“Clinical Research: What It Is and How It Works” Lori A. Nesbitt, editor, 2004, 274 pages, Jones and Bartlett, $57.95 Available at Amazon.com

Review by Norman M. Goldfarb

“Clinical Research: What It Is and How It Works” is an excellent introduction to clinical research, especially for investigators and other site personnel. The book’s straightforward and objective prose, large type size, and dimensions of 5” x 7” make it a much quicker read than its 274-page length suggests.

The book has nine chapters:

• Testing Treatments in Humans

• Bioethics and Human Advocacy

• The Clinical Research Industry

• Clinical Trial Implementation

• Data Management

• Quality Management and FDA Readiness

• The Research Participant

• The Business of Clinical Research

• The Clinical Research Site

The chapter on research participants is exceptional. It covers eight challenging types of study subjects, with advice on how to recognize and deal with each type. For example, the Information Seeker is well-informed but can consume lots of time with questions and notices any mistakes. The High-Maintenance Participant may want to discuss feelings and report multiple minor health complaints. The Professional Research Participant seems to know a lot about clinical research and may have evidence of recent venipunctures. All of them require special handling.

The detailed table of contents and index make information in the book easy to find. The text is footnoted. Each chapter ends with a concise list of best practices and answers to a handful of frequently-asked-questions.

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 .
 

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