EMA Issues Guidance on Patient-Reported Outcomes in Oncology Trials
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.
The guidance suggests baseline patient self-assessments last 20 minutes and subsequent assessments take 10 to 15 minutes to limit the burden on patients.
Read the guidance here: www.fdanews.com/04-22-16-EMAGuideline.pdf. ― José Vasquez
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