Statistical Aspects Of The Design And Analysis Of Clinical Trials (Revised Edition)

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Summary: Well Designed Intro to Statistical Aspect of Clinical Trials
Review: Statistical Aspects Of The Design And Analysis Of Clinical Trials Revised edition by Brian S. Everitt, Andrew Pickles (Imperial College Press: World Scientific) About 8000 clinical trials are undertaken annually in all areas of medicine, from the treatment of acne to the prevention of cancer. Correct interpretation of the data from such trials depends largely on adequate design and on performing the appropriate statistical analyses. In this book, the statistical aspects of both the design and analysis of trials are described, with particular emphasis on recently developed methods of analysis.
According to Sir David Cox, the randomized controlled clinical trial is perhaps the outstanding contribution of statistics to 20th century medical research. Nowadays about 8000 such trials are undertaken annually in all areas of medicine from the treatment of acne to the prevention of cancer. Although the vast majority of these trials take place away from the glare of public interest, some deal with issues that are controversial enough to make even the popular press; an obvious example is the use of AZT for the treatment of AIDS.
There are many excellent books available which give comprehensive accounts of how clinical trials should be carried out and organized. The aim of this book is different; the authors attempt to give relatively concise descriptions of the more statistical aspects of the design and analysis of clinical trials, particularly those methods developed over the last decade or so. Topics discussed in this text include randomization, interim analyses, sample size determination, the analysis of longitudinal data, Bayesian methods, survival analysis and meta-analysis. Many examples are included alongside some of the necessary technical material, the more difficult parts of which are confined to tables. An Appendix gives details of relevant software. The book should be useful to medical statisticians and others faced with the often difficult problems of designing and analyzing clinical trials.
The controlled clinical trial has become one of the most important tools in medical research and investigators planning to undertake such a trial have no shortage of excellent books to which to turn for advice and information. But unlike the many other books dealing with clinical trials, this text is primarily concerned with the statistical issues of certain aspects of their design (Chapters 2 and 3) and, in particular, their analysis (Chapters 4 to 10), rather than their day-to-day organization. This restriction will enable us to give fuller accounts of some recently developed methods that may be particularly useful for the type of data often generated from clinical trials. Some details of the software available that implements the methods described will be given in the Appendix.