Real world evidence (RWE) and real world data (RWD) are receiving increased attention from pharmaceutical industry and drug regulatory authorities (DRAs) in Europe due to advances in availability and analysis of RWD which have, in turn, expanded their role in supporting clinical development and regulatory decision making.
In this report, we synthesize key framework documents into a unified assessment
criteria offering a structured approach for determining the fit-for-purpose of real
world databases to support regulatory use cases. We then assess how two previously conducted European regulatory studies (1 PASS and 1 external control) successfully leveraged RWD based on this unified assessment criteria.
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