The U.S. Food and Drug Administration today published draft guidance designed to facilitate the use of Bayesian methodologies in clinical trials of drugs and biologics, helping drug developers make better use of available data, conduct more efficient clinical trials, and deliver safe and effective t
The FDA published a draft guidance to facilitate the use of Bayesian methodologies in clinical trials of drugs and biologics. The goal is to help sponsors use available data more effectively, conduct more efficient trials, and deliver safe and effective treatments to patients sooner. Bayesian methods may be especially valuable for rare or pediatric populations,…