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Preparation of Peripheral Blood Mononuclear Cell Pellets and Plasma from a Single Blood Draw at Clinical Trial Sites for Biomarker Analysis
Published on: March 20, 2021
Integrating biomarkers in clinical trials
Marc Buyse1, Stefan Michiels, Daniel J Sargent
1International Institute for Drug Development, 30 Avenue Provinciale, 1340 Louvain-la-Neuve, Belgium. marc.buyse@iddi.com
Expert Review of Molecular Diagnostics
|March 17, 2011
Summary
Molecular biomarkers are crucial for personalized medicine in clinical trials. This article details prognostic and predictive biomarkers and trial designs for validating their use in oncology.
Area of Science:
- Oncology
- Clinical Pharmacology
- Biostatistics
Background:
- The rise of targeted therapies necessitates precise patient stratification in clinical trials.
- Molecular biomarkers are increasingly vital for both clinical research and practice.
- Distinguishing between prognostic and predictive biomarkers is essential for effective trial design.
Purpose of the Study:
- To review the role of prognostic and predictive biomarkers in clinical trials.
- To discuss specific clinical trial designs (Phase II and III) for biomarker validation.
- To illustrate biomarker-based trial strategies using oncology examples.
Main Methods:
- Review of contemporary clinical trial designs.
- Focus on Phase II and III trial methodologies.
- Case examples from oncology research.
Main Results:
- Biomarker validation is key to establishing targeted therapy efficacy.
- Specific trial designs facilitate the evaluation of biomarkers.
- Oncology trials provide practical examples of biomarker application.
Conclusions:
- Biomarker-driven clinical trials are fundamental to personalized oncology.
- Prognostic and predictive biomarkers guide treatment selection and patient management.
- Validated biomarkers enhance the precision and efficiency of therapeutic development.
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