Oncology Patient-Reported Outcomes Tool May Lead To Comparative Tolerability Claims

New trial designs would be needed to support labeling claim using National Cancer Institute's PRO-CTCAE instrument.

A new patient-reported outcomes instrument for assessing toxicities in oncology trials ultimately could create an opportunity for comparative tolerability claims across cancer treatments.

The Patient-Reported Outcomes version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE) is an electronic-based system for patient self-reporting of symptomatic adverse events

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