On July 09, 2020, the U.S. Food and Drug Administration issued a Funding Opportunity Announcement (FOA) titled Development of Standard Core Clinical Outcomes Assessments (COAs) and Endpoints. The purpose of this FOA is to solicit applications for UG3/UH3 cooperative agreements to support the development of a publicly available standard core sets of COAs and their related endpoints in the following four areas: fluid overload in nephrotic syndrome; age appropriate domains of pediatric daily functioning; the mechanics of swallowing and speech from infancy to adulthood; and treatment effects in systemic sclerosis.
Standard core sets can include different types of COAs (i.e. patient-reported outcome [PRO], clinician-reported outcome [ClinRO], observer-reported outcome [ObsRO], performance outcome [PerfO] instruments) and their related endpoints that assess a minimum list of impacts that matter most to patients, are likely to demonstrate change (including differences in trial arms related to disease burden, treatment burden, and if applicable, physical function) and should be reported in a clinical trial.
The FDA’s Center for Drug Evaluation and Research (CDER) has recently posted a CDER Conversation on this funding opportunity. Information on past awards made under this grant program is available on the CDER Pilot Grant Program: Standard Core Clinical Outcome Assessments (COAs) and their Related Endpoints webpage. For any inquiries related to the grant program, please email CDER_StandardCoreCOAs@fda.hhs.
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