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# Draft Guide on Adolescents in Adult Oncology Trials
- URL: https://www.fdaweb.com/draft-guide-on-adolescents-in-adult-oncology-trials/
- Published: 2018-06-01T12:00:00.000Z
- Updated: 2026-09-15T00:09:41.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5141584

FDA has made available a [draft guidance](https://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM609513.pdf?ref=fdaweb.com) entitled “Considerations for the Inclusion of Adolescent Patients in Adult Oncology Clinical Trials.” The document focuses on appropriate criteria for including adolescents in adult trials at various stages of drug development, considerations for dosing and pharmacokinetic evaluations, safety monitoring, and ethical requirements.