biomarker stratification
The process of dividing patients into subgroups based on molecular characteristics to guide treatment decisions.
Full Definition
Biomarker stratification is the systematic classification of patients into distinct subgroups based on molecular, genetic, or protein expression patterns that predict treatment response or clinical outcomes. This approach enables precision medicine by identifying patients most likely to benefit from specific therapies while avoiding unnecessary treatment toxicity in non-responsive populations. Stratification may involve single biomarkers or complex molecular signatures, and can be prospective (planned in trial design) or retrospective (post-hoc analysis). Effective biomarker stratification requires validated assays, defined cutoff values, and clinical evidence demonstrating differential outcomes between biomarker-defined subgroups.
Usage
Usage note: Specify the biomarker and stratification criteria when used in protocols
In Context
- "Biomarker stratification identified patients with EGFR mutations for targeted therapy enrollment." — Clinical trial design document
- "Effective biomarker stratification requires prospective validation in independent patient cohorts." — Regulatory submission guidelines