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Activity Number: 150 - Lead with Statistics in Medical Device Innovations and Beyond
Type: Topic Contributed
Date/Time: Monday, July 30, 2018 : 10:30 AM to 12:20 PM
Sponsor: Section on Medical Devices and Diagnostics
Abstract #329029 Presentation
Title: A Propensity Score Stratified Bayesian Power Prior Approach for Incorporating Real-World Evidence in Single Group Medical Device Clinical Studies
Author(s): Chenguang Wang* and Ram Tiwari and Lilly Yue and Yunling Xu
Companies: John Hopkins University and Center for Devices and Radiologica Health, FDA and U.S. Food and Drug Administration and FDA/CDRH
Keywords: real-world data ; medical device; propensity score; Bayesian method

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.

Authors who are presenting talks have a * after their name.

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