Wang Bin, Lai Junkai, Yan Xiaoyan, Jin Feifei, Yi Bin, An Caixia, Li Yuanxiao, Yao Chen
Department of Biostatistics, Peking University First Hospital, Beijing, People's Republic of China.
Peking University Clinical Research Institute, Beijing, People's Republic of China.
Drug Des Devel Ther. 2020 Nov 19;14:5097-5108. doi: 10.2147/DDDT.S281700. eCollection 2020.
This study aims to comprehensively evaluate the characteristics of clinical drug trials to facilitate the collection of evidence for COVID-19 drug treatments.
A retrospective analysis of 910 trials retrieved on August 7, 2020.
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.
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.
本研究旨在全面评估新冠病毒疾病临床试验的特征，以促进新冠病毒疾病药物治疗证据的收集。
对2020年8月7日检索到的910项试验进行回顾性分析。
共评估了910项至少有一项药物干预的注册临床试验。来自美国的注册数量（32.4%，295项）占总数的近三分之一，远超其他国家的数量。此外，试验注册的高峰期在4月（34.3%，312项）。超过一半的试验（51.2%，466项）处于招募阶段，只有4.2%（38项）的试验已经完成。估计入组人数的中位数（四分位间距）为127（59，365）。在39%（355项）的试验中，估计入组人数少于100名参与者。共有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）使用盲法。共有287种药物名称已标准化并进行了映射。“羟氯喹”是注册试验中使用最多的药物（7.47%，68项）。在对“羟氯喹”进行研究的主要国家中，美国以36.76%（25项）的试验位居第一。
新冠病毒疾病临床药物试验的设计在随机化尤其是盲法的实施方面有了很大改进。在药物复用方面，药物种类大幅增加，数百种药物已用于疗效筛选。大样本注册试验的出现有望解决当前一些药物临床疗效的不确定性问题。
