Novel coronavirus pneumonia Clinical research Ethical review Status analysis
江苏省医院协会2020年度医院管理创新研究课题（JSYGY-3-2020-340）
目的：分析在中国临床试验注册中心官网注册的新冠肺炎临床研究方案的现状及特点。方法：以“新冠肺炎”、“2019-nCoV”等为检索词，检索官网2020年1-5月注册的所有关于新冠肺炎的临床研究，采用描述性方法分析数据。结果：共纳入504项研究。研究主办单位以湖北、上海、北京、广东居多；诊断试验、干预性研究、观察性研究分别占5.6%、48.8%、45.6%；研究对象以NCP患者为主，且研究类型、研究对象在注册时间分布上的差异有统计学意义；主要干预措施包括抗病毒治疗、激素治疗、免疫治疗等；有425项通过伦理委员会的审查并上传伦理审查批件；有289项获得了国家级/省级/医院/单位的科研项目资金支持；有339项人体标本使用后销毁；有319项设立了临床试验数据与安全监查委员会（DSMB）。结论：研究者应根据疫情发展及研究所在地的实际情况，注重研究设计的科学合理性、可行性、伦理性，积极探索2019-nCoV的有效防治措施。
Objective：Analysis the current status and characteristics of COVID-19 related clinical research protocols that have registered on the official website of China Clinical Trial Registry. Methods：Using“COVID-19” and “2019-nCOV” as search terms，all registered novel coronavirus pneumonia clinical studies on the official website from January to May 2020 as search subjects，and descriptive analysis and chi-squared test were used to analyze the data. Result：A total of 504 studies were included. The major study organizers were from Hubei，Shanghai，Beijing，Guangdong；Diagnostic tests，intervention studies，and observational studies accounted for 5.6%，48.8%，and 45.6% separately；the subjects were mainly NCP patients，and the three study types and different subjects were statistically significant in the registration time. The main intervention measures include antiviral therapy，hormone therapy，immunotherapy，etc.；425 studies have been reviewed by ethics committees and have uploaded ethical review approvals；289 studies have been funded by national/provincial/hospital/organization research projects；339 human specimens were destroyed after use；Clinical trial Data and Safety Monitoring committees（DSMB）were established in 319 cases. Conclusions：According to the development of epidemic situation and the actual situation of the research site，researchers should pay attention to the scientific rationality，feasibility and ethicality of clinical research，and explore effective prevention and treatment measures for 2019-nCoV.