Reagan-Udall Foundation For The Food And Drug Administration

SPARC: SUPPORTING PATIENT ACCESS, REAL-WORLD DATA, AND CRITICAL COLLABORATIONS

PATHWAYS FOR REGULATORY INNOVATION AND STRATEGIC MODERNIZATION (PRISM) - EFFECTIVE ENGAGEMENT WITH THE PUBLIC IS ESSENTIAL TO EXPAND THE IMPACT OF THE U.S. FOOD AND DRUG ADMINISTRATION, AND FOR THE EFFICIENT TRANSFER OF INFORMATION AND INSIGHTS AMONG THE AGENCY, PATIENTS, ACADEMIA, CONSUMERS, HEALTHCARE, AND REGULATED INDUSTRY. THROUGH PRISM: PATHWAYS FOR REGULATORY INNOVATION AND STRATEGIC MODERNIZATION, THE REAGAN-UDALL FOUNDATION FOR THE FDA PROPOSES A MULTI-YEAR EFFORT TO SUPPORT THE FDA'S MISSION TO PROTECT AND PROMOTE THE PUBLIC'S HEALTH. AS A CONGRESSIONALLY CHARTERED, INDEPENDENT NONPROFIT, THE FOUNDATION SERVES AS A NEUTRAL BRIDGE BETWEEN FDA AND DIVERSE STAKEHOLDERS, DELIVERING APPLIED REGULATORY SCIENCE, REAL-WORLD INSIGHTS, AND TRANSPARENT ENGAGEMENT. THE FOUNDATION DOES NOT PARTICIPATE IN REGULATORY DECISION-MAKING. BUILDING ON MORE THAN 70 COLLABORATIVE PROJECTS COMPLETED BETWEEN 2020 AND 2025, THE PRISM PROJECT PORTFOLIO ADVANCES FDA PRIORITIES THROUGH THREE SPECIFIC AIMS: 1) SUPPORT THE DEVELOPMENT AND USE OF REGULATORY SCIENCE TOOLS, 2) SUPPORT PROGRAMS AND RESEARCH TO ENHANCE DEVELOPMENT OF AND ACCESS TO FDA-REGULATED PRODUCTS, AND 3) ENGAGEMENTS, CONVENINGS, AND OPERATIONAL EVALUATIONS TO SUPPORT THE WORK OF FDA. AIM 1 STRENGTHENS REGULATORY SCIENCE TOOLS, WITH EMPHASIS ON MODERN USE OF REAL-WORLD DATA AND ARTIFICIAL INTELLIGENCE, EVALUATION OF DATA TRANSPARENCY, TRUST, AND GOVERNANCE, AND ASSESSMENT OF THE PREDICTIVE UTILITY OF ANIMAL STUDIES TO SUPPORT EFFORTS TO REDUCE ANIMAL TESTING. AIM 2 FOCUSES ON IMPROVING DEVELOPMENT OF AND ACCESS TO FDA-REGULATED PRODUCTS BY EXPANDING PATIENT- AND CONSUMER-CENTERED INITIATIVES, ENABLING ACCESS TO INVESTIGATIONAL NEW DRUGS, STUDYING APPROPRIATE USE OF CONTROLLED SUBSTANCES, SUPPORTING GOLD-STANDARD FOOD AND NUTRITION RESEARCH, INCENTIVIZING DRUG DEVELOPMENT FOR ANIMALS, AND ASSISTING RAPID RESPONSE COLLABORATION DURING CROSS-SECTORAL OUTBREAKS. AIM 3 LEVERAGES THE FOUNDATION'S EXPERTISE IN CONVENINGS—ROUNDTABLES, EXPERT PANELS, AND PUBLIC MEETINGS—TO SUPPORT FDA IMPLEMENTATION ACROSS COMPLEX POLICY AREAS, INCLUDING DRUG DEVELOPMENT, COSMETICS OVERSIGHT, RARE DISEASES, FOOD SAFETY, MENTAL HEALTH, AND COUNTERFEIT PRODUCTS. PROJECTS ARE JOINTLY DESIGNED WITH FDA STAFF, DELIVERED ON DEFINED TIMELINES AND BUDGETS, AND CULMINATE IN PUBLIC OUTPUTS TO PROMOTE LEARNING, TRANSPARENCY, TRUST, AND IMPACT. COLLECTIVELY, THROUGH PRISM, THE FOUNDATION PROVIDES FDA WITH TIMELY EVIDENCE, STAKEHOLDER INSIGHT, AND PRACTICAL TOOLS TO MODERNIZE REGULATORY SCIENCE AND ADDRESS EMERGING PUBLIC HEALTH CHALLENGES EFFICIENTLY, TRANSPARENTLY, AND IN A TRUSTWORTHY MANNER.

