TRANSLATION RESEARCH AND
IMPLEMENTATION SCIENCE THERE.
>>ANITA, YOU NEED TO COME OFF
MUTE, PLEASE.
>>I'M SORRY.
YOLANDA?
THANK YOU.
>>GOOD AFTERNOON, EVERYONE, AND
THANK YOU FOR JOINING US.
I AMYOLAN DAI AM FROM THE HEAL .
>>THANK YOU.
AND I HOPE I DON'T BUTCHER YOUR
NAME, BUT PRISHKA?
>>I'M AT THE NATIONAL INSTITUTE
OF MINORITY HEALTH AND HEALTH
DISPARITIES.
>>YOU A. SO NEXT UP IS PHIL.
>>THANK YOU.
I'M WITH THE DIVISION OF BLOOD
RESOURCES.
>>THANK YOU VERY MUCH FOR THOSE
BRIEF INTRODUCTIONS.
WE HAVE A FORTRESS BEHIND US, SO
YOU'VE HEARD EXCELLENT
PRESENTATIONS THAT WERE WELL
PREPARED BY NCATS AND NCCIH, SO
WE ARE READY NOW TO ENTERTAIN
YOUR QUESTIONS AND LOOK FORWARD
TO THEM.
LET ME JUST GET STARTED.
FIRST QUESTION, WILL THE PDF
SLIDES BE AVAILABLE AFTER THE
PRESENTATION?
WE CAN CERTAINLY MAKE THOSE
AVAILABLE TO YOU, CAN'T WE,
DR. WEBER?
WE HAVE THE LIST OF PEOPLE WHO
REGISTERED, BUT I ALSO WANT TO
REMIND YOU THAT THE NIH -- IT IS
AN NIH VIDEOCAST SO IT WILL BE
ARCHIVED AND AVAILABLE FOR YOUR
VIEWING UNDER PAST EVENTS IN
PROBABLY ABOUT 24 HOURS.
SO YOU CAN DO THE REPLAY.
THE NEXT QUESTION IS, FOR RFA
AT23002, IF THE CTSA10/HEAL ERN
CAN HANDLE ALL DATA MANAGEMENT,
HOW SHOULD WE FRAME THE DATA
SHARING PLAN, FOR EXAMPLE, WHO
DOES TIN/ERN DATA SHARING?
>>SO THE DATA COORDINATING
CENTER AT THE UNIVERSITY OF UTAH
WILL HELP PREPARE THE SETS,
AND -- BUT THE DATA OFFICIALLY
BELONGS TO THE PRINCIPAL
INVESTIGATOR OF THE GRANT, SO
THEY HAVE TO STILL HAVE A PLAN
FOR SHARING THE DATA.
IT BECOMES A LITTLE TRICKY WHEN
YOU HAVE CERTAIN POPULATIONS
INVOLVED THAT MAY HAVE
RESTRICTIONS ON DATA SHARING
TOO.
SO THOSE WOULD ALL NEED TO BE
WORKED OUT BY THE PRINCIPAL
INVESTIGATOR.
>>THANK YOU.
IF THE APPLICATION HAS MULTIPLE
PRINCIPAL INVESTIGATORS, DOES
EACH PRINCIPAL INVESTIGATOR HAVE
TO CONTRIBUTE A 20% LEVEL OF
EFFORT?
>>I CAN ANSWER THIS QUESTION.
AND SO, NO, THE REQUIREMENT IS
FOR 20% COMBINED EFFORT.
>>WHILE I HAVE YOU THERE, IS
THE LETTER OF INTENT REQUIRED?
>>ABSOLUTELY NOT.
ABSOLUTELY NOT REQUIRED.
BUT WE DO APPRECIATE ANY LETTER
OF INTENT WITH AT MUCH
INFORMATION AS YOU CAN.
IT HELPS US PREPARE, BUT ONCE
AGAIN, NO, ABC LIGHT NOT
REQUIABSOLUTELY NOTREQUIRED.
>>I LIKE TO SAY NOT REQUIRED
BUT DESIRED.
SO THE NEXT QUESTION, DOES EACH
COINVESTIGATOR LISTED IN THE
APPLICATION NEED TO SUBMIT A
LETTER OF SUPPORT?
>>SONIA, IF YOU WANT TO TAKE
THAT ONE?
>>THE QUESTION WAS FOR THE --
WHICH OF THE RFAs?
