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III期临床试验中二元治疗反应的适应性设计:争议与进展

Adaptive designs for binary treatment responses in phase III clinical trials: controversies and progress.

作者信息

Biswas A

机构信息

Applied Statistics Unit, Indian Statistical Institute, 203 B.T. Road, Kolkata 700 035, India.

出版信息

Stat Methods Med Res. 2001 Oct;10(5):353-64. doi: 10.1177/096228020101000504.

Abstract

In phase III clinical trials the problem is to compare two treatments or therapies for their effects. The randomized 50:50 allocation to the two competing treatments is popular in most of the cases. In contrast there is a class of adaptive designs available in literature for this purpose. The object is to treat a larger number of patients by the eventual better treatment. A few such adaptive designs were conducted out in practical applications and consequently a lot of controversy arose. In spite of that there is steady theoretical progress in this area over the past three decades. The present paper reviews some of the real-life adaptive clinical trials and discusses some logistics of such trials.

摘要

在III期临床试验中,问题在于比较两种治疗方法或疗法的效果。在大多数情况下,将患者以50:50的比例随机分配到两种相互竞争的治疗方法中很常见。相比之下,文献中有一种适用于此目的的适应性设计。目的是通过最终更好的治疗方法治疗更多患者。一些这样的适应性设计在实际应用中进行了,结果引发了很多争议。尽管如此,在过去三十年里,这一领域仍取得了稳步的理论进展。本文回顾了一些实际的适应性临床试验,并讨论了此类试验的一些后勤问题。

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