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Biomarker: Clinical Trials
- Introduction
- Challenges in Biomarker Validation
- Relationships Among Biomarker, Treatment, and True-Endpoint
- Multiplicity and False Positive Rate
- Validation of Biomarkers
- Clinical Trial with Biomarker
- Adaptive Design with Classifier Biomarker
- Adaptive Design with Prognostic Biomarker
- Adaptive Design with Predictive Marker
- Summary and Discussion
- References
Abstract
A biomarker is a characteristic that is objectively measured and evaluated as an indicator of normal biologic processes, pathogenic processes, or pharmacological responses to a therapeutic intervention. This entry discusses biomarker trial designs with classifier, prognostic, and predictive markers.
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