I DON'T THINK I HEARD THE ENTIRE
QUESTION.
>>I THINK IT WAS FOR EITHER, DO
THEY NEED LETTERS OF SUPPORT
FROM EACH OF THE
COINVESTIGATORS, I THINK WAS THE
QUESTION.
I THINK IT'S A GENERAL QUESTION
ABOUT APPLICATION.
>>NO.
THE RFA-AT-23-001 REQUIRES
LETTERS OF SUPPORT FROM EACH OF
THE HEALTHCARE SYSTEM PARTNERS,
BUT ONLY THAT RFA.
AND IT'S JUST THE HEALTHCARE
SYSTEM PARTNERS, NOT ALL THE
INVESTIGATORS WOULD NEED TO
SUBMIT THAT AS A SUPPORT.
>>THANK YOU, SONIA.
THANKS FOR THE CLARIFICATION.
,
DR. WEBER.
>>ANITA, CAN I INSERT A
CLARIFICATION I WANTED TO MAKE
ABOUT A CHANGE WE MADE FROM
THIS -- FROM LAST YEAR'S RFA TO
THIS YEAR'S RFA, AND JANE AND
YOLANDA, YOU MIGHT WANT TO
COMMENT ON THIS AS WELL OR
OTHERS MAY WANT TO COMMENT ON
IT.
ONE OF THE BIG CHANGES THAT WE
MADE THIS YEAR WITH THE RFA IS
WE'RE ALLOWING UP TO TWO YEARS
IN THE UG3 PLANNING PHASE.
THE FULL TOTAL TIME OF THE AWARD
IS STILL UP TO FIVE YEARS, SO IF
YOU REQUEST TWO YEARS IN THAT
PLANNING PHASE, THAT MEANS YOU
ONLY HAVE THREE YEARS TO CONDUCT
THE TRIAL IN THE UH3 PHASE, SO
YOU HAVE TO SORT OF PLAN FOR
THAT.
BUT ONE OF THE THINGS WE
RECOGNIZE IS THAT THERE WAS A
NEED TO ALLOW FOR PILOT STUDIES
IN FIRST PHASE, AND THAT
SOMETIMES APPLICANTS OR MORE
IMPORTANTLY REVIEWERS WERE
LOOKING FOR PILOT DATA
SPECIFICALLY IN THE SICKLE CELL
PATIENT POPULATION, AND SOME OF
THE APPLICATIONS COMING IN
DIDN'T HAVE THAT PILOT DATA, AND
SO REVIEWERS HAD QUESTIONS ABOUT
SORT OF WHILE THERE MAY BE GREAT
DATA IN OTHER PAIN POPULATIONS,
THEY DIDN'T KNOW WHAT THE
ACCEPTABILITY AND UPTAKE WOULD
BE IN PATIENTS WHO HAD SICKLE
CELL DISEASE THAT HAD PAIN.
SO THAT'S WHY WE'VE ALLOWED TO
HAVE PILOT STUDIES HAPPEN IN THE
UG3 PORTION OF THE APPLICATION,
AND SO IT IS SOMETHING TO THINK
ABOUT IF YOU DON'T ALREADY HAVE
PILOT DATA OF THIS INTERVENTION
THAT YOU'RE LOOKING AT IN THE
PATIENT POPULATION WITH SICKLE
CELL, YOU MIGHT WANT TO STRONGLY
CONSIDER CONDUCTING A PILOT
STUDY IN THE UG3 PORTION TO JUST
DEMONSTRATE THAT YOU CAN GET
PARTICIPANTS TO DO THE
INTERVENTION.
I DON'T KNOW IF ANYBODY ELSE
WANTS TO ADD TO THAT IN TERMS OF
QUESTIONS.
>>ANYONE ELSE WANT TO ADD TON?
TO ADD ON?
IF SOMEONE HAS A
SUPPLEMENT-BASED THERAPEUTIC NOT
YET APPROVED BY THE FDA BUT
APPROVED OVERSEAS SUCH AS INDIA
OR AUSTRALIA, CAN THEY PUT
TOGETHER AN APPLICATION THAT
ONLY INCLUDES SITES IN THOSE
COUNTRIES WITH THE INTENT TO GET
APPROVAL FROM THE FDA DURING THE
TRIAL PERIOD?
GO TO FOR OUR RFA, THE ANSWER WE
NO.
