What are the roles and valued attributes of a Trial Steering Committee? A ethnographic study of 8 clinical trials facing challenges

Anne Daykin, Lucy E Selman, Helen Cramer, Sharon McCann, Gillian W Shorter, Matthew R Sydes, Carrol Gamble, Rhiannon Macefield, J Athene Lane, Alison Shaw

    Research output: Contribution to journalArticle

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    Abstract

    Background: 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.MethodsAn ethnographic study design 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. ResultsEight TSC meetings and six Trial Management Group meetings were observed. 65 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 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. ConclusionsWe 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 on 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.
    LanguageEnglish
    Pages307-307
    JournalTrials
    Volume17
    Issue number1
    DOIs
    Publication statusPublished - 1 Jul 2016

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    Committee Membership
    Clinical Trials
    Patient Advocacy
    Aptitude
    Group Processes
    Interviews
    Love
    Biomedical Research
    Consensus
    Research Personnel

    Keywords

    • Randomised trials
    • Good Clinical Practice
    • Terms of Reference
    • Trial Steering Committees
    • Trial Monitoring

    Cite this

    Daykin, Anne ; Selman, Lucy E ; Cramer, Helen ; McCann, Sharon ; Shorter, Gillian W ; Sydes, Matthew R ; Gamble, Carrol ; Macefield, Rhiannon ; Lane, J Athene ; Shaw, Alison. / What are the roles and valued attributes of a Trial Steering Committee? A ethnographic study of 8 clinical trials facing challenges. In: Trials. 2016 ; Vol. 17, No. 1. pp. 307-307.
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    abstract = "Background: 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.MethodsAn ethnographic study design 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. ResultsEight TSC meetings and six Trial Management Group meetings were observed. 65 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 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. ConclusionsWe 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 on 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.",
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    author = "Anne Daykin and Selman, {Lucy E} and Helen Cramer and Sharon McCann and Shorter, {Gillian W} and Sydes, {Matthew R} and Carrol Gamble and Rhiannon Macefield and Lane, {J Athene} and Alison Shaw",
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    Daykin, A, Selman, LE, Cramer, H, McCann, S, Shorter, GW, Sydes, MR, Gamble, C, Macefield, R, Lane, JA & Shaw, A 2016, 'What are the roles and valued attributes of a Trial Steering Committee? A ethnographic study of 8 clinical trials facing challenges', Trials, vol. 17, no. 1, pp. 307-307. https://doi.org/10.1186/s13063-016-1425-y

    What are the roles and valued attributes of a Trial Steering Committee? A ethnographic study of 8 clinical trials facing challenges. / Daykin, Anne; Selman, Lucy E; Cramer, Helen; McCann, Sharon; Shorter, Gillian W; Sydes, Matthew R; Gamble, Carrol; Macefield, Rhiannon; Lane, J Athene; Shaw, Alison.

    In: Trials, Vol. 17, No. 1, 01.07.2016, p. 307-307.

    Research output: Contribution to journalArticle

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    T1 - What are the roles and valued attributes of a Trial Steering Committee? A ethnographic study of 8 clinical trials facing challenges

    AU - Daykin, Anne

    AU - Selman, Lucy E

    AU - Cramer, Helen

    AU - McCann, Sharon

    AU - Shorter, Gillian W

    AU - Sydes, Matthew R

    AU - Gamble, Carrol

    AU - Macefield, Rhiannon

    AU - Lane, J Athene

    AU - Shaw, Alison

    PY - 2016/7/1

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    N2 - Background: 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.MethodsAn ethnographic study design 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. ResultsEight TSC meetings and six Trial Management Group meetings were observed. 65 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 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. ConclusionsWe 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 on 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.

    AB - Background: 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.MethodsAn ethnographic study design 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. ResultsEight TSC meetings and six Trial Management Group meetings were observed. 65 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 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. ConclusionsWe 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 on 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.

    KW - Randomised trials

    KW - Good Clinical Practice

    KW - Terms of Reference

    KW - Trial Steering Committees

    KW - Trial Monitoring

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