Group Sequential and Confirmatory Adaptive Designs in Clinical Trials

  • Gernot Wassmer
  • Werner Brannath

Part of the Springer Series in Pharmaceutical Statistics book series (SSPS)

Table of contents

  1. Front Matter
    Pages i-xvi
  2. Group Sequential Designs

    1. Front Matter
      Pages 1-1
    2. Gernot Wassmer, Werner Brannath
      Pages 3-23
    3. Gernot Wassmer, Werner Brannath
      Pages 25-62
    4. Gernot Wassmer, Werner Brannath
      Pages 63-81
    5. Gernot Wassmer, Werner Brannath
      Pages 83-100
    6. Gernot Wassmer, Werner Brannath
      Pages 101-130
  3. Confirmatory Adaptive Designs with a Single Hypothesis

    1. Front Matter
      Pages 131-131
    2. Gernot Wassmer, Werner Brannath
      Pages 133-169
    3. Gernot Wassmer, Werner Brannath
      Pages 171-188
    4. Gernot Wassmer, Werner Brannath
      Pages 189-219
    5. Gernot Wassmer, Werner Brannath
      Pages 221-228
  4. Adaptive Designs with Multiple Hypotheses

    1. Front Matter
      Pages 229-229
    2. Gernot Wassmer, Werner Brannath
      Pages 231-239
    3. Gernot Wassmer, Werner Brannath
      Pages 241-276
  5. Back Matter
    Pages 277-301

About this book

Introduction

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.

Keywords

adaptive designs clinical trials group sequential designs multiple hypotheses sample size

Authors and affiliations

  • Gernot Wassmer
    • 1
  • Werner Brannath
    • 2
  1. 1.University of Cologne CologneGermany
  2. 2.University of BremenBremenGermany

Bibliographic information

  • DOI https://doi.org/10.1007/978-3-319-32562-0
  • Copyright Information Springer International Publishing Switzerland 2016
  • Publisher Name Springer, Cham
  • eBook Packages Mathematics and Statistics
  • Print ISBN 978-3-319-32560-6
  • Online ISBN 978-3-319-32562-0
  • Series Print ISSN 2366-8695
  • Series Online ISSN 2366-8709
  • About this book