>>AND I IMAGINE AND DR. W WEBER
PLEASE CHIME IN, BUT I IMAGINE
THE ANSWER WOULD ALSO BE NO FOR
THE PRAGMATIC TRIALS AND
IMPLEMENTATION STUDIES INTERVIEW
RFAs, BECAUSE AS IT
EMPHASIZED, IT IS LOOKING AT THE
IMPLEMENTATION OF ALREADY PROVEN
EVIDENCE-BASED INTERVENTIONS,
NOT INTERVENTIONS THAT ARE STILL
GOING THROUGH TRIALS IN THIS OR
OTHER COUNTRIES.
>>YEAH, I WOULD AGREE.
THETRIALS NEEDED TO GET FDA
APPROVAL FOR A NEW INCATION OR
FOR A NEW COMPOUND, AND WITH
FEDERAL FUNDING OF U.S. DOLLARS,
YOU WOULD ALREADY -- EVEN IF IT
WAS BEING DONE IN INTERNATIONAL
SITES, THERE WOULD STILL NEED TO
BE FDA REGULATORY OVERSIGHT IN
THE U.S., AND SO WE DON'T
ANTICIPATE THAT ANY OF THE
STUDIES FUNDED UNDER THESE
FUNDING MECHANISMS WOULD BE DONE
UNDER AN INVESTIGATIONAL NEW
DRUG APPLICATION.
DOES THAT SOUND RIGHT, JANE AND
YOLANDA?
>>YES.
BUT YOU CAN APPLY TO EPIC NET,
WHICH IS FOR APPROVAL OF NEW
COMPOUNDS, AND IT'S MAINLY PHASE
TWO THAT MIGHT BE AN APPROPRIATE
MECHANISM TO THINK ABOUT.
>>YOU CAN CHECK THE HEAL
WEBSITE FOR MORE INFORMATION
ABOUT EPIC NET.
>>YEAH.
GLO.
>>GOOD IDEA.
>>THANK YOU.
IS PILOT DATA COLLECTED ALLOWED
IN THE UG PHASE OF BOTH
MECHANISMS?
>>YES.
RIGHT, WENDY?
>>YEP.
>>OKAY.
>>WE ALLOWED IT IN BOTH.
I WILL SAY THAT WHILE PILOT DATA
IS ALLOWED, I WOULD SAY THAT A
BRAND NEW INTERVENTION PILOT
PROBABLY WOULD HAVE A TOUGH TIME
IN PEER REVIEW.
I THINK THE PRELIMINARY DATA
THAT SEEMED TO BE LACKING IN
PREVIOUS ROUNDS WAS REALLY
SPECIFICALLY IN THIS POPULATION,
THAT THERE'S A LOT OF OTHER DATA
ABOUT THE INTERVENTION AND MAYBE
EVEN SOME REALLY GREAT EFFICACY
DATA ABOUT PAIN MANAGEMENT WITH
SOME OF THE INTERVENTIONS BUT
MAYBE NOT AS MANY AS THEY'D LIKE
IN THE SICKLE CELL POPULATION
SPECIFICALLY.
>>PLEASE PAY ATTENTION TO
RESPONSIVENESS CRITERIA SINCE
THE RFA STATES STUDIES TO ASSIST
INITIAL FEASIBILITY OF THE
INTERVENTION ARE NOT RESPONSIVE.
SO JUST MAKE SURE THAT YOU DO
HAVE SOME DATA.
>>NEXT QUESTION.
IS THE UG3/UH3 INTENDED TO
SUPPORT WORK OF CLINICIANS OR
INTERVENTIONISTS?
>>THAT PROBABLY DEPENDS A
LITTLE BIT ON WHICH FOA WE'RE
TALKING ABOUT.
SO THE PRISSMM TO 001 RFA, IT
REALLY IS EXPECTED THAT THE
INTERVENTIONS WILL BE DELIVERED
AS PART OF HEALTHCARE DELIVERY
AND SO
TYPICALLY THE HEALTHCARE SYSTEMS
ARE DELIVERS THOSE INTERVENTIONS
AS PART OF GENERAL HEALTHCARE
DELIVERY AND IT'S NOT VERY
COMMON FOR PEOPLE TO INCLUDE
PAIN INTERVENTIONISTS AS PART OF
THE RESEARCH BUDGET.
