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Building on the techniques used in clinical trials of pharmaceuticals, this book summarizes for the first time the key principles and approaches to be used in medical device clinical trials, and then demonstrates implementation of these principles in a revealing series of detailed, real-world case studies. The highly experienced contributors show how to design and evaluated clinical trials of medical defvices, as well as collect data that is acceptable to the FDA. Nine detailed case studies illustrate the wide range of study designs that have been successfully applied to many different research problems and a variety of therapeutic or diagnostic products. Clinical Evaluation of Medical Devices provides today’s only source of case-study-based practical information on how clinical study design principles are best tailored to the successful evaluation of medical devices. This book serves as a technical resource for scientific and regulatory professionals working in the field of new medical device development and commercialization. Chapters cover the basic principles of clinical study design and analysis, (including protocol requirements, selecting suitable endpoints, selecting a control group, sample size calculations, monitoring, data analysis, and presentation); and those describing research approaches on different classes of such devices as implanted devices and in vitro diagnostics.
