Master Protocol

**Semantic type:** Intellectual Product

**Definition:** A trial design that tests multiple drugs and/or multiple subpopulations in parallel under a single protocol, without the need to develop new protocols for every trial. (FDA DRAFT Guidance: Master Protocols: Efficient Clinical Trial Design Strategies to Expedite Development of Oncology Drugs and Biologics. September 2018 and Woodcock J, LaVange LM. Master Protocols to Study Multiple Therapies, Multiple Diseases, or Both. N Engl J Med. 2017 Jul 6;377(1):62-70.)

**Synonyms:** - master protocol - master protocol