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. -BiometricsThis 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 SocietySample 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.