Group Sequential And Confirmatory Adaptive Designs In Clinical Trials by Gernot WassmerGroup Sequential And Confirmatory Adaptive Designs In Clinical Trials by Gernot Wassmer

Group Sequential And Confirmatory Adaptive Designs In Clinical Trials

byGernot Wassmer, Werner Brannath

Paperback | May 31, 2018

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This book provides an up-to-date review of the general principles of and techniques for confirmatory adaptive designs. Confirmatory adaptive designs are a generalization of group sequential designs. With these designs, interim analyses are performed in order to stop the trial prematurely under control of the Type I error rate. In adaptive designs, it is also permissible to perform a data-driven change of relevant aspects of the study design at interim stages. This includes, for example, a sample-size reassessment, a treatment-arm selection or a selection of a pre-specified sub-population.

Essentially, this adaptive methodology was introduced in the 1990s. Since then, it has become popular and the object of intense discussion and still represents a rapidly growing field of statistical research. This book describes adaptive design methodology at an elementary level, while also considering designing and planning issues as well as methods for analyzing an adaptively planned trial. This includes estimation methods and methods for the determination of an overall p-value. Part I of the book provides the group sequential methods that are necessary for understanding and applying the adaptive design methodology supplied in Parts II and III of the book. The book contains many examples that illustrate use of the methods for practical application.

The book is primarily written for applied statisticians from academia and industry who are interested in confirmatory adaptive designs. It is assumed that readers are familiar with the basic principles of descriptive statistics, parameter estimation and statistical testing. This book will also be suitable for an advanced statistical course for applied statisticians or clinicians with a sound statistical background.

Gernot Wassmer  is an Adjunct Professor of Biostatistics at the Institute of Medical Statistics, University of Cologne, Germany. He received his PhD from the University of Munich, Germany in 1993, after which he was a Research Fellow at Munich's Institute of Medical Statistics, at the Institute for Epidemiology, GSF Neuherberg, and at ...
Title:Group Sequential And Confirmatory Adaptive Designs In Clinical TrialsFormat:PaperbackProduct dimensions:301 pages, 23.5 × 15.5 × 0.02 inShipping dimensions:23.5 × 15.5 × 0.02 inPublished:May 31, 2018Publisher:Springer NatureLanguage:English

The following ISBNs are associated with this title:

ISBN - 10:3319813145

ISBN - 13:9783319813141


Table of Contents

Part I Group Sequential Designs.- Repeated Significance Tests: Procedures with Equally Sized Stages.- Procedures with Unequally Sized Stages.- Confidence Intervals,p-Values, and Point Estimation.- Applications.-Part II Adaptive Confirmatory Designs with a Single Hypothesis: Adaptive Group Sequential Tests.- Decision Tools for Adaptive Designs.- Estimation andp-Values for Two-stage Adaptive Designs.- Adaptive Designs with Survival Data.-Part III Adaptive Designs with Multiple Hypotheses: Multiple Testing in Adaptive Designs.- Applications and Case Studies.- Appendix - Software for Adaptive Designs.- Index.