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Abstract Details
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Activity Number:
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165
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Type:
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Topic Contributed
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Date/Time:
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Monday, July 30, 2012 : 10:30 AM to 12:20 PM
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Sponsor:
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Biopharmaceutical Section
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| Abstract - #304863 |
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Title:
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Good Practice of Bayesian Submission for Medical Devices
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Author(s):
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Xuefeng Li*+ and Pablo Bonangelino
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Companies:
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FDA and FDA
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Address:
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10903 New Hampshire Ave, Silver Spring, MD, 20993, United States
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Keywords:
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Bayesian Trials ;
Medical Devices
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Abstract:
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Successful Bayesian submission for medical device follows a set of clear and simple good practices. These principles include: flexibility/adaptability; direct probability statements about a parameter; use of accumulating information for prediction; and, use of priors to augment current analyses. After a discussion of what are practically very important adaptive designs with non-informative priors, I will talk about the problem of Type I error with the use of informative priors and discuss several ways to approach this issue. I will conclude with a summary of an internally developed quality assessment for Bayesian IDE evaluation.
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Authors who are presenting talks have a * after their name.
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