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Planning and Analyzing Clinical Trials with Composite Endpoints

  • Geraldine Rauch
  • Svenja Schüler
  • Meinhard Kieser

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

Table of contents

  1. Front Matter
    Pages i-xvi
  2. Part I

    1. Front Matter
      Pages 1-1
    2. Geraldine Rauch, Svenja Schüler, Meinhard Kieser
      Pages 3-7
    3. Geraldine Rauch, Svenja Schüler, Meinhard Kieser
      Pages 9-12
    4. Geraldine Rauch, Svenja Schüler, Meinhard Kieser
      Pages 13-19
    5. Geraldine Rauch, Svenja Schüler, Meinhard Kieser
      Pages 21-27
  3. Part II

    1. Front Matter
      Pages 29-29
    2. Geraldine Rauch, Svenja Schüler, Meinhard Kieser
      Pages 31-51
    3. Geraldine Rauch, Svenja Schüler, Meinhard Kieser
      Pages 53-63
    4. Geraldine Rauch, Svenja Schüler, Meinhard Kieser
      Pages 65-83
  4. Part III

    1. Front Matter
      Pages 85-86
    2. Geraldine Rauch, Svenja Schüler, Meinhard Kieser
      Pages 87-90
    3. Geraldine Rauch, Svenja Schüler, Meinhard Kieser
      Pages 91-99
    4. Geraldine Rauch, Svenja Schüler, Meinhard Kieser
      Pages 101-106
    5. Geraldine Rauch, Svenja Schüler, Meinhard Kieser
      Pages 107-141
  5. Part IV

    1. Front Matter
      Pages 143-143
    2. Geraldine Rauch, Svenja Schüler, Meinhard Kieser
      Pages 145-149
    3. Geraldine Rauch, Svenja Schüler, Meinhard Kieser
      Pages 151-155
    4. Geraldine Rauch, Svenja Schüler, Meinhard Kieser
      Pages 157-162
    5. Geraldine Rauch, Svenja Schüler, Meinhard Kieser
      Pages 163-187
  6. Part V

    1. Front Matter
      Pages 189-189
    2. Geraldine Rauch, Svenja Schüler, Meinhard Kieser
      Pages 191-204
    3. Geraldine Rauch, Svenja Schüler, Meinhard Kieser
      Pages 205-207
    4. Geraldine Rauch, Svenja Schüler, Meinhard Kieser
      Pages 209-216
  7. Part VI

    1. Front Matter
      Pages 217-217
    2. Geraldine Rauch, Svenja Schüler, Meinhard Kieser
      Pages 219-224
    3. Geraldine Rauch, Svenja Schüler, Meinhard Kieser
      Pages 225-248
  8. Back Matter
    Pages 249-255

About this book

Introduction

This book addresses the most important aspects of how to plan and evaluate clinical trials with a composite primary endpoint to guarantee a clinically meaningful and valid interpretation of the results. Composite endpoints are often used as primary efficacy variables for clinical trials, particularly in the fields of oncology and cardiology. These endpoints combine several variables of interest within a single composite measure, and as a result, all variables that are of major clinical relevance can be considered in the primary analysis without the need to adjust for multiplicity. Moreover, composite endpoints are intended to increase the size of the expected effects thus making clinical trials more powerful.

The book offers practical advice for statisticians and medical experts involved in the planning and analysis of clinical trials. For readers who are mainly interested in the application of the methods, all the approaches are illustrated with real-world clinical trial examples, and the software codes required for fast and easy implementation are provided. The book also discusses all the methods in the context of relevant guidelines related to the topic. To benefit most from the book, readers should be familiar with the principles of clinical trials and basic statistical methods.

Keywords

62L05, 62P10 composite endpoints clinical trials sample size calculation sequential designs multiple testing survival analysis competing risks

Authors and affiliations

  • Geraldine Rauch
    • 1
  • Svenja Schüler
    • 2
  • Meinhard Kieser
    • 3
  1. 1.Institute of Biometry and Clinical EpidemiologyCharité - Universitätsmedizin BerlinBerlinGermany
  2. 2.Institute of Medical Biometry and InformaticsUniversity of HeidelbergHeidelbergGermany
  3. 3.Institute of Medical Biometry and InformaticsUniversity of HeidelbergHeidelbergGermany

Bibliographic information

  • DOI https://doi.org/10.1007/978-3-319-73770-6
  • Copyright Information Springer International Publishing AG, part of Springer Nature 2017
  • Publisher Name Springer, Cham
  • eBook Packages Mathematics and Statistics
  • Print ISBN 978-3-319-73769-0
  • Online ISBN 978-3-319-73770-6
  • Series Print ISSN 2366-8695
  • Series Online ISSN 2366-8709
  • Buy this book on publisher's site