Abstract
BackgroundTrial oversight is important for trial governance and conduct. Patients and/or lay members of the public are increasingly included in trial oversight committees, influenced by international patient and public involvement (PPI) initiatives to improve the quality and relevance of research. However, there is a lack of guidance on how to undertake PPI in trial oversight and tokenistic PPI remains an issue. This paper explores how PPI functions in existing trial oversight committees and provides recommendations to optimise PPI in future trials. This was part of a larger study investigating the role and function of oversight committees in trials facing challenges.MethodsUsing 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 public 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.ResultsEight TSC and six TMG meetings from eight trials were observed, and 66 semi-structured interviews conducted with 52 purposively sampled oversight group members, including three public contributors. PPI was reported as beneficial in trial oversight, with public members contributing a patient voice and fulfilling a patient advocacy role. However, public contributors were not always active at oversight meetings and were sometimes felt to have a tokenistic role, with trialists reporting a lack of understanding of how to undertake PPI in trial oversight. To optimise PPI in trial oversight, the following areas were highlighted: the importance of planning effective strategies to recruit public contributors; considering the level of oversight and stage(s) of trial to include PPI; support for public contributors by the trial team between and during oversight meetings.ConclusionsWe present evidence-based recommendations to inform future PPI in trial oversight. Consideration should be given at trial design stage on how to recruit and involve public contributors within trial oversight, as well as support and mentorship for both public contributors and trialists (in how to undertake PPI effectively). Findings from this study further strengthen the evidence base on facilitating meaningful PPI within clinical trials.
Highlights
Robust clinical trial oversight helps to safeguard participants by ensuring that trial conduct is in accordance with international Good Clinical Practice guidelines, and trial results are accurately reported [1, 2]
Both the Medical Research Council (MRC) and the National Institute for Health Research (NIHR), two major funders of UK clinical trials, recommend that trial steering committee (TSC) include patient or public member(s), no such guidance exists for trial management group (TMG) [3, 13]
patient and public involvement (PPI) representation in eight trials facing challenges Overall, 14 meetings were observed from the eight trials (Table 2), with details of response rates reported previously [29]. Linked to these eight trials, 66 interviews were conducted with 52 individuals, including TSC and TMG members, three public contributors and other relevant informants (Table 3)
Summary
Robust clinical trial oversight helps to safeguard participants by ensuring that trial conduct is in accordance with international Good Clinical Practice guidelines, and trial results are accurately reported [1, 2]. The National Institute for Health Research (NIHR) National Standards for Public Involvement highlight the importance of involving the public in research governance and leadership to ensure “decisions promote and protect the public interest” [12] Both the MRC and the NIHR, two major funders of UK clinical trials, recommend that TSCs include patient or public member(s), no such guidance exists for TMGs [3, 13]. Patients and/or lay members of the public are increasingly included in trial oversight committees, influenced by international patient and public involvement (PPI) initiatives to improve the quality and relevance of research. This paper explores how PPI functions in existing trial oversight committees and provides recommendations to optimise PPI in future trials. PPI patient and public involvement, TMG trial management group, TSC trial steering committee *Extracted from interview topic guides. Data was triangulated to explore areas of divergence and convergence in the two datasets, and the different participant perspectives represented
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