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

Satoshi Nishiwaki,Yuichi Ando

doi:10.3389/fmed.2021.812370

Satoshi Nishiwaki, Yuichi Ando

Open Access

https://doi.org/10.3389/fmed.2021.812370

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Journal: Frontiers in Medicine	Publication Date: Dec 24, 2021
Citations: 7	License type: CC BY 4.0

Affiliation: Nagoya University Hospital

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.

Highlights

The coronavirus disease 2019 (COVID-19) pandemic is having an enormous impact on our various activities, with total case numbers reaching more than 240 million as of October 2021.Heath systems and economies around the world have been severely damaged; there is a concern that the development of medical technology, including the development of new drugs, will be hindered
The percentage change in newly started clinical trials for diseases other than COVID-19 in April 2020 by region are shown in Supplementary Figure 1, and the relationship between the percentage decrease and the prevalence of COVID-19 by region is shown in Supplementary Figure 2
There was a correlation between the percentage change and the prevalence of COVID19 in regions where more than 30 clinical trials were started in April 2020 (r = −0.83; Figure 2)

Summary

Introduction

The coronavirus disease 2019 (COVID-19) pandemic is having an enormous impact on our various activities, with total case numbers reaching more than 240 million as of October 2021. Heath systems and economies around the world have been severely damaged; there is a concern that the development of medical technology, including the development of new drugs, will be hindered. The U.S Food and Drug Administration (FDA) has released guidance for conducting clinical trials during the COVID-19 pandemic [1]. In addition to the flexible regulatory response under the pandemic, it is important to balance the budget and manpower between non-COVID-19 and COVID-19 studies. The importance of maintaining the integrity of clinical trials has been pointed out [2], analyses of the impact of the COVID-19 pandemic on conducting clinical trials, especially during the first wave, have been inadequate [3]

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