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COVID-19 trials: declarations of data sharing intentions at trial registration and at publication

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...

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Autores principales: Li, Rebecca, von Isenburg, Megan, Levenstein, Marcia, Neumann, Stan, Wood, Julie, Sim, Ida
Formato: Online Artículo Texto
Lenguaje:English
Publicado: BioMed Central 2021
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7891481/
https://www.ncbi.nlm.nih.gov/pubmed/33602275
http://dx.doi.org/10.1186/s13063-021-05104-z
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author Li, Rebecca
von Isenburg, Megan
Levenstein, Marcia
Neumann, Stan
Wood, Julie
Sim, Ida
author_facet Li, Rebecca
von Isenburg, Megan
Levenstein, Marcia
Neumann, Stan
Wood, Julie
Sim, Ida
author_sort Li, Rebecca
collection PubMed
description 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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spelling pubmed-78914812021-02-19 COVID-19 trials: declarations of data sharing intentions at trial registration and at publication Li, Rebecca von Isenburg, Megan Levenstein, Marcia Neumann, Stan Wood, Julie Sim, Ida Trials Research 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. BioMed Central 2021-02-18 /pmc/articles/PMC7891481/ /pubmed/33602275 http://dx.doi.org/10.1186/s13063-021-05104-z Text en © The Author(s) 2021 Open AccessThis article is licensed under a Creative Commons Attribution 4.0 International License, which permits use, sharing, adaptation, distribution and reproduction in any medium or format, as long as you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons licence, and indicate if changes were made. The images or other third party material in this article are included in the article's Creative Commons licence, unless indicated otherwise in a credit line to the material. If material is not included in the article's Creative Commons licence and your intended use is not permitted by statutory regulation or exceeds the permitted use, you will need to obtain permission directly from the copyright holder. To view a copy of this licence, visit http://creativecommons.org/licenses/by/4.0/. The Creative Commons Public Domain Dedication waiver (http://creativecommons.org/publicdomain/zero/1.0/) applies to the data made available in this article, unless otherwise stated in a credit line to the data.
spellingShingle Research
Li, Rebecca
von Isenburg, Megan
Levenstein, Marcia
Neumann, Stan
Wood, Julie
Sim, Ida
COVID-19 trials: declarations of data sharing intentions at trial registration and at publication
title COVID-19 trials: declarations of data sharing intentions at trial registration and at publication
title_full COVID-19 trials: declarations of data sharing intentions at trial registration and at publication
title_fullStr COVID-19 trials: declarations of data sharing intentions at trial registration and at publication
title_full_unstemmed COVID-19 trials: declarations of data sharing intentions at trial registration and at publication
title_short COVID-19 trials: declarations of data sharing intentions at trial registration and at publication
title_sort covid-19 trials: declarations of data sharing intentions at trial registration and at publication
topic Research
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7891481/
https://www.ncbi.nlm.nih.gov/pubmed/33602275
http://dx.doi.org/10.1186/s13063-021-05104-z
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