Statistical design, monitoring, and analysis of clinical trials : principles and methods / Weichung Joe Shih, Rutgers University, Piscataway, New Jersey, USA, Joseph Aisner, Rutgers Cancer Institute of New Jersey, New Brunswick, New Jersey, USA.

Book.

Includes bibliographical references and index.

"Developed from the authors' courses taught to public health and medical students, residents, and fellows during the past 15 years, the text shows how biostatistics in clinical trials is an integration of many fundamental scientific principles and statistical methods. The book begins with ethical and safety principles, core trial design concepts, the principles and methods of sample size and power calculation, and analysis of covariance and stratified analysis. It then focuses on sequential designs and methods for two-stage Phase II cancer trials to Phase III group sequential trials, covering monitoring safety, futility, and efficacy. The authors also discuss the development of sample size reestimation and adaptive group sequential procedures, explain the concept of different missing data processes, and describe how to analyze incomplete data by proper multiple imputations"-- Provided by publisher.