Article | July 26, 2021

New FDA Draft Guidance Provides Insights On Use Of Pros In Oncology Trials

By Irene Figari

iStock-1292777578-autoinjector-injector-device-patient

Incorporating patient-reported outcomes (PROs) into clinical trials can help sponsors better understand patients’ symptoms and how a therapy will affect their quality of life, and these insights can be particularly valuable in oncology research. However, there has been a lack of guidance to help sponsors ensure consistency and quality when incorporating PROs into cancer drug applications. That’s changed with the recent publication of a new draft guidance from the U.S Food and Drug Administration’s (FDA) Oncology Center of Excellence (OCE), Core Patient-Reported Outcomes in Cancer Clinical Trials.

VIEW THE ARTICLE!
Signing up provides unlimited access to:
Signing up provides unlimited access to:
  • Trend and Leadership Articles
  • Case Studies
  • Extensive Product Database
  • Premium Content
HELLO. PLEASE LOG IN. X

Not yet a member of Cell & Gene? Register today.

ACCOUNT SIGN UP X
Please fill in your account details
Login Information
ACCOUNT SIGN UP

Subscriptions

Sign up for the newsletter that brings you the industry's latest news, technologies, trends and products.

You might also want to: