Skip to main content

Table 5 Recommendations regarding trial oversight

From: ‘We all want to succeed, but we’ve also got to be realistic about what is happening’: an ethnographic study of relationships in trial oversight and their impact

1. Led by their Chairs, trial oversight committees must foster a culture of openness and mutual respect, recognising and drawing upon the skills of all trial oversight committee members. To ensure optimal decision-making and problem-solving, committee conduct should be respectful of all voices and Chairs should actively seek opinions from all members  
2. Recognise the partnership role of CTUs and TMs in managing a trial and supporting the CI in decision-making, management and achieving deliverables  
3. The differing priorities of trial stakeholders in overseeing and delivering the trial should be explicitly stated, considered and, where necessary, realigned to the shared priority across stakeholder groups to produce a good-quality trial that informs practice. Guidance and best practice on resolving differences should be shared and could be collated and hosted by CTUs and funders  
4. Clear lines of communication between oversight groups should be established in advance of the trial starting, documented in the trial Charter, shared between stakeholders, and maintained. From the trial outset, the frequency of oversight meetings should be considered and agreed. The frequency should be regular enough to be responsive to challenges and implement trial oversight decisions promptly, while allowing for extraordinary meetings in the event of challenges  
5. Ensure a primary, single point of contact for the trial and coordinate communication with trial oversight stakeholders  
6. Consider and agree before trial initiation who will act as arbiter if/when needed; the CTU may or may not play this role  
7. Consult with stakeholders to determine the full implications of funders appointing independent TSC members to trials, and agree an approach to this issue  
8. Clarify the roles and responsibilities of all those involved in trial oversight, and make stakeholders aware of these. This includes the different reasons for shutting down a trial, and which oversight bodies might do so in which circumstances. Each trial should consider these from the outset. Discuss before trial initiation the information needs of different stakeholders and communicate efficiently and in a timely manner as needed  
9. Be aware of how the threat of monitoring meetings, or of closing trials, can negatively impact trial conduct and relationships, especially the way a CI or TMG might present the trial to the TSC. It might be of benefit to identify risks to the trial from the outset, and report on these at each meeting  
10. Acknowledge how the close relationship between TSC and funder and the threat of the latter withdrawing funding is in tension with the role of the TSC in providing expert support to the TMG. Power hierarchies between committees can restrict the effectiveness of trial oversight, so efforts should be made to decentralise power  
  1. CI Chief Investigator, CTU Clinical Trials Unit, TMG Trial Management Group, TSC Trial Steering Committee