title: Exploring the role and function of trial steering committees: results of an expert panel meeting.
abstract: BACKGROUND
  The independent oversight of clinical trials, which is recommended by the Medical Research Council (MRC) Guidelines for Good Clinical Practice, is typically provided by an independent advisory Data Monitoring Committee (DMC) and an independent executive committee, to whom the DMC makes recommendations. The detailed roles and function of this executive committee, known as the Trial Steering Committee (TSC), have not previously been studied or reviewed since those originally proposed by the MRC in 1998.
  
  
  METHODS
  An expert panel (n = 7) was convened comprising statisticians, clinicians and trial methodologists with prior TSC experience. Twelve questions about the role and responsibilities of the TSC were discussed by the panel at two full-day meetings. Each meeting was transcribed in full and the discussions were summarised.
  
  
  RESULTS
  The expert panel reached agreement on the role of the TSC, to which it was accountable, the membership, the definition of independence, and the experience and training needed. The management of ethical issues, difficult/complex situations and issues the TSC should not ask the DMC to make recommendations on were more difficult to discuss without specific examples, but support existed for further work to help share issues and to provide appropriate training for TSC members. Additional topics discussed, which had not been identified by previous work relating to the DMCs but were pertinent to the role of the TSC, included the following: review of data sharing requests, indemnity, lifespan of the TSC, general TSC administration, and the roles of both the Funder and the Sponsor.
  
  
  CONCLUSIONS
  This paper presents recommendations that will contribute to the revision and update of the MRC TSC terms of reference. Uncertainty remains in some areas due to the absence of real-life examples; future guidance on these issues would benefit from a repository of case studies. Notably, the role of a patient and public involvement (PPI) contributor was not discussed, and further work is warranted to explore the role of a PPI contributor in independent trial oversight.
authors.affiliation: Medicines for Children Clinical Trials Unit, University of Liverpool, Liverpool, L12 2AP, UK. n.harman@liv.ac.uk.
authors.forename: Nicola L
authors.initials: NL
authors.lastname: Harman
authors.affiliation: Department of Biostatistics, University of Liverpool, Liverpool, L69 3GA, UK. ejconroy@liverpool.ac.uk.
authors.forename: Elizabeth J
authors.initials: EJ
authors.lastname: Conroy
authors.affiliation: Centre for Population Health Sciences, Edinburgh University, Edinburgh, UK. steff.lewis@ed.ac.uk.
authors.forename: Steff C
authors.initials: SC
authors.lastname: Lewis
authors.affiliation: Centre for Population Health Sciences, Edinburgh University, Edinburgh, UK. Gordon.Murray@ed.ac.uk.
authors.forename: Gordon
authors.initials: G
authors.lastname: Murray
authors.affiliation: Centre for Healthcare Randomised Trials (CHaRT), Aberdeen, UK. j.norrie@abdn.ac.uk.
authors.forename: John
authors.initials: J
authors.lastname: Norrie
authors.affiliation: MRC Clinical Trials Unit at UCL, London, UK. m.sydes@ucl.ac.uk.|London Hub for Trials Methodology Research, London, UK. m.sydes@ucl.ac.uk.
authors.forename: Matt R
authors.initials: MR
authors.lastname: Sydes
authors.affiliation: Bristol Randomised Trials Collaboration Trials Unit, Bristol, UK. athene.lane@bristol.ac.uk.
authors.forename: J Athene
authors.initials: JA
authors.lastname: Lane
authors.affiliation: Centre for Statistics in Medicine, Nuffield Department of Orthopaedics, Rheumatology & Musculoskeletal Sciences, University of Oxford, Oxford, UK. doug.altman@csm.ox.ac.uk.
authors.forename: Douglas G
authors.initials: DG
authors.lastname: Altman
authors.affiliation: Clinical Trial Service Unit & Epidemiological Studies Unit (CTSU), Nuffield Department of Population Health, University of Oxford, Oxford, UK. colin.baigent@ctsu.ox.ac.uk.
authors.forename: Colin
authors.initials: C
authors.lastname: Baigent
authors.affiliation: ICR-CTSU, Division of Clinical Studies, The Institute of Cancer Research, London, UK. Judith.Bliss@icr.ac.uk.
authors.forename: Judith M
authors.initials: JM
authors.lastname: Bliss
authors.affiliation: Health Services Research Unit, University of Aberdeen, Aberdeen, UK. m.k.campbell@abdn.ac.uk.
authors.forename: Marion K
authors.initials: MK
authors.lastname: Campbell
authors.affiliation: Department of Medical Statistics, London School of Hygiene and Tropical Medicine, London, UK. diana.elbourne@lshtm.ac.uk.
authors.forename: Diana
authors.initials: D
authors.lastname: Elbourne
authors.affiliation: Faculty of Epidemiology and Population Health, London School of Hygiene and Tropical Medicine, London, UK. stephen.evans@lshtm.ac.uk.
authors.forename: Stephen
authors.initials: S
authors.lastname: Evans
authors.affiliation: School for Clinical Sciences, University of Edinburgh, Edinburgh, UK. peter.sandercock@ed.ac.uk.
authors.forename: Peter
authors.initials: P
authors.lastname: Sandercock
authors.affiliation: Medicines for Children Clinical Trials Unit, University of Liverpool, Liverpool, L12 2AP, UK. carrolp@liverpool.ac.uk.
authors.forename: Carrol
authors.initials: C
authors.lastname: Gamble
mesh_terms: D026683:Advisory Committees / Q000191:economics / Q000941:ethics / Q000592:standards*; D026661:Clinical Trials Data Monitoring Committees / Q000191:economics / Q000941:ethics / Q000592:standards*; D002986:Clinical Trials as Topic / Q000191:economics / Q000941:ethics / Q000592:standards* / Q000706:statistics & numerical data; D032802:Committee Membership; D016265:Conflict of Interest; D032921:Consensus; D003627:Data Interpretation, Statistical; D006801:Humans; D024382:Professional Role; D012107:Research Design / Q000592:standards* / Q000706:statistics & numerical data; D012108:Research Personnel / Q000191:economics / Q000941:ethics / Q000592:standards*; D012109:Research Support as Topic / Q000592:standards; D011795:Surveys and Questionnaires