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"This Fourth Edition builds on the text's reputation as a straightforward, detailed, and authoritative presentation of quantitative methods for clinical trials. Readers will encounter principles of design for various types of clinical trials and are then skillfully guided through the complete process of planning the experiment, assembling a study cohort, assessing data, and reporting results. Throughout the process, the author alerts readers to problems that may arise during the course of a trial and provides common sense solutions. The Fourth Edition greatly expands its coverage, ranging from statistical principles to new and provocative topics, including four new chapters on generalizing results, operating characteristics, trial issues during the COVID-19 pandemic, and clinical trials using so-called "real world" data. Existing topics have been updated and expanded such as alternative medicine, ethics, middle development, comparative studies, and adaptive designs. Readers familiar with prior editions will discover revamped exercise sets; an updated and extensive reference section; new material on endpoints and the developmental pipeline, among others; and revisions of numerous sections."--

Clinical trials --- Clinical Trials as Topic --- Research Design --- Statistics as Topic --- Études cliniques --- Clinical trials --- Statistical methods. --- methods --- methods --- Méthodes statistiques. --- Statistical methods

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Written for clinicians and biostatisticians, describes nonparametric and quasiparametric (regression) methods of analyzing survivorship data in clinical studies, emphasizing the interpretation and reasoning behind the methods. Explains the established methods for summarizing the results of the major.

Mathematical statistics --- Biometry --- Survival Analysis --- Survival Rate --- Clinical trials --- Survival analysis (Biometry) --- Etudes cliniques --- Analyse de la survie (Biométrie) --- methods --- Clinical trials. --- Survival Analysis. --- Survival Rate. --- methods. --- Études cliniques --- Analyse de survie (biométrie) --- Analyse de la survie (Biométrie) --- Études cliniques. --- Monograph --- Biometry - methods. --- Études cliniques. --- Analyse de survie (biométrie)

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When is clinical research in developing countries exploitation? Exploitation is a concept in ordinary moral thought that has not often been analyzed outside the Marxist tradition. Yet it is commonly used to describe interactions that seem morally suspect in some way. A case in point is clinical research sponsored by developed countries and carried out in developing countries, with participants who are poor and sick, and lack education. Such individuals seem vulnerable to abuse. But does this, by itself, make such research exploitative? Exploitation and Developing Countries is an attempt by philosophers and bioethicists to reflect on the meaning of exploitation, to ask whether and when clinical research in developing countries counts as exploitative, and to consider what can be done to minimize the possibility of exploitation in such circumstances. These reflections should interest clinical researchers, since locating the line between appropriate and inappropriate use of subjects--the line between exploitation and fair use--is the central question at the heart of research ethics. Reflection on this rich and important moral concept should also interest normative moral philosophers of a non-Marxist bent. In addition to the editors, the contributors are Richard J. Arneson, Alisa L. Carse, Margaret Olivia Little, Thomas Pogge, Andrew W. Siegel, and Alan Wertheimer.

Clinical trials --- Moral and ethical aspects --- Controlled clinical trials --- Patient trials of new treatments --- Randomized clinical trials --- Trials, Clinical --- Études cliniques --- Pulmonary Surfactants. --- Human Experimentation --- Hepatitis A Vaccines. --- Developing Countries. --- Clinical Trials as Topic --- Developing Nations --- Least Developed Countries --- Less-Developed Nations --- Third-World Nations --- Under-Developed Nations --- Less-Developed Countries --- Third-World Countries --- Under-Developed Countries --- Countries, Developing --- Countries, Least Developed --- Countries, Less-Developed --- Countries, Third-World --- Countries, Under-Developed --- Country, Developing --- Country, Least Developed --- Country, Less-Developed --- Country, Third-World --- Country, Under-Developed --- Developed Countries, Least --- Developed Country, Least --- Developing Country --- Developing Nation --- Least Developed Country --- Less Developed Countries --- Less Developed Nations --- Less-Developed Country --- Less-Developed Nation --- Nation, Less-Developed --- Nation, Third-World --- Nation, Under-Developed --- Nations, Developing --- Nations, Less-Developed --- Nations, Third-World --- Nations, Under-Developed --- Third World Countries --- Third World Nations --- Third-World Country --- Third-World Nation --- Under Developed Countries --- Under Developed Nations --- Under-Developed Country --- Under-Developed Nation --- Havrix --- Hepatitis A Vaccine --- Hepatovirus Vaccines --- Vaqta --- Vaccine, Hepatitis A --- Vaccines, Hepatitis A --- Vaccines, Hepatovirus --- Pulmonary Surfactant --- Surfactant, Pulmonary --- Surfactants, Pulmonary --- Surface-Active Agents --- Clinical medicine --- Human experimentation in medicine --- Aspect social --- ethics. --- Research --- Developing Countries --- Hepatitis A Vaccines --- Pulmonary Surfactants --- Études cliniques --- ethics --- Clinical trials - Moral and ethical aspects - Developing countries --- Clinical Trials as Topic - ethics --- Human Experimentation - ethics --- Études cliniques - Aspect social - Pays en voie de développement