Real-World Data: Precertification Could Aid Use For Regulatory Decisions
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.
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CDER Director Woodcock says for regulatory purposes, using real-world data likely will remain a case-by-case decision.