< P> Group sequential methods answer the needs of clinical trial monitoring committees who must assess the data available at an interim analysis. These interim results may provide grounds for terminating the study-effectively reducing costs-or may benefit the general patient population by allowing early dissemination of its findings. Group sequential methods provide a means to balance the ethical and financial advantages of stopping a study early against the risk of an incorrect conclusion. Group Sequential Methods with Applications to Clinical Trials describes group sequential stopping rules designed to reduce average study length and control Type I and II error probabilities. The authors present one-sided and two-sided tests, introduce several families of group sequential tests, and explain how to choose the most appropriate test and interim analysis schedule. Their topics include placebo-controlled randomized trials, bio-equivalence testing, crossover and longitudinal studies, and linear and generalized linear models. Research in group sequential analysis has progressed rapidly over the past 20 years. Group Sequential Methods with Applications to Clinical Trials surveys and extends current methods for planning and conducting interim analyses. It provides straightforward descriptions of group sequential hypothesis tests in a form suited for direct application to a wide variety of clinical trials. Medical statisticians engaged in any investigations planned with interim analyses will find this book a useful and important tool.< /P>
< P> Group sequential methods answer the needs of clinical trial monitoring committees who must assess the data available at an interim analysis. These interim results may provide grounds for terminating the study-effectively reducing costs-or may benefit the general patient population by allowing early dissemination of its findings. Group sequential methods provide a means to balance the ethical and financial advantages of stopping a study early against the risk of an incorrect conclusion. Group Sequential Methods with Applications to Clinical Trials describes group sequential stopping rules designed to reduce average study length and control Type I and II error probabilities. The authors present one-sided and two-sided tests, introduce several families of group sequential tests, and explain how to choose the most appropriate test and interim analysis schedule. Their topics include placebo-controlled randomized trials, bio-equivalence testing, crossover and longitudinal studies, and linear and generalized linear models. Research in group sequential analysis has progressed rapidly over the past 20 years. Group Sequential Methods with Applications to Clinical Trials surveys and extends current methods for planning and conducting interim analyses. It provides straightforward descriptions of group sequential hypothesis tests in a form suited for direct application to a wide variety of clinical trials. Medical statisticians engaged in any investigations planned with interim analyses will find this book a useful and important tool.< /P>
Glossary. Introduction. Two-Sided Tests: Introduction. Two-Sided
Tests: General Applications. One-Sided Tests. Two-Sided Tests with
Early Stopping Under the Null Hypothesis. Equivalence Tests.
Flexible Monitoring: The Error Spending Approach. Analysis
Following a Sequential Test. Repeated Confidence Intervals.
Stochastic Curtailment. General Group Sequential Distribution
Theory. Binary Data. Survival Data. Internal Pilots Studies: Sample
Size Re-Estimation. Multiple Endpoints. Multi-Armed Trials.
Adaptive Treatment Assignment. Bayesian Approaches. Numerical
Computations for Group Sequential Tests. References
NTI/Sales Copy
"This book represents a comprehensive presentation of group
sequential methods. Written by active researchers in this area, it
provides an ideal source for those wishing an introduction to the
area and for those who desire a clear outline of specific topics or
methods. It should quickly become a standard reference both for
those wishing to apply the methods and for researchers in the
area…The extent of coverage of various topics broadly reflects
current usage…the discussion of each topic appears to be well
balanced…All in all, this is a very welcome book."
- Short Book Reviews of the ISI
"The statistical methodology for sequential trials is complicated.
This book provides an excellent presentation of it. It succeeds as
both a training text and as a reference source. I liked the
progression of the book…any statistician involved in designing or
analysing sequential trials should have a copy."
--Tim Auton, Protherics, Macclesfield
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