I THINK THAT'S QUITE DIFFERENT
FOR THE EFFECTIVENESS RESEARCH
NETWORK.
JANE OREO LAN OR YOLANDA, YOU WO
ANSWER THAT?
>>I'M TRYING TO THINK.
SO WOULD THE GRANT SUPPORT THE
ACTUAL INTERVENTION BEING
DELIVERED?
>>TYPICALLY.
I GUESS FOR ACUPUNCTURE OR
FOR -- A LOT OF THESE ARE -- I'M
JUST THINKING LIKE A CASE
MANAGER OR IMPLEMENTATION OF A
MULTIMODAL INTERVENTIONIST, A
NAVIGATOR, THAT WOULD BE COVERED
BY THE RESEARCH BUDGET.
DOES THAT HELP YOUR QUESTION?
>>I THINK THAT'S WHAT THEY WERE
LOOKING FOR.
>>THAT'S A GOOD ANSWER, YES.
>>SO THE NEXT QUESTION IS FOR
THE 001 RFA WHICH IS THE ONE
THAT RELATES TO THE PAIN
MANAGEMENT OF SICKLE CELL
DISEASE.
ARE INTERVENTIONS THAT INCLUDE
IMPROVING PAIN MANAGEMENT WITH
OPIOIDS ALLOWED?
>>YES, THEY ARE.
RFAs OR FUNDING OPPORTUNITIES
ALLOWED FOR THE CONTINUED USE OF
OPIOID MEDICATIONS AND THOSE
UNDER INVESTIGATION.
>>I THINK A GOOD DISTINCTION,
IT WOULD PROBABLY BE IN ADDITION
TO ANY OPIOIDS THAT THE
PARTICIPANTS MAY ALREADY BE ON.
AND I DON'T KNOW THAT EITHER OF
THE FOAs ARE REALLY LOOKING
FOR STUDIES SPECIFICALLY OF
OPIOIDS ALONE FOR THE TREATMENT
OF SICKLE CELL-RELATED PAIN
MANAGE WILL.
I THINK WE'RE HOPING TO ADD ON
AND STUDY OTHER INTERVENTIONS IN
ADDITION TO TRY TO IMPROVE PAIN
MANAGEMENT.
DOES IT SOUND LIKE PRIORITIES
FOR ALL OF THE INSTITUTES AND
CENTERS?
I'M SEEING LOTS OF HEADS
NODDING, SO GOOD.
>>IN UNISON.
SO WE'LL MOVE ON TO THE NEXT
QUESTION.
HOW WOULD YOU HANDLE A PROPOSAL
FOR LONG TERM CHRONIC
ADMINISTRATION OF AN AGENT
DESIGNED TO PREVENT THE
PATHOPSYCHOLOGICALLY LEADING TO
PAIN?
PATHOPHYSIOLOGY LEADING TO PAIN.
>>JUST TO CLARIFY, I KNOW IT
MAY NOT BE THERE IN THE QUESTION
FOR YOU TO CLARIFY FOR US,
ANITA, IT SOUNDS AS THOUGH THEY
WERE INTERESTED IN ESTABLISHING
THE EFFICACY OR EFFECTIVENESS OF
THIS TREATMENT FOR LONG TERM --
THIS LONG TERM TREATMENT FOR
PATHOPHYSIOLOGY OR -- AGAIN, IT
REALLY -- THE DISTINCTION
BETWEEN THE TWO FUNDING
OPPORTUNITIES IS REALLY -- IS
THE INTERVENTION IN QUESTION
ALREADY EVIDENCE-BASED?
DO YOU HAVE ESTABLISHED EVIDENCE
FORTY IMPACT IN THE WAY THAT YOU
ARE INTERESTED IN.
SO IF YOU NEED TO PRIMARILY
ESTABLISH ITS EFFICACY OR
EVIDENCE FOR, YOU KNOW,
LONG-TERM USE FOR THE MANAGEMENT
OF PAIN, THEN THAT WOULD
PROBABLY FALL MORE ALONG THE
LINES OF RFA-002.
BUT I'M NOT SURE I UNDERSTAND
THE QUESTION.
>>I THINK IN THIS CASE, IT
MIGHT BE A MORE COMPLICATED
DESIGN AND I WOULD ENCOURAGE YOU
TO REACH OUT TO THE PROGRAM
OFFICIAL OF THE INSTITUTE THAT
YOU INTEND TO TARGET.
