Biomarkers as Surrogate Endpoints in Drug Development: Finding Their Right Place.

IF 3.6 4区医学 Q2 PHARMACOLOGY & PHARMACY

Clinical therapeutics Pub Date : 2025-09-18 DOI:10.1016/j.clinthera.2025.07.026

Katarina Ilic

引用次数: 0

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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生物标志物作为替代终点在药物开发：找到他们的正确位置。

生物标志物和替代终点的使用在药物开发、监管决策和临床实践中变得越来越重要。本综述概述了临床终点和替代终点之间的区别，定义了生物标志物的类型，并概述了用于验证生物标志物作为替代终点的标准。最后，在心血管药物开发、抗癌药物开发和降糖药物开发的临床试验中选择的例子说明了这些概念如何应用于现实世界的药物开发。

本文章由计算机程序翻译，如有差异，请以英文原文为准。

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来源期刊

Clinical therapeutics 医学-药学

CiteScore

6.00

自引率

3.10%

发文量

154

审稿时长

9 weeks

期刊介绍： Clinical Therapeutics provides peer-reviewed, rapid publication of recent developments in drug and other therapies as well as in diagnostics, pharmacoeconomics, health policy, treatment outcomes, and innovations in drug and biologics research. In addition Clinical Therapeutics features updates on specific topics collated by expert Topic Editors. Clinical Therapeutics is read by a large international audience of scientists and clinicians in a variety of research, academic, and clinical practice settings. Articles are indexed by all major biomedical abstracting databases.