U.S. Food and Drug Administration Webinar on the RCT-DUPLICATE Initiative

U.S. Food and Drug Administration Webinar on the RCT-DUPLICATE Initiative: Emulating Randomized Clinical Trials with Non-Randomized Real-World Data Studies On Wednesday, April 29, 2026, the FDA is hosted a free public webinar to provide updates on RCT-DUPLICATE, one of FDA’s demonstration projects addressing key methodological challenges in studies using real-world data (RWD). This webinar highlights how the RCT-DUPLICATE initiative evaluates when and how non-randomized healthcare database studies have generated valid causal inferences, using randomized controlled trial findings as a benchmark. The initiative has demonstrated that results have been strongly concordant when those studies closely emulated trial designs and has helped clarify when and why divergence may occur. Building on these findings, the project has also predicted the results of seven randomized controlled trials that were ongoing at the time the database study was conducted and is developing a structured approach that may increase confidence in using RWE to support potential indication expansions. Event Agenda Welcome & Introduction: Marie Bradley, U.S. Food and Drug Administration Presentation on RCT-DUPLICATE Initiative: Shirley Wang, Brigham & Women’s Hospital and Harvard Medical School Sebastian Schneeweiss, Brigham & Women’s Hospital and Harvard Medical School This event is supported by the Food and Drug Administration (FDA) of the U.S. Department of Health and Human Services (HHS) as part of a financial assistance award U01FD008451 totaling $1,399,999 with 100 percent funded by FDA/HHS. The contents are those of the author(s) and do not necessarily represent the official views of, nor an endorsement, by FDA/HHS, or the U.S. Government.