Article | November 20, 2024

Lack Of Uptake By Sponsors Of The Draft FDA Recommendations For PROs In Oncology

By Anthony T. Everhart, MD

GettyImages-2036497698 clinical lab

Patient-reported outcomes (PROs) offer crucial insights into the real-world impact of cancer treatments, going beyond traditional clinical measures to capture how patients feel and function. Despite this value, the use of PROs in oncology drug development remains surprisingly low.

In 2021, the FDA issued draft guidance aimed at increasing the quality and consistency of PRO data in cancer trials. Yet, many pharmaceutical companies have been hesitant to implement these recommendations. This article explores the reasons behind this slow uptake, examining the challenges sponsors face in incorporating PROs into oncology research. We'll delve into the complexities of operationalizing PRO assessments, the ongoing struggle for standardization, and the lingering uncertainties around regulatory acceptance.

Most importantly, we'll offer practical solutions and strategies to overcome these hurdles, paving the way for wider adoption of PROs in oncology. By embracing these recommendations, we can move towards a more patient-centric approach to cancer drug development, where treatment decisions are informed by the patient's own experience.

access the Article!

Get unlimited access to:

Trend and Thought Leadership Articles
Case Studies & White Papers
Extensive Product Database
Members-Only Premium Content
Welcome Back! Please Log In to Continue. X

Enter your credentials below to log in. Not yet a member of Clinical Supply Leader? Subscribe today.

Subscribe to Clinical Supply Leader X

Please enter your email address and create a password to access the full content, Or log in to your account to continue.

or

Subscribe to Clinical Supply Leader