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A Manager’s Guide to the Design and Conduct of Clinical Trials. Phillip I. Good. New York: John Wiley & Sons, Inc., 2002, 242 pp., $64.95. ISBN 0-471-22615-7.

Core Laboratory for Clinical Studies, Washington University School of Medicine, St. Louis, MO 63110

This book is must-have reading for anyone in the business of designing, managing, or conducting clinical trials of drugs or medical devices. It is easy to read and full of practical pointers gleaned from the author’s experience as a statistician and a consultant to the Pharma industry; two resources often brought in after the fact to rescue a venture gone sour. Taken to heart, Good’s philosophy that it is better to prepare rather than to repair will go a long way in assuring the success of any clinical trial.

The book is arranged in a logical series of chapters, each covering a part of clinical trial planning, performance, or analysis. The use of topics and multiple short subtopics, usually 1–3 pages, devoted to a single concept makes it easy to find specific items when needed. As a result, the book is a usable handbook that can be referred to as needed. Emphasis is placed on planning and monitoring at all stages of the process as the best ways to reduce errors in clinical trials. The author obviously knows the cost in terms of time and money that errors contribute to the expense of a trial and the negative effect they have on regulatory agencies.

Unfortunately, the author misses an opportunity to describe several important roles of the clinical laboratory in performance of clinical trials as they are currently practiced. Phase III clinical trials, the focus of this book, are typically conducted at multiple clinical sites with specimens sent to a central laboratory for analysis. Good does not discuss the advantages of using a central laboratory vs multiple local laboratories with regard to the impact on data entry, data analysis, or study monitoring—three items that are stressed as critical for the success of clinical trials.

Chapter 10 is devoted to "Computer-Assisted Data Entry" and describes the advantages of electronic case report forms (e-CRF) over the typically used paper forms. At some time in the future, the widespread use of such e-CRFs will undoubtedly streamline data entry and improve the quality of such data. However, today most clinical trials use the pa-per forms, and the conversion to e-CRFs is slow. The possible mechanisms for the transfer of data from the central laboratory to the sponsor’s central database are mentioned only in passing in chapter 11 (Data Management). This is disconcerting given the large amount of data often collected and the need for the laboratory to take responsibility for notifying clinical sites and sponsors when specific test results exceed predefined critical limits (physician alert values).

Although the book gives little direct consideration to the role of the clinical laboratory in clinical trials, it will be of value to the laboratorian who wishes to be educated in the performance of clinical trials. Good’s liberal use of anecdotal sidebars is helpful to give practical depth to his suggestions, and the numerous references make this book a valuable reference resource.

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