Adaptive Designs at CBER: Opportunities, Challenges and Lessons Learned
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*John Scott, Division of Biostatistics, FDA / CBER / OBE 

Keywords: adaptive design, biologics, vaccines

The FDA's Center for Biologics Evaluation and Research (CBER) is responsible for regulating vaccines, blood components and blood products, and cellular, tissue and gene therapies, among other products. Because of the variety of products regulated by CBER, which include biologics, devices, and a small number of drugs, CBER reviewers have faced a number of unique challenges in reviewing proposals for adaptive design clinical trials. In this talk, I will provide a brief update on the status of adaptive design proposals at CBER and discuss some of the opportunities and challenges associated with specific product areas and indications. Finally, I will discuss some lessons learned from one case study and highlight outstanding questions and issues.