试验中的控制组:测试实验性埃博拉治疗的伦理

C. Coleman
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引用次数: 4

摘要

虽然随机对照试验(rct)通常被认为是测试实验性治疗的“金标准”,但将其用于埃博拉却受到了著名伦理学家和国际援助组织的强烈批评,目前正在进行的埃博拉治疗试验中只有一项是按这种方式设计的。这并不是发展中国家的随机对照试验第一次引发伦理争议,但对埃博拉临床试验的反对与过去提出的担忧有着根本的不同。在简要回顾了正在进行的实验性埃博拉治疗研究之后,本文在先前关于国际临床研究伦理的辩论的背景下考察了当前的争议。它的结论是,随机对照试验为开发有效的埃博拉治疗方法提供了最可靠的方法,其方法的严密性本身就是支持使用它们的有说服力的伦理论据。但是,为了满足参与者的期望和促进社区信任,可能有必要对理想的方法进行有限的偏离。
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Control Groups on Trial: The Ethics of Testing Experimental Ebola Treatments
Abstract Although randomized controlled trials (RCTs) are generally considered the “gold standard” for testing experimental treatments, their use for Ebola has been subject to strong criticism by prominent ethicists and international aid organizations, and only one of the ongoing Ebola treatment trials has been designed in this manner. This is not the first time that RCTs in developing countries have provoked ethical controversy, but the objections to the Ebola clinical trials are fundamentally different from the concerns that have been raised in the past. After briefing reviewing the ongoing research on experimental Ebola treatments, this Article examines the current controversies in the context of previous debates over the ethics of international clinical research. It concludes that RCTs provide the most reliable method for developing effective Ebola treatments, and that their methodological rigor is itself a persuasive ethical argument in favor of using them. However, limited departures from the methodologically ideal approach may be necessary to accommodate the expectations of participants and to promote community trust.
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