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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...
Autores principales: | , |
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Formato: | Online Artículo Texto |
Lenguaje: | English |
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Frontiers Media S.A.
2021
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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. |
format | Online Article Text |
id | pubmed-8739772 |
institution | National Center for Biotechnology Information |
language | English |
publishDate | 2021 |
publisher | Frontiers Media S.A. |
record_format | MEDLINE/PubMed |
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 |
work_keys_str_mv | AT nishiwakisatoshi covid19pandemicandtrendsinclinicaltrialsamultiregionandglobalperspective AT andoyuichi covid19pandemicandtrendsinclinicaltrialsamultiregionandglobalperspective |