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Qualitative data sharing practices in clinical trials in the UK and Ireland: towards the production of good practice guidance

Background: Data sharing enables researchers to conduct novel research with previously collected datasets, thus maximising scientific findings and cost effectiveness, and reducing research waste. The value of sharing, even de-identified, quantitative data from clinical trials is well recognised with...

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Autores principales: McCarthy, Megan, Gillies, Katie, Rousseau, Nikki, Wade, Julia, Gamble, Carrol, Toomey, Elaine, Matvienko-Sikar, Karen, Sydes, Matthew, Dowling, Maura, Bryant, Val, Biesty, Linda, Houghton, Catherine
Formato: Online Artículo Texto
Lenguaje:English
Publicado: F1000 Research Limited 2023
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10345597/
https://www.ncbi.nlm.nih.gov/pubmed/37456658
http://dx.doi.org/10.12688/hrbopenres.13667.1
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author McCarthy, Megan
Gillies, Katie
Rousseau, Nikki
Wade, Julia
Gamble, Carrol
Toomey, Elaine
Matvienko-Sikar, Karen
Sydes, Matthew
Dowling, Maura
Bryant, Val
Biesty, Linda
Houghton, Catherine
author_facet McCarthy, Megan
Gillies, Katie
Rousseau, Nikki
Wade, Julia
Gamble, Carrol
Toomey, Elaine
Matvienko-Sikar, Karen
Sydes, Matthew
Dowling, Maura
Bryant, Val
Biesty, Linda
Houghton, Catherine
author_sort McCarthy, Megan
collection PubMed
description Background: Data sharing enables researchers to conduct novel research with previously collected datasets, thus maximising scientific findings and cost effectiveness, and reducing research waste. The value of sharing, even de-identified, quantitative data from clinical trials is well recognised with a moderated access approach recommended. While substantial challenges to sharing quantitative data remain, there are additional challenges for sharing qualitative data in trials. Incorporating the necessary information about how qualitative data will be shared into already complex trial recruitment and consent processes proves challenging. The aim of this study was to explore whether and how trial teams share qualitative data collected as part of the design, conduct, analysis, or delivery of clinical trials. Methods: Phase 1 involved semi-structured, in-depth qualitative interviews and focus groups with key trial stakeholder groups including trial managers and clinical trialists (n=3), qualitative researchers in trials (n=9), members of research funding bodies (n=2) and trial participants (n=1). Data were analysed using thematic analysis. In Phase 2, we conducted a content analysis of 16 participant information leaflets (PIL) and consent forms (CF) for trials that collected qualitative data. Results: Three key themes were identified from our Phase 1 findings: ‘ Understanding and experiences of the potential benefits of sharing qualitative data from trials’, ‘Concerns about qualitative data sharing’, and ‘ Future guidance and funding’. In phase 2, the PILs and CFs received revealed that the benefits of data sharing for participants were only explained in two of the study documents. Conclusions: The value of sharing qualitative data was acknowledged, but there are many uncertainties as to how, when, and where to share this data. In addition, there were ethical concerns in relation to the consent process required for qualitative data sharing in trials. This study provides insight into the existing practice of qualitative data sharing in trials.
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spelling pubmed-103455972023-07-15 Qualitative data sharing practices in clinical trials in the UK and Ireland: towards the production of good practice guidance McCarthy, Megan Gillies, Katie Rousseau, Nikki Wade, Julia Gamble, Carrol Toomey, Elaine Matvienko-Sikar, Karen Sydes, Matthew Dowling, Maura Bryant, Val Biesty, Linda Houghton, Catherine HRB Open Res Research Article Background: Data sharing enables researchers to conduct novel research with previously collected datasets, thus maximising scientific findings and cost effectiveness, and reducing research waste. The value of sharing, even de-identified, quantitative data from clinical trials is well recognised with a moderated access approach recommended. While substantial challenges to sharing quantitative data remain, there are additional challenges for sharing qualitative data in trials. Incorporating the necessary information about how qualitative data will be shared into already complex trial recruitment and consent processes proves challenging. The aim of this study was to explore whether and how trial teams share qualitative data collected as part of the design, conduct, analysis, or delivery of clinical trials. Methods: Phase 1 involved semi-structured, in-depth qualitative interviews and focus groups with key trial stakeholder groups including trial managers and clinical trialists (n=3), qualitative researchers in trials (n=9), members of research funding bodies (n=2) and trial participants (n=1). Data were analysed using thematic analysis. In Phase 2, we conducted a content analysis of 16 participant information leaflets (PIL) and consent forms (CF) for trials that collected qualitative data. Results: Three key themes were identified from our Phase 1 findings: ‘ Understanding and experiences of the potential benefits of sharing qualitative data from trials’, ‘Concerns about qualitative data sharing’, and ‘ Future guidance and funding’. In phase 2, the PILs and CFs received revealed that the benefits of data sharing for participants were only explained in two of the study documents. Conclusions: The value of sharing qualitative data was acknowledged, but there are many uncertainties as to how, when, and where to share this data. In addition, there were ethical concerns in relation to the consent process required for qualitative data sharing in trials. This study provides insight into the existing practice of qualitative data sharing in trials. F1000 Research Limited 2023-02-06 /pmc/articles/PMC10345597/ /pubmed/37456658 http://dx.doi.org/10.12688/hrbopenres.13667.1 Text en Copyright: © 2023 McCarthy M et al. https://creativecommons.org/licenses/by/4.0/This is an open access article distributed under the terms of the Creative Commons Attribution Licence, which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.
spellingShingle Research Article
McCarthy, Megan
Gillies, Katie
Rousseau, Nikki
Wade, Julia
Gamble, Carrol
Toomey, Elaine
Matvienko-Sikar, Karen
Sydes, Matthew
Dowling, Maura
Bryant, Val
Biesty, Linda
Houghton, Catherine
Qualitative data sharing practices in clinical trials in the UK and Ireland: towards the production of good practice guidance
title Qualitative data sharing practices in clinical trials in the UK and Ireland: towards the production of good practice guidance
title_full Qualitative data sharing practices in clinical trials in the UK and Ireland: towards the production of good practice guidance
title_fullStr Qualitative data sharing practices in clinical trials in the UK and Ireland: towards the production of good practice guidance
title_full_unstemmed Qualitative data sharing practices in clinical trials in the UK and Ireland: towards the production of good practice guidance
title_short Qualitative data sharing practices in clinical trials in the UK and Ireland: towards the production of good practice guidance
title_sort qualitative data sharing practices in clinical trials in the uk and ireland: towards the production of good practice guidance
topic Research Article
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10345597/
https://www.ncbi.nlm.nih.gov/pubmed/37456658
http://dx.doi.org/10.12688/hrbopenres.13667.1
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