INNOVATION IN MEDICAL EVIDENCE DEVELOPMENT AND SURVEILLANCE(IMEDS)SERVES TO ADVANCE THE SCIENCE AND TOOLS NECESSARY TO SUPPORT POST-MARKET EVIDENCE G

REAL-WORLD ACCELERATOR TO EVOLVE THE STANDARD OF CARE AND ENGAGEMENT IN CLINICAL STUDIES (RACE) - INCOMPLETE AND INCONSISTENT CAPTURE OF RACE AND ETHNICITY DATA FROM REAL-WORLD DATA (RWD) LIMITS THE FULL DESCRIPTION OF THE DISTRIBUTION, SAFETY, AND EFFECTIVENESS OF FDA REGULATED PRODUCTS IN THE POPULATION. THE ISSUES INVOLVED WITH ACQUISITION AND TREATMENT OF RACE AND ETHNICITY DATA TOUCH MANY DOMAINS (E.G. HEALTH DISPARITIES, HEALTH IT, WORKFORCE TRAINING, STANDARDS AND POLICY DEVELOPMENT) AND REQUIRE DIVERSE VIEWPOINTS TO SHARE KNOWLEDGE AND PERSPECTIVES TO DRIVE SOLUTIONS. MOREOVER, LEADERSHIP FROM BOTH GOVERNMENT AND THE PRIVATE SECTOR ARE ESSENTIAL TO MUSTER ORGANIZATIONAL COMMITMENT AND PRIORITIZE RESOURCES TO IMPLEMENT SOLUTIONS TO THIS MULTI-FACTORIAL PUZZLE. THE STATUS QUO HAS BEEN TO THINK ABOUT THE PROBLEM AND SOLUTIONS IN SILOS AND THROUGH A NARROW LENS. OUR GOAL IS TO INCREASE DIVERSITY IN PRE- AND POST-MARKET STUDIES (INCLUDING THOSE CONDUCTED VIA RWD). OUR OBJECTIVE IS TO UNDERSTAND, ALIGN, AND DISSEMINATE BEST PRACTICES TO IMPROVE REAL-WORLD REPORTING, COLLECTION, CAPTURE, PROTECTION, AGGREGATION, INTEGRATION, AND INTERPRETATION OF RACE AND ETHNICITY DATA. RACE WILL BRING TOGETHER LEADERSHIP FROM BROAD SECTORS IN A SERIES OF ROUNDTABLES TO ADVANCE SOLUTIONS TO ENHANCE THE ACQUISITION AND TREATMENT OF RACE AND ETHNICITY DATA FROM REAL-WORLD SETTINGS FOR RESEARCH PURPOSES (AIM 1). ADDITIONALLY, WE WILL CONDUCT A LANDSCAPE ASSESSMENT OF BEST PRACTICES AND A PUBLIC POLL TO ASSESS PATIENTS’ REACTIONS TO QUESTIONS OF RACE AND ETHNICITY TO INFORM THE ROUNDTABLE SERIES. WE WILL SUMMARIZE BEST PRACTICES AND CROWD-SOURCE THE MOST VIABLE SOLUTIONS; AMPLIFYING THE FINDINGS IN PUBLIC- FACING MULTI-MEDIA TO REACH BROAD AUDIENCES AND STIMULATE FURTHER CONVERSATION AND ACTION. THE SIGNIFICANCE OF AIM 1 IS IN THE OPPORTUNITY FOR COLLECTIVE LEARNING AND COMMUNITY CAPACITY BUILDING. IN AIM 2, WE WILL EVALUATE THE IMPACT OF RACE TO INITIATE A CHANGE IN PRACTICE USING A PRE-POST, QUALITATIVE DESIGN. INTERVIEWS IN ~ 30 PEOPLE WILL BE RECORDED, TRANSCRIBED, AND CODED; USING A TEMPLATE ANALYSIS APPROACH TO ANALYZE THE DATA AND DEVELOP DOMAIN-LEVEL MEMOS TO FACILITATE QUALITATIVE ASSIGNMENT OF STRENGTH AND VALENCE FOR EACH DOMAIN. WE WILL ALSO CREATE STAKEHOLDER-LEVEL MEMOS TO ASSESS CHANGE ON THE GROUP LEVEL. THE SIGNIFICANCE OF DEMONSTRATING THAT BRINGING LEADERS TOGETHER IN A DYNAMIC FORUM MOTIVATES INDIVIDUAL CHANGE IS THAT THIS MODEL MAY BE APPLIED TO ADDRESS ADDITIONAL QUESTIONS. IN AIM 3, WE WILL MAP THE MOST SALIENT SOLUTIONS TO THE BARRIERS THEY ADDRESS. WE WILL PROVIDE THE SUMMARY OF THE BARRIER-SOLUTION TO RACE PARTICIPANTS AND REQUEST FEEDBACK ON THE PERCEIVED EFFORT AND VALUE OF IMPLEMENTING THE PROPOSED SOLUTIONS. THIS SUMMARY OUTPUT WILL SERVE AS A NOVEL, MULTI-DIMENSIONAL TOOL TO DEVELOP STRATEGIES FOR IMPLEMENTING PERCEIVED HIGH-VALUE SOLUTIONS; THE SIGNIFICANCE OF WHICH IS IN PROVIDING STAKEHOLDERS WITH A TOOL TO PRIORITIZE AND IMPLEMENT SOLUTIONS TO IMPROVE THE QUALITY OF RACE AND ETHNICITY DATA IN THEIR OWN ENVIRONMENT. IN SHORT, THIS WORK WILL ADVANCE THE DISCUSSION ABOUT THE COLLECTION AND USE OF RACE/ETHNICITY DATA TOWARD ACTION BY BUILDING COMMUNITY CAPACITY AMONG LEADERSHIP AND COLLABORATIVELY DEVELOPING TOOLS TO CHANGE PRACTICE.