Activity Number:
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547
- Section on Physical and Engineering Sciences P.M. Roundtable Discussion (Added Fee)
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Type:
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Roundtables
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Date/Time:
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Wednesday, August 1, 2018 : 12:30 PM to 1:50 PM
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Sponsor:
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Section on Physical and Engineering Sciences
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Abstract #330528
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Title:
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Successful Implementation of Bayesian Adaptive Designs in Medical Device Clinical Studies
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Author(s):
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Zengri Wang*
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Companies:
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Keywords:
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Bayesian Design;
Exchangeability;
Operating Characteristics;
Medical devices
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Abstract:
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Bayesian adaptive designs have been increasingly utilized in the medical device industry for PMA and 510(k) submissions. Some sponsors may have encountered unexpected issues or difficulties when implementing such study designs in practice. I'll share some experience learned from successful real-life examples and discuss relevant practical and operational requirements for the Bayesian design implementation including operating characteristics, partial exchangeability and effective integration of previous or existing data.
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Authors who are presenting talks have a * after their name.
