Fundamentals of Clinical Research
Bridging Medicine, Statistics and Operations
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ISBN-13:
9788847004917
Veröffentl:
2006
Erscheinungsdatum:
15.12.2006
Seiten:
343
Autor:
Antonella Bacchieri
Gewicht:
689 g
Format:
241x163x27 mm
Sprache:
Englisch
Beschreibung:
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.
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.
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.
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