Scaling Innovative Clinical Trial Approaches: Challenges, Progress, and Opportunities

This hybrid workshop, co-convened by the Duke-Margolis Institute for Health Policy and the U.S. Food and Drug Administration (FDA) CDER Center for Clinical Trial Innovation (C3TI), explores progress in clinical trial innovation to improve the efficiency of drug development. The meeting highlights C3TI’s activities, including the C3TI Demonstration Program, and emerging priorities. Sessions discuss lessons learned from recent efforts, the benefits of adopting innovative approaches in clinical trials, and persistent challenges. Participants discuss strategies to bridge from policy to implementation to broader adoption of innovative approaches in the design and conduct of clinical trials. This project 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 U19FD006602 totaling $5,192,495 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.