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- B4e8c245a6802311f1b814930c9ed57cf NCIT_P378 "CDISC-GLOSS" @default.
- B4e8c245a6802311f1b814930c9ed57cf type Axiom @default.
- B4e8c245a6802311f1b814930c9ed57cf annotatedProperty NCIT_P325 @default.
- B4e8c245a6802311f1b814930c9ed57cf annotatedSource NCIT_C165770 @default.
- B4e8c245a6802311f1b814930c9ed57cf annotatedTarget "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. NOTE: The term "master protocol" is often used to describe the design of such trials, with terms such as "umbrella", "basket", or "platform" describing specific designs. [After FDA DRAFT Guidance: Master Protocols: Efficient Clinical Trial Design Strategies to Expedite Development of Oncology Drugs and Biologics.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.] See also umbrella protocol, basket protocol, platform protocol, adaptive design." @default.