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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...
Autores principales: | , , |
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Formato: | Online Artículo Texto |
Lenguaje: | English |
Publicado: |
Cambridge University Press
2021
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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. |
format | Online Article Text |
id | pubmed-8220021 |
institution | National Center for Biotechnology Information |
language | English |
publishDate | 2021 |
publisher | Cambridge University Press |
record_format | MEDLINE/PubMed |
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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