Core Patient-Reported Outcomes in Cancer Clinical Trials; Guidance for Industry; Availability

摘要

The Food and Drug Administration (FDA or Agency) is announcing the availability of a final guidance for industry entitled "Core Patient-Reported Outcomes in Cancer Clinical Trials." This final guidance provides recommendations to sponsors regarding the collection of a core set of patient-reported clinical outcomes (herein referred to as core patient-reported outcomes) in cancer clinical trials and related considerations for instrument selection and trial design. This final guidance focuses on patient-reported outcome (PRO) measures and 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.