biomarker-driven trial
A clinical study that uses molecular characteristics to determine patient eligibility and treatment assignment.
Full Definition
A biomarker-driven trial represents a clinical research design where patient enrollment and treatment allocation are determined by specific molecular characteristics rather than traditional histological classifications. These studies may include basket trials that treat multiple cancer types with shared biomarkers, umbrella trials that test multiple treatments within a single cancer type, or adaptive designs that modify based on interim biomarker analyses. This approach enables more precise patient selection and accelerated drug development.
Usage
Usage note: Hyphenate when used as compound modifier. Distinguish from traditional trial designs.
In Context
- "The biomarker-driven trial enrolled patients across multiple tumor types with NTRK fusions." — Clinical trial description
- "Enrollment in the biomarker-driven trial required comprehensive genomic profiling results." — Study protocol