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COVID-19 Clinical Trials Registered Worldwide for Drug Intervention: An Overview and Characteristic Analysis
Drug Design, Development and Therapy ( IF 4.7 ) Pub Date : 2020-11-19 , DOI: 10.2147/dddt.s281700 Bin Wang 1 , Junkai Lai 1 , Xiaoyan Yan 2 , Feifei Jin 1 , Bin Yi 3 , Caixia An 3 , Yuanxiao Li 4 , Chen Yao 1, 2
Drug Design, Development and Therapy ( IF 4.7 ) Pub Date : 2020-11-19 , DOI: 10.2147/dddt.s281700 Bin Wang 1 , Junkai Lai 1 , Xiaoyan Yan 2 , Feifei Jin 1 , Bin Yi 3 , Caixia An 3 , Yuanxiao Li 4 , Chen Yao 1, 2
Affiliation
Objective: This study aims to comprehensively evaluate the characteristics of clinical drug trials to facilitate the collection of evidence for COVID-19 drug treatments.
Methods: A retrospective analysis of 910 trials retrieved on August 7, 2020.
Results: A total of 910 registered clinical trials with at least one drug intervention were evaluated. The number of registrations (32.4%, 295) from the United States accounted for nearly one-third of the total and far exceeded that of other countries individually. Furthermore, the peak number of trials were registered in April (34.3%, 312). Over half of the trials (51.2%, 466) are in the recruitment phase, and only 4.2% (38) of the trials have been completed. The median (interquartile range) estimated enrollment is 127 (59, 365). In 39% (355) of trials, the estimated enrollment is less than 100 participants. A total of 94.5% (790) of the trials use randomization in the allocation, 82.7% (753) use a parallel intervention mode, and 52.2% (475) use masking. A total of 287 drug names have been standardized and mapped. “Hydroxychloroquine” is the leading drug among the registered trials (7.47%, 68). Among the main countries contributing to investigations on “hydroxychloroquine”, the United States ranks first with 36.76% (25) of the trials.
Conclusion: The designs of COVID-19 clinical drug trials have greatly improved in terms of the implementation of randomization and, particularly, blinding methods. In terms of drug reuse, the number of drug types has greatly increased, and hundreds of drugs have been used for efficacy screening. The emergence of large-sample registration trials is expected to address the uncertainty regarding the current clinical efficacy of some drugs.
Keywords: COVID-19, clinical trials, investigation, intervention, drug, treatment
中文翻译：
全球注册的 COVID-19 药物干预临床试验：概述和特征分析
目的：本研究旨在综合评价临床药物试验的特点，以利于收集COVID-19药物治疗的证据。
方法：对 2020 年 8 月 7 日检索的 910 项试验进行回顾性分析。
结果：总共评估了 910 项至少有一种药物干预的注册临床试验。来自美国的注册数量（32.4%，295件）占总数的近三分之一，远远超过其他国家的注册数量。此外，4月份的试验数量达到顶峰（34.3%，312）。超过一半的试验（51.2%，466）处于招募阶段，只有 4.2%（38）的试验已经完成。预计入学人数中位数（四分位距）为 127 人 (59, 365)。在 39% (355) 的试验中，预计入组人数少于 100 名参与者。总共 94.5%（790 项）的试验在分配中使用随机化，82.7%（753 项）使用平行干预模式，52.2%（475 项）使用掩蔽。共有287个药物名称已被标准化和映射。 “羟氯喹”是注册试验中的领先药物（7.47%，68）。在对“羟氯喹”调查做出贡献的主要国家中，美国以36.76%（25项）的试验排名第一。
结论： COVID-19临床药物试验的设计在随机化、特别是盲法的实施方面有了很大的改进。在药品重复利用方面，药品种类大幅增加，数百种药品已用于药效筛选。大样本注册试验的出现有望解决一些药物目前临床疗效的不确定性。
关键词： COVID-19、临床试验、调查、干预、药物、治疗
更新日期：2020-11-19
Methods: A retrospective analysis of 910 trials retrieved on August 7, 2020.
Results: A total of 910 registered clinical trials with at least one drug intervention were evaluated. The number of registrations (32.4%, 295) from the United States accounted for nearly one-third of the total and far exceeded that of other countries individually. Furthermore, the peak number of trials were registered in April (34.3%, 312). Over half of the trials (51.2%, 466) are in the recruitment phase, and only 4.2% (38) of the trials have been completed. The median (interquartile range) estimated enrollment is 127 (59, 365). In 39% (355) of trials, the estimated enrollment is less than 100 participants. A total of 94.5% (790) of the trials use randomization in the allocation, 82.7% (753) use a parallel intervention mode, and 52.2% (475) use masking. A total of 287 drug names have been standardized and mapped. “Hydroxychloroquine” is the leading drug among the registered trials (7.47%, 68). Among the main countries contributing to investigations on “hydroxychloroquine”, the United States ranks first with 36.76% (25) of the trials.
Conclusion: The designs of COVID-19 clinical drug trials have greatly improved in terms of the implementation of randomization and, particularly, blinding methods. In terms of drug reuse, the number of drug types has greatly increased, and hundreds of drugs have been used for efficacy screening. The emergence of large-sample registration trials is expected to address the uncertainty regarding the current clinical efficacy of some drugs.
Keywords: COVID-19, clinical trials, investigation, intervention, drug, treatment
中文翻译：
全球注册的 COVID-19 药物干预临床试验：概述和特征分析
目的：本研究旨在综合评价临床药物试验的特点，以利于收集COVID-19药物治疗的证据。
方法：对 2020 年 8 月 7 日检索的 910 项试验进行回顾性分析。
结果：总共评估了 910 项至少有一种药物干预的注册临床试验。来自美国的注册数量（32.4%，295件）占总数的近三分之一，远远超过其他国家的注册数量。此外，4月份的试验数量达到顶峰（34.3%，312）。超过一半的试验（51.2%，466）处于招募阶段，只有 4.2%（38）的试验已经完成。预计入学人数中位数（四分位距）为 127 人 (59, 365)。在 39% (355) 的试验中，预计入组人数少于 100 名参与者。总共 94.5%（790 项）的试验在分配中使用随机化，82.7%（753 项）使用平行干预模式，52.2%（475 项）使用掩蔽。共有287个药物名称已被标准化和映射。 “羟氯喹”是注册试验中的领先药物（7.47%，68）。在对“羟氯喹”调查做出贡献的主要国家中，美国以36.76%（25项）的试验排名第一。
结论： COVID-19临床药物试验的设计在随机化、特别是盲法的实施方面有了很大的改进。在药品重复利用方面，药品种类大幅增加，数百种药品已用于药效筛选。大样本注册试验的出现有望解决一些药物目前临床疗效的不确定性。
关键词： COVID-19、临床试验、调查、干预、药物、治疗
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