SEALS Department of Clinical Chemistry, Prince of Wales Hospital and School of Medical Sciences, University of New South Wales, Australia; Screening and Test Evaluation Program, School of Public Health, University of Sydney, Australia.
Clin Chim Acta. 2014 Jan 1;427:49-57. doi: 10.1016/j.cca.2013.09.018. Epub 2013 Sep 27.
Regulators and healthcare payers are increasingly demanding evidence that biomarkers deliver patient benefits to justify their use in clinical practice. Laboratory professionals need to be familiar with these evidence requirements to better engage in biomarker research and decisions about their appropriate use. This paper by a multidisciplinary group of the European Federation of Clinical Chemistry and Laboratory Medicine describes the pathway of a laboratory assay measuring a biomarker to becoming a medically useful test. We define the key terms, principles and components of the test evaluation process. Unlike previously described linearly staged models, we illustrate how the essential components of analytical and clinical performances, clinical and cost-effectiveness and the broader impact of testing assemble in a dynamic cycle. We highlight the importance of defining clinical goals and how the intended application of the biomarker in the clinical pathway should drive each component of test evaluation. This approach emphasizes the interaction of the different components, and that clinical effectiveness data should be fed back to refine analytical and clinical performances to achieve improved outcomes. The framework aims to support the understanding of key stakeholders. The laboratory profession needs to strengthen collaboration with industry and experts in evidence-based medicine, regulatory bodies and policy makers for better decisions about the use of new and existing medical tests.
监管机构和医疗支付方越来越要求有证据表明生物标志物能为患者带来获益，以证明其在临床实践中的应用是合理的。实验室专业人员需要熟悉这些证据要求，以便更好地参与生物标志物研究和关于其合理应用的决策。本文由欧洲临床化学和实验室医学联合会的一个多学科小组撰写，介绍了测量生物标志物的实验室检测方法成为有医学价值的检测方法的途径。我们定义了检测评估过程的关键术语、原则和组成部分。与之前描述的线性阶段模型不同，我们展示了分析和临床性能、临床和成本效益以及检测更广泛影响的基本组成部分如何在一个动态循环中组合在一起。我们强调了定义临床目标的重要性，以及生物标志物在临床路径中的预期应用应如何推动检测评估的各个组成部分。这种方法强调了不同组成部分的相互作用，并且应该将临床效果数据反馈回来，以改进分析和临床性能，从而实现更好的结果。该框架旨在支持相关利益方的理解。实验室行业需要加强与工业界以及循证医学、监管机构和政策制定者的合作，以便更好地决策是否使用新的和现有的医疗检测方法。
