摘要
系统汇总自COVID-19疫情出现以来所有的国内外临床试验的进展情况及过去一年的人体挑战研究(Human challenge study,HCS)概况,掌握伦理审查的相关信息,探讨人体挑战研究的可行性,为利益相关方提供参考。基于中国临床试验注册中心和clinical trial.gov搜索与COVID-19相符的临床试验,时间截止到2020年6月11日,摘录基本信息,并分别从研究类型、临床分期、征募情况及伦理通过情况筛选试验数;基于Pub Med开展文献检索,时间范围为2019年1月1日至2020年6月11日,针对纳入文献进行基本信息的摘录、报告对HCS的看法。分别有638个、1935个临床试验在国内及国外进行,其中在湖北进行的临床试验数量达到323项;中国和美国进行了较多的干预性试验,另外,美国有最多的临床试验进入到了Ⅱ期,共有142项;大部分的临床试验处于征募研究对象的阶段;此外,国内总共有539项临床试验通过了伦理审批。人体挑战研究中共纳入5篇文献,共有4篇文献对HCS保有积极的态度,并对伦理审查提出了相应的思考。新冠肺炎疫情下,针对新药和新型冠状病毒疫苗的临床试验迅速增多,这对伦理审查的进度提出了更高的要求,面对此类突发公共卫生事件以及相应的特殊研究,建立健全伦理审查体系和伦理审查制度,构建特殊研究的伦理模型迫在眉睫。
To review systematically the progress of all domestic and foreign clinical trials since the emergence of the COVID-19 epidemic and the overview of human challenge study(HCS)in the past year,grasp relevant information of ethical review,and explores the feasibility of human challenge study and provide references for stake holders.Based on the Chinese Clinical Trial Registration Center and clinical trial.gov,clinical trials that were consistent with COVID-19 was searched,and the deadline was June 11,2020.Basic information was extracted and the number of trials was selected from the research type,clinical stage,recruitment status,and ethical passing status.Literature search was conducted based on Pubmed between January 1,2019 and June 11,2020.According to the included literature,basic information was extracted and opinions were reported on HCS.638 and 1935 clinical trials were carried out at home and abroad respectively,of which the number of clinical trials carried out in Hubei reached 323.China and the United States conducted more interventional trials,and the United States had the most clinical trials entered in Phase Ⅱ,there were a total of 142.Most of the clinical trials were in the stage of recruiting research subjects.In addition,a total of 539 clinical trials in China had passed ethical approval.A total of 5 documents were included in the Human Challenge Study,four maintained a positive attitude towards HCS and put forward corresponding thinking about ethical review.Under the COVID-19,clinical trials for new drugs and new coronavirus vaccines have rapidly increased,which puts forward higher requirements for the progress of ethical review.In the face of such public health emergencies and special research,it is urgent to establish a sound ethical review system and an ethical review system,as well as to construct an ethical model for special research.
作者
吴琼
董平平
徐晓莉
干振华
杨芳青
曹晓梅
WU Qiong;DONG Ping-ping;XU Xiao-li;GAN Zhen-hua;YANG Fang-qing;CAO Xiao-mei(General Hospital of Eastern theater of PLA,Nanjing 210000,China)
出处
《药物生物技术》
CAS
2021年第4期400-404,共5页
Pharmaceutical Biotechnology
