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# Cancer Trial Core Patient-Reported Outcomes Guide
- URL: https://www.fdaweb.com/cancer-trial-core-patient-reported-outcomes-guide/
- Published: 2024-10-17T12:00:00.000Z
- Updated: 2026-09-14T14:44:12.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5157999

FDA has published a guidance, *Core Patient-Reported Outcomes in Cancer Clinical Trials*, with 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. The [document](https://www.fda.gov/media/149994/download?ref=fdaweb.com) says some of the recommendations may also be relevant to other clinical outcome assessments, such as clinician-reported outcomes, observer-reported outcomes, or performance outcomes, in cancer clinical trials.

The recommendations supplement previous guidance on patient-reported outcome measures in clinical trials by providing additional considerations specific to the cancer clinical trial setting, FDA says. The guidance is specific to FDA-regulated trials for anti-cancer therapies intended to demonstrate an effect on survival, tumor response, or delay in the progression of a malignancy.

It contains an Introduction, Background, Core Patient-Reported Outcomes, Considerations for Instrument Selection to Measure the Core Patient-Reported Outcomes, Trial Design Considerations, and Labeling Considerations.