ETHICAL CONSIDERATIONS FOR OUTCOME-ADAPTIVE TRIAL DESIGNS: A CLINICAL RESEARCHER'S PERSPECTIVE
ETHICAL CONSIDERATIONS FOR OUTCOME-ADAPTIVE TRIAL DESIGNS: A CLINICAL RESEARCHER'S PERSPECTIVE
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DOI：
10.1111/bioe.12084
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发表时间：
2015-02-01
期刊：
影响因子：
2.2
通讯作者：
Saxman, Scott Brian
中科院分区：
文献类型：
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作者：
Saxman, Scott Brian
在典型的比较临床试验中，随机化方案在研究开始时是固定的，并在整个试验过程中保持不变。许多研究人员支持一种被称为结果适应性随机化的随机试验设计。“在这种类型的试验中，随着初步信息的出现，患者被招募到研究的特定分支的可能性增加或减少，表明治疗可能是上级或劣质的。虽然结果适应性试验的设计优点一直存在争议，但很少有人关注此类研究中出现的重大伦理问题。这些包括失去平衡，缺乏充分知情同意的过程，以及研究设计中固有的不平等，这些不平等可能导致对患者和研究企业产生负面影响的不公正感。本文探讨了结果适应性试验中固有的伦理困难。
In a typical comparative clinical trial the randomization scheme is fixed at the beginning of the study, and maintained throughout the course of the trial. A number of researchers have championed a randomized trial design referred to as outcome-adaptive randomization.' In this type of trial, the likelihood of a patient being enrolled to a particular arm of the study increases or decreases as preliminary information becomes available suggesting that treatment may be superior or inferior. While the design merits of outcome-adaptive trials have been debated, little attention has been paid to significant ethical concerns that arise in the conduct of such studies. These include loss of equipoise, lack of processes for adequate informed consent, and inequalities inherent in the research design which could lead to perceptions of injustice that may have negative implications for patients and the research enterprise. This article examines the ethical difficulties inherent in outcome-adaptive trials.