This book is about the science of doing clinical research in all its forms: translational research,clinical trials, patient-oriented research, epidemiologic studies, behavioral science and health services research. Codifying the nature of this broad-based science and how to do it is not straightforward, and there is no single approach that everyone agrees is best. Our first two editions drew on the terms and principles of epidemiology in a practical and reader-friendly way, emphasizing systematic and common sense approaches to the many judgments involved in designing a study.The Third Edition of Designing Clinical Research (DCR) follows the same path, adding new developments along the way. New material on observational studies includes case-crossover designs, and the use of propensity scores, instrumental variables and Mendelian randomization to control confounding. Reorganized chapters on clinical trials introduce adaptive designs, and those on studying medical tests and on utilizing existing datasets present expanded options that will be attractive to beginning investigators. The chapter on research ethics is extensively updated, the one on data management entirely new (reflecting current approaches to information technology),and a rewritten chapter on study implementation and quality control introduces practicalities of study startup and regulatory issues (‘‘Good Clinical Practices’’). An updated chapter on getting funded brings help for the challenges facing young investigators.
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In a clinical trial, the researchers design a plan or protocol that specifies the treatment that will be given to the participants. When conducting clinical trials, researchers may compare a novel medical treatment to an existing one, a placebo that has no active components, or nothing at all. Comparing treatments that are currently accessible in clinical trials is a common practice.
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