上海交通大学学报(医学版) ›› 2020, Vol. 40 ›› Issue (06): 707-712.doi: 10.3969/j.issn.1674-8115.2020.06.002

• 新型冠状病毒防控专栏 • 上一篇    

全球新型冠状病毒肺炎临床研究注册信息的分析与思考

渠田田1, 2*,冯铁男1, 2*,姜嘉媛1, 2,张 帆1, 2,钱碧云1, 2   

  1. 1. 上海交通大学医学院附属同仁医院虹桥国际医学研究院,上海 200050;2. 上海交通大学医学院临床研究中心,上海 200025
  • 出版日期:2020-06-28 发布日期:2020-08-11
  • 通讯作者: 钱碧云,电子信箱:qianbiyun@sjtu.edu.cn。
  • 作者简介:渠田田(1992—),女,初级监查员,硕士;电子信箱:13061676341@163.com。冯铁男(1983—),男,讲师,博士;电子信箱:tienan_feng@126.com。*为共同第一作者。
  • 基金资助:
    长宁区2018年校企合作人才共育项目培育支持计划(XQHZRC2018)。

Analysis and consideration of registration information of global coronavirus disease 2019 clinical study

QU Tian-tian1, 2*, FENG Tie-nan1, 2*, JIANG Jia-yuan1, 2, ZHANG Fan1, 2, QIAN Bi-yun1, 2   

  1. 1. Hongqiao International Institute of Medicine, Tongren Hospital, Shanghai Jiao Tong University School of Medicine, Shanghai 200050, China; 2. Clinical Research Center, Shanghai Jiao Tong University School of Medicine, Shanghai 200025, China
  • Online:2020-06-28 Published:2020-08-11
  • Supported by:
    The School-Enterprise Cooperation Project of Changning District in 2018 (XQHZRC2018).

摘要: 目的·通过分析已注册临床研究的注册特征,发现针对新型冠状病毒SARS-CoV-2(severe acute respiratory syndrome coronavirus 2)开展的临床研究的科学性及可行性问题,为后续研究注册的良好管理提供借鉴。方法·制定新型冠状病毒肺炎(coronavirus disease 2019,COVID-19)的检索关键词,于中国临床试验注册中心与ClinicalTrials官方网站进行检索。对注册信息中的伦理状况、入组人数、预计用时、分组数量、介入方式、研究终点类型、撤销情况、随机对照试验(randomized controlled trial,RCT)、研究分期、注册类型、分布省份、入组患者病情等注册特征进行归纳,并采用IBM SPSS 22.0软件对上述特征进行统计分析。结果·共计收集400项COVID-19注册临床研究。其中,有59项研究未通过伦理审批,15项研究已撤销,303项研究分期不明确,该3个特征在2个官方网站间的差异均具有统计学意义(均P<0.05);有14项研究入组人数超过1 000人,189项研究预计用时超过6个月,22项研究分组数量超过4组,且该3个特征在2个官方网站间差异均无统计学意义;仅有15项研究为企业主导发起;同时,多数研究分布在湖北省。结论·中国研究者发起COVID-19临床研究的注册意识有所增强,但通过整理分析注册信息发现,临床研究存在设计不严谨的问题,需加强研究注册的质量管理,增强研究设计的方法学论证。

关键词: 新型冠状病毒, 临床研究注册, 注册特征, 研究设计

Abstract: Objective · To analyze the registration characteristics of registered clinical research, and find the potential scientific and feasibility problems of clinical research on severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), providing reference for the good management of follow-up research registration. Methods · The key words of coronavirus disease 2019 (COVID-19) were identified and retrieved from Chinese Clinical Trial Registry and ClinicalTrials website. The registration characteristics of ethical status, number of recruits, total time, number of groups, intervention, study endpoint type, withdrawal, randomized controlled trial (RCT), stage, registration type, provinces distribution and patients' condition were summarized. IBM SPSS 22.0 software was used to analyze the above characteristics. Results · A total of 400 registered clinical studies were collected. Among them, 59 studies were not ethically approved, 15 studies were withdrawn, and stages of 303 studies were unclear. The differences of the three registration characteristics on the two official websites were statistically significant (all P<0.05). Fourteen studies recruited more than 1 000 people, the total time of 189 studies exceeded 6 months, and the number of groups in 22 studies exceeded 4 groups. There was no significant difference in the three registration characteristics on the two official websites. Only 15 studies were industry-sponsored trial. Most registered clinical studies were distributed in Hubei Province. Conclusion · The awareness of Chinese investigator initiating trial registration has increased. However, by collating and analyzing the registration information, it is found that the study design is not rigorous, so it is necessary to strengthen the registration quality management and study design methodological demonstration.

Key words: SARS-CoV-2 (severe acute respiratory syndrome coronavirus 2), clinical study registration, registration characteristics, study design

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