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 plannedtrial. 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.
