The FDA released its final guidance on the use of Bayesian statistics in medical device clinical trials Feb. 5. The guidance, issued by both the Center for Devices and Radiological Health (CDRH) and the Center for Biologics Evaluation and Research, updates the draft guidance CDRH issued in 2006.

“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,” FDA Commissioner Margaret Hamburg said in announcing the release of the guidance. “This is a terrific example of regulatory science in practice at FDA.”

The final guidance includes a new section on suggested information to include in submissions to FDA. “The FDA believes there are statistical issues unique to Bayesian trial designs that should be addressed in your submission,” the guidance stated. The guidance noted the suggestions “will facilitate a smoother review process and serve as a starting point when writing your protocol.”

The agency added that the suggestions are “not an exhaustive listing,” nor will all the suggestions apply to all studies.

The agency recommended including information on: prior information, criterion for success, justification for the proposed sample size, operating characteristics, prior probability of study claim, effective sample size, and program code.

For more on the guidance see the April issue of the Guide to Good Clinical Practice.