Investigator initiated clinical trial of remdesivir for the treatment of COVID-19 in Japan
Investigator initiated clinical trial of remdesivir for the treatment of COVID-19 in Japan
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DOI：
10.35772/ghm.2020.01106
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发表时间：
2021-01-01
期刊：
影响因子：
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通讯作者：
Ohmagari, Norio
中科院分区：
文献类型：
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作者：
Saito, Sho;Hayakawa, Kayoko;Ohmagari, Norio
冠状病毒病（COVID-19）由源自中国武汉的严重急性呼吸道综合征冠状病毒2（SARS-CoV-2）引起，已在全球迅速蔓延。2020年3月下旬至4月上旬，日本的COVID-19患者人数有所增加。由于抗病毒药物治疗COVID-19的方法于二零二零年三月尚未确立，临床试验在全球范围内迅速展开。我们参与了一项由制药商发起的抗病毒药物remdesivir的全球临床试验。准备和开始患者入组大约花了两个月的时间，在日本入组所有患者需要26天，从入组结束到发布第一份报告需要32天，总体反应相当迅速。在临床试验过程中，我们发现在日本进行传染病临床试验的一些关键问题需要得到解决和解决，以支持快速反应。这些问题包括需要建立一个研究网络来促进临床研究，建立一个临床试验通知快速审查制度的框架，以及加强与外包团队的合作。此外，日本要在传染病领域的全球合作研究和开发中发挥带头作用，就必须在国家基础上进一步发展人力资源和组织。日本在国家层面建立临床试验制度，为今后新发和再发传染病做好准备，是必不可少的。
Coronavirus disease (COVID-19), caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) originating in Wuhan, China, has spread globally very rapidly. The number of COVID-19 patients increased in Japan from late March to early April 2020. Since COVID-19 treatment methods with antiviral drugs were not established in March 2020, clinical trials began at a rapid pace worldwide. We participated in a global investigator-initiated clinical trial of the antiviral drug remdesivir. It took approximately two months to prepare for and start patient enrollment, 26 days to enroll all patients in Japan, and 32 days from the end of enrollment to the release of the first report, a fairly quick response overall. In the course of this clinical trial, we found some of the critical issues related to conducting an infectious disease clinical trial in Japan need to be addressed and tackled to support a rapid response. These included such things as the necessity of a research network to promote clinical research, a framework for a rapid review system of clinical trial notification, and better cooperation with outsourced teams. Furthermore, for Japan to take the lead in global collaborative research and development in the field of infectious diseases, it is necessary to develop further human resources and organization on a national basis. It is indispensable for Japan to establish a clinical trial system at the national level to prepare for future emerging and re-emerging infectious diseases.