Abstract #300654

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JSM 2003 Abstract #300654
Activity Number: 6
Type: Invited
Date/Time: Sunday, August 3, 2003 : 2:00 PM to 3:50 PM
Sponsor: Section on Bayesian Stat. Sciences
Abstract - #300654
Title: Bayesian Medical Device Trials in the Regulatory Setting
Author(s): Telba Z. Irony*+
Companies: Food and Drug Administration
Address: 1350 Piccard Dr.-HFZ-542, Rockville, MD, 20850-4307,
Keywords: Bayesian statistics ; clinical studies ; interim analysis ; medical devices ; prior information ; regulatory setting
Abstract:

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 several cases due to the availability of prior information. In addition, it provides flexibility with respect to interim analyses, prediction, meta-analysis, and missing data. We will summarize what has been happening at the Center for Devices and Radiological Health at the FDA, discuss the designs and techniques that have been successfully used in premarket applications, and highlight the peculiar problems and solutions for implementation of such techniques in the regulatory setting.

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