Principles and Practice of Clinical Research - Hardcover

Hardcover

ISBN 10: 0122740653 ISBN 13: 9780122740657

Publisher: Academic Press, 2002

Synopsis

Principles and Practice of Clinical Research is a comprehensive text which addresses the theoretical and practical issues involved in conducting clinical research.

This book is divided into three parts: ethical, regulatory, and legal issues; biostatistics and epidemiology; technology transfer, protocol development and funding. It is designed to fill a void in clinical research education and provides the necessary fundamentals for clinical investigators. It should be of particular benefit to all individuals engaged in clinical research, whether as physician or dental investigators, Ph.D. basic scientists, or members of the allied health professions, as well as both students and those actively participating in clinical research.

Key Features
* Comprehensive review ranging from a historical perspective to the current ethical, legal and social issues and an introduction to biostatistics and epidemiology
* Practical guide to writing a protocol, getting funding for clinical research, preparing images for publication and display
* Cohesive and clear presentation by authors carefully selected to teach a very popular course at NIH
* Excellent companion text for courses on clinical research

About this title

From the Back Cover

Molecular medicine, the human genome project and proteomics have opened vast opportunities for translation of basic science observations to the bedside through clinical research. Although the importance of research in medical education has long been recognized, education of the medical community about the clinical research process has received little attention until recently. This book is an introduction to the principles and practice of clinical research and is divided into three parts: ethical, regulatory, and legal issues; biostatistics and epidemiology; technology transfer, protocol development and funding. The book is designed to fill a void in clinical research education and provides the necessary fundamentals for clinical investigators. It should be of particular benefit to all individuals engaged in clinical research, whether as physician or dental investigators, Ph.D. basic scientists, or members of the allied health professions. It should be of particular benefit to both students and those actively participating in clinical research.

Reviews

This timely book on how to conduct, evaluate, and monitor clinical research was written by leading experts in the field. An important strength of the book is that many of the authors are, or have been, associated with the National Institutes of Health (NIH). In fact, the text is based on a course given at the NIH and headed by the book's editor, John I. Gallin. The authors are particularly knowledgeable about NIH guidelines and regulations that govern much of the clinical research conducted in the United States. The book also contains valuable sections on how to obtain funding from the NIH for clinical research and is particularly strong in the area of ethical, regulatory, and legal issues. Given the problems with clinical research protocols that have been sufficiently serious to close down entire universities in recent years, this book clearly fulfills an important function for anyone involved in clinical research. The book is up to date and includes chapters on women and minorities, telemedicine, and animal models of human diseases, each of which is well written and informative. However, one or more separate chapters on the unique issues associated with genetics, genomics, and gene therapy would have been an appropriate and important addition to this otherwise comprehensive book. The concise initial chapters on bioethics, institutional review boards (IRBs), and data and safety monitoring provide important information needed to prepare investigators for conducting clinical research, at least as judged by the questions on several of the examinations that the NIH and my own institution require for certification to conduct clinical research. Chapter 8 presents the instructive story of the development of, and problems with, the antiviral drug fialuridine, which was ultimately found to have mitochondrial toxicity. The story is a voyage through all of the institutional and societal regulators. It is also a personal account told by a scientist who was in the middle of a stressful and at times tragic story. This chapter, like all the others, is focused on educating the reader, rather than pushing a political agenda, an approach in keeping with the spirit of the book and its roots in the NIH course on clinical research. A useful chapter written by two employees of the Food and Drug Administration describes the critical functions of this government agency in the regulation of drugs and biologic products. Although one could criticize the editor for relying so heavily on insiders to write chapters in the book, I think this is actually a strength. There are certainly many controversial issues that cause tensions between clinical researchers and the federal agencies that oversee clinical research, but the point of this book is to provide a road map that investigators can use to navigate the complexities of regulations governing clinical research. Who better to draw this map than the regulators themselves? This book will be accessible to a wide range of readers. Seasoned clinical investigators will find it a useful reference and a valuable teaching tool. Beginning students and others who are involved in clinical research but who may not have had formal training in the field will find that this book provides an excellent introduction to the key issues all clinical investigators must be familiar with. The book contains an enormous amount of useful information, which is clearly presented. For example, the chapters on legal issues are explained in terms that can readily be understood by a physician or a nurse with no legal training. Brief chapters on statistical methods cover the high points that any clinical investigator needs to be comfortable with, including randomization, calculation of the sample size, hypothesis testing, and survival analysis. The discussions of small and large clinical trials are of course generic and limited to addressing the more obvious aspects of designing trials. These chapters are not likely to obviate the need for an experienced, well-trained principal investigator to serve as a mentor for such endeavors. The brief overviews of technology transfer, telemedicine, and animal models of human disease cover topics that are so complex that entire books could be written about them. Somewhat out of place is the chapter on how to prepare scientific images for publication and display. The chapter is too brief to provide sufficiently detailed information for those not already well versed in the use of these techniques and is too superficial to interest anyone who is already producing scientific images on desktop computers. This book is much needed and provides essentially all of the basic information required by investigators involved in clinical research, from both a practical perspective and a regulatory perspective. Although it will not take the place of more in-depth books in any of the many areas it touches on, there is very little information in this well-written and comprehensive book that all clinical investigators should not be familiar with. Given the appropriate increase in attention to regulations governing clinical research, this book will be an important resource for institutional libraries and IRBs. It is an excellent starting point for those embarking on a clinical research project, as well as a valuable reference that experienced investigators will probably want to have readily available. Andrew R. Marks, M.D.
Copyright © 2003 Massachusetts Medical Society. All rights reserved. The New England Journal of Medicine is a registered trademark of the MMS.

Edition details

• Publisher: Academic Press
• Publication date: 2002
• Language: English
• ISBN 10: 0122740653
• ISBN 13: 9780122740657
• Binding: Hardcover
• Edition number: 1
• Number of pages: 490
• Editor: Gallin John I., Ognibene Frederick P.