Lessons Learned from Trial Replication Analyses: Findings from the DUPLICATE Demonstration Project

This U.S. Food and Drug Administration public workshop, convened through a grant with the Duke-Margolis Center for Health Policy, reviewed findings from the RCT-DUPLICATE Demonstration Project. The discussion built on a previous public workshop convened by Duke-Margolis on February 16, 2021, which shared preliminary results from trial replication efforts with the goal of better understanding the strengths and limitations of observational studies. This workshop reported on additional results and further elaborate on lessons learned from RCT-DUPLICATE; potential implications for regulatory decision-making were also explored.