A study protocol of qualitative data sharing practices in clinical trials in the UK and Ireland: towards the production of good practice guidance

Catherine Houghton; Megan McCarthy; Katie Gillies; Nikki Rousseau; Julia Wade; Carrol Gamble; Elaine Toomey; Karen Matvienko-Sikar; Matthew Sydes; Maura Dowling; Val Bryant; Linda Biesty

doi:10.12688/hrbopenres.13269.2

A study protocol of qualitative data sharing practices in clinical trials in the UK and Ireland: towards the production of good practice guidance

HRB Open Res. 2021 Jun 22:4:47. doi: 10.12688/hrbopenres.13269.2. eCollection 2021.

Authors

Affiliations

¹ School of Nursing and Midwifery, National University of Ireland Galway, Galway, Ireland.
² Health Services Research Unit, University of Aberdeen, Aberdeen, UK.
³ Leeds Institute of Clinical Trials Research, University of Leeds, Leeds, UK.
⁴ Bristol Population Health Science Institute, University of Bristol, Bristol, UK.
⁵ Health Data Science, University of Liverpool, Liverpool, UK.
⁶ School of Allied Health, University of Limerick, Limerick, Ireland.
⁷ School of Public Health, University College Cork, Cork, Ireland.
⁸ MRC Clinical Trials Unit at UCL, Institute of Clinical Trials and Methodology, UCL, London, UK.
⁹ No particular affiliation, No particular affiliation, UK.

Abstract

Background: Data sharing enables researchers to conduct novel research with previously collected data sets, thus maximising scientific findings and cost effectiveness, and reducing research waste. The value of sharing anonymised data from clinical trials is well recognised with a moderated access approach recommended. While substantial challenges to data sharing remain, there are additional challenges for qualitative data. Qualitative data including videos, interviews, and observations are often more readily identifiable than quantitative data. Existing guidance from UK Economic and Social Research Council applies to sharing qualitative data but does not address the additional challenges related to sharing qualitative data collected within trials, including the need to incorporate the necessary information and consent into already complex recruitment processes, with the additional sensitive nature of health-related data. Methods: Work package 1 will involve separate focus group interviews with members of each stakeholder group: trial managers, clinical trialists, qualitative researchers, members of research funding bodies and trial participants who have been involved in qualitative research. Data will be analysed using thematic analysis and managed within QSR NVivo to enhance transparency. Work package 2 will involve a documentary analysis of current consent procedures for qualitative data collected as part of the conduct of clinical trials. We will include documents such as participant information leaflets and consent forms for the qualitative components in trials. We will extract data such as whether specific clauses for data sharing are included in the consent form. Content analysis will be used to analyse whether and how consent is being obtained for qualitative data sharing. Conclusions: This study will provide insight into the existing practice of sharing of qualitative data in clinical trials and the current issues and opportunities, to help shape future research and development of guidance to encourage maximum learning to be gained from this valuable data.

Keywords: data sharing; focus groups; qualitative; trials.

Abstract

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