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.EMA
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. The possible add-on value from a licensure perspective of such data to conventional efficacy and safety data is therefore emphasised. In particular the use of PRO data in order to estimate patient perception of side effects of therapy is highlighted.
This document has been named “reflection paper” in order to underline its preliminary status and to spur an open discussion on the value of PRO data in the development of medicinal products for the treatment of malignancies and in acknowledgment that PRO methodology is developing and evolving.
End of consultation (deadline for comments) is 30-NOV-2014
Comments should be provided using this template. The completed comments form should be sent to ONCWPsecretariat@ema.europa.eu
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[Acknowledgements: Prof David Hutchinson. Principal Author & Editor of Advisor]