Division of Clinical Research

Office of the Vice President and Innovation

FDA Virtual Workshop: Evaluating RWE from Observational Studies in Regulatory Decision-Making 

The U.S. Food and Drug Administration and the Duke-Margolis Center for Health Policy will hold a two-day virtual workshop on February 16-17, 2021, focused on considerations about observational (non-interventional) study design and conduct when using evidence from observational studies to inform regulatory decisions.    

FDA defines real-world evidence (RWE) as the clinical evidence regarding a medical product’s use and potential benefits or risks that is derived from analysis of real-world data (RWD), which are data relating to patients’ health status and health care delivery. Observational studies that use RWD to generate RWE could potentially contribute to regulatory decision-making about drug effectiveness, but there needs to be confidence in the validity of such evidence. 

The meeting will highlight preliminary results from ongoing trial replication efforts to better understand the strengths and limitations of observational studies when considering their potential use in answering questions about drug product effectiveness and informing regulatory decision-making. The conference will also focus on challenges with data adequacy and bias in observational studies that may affect casual inference, including provider and patient perceptions of the assigned treatment as well as differences in treatment adherence. Panel discussions will explore how to realize benefits and identify gaps in knowledge and strategies for addressing those gaps.  

Individuals can learn more and register for the workshop at FDA’s Evaluating RWE from Observational Studies in Regulatory Decision-Making webpage

Categories FDA Regulatory
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