Statistics Applied to Clinical Trials

The current book can be studied together with the texbook Statistics Applied To Clinical Trials by the same authors and from the same publisher (Second Edition, Dordrecht / Boston / London, 2002), or separately. The authors often hear that students have difficulties to understand statistics from a textbook, and that, for that purpose, self-assessment through exercises and examples is required. The current book was written mainly at their request. Rather than trying to be complete, it focuses on the main aspects, including the test statistics generally used for the primary analysis of continuous and proportional data from randomized controlled clinical trials. In the past few years statistical analysis has increasingly been left to the computer, and clinical investigators are at a loss to understand the limitations of the research and its statistical analysis, on the one hand, while on the other hand, statistical results are often overemphasized. Attention has been given to these issues, and for that purpose it is explained in a descriptive non-mathematical way how test statistics were invented, developed and implemented in current data management and analysis. Finally, guidelines are given for the biases due to conflicts of interest with sponsored research. This self-assessment book is not only useful for investigators involved in the field of clinical trials, but also for every physician who wishes to better understand the data from trials as published currently.