Placebo-controlled trials and active-control trials in the evaluation of new treatments - Part 2: Practical issues and specific cases
Placebo-controlled trials and active-control trials in the evaluation of new treatments - Part 2: Practical issues and specific cases
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DOI：
10.7326/0003-4819-133-6-200009190-00015
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发表时间：
2000-09-19
影响因子：
39.2
通讯作者：
Temple, R
中科院分区：
文献类型：
--
作者：
Ellenberg, SS;Temple, R
安慰剂对照通常用于研究治疗的临床试验，因为它们具有重要的优点。近年来，一些人批评在存在有效替代疗法的情况下使用安慰剂对照试验，而不管该疗法的预期效果如何。本文的第一部分讨论了伦理争论，并澄清了使用主动对照等效试验来确定新疗法疗效所固有的解释问题。然而，在某些情况下，不确定性可能会使关于适当使用安慰剂对照的决策变得复杂。第 2 部分更全面地讨论在特定医疗环境中使用安慰剂对照的伦理考虑。还探讨了在已证明有效治疗可用的情况下对新药进行安慰剂对照试验的价值和相关性。
Placebo controls are commonly used in clinical trials of investigational treatments because they have important advantages. In recent years, some have criticized the use of placebo-controlled trials when effective alternative therapy exists, regardless of the expected effect of the therapy. In part 1 of this paper, ethical arguments are addressed and the interpretive problems inherent in the use of active-control equivalence trials to establish efficacy of a new treatment are clarified. However, uncertainties may complicate decisions about appropriate use of placebo controls in some situations. Part 2 discusses more fully the ethical considerations for using placebo controls in particular medical settings. The value and relevance of placebo-controlled trials of new agents in situations in which proven effective therapy is available are also explored.