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Sample Size Determination in Clinical Trials with Multiple Endpoints

Part of the SpringerBriefs in Statistics Book Series

DOI: 10.1007/978-3-319-22005-5

ISBN: 978-3-319-22004-8

Publisher: Springer International Publishing - Springer Journals

Aug 21, 2015

Available

Introduction

Sozu, Takashi; Sugimoto, Tomoyuki; Hamasaki, Toshimitsu; Evans, Scott R.

Pages: 1 –6

[The effects of interventions are multi-dimensional. In clinical trials, use of more than one primary endpoint offers an attractive design feature to capture a more complete characterization of the intervention effects and provide more informative intervention comparisons. For these reasons, use...
Available

Continuous Co-primary Endpoints

Sozu, Takashi; Sugimoto, Tomoyuki; Hamasaki, Toshimitsu; Evans, Scott R.

Pages: 7 –23

[In this chapter, we provide an overview of the concepts and the technical fundamentals regarding power and sample size calculation when comparing two interventions with multiple co-primary continuous endpoints in a clinical trial. We provide numerical examples to illustrate the methods and...
Available

Binary Co-primary Endpoints

Sozu, Takashi; Sugimoto, Tomoyuki; Hamasaki, Toshimitsu; Evans, Scott R.

Pages: 25 –39

[In this chapter, we provide methods for power and sample size calculation for clinical trials with multiple co-primary binary endpoints. On the basis of three association measures among the multiple binary endpoints, we discuss five methods for power and sample size calculation: the asymptotic...
Available

Convenient Sample Size Formula

Sozu, Takashi; Sugimoto, Tomoyuki; Hamasaki, Toshimitsu; Evans, Scott R.

Pages: 41 –58

[In Chaps. 2 and 3, we discuss the methods for calculating the sample size required to design a trial with multiple co-primary endpoints. These methods require considerable mathematical sophistication and knowledge of programming techniques, effectively limiting their application in practice. To...
Available

Continuous Primary Endpoints

Sozu, Takashi; Sugimoto, Tomoyuki; Hamasaki, Toshimitsu; Evans, Scott R.

Pages: 59 –68

[In this chapter, we provide an overview of the concepts and technical fundamentals regarding power and sample size calculation for clinical trials comparing two interventions with multiple continuous outcomes as multiple primary endpoints. There are many procedures for controlling the type I...
Available

Further Developments

Sozu, Takashi; Sugimoto, Tomoyuki; Hamasaki, Toshimitsu; Evans, Scott R.

Pages: 69 –74

[In this book, we have focused our discussion on methods for sample size calculation in clinical trials with co-primary endpoints, although we have briefly discussed methods for clinical trials with multiple endpoints using the Bonferroni procedure. These discussions have been based on trials...

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