Real World Evidence Benefits, Limits Explored In US FDA Demonstrations
FDA's Jacqueline Corrigan-Curay lists three demonstrations now underway that are aimed at looking at different aspects of generating real world evidence and may inform the agency's evaluation of the data and methods.
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Voluntary precertification process could help ensure the quality and integrity of databases from which real-world evidence is derived, but the program could be a cost burden for data curators and accreditation criteria would need to be developed, experts said at a recent Duke-Margolis Center meeting.
Death typically is not included in electronic health records, and sources are disparate; Difficulties with endpoint expose potential limitation to real-world evidence use.