Treatment Effect Estimation For Post-Market Safety Using Commercial Claims Data

 
Carrie Nielson, PhD – Director, RWE Generation Innovation Unit, Gilead Sciences
 
As real-world data become increasingly central to post-market drug safety evaluation, methodological choices are essential to ensure valid causal inference. In this seminar, we present a post-authorization safety study of an osteoporosis treatment using two large U.S. commercial claims databases: MarketScan and Optum. Key design decisions, including comparator selection informed by negative control outcome studies, will be discussed, alongside strategies for addressing confounding, informative censoring, and competing risks. This talk will also highlight transparency practices, such as clean room analytic divisions, and the use of bias analysis to assess the impact of residual confounding.

 
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