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Activity Number: 297
Type: Contributed
Date/Time: Tuesday, August 5, 2014 : 8:30 AM to 10:20 AM
Sponsor: Section on Medical Devices and Diagnostics
Abstract #313233 View Presentation
Title: Practical Issues with Designing and Executing Bayesian Adaptive Medical Device Trials
Author(s): Rajesh Nair*+ and Nelson Lu and Xiting Yang
Companies: and FDA/CDRH and FDA
Keywords: medical device ; bayesian statisitcs ; adaptive design ; operating characteristics
Abstract:

Since the release of the FDA guidance document there has been an increase in the number of medical device trials utilizing Bayesian adaptive designs. The flexibility of Bayesian adaptive trials can result in more efficient decision making. However, designing and executing Bayesian adaptive trials can be complex. Practical challenges include selecting the number of interim looks since too many looks can result in higher bar at interim looks making the study more difficult to stop. Since the operating characteristics of the design are evaluated on frequentist grounds another consideration from a regulatory perspective is the alpha that is spent on the interim looks. These challenges will be illustrated using examples of Bayesian adaptive designs.


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