新型冠状病毒肺炎(COVID-19)临床研究的启示与国家临床试验网络构想  

Lessons from COVID-19 clinical trials and the concept of national clinical trials network

作　　者：姚晨[1,2] 赵文乐 YAO Chen;ZHAO Wenle(First Hospital,Peking University,Beijing 100034,P.R.China;Clinical Research Institute,Peking University,Beijing 100191,P.R.China;Department of Public Health Sciences,Medical University of South Carolina,Charleston 29425,SC,USA)

机构地区：[1]北京大学第一医院医学统计室,北京100034 [2]北京大学临床研究所,北京100191 [3]美国南卡罗来纳医科大学公共卫生系,美国南卡罗来纳州29425

出　　处：《中国循证医学杂志》2020年第5期497-503,共7页Chinese Journal of Evidence-based Medicine

摘　　要：新型冠状病毒肺炎(COVID-19)疫情爆发以来,从2020年1月23日至2020年3月5日由中国临床研究人员在中国临床试验注册中心(www.chictr.org.cn)和美国临床试验注册网站(www.clinicaltrials.gov)两个平台上登记注册并已经或将要在中国境内进行的针对新型冠状病毒肺炎的干预性临床试验项目总数已超过200个。这一现象引起了社会各界的关注。本文在对已登记注册的249个在中国开展的COVID-19临床试验项目的主要特征作描述性分析的基础上,借鉴美国国家卫生研究院(National Institutes of Health)组建的专项疾病领域国家临床试验网络的实践,思考在突发流行病情况下提高临床试验质量与效率的对策。Since the outbreak of the coronavirus disease(COVID-19), more than 200 interventional clinical trials have been registered in Chinese Clinical Trial Registry(www.chictr.org.cn) and the US Clinical Trials Registry(www.clinicaltrials.gov), testing or going to test treatments of COVID-19 in China from January 23rd, 2020 to March 5th,2020. This situation has drawn attentions from various sectors of society. This article summarizes the basic design features of 249 registered COVID-19 clinical trials in China, compares them with National Clinical Trials Network practices in the USA, and describes a concept of national clinical trials network as a strategy to enhance quality and efficiency of clinical research in cases like COVID-19 outbreak as well as other disease fields.

关 键 词：新型冠状病毒肺炎 临床试验 国家临床试验网络 

分 类 号：R563.1[医药卫生—呼吸系统]