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COVID-19 pandemic response varies by clinical trial sponsor type

INTRODUCTION: The COVID-19 pandemic has impacted millions of lives globally. To learn more about this disease and find potential diagnostic, therapeutic, and preventative products, the healthcare community has initiated a staggering number of clinical trials. METHODS: ClinicalTrials.gov was reviewed...

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Detalles Bibliográficos
Autores principales: Cooper, Lisa, Lee, Irene, Waldron Lechner, Doreen
Formato: Online Artículo Texto
Lenguaje:English
Publicado: Cambridge University Press 2021
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8220021/
https://www.ncbi.nlm.nih.gov/pubmed/34192064
http://dx.doi.org/10.1017/cts.2021.25
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author Cooper, Lisa
Lee, Irene
Waldron Lechner, Doreen
author_facet Cooper, Lisa
Lee, Irene
Waldron Lechner, Doreen
author_sort Cooper, Lisa
collection PubMed
description INTRODUCTION: The COVID-19 pandemic has impacted millions of lives globally. To learn more about this disease and find potential diagnostic, therapeutic, and preventative products, the healthcare community has initiated a staggering number of clinical trials. METHODS: ClinicalTrials.gov was reviewed to determine if trial sponsor type had a relationship to time to COVID-19 response, which was defined as the date from disease discovery in Wuhan, China to ClinicalTrials.gov study “First Posted” date. RESULTS: A total of 673 United States (US) sponsored, interventional study listings were retrieved, of which 293 (43.5%) were Industry-sponsored, 349 (51.9%) were Academic sponsored, and 31 (4.6%) were Other sponsor types. Of the Academic studies, 181 (51.9%) were Clinical and Translational Science Award (CTSA) hubs. The average response time for all sponsor types was 189 days, with Academic sponsors having the shortest average response time of 172.6 days (P < 0.001). CTSA hubs had a significantly (P < 0.001) shorter average response time (168.1 days) compared to all other sponsor types (197.4 days). However, while shorter in duration by 9.4 days, response time was not significantly different from non-CTSA sponsors (177.5 days; P = 0.238). Additionally, ANOVA indicated significant relationships (P < 0.001) between funding type, study phase, number of sites, and enrollment size on response time. CONCLUSIONS: Studies posted with the shortest response time were Academic-sponsored trials and included smaller sized investigations of repurposed approved or investigational drugs for the treatment of COVID-19 symptoms. A small second wave of study postings occurred approximately 4 months later, and included small, unique therapies targeting prevention or treatment of COVID-19.
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spelling pubmed-82200212021-06-23 COVID-19 pandemic response varies by clinical trial sponsor type Cooper, Lisa Lee, Irene Waldron Lechner, Doreen J Clin Transl Sci Research Article INTRODUCTION: The COVID-19 pandemic has impacted millions of lives globally. To learn more about this disease and find potential diagnostic, therapeutic, and preventative products, the healthcare community has initiated a staggering number of clinical trials. METHODS: ClinicalTrials.gov was reviewed to determine if trial sponsor type had a relationship to time to COVID-19 response, which was defined as the date from disease discovery in Wuhan, China to ClinicalTrials.gov study “First Posted” date. RESULTS: A total of 673 United States (US) sponsored, interventional study listings were retrieved, of which 293 (43.5%) were Industry-sponsored, 349 (51.9%) were Academic sponsored, and 31 (4.6%) were Other sponsor types. Of the Academic studies, 181 (51.9%) were Clinical and Translational Science Award (CTSA) hubs. The average response time for all sponsor types was 189 days, with Academic sponsors having the shortest average response time of 172.6 days (P < 0.001). CTSA hubs had a significantly (P < 0.001) shorter average response time (168.1 days) compared to all other sponsor types (197.4 days). However, while shorter in duration by 9.4 days, response time was not significantly different from non-CTSA sponsors (177.5 days; P = 0.238). Additionally, ANOVA indicated significant relationships (P < 0.001) between funding type, study phase, number of sites, and enrollment size on response time. CONCLUSIONS: Studies posted with the shortest response time were Academic-sponsored trials and included smaller sized investigations of repurposed approved or investigational drugs for the treatment of COVID-19 symptoms. A small second wave of study postings occurred approximately 4 months later, and included small, unique therapies targeting prevention or treatment of COVID-19. Cambridge University Press 2021-03-16 /pmc/articles/PMC8220021/ /pubmed/34192064 http://dx.doi.org/10.1017/cts.2021.25 Text en © The Association for Clinical and Translational Science 2021 https://creativecommons.org/licenses/by/4.0/This is an Open Access article, distributed under the terms of the Creative Commons Attribution licence (http://creativecommons.org/licenses/by/4.0/), which permits unrestricted re-use, distribution, and reproduction in any medium, provided the original work is properly cited.
spellingShingle Research Article
Cooper, Lisa
Lee, Irene
Waldron Lechner, Doreen
COVID-19 pandemic response varies by clinical trial sponsor type
title COVID-19 pandemic response varies by clinical trial sponsor type
title_full COVID-19 pandemic response varies by clinical trial sponsor type
title_fullStr COVID-19 pandemic response varies by clinical trial sponsor type
title_full_unstemmed COVID-19 pandemic response varies by clinical trial sponsor type
title_short COVID-19 pandemic response varies by clinical trial sponsor type
title_sort covid-19 pandemic response varies by clinical trial sponsor type
topic Research Article
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8220021/
https://www.ncbi.nlm.nih.gov/pubmed/34192064
http://dx.doi.org/10.1017/cts.2021.25
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