Group Sequential and Confirmatory Adaptive Designs in Clinical Trials

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 the Institute of Medical Statistics, University of Cologne. His major research interest is in the field of statistical procedures for group sequential and adaptive plans in clinical trials. He has been a member of independent data monitoring committees for international, multi-center trials in various therapeutic fields and also serves as a consultant for the pharmaceutical industry.  Werner Brannath is a Professor of Biostatistics at the Faculty of Mathematics and Informatics, University of Bremen, where he is also head of the biometry group at the Competence Center for Clinical Trials. He has extensiveexperience in the planning and analysis of clinical trials and has been a member of several independent data monitoring committees. His main research interests include adaptive and group sequential designs, as well as multiple testing.

“This is an up-to-date review of the general principles of, and techniques for, confirmatory adaptive designs. … Chapters are well illustrated with tables and figures for better understanding. … This is a valuable resource for clinicians and applied statisticians with a sound statistical background who are interested in confirmatory adaptive designs.” (Pooja Sethi, Doody's Book Reviews, October, 2016)

• 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 and p-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.