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# Draft Guide on Master Protocol Trial Designs
- URL: https://www.fdaweb.com/draft-guide-on-master-protocol-trial-designs/
- Published: 2018-10-01T12:00:00.000Z
- Updated: 2026-09-15T00:35:05.000Z
- Author: David McFarland
- Tags: FDA Policy/General, #legacy-id-D5142481

*Federal Register* notice: FDA has made available a draft guide entitled “Master Protocols: Efficient Clinical Trial Design Strategies to Expedite Development of Oncology Drugs and Biologics.” The document provides advice to sponsors intending to simultaneously evaluate more than one investigational drug or more than one cancer type within the same overall trial structure (master protocols) in adult and pediatric cancers. To view the notice, click [here](https://www.gpo.gov/fdsys/pkg/FR-2018-10-01/pdf/2018-21313.pdf?ref=fdaweb.com).