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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