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.
- data sharing
- focus groups