11 September 2019
Nortwestern University Clinical Outcome Assessment Team
On September 11, 2019 the FDA made three awards under a pilot grant program to support the development of publicly available core set(s) of Clinical Outcome Assessments (COAs) and their related endpoints for specific disease indications (RFA-FD-19-006). These awards will provide avenues to advance the use of patient input as an important part of drug development that can foster innovation and the availability of safe and effective drugs.
Dr. Kammerman will serve on the “External Technical Advisory Committee" to one of the awardees: the Northwestern University Clinical Outcome Assessment Team (NUCOAT). This project will develop and validate COAs with applicability across a range of chronic conditions that assess physical function using patient-reported and performance outcomes. The team of investigators, led by David Cella Ph.D., M.A., at Northwestern University, will research a full range of physical function severity. The investigators expect their work to result in core physical function outcome sets that measure the full range of physical function severity with potential generalizability across conditions.
Visit CDER Pilot Grant Program: Clinical Outcome Assessments (COAs) and their Related Endpoints to learn about the program and the three awardees.