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 measures in patients with malignancies focuses on the value of these data from a regulatory perspective.

The consultation period for the draft paper started on 17 June 2014 and ends on 30 November 2014.

For more details, go to: http://www.ema.europa.eu/ema/doc_index.jsp?curl=pages/includes/document/document_detail.jsp?webContentId=WC500168852&murl=menus/document_library/document_library.jsp&mid=0b01ac058009a3dc