Preferred Label : Master Protocol;
NCIt 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(FDA DRAFT Guidance: Master Protocols: Efficient Clinical Trial Design Strategies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.);
Alternative definition : MRCT-Ctr: An overall research plan that guides sub-studies that have their own research
questions. (https://mrctcenter.org/glossaryterm/master-protocol/); CDISC: 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); CDISC-GLOSS: A protocol designed to enable multiple substudies, which may have different
objectives and involve coordinated efforts to evaluate one or more investigational
drugs in one or more disease subtypes within the overall trial structure. 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 US FDA,
Master Protocols: Efficient Clinical Trial Design Strategies to Expedite Development
of Oncology Drugs and Biologics Guidance for Industry, 2022; 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 trial design, basket trial design,
platform trial design, adaptive design.;
NCI Metathesaurus CUI : CL978856;
Origin ID : C165770;
UMLS CUI : C5237445;
Semantic type(s)
- concept_is_in_subset
