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

被引:7
作者
Haynes, Richard [1 ]
Bowman, Louise [1 ]
Rahimi, Kazem [1 ]
Armitage, Jane [1 ]
机构
[1] Univ Oxford, Clin Trial Serv Unit, Oxford OX3 7LF, England
基金
英国医学研究理事会;
关键词
clinical trials; regulation; research governance; TRIALS; UK;
D O I
10.7861/clinmedicine.10-2-127
中图分类号
R5 [内科学];
学科分类号
1002 ; 100201 ;
摘要
Randomised controlled trials are the gold standard for testing the efficacy and safety of health interventions, especially medications, and researchers in the UK 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 UK 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.
引用
收藏
页码:127 / 129
页数:3
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  • [1] Setting up non-commercial clinical trials takes too long in the UK: findings from a prospective study
    Hackshaw, Allan
    Farrant, Hannah
    Bulley, Sue
    Seckl, Michael J.
    Ledermann, Jonathan A.
    [J]. JOURNAL OF THE ROYAL SOCIETY OF MEDICINE, 2008, 101 (06) : 299 - 304
  • [2] The Department of Health's research governance framework remains an impediment to multi-centre studies: findings from a national descriptive study
    Kielmann, Tara
    Tierney, Alison
    Porteous, Rosemary
    Huby, Guro
    Sheikh, Aziz
    Pinnock, Hilary
    [J]. JOURNAL OF THE ROYAL SOCIETY OF MEDICINE, 2007, 100 (05) : 234 - 238
  • [3] Research governance impediments to clinical trials: a retrospective survey
    Salman, Rustam Al-Shahi
    Brock, Timothy M.
    Dennis, Martin S.
    Sandercock, Peter A. G.
    White, Philip M.
    Warlow, Charles
    [J]. JOURNAL OF THE ROYAL SOCIETY OF MEDICINE, 2007, 100 (02) : 101 - 104
  • [4] Non-commercial clinical trials of a medicinal product: can they survive the current process of research approvals in the UK?
    Sheard, L.
    Tompkins, C. N. E.
    Wright, N. M. J.
    Adams, C. E.
    [J]. JOURNAL OF MEDICAL ETHICS, 2006, 32 (07) : 430 - 434
  • [5] Regulation-the real threat to clinical research
    Stewart, Paul M.
    Stears, Anna
    Tomlinson, Jeremy W.
    Brown, Morris J.
    [J]. BMJ-BRITISH MEDICAL JOURNAL, 2008, 337 : a1732