Design and Analysis of Clinical Trials: Concepts and Methodologies

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; and, 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-life examples and illustrations from clinical case studies, as well as numerous references - 280 of them new to the Second Edition - to the literature. "Design and Analysis of Clinical Trials, Second Edition" will benefit academic, pharmaceutical, medical, and regulatory scientists/researchers, statisticians, and graduate-level students in these areas by serving as a useful, thorough reference source for clinical research.