Clinical Reviewers To CDER: Give Us PRO Training
A repository of patient-reported outcomes instruments and dedicated PRO experts in each review division also could help boost the use of such data in drug labeling, FDA reviewers said.
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US agency's events could address a touchy subject: how much responsibility does FDA have for preventing adverse events, and how much falls to physicians?
Office of Hematology and Oncology Products now has PRO leads in each clinical review division and is working more collaboratively with, rather than parallel to, the agency’s Study Endpoints and Labeling Development team to give sponsors consistent advice on use of PRO measures in trials.
Public catalogue of assessment tools aims to foster collaborations and reduce regulatory uncertainties for drug developers trying to get clinical outcomes measurements into product labeling.