E-Book Overview
Focusing on an integral part of pharmaceutical development, Sample Size Calculations in Clinical Research, Second Edition presents statistical procedures for performing sample size calculations during various phases of clinical research and development. It provides sample size formulas and procedures for testing equality, noninferiority/superiority, and equivalence.
A comprehensive and unified presentation of statistical concepts and practical applications, this book highlights the interactions between clinicians and biostatisticians, includes a well-balanced summary of current and emerging clinical issues, and explores recently developed statistical methodologies for sample size calculation. Whenever possible, each chapter provides a brief history or background, regulatory requirements, statistical designs and methods for data analysis, real-world examples, future research developments, and related references.
One of the few books to systematically summarize clinical research procedures, this edition contains new chapters that focus on three key areas of this field. Incorporating the material of this book in your work will help ensure the validity and, ultimately, the success of your clinical studies.
E-Book Content
Biostatistics Series
Sample Size Calculations in Clinical Research Second Edition
© 2008 by Taylor & Francis Group, LLC
Biostatistics Series Editor-in-Chief Shein-Chung Chow, Ph.D. Professor Department of Biostatistics and Bioinformatics Duke University School of Medicine Durham, North Carolina, U.S.A.
Series Editors Byron Jones Senior Director Statistical Research and Consulting Centre (IPC 193) Pfizer Global Research and Development Sandwich, Kent, UK
Jen-pei Liu Professor Division of Biometry Department of Agronomy National Taiwan University Taipei, Taiwan
Karl E. Peace Director, Karl E. Peace Ce