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- NCIT_C165770 IAO_0000115 "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 (FDA DRAFT Guidance: Master Protocols: Efficient Clinical Trial Design Strategies to Expedite Development of Oncology Drugs and Biologics.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.)" @default.
- NCIT_C165770 NCIT_NHC0 "C165770" @default.
- NCIT_C165770 NCIT_P106 "Intellectual Product" @default.
- NCIT_C165770 NCIT_P108 "Master Protocol" @default.
- NCIT_C165770 NCIT_P208 "CL978856" @default.
- NCIT_C165770 NCIT_P322 "CDISC" @default.
- NCIT_C165770 NCIT_P322 "CDISC-GLOSS" @default.
- NCIT_C165770 NCIT_P325 "A protocol designed for a parent study that provides the plan for coordinated conduct across the entirety of the study, with one or more substudies, which may have different objectives, to evaluate one or more investigational drugs and/or diseases within the overall trial structure. (FDA Guidance Document: Master Protocols: Efficient Clinical Trial Design Strategies to Expedite Development of Oncology Drugs and Biologics Guidance for Industry)" @default.
- NCIT_C165770 NCIT_P325 "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 [After FDA DRAFT Guidance: Master Protocols: Efficient Clinical Trial Design Strategies to Expedite Development of Oncology Drugs and Biologics.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.
- NCIT_C165770 normalizedInformationContent "90.826665450122817" @default.
- NCIT_C165770 referenceCount "4" @default.
- NCIT_C165770 hasExactSynonym "Master Protocol" @default.
- NCIT_C165770 hasExactSynonym "master protocol" @default.
- NCIT_C165770 inSubset NCIT_C132298 @default.
- NCIT_C165770 inSubset NCIT_C197998 @default.
- NCIT_C165770 inSubset NCIT_C61410 @default.
- NCIT_C165770 inSubset NCIT_C67497 @default.
- NCIT_C165770 type Class @default.
- NCIT_C165770 isDefinedBy ncit.owl @default.
- NCIT_C165770 label "Master Protocol" @default.
- NCIT_C165770 subClassOf NCIT_C165770 @default.
- NCIT_C165770 subClassOf NCIT_C19498 @default.
- NCIT_C165770 subClassOf NCIT_C20181 @default.
- NCIT_C165770 subClassOf NCIT_C25198 @default.
- NCIT_C165770 subClassOf NCIT_C25320 @default.
- NCIT_C165770 subClassOf NCIT_C42651 @default.
- NCIT_C165770 subClassOf NCIT_C70817 @default.
- NCIT_C165770 subClassOf NCIT_C97331 @default.