Guidance on Use of Bayesian Statistical Methods to Streamline Clinical Trials Issued by FDA

February 5, 2010—The US Food and Drug Administration (FDA) announced that it has issued guidance on Bayesian statistical methods in the design and analysis of medical device clinical trials that could result in less costly and more efficient patient studies. The Bayesian statistical method applies an algorithm that makes it possible for companies to combine data collected in previous studies with data collected in a current trial. The combined data may provide sufficient justification for smaller or shorter clinical studies, the FDA stated.

"Guidance for the Use of Bayesian Statistics in Medical Device Clinical Trials" is available on the FDA Web site. The final guidance document describes the use of Bayesian methods, design and analysis of medical device clinical trials, the benefits and difficulties with the Bayesian approach, and comparisons with standard statistical methods. The guidance also presents ideas for using Bayesian methods in postmarket studies.

"This final guidance on the use of Bayesian statistics is consistent with the FDA’s commitment to streamline clinical trials, when possible, in order to get safe and effective products to market faster," commented FDA Commissioner Margaret A. Hamburg, MD.