Conferencistas Internacionais

The Bayesian framework at the Center for Devices at the FDA

Telba Z. Irony (FDA–EUA)

The use of Bayesian methods in design and analysis of medical device clinical trials for submission to the U.S. Food and Drug Administration has increased considerably in recent years. In the medical device arena, Bayesian methods are particularly helpful, not only due to the availability of prior information, but mainly because they provide flexibility with respect to interim analyses, prediction, meta analysis, and missing data. In addition, the Agency is currently exploring the use of formal Decision Analysis methodology which is inherent to the Bayesian approach.

In this presentation we will discuss the designs and techniques that have been successfully used in FDA applications, highlight the peculiar problems and solutions for implementation of such techniques in the regulatory setting and summarize what is presently happening at the Center.