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January 12, 2026
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FDA Issues Guidance on Modernizing Statistical Methods for Clinical Trials

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Today, the FDA published draft guidance designed to facilitate the use of Bayesian methodologies in clinical trials of drugs and biologics, helping sponsors make better use of available data and conduct more efficient clinical trials.

Today, the FDA published draft guidance designed to facilitate the use of Bayesian methodologies in clinical trials of drugs and biologics, helping sponsors make better use of available data and conduct more efficient clinical trials.

The guidance provides recommendations on the appropriate use of Bayesian methods, with a primary focus on the use of these methods to support primary inference.

For more information, see the FDA News Release: https://www.fda.gov/news-events/press-announcements/fda-issues-guidance-modernizing-statistical-methods-clinical-trials

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