Approaches to sharing trial results with adult patients and the public: a qualitative interview and focus group study

Abstract

<title>Abstract</title> Background Sharing trial results with participants is increasingly recognised as an ethical obligation that fosters trust, respect, and engagement. Yet in practice, results are rarely shared. Researchers often lack guidance on what information to include or how best to present it. To create guidance that is both practical and meaningful, it is important to understand the perspectives of researchers as well as patient and public contributors. We explored these perspectives to inform the development of a reporting guideline for sharing trial results with patients and the public. Methods We conducted a qualitative study using semi-structured interviews followed by focus group discussions. Participants included researchers with experience in clinical trials (such as chief investigators, trial managers, and statisticians), members of the public, and patient representatives. We conducted 29 interviews and 3 focus groups between May and November 2024. Data were analysed thematically, with coding and interpretation informed by both the research team and participants. Results We identified six descriptive themes that reflected the participants’ experiences and perspectives. Participants strongly endorsed the principle of sharing trial results with patients and the public, citing respect, transparency, and empowerment as key reasons. Researchers highlighted uncertainties about what to report, when to disseminate, and how to present results, and noted resource and structural barriers. Patients and public participants prioritised plain language, clarity, and contextualisation, and stressed the need for inclusive communication for under-represented groups. There was broad agreement on core elements for trial result summaries, including study purpose, key findings, potential harms, implications, and next steps. Preferences varied, however, regarding the level of detail and presentation style. Flexibility, with a set of core items complemented by optional elements, was seen as the most workable solution. Conclusions This study highlights how patients, members of the public, and researchers view the sharing of clinical trial results as both a moral responsibility and a practical challenge. The findings provide evidence-based recommendations to guide the development of a reporting guideline that supports consistent, transparent, and meaningful communication of trial results beyond the research community.