Trial Design
Basket Trial
A basket trial is a clinical trial that tests one investigational therapy across multiple disease types (typically cancers) that share a common molecular biomarker or genetic alteration.
Basket trials are central to precision oncology. Examples include the NCI-MATCH and TAPUR studies, which assign patients to targeted therapies based on tumor genomic profiles regardless of histology. Larotrectinib's tissue-agnostic FDA approval for NTRK-fusion cancers came directly from basket-trial evidence.
Statistically, basket trials use Bayesian hierarchical models to borrow information across baskets while preserving the ability to detect tumor-specific responses.
Related terms
Platform Trial
A platform trial is a clinical trial that evaluates multiple investigational treatments against a common control under a single master protocol, with treatments added or dropped over time based on accumulating evidence.
Umbrella Trial
An umbrella trial is a clinical trial that evaluates multiple targeted therapies in patients with a single disease, stratified by molecular or genetic subtype, under one master protocol.
Master Protocol
A master protocol is a single overarching trial protocol that supports the simultaneous evaluation of multiple drugs, multiple diseases, or multiple sub-populations, typically under one IND and shared operational infrastructure.
Biomarker
A biomarker is a measurable biological characteristic (molecular, histologic, radiographic, or physiologic) used in clinical trials to indicate normal biology, disease state, treatment response, or prognosis.
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