Daykin, A;
Selman, LE;
Cramer, H;
McCann, S;
Shorter, GW;
Sydes, MR;
Gamble, C;
... Shaw, A; + view all
(2016)
What are the roles and valued attributes of a Trial Steering Committee? Ethnographic study of eight clinical trials facing challenges.
Trials
, 17
, Article 307. 10.1186/s13063-016-1425-y.
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Daykin et al What are the roles and valued attributes of a Trial Steering Committee - A ethnographic study of 8 clinical trials facing challenges VoR.pdf Download (516kB) | Preview |
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. METHODS: An 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. RESULTS: Eight 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. CONCLUSIONS: We 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.
| Type: | Article |
|---|---|
| Title: | What are the roles and valued attributes of a Trial Steering Committee? Ethnographic study of eight clinical trials facing challenges |
| Open access status: | An open access version is available from UCL Discovery |
| DOI: | 10.1186/s13063-016-1425-y |
| Publisher version: | http://dx.doi.org/10.1186/s13063-016-1425-y |
| Language: | English |
| Additional information: | Copyright © 2016 Daykin et al. Open Access: This article is distributed under the terms of the Creative Commons Attribution 4.0 International License (CC BY 4.0) (http://creativecommons.org/licenses/by/4.0/), which permits unrestricted use, distribution, and reproduction in any medium, provided you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons license, and indicate if changes were made. The Creative Commons Public Domain Dedication waiver (http://creativecommons.org/publicdomain/zero/1.0/) applies to the data made available in this article, unless otherwise stated. |
| Keywords: | Randomised trials; Good clinical practice; Terms of reference; Trial Steering Committees; Trial monitoring |
| UCL classification: | UCL UCL > Provost and Vice Provost Offices > School of Life and Medical Sciences UCL > Provost and Vice Provost Offices > School of Life and Medical Sciences > Faculty of Population Health Sciences > Inst of Clinical Trials and Methodology UCL > Provost and Vice Provost Offices > School of Life and Medical Sciences > Faculty of Population Health Sciences > Inst of Clinical Trials and Methodology > MRC Clinical Trials Unit at UCL |
| URI: | https://discovery.ucl.ac.uk/id/eprint/1502393 |
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