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# Draft Guide on Drug Study Expansion Cohorts
- URL: https://www.fdaweb.com/draft-guide-on-drug-study-expansion-cohorts/
- Published: 2018-08-13T12:00:00.000Z
- Updated: 2026-09-15T00:25:23.000Z
- Author: David McFarland
- Tags: FDA Policy/General, #legacy-id-D5142089

*Federal Register* notice: FDA has made available a draft guidance entitled “Expansion Cohorts: Use in First-In-Human Clinical Trials to Expedite Development of Oncology Drugs and Biologics.” The document discusses study designs that employ multiple, concurrently accruing, patient cohorts, where individual cohorts assess different aspects of the safety, pharmacokinetics, and anti-tumor activity of a drug. To view the notice, click [here](https://www.gpo.gov/fdsys/pkg/FR-2018-08-13/pdf/2018-17273.pdf?ref=fdaweb.com).