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Propensity Score–Integrated Statistical Approaches for Augmenting Medical Device Studies with Real-World Data (302451)

Wei-chen Chen, FDA/CDRH 
Heng Li, FDA/CDRH 
Nelson Lu, FDA/CDRH 
Changhong Song, FDA/CDRH 
Ram Tiwari, Bristol Myers Squibb 
Chenguang Wang, Johns Hopkins University 
*Yunling Xu, FDA/CDRH 
Lilly Yue, US Food and Drug Administration 

Keywords: propensity score integrated approach, power prior, composite likelihood, covariate, real-world data

In this presentation, propensity score-integrated statistical approaches will be discussed for Augmenting Medical Device Studies using Real-World Data. Those approaches integrate propensity score method with power prior or composite likelihood modeling, emphasizing efficient use of covariates information to mimic randomization. Furthermore, those approaches are fitted into a two-stage study design framework to better maintain integrity of the augmented studies with real-world data.