Bayesian Adaptive Medical Device Trials in the Regulatory Setting
Telba Z. Irony, FDA/CDRH 


The use of Bayesian statistics in analyses of medical device clinical trials for premarket submissions to the Food and Drug Administration has increased considerably in recent years. In the medical device arena, Bayesian analysis is particularly helpful in because it provides flexibility with respect to interim analyses, prediction, meta analysis, and missing data.

In this presentation we will discuss the designs and techniques that have been successfully used in premarket applications, highlight the peculiar problems and solutions for implementation of such techniques and discuss how Bayesians estimate the treatment effect of adaptive trials in the regulatory setting.