Essentials of Clinical Research - Hardcover

Hardcover

ISBN 10: 1402084854 ISBN 13: 9781402084850

Publisher: Springer-Verlag New York Inc., 2008

Synopsis

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.

About this title

Review

“Essentials of Clinical Research”

Stephen P. Glasser, editor, 2008, 360 pages, Springer, $79.95

Review by Norman M. Goldfarb

 “Essentials of Clinical Research,” despite its name, offers the academic researcher anunusual selection of basic and advanced topics relating to clinical research. The introductory material on clinical trials and statistics is available elsewhere, but not the discussions of research methods for studies of diagnostic tests, genetics and implementation. The book also includes essays on the ancillary but important topics of grant writing, mentoring and advising, presentation skills, and, for the blessed/cursed, dealing with the media. Implementation research, as one might guess, deals with the problems of moving scientific findings into clinical practice. “One oft-quoted estimate claims that it takes an average of 17 years for even well-established clinical knowledge to be fully adopted into routine practice... In 2003, a landmark study by McGlynn et al. estimated that the American public was only receiving about 55% of recommended care.” The book consists of 22 essays by 18 contributors:

·         Clinical Research: Definitions, “Anatomy and Physiology,” and the Quest for

·         “Universal Truth”

·         Introduction to Clinical Research and Study Designs

·         Clinical Trials

·         Alternative Interventional Designs

·         Postmarketing Research

·         The United States Food & Drug Administration (FDA)

·         The Placebo and Nocebo Effect

·         Recruitment and Retention

·         Data Safety and Monitoring Boards (DSMBs)

·         Meta-Analysis

·         Research Methods for Genetic Studies

·         Research Methods for Pharmacoepidemiology Studies

·         Implementation Research: Beyond the Traditional Randomized Clinical Trial

·         Research Methods for Studies of Diagnostic Tests

·         Statistical Power and Sample Size: Some Fundamentals for Clinical Researchers

·         Association, Cause and Effect Modification

·         Bias, Confounding and Effect Modification

·         It’s All About Uncertainty

·         Grant Writing

·         The Media and Clinical Research

·         Mentoring and Advising

·         Presentation Skills: How to Present

Research Results

Dr. Glasser authored or co-authored 18 of the essays. The book is available in bookstores.

Reviewer

Norman M. Goldfarb is Managing Director of First Clinical Research LLC, a provider of clinical

research best practices information, consulting and training services. Contact him at

1.650.465.0119 or ngoldfarb@firstclinical.com.

From the Back Cover

In its extensively revised and updated Second Edition, this book provides a solid foundation for readers interested in clinical research. Discussion encompasses genetic, pharmacoepidemiologic and implementation research.

All chapters have been updated with new information and many new tables have been added to elucidate key points. The book now offers discussion on how to handle missing data when analyzing results, and coverage of Adaptive Designs and Effectiveness Designs and new sections on Comparative Effectiveness Research and Pragmatic Trials. Chapter 6 includes new material on Phase 0 Trials, expanded coverage of Futility Trials, a discussion of Medical Device approval, Off Label Drug use and the role of the FDA in regulating advertising. Additional new information includes the role of pill color and shape in association with the placebo effect and an examination of issues surrounding minority recruitment. The final chapter offers a new section on manuscript preparation along with a discussion of various guidelines being adopted by journals: CONSORT, STROBE, PRISMA, MOOSE and others; and coverage of Conflicts of Interest, Authorship, Coercive Citation, and Disclosures in Industry-Related Associations.

Building on the strengths of its predecessor in its comprehensive approach and authoritative advice, the new edition offers more of what has made this book a popular, trusted resource for students and working researchers alike.

Edition details

• Publisher: Springer-Verlag New York Inc.
• Publication date: 2008
• Language: English
• ISBN 10: 1402084854
• ISBN 13: 9781402084850
• Binding: Hardcover
• Number of pages: 360
• Editor: Glasser Stephen P., Glasser P.