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 |