menu selections (and SPSS syntax) shown, and theoutput from the software is printed. This structurewill certainly make it easier to use SPSS on one'sown data. However, the sometimes several pagesof output (nine in chapter 13) are only commentedon very brie#y, and not su$ciently detailed forreaders to be able to draw similar inferences basedon their own data.

At no point is the reader presented with a math-ematical formula. A non-mathematically inclinedperson may feel that this provides an opportunityto learn to analyse and interpret data from aninteresting subject matter without getting side-tracked by technical details. Personally, I do notlike this approach because the lack of an unam-biguously de"ned model makes it unclear exactlywhat questions are being answered. This is trueunless, of course, the reader already knows detailsabout the model, in which case reading the bookbecomes unnecessary.

In conclusion, the book never really succeedsin reaching a well-de"ned audience. The sameamount of space is given to simple as well as rathercomplicated analyses. The result is that manychapters are trivial for the reader who knowssomething about statistics, whereas other chaptersmust be incomprehensible for the reader whoknows little. The book could be used as a comp-lement to the SPSS manuals and as a quick refer-ence to speci"c procedures for users who have hadsome exposure to statistics and are already ac-quainted with SPSS, but so could probably manyother books.

J"RGEN HOLM PETERSEN

Department of BiostatisticsUniversity of Copenhagen

Blegdamsvej 3DK-2200 Copenhagen N

Denmark

3. GOOD CLINICAL PRACTICE. STANDARD OPERAT-

ING PROCEDURES FOR CLINICAL RESEARCHERS.

Josef Kolman, Paul Meng and Graeme Scott (eds),Wiley, Chichester, 1998, No of Pages: xi#177.Price: @29.25. ISBN 0-471-96936-2

The intended readers of the book are investigatorsat trial sites. The book gives a brief overview of thetopic &Clinical trials in relation to drug develop-ment'. As the authors point out, the intention hasnot been to give a thorough review of the topic,and the interested reader is referred to other morespecialized books in this "eld.

The authors suggest development of standardoperating procedures (SOPs) at the investigator'ssite, to ease in ful"lling the investigator obligationsin relation to EU and International Committee ofHarmonisation-Good Clinical Practice (ICH-GCP) regulations. As pointed out by authors thereare no formal requirements for the suggested SOPsin this area, but just as the development of SOPs inmany pharmaceutical companies have proven tobe a helpful tool for review of the internal proc-dures, the authors suggest that similar bene"tmight be possible at the investigational sites. TheSOPs proposed are intended to cover only thesituation where the sponsor responsibility is takenby a company. That is, they are not exclusive forinvestigator sponsored trials, in which case the

SOPs covering the sponsor obligations in relationto GCP guidelines are required.

The SOP templates provided cover the topics:SOP 0. Preparation, Approval and Review ofSOPs; SOP 1. Study Organisation and Planning;SOP 2. Study Team: De"nition and Responsibili-ties; SOP 3. Study Files and Filing; SOP 4. LocalManagement Requirements; SOP 5. Review andValidation of the Protocol; SOP 6. Review of Pro-tocol Amendments; SOP 7. Case Report Form(CRF) Review; SOP 8. Investigator's Brochure;SOP 9. Estimation of Patient Numbers; SOP 10.Ethics Committee; SOP 11. Indemnity, Compen-sation and Insurance; SOP 12. Laboratory; SOP13. Pre-study Monitoring Visits; SOP 14. PatientRecruitment and Intention to Enrol; SOP 15. Ob-taining Personal Written Informed Consent; SOP16. Obtaining Informed Consent for PatientsUnable to give Personal Consent; SOP 17. Ran-domisation and Strati"cation; SOP 18. Blinding:Codes and Code Breaking; SOP 19. Case ReportForm (CRF) Completion; SOP 20. Study Drug;SOP 21. Monitoring Visits; SOP 22. AdverseEvent and Serious Adverse Event Reporting; SOP23. Nursing Procedures; SOP 24. Clinical Proced-ures; SOP 25. Trial Report; SOP 26. Archiving,and SOP 27. Audits and Inspections.

