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UK publicly funded Clinical Trials Units supported a controlled access approach to share individual participant data but highlighted concerns

OBJECTIVES: Evaluate current data sharing activities of UK publicly funded Clinical Trial Units (CTUs) and identify good practices and barriers. STUDY DESIGN AND SETTING: Web-based survey of Directors of 45 UK Clinical Research Collaboration (UKCRC)–registered CTUs. RESULTS: Twenty-three (51%) CTUs...

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Autores principales: Hopkins, Carolyn, Sydes, Matthew, Murray, Gordon, Woolfall, Kerry, Clarke, Mike, Williamson, Paula, Tudur Smith, Catrin
Formato: Online Artículo Texto
Lenguaje:English
Publicado: Elsevier 2016
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4742521/
https://www.ncbi.nlm.nih.gov/pubmed/26169841
http://dx.doi.org/10.1016/j.jclinepi.2015.07.002
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author Hopkins, Carolyn
Sydes, Matthew
Murray, Gordon
Woolfall, Kerry
Clarke, Mike
Williamson, Paula
Tudur Smith, Catrin
author_facet Hopkins, Carolyn
Sydes, Matthew
Murray, Gordon
Woolfall, Kerry
Clarke, Mike
Williamson, Paula
Tudur Smith, Catrin
author_sort Hopkins, Carolyn
collection PubMed
description OBJECTIVES: Evaluate current data sharing activities of UK publicly funded Clinical Trial Units (CTUs) and identify good practices and barriers. STUDY DESIGN AND SETTING: Web-based survey of Directors of 45 UK Clinical Research Collaboration (UKCRC)–registered CTUs. RESULTS: Twenty-three (51%) CTUs responded: Five (22%) of these had an established data sharing policy and eight (35%) specifically requested consent to use patient data beyond the scope of the original trial. Fifteen (65%) CTUs had received requests for data, and seven (30%) had made external requests for data in the previous 12 months. CTUs supported the need for increased data sharing activities although concerns were raised about patient identification, misuse of data, and financial burden. Custodianship of clinical trial data and requirements for a CTU to align its policy to their parent institutes were also raised. No CTUs supported the use of an open access model for data sharing. CONCLUSION: There is support within the publicly funded UKCRC-registered CTUs for data sharing, but many perceived barriers remain. CTUs are currently using a variety of approaches and procedures for sharing data. This survey has informed further work, including development of guidance for publicly funded CTUs, to promote good practice and facilitate data sharing.
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spelling pubmed-47425212016-02-26 UK publicly funded Clinical Trials Units supported a controlled access approach to share individual participant data but highlighted concerns Hopkins, Carolyn Sydes, Matthew Murray, Gordon Woolfall, Kerry Clarke, Mike Williamson, Paula Tudur Smith, Catrin J Clin Epidemiol Original Article OBJECTIVES: Evaluate current data sharing activities of UK publicly funded Clinical Trial Units (CTUs) and identify good practices and barriers. STUDY DESIGN AND SETTING: Web-based survey of Directors of 45 UK Clinical Research Collaboration (UKCRC)–registered CTUs. RESULTS: Twenty-three (51%) CTUs responded: Five (22%) of these had an established data sharing policy and eight (35%) specifically requested consent to use patient data beyond the scope of the original trial. Fifteen (65%) CTUs had received requests for data, and seven (30%) had made external requests for data in the previous 12 months. CTUs supported the need for increased data sharing activities although concerns were raised about patient identification, misuse of data, and financial burden. Custodianship of clinical trial data and requirements for a CTU to align its policy to their parent institutes were also raised. No CTUs supported the use of an open access model for data sharing. CONCLUSION: There is support within the publicly funded UKCRC-registered CTUs for data sharing, but many perceived barriers remain. CTUs are currently using a variety of approaches and procedures for sharing data. This survey has informed further work, including development of guidance for publicly funded CTUs, to promote good practice and facilitate data sharing. Elsevier 2016-02 /pmc/articles/PMC4742521/ /pubmed/26169841 http://dx.doi.org/10.1016/j.jclinepi.2015.07.002 Text en © 2016 The Authors http://creativecommons.org/licenses/by/4.0/ This is an open access article under the CC BY license (http://creativecommons.org/licenses/by/4.0/).
spellingShingle Original Article
Hopkins, Carolyn
Sydes, Matthew
Murray, Gordon
Woolfall, Kerry
Clarke, Mike
Williamson, Paula
Tudur Smith, Catrin
UK publicly funded Clinical Trials Units supported a controlled access approach to share individual participant data but highlighted concerns
title UK publicly funded Clinical Trials Units supported a controlled access approach to share individual participant data but highlighted concerns
title_full UK publicly funded Clinical Trials Units supported a controlled access approach to share individual participant data but highlighted concerns
title_fullStr UK publicly funded Clinical Trials Units supported a controlled access approach to share individual participant data but highlighted concerns
title_full_unstemmed UK publicly funded Clinical Trials Units supported a controlled access approach to share individual participant data but highlighted concerns
title_short UK publicly funded Clinical Trials Units supported a controlled access approach to share individual participant data but highlighted concerns
title_sort uk publicly funded clinical trials units supported a controlled access approach to share individual participant data but highlighted concerns
topic Original Article
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4742521/
https://www.ncbi.nlm.nih.gov/pubmed/26169841
http://dx.doi.org/10.1016/j.jclinepi.2015.07.002
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