Year: 2024
Type: article
Abstract: The second edition of this book comes approximately 14 years after the previous edition of this book. Like the first edition, this edition is a handbook that helps researchers who need to perform sample size calculations for clinical trials. There have been numerous developments in clinical trials over the past 14 years, and this extensively updated edition reflects those changes. There are additions to each chapter, with four new chapters focusing on multiplicity, cluster trials, pilot studies, and single-arm trials. The author has added material extensively to most chapters, as reflected by numerous citations of work done after 2009. The book covers standard parallel group trials, cross-over studies, equivalence studies, and noninferiority studies in a wide variety of situations. It includes calculations for continuous data, binary data, ordinal data, and survival data; these situations make up the majority of commonly seen clinical trial designs. The only potential limitation that I can see for this book is that it focuses on closed-form sample size calculations. For situations for which there are no closed-form solutions for sample size calculations, simulation studies can be done to estimate sample size. I would recommend readers interested in becoming an expert in sample size calculations supplement the material in this book with material on the use of simulations to calculate sample size.
Author: Amit K Chowdhry
Institutions: University of Rochester Medicine, University of Rochester
Language: English
Subfield: Statistics and Probability
Field: Mathematics
Domain: Physical Sciences
Open Access status: bronze
OpenAlex ID: W4403215762