The templates, and especially the checklists sug-gested as part of most of the SOP templates, could

BOOK REVIEWS 2985

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be valuable tools for investigators in the reviewof their own internal procedures. For individualtrials sponsored by pharmaceutical companies,however, monitors and other sta! from the com-pany will most often o!er assistance in order forinvestigators to ful"l their obligations. SOPs arein general a help in adherence to GCP, but too

detailed SOPs at investigator sites could causea problem at sites running multiple trials for di!er-ent sponsors.

MERETE J"RGENSEN

Statistics/Diabetes, Novo Nordisk A/SNovo Alle, DK 2820 Bagsvaerd, Denmark

4. PRINCIPLES OF EXPERIMENTAL DESIGN FOR THE

LIFE SCIENCES. Murray R. Selwyn, CRC Press,Boca Raton, 1996. No. of pages: 160. Price: $ 49.95.ISBN 0-8493-9461-9

This book is &intended for clinicians, biologicalscientists, and engineers involved in the design,conduct, and interpretation of biomedical studies'.Its objective is: &by presenting experimental designtopics in an understandable and nontechnicalmanner, free of statistical jargon and formulas,I hope to acquaint readers with the fundamentaldesign concepts in a way that makes them easy tounderstand and apply in practice'.

The book has nine chapters: 1 &Introductionand overview'; 2 &Planning biomedical studies';3 &Principles of statistical design'; 4 &Sample sizeestimation'; 5 &Common designs in biological ex-perimentation'; 6 &Sequential clinical trials'; 7 &Highdimensional designs and process optimization';8 &The correspondence between objectives, designand analysis * revisited'; and 9 &Summary andconcluding remarks'. These nine chapters providean overview of many aspects of the design of ex-periments. As can be expected, the book coversmajor topics such as randomization, factorial de-signs, Latin squares, balanced complete blockdesign, balanced incomplete block design and soon. However, it also discusses topics such as frac-tional designs and rotatable designs in some detail.For such a short book it covers a lot of ground.The style is therefore necessarily succinct and con-centrates on explaining the essentials. Technicaldetail is generally either avoided or hidden in oneof the many good examples. Mathematics is eitherabsent or simple. Although the book is generallywell written, its compactness means that it requirescareful reading. Important issues such as the repre-sentativeness of study samples for the population,

which can be moot in many clinical studies, arediscussed in a single sentence or a footnote. Its lackof technical detail would make the book less suit-able as a reference book on experimental design.However, it does seem ideal for teaching a "rstcourse on this subject to science students or epi-demiologists. The book can also be recommendedto its target audience, namely scientists involved inbiomedical studies looking for a quick way tobetter understand the rationale of the designs theyhave been using, or should be using, in practice.Almost as an afterthought the author includesa section on &analysis strategies' (in Chapter 8),perhaps realizing that even data obtained froma well-designed experiment need to be analysed.This section, however, is of questionable usefulnessowing to its brevity, and is perhaps better skipped.Recommending some good texts, would have beenbetter.

The uses and advantages of many designs arenot always emphasized correctly. For example(p. 55) the author states that &in situations in whichexperimenters are interested in assessing the jointe!ect of two or more factors, they can utilize fac-torial designs'. However, in practice one of thegreat advantages of factorial designs is that itallows an investigator to use precious patients oranimals to answer several questions simulta-neously without loss of power.

Despite its minor shortcomings, the book isa useful addition to the range of texts available onthe subject.

NICO NAGELKERKE

National Institute of Public Health and theEnvironment (RIVM)

NL-3720 BA BilthovenThe Netherlands

2986 BOOK REVIEWS

Copyright ( 1999 John Wiley & Sons, Ltd. Statist. Med. 18, 2983}2986 (1999)