Introduction to Statistical Methods for Clinical Trials

This text provides a solid understanding of the various statistical topics relevant to the design monitoring and analysis of a clinical trial. It covers basic experimental design sample size randomization procedures interim and survival analyses quality of life assessment and longitudinal methods. The book describes all phases of a clinical trial and explores the advantages of and objections to the intent-to-treat principle as well as its implementation. With exercises at the end of most chapters it also illustrates methods using examples with real data from a variety of disease areas including heart and lung diseases cancer and AIDS.