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Sample Size Calculations in Clinical Research
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Shein-Chung Chow
Jun Shao
Hansheng Wang
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Sample size calculation is usually conducted through a pre-study power analysis. The purpose is to select a sample size such that the selected sample size will achieve a desired power for correctly detection of a prespecified clinically meaningful difference at a given level of significance. In clinical research, however, it is not uncommon to perform sample size calculation with inappropriate test statistics for wrong hypotheses regardless what study design is employed. This book provides formulas and/or procedures for determination of sample size required not only for testing equality, but also for testing non-inferiority/superiority, and equivalence (similarity) based on both untransformed (raw) data and log-transformed data under a parallel-group design or a crossover design with equal or unequal ratio of treatment allocations. It provides not only a comprehensive and unified presentation of various statistical procedures for sample size calculation that are commonly employed at various phases of clinical development, but also a well-balanced summary of current regulatory requirements, methodology for design and analysis in clinical research, and recent developments in the area of clinical development.
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