Wagner J A, Ball J R
Takeda Pharmaceuticals International Co, Clinical and Translational Sciences, Cambridge, Massachusetts, USA.
American College of Physicians, Philadelphia, Pennsylvania, USA.
Clin Pharmacol Ther. 2015 Jul;98(1):12-5. doi: 10.1002/cpt.129. Epub 2015 May 19.
The Institute of Medicine (IOM) released a groundbreaking 2010 report, Evaluation of Biomarkers and Surrogate Endpoints in Chronic Disease. Key recommendations included a harmonized scientific process and a general framework for biomarker evaluation with three interrelated steps: (1) Analytical validation -- is the biomarker measurement accurate? (2) Qualification -- is the biomarker associated with the clinical endpoint of concern? (3) Utilization -- what is the specific context of the proposed use?
美国医学研究所（IOM）于2010年发布了一份具有开创性的报告《慢性病生物标志物和替代终点评估》。主要建议包括一个统一的科学流程以及生物标志物评估的总体框架，该框架包含三个相互关联的步骤：（1）分析验证——生物标志物测量是否准确？（2）鉴定——该生物标志物是否与所关注的临床终点相关？（3）应用——所提议用途的具体背景是什么？
