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Device Center Enthusiastic About Bayesian Trial Submissions

This article was originally published in The Gray Sheet

Executive Summary

FDA's device center continues to ramp up its resources to deal with a potential influx of PMA submissions that rely on an advanced statistical technique that can speed up clinical trials

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Bayesian Gets A Boost With Guidance, But Technique Still Not For Everyone

The complex calculations of Bayesian statistics are not likely to become standard for FDA device submissions anytime soon, but they could help streamline clinical trials in many more instances, CDRH's top statistics official says

Bayesian Gets A Boost With Guidance, But Technique Still Not For Everyone

The complex calculations of Bayesian statistics are not likely to become standard for FDA device submissions anytime soon, but they could help streamline clinical trials in many more instances, CDRH's top statistics official says

Bayesian guidance released

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)

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