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Doody's Review ServiceReviewer: Aryeh Hurwitz, M.D.(University of Kansas School of Medicine)
Description: This book discusses the practicalities of implementing studies of clinical biomarkers in the process of drug development. Several chapters are devoted to validation, statistical, and regulatory concerns.
Purpose: Its purpose is to discuss the application of biomarkers to drug development, especially to provide "informed perspectives and advice on the unique challenges" involved in applying biomarkers to "development, registration, and commercialization of pharmaceuticals in today's environment." While such a book is clearly of use, the authors have not been entirely successful in achieving their goals. Several of the chapters are redundant. They provide practical guidance in collection, processing,and transport of clinical specimens and in handling of data. This information is readily available in standard texts of clinical pathology and chemistry.
Audience: The book is obviously targeted to people working in the pharmaceutical industry, who gather data for New Drug Applications and have to contend with regulatory agencies.
Features: Some of the chapters are excellent. Those on imaging biomarkers and on cardiac repolarization are standouts. The chapter on quality assurance and regulatory compliance has a valuable glossary of terms and abbreviations for the uninitiated. Many of the other chapters are too short and superficial to be self sufficient. The bibliographies of most chapters are reasonably current, although some cite no references past the year 2000. What is lacking is any meaningful coverage of biomarkers for common clinical conditions, such as cardiovascular, neurodegenerative, malignant, rheumatologic, psychiatric, and other diseases. In such conditions, which commonly take decades to develop, it would be useful to present and evaluate availability and validity of biomarkers for identifying susceptible patients and for following courses of their diseases and responses to drug therapy.
Assessment: This is an uneven book. Some chapters are well written, complete, current, and comprehensive enough to stand alone. Others are superficial, trivial, and laden with jargon. At a rather high price it is not a particularly good buy. Other recent books, such as Biomarkers of Disease: An Evidence-Based Approach, edited by Trull et al. (Cambridge University Press, 2002), and Biomarkers and Surrogate Endpoints: Clinical Research and Applications, edited by Downing (Elsevier, 2000), are better.