Sample Size Calculations in Clinical Research

Praise for the Second Edition:


". . . this is a useful, comprehensive compendium of almost every possible sample size formula. The strong organization and carefully defined formulae will aid any researcher designing a study." -Biometrics


"This impressive book contains formulae for computing sample size in a wide range of settings. One-sample studies and two-sample comparisons for quantitative, binary, and time-to-event outcomes are covered comprehensively, with separate sample size formulae for testing equality, non-inferiority, and equivalence. Many less familiar topics are also covered . . ." - Journal of the Royal Statistical Society


Sample Size Calculations in Clinical Research, Third Edition presents statistical procedures for performing sample size calculations during various phases of clinical research and development. A comprehensive and unified presentation of statistical concepts and practical applications, this book includes a well-balanced summary of current and emerging clinical issues, regulatory requirements, and recently developed statistical methodologies for sample size calculation.


Features:


Compares the relative merits and disadvantages of statistical methods for sample size calculations


Explains how the formulae and procedures for sample size calculations can be used in a variety of clinical research and development stages


Presents real-world examples from several therapeutic areas, including cardiovascular medicine, the central nervous system, anti-infective medicine, oncology, and women's health


Provides sample size calculations for dose response studies, microarray studies, and Bayesian approaches


This new edition is updated throughout, includes many new sections, and five new chapters on emerging topics: two stage seamless adaptive designs, cluster randomized trial design, zero-inflated Poisson distribution, clinical trials with extremely low incidence rates, and clinical trial simulation.

Introduction. Considerations Prior to Sample Size Calculation. Comparing Means. Large Sample Tests for Proportions. Exact Tests for Proportions. Tests for Goodness-of-Fit and Contingency Tables. Comparing Time-to-Event Data. Group Sequential Methods. Comparing Variabilities. Bioequivalence Testing. Dose Resonse Studies. Microarray Studies. Bayesian Sample Size Calculation. Nonparametrics. Cluster Randomized Design. Sample Size Calculation for Two-Stage Adaptive Design. Sample Size for Clinical Trials with Extremely Low Incidence Rates. Clinical Trial Simulation for Sample Size Estimation. Sample Size Calculation in Other Areas.