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June 30th: Public Meeting for the Use of Bayesian Statistics in Medical Device Clinical Trials

On May 23rd CDRH released "Draft Guidance for Industry and Food and Drug Administration Staff; Guidance for the Use of Bayesian Statistics in Medical Device” for public comment.

This draft guidance provides FDA's recommendations on the use of Bayesian statistical methods in the design and analysis of medical device clinical trials. Development of this guidance was influenced by CDRH’s unique experience in planning and evaluating Bayesian clinical trials in the regulatory setting. This draft guidance is neither final nor is it in effect at this time. The public can submit written or electronic comments on this draft guidance to Docket No. 2006D-0191 for a period of 90 days, until August 21, 2006. The dockets management website is located at http://www.fda.gov/ohrms/dockets/.

This document provides guidance on statistical aspects of the design and analysis of clinical trials for medical devices that use Bayesian statistical methods. 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. Traditional (frequentist) statistical methods formally use prior information only in the design of a clinical trial. In the data analysis stage, prior information is considered only informally, as a complement to, but not part of the analysis. In contrast, the Bayesian approach uses a consistent, mathematically formal method called Bayes’ Theorem for combining prior information with current information on a quantity of interest. This is done throughout both the design and analysis stages of a trial.

Bayesian approach may enable FDA to reach the same decision on a device with a smaller-sized or shorter-duration pivotal trial.

For complete Draft Guidance, Please refer to following link
http://www.fda.gov/cdrh/osb/guidance/1601.html

For complete FDA report, Please refer to following link
http://www.fda.gov/cdrh/meetings/072706-bayesian.html

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

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