PHARMACEUTICAL STATISTICS

Pharmaceut. Statist. 2005; 4: 225–228

Published online in Wiley InterScience (www.interscience.wiley.com).

Book Reviews

This section of the journal is designed to inform you about books

that have been published recently. We aim to provide reviews of

books that are specifically about the theory and application of

statistics in the pharmaceutical sector, though we will accept

reviews of statistical books that are relevant to a wider audience.

We will cover new books or substantially new editions, and will

include both those aimed at statisticians and those intended to

inform scientists about statistics. We are also interested in

comparative reviews of books on a similar subject. Please contact

Peter Lane (peter.w.lane@gsk.com) to offer to review a book,

to suggest someone else who might be interested in reviewing a

book, or to suggest further books that should be reviewed. You

can find a list of books already suggested for review on the PSI

website, at http://www.psiweb.org/resources/.asp?parentfolder-

id=252&subgroup id=4 and this includes information about

the current status of reviews. The list is updated approximately

monthly, and is published quarterly in SPIN, the Newsletter of

the PSI.

Statistical Aspects of the Design and Analysis of Clinical Trials

(Revised Edition)

Everitt BS, Pickles A (2004)

ISBN 1860944418; 340 pages; £48.00, $78.00

Imperial College Press; http://www.icpress.co.uk/books/lifesci/

p321.html

This book has an aim somewhat different from others that

provide comprehensive accounts of how clinical trials should be

carried out and organized. As the title suggests, it provides a

concise account of the more statistical aspects of the design and

analysis of clinical trials. The authors have particularly focused

on statistical methods developed over the last decade or so and

are also largely concerned with Phase III trials. As mentioned in

the preface, the authors hope that the book will be useful to

medical statisticians and others faced with the task of designing

and analysing clinical trials.

The book is divided into ten succinct chapters, with an

appendix related to software. The first chapter gives a brief

introduction to clinical trials from a historical and ethical

perspective, as well as introducing the four phases of drug

development. The second chapter discusses allocation to

treatment, sample-size determination and the reporting of

results. Various methods of randomization are illustrated with

examples. Unfortunately, the subsection on determining the size

of a trial is described briefly and without examples. In the third

chapter, the authors describe methods that should be utilized

when monitoring the progress of a clinical trial. Importantly, the

intention-to-treat approach is discussed, as well as approaches

for dealing with missing data and dropouts. The subsection on

interim analyses gives comprehensive references concerning the

overall maintenance of alpha in clinical trials. The following six

chapters introduce analysis methods within clinical trials,

including generalized linear models, analysis of longitudinal

data, survival analysis, Bayesian methods for longitudinal data,

and meta-analysis. In some cases, theoretical descriptions are

given in tables, which help to maintain the overall flow of the

text and are ideally designed for future reference. The appendix

is a welcome part of the book that will allow the user to further

investigate the software mentioned throughout the text.

Each chapter has several subsections of topics and an overall

summary. The relative strengths and weaknesses of methods

introduced are given along with their practical application; but

those seeking either detailed theory or application will need to

refer to other material. Furthermore, the vast majority of the

content focuses on longitudinal analyses and does not delve into

other new areas such as genomics: a chapter on emerging

methodologies in clinical trials could have dealt with this issue. As

a statistician in the pharmaceutical industry, I was also interested

in knowing how acceptable many of these methodologies were to

regulatory authorities. Unfortunately, any detailed experience the

authors have in this area was missing from the book.

As a concise reference, I found the book to be very useful. In

providing a concise description of the statistical aspects of the

design and analysis of clinical trials, free of any major

typographical errors, the authors have succeeded. Those

concerned with the correct design and analysis of clinical trials,

but wishing to avoid either the advanced theoretical aspects or

too much focus on application of methodologies, will find this

book to be very accessible with relatively up-to-date references.

Jatinder Singh

PRA International, Canada

(DOI: 10.1002/pst.165)

Copyright # 2005 John Wiley & Sons, Ltd.Received 15 January 20012005