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 to
improve 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.
conduct. Patients and/or lay members of the public are increasingly
included in oversight committees, influenced by international
patient and public involvement (PPI) initiatives to
improve 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.
| Original language | English |
|---|---|
| Pages | 578-578 |
| Publication status | Published (in print/issue) - 22 Oct 2019 |
| Event | International Clinical Trials Methodology Conference - Brighton, United Kingdom Duration: 6 Oct 2019 → 10 Oct 2019 |
Conference
| Conference | International Clinical Trials Methodology Conference |
|---|---|
| Abbreviated title | ICTMC2019 |
| Country/Territory | United Kingdom |
| City | Brighton |
| Period | 6/10/19 → 10/10/19 |
Keywords
- Trial Oversight
- Trial Monitoring
- Trial Conduct
- patient and public involvement
- randomised control trials
- randomized control trials