DESIGN AND ANALYSIS OF CLINICAL TRIALS....Concepts and Methodologies

Clinical trials are scientific investigations that examine and evaluate safety and efficacy of drug therapies in human subjects. Biostatistics has been recognized and extensively employed as an indispensable tool for planning, conduct, and interpretation of clinical trials. In clinical research and development, the bio-statistician plays an important role that contributes toward the success of the trial. An open and effective communication among clinician, biostatistician, and other related clinical scientists will result in a successful clinical trial. The mutual communication, however, is a two-way street: not only (1) the biostatistician must effectively deliver statistical concepts and methodologies to his/her colleagues but also (2) the clinician must communicate thoroughly clinical and scientific principles embedded in clinical research to the biostatistician. The biostatistician can then formulate these clinical and scientific principles into valid statistical hypotheses, models, and methodologies for data analyses. The integrity, quality, and success of a clinical trial depend on the interaction, mutual respect, and understanding among the clinician, the biostatistician, and other clinical scientists. There are many books on clinical trials already on the market. These books, however, emphasize either statistical or clinical aspects. None of these books provides a balanced view of statistical concepts and clinical issues. Therefore the purpose of this book is not only to fill the gap between clinical and statistical disciplines but also to provide a comprehensive and unified presentation of clinical and scientific issues, statistical concepts, and methodologies. Moreover this book focuses on the interactions among clinicians, biostatisticians, and other clinical scientists that often occur during the various phases of clinical research and development. This book is intended to give a well-balanced overview of current and emerging clinical issues and newly developed statistical methodologies. Although this book is written from a viewpoint of pharmaceutical research and development, the principles and concepts presented in this book can be applied to nonbiopharmaceutical settings.