期刊
STATISTICS IN MEDICINE
卷 28, 期 10, 页码 1445-1463出版社
WILEY
DOI: 10.1002/sim.3559
关键词
flexible design; sub-population selection; time to event data; predictive power; posterior probability; closure principle; group sequential design; biomarker; combination test
类别
资金
- Austrian Research Foundation [P18698-N15]
- Austrian Science Fund (FWF) [P18698] Funding Source: Austrian Science Fund (FWF)
The ability to select a sensitive patient population may be crucial for the development of a targeted therapy. Identifying such a population with an acceptable level of confidence may lead to an inflation in development time and cost. We present all approach that allows to decrease these costs and to increase the reliability of the population selection. It is based on an actual adaptive phase II/III design and uses Bayesian decision tools to select the population of interest at an interim analysis. The primary endpoint is assumed to be the time to some event like e.g. progression. It is shown that the use of appropriately stratified logrank tests in the adaptive test procedture guarantees overall type I error control also when using information on patients that are censored at the adaptive interim analysis. The use of Bayesian decision tools for the population selection decision making is discussed. Simulations are presented to illustrate the operating characteristics of the study design relative to a more traditional development approach. Estimation of treatment effects is considered as well. Copyright (C) 2009 John Wiley & Sons. Ltd.
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