WESTERN INSTITUTE FOR VETERANS INSTITUTE
Programs
Real World Evidence Research
RESEARCHERS WILL USE REAL WORLD EVIDENCE (VA EHR DATA) AUGMENTED AND AMPLIFIED WITH ADVANCED ANALYTICS TO UNDERSTAND THE DIAGNOSIS, TREATMENTS, INTERVENTIONS AND PREVENTION STRATEGIES, RELEVANT TO SPECIFIC SUBGROUP POPULATIONS. THIS STUDY WILL EXPAND THE FDA'S ABILITY TO UNDERSTAND FDA REGULATED PRODUCTS (E.G. DOAC AND COVID-19) IN THE REAL WORLD AND IN THE POPULATION FOR WHICH IT IS INTENDED TO HELP AND INCREASE UNDERSTANDING REGARDING ANY POTENTIAL OBSERVED EFFICACY OR SAFETY DIFFERENCES IN CLINICAL TRIAL POPULATIONS IN A REAL-WORLD SETTING COMPARED TO THE POPULATIONS THAT WERE ENROLLED IN THE PIVOTAL CLINICAL TRIALS THAT SUPPORTED MARKETING APPROVAL.GeographiesNot indicatedDatesJan 1, 2022 – Dec 31, 2022Source990No causes providedNo populations provided–$545.7KInvestigator Initiated Research Support
THESE FUNDS ARE RESIDUAL FUNDS FROM PREVIOUS INDUSTRY SPONSORED (FIXED-PRICE) STUDIES. THESE FUNDS ARE USED BY RESEARCHERS TO CONDUCT INVESTIGATOR INITIATED RESEARCH STUDIES, TRAVEL TO RESEARCH RELATED CONFERENCES AND MEETINGS, PROVIDE BRIDGE FUNDS FOR STAFF AND PURCHASE RESEARCH RELATED SUPPLIES AND SERVICES TO SUPPORT FURTHER DEVELOPMENT OF VA APPROVED RESEARCH PROGRAMS.GeographiesNot indicatedDatesJan 1, 2022 – Dec 31, 2022Source990No causes providedNo populations provided–$459.4KReal World Evidence Development
THIS RESEARCH WILL RESULT IN THE GENERATION OF A PIPELINE TO RAPIDLY DEVELOP STUDY POPULATIONS AND ANALYTIC VARIABLES AS REAL WORLD EVIDENCE TO SUPPORT A VARIETY OF SUBSEQUENT REAL-WORLD EVIDENCE CAPABILITIES INCLUDING CHARACTERIZATION, EXAMINING OFF-LABEL USE, POST-MARKET SURVEILLANCE, SAFETY STUDIES, COMPARATIVE EFFECTIVENESS STUDIES, EMULATION OF PRAGMATIC TRIALS, CLINICAL TRIAL RECRUITMENT SUPPORT, STUDY CRITERIA SENSITIVITY ANALYSES, AND STUDY REPLICATION.GeographiesNot indicatedDatesJan 1, 2022 – Dec 31, 2022Source990No causes providedNo populations provided–$314.3K
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