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.
机构:
Univ Edinburgh, Western Gen Hosp, Div Clin Neurosci, Edinburgh EH4 2XU, Midlothian, ScotlandUniv Edinburgh, Western Gen Hosp, Div Clin Neurosci, Edinburgh EH4 2XU, Midlothian, Scotland
Salman, Rustam Al-Shahi
Brock, Timothy M.
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Univ Edinburgh, Western Gen Hosp, Div Clin Neurosci, Edinburgh EH4 2XU, Midlothian, ScotlandUniv Edinburgh, Western Gen Hosp, Div Clin Neurosci, Edinburgh EH4 2XU, Midlothian, Scotland
Brock, Timothy M.
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机构:
Dennis, Martin S.
Sandercock, Peter A. G.
论文数: 0引用数: 0
h-index: 0
机构:
Univ Edinburgh, Western Gen Hosp, Div Clin Neurosci, Edinburgh EH4 2XU, Midlothian, ScotlandUniv Edinburgh, Western Gen Hosp, Div Clin Neurosci, Edinburgh EH4 2XU, Midlothian, Scotland
Sandercock, Peter A. G.
White, Philip M.
论文数: 0引用数: 0
h-index: 0
机构:
Univ Edinburgh, Western Gen Hosp, Div Clin Neurosci, Edinburgh EH4 2XU, Midlothian, ScotlandUniv Edinburgh, Western Gen Hosp, Div Clin Neurosci, Edinburgh EH4 2XU, Midlothian, Scotland
White, Philip M.
Warlow, Charles
论文数: 0引用数: 0
h-index: 0
机构:
Univ Edinburgh, Western Gen Hosp, Div Clin Neurosci, Edinburgh EH4 2XU, Midlothian, ScotlandUniv Edinburgh, Western Gen Hosp, Div Clin Neurosci, Edinburgh EH4 2XU, Midlothian, Scotland
机构:
Univ Edinburgh, Western Gen Hosp, Div Clin Neurosci, Edinburgh EH4 2XU, Midlothian, ScotlandUniv Edinburgh, Western Gen Hosp, Div Clin Neurosci, Edinburgh EH4 2XU, Midlothian, Scotland
Salman, Rustam Al-Shahi
Brock, Timothy M.
论文数: 0引用数: 0
h-index: 0
机构:
Univ Edinburgh, Western Gen Hosp, Div Clin Neurosci, Edinburgh EH4 2XU, Midlothian, ScotlandUniv Edinburgh, Western Gen Hosp, Div Clin Neurosci, Edinburgh EH4 2XU, Midlothian, Scotland
Brock, Timothy M.
论文数: 引用数:
h-index:
机构:
Dennis, Martin S.
Sandercock, Peter A. G.
论文数: 0引用数: 0
h-index: 0
机构:
Univ Edinburgh, Western Gen Hosp, Div Clin Neurosci, Edinburgh EH4 2XU, Midlothian, ScotlandUniv Edinburgh, Western Gen Hosp, Div Clin Neurosci, Edinburgh EH4 2XU, Midlothian, Scotland
Sandercock, Peter A. G.
White, Philip M.
论文数: 0引用数: 0
h-index: 0
机构:
Univ Edinburgh, Western Gen Hosp, Div Clin Neurosci, Edinburgh EH4 2XU, Midlothian, ScotlandUniv Edinburgh, Western Gen Hosp, Div Clin Neurosci, Edinburgh EH4 2XU, Midlothian, Scotland
White, Philip M.
Warlow, Charles
论文数: 0引用数: 0
h-index: 0
机构:
Univ Edinburgh, Western Gen Hosp, Div Clin Neurosci, Edinburgh EH4 2XU, Midlothian, ScotlandUniv Edinburgh, Western Gen Hosp, Div Clin Neurosci, Edinburgh EH4 2XU, Midlothian, Scotland