Biomarkers as Surrogate Endpoints in Drug Development: Finding Their Right Place
Related Experiment Video
Updated: Jan 17, 2026

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
1The Degge Group Ltd., Bridge to Data Massachusetts.
Abstract:
The use of biomarkers and surrogate endpoints has become increasingly important in drug development, regulatory decision-making, and clinical practice. This review provides an overview of the distinctions between clinical and surrogate endpoints, defines types of biomarkers, and outlines the criteria used to validate biomarkers as surrogate endpoints. Finally, selected examples in clinical trials in cardiovascular drug development, anticancer drug development and antidiabetic drugs drug development illustrate how these concepts are applied in real-world drug development.
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