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

This book provides an extensive overview of the principles and methods of sample size calculation and recalculation in clinical trials. Appropriate calculation of the required sample size is crucial for the success of clinical trials. At the same time, a sample size that is too small or too large is...

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Bibliographic Details
Main Author:	Kieser, Meinhard (Author)
Corporate Author:	SpringerLink (Online service)
Format:	eBook
Language:	English
Published:	Cham : Springer International Publishing : Imprint: Springer, 2020.
Edition:	1st ed. 2020.
Series:	Springer Series in Pharmaceutical Statistics,
Subjects:	Statistics . Biostatistics. Pharmaceutical technology. Statistical Theory and Methods. Statistics for Life Sciences, Medicine, Health Sciences. Pharmaceutical Sciences/Technology. Electronic books.
Online Access:	Connect to the full text of this electronic book

Table of Contents:

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
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
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.