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Heng Li

U.S. Food and Drug Administration



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Lilly Q. Yue

U.S. Food and Drug Administration



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143 – Critical Role of Statistics in Evaluating Real World Evidence for Legal and Regulatory Applications

Critical Role of Statistics in Leveraging Real World Data and Evidence for Regulatory Decision-Making

Sponsor: Stats. Partnerships Among Academe Indust. & Govt. Committee
Keywords: Real-world data, Real-world evidence, Propensity score, Power Prior, Composite likelihood.

Heng Li

U.S. Food and Drug Administration

Lilly Q. Yue

U.S. Food and Drug Administration

There are a variety of sources of real-world healthcare data that could be leveraged in the clinical studies in the regulatory settings. While such abundant data reflecting real-world clinical practice could potentially be used to reduce the cost of clinical trials, challenges arise concerning real-world data (RWD) quality, innovative analytical approaches for generating robust real-world evidence (RWE) from RWD, and appropriate use of RWE for regulatory decisions. Statistics plays a vital role in meeting all those challenges. This presentation will discuss such challenges, and the opportunities they bring about, from statistical and regulatory perspectives, illustrated with examples from medical device regulatory evaluations.

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