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Group-Sequential Clinical Trials with Multiple Co-Objectives

  • Toshimitsu Hamasaki
  • Koko Asakura
  • Scott R. Evans
  • Toshimitsu Ochiai

Part of the SpringerBriefs in Statistics book series (BRIEFSSTATIST)

Also part of the JSS Research Series in Statistics book sub series (JSSRES)

Table of contents

  1. Front Matter
    Pages i-ix
  2. Toshimitsu Hamasaki, Koko Asakura, Scott R. Evans, Toshimitsu Ochiai
    Pages 1-14
  3. Toshimitsu Hamasaki, Koko Asakura, Scott R. Evans, Toshimitsu Ochiai
    Pages 15-39
  4. Toshimitsu Hamasaki, Koko Asakura, Scott R. Evans, Toshimitsu Ochiai
    Pages 41-49
  5. Toshimitsu Hamasaki, Koko Asakura, Scott R. Evans, Toshimitsu Ochiai
    Pages 51-65
  6. Toshimitsu Hamasaki, Koko Asakura, Scott R. Evans, Toshimitsu Ochiai
    Pages 67-80
  7. Toshimitsu Hamasaki, Koko Asakura, Scott R. Evans, Toshimitsu Ochiai
    Pages 81-95
  8. Toshimitsu Hamasaki, Koko Asakura, Scott R. Evans, Toshimitsu Ochiai
    Pages 97-102
  9. Back Matter
    Pages 103-113

About this book

Introduction

This book focuses on group sequential methods for clinical trials with co-primary endpoints based on the decision-making frameworks for: (1) rejecting the null hypothesis (stopping for efficacy), (2) rejecting the alternative hypothesis (stopping for futility), and (3) rejecting the null or alternative hypothesis (stopping for either futility or efficacy), where the trial is designed to evaluate whether the intervention is superior to the control on all endpoints. For assessing futility, there are two fundamental approaches, i.e., the decision to stop for futility based on the conditional probability of rejecting the null hypothesis, and the other based on stopping boundaries using group sequential methods. In this book, the latter approach is discussed. The book also briefly deals with the group sequential methods for clinical trials designed to evaluate whether the intervention is superior to the control on at least one endpoint. In addition, the book describes sample size recalculation and the resulting effect on power and type I error rate. The book also describes group sequential strategies for three-arm clinical trials to demonstrate the non-inferiority of experimental intervention to actively control and to assess the assay sensitivity to placebo control.

Keywords

Group Sequential Designs Interim Analysis Multiple Endpoints Noninferiority Sample Size Calculation Sample Size Recalculation

Authors and affiliations

  • Toshimitsu Hamasaki
    • 1
  • Koko Asakura
    • 2
  • Scott R. Evans
    • 3
  • Toshimitsu Ochiai
    • 4
  1. 1.Department of Data ScienceNatl Cerebral & Cardiovascular CtrSuitaJapan
  2. 2.Department of Data ScienceNational Cerebral & Cardiovascular CtrSuitaJapan
  3. 3.Dept. of Biostat. & the ctr for Biostat.Harvard T.H. Chan Sc. of Pub. HealthBostonUSA
  4. 4.Biostatistics DepartmentShionogi & Co., Ltd.OsakaJapan

Bibliographic information

  • DOI https://doi.org/10.1007/978-4-431-55900-9
  • Copyright Information The Author(s) 2016
  • Publisher Name Springer, Tokyo
  • eBook Packages Mathematics and Statistics
  • Print ISBN 978-4-431-55898-9
  • Online ISBN 978-4-431-55900-9
  • Series Print ISSN 2191-544X
  • Series Online ISSN 2191-5458
  • Buy this book on publisher's site