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Edited by Roberto J Guiloff (Pp 542, EUR178,00). Published by Springer, London, 2001. ISBN 1-85233-239-5
This much needed book is a gem. If you are involved in a clinical trial make sure you and all your collaborators have read it, before the trial commences. The application of the methodology of the randomised clinical trial has become the absolute test of all new medicines, not only in neurology but also generally in medicine and surgery. Once one is involved in a trial, however, it is difficult to keep a sense of independence from the desire that the trial should have a positive outcome—that, after all, is one of the several major reasons for using randomisation and double blinding. This book provides the information the clinician needs to understand how trials are organised, how data are collected, how they are analysed, and how their clinical significance should be assessed. Dr Guiloff has assembled an impressive team of contributors, all with expertise and experience in their subject. The book is organised in two parts. In the first part, general issues relating to ethics, regulatory matters, assessment, measurement, statistics, quality control, and important specific issues, such as the use of intention to treat analysis, handling drop outs in repeated measures analysis, and survival analysis, are presented. Well chosen examples enliven the text and tables. The role of the Cochrane Collaboration and of meta-analyses is considered in separate chapters. The second part of the book is concerned with the application of these general principles to neurological disorders. This section consists of groups of chapters related to ethical issues, trial design, measurement, sample size, data analysis, and critical discussion of the results of large trials in the major neurological disorders. The consistent high quality of these chapters is remarkable in a multiauthored text and a tribute to the hard work of the editor. The book concludes with a review by Michael Brooke that should be required reading for every neurologist. This book not only fills a gap on the neurologist’s bookshelf but also will be opened again and again.