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. 2021 Dec 24:8:812370.
doi: 10.3389/fmed.2021.812370. eCollection 2021.

COVID-19 Pandemic and Trends in Clinical Trials: A Multi-Region and Global Perspective

Satoshi Nishiwaki  1 , Yuichi Ando  1
Affiliations

COVID-19 Pandemic and Trends in Clinical Trials: A Multi-Region and Global Perspective

Satoshi Nishiwaki et al. Front Med (Lausanne). .

Abstract

To evaluate the effect of the COVID-19 pandemic on clinical development, the number of newly started clinical trials in each geographical region between January 2018 and December 2020 were calculated based on data from the ClinicalTrials.gov database. Data regarding new drug applications were obtained from European Medicines Agency monthly reports, pharmaceutical company press releases, and the archives of the Drugs.com database. The mean percentage change in newly started clinical trials for diseases other than COVID-19 between each month in 2019 and the corresponding month in 2020 was -7.5%, with the maximum of -57.3% observed between April 2019 and April 2020. Similarly, the mean percentage change of reported results for each month in 2019 and 2020 was -5.1%, with the maximum of -27.4% observed in July 2020. The activity of clinical trials was decreased as the number of COVID-19 patients was increased, and a statistically negative correlation was observed between the prevalence of COVID-19 and the percentage decrease in the number of clinical trials stared or reported results. As for new drug submissions, decreases were observed in the latter half of 2020 compared with the same period during the previous year, for each indicator. A considerable decline in non-COVID-19 activity for all indicators regarding clinical developments was suggested during the first wave of the COVID-19 pandemic. It is important to recognize the situation and continue to make efforts to conduct clinical trials for both COVID-19 and no-COVID-19 for new medical developments in the future.

Keywords: COVID-19 pandemic; clinical development; clinical trial; new drug application; non-COVID-19 activity.

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Conflict of interest statement

YA reports grants and personal fees from Chugai Pharmaceutical Co., Ltd., Kyowa Hakko Kirin Co., Ltd., Nippon Kayaku Co., Ltd., Yakult Honsha Co., Ltd., Eli Lilly Japan K.K., Mochida Pharmaceutical Co., Ltd., Ono Pharmaceutical Co., Ltd., and Taiho Pharmaceutical Co., Ltd., personal fees from Novartis Pharma K.K., Merck Serono Co., Ltd., Bayer Holding Ltd., Bristol-Myers Squibb, Otsuka Holdings Co., Ltd., and Sawai Pharmaceutical Co., Ltd., grants and personal fees from Daiichi Sankyo Company, Ltd., grants from Eisai Co., Ltd., Hisamitsu Pharmaceutical Co., Inc., and Takeda Pharmaceutical Co., Ltd., personal fees from Tsumura & Co., Shionogi & Co., Ltd., Janssen Pharmaceutical K.K., and Pharma International Inc., outside the submitted work. The remaining author declares that the research was conducted in the absence of any commercial or financial relationships that could be construed as a potential conflict of interest.

Figures

Figure 1
Figure 1
Number of newly started clinical trials. (A) Number of newly started clinical trials for diseases other than COVID-19; (B) Percentage change of newly started clinical trials for diseases other than COVID-19.
Figure 2
Figure 2
Relationship between total cases of COVID-19 and percentage change of the number of newly started clinical trials for diseases other than COVID-19 in regions with more than 30 studies, April 2020. The size of the bubbles reflected the number of studies.
Figure 3
Figure 3
Number of clinical trial results reported. (A) Number of clinical trials for diseases other than COVID-19 with results; (B) Percentage change of clinical trials for diseases other than COVID-19 with results.
Figure 4
Figure 4
Relationship between total cases of COVID-19 and percentage change of the number of clinical trials with results in regions with more than 30 studies, May 2020. The size of the bubbles reflected the number of studies.
Figure 5
Figure 5
Number and percentage change of new drug applications to regulatory authorities. (A) Number of applications started in EMA; (B) Percentage change of applications started in EMA; (C) Number of pharmaceutical company press release regarding NDA or BLA to FDA; (D) Percentage change of pharmaceutical company press release regarding NDA or BLA to FDA; (E) Number of new drug application archives in the Drugs.com database; (F) Percentage change of new drug application archives in the Drugs.com database.
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