EMA Outlines Best Practices for Patient-Reported Outcomes in Oncology Studies

The European Medicines Agency is providing guidance on how drugmakers can best incorporate patient-reported outcomes in developing oncology studies.

The guidance details prospective study designs, methodologies, instruments and benefits.

Early in the development of an oncology study, companies should consider whether PRO data could be meaningful. As with any endpoint, there should be a clear justification for the inclusion of PROs, the timing of assessments and the selection of instruments.