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Health On Fractures and Dislocations
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Infrared Spectroscopy - Life and Biomedical Sciences
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The Alexander Technique Workbook: Your Personal Program for Health, Poise and Fitness
Surviving Health Care: A Manual for Patients and Their Families [Repost]
Studies on Men's Health and Fertility [Repost]
Scientific, Health and Social Aspects of the Food Industry
Measurement in Nursing and Health Research (4th edition)
Health and Environment in Aquaculture
Medical Physiology - Principles for Clinical Medicine (4th edition)
Health Bacterial Meningitis and Meningococcal Septicaemia
Lifestyle Management in Health and Social Care
Health and Well Being - A Social and Cultural Perspective
Medical Physiology: Principles for Clinical Medicine (4th edition) [Repost]
Health Sex Hormones by Raghvendra K. Dubey (ed.)
Essential Epidemiology - An Introduction for Students and Health Professionals
Health Molecular Regulation of Endocytosis
Biomedical Knowledge Management - Infrastructures and Processes for E-Health Systems
Essentials of Psychiatric Mental Health Nursing: Concepts of Care in Evidence-Based Practice (repost)
Flour and Breads and their Fortification in Health and Disease Prevention (repost)
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Fundamentals of Clinical Research (Statistics for Biology and Health)
Posted on 2010-03-15
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By Antonella Bacchieri, Giovanni Della Cioppa,
Book Description: 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. Nevertheless, here is a new book on methods and issues in clinical research. The 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 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.
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