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

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Download document Draft reflection paper on the use of patient reported outcome (PRO) measures in oncology studies
Reference number EMA/CHMP/292464/2014
Status draft: consultation open
First published 17/06/2014
Last updated 17/06/2014
Consultation start date 17/06/2014
Consultation end date 30/11/2014
Email address for submissions oncwpsecretariat@ema.europa.eu

Summary

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.