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

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 obtain...

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Autores principales: Nishiwaki, Satoshi, Ando, Yuichi
Formato: Online Artículo Texto
Lenguaje:English
Publicado: Frontiers Media S.A. 2021
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8739772/
https://www.ncbi.nlm.nih.gov/pubmed/35004791
http://dx.doi.org/10.3389/fmed.2021.812370
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author Nishiwaki, Satoshi
Ando, Yuichi
author_facet Nishiwaki, Satoshi
Ando, Yuichi
author_sort Nishiwaki, Satoshi
collection PubMed
description 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.
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spelling pubmed-87397722022-01-08 COVID-19 Pandemic and Trends in Clinical Trials: A Multi-Region and Global Perspective Nishiwaki, Satoshi Ando, Yuichi Front Med (Lausanne) Medicine 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. Frontiers Media S.A. 2021-12-24 /pmc/articles/PMC8739772/ /pubmed/35004791 http://dx.doi.org/10.3389/fmed.2021.812370 Text en Copyright © 2021 Nishiwaki and Ando. https://creativecommons.org/licenses/by/4.0/This is an open-access article distributed under the terms of the Creative Commons Attribution License (CC BY). The use, distribution or reproduction in other forums is permitted, provided the original author(s) and the copyright owner(s) are credited and that the original publication in this journal is cited, in accordance with accepted academic practice. No use, distribution or reproduction is permitted which does not comply with these terms.
spellingShingle Medicine
Nishiwaki, Satoshi
Ando, Yuichi
COVID-19 Pandemic and Trends in Clinical Trials: A Multi-Region and Global Perspective
title COVID-19 Pandemic and Trends in Clinical Trials: A Multi-Region and Global Perspective
title_full COVID-19 Pandemic and Trends in Clinical Trials: A Multi-Region and Global Perspective
title_fullStr COVID-19 Pandemic and Trends in Clinical Trials: A Multi-Region and Global Perspective
title_full_unstemmed COVID-19 Pandemic and Trends in Clinical Trials: A Multi-Region and Global Perspective
title_short COVID-19 Pandemic and Trends in Clinical Trials: A Multi-Region and Global Perspective
title_sort covid-19 pandemic and trends in clinical trials: a multi-region and global perspective
topic Medicine
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8739772/
https://www.ncbi.nlm.nih.gov/pubmed/35004791
http://dx.doi.org/10.3389/fmed.2021.812370
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