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A cohort examination to establish reporting of the remit and function of Trial Steering Committees in randomised controlled trials

Overview of attention for article published in Trials, December 2017
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Title
A cohort examination to establish reporting of the remit and function of Trial Steering Committees in randomised controlled trials
Published in
Trials, December 2017
DOI 10.1186/s13063-017-2300-1
Pubmed ID
Authors

Elizabeth J. Conroy, Barbara Arch, Nicola L. Harman, J. Athene Lane, Steff C. Lewis, John Norrie, Matthew R. Sydes, Carrol Gamble

Abstract

The DAMOCLES project established a widely used Data Monitoring Committee (DMC) Charter for randomised controlled trials (RCTs). Typically, within the UK, the DMC is advisory and recommends to another executive body; the Trial Steering Committee (TSC). Despite the executive role of the TSC, the CONSORT Statement does not explicitly require reporting of TSC activity, although is included as an example of good reporting. A lack of guidance on TSC reporting can impact transparency of trial oversight, ultimately leading to a misunderstanding regarding role and, subsequently, further variation in practice. This review aimed to establish reporting practice of TSC involvement in RCTs, and thus make recommendations for reporting. A cohort examination identifying reporting practice was undertaken. The cohort comprised RCTs published in three leading medical journals (the British Medical Journal, The Lancet and the New England Journal of Medicine) within 6 months in 2012 and the full NIHR HTA Monograph series. Details of TSC constitution and impact were extracted from main publications and published supplements. Of 415 publications, 264 were eligible. These were typical in terms of trial design. Variations in reporting between journals and monographs was notable. TSC presence was identified in approximately half of trials (n = 144), of which 109 worked alongside a DMC. No publications justified not convening a TSC. When reported, the role of the committee and examples of impact in design, conduct and analysis were summarised. We present the first review of reporting TSC activity in the published academic literature. An absence of reporting standards with regards to TSC constitution, activity and impact on trial conduct was identified which can influence transparency of reporting trial oversight. Consistent reporting is vital for the benefits and impact of the TSC role to be understood to support adoption of this oversight structure and reduce global variations in practice.

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Mendeley readers

The data shown below were compiled from readership statistics for 19 Mendeley readers of this research output. Click here to see the associated Mendeley record.

Geographical breakdown

Country Count As %
Unknown 19 100%

Demographic breakdown

Readers by professional status Count As %
Other 3 16%
Student > Ph. D. Student 3 16%
Researcher 3 16%
Student > Master 1 5%
Student > Postgraduate 1 5%
Other 0 0%
Unknown 8 42%
Readers by discipline Count As %
Medicine and Dentistry 6 32%
Pharmacology, Toxicology and Pharmaceutical Science 3 16%
Nursing and Health Professions 2 11%
Business, Management and Accounting 1 5%
Unknown 7 37%