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Abstract:
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Since the introduction of the FDA draft framework for RWE Framework in 2016, we’ve seen numerous examples of use of RWE in regulatory submissions. Some of these have been successful and some not. This has given us an opportunity to learn and understand how regulators evaluate the use of RWD in different clinical and regulatory settings. Recent advent of draft FDA guidance on RWD has further enhanced our understanding of use of RWE in regulatory submissions. While the “holy grail” of real world evidence may be to provide an external control arm for small, single arm studies to potentially lead to a regular approval with substantial evidence of efficacy, there have been multiple valid issues raised by regulators that limit the near term viability of leveraging EHR based retrospective RWE for this use. Though there are challenges with RWD, there are opportunities too. My talk will focus on learnings from regulatory feedback so far, near term opportunities for RWE in the regulatory setting and some of the recent methodological advances by the RWD community to move the field forward.
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