SO YOU CAN HAVE A MORE IN DEPTH
CONVERSATION.
>>THANK YOU, JANE.
>>ABOUT THE AGENT, WHAT IT'S
USED FOR ALREADY.
>>WELL, THANK YOU FOR THAT.
>>I'M WONDERING, PHIL, IF NHLBI
WOULD BE MORE INTERESTED IN
APPLICATIONS THAT MIGHT ADDRESS
SORT OF THE UNDERLYING
PATHOPHYSIOLOGY THAT LEADS TO
PAIN, OR SORT OF ADDRESSING THE
PATHOPHYSIOLOGY OF SICKLE CELL
DISEASE, THAT IN THE LONG RUN,
ENDS UP WITH -- YOU THINK YOU
MIGHT BE THE RIGHT PROGRAM
PERSON TO TALK TO THIS ONE?
WHAT DO YOU THINK?
>>YES, YES, YOU CAN REACH OUT
AND GIVE ME A CALL AND WE CAN
DISCUSS IT IN FURTHER DETAIL.
>>GREAT.
NEXT QUESTION, IS IT NECESSARY
TO BUDGET FOR A BIOSTATISTICIAN
OR WILL ONE BE PROVIDED?
B
>>SO USUALLY THE STUDY TEAM
LEADS FOR THE ERN, THE STUDY
TEAM NEEDS A STATISTICIAN TO
WORK WITH THE INVESTIGATORS AT
THE INSTITUTION.
AND I'M BECOMING MORE AND MORE
ACQUAINT WITH STATISTICAL TEAMS
IN TRIALS, SO WHAT WE REALLY
WANT IS AN INDEPENDENT ANALYSIS
OF THE DATA, BUT SECONDARY
PAPERS USUALLY ARE DRIVEN AND
LED BY THE INDIVIDUAL P.I.
>>AND I WOULD ADD TO JANE'S
COMMENT THAT THE STUDY TEAM
STATISTICIAN WOULD BE EXPECTED
TO COLLABORATE WITH THE HEAL ERN
STATISTICIANS AS WELL THROUGHOUT
THE TENURE OF THE PROJECT.
>>I WAS GOING TO SAY, FOR THE
001 RFA FOR PRISM, YOU
ABSOLUTELY NEED AT LEAST ONE
BIOSTATISTICIAN TO HELP YOU IN
PLANNING THE DESIGN AND CONDUCT
OF THE STUDY AND THAT SIMILARLY
THAT BIOSTATISTICIAN WILL WORK
WITH THE COORDINATING CENTER'S
BIOSTATISTICAL EXPERTISE TEAM TO
HELP REFINE THE STUDY PROTOCOL
AND ANALYTIC PLANS AND THOSE
TYPES OF THINGS.
WE'VE FOUND THAT THAT -- YOU GET
TO MEET WITH EVERYBODY'S
BIOSTATISTICIANS SO IT'S SORT OF
LIKE THIS AMAZING THINK TANK OF
BIOSTATISTICAL ADVICE THAT YOU
GET AS PARTICIPATING IN PART OF
THE PROGRAM, SO ALL OF OUR
STATISTICIANS HAVE REALLY
ENJOYED THE OPPORTUNITY TO
REALLY ADVANCE THE SCIENCE IN
THE DESIGN AND ANALYTIC METHODS
OF THE PROJECTS.
>>THANK YOU.
I'D LIKE TO SAY THE QUESTIONS WE
WERE STRUGGLING WITH THIS WAY OR
THAT WAY, THE INDIVIDUAL SAID
THAT IT WAS VERY HELPFUL, THE
RESPONSES THAT HE WAS GIVEN.
THE NEXT QUESTION IS, AS A
FOLLOW-UP, WE'RE HOPING TO
IMPLEMENT EVIDENCE-BASED
GUIDELINES FOR TREATMENT OF VOC
IN THE E.D. AND FREE HEALTHCARE
SYSTEMS.
THE GUIDELINES RECOMMEND
INDIVIDUALIZED OPIOID DOSING.
SO THE GUIDELINES ARE MOSTLY BUT
NOT ALL OPIOID-FOCUSED.
IS THIS TOO FOCUSED ON OPIOIDS
IS THE QUESTION.
>>IF YOU WANT TO TAKE THAT ONE
ABOUT THE IMPLEMENTATION
GUIDELINES?
