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Author Bacchieri, Antonella.
Title Fondamenti di ricerca clinica. English
Fundamentals of clinical research : bridging medicine, statistics, and operations / Antonella Bacchieri, Giovanni Della Cioppa.
Imprint Milano : Springer, 2007.

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Author Bacchieri, Antonella.
Series Statistics for biology and health
Statistics for biology and health.
Subject Medicine -- Research.
Biomedical Research -- methods.
Research Design.
Genre/Form Electronic books.
Alt Name Della Cioppa, Giovanni.
Description 1 online resource (xxv, 343 pages) : illustrations.
Bibliography Note Includes bibliographical references (pages 331-335) and index.
Contents Variability 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 -- The drug development process and the phases of clinical sx research.
Summary The scope of clinical research is to evaluate the effect of a treatment on the evolution of a disease in the human species. The treatment can be pharmacological, surgical, psychological/behavioral or organizational/logistic. The disease, intended as an impairment of a state of well-being or a condition capable of provoking such impairment over time, can be universally accepted as such (e.g. a cancer or a bone fracture) or perceived as such only by limited groups of individuals in a given cultural context (e.g. hair loss or weight gain). The course of the disease that ones wishes to change can be the one with no intervention or, more frequently, the one observed with the available treatment. The evaluation of the effect of a treatment on the course of a disease is a lengthy process, which progresses in increasingly complex stages. A detailed coverage of the logistic, administrative and legal aspects of clinical research is outside the scope of this book. However, throughout the book we keep reminding the reader of these aspects because, as already mentioned, we firmly believe they have a crucial role in determining the success of a study. The history of clinical research is paved with relics of studies started with great pomp, riding great ideas and great hopes, which drowned miserably because of inadequate logistical preparation. In our experience, the excessive complexity of a clinical trial is the single most frequent cause of failure: the study is perfect on paper, but impossible to implement by patients and staff alike. The distance between the principal investigators and the reality of clinical research in its day-to-day practice is often the main cause of such disasters. We warmly encourage everyone involved in clinical research to get involved in the logistics of a study, learning from colleagues responsible for its practical conduct (clinical research associates, data managers, etc.) and to take part, in person, in the practical implementation of a trial before attempting to design a study protocol. The book ends with a brief description of the drug development process and to the phases of clinical development. The authors.
Note Translated from the Italian.
Print version record.
ISBN 9788847004917
OCLC # 209962241
Additional Format Print version: Bacchieri, Antonella. Fondamenti di ricerca clinica. English. Fundamentals of clinical research. Milano : Springer, 2007 9788847004917 8847004918 (DLC) 2006938039 (OCoLC)79447335