Guide to Clinical Trials by Lippincott Williams & Wilkins 
Guide to Clinical Trials is the definitive text and reference that sets the standard in contemporary clinical trial methodology. More than 130 chapters grouped into twelve sections take the reader step by step through every phase of a clinical trial--from planning trials and writing protocols to analyzing data, publishing results, and evaluating published literature. Dr. Spilker's approach is uniquely practical, addressing problems of study design and data interpretation from a clinical, nonmathematical perspective. Another particularly helpful feature of the book is an extensive collection of tables, figures, and checklists.
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