2023-25854: Advancing the Use of Complex Innovative Designs in Clinical Trials: From Pilot to Practice; Public Workshop; Request for Comments
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The Food and Drug Administration (FDA or the Agency) is announcing the following public workshop entitled "Advancing the Use of Complex Innovative Designs in Clinical Trials: From Pilot to Practice." The purpose of the public workshop is to discuss aspects of complex adaptive, Bayesian, and other novel clinical trial designs. This workshop is being conducted to meet the performance goal of convening a public workshop on complex innovative design (CID) included in the seventh authorization of the Prescription Drug User Fee Act (PDUFA VII). The workshop may also inform a draft guidance on the use of Bayesian methodology in clinical trials of drugs and biological products. In conjunction with the workshop, FDA is seeking comments on the use of CID to inform regulatory decision making, including high- level case examples of CIDs and approaches that can advance the use of these designs. The public workshop will be held on March 5, 2024, from 9 a.m. to 3:30 p.m. Eastern Time.
The agency’s own summary, as published.
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