Designing Observational Comparative Studies Using Registry Data in Regulatory Settings
Nelson T Lu, FDA/CDRH  Yunling Xu, FDA/CDRH  *Lilly Q Yue, FDA/CDRH 

Keywords: Registries, Regulatory decision making, Propensity score design

National and international registries, which reflect real world evidence, can play important roles in regulatory decision making in both pre-market and post-market settings. This presentation focuses on developing innovative strategies to utilize such data – prospectively designing clinical studies with propensity score methodology, and examples will be given based on regulatory reviews.