>>TO THE EXTENT NHLBI WE'RE
INTERESTED IN GUIDELINE
IMPLEMENTATION AND
EVIDENCE-BASED RECOMMENDATIONS
FROM GUIDELINES.
SO IF THE GUIDELINE ITSELF IS
FOCUSED ON OPIOID BUT IT DOESN'T
REALLY PRECLEUMED MAYBE ADDING
OTHER APPROACHES OR -- SORT OF
DIFFERENT APPROACHES, SO I MEAN,
I WOULD CERTAINLY BE HAPPY TO
TALK FURTHER ABOUT MORE
SPECIFICS BUT I THINK FROM THE
GUIDELINE AND IMPLEMENTATION
PERSPECTIVE, WE ARE INTERESTED
THERE, MAYBE WE CAN TALK ABOUT
WHAT TYPE OF APPROACHES YOU'RE
THINKING ABOUT.
>>THAT SOUNDS GREAT.
>>NEXT QUESTION, DO
APPLICATIONS NEED TO INCLUDE A
COMPLEMENTARY HEALTH APPROACH?
>>I CAN TAKE THAT ONE.
SO WHILE THESE FUNDING
ANNOUNCEMENTS ARE BEING ISSUED
BY NCCIH AND OUR TEAM IS HELPING
TO DO ALL OF THE REVIEWS, AS YOU
CAN SEE FROM THE WIDE RANGE OF
INSTITUTES AND CENTERS ON THE
CALL, WE HAVE A BROAD RANGE OF
INTERESTS AND THE APPLICATION
DOES NOT HAVE TO INCLUDE A
COMPLEMENTARY HEALTH
APPROACHMENT WE'RE APPROACH.WOFE
INTERESTED IN THAT BUT EVERYBODY
ELSE HAS DIFFERENT INTERESTS
ACROSS THE DIFFERENT INSTITUTES
AND CENTERS.
>>AND THEY'RE ALL NOTED IN THE
FUNDING OPPORTUNITY
ANNOUNCEMENTS, THE SPECIFIC
AREAS OF INTEREST.
NEXT QUESTION, DO ALL SOFTWARE
TOOLS NEEDED FOR IMPLEMENTATION
NEED TO BE DEVELOPED DURING THE
PLANNING PHASE, OR CAN THESE BE
DEVELOPED AFTER A PROJECT IS
SELECTED FOR TRANSITION TO THE
UH3 TRIAL CONDUCT PHASE?
>>SO IN THE ERN, THE DATA
COORDINATING CENTER IS GOING TO
START DEVELOPING A DATA SYSTEM
SORT OF AT RISK DURING THE UG3
PHASE.
BECAUSE WE'VE FOUND THAT TRIAL
IMPLEMENTATION USUALLY TAKES
LONGER THAN WE THINK IT'S GOING
TO AND WE WANT TO HIT THE GROUND
RUNNING.
THE GOAL FOR US IS TO HAVE --
IT'S REALLY NICE IF YOU CAN GET
SINGLE IRB APPROVAL OF THE MAIN
STUDY PROTOCOL, MAYBE NOT ALL
THE RELIANCE AGREEMENTS WILL BE
IN PLACE, BUT HAVING A DATA AND
SAFETY MONITORING BOARD AT LEAST
ONE MEETING AND THEN WE WOULD
REALLY LIKE TO START RECRUITMENT
IN OCTOBER OR NOVEMBER OF THE
UH3 FIRST YEAR.
>>I WOULD ALSO ADD TO JANE'S
COMMENT THAT THROUGH THE HEAL
ERN, THE RESOURCES ARE ALREADY
IN PLACE THROUGH THE RECRUITMENT
RESOURCE CENTER, INCLUDING
SOFTWARE, SITE SELECTION, ET
CETERA WILL ALREADY BE IN PLACE
AND AVAILABLE.
>>FOR THE RFA001 FOR ERN, YOU
NEED TO HAVE EVERYTHING READY TO
GO, REALLY, BY THE TIME YOU MAKE
THAT TRANSITION.
SO IF YOU NEED TO DEVELOP
SOFTWARE FOR, LIKE, CLINICIAN
DECISION SUPPORT TOOLS OR OTHER
THINGS THAT ARE EMBEDDED IN THE
ELECTRONIC HEALTH RECORD, THAT
ABSOLUTELY NEEDS TO BE DONE IN
THE UG3 PHASE SO THAT YOU'RE
READY TO GO WHEN THE STUDY
LAUNCHES.
