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Methods and Applications of Sample Size Calculation and Recalculation in Clinical Trials

Covering basic as well as more advanced and recently developed methods, it is suitable forbeginners, experienced applied statisticians, and practitioners. To gain maximum benefit, readers should be familiar with introductory statistics. The content of this book has been successfully used for courses...

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Bibliographic Details
Main Author: Kieser, Meinhard
Format: eBook
Language:English
Published: Cham Springer International Publishing 2020, 2020
Edition:1st ed. 2020
Series:Springer Series in Pharmaceutical Statistics
Subjects:
Statistical Theory And Methods
Pharmaceutical Chemistry
Statistics 
Biostatistics
Pharmaceutics
Biometry
Online Access:
Collection: Springer eBooks 2005- - Collection details see MPG.ReNa
Table of Contents:
  • Chapter 24 - Comparison of two groups for normally distributed outcomes and test for equivalence.-Chapter 25 - Regulatory and operational aspects
  • Chapter 26 - Concluding remarks.-Part IIIB: Unblinded sample size recalculation in adaptive designs
  • Chapter 27 - Background and notation
  • Chapter 28 - Sample size recalculation based on conditional power
  • Chapter 29 - Sample size recalculation by optimization
  • Chapter 30 - Regulatory and operational aspects
  • Chapter 31 - Concluding remarks
  • Chapter 13 - Cluster-randomized trials
  • Chapter 14 - Multi-regional trials
  • Chapter 15 - Integrated planning of phase II/III drug development programs
  • Chapter 16 - Simulation-based sample size calculation
  • Part III: Sample size recalculation
  • Chapter 17 – Background
  • Part IIIA: Blinded sample size recalculation in internal pilot study designs
  • Chapter 18 - Background and notation
  • Chapter 19 - A general approach for controlling the type I error rate for blinded sample size recalculation.-Chapter 20 - Comparison of two groups for normally distributed outcomes and test for difference or superiority
  • Chapter 21 - Comparison of two groups for binary outcomes and test for difference or superiority
  • Chapter 22 - Comparison of two groups for normally distributed outcomes and test for non-inferiority
  • Chapter 23 - Comparison of two groups for binary outcomes and test for non-inferiority
  • Part I: Basics
  • Chapter 1- Introduction
  • Chapter 2 - Statistical test and sample size calculation
  • Part II : Sample size calculation
  • Chapter 3 - Comparison of two groups for normally distributed outcomes and test for difference or superiority.-Chapter 4 - Comparison of two groups for continuous and ordered categorical outcomes and test for difference or superiority
  • Chapter 5 - Comparison of two groups for binary outcomes and test for difference and superiority
  • Chapter 6 - Comparison of two groups for time-to-event outcomes and test for differences or superiority
  • Chapter 7 - Comparison of more than two groups and test for difference
  • Chapter 8 - Comparison of two groups and test for non-inferiority
  • Chapter 9 - Comparison of three groups in the gold standard non-inferiority design
  • Chapter 10 - Comparison of two groups for normally distributed outcomes and test for equivalence
  • Chapter 11 - Multiple comparisons
  • Chapter 12 - Assessment of safety

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