Evaluating RWE from Observational Studies in Regulatory Decision-Making: Lessons Learned from Trial Replication Analyses

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Public Workshop

Evaluating RWE from Observational Studies in Regulatory Decision-Making: Lessons Learned from Trial Replication Analyses

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February 16, 2021 1:00PM - February 17, 2021 3:30PM

Virtual Workshop

Observational (non-interventional) studies—typically involving analyses of real-world data (RWD) from administrative claims and electronic health records—can broaden our understanding about the effectiveness of medical products, but questions remain about the credibility of observational studies using data generated for non-research purposes (secondary use of health data). As part of its Real-World Evidence (RWE) Program, FDA is evaluating the potential role of observational studies in contributing to evidence of drug product effectiveness. This virtual conference will consider attributes of observational study design and conduct to better understand considerations for using evidence from observational studies to inform regulatory decisions.  

The meeting will focus on sharing preliminary results from ongoing trial replication efforts to better understand strengths and limitations of observational studies when considering their potential use to answer questions about drug product effectiveness and inform regulatory decision-making. The conference will explore challenges with data adequacy, bias in observational studies that may impact casual inference, including provider- and patient-based perceptions of the assigned treatment and differential adherence to treatment. Panel discussions will explore how benefits can be realized, identify gaps in knowledge, and consider strategies for addressing those gaps.