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The use of telecommunication and virtualization among ongoing and discontinued COVID-19 clinical trials: A cross-sectional analysis

IMPORTANCE: The COVID-19 pandemic has impacted clinical research due to safety measures such as social distancing and lockdowns. However, developing treatments for COVID-19 relies on conducting clinical trials. Using telemedicine or virtual methods may support ongoing trials and limit the pandemic&#...

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Autores principales: Greenough, Mary C., Sajjadi, Nicholas B., Rucker, Brayden, Vassar, Matt, Hartwell, Micah
Formato: Online Artículo Texto
Lenguaje:English
Publicado: Elsevier Inc. 2022
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8761257/
https://www.ncbi.nlm.nih.gov/pubmed/35045363
http://dx.doi.org/10.1016/j.cct.2022.106681
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author Greenough, Mary C.
Sajjadi, Nicholas B.
Rucker, Brayden
Vassar, Matt
Hartwell, Micah
author_facet Greenough, Mary C.
Sajjadi, Nicholas B.
Rucker, Brayden
Vassar, Matt
Hartwell, Micah
author_sort Greenough, Mary C.
collection PubMed
description IMPORTANCE: The COVID-19 pandemic has impacted clinical research due to safety measures such as social distancing and lockdowns. However, developing treatments for COVID-19 relies on conducting clinical trials. Using telemedicine or virtual methods may support ongoing trials and limit the pandemic's impact on clinical research. OBJECTIVE: To examine the use of virtual methods among ongoing and discontinued COVID-19 clinical trials. DESIGN: In this cross-sectional analysis, we performed a systematic search of ClinicalTrials.gov for COVID-19 related trials registered since the pandemic began. In masked, duplicate fashion, authors extracted data from included studies, noting whether trialists reported using telecommunication, virtualization, or remote data collection to deliver interventions and monitor outcome measures. The authors also coded the use of virtual methods for recruitment, enrollment, or follow-up visits. Chi-square tests and Kruskal-Wallis tests were used to assess differences in the use of virtual methods between ongoing and discontinued studies and differences between intervention types. RESULTS: Our search returned 2549 clinical trials, of which 2383 were included. Of included studies, 2109 (88.5%) were ongoing and 274 (11.5%) were discontinued. Overall, 519 (24.6%) ongoing COVID-19 trials reported using virtual methods for trial conduct and 43 (15.7%) discontinued trials reported using virtual methods. There was a statistically significant difference in the rate of reporting virtual methods between discontinued and ongoing trials (X(2)(1) = 27.2, P < .001). Studies listed as Behavioral or Other were more likely to report using virtual methods for delivering interventions compared to other intervention types (X(2)(1) = 751.88, P < .001). CONCLUSIONS AND RELEVANCE: The COVID-19 pandemic has presented an unprecedented need for safe and efficient clinical trial conduct. Nearly a quarter of ongoing COVID-19 clinical trials in our sample reported using virtual methods for supporting trial progress. Ongoing trials were more likely to report virtual methods compared to discontinued trials. Developing strategies that allow for continuing trials during emergencies may limit trial disruption. Exploring and developing remote trial methods may continue to be valuable in light of emerging COVID-19 variants and may persist beyond the pandemic.
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spelling pubmed-87612572022-01-18 The use of telecommunication and virtualization among ongoing and discontinued COVID-19 clinical trials: A cross-sectional analysis Greenough, Mary C. Sajjadi, Nicholas B. Rucker, Brayden Vassar, Matt Hartwell, Micah Contemp Clin Trials Short Communication IMPORTANCE: The COVID-19 pandemic has impacted clinical research due to safety measures such as social distancing and lockdowns. However, developing treatments for COVID-19 relies on conducting clinical trials. Using telemedicine or virtual methods may support ongoing trials and limit the pandemic's impact on clinical research. OBJECTIVE: To examine the use of virtual methods among ongoing and discontinued COVID-19 clinical trials. DESIGN: In this cross-sectional analysis, we performed a systematic search of ClinicalTrials.gov for COVID-19 related trials registered since the pandemic began. In masked, duplicate fashion, authors extracted data from included studies, noting whether trialists reported using telecommunication, virtualization, or remote data collection to deliver interventions and monitor outcome measures. The authors also coded the use of virtual methods for recruitment, enrollment, or follow-up visits. Chi-square tests and Kruskal-Wallis tests were used to assess differences in the use of virtual methods between ongoing and discontinued studies and differences between intervention types. RESULTS: Our search returned 2549 clinical trials, of which 2383 were included. Of included studies, 2109 (88.5%) were ongoing and 274 (11.5%) were discontinued. Overall, 519 (24.6%) ongoing COVID-19 trials reported using virtual methods for trial conduct and 43 (15.7%) discontinued trials reported using virtual methods. There was a statistically significant difference in the rate of reporting virtual methods between discontinued and ongoing trials (X(2)(1) = 27.2, P < .001). Studies listed as Behavioral or Other were more likely to report using virtual methods for delivering interventions compared to other intervention types (X(2)(1) = 751.88, P < .001). CONCLUSIONS AND RELEVANCE: The COVID-19 pandemic has presented an unprecedented need for safe and efficient clinical trial conduct. Nearly a quarter of ongoing COVID-19 clinical trials in our sample reported using virtual methods for supporting trial progress. Ongoing trials were more likely to report virtual methods compared to discontinued trials. Developing strategies that allow for continuing trials during emergencies may limit trial disruption. Exploring and developing remote trial methods may continue to be valuable in light of emerging COVID-19 variants and may persist beyond the pandemic. Elsevier Inc. 2022-03 2022-01-16 /pmc/articles/PMC8761257/ /pubmed/35045363 http://dx.doi.org/10.1016/j.cct.2022.106681 Text en © 2022 Elsevier Inc. All rights reserved. Since January 2020 Elsevier has created a COVID-19 resource centre with free information in English and Mandarin on the novel coronavirus COVID-19. The COVID-19 resource centre is hosted on Elsevier Connect, the company's public news and information website. Elsevier hereby grants permission to make all its COVID-19-related research that is available on the COVID-19 resource centre - including this research content - immediately available in PubMed Central and other publicly funded repositories, such as the WHO COVID database with rights for unrestricted research re-use and analyses in any form or by any means with acknowledgement of the original source. These permissions are granted for free by Elsevier for as long as the COVID-19 resource centre remains active.
spellingShingle Short Communication
Greenough, Mary C.
Sajjadi, Nicholas B.
Rucker, Brayden
Vassar, Matt
Hartwell, Micah
The use of telecommunication and virtualization among ongoing and discontinued COVID-19 clinical trials: A cross-sectional analysis
title The use of telecommunication and virtualization among ongoing and discontinued COVID-19 clinical trials: A cross-sectional analysis
title_full The use of telecommunication and virtualization among ongoing and discontinued COVID-19 clinical trials: A cross-sectional analysis
title_fullStr The use of telecommunication and virtualization among ongoing and discontinued COVID-19 clinical trials: A cross-sectional analysis
title_full_unstemmed The use of telecommunication and virtualization among ongoing and discontinued COVID-19 clinical trials: A cross-sectional analysis
title_short The use of telecommunication and virtualization among ongoing and discontinued COVID-19 clinical trials: A cross-sectional analysis
title_sort use of telecommunication and virtualization among ongoing and discontinued covid-19 clinical trials: a cross-sectional analysis
topic Short Communication
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8761257/
https://www.ncbi.nlm.nih.gov/pubmed/35045363
http://dx.doi.org/10.1016/j.cct.2022.106681
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