| 我国COVID-19相关临床试验注册特点及存在的伦理学问题 |
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| 引用本文： | 毛玉锋,刘诗洋,郭玉明,李元元,王福生.我国COVID-19相关临床试验注册特点及存在的伦理学问题[J].蚌埠医学院学报,2023,48(1):14-18, 22. |
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| 作者姓名： | 毛玉锋 刘诗洋 郭玉明 李元元 王福生 |
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| 作者单位： | 1.蚌埠医学院, 安徽 蚌埠 2330302.中国人民解放军总医院第五医学中心 感染病医学部, 北京 100039 |
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| 基金项目： | 传染病突发事件的伦理问题与监管XBKJLL2020001 |
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| 摘 要： | 目的：通过对我国新型冠状病毒感染(COVID-19)相关临床试验注册信息多角度分析，探讨其中存在的伦理学问题，以期为新突发传染病等公共卫生事件临床伦理的规范化提供依据。方法：在美国临床试验注册中心(ClinicalTrials.gov)和中国临床试验注册中心(ChiCTR)使用“新型冠状病毒”“COVID-19”等关键词检索2020年1月1日至2022年11月15日注册的COVID-19相关临床试验，归纳分析其注册的时空分布特点、研究类型、干预措施、研究状态及伦理等信息，发现并探讨相关伦理学问题。结果：共纳入1 560项COVID-19相关的临床试验，其中ClinicalTrials.gov注册481项，ChiCTR注册1 079项。临床试验注册高峰期集中在2020年2-4月；根据省级行政区划分湖北省、上海市、北京市临床试验注册量较多。干预性研究(843/1 560,54.00%)在所有注册类型中占比最高，注册内容涉及疫苗(202/843,23.96%)、化学药品(193/843,22.89%)、中医药(153/843,18.15%)及生物制品(90/843,10.68%)等多个方面；...
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| 关 键 词： | 新型冠状病毒感染 临床试验 注册 伦理 |
| 收稿时间： | 2022-12-06 |
Ethical issues arising from characteristics of COVID-19 clinical trials registration in china |
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| Affiliation: | 1.Bengbu Medical College, Bengbu Anhui 2330302.Department of Infectious Diseases Medicine, Fifth Medical Center of Chinese PLA General Hospital, Beijing 100039, China |
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| Abstract: | ObjectiveBy analyzing the information on COVID-19-related clinical trial registration in China from multiple perspectives, we explore the ethical issues involved to provide a basis for the standardization of clinical ethics for public health events such as emerging infectious diseases.MethodsWe searched ClinicalTrials.gov and China Clinical Trials Registry (ChiCTR) for COVID-19-related clinical trials registered from January 1, 2020, to November 15, 2022, using keywords such as "2019-nCoV" and "COVID-19".We summarized and analyzed information on the spatial and temporal distribution characteristics, study types, interventions, study status, and ethics of clinical trial registration to identify and explore the ethical issues.ResultsA total of 1 560 COVID-19-related clinical trials were included, of which 481 were registered on ClinicalTrials.gov and 1 079 were registered on ChiCTR.The peak period of clinical trial registration mas concentrated from February to April 2020;the number of clinical trials registration in Hubei, Shanghai, and Beijing was the Top 3 among all of the provincial administrative regions in China.Interventional studies (843/1 560, 54.00%) accounted for the highest percentage of all registration types, with registrations involving vaccines(202/843, 23.96%), chemicals(193/843, 22.89%), Chinese medicine(153/843, 18.15%) and biologics(90/843, 10.68%), and many other categories; the clinical trials that lacked informed consent, lacked ethical review and chose not to disclose trial results accounted for 11.40%(178/1 560), 3.33%(52/1 560) and 19.66%(307/1 560), respectively.ConclusionsAt present, there are a large number of COVID-19-related clinical trials registered, but the scientific and ethical norms of some clinical trials still need to be regulated and improved. |
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