Fundamentals of Clinical Research: Bridging Medicine, Statistics and Operations

by Antonella Bacchieri, Giovanni Della Cioppa

Overview

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 Fisher’s legendary book raised my hopes that I could finally get to the heart of the matter.

Product Details

ISBN-13:	9788847056336
Publisher:	Springer Milan
Publication date:	11/27/2014
Series:	Statistics for Biology and Health
Edition description:	2007
Pages:	343
Product dimensions:	6.10(w) x 9.25(h) x 0.03(d)

Table of Contents

Viability of Biological Phenomena and Measurement Errors.- Distinctive Aspects of a Biomedical Study Observational and Experimental Studies.- Observational Studies.- Defining the Treatment Effect.- Probability, Inference and Decision Making.- The Choice of the Sample.- The Choice of Treatments.- Experimental Design: Fallacy of “Before-After” Comparisons in Uncontrolled Studies.- Experimental Design: the Randomized Blinded Study as an Instrument to Reduce Bias.- Experimental Designs.- Study Variants Applicable to More than One Type of Design: Equivalence Studies, Interim Analyses, Adaptive Plans and Repeated Measurements.- The Drug Development Process and the Phases of Clinical Research.

Editorial Reviews

From the reviews:

"The first three chapters of the book provide important foundational information. ...Chapters 4, 6, and 7 are the stars of this book. The authors lay out in great detail the complex process of arriving at a measure of treatment effect. We statisticians are so used to having this handed to us that we never think about how important this process is. The authors also provide pragmatic advice about whether to select your sample to be mildly ill or seriously ill, or whether you should choose healthy volunteers instead." Steve Simon, Journal of Biopharmaceutical Statistics, Issue 2, 2008

"Main aim of this book is to explain the three pillars of clinical research: medicine, statistics and logistics in an easily digestible manner. … A very lucid and well-structured account of the basic statistical and epidemiological concepts is definitely a great plus point of this book … . I have truly enjoyed reading this book and it gives a refreshing and focused outline of the clinical research. I would recommend all clinicians who aspire to be/are involved in clinical research to give it an audience." (Faisel Yunus, Journal of Applied Statistics, Vol. 35 (2), 2008)

"Readership: … the clinical researcher who wants an intelligent discussion on the (mainly) statistical aspects of clinical research. It would make a useful background reading for a course in clinical trials. … The book is well written. … is essentially an extended essay on the application of statistical inference in clinical research." (M. J. Campbell, International Statistical Review, Vol. 75 (3), 2007)

"A comprehensive introductory text that addresses statistical methods and operational issues in the conduct of clinical research. ... The authors avoid overuse of mathematical formulas and carefully balance practical and theoretical aspects of clinical research. Format and writing clarity are good, with numerous examples used to illustrate conceptsthroughout the text. ... Recommended Readership: Doctoral and postdoctoral trainees and junior or research inexperienced clinical researchers and scientists." (Paul V. Targonslci, Mayo Clinic Proceedings, Vol. 82 (11), November, 2007)

"The text is directed toward physicians conducting clinical trials research and statisticians consulting on clinical trials. … I recommend it for physicians, statisticians, and technical personnel with a novice knowledge level of clinical trials. At the same time it could be used as a text for an introductory graduate level class in clinical trials. To those entering the field of clinical trials I wholeheartedly recommend Fundamentals of Clinical Research … as it provides a foundation pertinent to a variety of aspects of clinical trials research." (Gregory E. Gilbert, The American Statistician, Vol. 63 (1), February, 2009)

“The authors’ book on methods and issues in clinical research is directed at biomedical researchers as well as statisticians. … it addresses the integration of medical and statistical components of clinical research in order to create a logical flow of reasoning understandable for both the medical/biological and the statistical expert. … The whole book is written in a convenient, comprehensible style … and is therefore useful also for readers having more advanced knowledge and experience in the field of clinical trials.” (Lutz Edler, Zentralblatt MATH, Vol. 1210, 2011)

From the Publisher