Antonella Bacchieri, Giovanni Della Cioppa

Fundamentals of Clinical Research (eBook, PDF)

Bridging Medicine, Statistics and Operations

• Format: PDF

Produktbeschreibung

The scope of clinical research is to evaluate the effect of a treatment on the evolution of a disease in the human species. In recent years many introductory textbooks on clinical trial methodology have been published, some of which are excellent, in addition to a very extensive specialist literature. 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.

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Produktdetails

• Verlag: Springer Milan
• Seitenzahl: 343
• Erscheinungstermin: 29. April 2007
• Englisch
• ISBN-13: 9788847004924
• Artikelnr.: 37411753

Autorenporträt

Antonella Bacchieri, Roma, Italia / Giovanni Della Cioppa, London, UK

Inhaltsangabe

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.

Rezensionen

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)