Integrating patients’ views in clinical studies of anticancer medicines

EMA publishes new guidance on the use of patient-reported outcome measures in oncology studies. 

The new guidance is an appendix on the evaluation of anticancer medicinal products in man, which was last revised in July 2013.

The new guidance outlines principles of scientific best practice rather than prescribing a particular approach to the selection and application of patient-reported outcomes and provides guidance on how patient-reported outcome data should be integrated in oncology clinical trials.


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