Appendix 2 to the guideline on the evaluation of anticancer medicinal products in man - the use of patient-reported outcome (PRO) measures in oncology studies - Scientific guideline

This document covers general aspects of the use of patient report outcome (PRO) endpoints in oncology studies such as the designing and carrying out of clinical studies, the acceptability of instruments and the clinically important differences and added value.

Keywords: Patient reported outcome (PRO), health related quality of life (HRQL)

Current effective version

Appendix 2 to the guideline on the evaluation of anticancer medicinal products in man

AdoptedLegal effective date: 01/11/2016Reference Number: EMA/CHMP/292464/2014Summary:

The use of patient-reported outcome (PRO) measures in oncology studies.

Document history

Draft reflection paper on the use of patient reported outcome (PRO) measures in oncology studies

Consultation dates: 17/06/2014 to 30/11/2014Draft: consultation closedReference Number: EMA/CHMP/292464/2014Summary:

The importance of the patient’s point of view on their health status is fully acknowledged and such information may in principle be used in drawing regulatory conclusions regarding treatment effects. This reflection paper on the use of patient reported outcome (PRO) measures in patients with malignancies focuses on the value of these data from a regulatory perspective.