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Qualitative data sharing practices in clinical trials in the UK and Ireland: towards the production of good practice guidance [version 1; peer review: awaiting peer review]

Sydes, Matthew; (2023) Qualitative data sharing practices in clinical trials in the UK and Ireland: towards the production of good practice guidance [version 1; peer review: awaiting peer review]. HRB Open Research , 6 , Article 10. 10.12688/hrbopenres.13667.1. Green open access

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Abstract

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.

Type: Article
Title: Qualitative data sharing practices in clinical trials in the UK and Ireland: towards the production of good practice guidance [version 1; peer review: awaiting peer review]
Open access status: An open access version is available from UCL Discovery
DOI: 10.12688/hrbopenres.13667.1
Publisher version: https://doi.org/10.12688/hrbopenres.13667.1
Language: English
Additional information: Copyright: © 2023 McCarthy M et al. This is an open access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.
Keywords: qualitative, data sharing, trials, focus groups
UCL classification: UCL
UCL > Provost and Vice Provost Offices > School of Life and Medical Sciences
UCL > Provost and Vice Provost Offices > School of Life and Medical Sciences > Faculty of Population Health Sciences > Inst of Clinical Trials and Methodology
UCL > Provost and Vice Provost Offices > School of Life and Medical Sciences > Faculty of Population Health Sciences > Inst of Clinical Trials and Methodology > MRC Clinical Trials Unit at UCL
URI: https://discovery.ucl.ac.uk/id/eprint/10164439
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