Principles and Practice of Clinical Research

Principles and Practice of Clinical Research

John I. Gallin, Ed. (Academic Press, San Diego, CA, 2002), 490 pages, hardcover, ISBN: 0122740653, $99.95.

A quotation from its preface offers the best description of this booka product of an introductory course of the same title first offered at the NIH Clinical Center in Bethesda in 1996. More than 40 scientists, most from the National Institutes of Health, contributed to it. Topics covered include ethical, regulatory, and legal issues; integrity in research; IRBs; data management; clinical trial design; technology transfer; getting funding; and navigating the NIH peer review process.

The book can be considered valuable for those who are involved in clinical research at the NIH and affiliated academic institutions. It can help the reader to understand the clinical research paradigm at the NIH.

As expected from a book based on a teaching course, some of the chapters overlap considerably (for example, those on clinical trial design) and are based on the interests of the authors rather than compiled as a systematic course in clinical research. In addition, data in a number of chapters have not been updated. In many cases, the book uses references dated before 2000. The book also cites examples of clinical research tools and roles of clinical research staff that seem at odds with those currently used in clinical drug development. Results of recent discussions on conflict of interest (particularly financial) by investigators, potential conflicts between clinical research and clinical practice, and the trend toward including special populations (such as pediatric subjects) are not presented.

Readers interested in clinical drug development will be disappointed. The chapter on The Regulation of Drugs and Biological Products by the Food and Drug Administration is very general and one of the shortest in this book (only 10 pages). The standard description of clinical trials used by the FDA and the pharmaceutical industry (as Phases 14) is mentioned only in one table. Instead the book includes chapters on Design and Conduct of Observational Studies and Clinical Trials, Small Clinical Trials, and Large Clinical Trials: Clinical Research Institutes.

The book would have been of considerable interest to the readers of Applied Clinical Trials if it had been structured as a systematic approach to clinical drug development, included broader references to FDA regulations, and bridged the differences between principles and practices of clinical research at the NIH with those currently used in clinical drug development.

Insofar as this book can be considered the golden standard for clinical research at the NIH and related academic institutions, it may further explain the continued decline in the number of industry-sponsored studies con-ducted at academic institutions.