Optimal COA Measurement Strategy in Modern Oncology Trials Date Published: May 15, 2023 Article The inclusion of patient-reported outcomes (PRO) data in oncology medication labeling in the U.S. has been comparatively limited. Recent FDA draft guidance provides a framework for selecting and implementing patient-reported outcome measures (PROMs) in oncology clinical trials. It addresses two areas for improvement that may lead to an increase in PROM-related labeling claims: sub-optimal timing of assessments and lack of specificity in measures. Signant’s Bill Byrom, Ph.D. and Anthony T. Everhart, MD, FACP examine each of these in detail in this article as well as offer recommendations such as adaptations that will help researchers satisfy the draft FDA guidance. Read Now Share: LinkedInTweet Recommended Resources Article How To Run Successful, Decentralized Oncology Trials Oncology research, especially decentralized oncology trials, continue to undergo rapid transformation, driven by a number of factors including: Learn from... Download Now Considerations & Opportunities in Capturing Oncology Patients’ PRO Data Watch Now Webinar PROMIS CAT: Patient-Focused COA Solutions Download Now Brochure