期刊
CLINICAL TRIALS
卷 12, 期 2, 页码 8-12出版社
SAGE PUBLICATIONS LTD
DOI: 10.1177/1740774514563583
关键词
Adaptive randomization; ethics; equipoise; therapeutic misconception
资金
- PACEOMICS project - Genome Canada
- Genome Quebec
- Genome Alberta
- Canadian Institute for Health Research (CIHR)
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.
作者
我是这篇论文的作者
点击您的名字以认领此论文并将其添加到您的个人资料中。
推荐
暂无数据