This volume provides formulas and procedures for determination of sample size required not only for testing equality, but also for testing non-inferiority/superiority, and equivalence (similarity) based on both untransformed (raw) data and log-transformed data under a parallel-group design or a crossover design with equal or unequal ratio of treatment allocations. It contains a comprehensive and unified presentation of statistical procedures for sample size calculation that are commonly employed at various phases of clinical development. Each chapter includes, whenever possible, real examples of clinical studies from therapeutic areas such as cardiovascular, central nervous system, anti-infective, oncology, and women's health to demonstrate the clinical and statistical concepts, interpretations, and their relationships and interactions.
The book highlights statistical procedures for sample size calculation and justification that are commonly employed in clinical research and development. It provides clear, illustrated explanations of how the derived formulas and/or statistical procedures can be used.
Stewart Wolf suggests that Claude Bernard's genius in physiological experimentation is similar to the extraordinary Sherlock Holmes' capacity to solve crimes and William Osler's uncanny abilities in clinical diagnosis. Like both of those creative searchers, Claude Bernard typically focused on findings that did not accord with prevailing theory. His curiosity led him to attempt to explain the finding by a tentative hypothesis; he would then devise an experiment. Although he sought for a quantitative result that might serve as a basis of a theory, he had little confidence in statistics as a guide to certainty. Bernard's opposition scientists' prevailing habit of segregating their inquiries into systems rather than studying the unified organism is particularly striking. This volume will be important for those in the medical field as well as those interested in the history of science.
Advocates of animal experimentation have been slow to respond to these arguments. Given that the worldwide toll of communicable diseases is still immense--and that deadly new pathogens may emerge at any time in the future to menace human health--failing to defend animal experimentation from the arguments of its opponents has disastrous implications. A quick response to an unanticipated threat on the order of the AIDS epidemic is unimaginable absent a vigorous research establishment, which in turn is dependent on animal proxies. Why Animal Experimentation Matters is a first attempt by research scientists and moral philosophers to mount a convincing defense against animal rights enthusiasts. Because opponents of animal experimentation come from a variety of intellectual backgrounds, this defense is necessarily interdisciplinary as well. In this collection of eight essays, the authors scrutinize how animal experimentation actually functions in the laboratory, the vital role that it plays in palliating and eradicating human and animal diseases, and the moral justification for sacrificing animals for the betterment of human life.
The subjects covered in the essays include the moral status of animals and persons, the importance of animals for advancing scientific knowledge, the history of animal experimentation (and of its detractors), differing theoretical approaches of American and European animal-experimentation regulations, the heavily restrictive legislation promoted by animal rights activists, and the threats posed to research and researchers by violent animal rights zealots. Contributors include Baruch Brody, H. Tristram Englehardt, Jr., R. G. Frey, Kenneth F. Kiple and Kriemhild Cone Ornelas, Adrian R. Morrison, Charles S. Nicoll and Sharon M. Russell, Jerrold Tannenbaum, and Stuart M. Zola. This important anthology will be of interest to scientists, philosophers, individuals suffering from heritable or communicable diseases, relatives of afflicted individuals, and policymakers.
Ellen Frankel Paul is deputy director of the Social Philosophy and Policy Center, professor of political science and philosophy at Bowling Green State University, and editor-in-chief of the journal Social Philosophy & Policy.
Fred D. Miller, Jr., and Jeffrey Paul are, respectively, the executive director and associate director of the Social Philosophy and Policy Center; both are professors of philosophy at Bowling Green State University.