(Ebook) Introduction to Randomized Controlled Clinical Trials, Second Edition (Texts in Statistical Science Series) by John N.S. Matthews ISBN 9781584886242, 1584886242

(Ebook) Introduction to Randomized Controlled Clinical Trials, Second Edition (Texts in Statistical Science Series) by John N.S. Matthews ISBN 9781584886242, 1584886242

PrefacesFirst EditionClinical trials are experiments performed on human subjects, usuallypatients, in order to assess the efficacy of a treatment that is under investigation.Over the last two to three decades randomized concurrently controlledclinical trials have become established as the method whichinvestigators must use to assess new treatments if their claims are to findwidespread acceptance. The methodology underpinning these trials is firmlybased in statistical theory, and the success of randomized trials perhapsconstitutes the greatest achievement of statistics in the second half of thetwentieth century. As such it is important that students of statistics shouldbe able to study this area of their subject as soon as possible in their courses.Whereas there are many excellent books on clinical trial methodology,almost all are written for the practitioner, whether statistician or doctor, whois about to participate in the running of a trial. There is a natural tendencyin such books both to cover administrative issues and to keep to a minimumany mathematical passages. However, while trial administration is ofundoubted importance, too much emphasis on it is unnecessary and anunwelcome distraction for students making their first acquaintance with theunderlying principles. Moreover, for a readership whose knowledge of mathematicsis likely to be substantially greater than their knowledge of medicine,many of the principles involved can be introduced more precisely and succinctlyby the appropriate use of mathematics. This book is intended as anintroduction to the statistical methodology that underpins randomized controlledtrials, and is aimed primarily at the student of statistics. Administrativeaspects receive little emphasis and, if it is believed that it would helpthe primary readership, a mathematical approach is adopted.Although it is hoped that many will find the book useful as an introductionto the subject, the needs of final-year undergraduate or postgraduate studentsat British universities have been my main concern. However, there isconsiderable variation within this group in the statistical techniques theyalready know, and I have attempted to rely only on a few basic prerequisites.This has led to a slight distortion of the subject matter. For example, so thata knowledge of logistic regression is not needed for this book, trials withbinary outcomes are given less prominence than might be expected fromtheir prevalence in practice. The complete avoidance of survival analysisperhaps leads to an even greater distortion. However, I believe these distortionsare justified by the wider accessibility that results.Second EditionThe change of publisher between editions, from Edward Arnold to Chapman& Hall/CRC, has given me the opportunity to make corrections and addsome new material. The aim, to write a book for students of statistics focusingon statistical rather than administrative aspects of clinical trials, remainsthe same. Some extra material on more sophisticated methods for balancingclinical trials with binary or survival time outcomes. Many trials have outcomesof this kind, and in the preface to the first edition I acknowledgedthat the exclusion of outcomes of these forms was a distortion of the subject.This was done to ensure that the book did not require the reader to befamiliar with more sophisticated methods of analysis, such as logistic regressionand proportional hazards models. On reflection, this was an unnecessaryrestriction. None of the chapters in the book depend on Chapter 7, sothose wishing to avoid this material can still avoid it. The chapter is quitelong because an attempt has been made to provide brief introductions tothe required techniques.