FDA issues final guidance to shorten medical device trials

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The FDA issued a final guidance on Bayesian statistical methods used in the design and analysis of medical device clinical trials on Feb. 5, allowing for medical device companies to combine trial data.

The Bayesian statistical method, which applies an algorithm that makes it possible for companies to combine data collected in previous studies with data collected in a current trial, may result in less costly and more efficient patient studies, as the combined data may merit shorter clinical studies, said the agency.

The final document includes input from public comment which was gathered in 2006 and describes the use of Bayesian methods, design and analysis of medical device clinical trials and the benefits and difficulties with this approach. The guidance also includes comparisons of the Bayesian method with standard statistical methods, as well as ideas for the utilization of Bayesian methods in post-market 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,” said FDA Commissioner Margaret Hamburg, MD.