Back to Resource Hub Article

Optimal COA Measurement Strategy for Modern Oncology Trials

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Recent FDA draft guidance provides a framework for selecting and implementing patient-reported outcome measures (PROMs) in oncology clinical trials.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

Similar posts

Looking for more insights? Explore related resources.

BLOG POST

Antibody-Drug Conjugates in Oncology: Revolutionizing Cancer Treatment

VISIT THE BLOG
WEBINAR

Unleashing the Power of PROs Throughout Oncology Drug Development

WATCH THE WEBINAR
ARTICLE

The Changing Face of Oncology Endpoint Monitoring

READ THE ARTICLE

Get notified on new marketing insights

Here mention the benefits of subscribing