The Direct Assignment Option as a Modular Design Component: An Example for the Setting of Two Predefined Subgroups

Background. A phase II design with an option for direct assignment (stop randomization and assign all patients to experimental treatment based on interim analysis, IA) for a predefined subgroup was previously proposed. Here, we illustrate the modularity of the direct assignment option by applying it...

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Bibliographic Details
Main Authors: Ming-Wen An, Xin Lu, Daniel J. Sargent, Sumithra J. Mandrekar
Format: Article
Language:English
Published: Hindawi Limited 2015-01-01
Series:Computational and Mathematical Methods in Medicine
Online Access:http://dx.doi.org/10.1155/2015/210817