Methods and Applications of Sample Size Calculation and Recalculation in Clinical Trials. 1st ed. 2020

種類:

電子ブック

責任表示:

by Meinhard Kieser

出版情報:

Cham : Springer International Publishing : Imprint: Springer, 2020

著者名:

• Kieser, Meinhard.
• SpringerLink (Online service)

シリーズ名:

Springer Series in Pharmaceutical Statistics ;

ISBN:

9783030495282 [3030495280]    

注記:

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 tr
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 problematic due to ethical, scientific, and economic reasons. Therefore, state-of-the art methods are required when planning clinical trials. Part I describes a general framework for deriving sample size calculation procedures. This enables an understanding of the common principles underlying the numerous methods presented in the following chapters. Part II addresses the fixed sample size design, where the required sample size is determined in the planning stage and is not changed afterwards. It covers sample size calculation methods for superiority, non-inferiority, and equivalence trials, as well as comparisons between two and more than two groups. A wide range of further topics is discussed, including sample si

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