WE DO KNOW THAT THERE'S A FEW
THINGS THAT NEED TO HAPPEN AS
YOU TRANSITION TO THE UH3 PHASE
LIKE THE EXECUTING YOUR
CONTRACTS AND SOME THINGS LIKE
THAT, BUT WE ALSO WANT PEOPLE TO
START RECRUITMENT AND BE ABLE TO
LAUNCH THE TRIAL WITHIN THE
FIRST FEW MONTHS OF THE UH3
PHASE IN THAT SECOND PHASE.
>>NEXT QUESTION, CAN THE
PRAGMATIC TRIAL BE EMBEDDED ON
AN ONGOING PROJECT, LOOKING AT
DECENTRALIZATION AND
STRENGTHENING CARE AT DIFFERENT
LEVELS OF CARE?
>>I'M RE-READING THE QUESTION.
I THINK THIS IS ONE WE MAY NEED
A FOLLOW-UP CALL BECAUSE I'M NOT
100% SURE.
DOES ANYONE ELSE HAVE --
DECENTRALIZATION OF CARE.
CERTAINLY MULTILEVEL
INTERVENTIONS THAT TARGET CARE
AT DIFFERENT GROUPS OR
MULTILEVEL INTERVENTIONS THAT
MIGHT TARGET AT THE PATIENT,
PROVIDER OR CLINIC LEVEL, FOR
EXAMPLE, COULD BE INCLUDED.
I THINK THE TRIAL CERTAINLY CAN
BE EMBEDDED INTO EXISTING
REGISTRIES OR BE EMBEDDED INTO
EXISTING COHORTS AND ADD TRIALS
IN AS A WAY TO RECRUIT FROM
THOSE POPULATIONS, BUT WE MAY
NEED TO HAVE A FOLLOW-UP EMAIL
DIRECTLY WITH THIS INDIVIDUAL TO
BETTER UNDERSTAND.
>>WE'RE COMING NEAR THE END OF
THE WEBINAR HOUR, SO I'M GOING
TO ASK THIS QUESTION.
IS THE PLAN TO FUND THREE
APPLICATIONS FOR EACH FOA, SO A
TOTAL OF SIX, OR TO PICK THREE
ACROSS BOTH THE FOAs?
>>I BELIEVE THE PLAN IS TO FUND
THREE APPLICATIONS FOR EACH FOA.
>>I'M NOT SURE, PART OF IT IS
GOING TO DEPEND ON WHAT FUNDS
ARE AVAILABLE IN THE NEXT YEAR.
I THINK WE'LL LOOK ACROSS BOTH
FOAs AND LOOK FOR THE
STRONGEST SCIENCE ACROSS BOTH OF
THE FOAs.
JANE, DO YOU REMEMBER, WAS IT
THREE TOTAL --
>>I THINK IT WAS THREE TOTAL.
SO, YEAH.
SOUNDS LIKE THAT'S TO BE
DETERMINED, DEPENDING ON THE
FINAL FUNDING?
>>EVERY YEAR THE BUDGET IS KIND
OF A BIG QUESTION MARK, SO WE
JUST HAVE TO SEE HOW MUCH --
WHAT THE FUNDING IS LIKE.
>>OKAY.
I GUESS THE ANSWER IS WE'LL FUND
AS MANY AS WE CAN.
>>YEAH.
>>AND WE ABSOLUTELY WANT TO GET
AS MANY GREAT APPLICATIONS AS
POSSIBLE, AND IF WE GET REALLY
EXCELLENT APPLICATIONS, WE CAN
TRY TO MAKE THE CASE TO FUND
MORE.
SO PLEASE WE WOULD LOVE TO GET A
LOT OF GREAT APPLICATIONS IN.
>>AND THAT'S A GREAT TRANSITION
INTO MY CLOSING REMARKS,
DR. WEBER.
DOES ANYONE HERE, OUR IC
PARTNERS OR OUR SPEAKERS, HAVE
ANYTHING BURNING THEY WANT TO
SAY BEFORE I CLOSE OUT THE
VIDEOCAST?
ANYTHING, ANY MESSAGE THIS THEY
WANT TO DELIVER THAT WASN'T
ALREADY ELOQUENTLY DONE IN YOUR
TALK?
OKAY.
