2020年中国药物临床试验进展分析  

Progress Analysis of 2020 Drug Clinical Trials in China

作　　者：苏娴 姚珠星 王海学[1] 王涛[1] SU Xian;YAO Zhu-xing;WANG Hai-xue;WANG Tao(Center for Drug Evaluation,National Medical Products Administration)

机构地区：[1]国家药品监督管理局药品审评中心

出　　处：《中国食品药品监管》2021年第10期14-19,共6页China Food & Drug Administration Magazine

摘　　要：目的:为全面掌握我国药物临床试验现状,对我国药物临床试验年度进展进行汇总和分析。方法:主要根据2020年登记的药物临床试验信息,从临床试验概况、临床试验涉及的靶点和适应症领域分布情况、临床试验实施情况3个方面对2020年登记的药物临床试验的现状进行分析。结果:2020年,药物临床试验登记与信息公示平台共登记1473项药物临床试验,较2019年总体增长22.5%。药物类型以化学药品和生物制品为主,注册分类中占比最高的均为1类;国内申办者占比超过70%,试验范围以国内为主(85.9%);I期临床试验占比最高(47.3%);受试者人群中儿童占比为8.8%;靶点主要集中在PD1、VEGFR、CYP51A1;适应症主要集中在抗肿瘤和抗感染。47.4%的首次新药临床试验申请(IND)获批品种未在1年内启动临床试验。结论与建议:我国临床试验改革有效地促进了创新药物进入临床试验,国内制药企业已成为药物研发的重要力量,但也存在着靶点和适应症同质化以及实施效率不高等挑战。引导医药企业开展差异化的新药研发、鼓励新技术和新方法在临床试验中的应用以扩展儿科用药和提高临床试验效率,将帮助我国医药创新保持良性生态。Objective:To present the current situation of drug clinical trials in China,a summary is made on the annual progress of new drug clinical trials.Methods:Based on the information of drug clinical trials registered in 2020,analysis is made from three aspects:clinical trial overview,targets and indications involved in clinical trials,and conduct of clinical trials.Results:In 2020,a total of 1,473 drug clinical trials were registered on the Drug Clinical Trial Registration and Information Disclosure Platform,an overall increase of 22.5%compared with 2019.Chemical drugs and biological products were the main drug types,with the highest percentage in Category 1 of the drug registration classification.The proportion of domestic sponsors was more than 70%,and most trials were conducted in China(85.9%).Phase I clinical trials had the highest percentage(47.3%),and children accounted for 8.8%of all trial subjects.PD1,VEGFR and CYP51A1 were the main drug targets,and drug indications were mainly focused on oncology and anti-infection areas.47.4%Investigational New Drug(IND)applications were not initiated within one year of approval.Conclusion and Recommendations:China’s clinical trial reform has effectively accelerated the process of innovative drugs entering clinical trials.Domestic pharmaceutical companies have become an important force in drug research and development,but there are still challenges such as too much focus on a narrow set of drug targets and indications and low efficiency in conducting clinical trials.To create a favorable environment for drug innovation,it is necessary to guide pharmaceutical enterprises carrying out differentiated drug research and development,and encourage the application of new technologies and new methods in clinical trials to expand pediatric drugs and improve clinical trial efficiency.

关 键 词：临床试验 监管科学 大数据 

分 类 号：R969[医药卫生—药理学]