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Doody's Review ServiceReviewer: Vincent F Carr, DO, MSA, FACC, FACP (Uniformed Services University of the Health Sciences)
Description: This book details the history of how clinical research studies began in the U.S. and explains phase I through IV clinical trials, observational research, and regression techniques.
Purpose: The purpose is to demonstrate the importance of observational clinical research and to reinforce that there is a valid place for this kind of research even in these times of emphasis on the classic, double-blind, large, multicenter, and longitudinal research studies. The authors and contributors are highly experienced clinicians and researchers.
Audience: The book is designed to help younger researchers who have difficulty obtaining funding for their studies recognize that there are still opportunities to become published with observational research.
Features: It begins with the advances and the problems with early research studies and how many of the ethical considerations have developed. For young researchers, this is extremely valuable material. The second section, "Principles of Clinical Experimentation," outlines the different phases of clinical trials with a great deal of practical information on phase III and IV clinical trials. One of the nicer aspects of the book is the way it presents specific sketches of how valuable information has been gained in these phase III and IV studies. Another is the way this book differs from other research books that focus on the statistics or the history. This is a very practical book.
Assessment: What makes this book on research stand out is the focus on observational studies as a way to develop experience in research at a time when funding for larger double-blind studies is difficult to get.