新型冠状病毒肺炎防治临床试验注册项目的分析与思考

Analysis and Consideration on Clinical Trials of COVID-19

关键词:  新型冠状病毒  肺炎  临床试验

Key words:  SARS-CoV-2  pneumonia  clinical trial

摘要:

目的 通过多维度分析已注册新型冠状病毒感染肺炎防治的临床研究信息，为疫情防控时期其他临床研究的开展提供数据和经验。方法 检索中国临床试验注册中心网站（Chictr.org.cn）和美国国立卫生研究院临床试验注册平台（ClinicalTrials.gov），根据临床试验研究设计、研究类型、中心数、组长单位所在地及受试人群等方面评价已注册项目整体情况，并从研究对象层面探讨现有药物及非药物治疗相关试验情况。结果 截至2020年2月7日，共有45项临床试验完成注册，其中41项（占91.1%）为药物治疗临床研究，涉及抗病毒药物治疗、激素治疗、中药/中成药治疗的项目分别为18，2和21项。随机对照临床试验是注册项目中常见的研究设计，在已统计数据中，44项（占97.8%）为干预性研究，组长单位地域多在湖北、北京、浙江、广东等地，样本量≤ 100例的占比较大（51.1%）。结论 在疫情全面暴发且尚无特效救治药物的情况下，临床试验的迅速开展，为积极寻求药物治疗方案并战胜疾病提供了更多可能。

Abstract:

OBJECTIVE To multi-dimensional analyze registration information of clinical trials of COVID-19, so as to provide data and experience for other clinical trials during the epidemic control period. METHODS Overall situation of registered projects was objectively evaluated in terms of clinical trial design, study type, number of centres, the location of the group leader, and subject population by searching through both of the Chinese Clinical Trial Registry site(Chictr.org.cn) and the National Institutes of Health clinical trial registration platform(ClinicalTrials.gov). In addition, from the perspective of the research object, the related trials of both listed medication and non-medication treatments were discussed. RESULTS By February 7, 2020, a total of 45 clinical trials had been registered, of which 41(91.1%) were medication therapy clinical trials. The number of items involved in antiviral therapy, hormone therapy, and traditional Chinese medicine treatment was 18, 2 and 21, respectively. Randomized controlled clinical trials were the common study designs in registered programs and 44(97.8%) were intervention studies among the statistics. Most of the group leaders were located in Hubei, Beijing, Zhejiang and Guangdong, and the proportion of sample size within 100 cases(≤ 100) was relatively large(51.1%). CONCLUSION In the absence of specific medication treatment for the current outbreak, the rapid development of clinical trials of the therapeutic drugs can provide a more favourable chance of seeking suitable drug treatment options and suppress the pandemic.