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.
Publisher: Springer Verlag
Number of pages: 343
Weight: 569 g
Dimensions: 235 x 155 x 20 mm
Edition: 2007 ed.
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 concepts throughout 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)
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