The U.S. Food and Drug Administration (FDA) has issued new draft guidance to encourage the use of modern Bayesian statistical methods in drug and biologic clinical trials. This guidance aims to help sponsors design more efficient trials, make better decisions with available data, and potentially accelerate the delivery of new treatments to patients.
The guidance outlines how Bayesian methodologies, which combine trial data with existing scientific knowledge, can be applied. Key applications include making earlier success/futility decisions in adaptive trials and incorporating data from external sources like real-world evidence.
This action fulfills a commitment under the Prescription Drug User Fee Act (PDUFA VII). FDA is now seeking public comment on the draft guidance document.
Source | https://www.fda.gov/news-events/press-announcements/fda-issues-guidance-modernizing-statistical-methods-clinical-trials
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