Design and Analysis of Clinical Trials

Praise for the First Edition of Design and Analysis of Clinical Trials. "An excellent book, providing a discussion of the clinical trial process from designing the study through analyzing the data, and to regulatory requirement . . . could easily be used as a classroom text to understand the process in the new drug development area.". – Statistical Methods in Medicine. A complete and balanced presentation now revised, updated, and expanded. As the field of research possibilities expands, the need for a working understanding of how to carry out clinical trials only increases. New developments in the theory and practice of clinical research include a growing body of literature on the subject, new technologies and methodologies, and new guidelines from the International Conference on Harmonization (ICH). Design and Analysis of Clinical Trials , Second Edition provides both a comprehensive, unified presentation of principles and methodologies for various clinical trials, and a well-balanced summary of current regulatory requirements. This unique resource bridges the gap between clinical and statistical disciplines, covering both fields in a lucid and accessible manner. Thoroughly updated from its first edition, the Second Edition of Design and Analysis of Clinical Trials features new topics such as:.:.; Clinical trials and regulations, especially those of the ICH.; Clinical significance, reproducibility, and generalizability.; Goals of clinical trials and target population.; New study designs and trial types.; Sample size determination on equivalence and noninferiority trials, as well as comparing variabilities. Also, three entirely new chapters cover:.:.; Designs for cancer clinical trials.; Preparation and implementation of a clinical protocol.; Data management of a clinical trial. Written with the practitioner in mind, the presentation assumes only a minimal mathematical and statistical background for its reader. Instead, the writing emphasizes real-l