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# Cancer Trial Patient-Reported Outcomes Draft Guidance
- URL: https://www.fdaweb.com/cancer-trial-patient-reported-outcomes-draft-guidance/
- Published: 2021-06-09T12:00:00.000Z
- Updated: 2026-09-14T17:02:29.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5149492

FDA has published a draft guidance, *Core Patient-Reported Outcomes in Cancer Clinical Trials*, with recommendations to sponsors for the collection of a core set of patient-related clinical outcomes in cancer clinical trials and related considerations for instrument selection and trial design. The [document](https://www.fda.gov/regulatory-information/search-fda-guidance-documents/core-patient-reported-outcomes-cancer-clinical-trials?ref=fdaweb.com) says some of the recommendations may be relevant to other clinical outcome assessments (clinician-reported outcome, observer-reported outcome, performance outcome) in cancer clinical trials.

The recommendations supplement previous guidance on the use of patient-reported outcome measures in clinical trials by providing additional considerations specific to the clinical cancer trial setting, FDA says. The draft says the agency does not endorse any specific patient-reported outcome measure and examples in the document are illustrative and should not be construed as endorsements.

The 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, FDA says.