Designing Clinical Research

For more than 30 years, Designing Clinical Research has set the standard as the most practical, authoritative guide for physicians, nurses, pharmacists, and other practitioners involved in all forms of clinical and public health research. Using a reader-friendly writing style, Drs. Warren S. Browner, Thomas B. Newman, Steven R. Cummings, Deborah G. Grady, Alison J. Huang, Alka M. Kanaya, and Mark J. Pletcher, all of the University of California, San Francisco, provide up-to-date, commonsense approaches to the challenging judgments involved in designing, funding, and implementing a study. This state-of-the-art fifth edition features new figures, tables, and design, as well as new editors, new content, and extensively updated references to keep you current.

• Covers clinical research in its many forms, including clinical trials, observational studies, translational science, and patient-oriented research.

• Presents epidemiologic terms and principles and advanced conceptual material in a practical and reader-friendly manner.

• Discusses key changes in the field, including confounding and directed acyclic graphs, surrogate outcomes and biomarkers, instrumental variables and Mendelian randomization, regression discontinuity designs, alternative data sources, AI and machine learning, pilot studies, as well as an update on P values and Bayesian analysis..

• Covers modifications of classic randomized trials, such as pre/post, interrupted time series, difference-in-differences, stepped wedge and cluster randomized designs, as well as randomized trials in health systems.

• Adds new chapters on qualitative approaches to clinical research and on community-engaged research

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