FDA debuts pilot program to make drug development process more modern and efficient

On Wednesday, the US Food and Drug Administration announced a new pilot program (complex innovative designs [CID] 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 includes the use of seamless trial designs, modeling and simulations to assess trial operating characteristics, the use of biomarker enriched populations, complex adaptive designs, Bayesian models and other benefit-risk determiniations, and other novel designs. 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. It is often the case that the use of novel approaches to clinical trial designs requires earlier and more intensive feedback from the agency to help advance these opportunities. In meetings granted under this pilot program, FDA staff across disciplines within the Center for Drug Evaluation and Research (CDER) and Center for Biologic Evaluation and Research (CBER) will provide advice and direction on how a proposed CID approach can be used in a specific drug development program.