FDA launches new pilot to advance innovative clinical trial design

FDA on Wednesday announced a new pilot program ("Complex Innovative Designs Pilot Meeting Program") in which drug and biologic companies who participate in the pilot program will have additional opportunities to meet with agency staff to discuss the use of novel complex innovative trial designs (CID) for their clinical development programs.

FDA on Wednesday announced a new pilot program ("Complex Innovative Designs Pilot Meeting Program") in which drug and biologic companies who participate in the pilot program will have additional opportunities to meet with agency staff to discuss the use of novel complex innovative trial designs (CID) for their clinical development programs. Complex innovative trial designs include the use of seamless trial designs, modeling and simulations to assess trial operating characteristics, the use of biomarker enriched populations, complex adaptive designs, and Bayesian models. The new program is aimed at helping to solidify the science used to support these novel approaches, and promote their adoption in drug development programs where these trial constructs can advance innovation. These meetings are intended to help stimulate and inform individual product development programs and propose innovative trial designs to inform regulatory decision making. In meetings granted under this pilot program, FDA staff across disciplines within the Center for Drug Evaluation and Research and Center for Biologic Evaluation and Research will provide advice and direction on how a proposed CID approach can be used in a specific drug development program. FDA is committed to sharing innovative CID approaches considered through this pilot program with the broader scientific community through public presentations, including trial designs for drugs that have not yet been approved by FDA. Meetings under the pilot program will be conducted through the fall of 2023.