'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

*Corresponding author for this work

Research output: Contribution to journalArticle

1 Citation (Scopus)
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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. Results: Eight TSC and six TMG meetings from eight trials were observed and audio-recorded, and 66 semi-structured interviews conducted with 52 purposively sampled key informants. Five themes are presented: (1) Collaboration within the TMG and role of the CTU; (2) Collaboration and conflict between oversight committees; (3) Priorities; (4) Communication between trial oversight groups and (5) 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 that 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.

Original languageEnglish
Article number612
JournalTrials
Volume18
Issue number1
DOIs
Publication statusPublished - 22 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

  • Ethnography
  • Qualitative research
  • Randomised controlled trials
  • Trial management
  • Trial oversight
  • Trial steering committee

ASJC Scopus subject areas

  • Medicine (miscellaneous)
  • Pharmacology (medical)

Cite this

'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. 1, 612, 22.12.2017.

Research output: Contribution to journalArticle

Daykin, A, Selman, LE, Cramer, H, McCann, S, Shorter, GW, Sydes, MR, Gamble, C, Macefield, R, Lane, JA & Shaw, A 2017, ''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', Trials, vol. 18, no. 1, 612. https://doi.org/10.1186/s13063-017-2305-9
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. 1.
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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. Results: Eight TSC and six TMG meetings from eight trials were observed and audio-recorded, and 66 semi-structured interviews conducted with 52 purposively sampled key informants. Five themes are presented: (1) Collaboration within the TMG and role of the CTU; (2) Collaboration and conflict between oversight committees; (3) Priorities; (4) Communication between trial oversight groups and (5) 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 that 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.",
keywords = "Ethnography, Qualitative research, Randomised controlled trials, Trial management, Trial oversight, Trial steering committee",
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",
note = "Funding This work was funded by the Medical Research Council (MRC) Network of Hubs for Trials Methodology Research (HTMR) (MR/L004933/1-R34) and undertaken with the support of the MRC ConDuCT Hub (Collaboration and innovation in Difficult or complex randomised Controlled Trials – G0800800). Availability of data and materials The datasets generated and analysed during the current study are not publicly available due to the nature of the consent provided by participants, but anonymised data are available from the corresponding author on reasonable request.",
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T1 - 'We all want to succeed, but we've also got to be realistic about what is happening'

T2 - 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

N1 - Funding This work was funded by the Medical Research Council (MRC) Network of Hubs for Trials Methodology Research (HTMR) (MR/L004933/1-R34) and undertaken with the support of the MRC ConDuCT Hub (Collaboration and innovation in Difficult or complex randomised Controlled Trials – G0800800). Availability of data and materials The datasets generated and analysed during the current study are not publicly available due to the nature of the consent provided by participants, but anonymised data are available from the corresponding author on reasonable request.

PY - 2017/12/22

Y1 - 2017/12/22

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. Results: Eight TSC and six TMG meetings from eight trials were observed and audio-recorded, and 66 semi-structured interviews conducted with 52 purposively sampled key informants. Five themes are presented: (1) Collaboration within the TMG and role of the CTU; (2) Collaboration and conflict between oversight committees; (3) Priorities; (4) Communication between trial oversight groups and (5) 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 that 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. Results: Eight TSC and six TMG meetings from eight trials were observed and audio-recorded, and 66 semi-structured interviews conducted with 52 purposively sampled key informants. Five themes are presented: (1) Collaboration within the TMG and role of the CTU; (2) Collaboration and conflict between oversight committees; (3) Priorities; (4) Communication between trial oversight groups and (5) 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 that 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 - Ethnography

KW - Qualitative research

KW - Randomised controlled trials

KW - Trial management

KW - Trial oversight

KW - Trial steering committee

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DO - 10.1186/s13063-017-2305-9

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