Are outcome-adaptive allocation trials ethical?
Are outcome-adaptive allocation trials ethical?
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DOI：
10.1177/1740774514563583
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发表时间：
2015-04-01
期刊：
影响因子：
--
通讯作者：
Kimmelman, Jonathan
中科院分区：
文献类型：
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作者：
Hey, Spencer Phillips;Kimmelman, Jonathan
随机化是临床试验方法的基石。然而，随机化的伦理问题仍然存在争议。默认且最有效的分配方案在所有研究组中平均（1：1）随机分配患者。然而，许多随机试验正在使用结果适应性分配方案，动态调整分配比例，有利于更好地执行治疗arm. Advocates的结果适应性分配主张，它更好地适应临床平衡，促进知情同意，因为这样的试验限制病人受试者暴露于次优护理。在这篇文章中，我们认为，这种所谓的结果适应性分配的伦理优势，经不起仔细审查，在设置双臂研究和/或早期阶段的研究。
Randomization is firmly established as a cornerstone of clinical trial methodology. Yet, the ethics of randomization continues to generate controversy. The default, and most efficient, allocation scheme randomizes patients equally (1:1) across all arms of study. However, many randomized trials are using outcome-adaptive allocation schemes, which dynamically adjust the allocation ratio in favor of the better performing treatment arm. Advocates of outcome-adaptive allocation contend that it better accommodates clinical equipoise and promotes informed consent, since such trials limit patient-subject exposure to sub-optimal care. In this essay, we argue that this purported ethical advantage of outcome-adaptive allocation does not stand up to careful scrutiny in the setting of two-armed studies and/or early-phase research.