Literature DB >> 20437980

How the NHS research governance procedures could be modified to greatly strengthen clinical research.

Richard Haynes1, Louise Bowman, Kazem Rahimi, Jane Armitage.   

Abstract

Randomised controlled trials are the gold standard for testing the efficacy and safety of health interventions, especially medications, and researchers in the U.K. are required to gain approval from ethics committees, the regulatory body (Medicines and Healthcare products Regulatory Agency) and local NHS research governance departments for such trials. Although research governance is important to reassure trial participants that their rights and interests are protected, current practice is impeding research and presents a genuine threat to the U.K. and to the NHS's ability to deliver high-quality evidence on which doctors can base clinical decisions and improve the delivery of care. This article discusses recent experience of running large-scale clinical trials and suggests measures that could improve the current situation.

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Year:  2010        PMID: 20437980      PMCID: PMC4952081          DOI: 10.7861/clinmedicine.10-2-127

Source DB:  PubMed          Journal:  Clin Med (Lond)        ISSN: 1470-2118            Impact factor:   2.659


  3 in total

1.  Opening research sites in multicentre clinical trials within the UK: a detailed analysis of delays.

Authors:  Anna Kearney; Andrew McKay; Helen Hickey; Silviya Balabanova; Anthony G Marson; Carrol Gamble; Paula Williamson
Journal:  BMJ Open       Date:  2014-09-16       Impact factor: 2.692

2.  Cost-effective recruitment methods for a large randomised trial in people with diabetes: A Study of Cardiovascular Events iN Diabetes (ASCEND).

Authors:  Theingi Aung; Richard Haynes; Jill Barton; Jolyon Cox; Aleksandra Murawska; Kevin Murphy; Michael Lay; Jane Armitage; Louise Bowman
Journal:  Trials       Date:  2016-06-13       Impact factor: 2.279

3.  The Treatment In Morning versus Evening (TIME) study: analysis of recruitment, follow-up and retention rates post-recruitment.

Authors:  David A Rorie; Robert W V Flynn; Isla S Mackenzie; Thomas M MacDonald; Amy Rogers
Journal:  Trials       Date:  2017-11-23       Impact factor: 2.279

  3 in total

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