Complex Innovative Trial Designs Pilot Program

OccamPoint

FDA announces a set of presentations and a pilot program to advance Complex Innovative Clinical Trial Designs (CIDs) as a part of PDUFA VI (Aug 2017). The initiative is aimed to facilitate the discussion about the use of CIDs in drug development and regulatory decision-making. It covers the use of complex adaptive, Bayesian and other approaches to maximize the use of evidence across external and historic controls, multiple interventions and indications. Further details are below.

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