Understanding and optimising patient and public involvement in trial oversight: an ethnographic study of eight clinical trials

Karen Coulman*, Alex Nicholson, Alison R G Shaw, Anne Daykin, Lucy Selman, Rhiannon Macefield, Gillian Shorter, Helen Cramer, Matthew Sydes, Carrol Gamble, Malcolm Pick, Gordon Taylor, J. Athene Lane

*Corresponding author for this work

Research output: Contribution to journalArticle (Academic Journal)peer-review

15 Citations (Scopus)
75 Downloads (Pure)


Background: Trial 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.

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, and 66 semi-structured interviews conducted with 52 purposively sampled oversight group members, including three PPI contributors. PPI was reported as beneficial in trial oversight, with PPI members contributing a patient voice and fulfilling a patient advocacy role. However, PPI 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 PPI contributors; considering the level of oversight and stage(s) of trial to include PPI; support for PPI contributors by the trial team between and during oversight meetings.

Conclusions: We 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 PPI contributors within trial oversight, as well as support and mentorship for both PPI 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.
Original languageEnglish
Article number543 (2020)
Number of pages15
Publication statusPublished - 18 Jun 2020

Structured keywords

  • Centre for Surgical Research
  • BRTC
  • BTC (Bristol Trials Centre)


  • Public involvement
  • user involvement
  • patient involvement
  • randomized trials
  • Trial Steering Committees
  • Trial Management Groups
  • trial monitoring
  • trial oversight


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