9 June 2021 - 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 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. 

Recommendations supplement previous guidance on use of patient reported outcome measures in clinical trials by providing additional considerations specific to the cancer clinical trial setting.

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