Impediments to Clinical Research in the United States

被引：38

作者：

Kramer, J. M. ^{[1
,2
,3
]}

Smith, P. B. ^{[2
,3
,4
]}

Califf, R. M. ^{[1
,2
,3
]}

机构：

[1] Duke Univ, Med Ctr, Dept Med, Durham, NC 27710 USA

[2] Duke Univ, Med Ctr, Duke Clin Res Inst, Durham, NC 27710 USA

[3] Duke Univ, Med Ctr, Duke Translat Med Inst, Durham, NC 27710 USA

[4] Duke Univ, Med Ctr, Dept Pediat, Durham, NC 27710 USA

来源：

CLINICAL PHARMACOLOGY & THERAPEUTICS | 2012年 / 91卷 / 03期

关键词：

IMPACT; CHALLENGES; PRIVACY; CARE;

D O I：

10.1038/clpt.2011.341

中图分类号：

R9 [药学];

学科分类号：

1007 ;

摘要：

Clinical trials are essential to the evaluation of promising scientific discoveries, but they are becoming unsustainably burdensome, threatening to deprive patients and health-care providers of new therapies and new evidence to guide the use of existing treatments. Regulations are often blamed for impeding clinical research, but there are other elements of the clinical trials enterprise that also have the potential to add burdens, through either imposed requirements or incentives that do not favor clinical research (Figure 1).(1-3)

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页码：535 / 541

页数：7

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