Statistics Applied to Clinical Trials
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Beschreibung
This fourth edition has been updated and extended to serve as a more complete guide and reference for students, physicians, and investigators, and, at the same time, preserves the common sense approach to statistical problem-solving of the previous editions.
In clinical medicine appropriate statistics has become indispensable to evaluate treatment effects. Randomized controlled trials are currently the only trials that truly provide evidence-based medicine. Evidence based medicine has become crucial to optimal treatment of patients. We can define randomized controlled trials by using Christopher J. Bulpitt’s definition “a carefully and ethically designed experiment which includes the provision of adequate and appropriate controls by a process of randomization, so that precisely framed questions can be answered”. The answers given by randomized controlled trials constitute at present the way how patients should be clinically managed. In the setup of such randomized trial one of the most important issues is the statistical basis. The randomized trial will never work when the statistical grounds and analyses have not been clearly defined beforehand. All endpoints should be clearly defined in order to perform appropriate power calculations. Based on these power calculations the exact number of available patients can be calculated in order to have a sufficient quantity of individuals to have the predefined questions answered. Therefore, every clinical physician should be capable to understand the statistical basis of well performed clinical trials. It is therefore a great pleasure that Drs. T. J. Cleophas, A. H. Zwinderman, and T. F. Cleophas have published a book on statistical analysis of clinical trials. The book entitled “Statistics Applied to Clinical Trials” is clearly written and makes complex issues in statistical analysis transparant.
The authors have both medical and mathematical backgrounds
Based on famous modules from the Socrates educational project Eudipharm of the EC
Innovative because of the explanatory rather than mathematical approach
Emphasizes non-classical but increasingly frequently used methods such as equivalence testing, interaction assessment and analysis of genetic data
Not equivalent to any current textbook on statistics
In 1948 the first randomized controlled trial was published by the English Medical Research Council in the British Medical Journal. Until then, observations had been uncontrolled. The intervening decades have seen significant improvement in the accuracy of trials. Today, clinical trial protocols are now routinely scrutinized by ethics committees, institutional and federal review boards, national and international scientific organizations, and monitoring committees charged with conducting interim analyses. The updated Third Edition of Statistics Applied to Clinical Trials explains classical statistical analyses of clinical trials, but equivalence testing, interim analyses, sequential analyses, meta-analyses, and provides a framework of the best statistical methods currently available for such purposes.
Autor*in
Ton J. Cleophas
Themen in »Statistics Applied to Clinical Trials«
Analysis of variance Measure Regression analysis data analysis linear regression statistics
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From the reviews of the fourth edition:
"Readership: Students, physicians and investigators interested in statistical methods for clinical trials. This book was originally written for a course in medical statistics given in the EU sponsored program European Interuniversity Diploma of Pharmaceutical Medicine starting in the year 2000. … it has been expanded and updated in order to serve as a guide and reference-text to students, physicians and investigators." (Andreas Rosenblad, International Statistical Review, Vol. 77 (3), 2009)
“The book is written for students in health care and physicians and can be viewed as a guide and reference textbook. … an important contribution to the clinical trials and medical statistics community. … The book’s main strength is its presentation, which deepens the knowledge and understanding of applications of statistical methods and analyses of clinical trials. … The many good motivating examples make the book a useful resource for instructors teaching introductory statistics courses. I enjoyed reading this book, and you will too.” (Technometrics, Vol. 52 (2), May, 2010)
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