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.
