22 April 2016 - The EMA has published new guidance on the use of patient-reported outcome (PRO) measures in oncology studies.
The new guidance is an appendix to the guideline on the evaluation of anticancer medicinal products in man, which was last revised in July 2013.
This guidance document issued by the CHMP and its Oncology Working Party describes the use of PROs and health related quality of life measures in clinical studies. It acknowledges the importance of bringing the perspective of patients on their disease and the treatment they receive to the assessment of benefits and risks of cancer medicines.
The new guidance outlines principles of scientific best practice rather than prescribing a particular approach to the selection and application of PROs and provides guidance on how patient-reported outcome data should be integrated in oncology clinical trials.