top of page

Core Patient-Reported Outcomes in Cancer Clinical Trials - USFDA

Writer's picture: Sharan MuruganSharan Murugan

This is a DRAFT GUIDANCE distributed for comment purposes only.


This guidance provides recommendations to sponsors for the collection of a core set of patient-reported clinical outcomes in cancer clinical trials and related considerations for instrument selection and trial design.

Although this guidance focuses on patient-reported outcome (PRO) measures, some of these recommendations may be relevant to other clinical outcome assessments (i.e., clinician-reported outcome, observer-reported outcome, performance outcome) in cancer clinical trials.


This guidance is specific to registration trials for anti-cancer therapies intended to demonstrate an effect on survival, tumor response, or delay in the progression of a malignancy.

Comments


I Sometimes Send Newsletters

Thanks for submitting!

  • LinkedIn
  • Facebook
  • Twitter
  • Instagram

DISCLAIMER

The views expressed in this publication do not necessarily reflect the views of any guidance of government, health authority, it's purely my understanding. This Blog/Web Site is made available by a regulatory professional, is for educational purposes only as well as to give you general information and a general understanding of the pharmaceutical regulations, and not to provide specific regulatory advice. By using this blog site you understand that there is no client relationship between you and the Blog/Web Site publisher. The Blog/Web Site should not be used as a substitute for competent pharma regulatory advice and you should discuss from an authenticated regulatory professional in your state.  We have made every reasonable effort to present accurate information on our website; however, we are not responsible for any of the results you experience while visiting our website and request to use official websites.

bottom of page