Patient and public involvement (PPI) in trial oversight: an ethnographic study of eight clinical trials

KD Coulman, A Nicholson, A Shaw, Anne Daykin, Helen Cramer, Carrol Gamble, Rhiannon Macefield, Malcolm E Pick, Lucy E Selman, Gillian W Shorter, Matt R Sydes, Gordon Taylor, J Athene Lane

Research output: Contribution to conferencePaper

Abstract

Introduction: Trial oversight is important for trial governance andconduct. Patients and/or lay members of the public are increasinglyincluded in oversight committees, influenced by internationalpatient and public involvement (PPI) initiatives toimprove research quality and relevance. However, guidance onundertaking PPI in trial oversight is lacking. We explore how PPIfunctions in oversight committees and provide recommendationsto optimise PPI in future trials as part of a larger study investigatingthe role and function of oversight committees in trials facingchallenges.Methods: Using an ethnographic study design, we observed oversightmeetings of eight UK trials and conducted semi-structured interviewswith members of their trial steering committees (TSCs) andtrial management groups (TMGs) including PPI contributors, trialsponsors and funders. Thematic analysis of data was undertaken,with findings integrated to provide a multi-perspective account ofhow PPI functions in trial oversight.Results: Eight TSC and six TMG meetings from eight trials wereobserved. 52 purposively sampled oversight group members, includingthree PPI contributors, were interviewed. PPI was reportedas beneficial in trial oversight, with PPI memberscontributing a patient voice and advocacy role. However, PPI contributorswere not always active at meetings and were sometimesfelt to have a tokenistic role, with trialists reporting a lack of understandingof how to undertake PPI. Interviewees highlightedthe importance of planning effective strategies to recruit PPI contributors,considering the level of oversight and stage(s) of trialto include PPI, and regular support for PPI contributors by thetrial team.Discussion: Consideration should be given at trial design stage onhow 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 furtherstrengthens the evidence base on facilitating meaningful PPIwithin clinical trials.
Original languageEnglish
Number of pages1
Publication statusPublished - 22 Oct 2019
Event5th International Clinical Trials Methodology Conference - Brighton, United Kingdom
Duration: 06 Oct 202009 Oct 2020
https://ictmc2019.com/

Conference

Conference5th International Clinical Trials Methodology Conference
CountryUnited Kingdom
CityBrighton
Period06/10/202009/10/2020
Internet address

Bibliographical note

International Clinical Trials Methodology Conference, ICTMC2019 ; Conference date: 06-10-2019 Through 10-10-2019

Keywords

  • Trial Oversight
  • Trial Monitoring
  • Trial Conduct
  • patient and public involvement
  • randomised control trials
  • randomized control trials

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