Interim Evaluation of Efficacy in Clinical Trials with Two Primary Endpoints

  • Toshimitsu Hamasaki
  • Koko Asakura
  • Scott R. Evans
  • Toshimitsu Ochiai
Chapter
Part of the SpringerBriefs in Statistics book series (BRIEFSSTATIST)

Abstract

In this chapter, we provide an overview of the fundamental concepts and technical details for group-sequential designs for clinical trials comparing two interventions based on two primary endpoints. In this situation, there are many procedures for controlling the Type I error rate. We discuss the simplest procedure, i.e., the weighted Bonferroni procedure which is commonly applied in practice. We evaluate the behavior of the sample size, power, and Type I error rate associated with the procedure.

Keywords

Average sample size Efficacy stopping Lan–DeMets error-spending method Maximum sample size Recycled significance level Union–intersection test Weighted Bonferroni procedure 

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Copyright information

© The Author(s) 2016

Authors and Affiliations

  • Toshimitsu Hamasaki
    • 1
  • Koko Asakura
    • 2
  • Scott R. Evans
    • 3
  • Toshimitsu Ochiai
    • 4
  1. 1.Department of Data ScienceNational Cerebral and Cardiovascular CenterSuitaJapan
  2. 2.Department of Data ScienceNational Cerebral and Cardiovascular CenterSuitaJapan
  3. 3.Department of Biostatistics and the Center for Biostatistics in AIDS ResearchHarvard T.H. Chan School of Public HealthBostonUSA
  4. 4.Biostatistics DepartmentShionogi & Co., Ltd.OsakaJapan

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