Master Protocols for Drug and Biological Product Development

1st July 2026

Summary: This FDA guidance provides recommendations on designing and conducting clinical trials using master protocols for drug and biological product development. It explains how platform, umbrella and basket trial designs can be used to evaluate multiple therapies, diseases or patient populations within a single overarching protocol. The guidance outlines key considerations for trial design, statistical analysis, operational planning and regulatory interactions, with the aim of improving the efficiency of clinical development while maintaining robust scientific and ethical standards.

Link: https://www.fda.gov/regulatory-information/search-fda-guidance-documents/master-protocols-drug-and-biological-product-development

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