The importance of the patient’s point of view on their health status is fully acknowledged and such information may be used in drawing regulatory Cancerconclusions regarding treatment effects, in the benefit risk balance assessment or as specific therapeutic claims in Section 5.1 of the SmPC (Secord et al., 2015, CHMP Reflection paper on the regulatory guidance for the use of Health-related quality of life (HRQL) measures in the evaluation of medicinal products, 2005). For specific therapeutic claims, valid measures should be selected based on their ‘fit’ with a hypothesis led strategy, resulting in unbiased outcomes.
This appendix on the use of patient-reported outcome (PRO) measures in patients with cancer 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 in benefit risk assessment is therefore emphasised.

This document has been developed to outline broad principles of scientific best practice and to provide guidance on the value of PRO data in the development of medicinal products for the treatment of cancer, whilst recognizing that PRO methodology is developing and evolving (Calvert et al., 2014, Kyte et al., 2014, Secord et al., 2015).
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Acknowledgements: Prof David Hutchinson, Clinical Research – Clinical Quality Assurance Advisor, Canary Ltd