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Activity Number:
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150
- Lead with Statistics in Medical Device Innovations and Beyond
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Type:
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Topic Contributed
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Date/Time:
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Monday, July 30, 2018 : 10:30 AM to 12:20 PM
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Sponsor:
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Section on Medical Devices and Diagnostics
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Abstract #329029
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Presentation
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Title:
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A Propensity Score Stratified Bayesian Power Prior Approach for Incorporating Real-World Evidence in Single Group Medical Device Clinical Studies
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Author(s):
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Chenguang Wang* and Ram Tiwari and Lilly Yue and Yunling Xu
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Companies:
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John Hopkins University and Center for Devices and Radiologica Health, FDA and U.S. Food and Drug Administration and FDA/CDRH
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Keywords:
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real-world data ;
medical device;
propensity score;
Bayesian method
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Abstract:
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The amount of real-world data (RWD) collected from sources in real-world settings are increasing ultrarapidly. With the wide availability of various RWD, there has been a great level of interest in using real-world data in regulatory decision makings. Based on propensity score adjustment, we propose a modified Bayesian power prior approach for incorporating RWD in the design and analysis of pre-market clinical trials. Numerical studies are conducted to evaluate the performance of the proposed method in different settings. In addition, a hypothetical single group medical device study is provided to illustrate the proposed method in the context of regulatory review.
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Authors who are presenting talks have a * after their name.
