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Abstract:
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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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