Laboratory of Psychiatric Pharmacogenomics, Department of Psychiatry, Massachusetts General Hospital and Harvard Medical School, Boston, MA 02114, USA.
Mol Psychiatry. 2011 Nov;16(11):1076-87. doi: 10.1038/mp.2011.63. Epub 2011 Jun 28.
Biomarkers are the measurable characteristics of an individual that may represent risk factors for a disease or outcome, or that may be indicators of disease progression or of treatment-associated changes. In general, the process by which biomarkers, once identified, might be translated into clinical practice has received scant attention in recent psychiatric literature. A body of work in diagnostic development suggests a framework for evaluating and validating novel biomarkers, but this work may be unfamiliar to clinical and translational researchers in psychiatry. Therefore, this review focuses on the steps that might follow the identification of putative biomarkers. It first addresses standard approaches to characterizing biomarker performance, followed by demonstrations of how a putative biomarker might be shown to have clinical relevance. Finally, it addresses ways in which a biomarker-based test might be validated for clinical application in terms of efficacy and cost-effectiveness.
生物标志物是个体可测量的特征，可能代表疾病或结果的危险因素，也可能是疾病进展或与治疗相关变化的指标。一般来说，最近的精神科文献很少关注一旦确定生物标志物，如何将其转化为临床实践的过程。在诊断开发方面有大量工作提出了评估和验证新型生物标志物的框架，但这对于精神科的临床和转化研究人员来说可能并不熟悉。因此，本综述重点介绍了在确定候选生物标志物之后可能采取的步骤。它首先介绍了用于描述生物标志物性能的标准方法，然后展示了如何证明候选生物标志物具有临床相关性。最后，它讨论了如何根据疗效和成本效益验证基于生物标志物的测试在临床应用中的有效性。
