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GUIDANCE DOCUMENT

Core Patient-Reported Outcomes in Cancer Clinical Trials Guidance for Industry October 2024

Download the Final Guidance Document Read the Federal Register Notice
Final
Docket Number:
FDA-2020-D-2303
Issued by:
Guidance Issuing Office
Oncology Center of Excellence
Center for Biologics Evaluation and Research
Center for Drug Evaluation and Research

This guidance provides recommendations to sponsors for 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.

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All written comments should be identified with this document's docket number: FDA-2020-D-2303.

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