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Updated: May 22, 2026
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Selecting Multiple Biomarker Subsets with Similarly Effective Binary Classification Performances
Published on: October 11, 2018
[The designs of exploratory biomarker study]
Masahiko Gosho1, Kengo Nagashima, Yasunori Sato
1Graduate School of Engineering, Tokyo University of Science.
Nihon Rinsho. Japanese Journal of Clinical Medicine
|May 25, 2012
Summary
Biomarker validation in clinical research requires careful consideration of scientific rationale, study design, and cost. This review highlights key aspects for designing clinical studies incorporating biomarkers for drug discovery and development.
Area of Science:
- Biomarker discovery and validation
- Molecular biology applications
- Clinical research methodology
Context:
- Biomarkers are crucial in modern drug discovery and development.
- Clinical research designs must address scientific rationale, study design, marker assessment, cost, and feasibility.
- Distinguishing between prognostic and predictive markers is essential.
Purpose:
- To define biomarkers and differentiate prognostic from predictive types.
- To outline study design considerations for exploratory biomarker screening and evaluation.
- To review the design of confirmatory clinical trials for novel treatments and companion diagnostics.
Summary:
- This review emphasizes critical considerations for clinical research designs involving biomarkers.
- It covers the definition and types of biomarkers, exploratory study designs for biomarker evaluation, and confirmatory trial designs for treatments and companion diagnostics.
- Key aspects include scientific rationale, study design, marker assessment, cost, and feasibility.
Impact:
- Provides a framework for optimizing biomarker validation in clinical research.
- Aids in the efficient development of targeted therapies and companion diagnostics.
- Enhances the integration of biomarkers into drug discovery and development pipelines.
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