Real-World Data: Precertification Could Aid Use For Regulatory Decisions

18 Oct 2018

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.

A precertification program for medical data aggregators could help expedite the use of real-world evidence for regulatory purposes. However, such a program could be a cost burden for small data curators, and it’s unclear who would do the certifying and what the criteria would be for accreditation, a panel of experts said at a recent Duke-Margolis Center for Health Policy meeting.

A voluntary precertification process would be a way of ensuring the quality and integrity of the databases from which real-world...