S-C. Chow, Biostatistics & Data Management, Covance Inc., USA, J-P. Liu, Biostatistics & Research Information Sciences, Berlex Laboratories Inc., USA

Design and Analysis of Clinical Trials aims to fill the gap between clinical and statistical disciplines as well as providing a comprehensive and unified presentation of clinical and scientific issues, statistical concepts and methodologies. The authors focus on interactions among clinicians, biostatisticians and other clinical scientists that often occur during the various phases of clinical research and development. The result is a well balanced summarisation of current and emerging clinical issues with newly developed statistical methodologies which, although written from a pharmaceutical research viewpoint, can be applied to a non-biopharmaceutical setting.

Contents

• Introduction
• Basic Statistical Concepts
• Basic Design Consideration
• Randomization and Blinding
• Designs for Clinical Trials
• Classification of Clinical Trials
• Analysis of Continuous Data
• Analysis of Categorical Data
• Censored Data and Interim Analysis
• Sample Size Determination
• Issues in Efficacy Evaluation
• Safety Assessment