What are the roles and valued attributes of a Trial Steering Committee? Ethnographic study of eight clinical trials facing challenges

Author:

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

Funder

Medical Research Council (MRC) Network of Hubs for Trials Methodology Research (HTMR)

Publisher

Springer Science and Business Media LLC

Subject

Pharmacology (medical),Medicine (miscellaneous)

Reference19 articles.

1. Conroy E et al. Trial steering committees for randomised controlled trials: updating and redeveloping guidance and terms of reference informed by current practice and experience. Trials. 2013;14(1):1.

2. Medical Research Council. Guidelines for good clinical practice in clinical trials. London: Medical Research Council; 1998.

3. Sydes MR et al. Systematic qualitative review of the literature on data monitoring committees for randomized controlled trials. Clin Trials. 2004;1(1):60–79.

4. MRC and NIHR. Medical Research Council and National Institute for Health Research Efficacy and Mechanism Evaluation Programme Research Governance Guidelines. Southampton. 2016. http://www.nets.nihr.ac.uk/__data/assets/pdf_file/0014/165110/NETSCC_TSC_SSC-Guidance_April-2016.pdf . Accessed 29 Jun 2016.

5. Damocles Study Group. A proposed charter for clinical trial data monitoring committees: helping them to do their job well. Lancet. 2005;365(9460):711–22.

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