What are biomarkers?
What are biomarkers?
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DOI：
10.1097/coh.0b013e32833ed177
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发表时间：
2010-11
影响因子：
4.1
通讯作者：
Tavel JA
中科院分区：
文献类型：
--
作者：
Strimbu K;Tavel JA
本文提供了工作定义和概念框架，以了解生物标志物在临床研究中的作用。本文中讨论的术语的定义-医学体征、症状、生物标志物、替代终点、临床终点、验证-仍在讨论中，它们之间的关系也在讨论中，但在过去的15年中，已经就区分替代终点和临床终点的必要性达成了广泛的共识。本文概述了在这一领域的关键术语的主要定义，并考虑选择的情况下，对这些术语的误解导致有缺陷的研究结论。
This article provides working definitions and a conceptual framework to understand the roles of biomarkers in clinical research. The definitions of the terms discussed in this article—medical signs, symptoms, biomarkers, surrogate endpoints, clinical endpoints, validation—are still under discussion, as are their relationships to each other, but broad consensus has developed in the past decade and a half about the necessity of distinguishing between, in particular, surrogate and clinical endpoints. This article outlines the major definitions of the key terms in this field and considers select cases where misunderstandings about the terms led to flawed research conclusions.