Preferred Label : Platform Trial Design;
NCIt definition : A type of trial design under a master protocol framework that tests multiple, targeted
therapies that may be adapted over the course of the study. NOTE: Platform trials
often include an adaptive design that may eliminate or add treatments based on interim
analysis. These trials may also include elements of basket or umbrella trials and
may have no pre-determined end date. [After 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.;
After US FDA, Master Protocols: Efficient Clinical Trial Design Strategies to Expedite
Development of Oncology Drugs and Biologics Guidance for Industry, 2022];
Alternative definition : CDISC-GLOSS: A type of trial design under a master protocol framework that tests multiple,
targeted therapies that may be adapted over the course of the study. NOTE: Platform
trials often include an adaptive design that may eliminate or add treatments based
on interim analysis. These trials may also include elements of basket or umbrella
trials and may have no pre-determined end date. [After 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.; After US FDA, Master Protocols: Efficient Clinical Trial Design
Strategies to Expedite Development of Oncology Drugs and Biologics Guidance for Industry,
2022] See also master protocol, adaptive design.;
NCI Metathesaurus CUI : CL1921885;
Origin ID : C202581;
UMLS CUI : C5908628;
Semantic type(s)
- concept_is_in_subset
