Online Program

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Tuesday, September 24
Tue, Sep 24, 4:15 PM - 5:30 PM
Thurgood Marshall North
Real-World Evidence, Regulatory Decisions, and Product Safety and Effectiveness

Real-World Evidence for Regulatory Decision-Making in Drug Safety and Efficacy (301016)

*Rongmei Zhang, FDA 

Keywords: Real world evidence, regulatory decision, drug evaluation

Real world evidence (RWE) is derived from a variety of data sources relating to patient health status and/or the delivery of health care, including electronic health records, administrative claims, products and disease registries, and data gathered through personal devices and health applications. The Framework of FDA’s RWE program issued in December 2018 outlines FDA’s plan to implement the RWE program. This talk will discuss the spectrum of potential uses of Real World Data (RWD) and RWE in drug development and regulatory science. We will focus on how RWE is currently used to inform regulatory decisions in postmarket safety surveillance, present examples of comparing safety and effectiveness for anticoagulants, and discuss statistical considerations and challenges.