1328 BOOK REVIEWS

3. INTRODUCTION TO RANDOMIZED CONTROL-LED CLINICAL TRIALS (2nd edn). John N. S.Matthews, Chapman & Hall/CRC, Boca Raton,FL, 2006. No. of pages: 283. Price: $59.95. ISBN978-1-58488-624-2

This revised version of the popular text by JohnMatthews includes several welcome additions andsome thoughtful reworking. The aim of the bookremains, as for the first edition, to provide an in-troductory text on clinical trial methodology forfinal-year undergraduate or postgraduate studentsof statistics. The author does not define its remitto include issues of trial management and practicalimplementation, which are amply covered by otherauthors, such as Altman [1], Friedman et al. [2]and Pocock [3]. Instead, the focus is on describingthe fundamental statistical and mathematical prin-ciples which underpin the randomized concurrentlycontrolled clinical trial that is used in many areasof medical research.

The 12 chapters of the book now cover all ofthe essential topics in this area. The first six dealwith the topics of basic background, bias, samplesize calculations, methods of allocating patients,blinding and placebos and analysis issues. In thefirst edition of the book, most of the mathematicalconcepts were presented for the case of normallydistributed data. This is still largely (although notexclusively) true for the chapters that are in com-mon between the two editions, but in the secondedition there is a new chapter (Chapter 7) on theanalysis of clinical trials involving binary and sur-vival time endpoints. This is a definite strength,and at over 50 pages, the addition represents asubstantial inclusion of new material. Topics cov-ered include analysis of data from trials of binaryand survival time outcomes, adjusting binary out-comes for baseline observations and analyses usingrandomization models. Treatment of material isconcise, but the key concepts are covered clearlyand at a suitable level. The remaining five chaptersof the book cover the topics of monitoring data,subgroups and multiple outcomes, protocols, spe-cial designs (crossovers, equivalence and cluster

randomized trials) and meta-analysis. A minorpoint is that there is very limited discussion ofBayesian approaches and repeated measures anal-ysis. Coverage of all the topics is logically struc-tured, clearly written and well motivated. Eachchapter ends with exercises, the solutions to whichare included at the end of the book.

Throughout the book, worked examples aregiven which have been taken from the medicalliterature. The methods described in the text areimplemented, often in the context of the exam-ples, using two software packages, Minitab and R.The use of R, which is universally available, willallow the book to be of use to a wider audience.Preceding the ‘Solutions to Exercises’ is a sectionon ‘Further Reading’. The author acknowledgesthat this is ‘a highly selected and personal viewof an extensive literature’. However, this sec-tion, together with the References, could be morecomprehensive.

In summary, this second edition is a verywelcome revision. The author has drawn upon hisexperiences to provide a valuable account of theimportant statistical underpinnings of the random-ized clinical trial. Having a text written primarilyfor students of statistics is highly desirable andthis book is ideal for its intended audience.

REFERENCES

1. Altman DG. Practical Statistics for MedicalResearch. Chapman & Hall/CRC: London, 1991.

2. Friedman LM, Furberg CD, DeMets DL. Funda-mentals of Clinical Trials (3rd edn). Springer: NewYork, 1998.

3. Pocock SJ. Clinical Trials: A Practical Approach.Wiley: New York, 1983.

SUSAN TODDMedical & Pharmaceutical Statistics

Research UnitThe University of Reading

Reading, U.K.

(DOI: 10.1002/sim.3075)

Copyright q 2008 John Wiley & Sons, Ltd. Statist. Med. 2008; 27:1325–1328