Sequential monitoring of randomization tests: stratified randomization
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Yanqiong Zhang1, William F Rosenberger, Robert T Smythe
1Merck & Co., Ry34-A316, P.O. Box 2000, Rahway, New Jersey 07065-0900, USA. yanqiong_zhang@merck.com
Abstract:
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.
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