Development and Communication of Bayesan Methodology for Medical Device Clinical Trials

Abstract

This paper presents Bayesian methods that have been proposed for the analysis (O’Malley, Normand, and Kuntz, 2003) and design (O’Malley, Normand, and Kuntz, 2002) of medical device clinical trials. Whereas the referenced papers are methodological, this paper is application oriented. This work is motivated by medical device trials, particularly those of coronary-artery stents (small metallic scaffolds used to enlarge coronary artery segments with plaque narrowing) .However, it has applications to all clinical trials.