Fundamentals of Clinical Research Bridging Medicine, Statistics and Operations [Hardcover]

Here is a new book on methods and issues in clinical research. Its objectives can be summarized in three points. 1. Integrate medical and statistical components of clinical research. 2. Do justice to the operational and practical requirements of clinical research. 3. Give space to the ethical implications of methodological issues in clinical research. The book ends with a brief description of the drug development process and the phases of clinical development.

Statistical methodology is an essential component of clinical (and biological) - search. Therefore it is not surprising that many textbooks aiming at explaining statistical methods to researchers have been published and continue to appear in print. The complexity of the basic issue, that of communication between st- isticians and researchers, is illustrated and discussed very well by the authors of this book in their Introduction. Thus it would be of no benefit to dwell further on this theme and on the difficulty of producing truly effective material. I prefer to start from a personal episode. Way back in 1959, a freshman of the faculty of Statistical Sciences, I found by chance on a stand, the book Metodi statistici ad uso dei ricercatori, which was the Italian translation of the famous book by RA Fisher. The textbook for the first course of statistics used that year at of our University had left me perplexed. A student like myself, with a good high school scientific education, was fascinated by the wealth of real life ex- ples, but was unable to reconstruct the thread of logical-mathematical reas- ing, especially the inductive one. The unexpected access to Fishers legendary book raised my hopes that I could finally get to the heart of the matter.1. Variability of Biological Phenomena and Measurement Errors1.1. Phenotypic Variability1.2. Temporal Variability.1.3. Measurement - Related Variability1.3.1. The Measurement1.3.2. Measurement Errors1.4. Variability of Diagnostic TestsSummary2l3$