Exploring the role and function of trial steering committees

results of an expert panel meeting

Nicola L Harman, Elizabeth J Conroy, Steff C Lewis, Gordon Murray, John Norrie, Matt R Sydes, J Athene Lane, Douglas G Altman, Colin Baigent, Judith M Bliss, Marion K Campbell, Diana Elbourne, Stephen Evans, Peter Sandercock, Carrol Gamble

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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.

Original languageEnglish
Article number597
Number of pages14
JournalTrials
Volume16
Issue number1
DOIs
Publication statusPublished - 2015

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Clinical Trials Data Monitoring Committees
Biomedical Research
Committee Membership
Information Dissemination
Executive Function
Insurance
Ethics
Uncertainty
Clinical Trials
Guidelines

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Harman, N. L., Conroy, E. J., Lewis, S. C., Murray, G., Norrie, J., Sydes, M. R., ... Gamble, C. (2015). Exploring the role and function of trial steering committees: results of an expert panel meeting. Trials, 16(1), [597]. https://doi.org/10.1186/s13063-015-1125-z

Exploring the role and function of trial steering committees : results of an expert panel meeting. / Harman, Nicola L; Conroy, Elizabeth J; Lewis, Steff C; Murray, Gordon; Norrie, John; Sydes, Matt R; Lane, J Athene; Altman, Douglas G; Baigent, Colin; Bliss, Judith M; Campbell, Marion K; Elbourne, Diana; Evans, Stephen; Sandercock, Peter; Gamble, Carrol.

In: Trials, Vol. 16, No. 1, 597, 2015.

Research output: Contribution to journalArticle

Harman, NL, Conroy, EJ, Lewis, SC, Murray, G, Norrie, J, Sydes, MR, Lane, JA, Altman, DG, Baigent, C, Bliss, JM, Campbell, MK, Elbourne, D, Evans, S, Sandercock, P & Gamble, C 2015, 'Exploring the role and function of trial steering committees: results of an expert panel meeting', Trials, vol. 16, no. 1, 597. https://doi.org/10.1186/s13063-015-1125-z
Harman, Nicola L ; Conroy, Elizabeth J ; Lewis, Steff C ; Murray, Gordon ; Norrie, John ; Sydes, Matt R ; Lane, J Athene ; Altman, Douglas G ; Baigent, Colin ; Bliss, Judith M ; Campbell, Marion K ; Elbourne, Diana ; Evans, Stephen ; Sandercock, Peter ; Gamble, Carrol. / Exploring the role and function of trial steering committees : results of an expert panel meeting. In: Trials. 2015 ; Vol. 16, No. 1.
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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.",
author = "Harman, {Nicola L} and Conroy, {Elizabeth J} and Lewis, {Steff C} and Gordon Murray and John Norrie and Sydes, {Matt R} and Lane, {J Athene} and Altman, {Douglas G} and Colin Baigent and Bliss, {Judith M} and Campbell, {Marion K} and Diana Elbourne and Stephen Evans and Peter Sandercock and Carrol Gamble",
note = "Acknowledgements This work was supported by the Medical Research Council (MRC) Network of Hubs for Trials Methodology Research (MR/L004933/1-R30).",
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T1 - Exploring the role and function of trial steering committees

T2 - results of an expert panel meeting

AU - Harman, Nicola L

AU - Conroy, Elizabeth J

AU - Lewis, Steff C

AU - Murray, Gordon

AU - Norrie, John

AU - Sydes, Matt R

AU - Lane, J Athene

AU - Altman, Douglas G

AU - Baigent, Colin

AU - Bliss, Judith M

AU - Campbell, Marion K

AU - Elbourne, Diana

AU - Evans, Stephen

AU - Sandercock, Peter

AU - Gamble, Carrol

N1 - Acknowledgements This work was supported by the Medical Research Council (MRC) Network of Hubs for Trials Methodology Research (MR/L004933/1-R30).

PY - 2015

Y1 - 2015

N2 - 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.

AB - 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.

U2 - 10.1186/s13063-015-1125-z

DO - 10.1186/s13063-015-1125-z

M3 - Article

VL - 16

JO - Trials

JF - Trials

SN - 1745-6215

IS - 1

M1 - 597

ER -