THAT BEING SAID, I REALLY --
>>MAY I JUST REMIND PEOPLE, I
KNOW YOU'VE ALREADY SAID IT BUT
I JUST WANT TO REMIND THE
AUDIENCE MEMBERS THAT THE
CONTACT INFORMATION FOR ALL OF
THE PROGRAM DIRECTORS OF THE
SUPPORTING INSTITUTES AND
CENTERS WILL BE INCLUDED IN THE
SLIDE DECK THAT WOULD BE POSTED
ONLINE AND PROVIDED TO YOU.
SO YOU WILL HAVE THE ABILITY TO
REACH OUT.
I KNOW SOMEONE POTENTIALLY IS
GOING TO REACH OUT TO PHIL, AND
MAYBE OTHER PROGRAM DIRECTORS.
SO THE PROGRAM INFORMATION WILL
BE IN THE SLIDE DECK PROVIDED
ONLINE FOR YOUR REFERENCE.
>>THANK YOU.
>>ANITA, YOU MADE ME THINK OF
ONE OTHER THING THAT WE ALWAYS
TRY TO SAY, WHICH IS, IT'S
ALWAYS A REALLY GOOD IDEA TO
TALK TO A PROGRAM OFFICIAL
BEFORE YOU SUBMIT AN
APPLICATION.
I SEE LOTS OF HEADS NODDING.
SO PLEASE FEEL FREE TO SEND US
YOUR ONE-PAGE SPECIFIC AIMS IF
YOU'RE TRYING TO FIGURE OUT
WHICH INSTITUTE OR CENTER IS
MAYBE THE BEST FIT.
IN SOME WAYS YOU DON'T NEED TO
WORRY TOO MUCH ABOUT THIS.
THEY'LL ALL GET REVIEWED AND
WE'LL FIND THE BEST FIT FOR
THEM.
BUT IT'S REALLY HELPFUL TO TALK
TO A PROGRAM OFFICIAL BEFORE YOU
SUBMIT YOUR APPLICATION JUST TO
MAKE SURE YOU'VE SELECTED MAYBE
THE RIGHT FUNDING ANNOUNCEMENT
FOR THE SCIENCE THAT YOU WANT TO
DO, AS WELL AS TO MAKE SURE THAT
WHAT YOU'RE PROPOSING IS GOING
TO BE RESPONSIVE AND THEN IT
DOES MAKE TO SONIA'S TEAM AND
ACTUALLY GETS REVIEWED.
SO THAT WOULD BE THE ONE BIT OF
ADVICE I WOULD GIVE EVERYBODY,
IS TO BE SURE TO REACH OUT.
WE'D LOVE TO HEAR FROM YOU.
>>AND REACH OW NOW AND MAKE
THAT CONTACT NOW.
DON'T WAIT UNTIL THE DEADLINE
NOVEMBER 21ST AND THEY'RE MAKING
THANKSGIVING HOLIDAY PLANS.
SO I ENCOURAGE YOU TO THINK
ABOUT IT AND REACH OUT.
SO WITH THAT SAID, I JUST WANT
TO THANK EVERYONE WHO JOINED THE
VIDEOCAST TODAY.
THERE WERE OVER 90 OF YOU THAT
REGISTERED AND WE REALLY
APPRECIATE IT.
PLEASE NOTE THAT THE ENTIRE
VIDEOCAST WILL BE ARCHIVED ON
THE NIH VIDEOCAST WEBSITE,
PROBABLY IN ABOUT 24 HOURS, SO
YOU CAN LOOK AT IT AGAIN, SHARE
IT WITH YOUR FRIENDS, AND AS
MENTIONED, WE WILL SEND YOU A
PDF OF THE SLIDESET THAT WERE
PRESENTED BY OUR SPEAKERS TODAY.
I DO WANT TO THANK OUR SPEAKERS
PERSONALLY.
EXCELLENT PRESENTATIONS, REALLY
PROVIDING THE REAL GOOD NITTY
GRITTY DETAILS FOR THE AUDIENCE.
SO WE REALLY DO LOOK FORWARD TO
SOME EXCELLENT APPLICATIONS
COMING ACROSS THE BOARD TO OUR
PARTNER ICs AND TO NCCIH.
SO THANK YOU AGAIN.
I HOPE YOU ENJOY THE DAY
ENJOYED THIS WEBCAST.
THANK YOU.