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Doody's Review ServiceReviewer: Christopher J. Kratochvil, MD (University of Nebraska Medical Center)
Description: A systematic overview of clinical research from the investigator's perspective is provided. The editors provide a timely update of the first edition, which was published in 1995.
Purpose: The editors developed this book to provide pertinent information about all aspects of drug research in man, "... from the initial research idea to the ultimate publication and every step in between."
Audience: The book is designed to be a primer for those setting out to become clinical investigators, as well as a tool to "fill the gaps" for those with more experience in the field. The editors have succeeded in these aims by assembling a diverse panel of expert contributors. Although the focus is upon pharmaceutical research, the book is quite appropriate for anyone designing or conducting clinical research.
Features: The title is an apt description of this book as a guide, as readers are led systematically through the preparation, completion, and reporting of a clinical trial. Issues regarding study design, facilities, equipment, planning, coordinating, data management, ethical considerations, and good clinical practices are all reviewed. Particularly useful are the descriptions of what an informed investigator should know about a drug prior to initiating or agreeing to participate in a clinical trial. This book is not a complete reference for those designing and conducting clinical research, but it is an excellent overview and readers are directed to pertinent references.
Assessment: As an investigator who conducts investigator-initiated as well as collaborative multi-site trials, I found this book to have great utility. There are few resources in which these important issues are addressed. I would recommend this book to those conducting multi-site trials as a guide for critically evaluating proposed projects and to those designing and implementing their own studies as an excellent guide about what to do and what not to forget.