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Sharing data among clinical trials of therapeutics in COVID-19: Barriers and facilitators to collaborating in a crisis

BACKGROUND: The Clinical and Translational Science Award Program (CTSA) Trial Innovation Network (TIN) was launched in 2016 to increase the efficiency and effectiveness of multisite trials by supporting the development of national infrastructure. With the advent of the COVID-19 pandemic, it was ther...

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Autores principales: Palm, Marisha E., Lindsell, Christopher J., Selker, Harry P.
Formato: Online Artículo Texto
Lenguaje:English
Publicado: Cambridge University Press 2021
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9114727/
https://www.ncbi.nlm.nih.gov/pubmed/35599687
http://dx.doi.org/10.1017/cts.2021.866
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author Palm, Marisha E.
Lindsell, Christopher J.
Selker, Harry P.
author_facet Palm, Marisha E.
Lindsell, Christopher J.
Selker, Harry P.
author_sort Palm, Marisha E.
collection PubMed
description BACKGROUND: The Clinical and Translational Science Award Program (CTSA) Trial Innovation Network (TIN) was launched in 2016 to increase the efficiency and effectiveness of multisite trials by supporting the development of national infrastructure. With the advent of the COVID-19 pandemic, it was therefore well-positioned to support clinical trial collaboration. The TIN was leveraged to support two initiatives: (1) to create and evaluate a mechanism for coordinating Data and Safety Monitoring Board (DSMB) activities among multiple ongoing trials of the same therapeutic agents, and (2) to share data across clinical trials so that smaller, likely underpowered studies, could be combined to produce meaningful and actionable data through pooled analyses. The success of these initiatives was understood to be dependent upon the willingness of investigators, study teams, and US National Institutes of Health research networks to collaborate and share information. METHODS: To inform these two initiatives, we conducted semistructured interviews with members of CTSA hubs and clinical research stakeholders that probed barriers and facilitators to collaboration. Thematic analysis identified topics relevant across institutions, individuals, and DSMBs. RESULTS: The DSMB coordination initiative was viewed as less controversial, while the data pooling initiative was seen as complex because of its potential impact on publication, authorship, and the rewards of discovery. Barriers related to resources, centralization, and technical work were significant, but interviewees suggested these could be handled by the provision of central funding and supportive frameworks. The more intractable findings were related to issues around credit and ownership of data. CONCLUSION: Based on our interviews, we conclude with nine recommended actions that can be implemented to support collaboration.
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spelling pubmed-91147272022-05-18 Sharing data among clinical trials of therapeutics in COVID-19: Barriers and facilitators to collaborating in a crisis Palm, Marisha E. Lindsell, Christopher J. Selker, Harry P. J Clin Transl Sci Research Article BACKGROUND: The Clinical and Translational Science Award Program (CTSA) Trial Innovation Network (TIN) was launched in 2016 to increase the efficiency and effectiveness of multisite trials by supporting the development of national infrastructure. With the advent of the COVID-19 pandemic, it was therefore well-positioned to support clinical trial collaboration. The TIN was leveraged to support two initiatives: (1) to create and evaluate a mechanism for coordinating Data and Safety Monitoring Board (DSMB) activities among multiple ongoing trials of the same therapeutic agents, and (2) to share data across clinical trials so that smaller, likely underpowered studies, could be combined to produce meaningful and actionable data through pooled analyses. The success of these initiatives was understood to be dependent upon the willingness of investigators, study teams, and US National Institutes of Health research networks to collaborate and share information. METHODS: To inform these two initiatives, we conducted semistructured interviews with members of CTSA hubs and clinical research stakeholders that probed barriers and facilitators to collaboration. Thematic analysis identified topics relevant across institutions, individuals, and DSMBs. RESULTS: The DSMB coordination initiative was viewed as less controversial, while the data pooling initiative was seen as complex because of its potential impact on publication, authorship, and the rewards of discovery. Barriers related to resources, centralization, and technical work were significant, but interviewees suggested these could be handled by the provision of central funding and supportive frameworks. The more intractable findings were related to issues around credit and ownership of data. CONCLUSION: Based on our interviews, we conclude with nine recommended actions that can be implemented to support collaboration. Cambridge University Press 2021-10-07 /pmc/articles/PMC9114727/ /pubmed/35599687 http://dx.doi.org/10.1017/cts.2021.866 Text en © The Author(s) 2022 https://creativecommons.org/licenses/by/4.0/This is an Open Access article, distributed under the terms of the Creative Commons Attribution licence (https://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
Palm, Marisha E.
Lindsell, Christopher J.
Selker, Harry P.
Sharing data among clinical trials of therapeutics in COVID-19: Barriers and facilitators to collaborating in a crisis
title Sharing data among clinical trials of therapeutics in COVID-19: Barriers and facilitators to collaborating in a crisis
title_full Sharing data among clinical trials of therapeutics in COVID-19: Barriers and facilitators to collaborating in a crisis
title_fullStr Sharing data among clinical trials of therapeutics in COVID-19: Barriers and facilitators to collaborating in a crisis
title_full_unstemmed Sharing data among clinical trials of therapeutics in COVID-19: Barriers and facilitators to collaborating in a crisis
title_short Sharing data among clinical trials of therapeutics in COVID-19: Barriers and facilitators to collaborating in a crisis
title_sort sharing data among clinical trials of therapeutics in covid-19: barriers and facilitators to collaborating in a crisis
topic Research Article
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9114727/
https://www.ncbi.nlm.nih.gov/pubmed/35599687
http://dx.doi.org/10.1017/cts.2021.866
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