US FDA Wants More Examples Of Real-World Data Use
CDER Director Woodcock says for regulatory purposes, using real-world data likely will remain a case-by-case decision.
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Frontiers In Real-World Evidence: US FDA Partners With Syapse To Explore Sources Beyond Electronic Records
Oncology Center of Excellence will collaborate with the health data company to explore RWE sources for precision medicine.
Emerging standards for regulatory use of RWE should resist the temptation to impose the standards and expectations of randomized clinical trials to a fundamentally different kind of evidence, Dreyer cautions.
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.