University of Michigan Comprehensive Cancer Center, Ann Arbor, MI 48109-5843, USA.
Mol Oncol. 2012 Apr;6(2):140-6. doi: 10.1016/j.molonc.2012.01.010. Epub 2012 Feb 6.
Biomarkers have many potential applications in oncology, including risk assessment, screening, differential diagnosis, determination of prognosis, prediction of response to treatment, and monitoring of progression of disease. Because of the critical role that biomarkers play at all stages of disease, it is important that they undergo rigorous evaluation, including analytical validation, clinical validation, and assessment of clinical utility, prior to incorporation into routine clinical care. In this review we address key steps in the development of biomarkers, including ways to avoid introducing bias and guidelines to follow when reporting results of biomarker studies.
生物标志物在肿瘤学中有许多潜在的应用，包括风险评估、筛查、鉴别诊断、预后判断、治疗反应预测和疾病进展监测。由于生物标志物在疾病的各个阶段都起着至关重要的作用，因此在将其纳入常规临床护理之前，对其进行严格的评估，包括分析验证、临床验证和临床实用性评估，这一点非常重要。在这篇综述中，我们讨论了生物标志物开发的关键步骤，包括避免引入偏差的方法和报告生物标志物研究结果时应遵循的指南。
