title: What are the roles and valued attributes of a Trial Steering Committee? Ethnographic study of eight clinical trials facing challenges.
abstract: Clinical trials oversight by a Trial Steering Committee (TSC) is mandated by Good Clinical Practice. This study used qualitative methods to explore the role and valued attributes of the TSC to inform planned updates of Medical Research Council guidance and TSC terms of reference.
  
  
  
  An ethnographic study was conducted during 2013-2014. TSC and Trial Management Group meetings from eight trials were observed and audio-recorded, and semi-structured interviews conducted with purposively sampled key informants: independent and non-independent TSC members, trial sponsor representatives, funder representatives and chief investigators. The selected trials were currently recruiting and dealing with challenging scenarios. Data were analysed thematically and findings triangulated and integrated to give a multi-perspective account of the role and valued attributes of a TSC.
  
  
  
  Eight TSC meetings and six Trial Management Group meetings were observed. Sixty-five interviews were conducted with 51 informants. The two main roles played by the TSC were quality assurance and patient advocacy. Quality assurance involved being a 'critical friend' or a provider of 'tough love'. Factors influencing the ability of the TSC to fulfil this role included the TSC Chair, other independent TSC members and the model of the TSC and its fit with the trial subject. The role of the TSC as an advocate for patient well-being was perceived as paramount. Two attributes of TSC members emerged as critical: experience (of running a trial, trial oversight or in a clinical/methodological area) and independence. While independence was valued for giving impartiality, the lack of consensus about its definition and strict requirements of some funders made it difficult to operationalise.
  
  
  
  We found tensions and ambiguities in the roles expected of TSCs and the attributes valued of TSC members. In particular, the requirements of independence and experience could conflict, impacting the TSCs' quality assurance role. Concerns were raised regarding whose interests are served by funders' criteria of independence; in particular, funders' selection of TSC members was thought to potentially inhibit TSCs' ability to fulfil their patient advocacy role. These findings should be incorporated in revising guidance and terms of reference for TSCs.
authors.affiliation: MRC ConDuCT Hub for Trials Methodology Research, School of Social and Community Medicine, University of Bristol, Bristol, BS8 2PS, UK. anne.daykin@bristol.ac.uk.
authors.forename: Anne
authors.initials: A
authors.lastname: Daykin
authors.affiliation: MRC ConDuCT Hub for Trials Methodology Research, School of Social and Community Medicine, University of Bristol, Bristol, BS8 2PS, UK.
authors.forename: Lucy E
authors.initials: LE
authors.lastname: Selman
authors.affiliation: MRC ConDuCT Hub for Trials Methodology Research, School of Social and Community Medicine, University of Bristol, Bristol, BS8 2PS, UK.
authors.forename: Helen
authors.initials: H
authors.lastname: Cramer
authors.affiliation: Formerly: Health Services Research Unit, University of Aberdeen, Aberdeen, AB25 2ZD, UK.
authors.forename: Sharon
authors.initials: S
authors.lastname: McCann
authors.affiliation: Trinity Centre for Practice and Healthcare Innovation, School of Nursing and Midwifery, Trinity College Dublin, Belfast, BT12 6BJ, UK.|National Institute for Mental Health Research, ANU College of Medicine Biology & Environment, The Australian National University, Canberra, ACT 0200, Australia.
authors.forename: Gillian W
authors.initials: GW
authors.lastname: Shorter
authors.affiliation: MRC Clinical Trials Unit at UCL, London, WC2B 6NH, UK.|MRC London Hub for Trial Methodology Research, London, UK.
authors.forename: Matthew R
authors.initials: MR
authors.lastname: Sydes
authors.affiliation: MRC North West Hub for Trials Methodology Research, Institute of Translational Medicine, University of Liverpool, Liverpool, L69 3BX, UK.
authors.forename: Carrol
authors.initials: C
authors.lastname: Gamble
authors.affiliation: MRC ConDuCT Hub for Trials Methodology Research, School of Social and Community Medicine, University of Bristol, Bristol, BS8 2PS, UK.
authors.forename: Rhiannon
authors.initials: R
authors.lastname: Macefield
authors.affiliation: MRC ConDuCT Hub for Trials Methodology Research, School of Social and Community Medicine, University of Bristol, Bristol, BS8 2PS, UK.
authors.forename: J Athene
authors.initials: JA
authors.lastname: Lane
authors.affiliation: MRC ConDuCT Hub for Trials Methodology Research, School of Social and Community Medicine, University of Bristol, Bristol, BS8 2PS, UK.
authors.forename: Alison
authors.initials: A
authors.lastname: Shaw
mesh_terms: D000884:Anthropology, Cultural; D002986:Clinical Trials as Topic; D032802:Committee Membership; D003430:Cross-Sectional Studies; D006801:Humans; D010344:Patient Advocacy; D036301:Qualitative Research
keywords: Good clinical practice; Randomised trials; Terms of reference; Trial Steering Committees; Trial monitoring