International Journal of Clinical Research
International Journal of Clinical Research. 2023; 7: (2) ; 10.12208/j.ijcr.20230064 .
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翰博瑞强（上海）医药科技有限公司 上海
*通讯作者： 孟凡强,单位：翰博瑞强（上海）医药科技有限公司 上海；
生物标志物是指能被客观测量和评价，反映生理或病理过程，以及对暴露或治疗干预措施产生生物学效应的指标。生物标志物已经成为新药研发的重要工具，是临床试验中替代终点的选择、剂量-暴露量-效应分析、富集设计、分层因素、不良反应监测的重要考虑要素。自2004年以来，生物标志在药物研发中作用日益得到重视，FDA、EMA、ICH、NMPA先后出台了相关生物标志物用于药物研发的资格认定程序和指导原则用以规范和鼓励新和生物标志物的开发。生物标志物助力新药上市的实例层出不穷。本文对生物标志物的定义、分类、资格认定规范以及不同种类生物标志物在新药临床试验中应用的经典实例进行综述，为我国创新药研发企业提供参考。
Biomarkers are indicators that can be objectively measured and evaluated, reflect physiological or pathological processes, and have biological effects on exposure or treatment interventions. Biomarkers have become an important tool for new drug research and development, and are important considerations for the selection of alternative endpoints, dose-exposure-effect analysis, enrichment design, stratification factors, and adverse reaction monitoring in clinical trials. Since 2004, the role of biomarkers in drug research and development has been increasingly valued. FDA, EMA, ICH and NMPA have successively issued the qualification procedures and guidelines for the use of biomarkers in drug research and development to standardize and encourage the development of new and biomarkers. There are many examples of biomarkers helping new drugs to market. This article reviews the definition, classification, qualification criteria of biomarkers and the classic examples of the application of different kinds of biomarkers in clinical trials of new drugs, so as to provide reference for innovative drug research and development enterprises in China.
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