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

Current version

PDF iconAdopted guideline

Reference numberEMA/CHMP/292464/2014
Published22/04/2016
Effective from01/11/2016
KeywordsPatient reported outcome (PRO), health related quality of life (HRQL)
DescriptionThis 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.


Document history

First version

Current version

PDF iconAdopted guideline


PDF iconDraft reflection paper

In operation: 01/11/2016


Published: 17/06/2014


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