Bayesian guidance released

Executive Summary

FDA says its Feb. 5 guidance on applying Bayesian statistics in medical device trials will help streamline device pivotal studies. The document finalizes a 2006 draft version and includes updates based on several years of input from industry and others. CDRH has been accepting pre-market submissions including Bayesian statistics since the late 1990s, but it has ramped up staff with expertise in the techniques since releasing the 2006 draft (1"The Gray Sheet" July 31, 2006). By allowing sponsors to incorporate data from prior studies, Bayesian statistics makes it possible to yield sufficient trial results from smaller or shorter trials (2"The Gray Sheet" May 31, 2004)