BOOK REVIEW

Gary P. Wormser, Section Editor

lation of drugs and biological products.

Principles and Practice
of Clinical Research
Edited by John I. Gallin
San Diego, CA: Academic Press, 2002.
490 pp., illustrated. $99.95 (cloth).
Principles and Practice of Clinical Research
is a textbook that is based on an intro-
ductory course on clinical research that
has been taught since 1996 at the National
Institutes of Health (NIH) Clinical Center
Many chapters include a historical per-
spective on their topics.
The section “Biostatistics and Epide-
miology” focuses particularly on clinical
trials. Many of the chapters use specific
examples from published studies to illus-
trate principles of both the design and
analysis of clinical trials. This section also
contains chapters about survival analysis,
meta-analysis, and measurements of func-
tion and health-related quality of life.
There is a particularly good chapter en-
New Books Received
Gilligan PH, Smiley ML, Shapiro DS. Cases
in Medical Microbiology and Infectious Dis-
eases, 3rd Edition. Washington, DC: Amer-
ican Society for Microbiology Press, 2003.
440 pp. $49.95. ISBN: 1-55581-207-4.
Yu VL, Weber R, Raoult D. Microbes. An-
timicrobial Therapy and Vaccines, 2nd Edi-
tion, vol. 1. New York: Apple Trees Produc-
tions, 2002. 1735 pp. $195.00. ISBN: 0-
9700027-5-0.

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(Bethesda, Maryland). The chapters in the
book are written mostly by the faculty
members who have taught the course. A
major strength of the book is that it is
remarkably comprehensive. It is divided
into 3 sections: “Ethical, Regulatory, and
Legal Issues,” “Biostatistics and Epidemi-
ology,” and “Technology Transfer, Proto-
col Development, and Funding.” The
book is particularly designed for persons
beginning their careers in clinical research,
although more experienced investigators
also will find it to be useful.
There are a number of chapters that
address issues that one will not find in
other introductory clinical research text-
books. For example, there is a chapter that
describes the organization and workings
of the NIH and includes application pro-
cedures for grant awards and suggestions
for preparing applications. There are
chapters on both the development and
transfer of technology (i.e., patents), the
use of telemedicine systems, the prepara-
tion of scientific images for publication
and display, and the conduct and evalu-
ation of clinical research on complemen-
tary and alternative medicine. There are
also chapters about ethical issues and risks
in clinical research, as well as chapters
about institutional review boards, data and
safety monitoring boards, and the regu-
Permission to reprint a book review printed in this section
may be obtained only from the reviewer.
titled “Small Clinical Trials” in which im-
portant conceptual issues are covered in a Anaissie EJ, McGinnis MR, Pfaller MA. Clin-
concise, yet complete, manner. There is ical Mycology. Philadelphia: Churchill Liv-
also a chapter on introductory biostatistics ingstone, 2003. 608 pp. $139.00. ISBN: 0-
that includes discussion of many funda- 443-0793-7.
mental concepts in this field. The discus-
sion of observational clinical studies is Long SS, Pickering LK, Prober CG. Princi-
less complete. For example, the term ples and Practice of Pediatric Infectious Dis-
“bias” is not indexed, and the discussions eases, 2nd Edition. Philadelphia: Churchill
about issues related to bias could be more Livingstone, 2003. 1645 pp. $195.00. ISBN:
extensive. 0-443-06567-5.
Because each chapter has a different au-
thor, there is considerable variation among
the styles of writing, although most chap-
ters are well written and well edited. In-
deed, for a book that is so broad in its
scope, most issues are covered with sur-
prising depth for an introductory text.
Students and investigators who want more
detail in regard to specific areas of clinical
research will need to refer to other, more
specialized texts or articles. Most chapters
are well referenced and will provide good
guidance about where to look for addi-
tional information. The index is not as
complete as one might have wished. Nev-
ertheless, this volume provides an out-
standingly comprehensive introduction to
the field and can be recommended for vir-
tually anyone who is interested in clinical
research.
Eugene D. Shapiro
Department of Pediatrics, Yale University School
of Medicine, New Haven, Connecticut

BOOK REVIEW • CID 2003:36 (1 March) • 677