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This is the fourth edition of a very successful textbook on clinical trials methodology, written by three recognized experts who have long and extensive experience in all areas of clinical trials. Most chapters have been revised considerably from the third edition. A chapter on ethics has been added and topics such as noninferiority and adaptive designs now receive considerable discussion. There is much new material on adverse events, adherence, data monitoring, and issues in analysis. This book is intended for the clinical researcher who is interested in designing a clinical trial and developing a protocol. It is also of value to researchers and practitioners who must critically evaluate the literature of published clinical trials and assess the merits of each trial and the implications for the care and treatment of patients. The authors use numerous examples of published clinical trials from a variety of medical disciplines to illustrate the fundamentals. The text is organized sequentially from defining the question to trial closeout. One chapter is devoted to each of the critical areas to aid the clinical trial researcher. These areas include pre-specifying the scientific questions to be tested and appropriate outcome measures, determining the organizational structure, estimating an adequate sample size, specifying the randomization procedure, implementing the intervention and visit schedules for participant evaluation, establishing an interim data and safety monitoring plan, detailing the final analysis plan, and reporting the trial results according to the pre-specified objectives. Although a basic introductory statistics course is helpful in maximizing the benefit of this book, a researcher or practitioner with limited statistical background would still find most if not all the chapters understandable and helpful. While the technical material has been kept to a minimum, the statistician may still find the principles and fundamentals presented in this text useful. This book has been successfully used for teaching courses in clinical trial methodology.
Statistics. --- Statistics for Life Sciences, Medicine, Health Sciences. --- Public Health/Gesundheitswesen. --- Epidemiology. --- Cancer Research. --- Oncology. --- Statistique --- Cancérologie --- Epidémiologie --- Clinical Trials --- Clinical trials --- Controlled clinical trials --- Patient trials of new treatments --- Randomized clinical trials --- Trials, Clinical --- Clinical medicine --- Human experimentation in medicine --- Research
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Animal welfare is attracting increasing interest worldwide, but particularly from those in developed countries, who now have the knowledge and resources to be able to offer the b est management systems for their farm animals, as well as potentially being able to offer plentiful resources for companion, zoo and laboratory animals. The increased attention given to animal welfare in the West derives la rgely from the fact that the relentless pursuit of financial reward and efficiency has lead to the development of intensive animal production systems that offend the conscience of many consumers in those countries. In devel oping countries, human survival is still a daily uncertainty, so that provision fo r animal welfare has to be balanced against human welfare. Welfare is usua lly provided for only if it supports the output of the animal, be it food, work, clothing, sport or companionship. In reality there are resources for all if they are properly husbanded in both developing and developed countries. The inequitable division of the world’s riches creates physical and psychological poverty for humans and animals alike in all sectors of the world. Liv estock are the world’s biggest land user (FAO, 2002) and the population, particularly of monogastric animals, is increasing rapidly to meet the need of an expanding human population. Populations of animals managed by humans are therefore increasing worldwide, so there is the tendency to allocate fewer resources to each one.
Animal Welfare. --- Animals, Laboratory. --- Animal welfare. --- Laboratory animals. --- Animaux --- Animaux de laboratoire --- Protection --- Agriculture. --- Laboratory animals --- Animal welfare --- Animal Welfare --- Animals, Laboratory --- Animal Population Groups --- Social Control, Formal --- Sociology --- Animals --- Social Sciences --- Eukaryota --- Anthropology, Education, Sociology and Social Phenomena --- Organisms --- Zoology - General --- Social Welfare & Social Work - General --- Animal Sciences --- Zoology --- Agriculture --- Social Welfare & Social Work --- Health & Biological Sciences --- Earth & Environmental Sciences --- Animals, Experimental --- Animals in research --- Experimental animals --- Lab animals --- Animal culture --- Laboratory organisms --- Working animals --- Animal experimentation --- Abuse of animals --- Animal cruelty --- Animals, Cruelty to --- Animals, Protection of --- Animals, Treatment of --- Cruelty to animals --- Humane treatment of animals --- Kindness to animals --- Mistreatment of animals --- Neglect of animals --- Prevention of cruelty to animals --- Protection of animals --- Treatment of animals --- Welfare, Animal --- Abuse of --- Social aspects --- Zoology. --- Animal genetics. --- Animal behavior. --- Animal physiology. --- Veterinary medicine. --- Animal Genetics and Genomics. --- Behavioral Sciences. --- Animal Physiology. --- Veterinary Medicine/Veterinary Science. --- Farriery --- Large animal medicine --- Large animal veterinary medicine --- Livestock medicine --- Veterinary science --- Medicine --- Animal health --- Domestic animals --- Livestock --- Animal physiology --- Biology --- Anatomy --- Animals, Habits and behavior of --- Behavior, Animal --- Ethology --- Animal psychology --- Ethologists --- Psychology, Comparative --- Genetics --- Natural history --- Diseases --- Losses --- Physiology --- Behavior --- Behavioral sciences. --- Animal Husbandry. --- Dogs. --- Rabbits. --- Animal Husbandry --- Dogs --- Rabbits --- Primates --- Rodents --- Swine
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