Core Patient-Reported Outcomes in Cancer Clinical Trials - USFDA

This is a DRAFT GUIDANCE distributed for comment purposes only.

This guidance provides recommendations to sponsors for the collection of a core set of patient-reported clinical outcomes in cancer clinical trials and related considerations for instrument selection and trial design.

Although this guidance focuses on patient-reported outcome (PRO) measures, some of these recommendations may be relevant to other clinical outcome assessments (i.e., clinician-reported outcome, observer-reported outcome, performance outcome) in cancer clinical trials.

This guidance is specific to registration trials for anti-cancer therapies intended to demonstrate an effect on survival, tumor response, or delay in the progression of a malignancy.