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Table 3 Potential models of participant involvement in trials

From: When participants get involved: reconsidering patient and public involvement in clinical trials at the MRC Clinical Trials Unit at UCL

Role Model Appropriate for participant involvement? Comments
Managerial Patient/public representative on Trial Management Group Yes Thought should be given to how to recruit and train participants who might be involved in a TMG – they need an understanding of research and to be confident and articulate in this type of setting
Oversight Patient and participant research partners Yes A committee made up of participants and patients with an oversight remit and clear reporting route into TMG and/or TSC
Patient/public representative on Trial Steering Committee Yes – but with caveats Should not be voting members as not independent of the trial
Patient/public representative on Data Safety Monitoring Committee No Involvement not appropriate because of danger of un-blinding and of bias Information from an advisory group (e.g. patient and participant research partners) could be considered by a DSMC
Responsive Involvement on specific tasks (e.g. facilitated through existing patient groups) Yes Participants involved in specific tasks, either on a one-off or ongoing basis. For example, participants help to design interview schedules, draft key messages of trial results, be advocates for the trial findings, etc.
Ad hoc participant meetings Yes Participant meetings to discuss topics and issues as they arise. For example, ways to address slow accrual, ways to respond to negative rumours, etc.
Ongoing participant groups Yes Regular meetings of participants to provide feedback and actions to trialists on a regular basis
Community advisory groups Yes Participants contribute via membership of a community advisory group for the ongoing trial
Community meetings to advise trial teams Yes Participants contribute via community meetings held to advise the ongoing trial