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# Guide on Pediatric Patients in Cancer Trials
- URL: https://www.fdaweb.com/guide-on-pediatric-patients-in-cancer-trials/
- Published: 2020-07-13T12:00:00.000Z
- Updated: 2026-09-14T16:20:48.000Z
- Author: David McFarland
- Tags: FDA Policy/General, #legacy-id-D5147178

*Federal Register* notice. FDA has made available a final guidance entitled “Cancer Clinical Trial Eligibility Criteria: Minimum Age Considerations for Inclusion of Pediatric Patients.” The document says that eligibility of a specific pediatric population for a cancer clinical trial should be considered when there is clinical evidence or a strong scientific rationale to suggest that “pediatric patients with a specific cancer diagnosis, histologic subtype, or tumor associated with the same relevant molecular target may benefit and when there is compelling nonclinical and/or adequate clinical information to sufficiently justify patient risk.” To view the notice, click [here](https://www.govinfo.gov/content/pkg/FR-2020-07-13/pdf/2020-14998.pdf?ref=fdaweb.com).