FDA Embraces Bayesian Toolkit to Accelerate Drug Trials

The FDA issued a draft guidance to promote the use of Bayesian methodologies in clinical trials for drugs and biologics, aiming to use prior information and data more efficiently to shorten timelines and reduce costs. The guidance outlines when Bayesian methods can support primary inference and trial design, including early futility/success decisions, dose selection, incorporating external data, enabling subgroup analyses, and aiding rare or pediatric studies; public comment is invited as part of PDUFA VII commitments.