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