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Tytuł:
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COVID-19 trials: declarations of data sharing intentions at trial registration and at publication.
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Autorzy:
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Li R; Vivli, Cambridge, USA. .; Harvard, Center for Bioethics, Boston, MA, USA. .
von Isenburg M; Duke University, Durham, NC, USA.
Levenstein M; Vivli, Cambridge, USA.
Neumann S; Vivli, Cambridge, USA.
Wood J; Vivli, Cambridge, USA.
Sim I; Vivli, Cambridge, USA.; University of California, San Francisco, CA, USA.
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Źródło:
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Trials [Trials] 2021 Feb 18; Vol. 22 (1), pp. 153. Date of Electronic Publication: 2021 Feb 18.
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Typ publikacji:
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Comparative Study; Journal Article; Review
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Język:
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English
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Imprint Name(s):
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Original Publication: [London] : BioMed Central, 2006-
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MeSH Terms:
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Information Dissemination*
COVID-19/*therapy
Clinical Trials as Topic/*statistics & numerical data
Publications/*statistics & numerical data
Research Design/*statistics & numerical data
COVID-19/epidemiology ; Humans ; Intention ; Pandemics/prevention & control
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References:
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PLoS One. 2020 Feb 18;15(2):e0226143. (PMID: 32069305)
Lancet Oncol. 2017 Jan;18(1):15-16. (PMID: 27864014)
Trials. 2017 Feb 14;18(1):71. (PMID: 28196540)
Ann Intern Med. 2017 Jul 4;167(1):63-65. (PMID: 28586790)
AMIA Annu Symp Proc. 2020 Mar 04;2019:647-654. (PMID: 32308859)
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Entry Date(s):
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Date Created: 20210219 Date Completed: 20210222 Latest Revision: 20210222
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Update Code:
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20240105
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PubMed Central ID:
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PMC7891481
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DOI:
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10.1186/s13063-021-05104-z
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PMID:
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33602275
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Background: The sharing of individual participant-level data from COVID-19 trials would allow re-use and secondary analysis that can help accelerate the identification of effective treatments. The sharing of trial data is not the norm, but the unprecedented pandemic caused by SARS-CoV-2 may serve as an impetus for greater data sharing. We sought to assess the data sharing intentions of interventional COVID-19 trials as declared in trial registrations and publications.
Methods: We searched ClinicalTrials.gov and PubMed for COVID-19 interventional trials. We analyzed responses to ClinicalTrials.gov fields regarding intent to share individual participant level data and analyzed the data sharing statements in eligible publications.
Results: Nine hundred twenty-four trial registrations were analyzed. 15.7% were willing to share, of which 38.6% were willing to share immediately upon publication of results. 47.6% declared they were not willing to share. Twenty-eight publications were analyzed representing 26 unique COVID-19 trials. Only seven publications contained data sharing statements; six indicated a willingness to share data whereas one indicated that data was not available for sharing.
Conclusions: At a time of pressing need for researchers to work together to combat a global pandemic, intent to share individual participant-level data from COVID-19 interventional trials is limited.
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