Conference Program

Propensity Score–Integrated Power Prior Approach for Incorporating Real-World Evidence (303678)

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

Keywords: power prior, propensity score, real-world data, real-world evidence

A propensity score-integrated power prior approach is developed to augment a treatment group (in a single-arm study or a two-arm randomized controlled trial) from real-world data and/or historical clinical studies containing subject-level outcomes and covariates. The propensity scores for the subjects in the external data sources versus the subjects in the RCT are first estimated, and then subjects are placed in different strata based on their estimated propensity scores. Within each propensity score stratum, a power prior is formulated with the information contributed by the external data sources, and Bayesian inference on the treatment effect is obtained. Results of simulation studies and an example will be presented.