Drug clinical trial of COVID-19 in China: A brief analysis

X. Mu, Y. Zhao, L. Zhang, Y. Cui, Y. Zhang, G. Du
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Abstract

AIM: To provide suggestion for research and development of drugs against coronavirus disease 2019 (COVID-19) by analyzing the characteristics of the drug clinical trial registration information of COVID-19 in China METHODS: The clinical trials of COVID-19 were searched from Chinese Clinical Trial Registry, and the type, purpose, and design of the studies were analyzed RESULTS: Totally 271 drug clinical trials have been registered till July 1st, 2020 Most of the drugs are marketed ones, including chemical drugs, traditional Chinese medicines, and biologics Combined applications were adopted in some projects Randomized or non-randomized parallel control trials were conducted in most projects Others included single arm, sequential, and factorial design CONCLUSION: To deal with the epidemic, it is important to conduct emergent drug clinical trials to find out effective drugs as soon as possible However, some weaknesses and deficiencies on trials design, conduct and supervision were exposed in the drug clinical trials against COVID-19 It is suggested to enhance the scientific evaluation of candidate drugs, standardize the investigator initiated trials, and establish the national multi-subject research and development platform, and the collaborative and innovative key-task tackling mechanism, thus to improve the ability and level of antiviral drug research and development
中国新冠肺炎药物临床试验分析
目的:通过分析新冠肺炎药物临床试验注册信息的特点,为2019冠状病毒病(新冠肺炎)药物的研发提供建议,结果:截至2020年7月1日,共有271项药物临床试验注册。大多数药物是上市药物,包括化学药物、中药和生物制品。一些项目采用联合应用。大多数项目进行随机或非随机平行对照试验。其他项目包括单臂,结论:为应对疫情,应尽快开展应急药物临床试验,找出有效药物。但新冠肺炎药物临床试验在试验设计、实施和监督方面暴露出一些薄弱环节和不足,规范研究者启动试验,建立国家多学科研发平台和协同创新攻关机制,提高抗病毒药物研发能力和水平
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