Experience with Reviewing Bayesian Medical Device Trials

The purpose of this paper is to present a statistical reviewer's perspective on some technical aspects of reviewing Bayesian medical device trials submitted to the Food and Drug Administration. The discussion reflects the experiences of the authors and should not be misconstrued as official guidance by the FDA. A variety of applications are described, reflecting our experience with therapeutic and diagnostic devices. In addition to Bayesian analysis of trials, Bayesian trial design and Bayesian monitoring are discussed. Analyses were implemented in WinBUGS (http://www.mrc-bsu.cam.ac.uk/bugs/winbugs/contents.shtml), with the code provided.