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.
“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.
