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Quantifying the impact of the COVID-19 pandemic on clinical trial screening rates over time in 37 countries

The COVID-19 pandemic has had an unprecedented and disruptive impact on people’s health and lives worldwide. In addition to burdening people’s health in the short-term in the form of infection, illness, and mortality, there has been an enormous negative impact on clinical research. Clinical trials e...

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Autores principales: McDonald, Kelsey, Seltzer, Earl, Lu, Mary, Gaisenband, Stefan Diaz, Fletcher, Cassandra, McLeroth, Patrick, Saini, Kamal S
Formato: Online Artículo Texto
Lenguaje:English
Publicado: BioMed Central 2023
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10071259/
https://www.ncbi.nlm.nih.gov/pubmed/37013558
http://dx.doi.org/10.1186/s13063-023-07277-1
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author McDonald, Kelsey
Seltzer, Earl
Lu, Mary
Gaisenband, Stefan Diaz
Fletcher, Cassandra
McLeroth, Patrick
Saini, Kamal S
author_facet McDonald, Kelsey
Seltzer, Earl
Lu, Mary
Gaisenband, Stefan Diaz
Fletcher, Cassandra
McLeroth, Patrick
Saini, Kamal S
author_sort McDonald, Kelsey
collection PubMed
description The COVID-19 pandemic has had an unprecedented and disruptive impact on people’s health and lives worldwide. In addition to burdening people’s health in the short-term in the form of infection, illness, and mortality, there has been an enormous negative impact on clinical research. Clinical trials experienced challenges in ensuring patient safety and enrolling new patients throughout the pandemic. Here, we investigate and quantify the negative impact that the COVID-19 pandemic has industry-sponsored clinical trials, both in the USA and worldwide. We find a negative correlation between the severity of the COVID-19 pandemic and clinical trial screening rate, with the relationship being strongest during the first three months of the pandemic compared to the entire duration of the pandemic. This negative statistical relationship holds across therapeutic areas, across states in the USA despite the heterogeneity of responses at the state-level, and across countries. This work has significant implications for the management of clinical trials worldwide in response to the fluctuating severity of COVID-19 moving forward and for future pandemics.
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spelling pubmed-100712592023-04-04 Quantifying the impact of the COVID-19 pandemic on clinical trial screening rates over time in 37 countries McDonald, Kelsey Seltzer, Earl Lu, Mary Gaisenband, Stefan Diaz Fletcher, Cassandra McLeroth, Patrick Saini, Kamal S Trials Commentary The COVID-19 pandemic has had an unprecedented and disruptive impact on people’s health and lives worldwide. In addition to burdening people’s health in the short-term in the form of infection, illness, and mortality, there has been an enormous negative impact on clinical research. Clinical trials experienced challenges in ensuring patient safety and enrolling new patients throughout the pandemic. Here, we investigate and quantify the negative impact that the COVID-19 pandemic has industry-sponsored clinical trials, both in the USA and worldwide. We find a negative correlation between the severity of the COVID-19 pandemic and clinical trial screening rate, with the relationship being strongest during the first three months of the pandemic compared to the entire duration of the pandemic. This negative statistical relationship holds across therapeutic areas, across states in the USA despite the heterogeneity of responses at the state-level, and across countries. This work has significant implications for the management of clinical trials worldwide in response to the fluctuating severity of COVID-19 moving forward and for future pandemics. BioMed Central 2023-04-04 /pmc/articles/PMC10071259/ /pubmed/37013558 http://dx.doi.org/10.1186/s13063-023-07277-1 Text en © The Author(s) 2023 https://creativecommons.org/licenses/by/4.0/Open AccessThis article is licensed under a Creative Commons Attribution 4.0 International License, which permits use, sharing, adaptation, distribution and reproduction in any medium or format, as long as you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons licence, and indicate if changes were made. The images or other third party material in this article are included in the article's Creative Commons licence, unless indicated otherwise in a credit line to the material. If material is not included in the article's Creative Commons licence and your intended use is not permitted by statutory regulation or exceeds the permitted use, you will need to obtain permission directly from the copyright holder. To view a copy of this licence, visit http://creativecommons.org/licenses/by/4.0/ (https://creativecommons.org/licenses/by/4.0/) . The Creative Commons Public Domain Dedication waiver (http://creativecommons.org/publicdomain/zero/1.0/ (https://creativecommons.org/publicdomain/zero/1.0/) ) applies to the data made available in this article, unless otherwise stated in a credit line to the data.
spellingShingle Commentary
McDonald, Kelsey
Seltzer, Earl
Lu, Mary
Gaisenband, Stefan Diaz
Fletcher, Cassandra
McLeroth, Patrick
Saini, Kamal S
Quantifying the impact of the COVID-19 pandemic on clinical trial screening rates over time in 37 countries
title Quantifying the impact of the COVID-19 pandemic on clinical trial screening rates over time in 37 countries
title_full Quantifying the impact of the COVID-19 pandemic on clinical trial screening rates over time in 37 countries
title_fullStr Quantifying the impact of the COVID-19 pandemic on clinical trial screening rates over time in 37 countries
title_full_unstemmed Quantifying the impact of the COVID-19 pandemic on clinical trial screening rates over time in 37 countries
title_short Quantifying the impact of the COVID-19 pandemic on clinical trial screening rates over time in 37 countries
title_sort quantifying the impact of the covid-19 pandemic on clinical trial screening rates over time in 37 countries
topic Commentary
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10071259/
https://www.ncbi.nlm.nih.gov/pubmed/37013558
http://dx.doi.org/10.1186/s13063-023-07277-1
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