> ## Content Index
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# Guide on Patient-reported Outcomes in Cancer Trials
- URL: https://www.fdaweb.com/guide-on-patient-reported-outcomes-in-cancer-trials/
- Published: 2021-06-10T12:00:00.000Z
- Updated: 2026-09-14T17:02:44.000Z
- Author: David McFarland
- Tags: FDA Policy/General, #legacy-id-D5149514

*Federal Register* notice: FDA has made available a draft guidance entitled *Core Patient-Reported Outcomes in Cancer Clinical Trials*. The document provides recommendations to sponsors regarding the collection of a core set of patient-reported clinical outcomes in cancer clinical trials and related considerations for instrument selection and trial design. It focuses on patient-reported outcome 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. To view the notice, click [here](https://www.govinfo.gov/content/pkg/FR-2021-06-10/pdf/2021-12166.pdf?ref=fdaweb.com).