'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

• Published in: Current controlled trials in cardiovascular medicine 2017-12, Vol.18 (1), p.612-612, Article 612
• Main Authors: Daykin, Anne, Selman, Lucy E, Cramer, Helen, McCann, Sharon, Shorter, Gillian W, Sydes, Matthew R, Gamble, Carrol, Macefield, Rhiannon, Lane, J Athene, Shaw, Alison
• Format: Article
• Language: English
• Subjects: Anthropology, Cultural; Clinical medicine; Clinical practice guidelines; Clinical trials; Clinical Trials Data Monitoring Committees; Committees; Communication; Corporate sponsorship; Cross-Sectional Studies; Data collection; Decision making; Ethnography; Female; Health services; Humans; Intersectoral Collaboration; Interviews; Male; Medical research; Meetings; Qualitative research; Randomised controlled trials; Randomized Controlled Trials as Topic - methods; Research Design; Trial management; Trial oversight; Trial steering committee; Verbal communication
• ISSN: 1745-6215; 1745-6215
• DOI: 10.1186/s13063-017-2305-9

The oversight and conduct of a randomised controlled trial involves several stakeholders, including a Trial Steering Committee (TSC), Trial Management Group (TMG), Data Monitoring Committee (DMC), funder and sponsor. We aimed to examine how the relationships between these stakeholders affect the trial oversight process and its rigour, to inform future revision of Good Clinical Practice guidelines. Using an ethnographic study design, we observed the oversight processes of eight trials and conducted semi-structured interviews with members of the trials' TSCs and TMGs, plus other relevant informants, including sponsors and funders of trials. Data were analysed thematically, and findings triangulated and integrated to give a multi-perspective account of current oversight practices in the UK. Eight TSC and six TMG meetings from eight trials were observed and audio-recorded, and 66 semi-structured interviews conducted with 52 purposively sampled key informants. Five themes are presented: (1) Collaboration within the TMG and role of the CTU; (2) Collaboration and conflict between oversight committees; (3) Priorities; (4) Communication between trial oversight groups and (5) Power and accountability. There was evidence of collaborative relationships, based on mutual respect, between CTUs, TMGs and TSCs, but also evidence of conflict. Relationships between trial oversight committees were influenced by stakeholders' priorities, both organisational and individual. Good communication following specific, recognised routes played a central role in ensuring that relationships were productive and trial oversight efficient. Participants described the possession of power over trials as a shifting political landscape, and there was lack of clarity regarding the roles and accountability of each committee, the sponsor and funder. Stakeholders' perceptions of their own power over a trial, and the power of others, influenced relationships between those involved in trial oversight. Recent developments in trial design and conduct have been accompanied by changes in roles and relationships between trial oversight groups. Recognising and respecting the value of differing priorities among those involved in running trials is key to successful relationships between committees, funders and sponsors. Clarity regarding appropriate lines of communication, roles and accountability is needed. We present 10 evidence-based recommendations to inform updates to international trial guidance, parti