Essentials of Clinical Research / edited by Stephen P. Glasser.

Springer eBooks

I -- Clinical Research: Definitions, “Anatomy and Physiology,” and the Quest for “Universal Truth” -- to Clinical Research and Study Designs -- Clinical Trials -- Alternative Interventional Study Designs -- Postmarketing Research -- The United States Federal Drug Administration (FDA) and Clinical Research -- The Placebo and Nocebo Effect -- Recruitment and Retention -- Data Safety and Monitoring Boards (DSMBs) -- Meta-Analysis -- II -- Research Methods for Genetic Studies -- Research Methods for Pharmacoepidemiology Studies -- Implementation Research: Beyond the Traditional Randomized Controlled Trial -- Research Methodology for Studies of Diagnostic Tests -- III -- Statistical Power and Sample Size: Some Fundamentals for Clinician Researchers -- Association, Cause, and Correlation -- Bias, Confounding, and Effect Modification -- It’s All About Uncertainty -- Grant Writing -- IV -- The Media and Clinical Research -- Mentoring and Advising -- Presentation Skills: How to Present Research Results.

This book is designed to provide the “student” interested in clinical research a foundation upon which to build more advanced study. The book focuses on clinical trials, in contrast to the many excellent textbooks that address epidemiological research. With the recent interest in patient oriented research, this book should provide a knowledge base that is not necessarily covered in other texts. Chapters discussing the FDA’s role in clinical research, Data Safety and Monitoring Boards, Postmarketing studies, the use of placebo controls, and a focus on clinical trials illustrates this point. In addition, new types of clinical research are evolving, and as such, this book discusses genetic, pharmacoepidemiologic, and implementation research. Finally, chapters on tips on how to write a grant, the mentoring process, and how to present ones research results are unique to this book.

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