Sharing data among clinical trials of therapeutics in COVID-19: Barriers and facilitators to collaborating in a crisis
Abstract 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,...
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| Format: | Article |
| Language: | English |
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Cambridge University Press
2022-01-01
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| Series: | Journal of Clinical and Translational Science |
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| Online Access: | https://www.cambridge.org/core/product/identifier/S2059866121008669/type/journal_article |
| _version_ | 1811156519902773248 |
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| author | Marisha E. Palm Christopher J. Lindsell Harry P. Selker |
| author_facet | Marisha E. Palm Christopher J. Lindsell Harry P. Selker |
| author_sort | Marisha E. Palm |
| collection | DOAJ |
| description |
Abstract
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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| first_indexed | 2024-04-10T04:53:03Z |
| format | Article |
| id | doaj.art-d3ba450208c244d6a583a139e155261c |
| institution | Directory Open Access Journal |
| issn | 2059-8661 |
| language | English |
| last_indexed | 2024-04-10T04:53:03Z |
| publishDate | 2022-01-01 |
| publisher | Cambridge University Press |
| record_format | Article |
| series | Journal of Clinical and Translational Science |
| spelling | doaj.art-d3ba450208c244d6a583a139e155261c2023-03-09T12:31:04ZengCambridge University PressJournal of Clinical and Translational Science2059-86612022-01-01610.1017/cts.2021.866Sharing data among clinical trials of therapeutics in COVID-19: Barriers and facilitators to collaborating in a crisisMarisha E. Palm0https://orcid.org/0000-0002-9760-7196Christopher J. Lindsell1https://orcid.org/0000-0002-3297-2811Harry P. Selker2Institute for Clinical Research and Health Policy Studies, Tufts Medical Center, Boston, Massachusetts, USA Tufts Clinical and Translational Science Institute, Tufts University, Boston, Massachusetts, USADepartment of Biostatistics, Vanderbilt University Medical Center, Nashville, Tennessee, USAInstitute for Clinical Research and Health Policy Studies, Tufts Medical Center, Boston, Massachusetts, USA Tufts Clinical and Translational Science Institute, Tufts University, Boston, Massachusetts, USA Abstract 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. https://www.cambridge.org/core/product/identifier/S2059866121008669/type/journal_articleCOVID-19Trial Innovation NetworkCTSAclinical trialsDSMBdata sharingcollaboration |
| spellingShingle | Marisha E. Palm Christopher J. Lindsell Harry P. Selker Sharing data among clinical trials of therapeutics in COVID-19: Barriers and facilitators to collaborating in a crisis Journal of Clinical and Translational Science COVID-19 Trial Innovation Network CTSA clinical trials DSMB data sharing collaboration |
| 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 | COVID-19 Trial Innovation Network CTSA clinical trials DSMB data sharing collaboration |
| url | https://www.cambridge.org/core/product/identifier/S2059866121008669/type/journal_article |
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