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May 22: Guidance for the Use of Bayesian Statistics in Medical Device Clinical Trials - Draft Guidance for Industry and FDA Staff

The draft guidance titled, "Bayesian Statistics in Medical Device Clinical Trials provides FDA's recommendations on the use of Bayesian statistical methods in the design and analysis of medical device clinical trials. Although this guidance is not yet final, it is a very exciting move in the direction of expediting new technology to the public.

The purpose of this guidance is to discuss important statistical issues in Bayesian clinical trials for medical devices and not to describe the content of a medical device submission. Bayesian statistics is a statistical theory and approach to data analysis that provides a coherent method for learning from evidence as it accumulates. The Bayesian approach may enable FDA to reach the same decision on a device with a smaller-sized or shorter-duration pivotal trial.

The Bayesian approach may also be useful in the absence of informative prior information. First, the approach can provide flexible methods for handling interim analyses and other modifications to trials in midcourse (e.g., changes to the sample size or changes in the randomization scheme). Second, the Bayesian approach can be useful in complex modeling situations where a frequentist analysis is difficult to implement or does not exist. The Bayesian methodology may reduce the sample size FDA needs to reach a regulatory decision. Bayesian approach can also offer the flexibility of midcourse changes to a trial. The Bayesian approach can sometimes be used to obtain an exact analysis when the corresponding frequentist analysis is only approximate or is too difficult to implement.

For complete FDA report of this update, please refer to following links:
http://www.fda.gov/cdrh/osb/guidance/1601.html

If you have comments regarding this update, please email us at info@mdiconsultants.com

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