"After reviewing the history, ethics, protocol, and regulatory issues of clinical trials, the book provides guidelines for formulating primary and secondary questions and translating clinical questions into statistical ones. It examines designs used in clinical trials, presents methods for determining sample size, and introduces constrained randomization procedures. The authors also discuss how various types of data must be collected to answer key questions in a trial. In addition, they explore common analysis methods, describe statistical methods that determine what an emerging trend represents, and present issues that arise in the analysis of data. The book concludes with suggestions for reporting trial results that are consistent with universal guidelines recommended by medical journals." "Providing a solid understanding of the statistical approaches used in clinical trials, this text shows that the results of randomized controlled trials are best understood through the application of sound statistical principles."--BOOK JACKET.DeMets, David L. is the author of 'Statistical Methods in Clinical Trials', published 2007 under ISBN 9781584880271 and ISBN 1584880279.