Exploring the role and function of trial steering committees: results of an expert panel meeting
Open accessAbstract
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.
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Randomised trials often include various committees or groups (e.g., a trial management group for day-to-day conduct and a trial steering committee for executive decisions) to facilitate trial coordination and conduct.
“A randomised trial will often include various committees or groups to facilitate trial coordination and conduct—for example, a trial management group (day-to-day trial conduct) and a trial steering committee (executive decisions).54 55”
From SPIRIT 2025 explanation and elaboration: updated guideline for protocols of randomised trials (2025) · cites this paper as [55]
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- Authors
- Harman, N. L., Conroy, E. J., Lewis, S. C., Murray, G., Norrie, J., Sydes, M. R., Lane, J. A., Altman, D. G., Baigent, C., Bliss, J. M., Campbell, M. K., Elbourne, D., Evans, S., Sandercock, P., & Gamble, C.
- Affiliations
- University of Liverpool (GB)
- University of Edinburgh (GB)
- University of Aberdeen (GB)
- At Bristol (GB)
- University of Oxford (GB)
- Institute of Cancer Research (GB)
- London School of Hygiene & Tropical Medicine (GB)
- Corresponding author
- Harman, Nicola L.
- ORCID
- Venue
- Trials
- Published
- 2015-12
- Volume
- 16
- Issue
- 1
- Pages
- 597-597
- ISSN
- 1745-6215 (ISSN-L)
- PMC
- PMC4696246
- OpenAlex
- W2215498500
- Cited by
- 33
- References
- 22
- Citations by year
- 2026: 2 · 2025: 3 · 2024: 2 · 2023: 3 · 2022: 3 · 2021: 1 · 2020: 4 · 2019: 6 · 2018: 4 · 2017: 4 · 2016: 1
- FWCI
- 3.22
- Type
- journal article
- Language
- en
- Open access
- gold
- doi.org
- Licence
- cc-by
- Locations
- Trials (publishedVersion, cc-by)
- Europe PMC (PubMed Central) (publishedVersion, cc-by)
- PubMed Central (publishedVersion, cc-by)
- PubMed (publishedVersion)
- LSHTM Research Online (London School of Hygiene and Tropical Medicine) (acceptedVersion)
- Edinburgh Research Explorer (University of Edinburgh) (submittedVersion, other-oa)
- Aberdeen University Research Archive (Aberdeen University) (submittedVersion)
- UCL Discovery (University College London) (submittedVersion)
- Funders
- Medical Research Council (MRC) Network of Hubs for Trials Methodology Research (MR/L004933/1-R30)
- Topics
- Health Sciences › Medicine › Public Health, Environmental and Occupational Health › Ethics in Clinical Research
- Physical Sciences › Mathematics › Statistics and Probability › Statistical Methods in Clinical Trials
- Health Sciences › Medicine › Physiology › Biomedical Ethics and Regulation
- Keywords
- trial steering committee, data monitoring committees, committee independence, clinical trial ethics, indemnity, patient and public involvement, clinical trial governance
- MeSH terms
- Clinical Trials as Topic, Data Interpretation, Statistical, Humans, Surveys and Questionnaires, Research Design, Research Personnel, Research Support as Topic, Conflict of Interest, Professional Role, Clinical Trials Data Monitoring Committees, Advisory Committees, Committee Membership, Consensus
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