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运用实证数据为安慰剂对照试验的伦理评估提供依据。

Using empirical data to inform the ethical evaluation of placebo controlled trials.

作者信息

Sugarman Jeremy

机构信息

Phoebe R Berman Bioethics Institute, Johns Hopkins University, Baltimore MD 21205, USA.

出版信息

Sci Eng Ethics. 2004 Jan;10(1):29-35. doi: 10.1007/s11948-004-0059-8.

Abstract

There has been considerable debate about the ethical acceptability of using placebo-controls in clinical research. Although this debate has been rich in rhetoric, considering that much of this research is predicated upon the assumption that data from this research is vital to clinical decision-making, it is ironic that researchers have introduced little data into these discussions. Using some published research concerning the use of placebo-controls in clinical research in hypertension and psychiatric drug trials, I suggest some ways that such data might be incorporated into the ethical analysis concerning placebo use in clinical trials. This approach promises to be important for enhancing conceptual and scientific understanding as well as public policy decision-making.

摘要

关于在临床研究中使用安慰剂对照的伦理可接受性,一直存在相当多的争论。尽管这场争论言辞激烈,但鉴于此类研究大多基于这样一种假设,即该研究数据对临床决策至关重要,具有讽刺意味的是,研究人员在这些讨论中几乎没有引入数据。利用一些已发表的关于在高血压和精神科药物试验的临床研究中使用安慰剂对照的研究,我提出了一些方法,可将此类数据纳入关于临床试验中使用安慰剂的伦理分析。这种方法有望对加强概念理解和科学认识以及公共政策决策具有重要意义。

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