Keywords: Complex Innovative Designs, Adaptive Designs, PDUFA VI
The 21st Century Cures Act and the Prescription Drug User Fee Act reauthorization for fiscal years 2018-2022 (PDUFA VI) include provisions aimed at enhancing the use of innovative clinical trial designs. The scope of the legislation includes complex adaptive, Bayesian and other trial designs for which analytically derived properties may not be feasible and simulations are necessary to evaluate the operating characteristics. Deliverables within the legislation include the establishment of a complex innovative designs (CID) pilot program, conduct of a public workshop, and modification or issuance of guidance. This presentation will provide an update on the status of FDA efforts with an emphasis on the pilot program.