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Competition for recruitment in SARS-CoV-2 Trials in the United States: a longitudinal cohort analysis

OBJECTIVE: Competition among trials for patient enrollment can impede recruitment. We hypothesized that this occurred early in the COVID-19 pandemic, when an unprecedented number of clinical trials were launched. We performed a simple and multivariable regression analysis evaluating the relationship...

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Autores principales: Hutchinson, Nora, Klas, Katarzyna, Carlisle, Benjamin G., Polak, Maciej, Kimmelman, Jonathan, Waligora, Marcin
Formato: Online Artículo Texto
Lenguaje:English
Publicado: BioMed Central 2022
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9742655/
https://www.ncbi.nlm.nih.gov/pubmed/36510308
http://dx.doi.org/10.1186/s13104-022-06263-1
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author Hutchinson, Nora
Klas, Katarzyna
Carlisle, Benjamin G.
Polak, Maciej
Kimmelman, Jonathan
Waligora, Marcin
author_facet Hutchinson, Nora
Klas, Katarzyna
Carlisle, Benjamin G.
Polak, Maciej
Kimmelman, Jonathan
Waligora, Marcin
author_sort Hutchinson, Nora
collection PubMed
description OBJECTIVE: Competition among trials for patient enrollment can impede recruitment. We hypothesized that this occurred early in the COVID-19 pandemic, when an unprecedented number of clinical trials were launched. We performed a simple and multivariable regression analysis evaluating the relationship between the proportion of SARS-CoV-2 investigational trial sites within each USA state with unsuccessful patient-participant recruitment and: (i) the proportion of cases required to reach state recruitment goals; (ii) state population based on data from the US Census; and, (iii) number of trial sites per state. RESULTS: Our study included 151 clinical trials. The proportion of trials with successful recruitment was 72.19% (109 of 151 trials). We did not find a significant relationship between unsuccessful patient-participant recruitment, state recruitment goals, state population or the number of trial sites per state in both our simple and multivariable regression analyses. Our results do not suggest that early in the COVID-19 pandemic, competition for patient-participants impeded successful recruitment in SARS-CoV-2 trials. This may reflect the unique circumstances of the first few months of the pandemic in the United States, in which the number and location of SARS-CoV-2 cases was sufficient to meet trial recruitment requirements, despite the large number of trials launched.
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spelling pubmed-97426552022-12-12 Competition for recruitment in SARS-CoV-2 Trials in the United States: a longitudinal cohort analysis Hutchinson, Nora Klas, Katarzyna Carlisle, Benjamin G. Polak, Maciej Kimmelman, Jonathan Waligora, Marcin BMC Res Notes Research Note OBJECTIVE: Competition among trials for patient enrollment can impede recruitment. We hypothesized that this occurred early in the COVID-19 pandemic, when an unprecedented number of clinical trials were launched. We performed a simple and multivariable regression analysis evaluating the relationship between the proportion of SARS-CoV-2 investigational trial sites within each USA state with unsuccessful patient-participant recruitment and: (i) the proportion of cases required to reach state recruitment goals; (ii) state population based on data from the US Census; and, (iii) number of trial sites per state. RESULTS: Our study included 151 clinical trials. The proportion of trials with successful recruitment was 72.19% (109 of 151 trials). We did not find a significant relationship between unsuccessful patient-participant recruitment, state recruitment goals, state population or the number of trial sites per state in both our simple and multivariable regression analyses. Our results do not suggest that early in the COVID-19 pandemic, competition for patient-participants impeded successful recruitment in SARS-CoV-2 trials. This may reflect the unique circumstances of the first few months of the pandemic in the United States, in which the number and location of SARS-CoV-2 cases was sufficient to meet trial recruitment requirements, despite the large number of trials launched. BioMed Central 2022-12-12 /pmc/articles/PMC9742655/ /pubmed/36510308 http://dx.doi.org/10.1186/s13104-022-06263-1 Text en © The Author(s) 2022 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 Research Note
Hutchinson, Nora
Klas, Katarzyna
Carlisle, Benjamin G.
Polak, Maciej
Kimmelman, Jonathan
Waligora, Marcin
Competition for recruitment in SARS-CoV-2 Trials in the United States: a longitudinal cohort analysis
title Competition for recruitment in SARS-CoV-2 Trials in the United States: a longitudinal cohort analysis
title_full Competition for recruitment in SARS-CoV-2 Trials in the United States: a longitudinal cohort analysis
title_fullStr Competition for recruitment in SARS-CoV-2 Trials in the United States: a longitudinal cohort analysis
title_full_unstemmed Competition for recruitment in SARS-CoV-2 Trials in the United States: a longitudinal cohort analysis
title_short Competition for recruitment in SARS-CoV-2 Trials in the United States: a longitudinal cohort analysis
title_sort competition for recruitment in sars-cov-2 trials in the united states: a longitudinal cohort analysis
topic Research Note
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9742655/
https://www.ncbi.nlm.nih.gov/pubmed/36510308
http://dx.doi.org/10.1186/s13104-022-06263-1
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