What does a Trial Steering Committee actually do? An study of eight clinical trials under pressure

What is it about?

Trial Steering Committees (TSCs) are required under Good Clinical Practice guidelines for late-phase randomised controlled trials in the UK, yet their actual functioning in practice was poorly understood. This ethnographic study, conducted during 2013 and 2014 as part of the MRC ConDuCT Hub for Trials Methodology Research, observed TSC and Trial Management Group meetings across eight UK clinical trials that were all currently recruiting and dealing with challenging scenarios. Meetings were audio-recorded and semi-structured interviews were conducted with a purposive sample of key informants including independent and non-independent TSC members, chief investigators, sponsors and funders. The study aimed to clarify the roles TSCs play, identify the personal attributes and behaviours valued in TSC members, and generate evidence to inform planned updates to MRC guidance and TSC terms of reference. The findings distinguish between the formal governance functions of TSCs and the interpersonal and relational dimensions that enable or obstruct effective oversight in practice.

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Why is it important?

TSCs sit at the heart of clinical trial governance, yet at the time of this study there was almost no empirical evidence about how they actually operate, what members do in practice, or what makes a TSC effective or ineffective. This study directly addressed that gap at a moment when the MRC was updating its guidance, making the findings immediately actionable for policymakers responsible for trial oversight standards. By using ethnographic methods inside real trial committees, the research captured dynamics that cannot be detected through surveys or document analysis alone, including how independent members exercise judgement under uncertainty and how relationships between committee members shape decisions. The study forms part of a programme of trials methodology research, including companion papers on PPI and on relationships in oversight, that substantially strengthened the evidence base for UK clinical trial governance practice.