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Review
. 2021 Apr 30;3(2):62-66.
doi: 10.35772/ghm.2020.01106.

Investigator initiated clinical trial of remdesivir for the treatment of COVID-19 in Japan

Sho Saito  1 , Kayoko Hayakawa  1 , Ayako Mikami  2 , Shinyu Izumi  3 , Hideki Funazaki  4 , Shinobu Ashida  1 , Wataru Sugiura  2 , Haruhito Sugiyama  5 , Norihiro Kokudo  5 , Norio Ohmagari  1
Affiliations
Review

Investigator initiated clinical trial of remdesivir for the treatment of COVID-19 in Japan

Sho Saito et al. Glob Health Med. .

Abstract

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.

Keywords: SARS-CoV-2; clinical trial; infectious diseases.

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Conflict of interest statement

S.S. received a grant from Shionogi, and N.O. received grants from Sanofi Pasteur. Other authors have no conflicts of interest to disclose.

Figures

Figure 1.
Figure 1.
Approval process of investigator-initiated clinical trials in Japan. IRB: Institutional Review Board; CTN: Clinical Trial Notification; PMDA: Pharmaceuticals and Medical Devices Agency.
See this image and copyright information in PMC

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