“We all want to succeed, but we've also got to be realistic about what is happening”: An ethnographic study of relationships in trial oversight and their impact

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

1 Citation (Scopus)

Abstract

Background The oversight and conduct of a randomised controlled trial involves several stakeholders, including a Trial Steering Committee (TSC), Trial Management Group (TMG), Data Monitoring Committee (DMC), funder, and sponsor. We aimed to examine how the relationships between these stakeholders affect the trial oversight process and its rigour, to inform future revision of Good Clinical Practice guidelines. Methods Using an ethnographic study design, we observed the oversight processes of eight trials and conducted semi-structured interviews with members of the trials’ TSCs and TMGs, plus other relevant informants, including sponsors and funders of trials. Data were analysed thematically, and findings triangulated and integrated to give a multi-perspective account of current oversight practices in the UK. Findings Eight TSC and six TMG meetings from eight trials were observed and audio-recorded, and 66 semistructured interviews conducted with 52 purposively sampled key informants. Five themes are presented: Collaboration within the TMG and role of the CTU; Collaboration and conflict between oversight committees; Priorities; Communication between trial oversight groups; and Power and accountability. There was evidence of collaborative relationships, based on mutual respect, between CTUs, TMGs and TSCs, but also evidence of conflict. Relationships between trial oversight committees were influenced by stakeholders’ priorities, both organisational and individual. Good communication following specific, recognised routes played a central role in ensuring relationships were productive and trial oversight efficient. Participants described the possession of power over trials as a shifting political landscape, and there was lack of clarity regarding the roles and accountability of each committee, the sponsor, and funder. Stakeholders’ perceptions of their own power over a trial, and the power of others, influenced relationships between those involved in trial oversight. Conclusions Recent developments in trial design and conduct have been accompanied by changes in roles and relationships between trial oversight groups. Recognising and respecting the value of differing priorities among those involved in running trials is key to successful relationships between committees, funders and sponsors. Clarity regarding appropriate lines of communication, roles, and accountability is needed. We present 10 evidence-based recommendations to inform updates to international trial guidance, particularly the Medical Research Council guidelines
LanguageEnglish
Pages1-16
JournalTrials
Volume18
Issue number612
Early online date21 Dec 2017
DOIs
Publication statusE-pub ahead of print - 21 Dec 2017

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Social Responsibility
Communication
Clinical Trials Data Monitoring Committees
Interviews
Group Processes
Practice Guidelines
Biomedical Research
Randomized Controlled Trials
Guidelines
Power (Psychology)
Conflict (Psychology)

Keywords

  • Randomised Controlled Trials
  • Randomized Controlled Trials
  • Trial Oversight
  • Trial Steering Committee
  • Trial Management
  • Ethnography
  • Qualitative Research

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. / “We all want to succeed, but we've also got to be realistic about what is happening”: An ethnographic study of relationships in trial oversight and their impact. In: Trials. 2017 ; Vol. 18, No. 612. pp. 1-16.
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“We all want to succeed, but we've also got to be realistic about what is happening”: An ethnographic study of relationships in trial oversight and their impact. / 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. 18, No. 612, 21.12.2017, p. 1-16.

Research output: Contribution to journalArticle

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T1 - “We all want to succeed, but we've also got to be realistic about what is happening”: An ethnographic study of relationships in trial oversight and their impact

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 - 2017/12/21

Y1 - 2017/12/21

N2 - Background The oversight and conduct of a randomised controlled trial involves several stakeholders, including a Trial Steering Committee (TSC), Trial Management Group (TMG), Data Monitoring Committee (DMC), funder, and sponsor. We aimed to examine how the relationships between these stakeholders affect the trial oversight process and its rigour, to inform future revision of Good Clinical Practice guidelines. Methods Using an ethnographic study design, we observed the oversight processes of eight trials and conducted semi-structured interviews with members of the trials’ TSCs and TMGs, plus other relevant informants, including sponsors and funders of trials. Data were analysed thematically, and findings triangulated and integrated to give a multi-perspective account of current oversight practices in the UK. Findings Eight TSC and six TMG meetings from eight trials were observed and audio-recorded, and 66 semistructured interviews conducted with 52 purposively sampled key informants. Five themes are presented: Collaboration within the TMG and role of the CTU; Collaboration and conflict between oversight committees; Priorities; Communication between trial oversight groups; and Power and accountability. There was evidence of collaborative relationships, based on mutual respect, between CTUs, TMGs and TSCs, but also evidence of conflict. Relationships between trial oversight committees were influenced by stakeholders’ priorities, both organisational and individual. Good communication following specific, recognised routes played a central role in ensuring relationships were productive and trial oversight efficient. Participants described the possession of power over trials as a shifting political landscape, and there was lack of clarity regarding the roles and accountability of each committee, the sponsor, and funder. Stakeholders’ perceptions of their own power over a trial, and the power of others, influenced relationships between those involved in trial oversight. Conclusions Recent developments in trial design and conduct have been accompanied by changes in roles and relationships between trial oversight groups. Recognising and respecting the value of differing priorities among those involved in running trials is key to successful relationships between committees, funders and sponsors. Clarity regarding appropriate lines of communication, roles, and accountability is needed. We present 10 evidence-based recommendations to inform updates to international trial guidance, particularly the Medical Research Council guidelines

AB - Background The oversight and conduct of a randomised controlled trial involves several stakeholders, including a Trial Steering Committee (TSC), Trial Management Group (TMG), Data Monitoring Committee (DMC), funder, and sponsor. We aimed to examine how the relationships between these stakeholders affect the trial oversight process and its rigour, to inform future revision of Good Clinical Practice guidelines. Methods Using an ethnographic study design, we observed the oversight processes of eight trials and conducted semi-structured interviews with members of the trials’ TSCs and TMGs, plus other relevant informants, including sponsors and funders of trials. Data were analysed thematically, and findings triangulated and integrated to give a multi-perspective account of current oversight practices in the UK. Findings Eight TSC and six TMG meetings from eight trials were observed and audio-recorded, and 66 semistructured interviews conducted with 52 purposively sampled key informants. Five themes are presented: Collaboration within the TMG and role of the CTU; Collaboration and conflict between oversight committees; Priorities; Communication between trial oversight groups; and Power and accountability. There was evidence of collaborative relationships, based on mutual respect, between CTUs, TMGs and TSCs, but also evidence of conflict. Relationships between trial oversight committees were influenced by stakeholders’ priorities, both organisational and individual. Good communication following specific, recognised routes played a central role in ensuring relationships were productive and trial oversight efficient. Participants described the possession of power over trials as a shifting political landscape, and there was lack of clarity regarding the roles and accountability of each committee, the sponsor, and funder. Stakeholders’ perceptions of their own power over a trial, and the power of others, influenced relationships between those involved in trial oversight. Conclusions Recent developments in trial design and conduct have been accompanied by changes in roles and relationships between trial oversight groups. Recognising and respecting the value of differing priorities among those involved in running trials is key to successful relationships between committees, funders and sponsors. Clarity regarding appropriate lines of communication, roles, and accountability is needed. We present 10 evidence-based recommendations to inform updates to international trial guidance, particularly the Medical Research Council guidelines

KW - Randomised Controlled Trials

KW - Randomized Controlled Trials

KW - Trial Oversight

KW - Trial Steering Committee

KW - Trial Management

KW - Ethnography

KW - Qualitative Research

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