Abstract
Introduction: Trial oversight is important for trial governance and conduct. Patients and/or lay members of the public are increasingly included in oversight committees, influenced by international patient and public involvement (PPI) initiatives tonimprove research quality and relevance. However, guidance on undertaking PPI in trial oversight is lacking. We explore how PPI functions in oversight committees and provide recommendations to optimise PPI in future trials as part of a larger study investigating the role and function of oversight committees in trials facing challenges.
Methods: Using an ethnographic study design, we observed oversight meetings of eight UK trials and conducted semi-structured interviews with members of their trial steering committees (TSCs) and trial management groups (TMGs) including PPI contributors, trial sponsors and funders. Thematic analysis of data was undertaken, with findings integrated to provide a multi-perspective account of how PPI functions in trial oversight.
Results: Eight TSC and six TMG meetings from eight trials were observed. 52 purposively sampled oversight group members, including three PPI contributors, were interviewed. PPI was reported as beneficial in trial oversight, with PPI members contributing a patient voice and advocacy role. However, PPI contributors were not always active at meetings and were sometimes felt to have a tokenistic role, with trialists reporting a lack of understanding of how to undertake PPI. Interviewees highlighted the importance of planning effective strategies to recruit PPI contributors, considering the level of oversight and stage(s) of trial to include PPI, and regular support for PPI contributors by the trial team.
Discussion: Consideration should be given at trial design stage on how to recruit and involve PPI contributors within trial oversight, and support and mentorship for both PPI contributors and trialists (in how to undertake PPI effectively). This study further strengthens the evidence base on facilitating meaningful PPI within clinical trials.
Methods: Using an ethnographic study design, we observed oversight meetings of eight UK trials and conducted semi-structured interviews with members of their trial steering committees (TSCs) and trial management groups (TMGs) including PPI contributors, trial sponsors and funders. Thematic analysis of data was undertaken, with findings integrated to provide a multi-perspective account of how PPI functions in trial oversight.
Results: Eight TSC and six TMG meetings from eight trials were observed. 52 purposively sampled oversight group members, including three PPI contributors, were interviewed. PPI was reported as beneficial in trial oversight, with PPI members contributing a patient voice and advocacy role. However, PPI contributors were not always active at meetings and were sometimes felt to have a tokenistic role, with trialists reporting a lack of understanding of how to undertake PPI. Interviewees highlighted the importance of planning effective strategies to recruit PPI contributors, considering the level of oversight and stage(s) of trial to include PPI, and regular support for PPI contributors by the trial team.
Discussion: Consideration should be given at trial design stage on how to recruit and involve PPI contributors within trial oversight, and support and mentorship for both PPI contributors and trialists (in how to undertake PPI effectively). This study further strengthens the evidence base on facilitating meaningful PPI within clinical trials.
| Original language | English |
|---|---|
| Title of host publication | Trials |
| Subtitle of host publication | Meeting abstracts from the 5th International Clinical Trials Methodology Conference (ICTMC 2019), Brighton, UK. 06-09 October 2019 |
| Volume | 20 |
| Publication status | Published - 22 Oct 2019 |