New FDA guidance would speed up medical device trials

The Food and Drug Administration has issued guidance on the use of a new statistical method the agency said could result in faster and less costly medical device clinical trials.

The guidance makes use of the Bayesian statistical method, which uses an algorithm that allows device makers to combine data used in previous studies with information from the newer study. This could make for smaller and shorter clinical studies, FDA officials said.

“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 A. Hamburg, M.D. “This is a terrific example of regulatory science in practice at FDA.”

The Bayesian method has been used frequently by the FDA in other types of clinical studies, and the agency has approved a number of medical devices using the method.

The final guidance, titled “Guidance for Use of Bayesian Statistics in Medical Device Clinical Trials,” describes the method, design and analysis of medical device clinical trials; lists some of the benefits and difficulties of the Bayesian approach, and makes comparisons with standard statistical methods. The guidance also presents ideas for using Bayesian methods in post-market studies.