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"This Fourth Edition builds on the text's reputation as a straightforward, detailed, and authoritative presentation of quantitative methods for clinical trials. Readers will encounter principles of design for various types of clinical trials and are then skillfully guided through the complete process of planning the experiment, assembling a study cohort, assessing data, and reporting results. Throughout the process, the author alerts readers to problems that may arise during the course of a trial and provides common sense solutions. The Fourth Edition greatly expands its coverage, ranging from statistical principles to new and provocative topics, including four new chapters on generalizing results, operating characteristics, trial issues during the COVID-19 pandemic, and clinical trials using so-called "real world" data. Existing topics have been updated and expanded such as alternative medicine, ethics, middle development, comparative studies, and adaptive designs. Readers familiar with prior editions will discover revamped exercise sets; an updated and extensive reference section; new material on endpoints and the developmental pipeline, among others; and revisions of numerous sections."--

Clinical trials --- Clinical Trials as Topic --- Research Design --- Statistics as Topic --- Études cliniques --- Statistical methods. --- methods --- Méthodes statistiques. --- Statistical methods