umbrella trial
A clinical trial design that tests multiple treatments within a single cancer type based on molecular subtypes.
Full Definition
An umbrella trial is a master protocol clinical trial design that evaluates multiple targeted therapies simultaneously within a single cancer type, with treatment assignment based on molecular profiling results. Unlike basket trials that cross tumor types, umbrella trials focus on one primary cancer but create multiple treatment arms corresponding to different molecular subtypes or biomarker profiles within that cancer. This design streamlines patient screening, reduces infrastructure costs, and enables comparison of different targeted approaches within a unified framework. Umbrella trials are particularly useful for cancers with multiple known driver mutations requiring different therapeutic strategies.
Usage
Usage note: Always hyphenate; clearly distinguish from basket trial designs
In Context
- "The lung cancer umbrella trial assigned patients to treatment arms based on specific driver mutations." — Clinical trial design document
- "Umbrella trial methodology allows efficient evaluation of multiple precision therapies simultaneously." — Protocol development guidelines