Zhang Yanqiong, Rosenberger William F, Smythe Robert T
Merck & Co., Ry34-A316, P.O. Box 2000, Rahway, New Jersey 07065-0900, USA.
Biometrics. 2007 Sep;63(3):865-72. doi: 10.1111/j.1541-0420.2006.00735.x.
In many clinical trials, it is desirable to establish a sequential monitoring plan, whereby the test statistic is computed at an interim point or points in the trial and a decision is made whether to stop early due to evidence of treatment efficacy. In this article, we will set up a sequential monitoring plan for randomization-based inference under the permuted block design, stratified block design, and stratified urn design. We will also propose a definition of information fraction in these settings and discuss its calculation under these different designs.
在许多临床试验中,希望制定一个序贯监测计划,据此在试验的一个或多个中间点计算检验统计量,并根据治疗效果的证据决定是否提前停止试验。在本文中,我们将针对置换区组设计、分层区组设计和分层瓮设计建立基于随机化推断的序贯监测计划。我们还将在这些情况下提出信息分数的定义,并讨论在这些不同设计下它的计算方法。