Clinical Trials: Design, Conduct, and Analysis. Monographs in Epidemiology and Biostatistics, vol 8.

Clinical Trials: Design, Conduct, and Analysis. Monographs in Epidemiology and Biostatistics, vol 8 This series has contributed a number of gems to the literature, including the monograph Epidemiology of Musculoskeletal Disorders, by Kelsey; although perhaps not directly relevant to physical therapy, it is of substantial interest to clinician-scholars. This monograph by Meinert is an extraordinarily well-documented and comprehensive volume on the most pertinent aspects of clinical research. Although the author's focus is on epidemiology in medicine, the conceptual issues are just as germane to physical therapy. Because the author's expertise is in large-scale multi-institutional clinical trials, including the University Group Diabetes Program, much of the information provided is directed toward National Institutes of Health-caliber clinical research.

The book contains seven parts, including research design, implementation, data analysis and interpretation, and a concise summary of the administrative and clerical aspects of clinical research. The very practical, applied sketches of multicentered clinical trials are found in a concise and informative appendix that provides a comprehensive point of view unlike any I have seen in other sources. This volume is comprehensive, clear, and authoritative and has more than 500 references. It accurately documents all aspects of clinical trials from single-research sites to multicenter studies, from decisions concerning the designation of authorship on final papers and reports to data filing and how long to retain data. Many physical therapists will find that although the National Institutes of Health budget examples are clear and helpful, the outline and suggested proposal format may be redundant for the shorter proposals most physical therapists submit.

My major criticism of the book is its cost. The information provided is so helpful and so well presented that the book would make a superb text for advanced research-design courses; however, it clearly is priced to be affordable only by institutions and libraries.

I suspect that this volume's coverage of major issues, such as sample design and the responsibility of investigators when patients are involved, will make it a classic in the research-design literature. Its only competition is Fundamentals of Clinical Trials by Friedman, Furberg, and Demets; however, I believe Meinert's work is substantially more comprehensive and better documented. I enthusiastically recommend this book to all who can afford it and encourage the rest of us to obtain the book on loan, if only for the fascinating introductory section that includes the history of clinical trials.