"The previous edition of this title has an excellent track record, and its continued comprehensive coverage is unparalleled by the competition. The author, who is renowned throughout the world, has significantly and thoroughly refined and retooled this edition.

This updated volume continues its straightforward, authoritative review of basic statistical methods for clinical trials. Even though numerous books have appeared on the subject matter, very few of them, except for this title, emphasize accessible coverage of statistical methods -- the crucial building blocks of medical research. The author's hands-on approach, embracing a number of different trial designs and clinical fields, guides readers through the process of planning an experiment, putting together a study cohort, assessing data, and reporting results, and addresses the problems that are likely to confront any such study. Paramount throughout is the effort to strike a common ground between qualitative clinical and rigorous statistical methods.

• Covers vital design considerations
• Emphasizes experimental designs to search for treatment advances
• Focuses on concepts that unify
• Explores areas of controversy such as ethics (now greatly expanded) and offers pragmatic information regarding allegations of fraud or misconduct
• Includes summaries, revised discussion questions, and updated references in each chapter
• Accompanied by an ftp site, dozens of new, redrawn, and/or updated illustrations, a comprehensive bibliography, and multiple indexes
• Incorporates new content, including new chapters on contexts, perspectives, transitional trials, and early developmental drug design
• Now, extensively class-tested