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Abstract Details

Activity Number: 454
Type: Topic Contributed
Date/Time: Wednesday, August 1, 2012 : 8:30 AM to 10:20 AM
Sponsor: Biopharmaceutical Section
Abstract - #304706
Title: Use of Bayesian Adaptive Design in Medical Device Trials
Author(s): Weihua Cao*+ and Nelson Lu and Rajesh Nair
Companies: FDA and FDA and FDA
Address: WO 66, Rm 2107, Silver Spring, MD, ,
Keywords: medical device ; Bayesian statistics ; adaptive design
Abstract:

Bayesian adaptive design has seen its increase use in medical device trials, especially with the recent release of the FDA guidance document. In general, Bayesian adaptive trials are challenging to design, conduct and analyze. This talk will address some practical issues with Bayesian adaptive device trials, involving prior selection, predictive probability calculation, and control of type I error rate among others. Some examples of Bayesian adaptive device trials will be discussed.


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