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 Recent FDA draft guidance provides a framework for selecting and implementing patient-reported outcome measures (PROMs) in oncology clinical trials.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.