Trial Design
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.
Umbrella trials match patients to the investigational arm best aligned with their tumor biology. The Lung-MAP trial in advanced squamous-cell lung cancer is a canonical example, screening patients across hundreds of U.S. sites and assigning them to biomarker-defined sub-studies.
Umbrella designs improve enrollment efficiency for biomarker-defined sub-populations that would otherwise be too small to study independently.
Related terms
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.
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.
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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