Examining the Impact of Real-World Evidence on Medical Product Development I. Incentives: Proceedings of a Workshop—in Brief


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Randomized, controlled clinical trials (RCTs) have traditionally served as the gold standard for evidence generation in support of medical product development and evaluation. However, it is increasingly recognized that RCTs have inherent limitations, particularly with regard to generalizability, and time and monetary investment. Data from sources supplemental to RCTs, such as safety surveillance, observational studies, registries, claims, or patient-centered outcomes research, would be valuable to support biomedical research, including medical product development and evaluation. This September 2017 workshop, the first in a three-part series being convened by the National Academies’ Forum on Drug Discovery, Development, and Translation and sponsored by FDA , focused on how to align incentives to support collection and use of real-world evidence in medical product review, payment, and delivery, including incentives needed to address barriers impeding the uptake of real-world evidence, such as transparency. The workshop rapporteurs have prepared this proceedings in Brief as a factual summation of the session discussions.