This text is intended for the clinical researcher who is interested in designing a clinical trial and developing a protocol. It also is of value to researchers and practitioners who must critically evaluate the literature of published clinical trials and assess the merits of each trial and the implications for the care and treatment of patients.

The organization of the text in Fundamentals of Clinical Trials presents the essentials in the order they would be used to develop a typical protocol. To best aid the clinical trial researcher, a chapter is devoted to each of the critical areas of a protocol. The fundamentals described in this text are based on sound scientific methodology, statistical principles, and years of accumulated experience by the three authors.

Lawrence M. Friedman, M.D., Curt D. Furberg, M.D., Ph.D., and David L. DeMets, Ph.D.
361 pages, 1998, softbound , ISBN 0-387-98586-7