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Expérimentation humaine en médecine --- Essais cliniques des médicaments

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"This book is for busy health professionals who wish to understand the theory of randomized controlled trails and their influence on clinical, research or policy decisions."--Jacket.

Randomized Controlled Trials. --- Quality Control. --- Clinical trials --- Etudes cliniques --- Randomized Controlled Trials as Topic --- Quality Control --- Études cliniques --- Essais cliniques des médicaments --- Clinical trials. --- Études cliniques. --- Essais cliniques des médicaments. --- Quality control --- Randomized controlled trials as topic --- Quality control.

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Maladie rare.Virus émergent.Cancer qui récidive.Souvent, les patients touchés sont confrontés à l’absence de traitement sûr et efficace. Et s’ils en ont un, encore faut-il en obtenir le remboursement. Quelles sont les possibilités qui s’offrent à ces patients ? La présente thèse étudie les procédures pour accéder aux médicaments qui ne sont pas, ou pas encore, mis sur le marché suisse. Elle s’intéresse tout particulièrement à l’importation de médicaments par le patient lui-même ou par un professionnel de la santé ; elle analyse les autorisations à durée limitée des articles 9a et 9b al. 1 de la Loi sur les produits thérapeutiques ; elle explore les procédures de remboursement selon la Loi sur l’assurance-maladie. Afin de mettre en évidence les lacunes du droit suisse, l’ouvrage propose une comparaison avec les systèmes de l’Union européenne et des Etats-Unis La thèse expose également les enjeux de l’accès compassionnel pour les acteurs de la santé impliqués, favorisant une vision globale de la thématique. Elle apporte finalement des solutions susceptibles de surmonter les obstacles recensés. Puisse cette thèse permettre au lecteur, juriste ou non, de circuler habilement dans le dédale administratif de l’accès aux médicaments à titre compassionnel.

Droit médical --- Suisse --- Accès aux médicaments --- Maladies rares. --- Droit --- Essais cliniques des médicaments --- Bioéthique --- Droit.

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Clinical Trials as Topic. --- Heart Diseases --- Cardiovascular Agents. --- Études cliniques. --- Essais cliniques des médicaments. --- Coeur --- Médicaments de l'appareil cardiovasculaire. --- drug therapy. --- Maladies --- Thérapeutique.

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This Third Edition builds on the text's reputation as a straightforward, detailed, and authoritative presentation of quantitative methods for clinical trials. Readers will encounter the 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 the trial and provides common sense solutions.All stages of therapeutic development are discussed in detail, and the methods are not restricted to a single clinical application area. The author bases current revisions and updates on his own experience, classroom instruction, and feedback from teachers and medical and statistical professionals involved in clinical trials. The Third Edition greatly expands its coverage, ranging from statistical principles to new and provocative topics, including alternative medicine and ethics, middle development comparative studies, and adaptive designs.At the same time, it offers more pragmatic advice for issues such as selecting outcomes, sample size, analysis, reporting, and handling allegations of misconduct. Readers familiar with the First and Second 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.In addition, this book : - Features accessible and broad coverage of statistical design methods—the crucial building blocks of clinical trials and medical research—now complete with new chapters on overall development, middle development, comparative studies, and adaptive designs ; - Teaches readers to design clinical trials that produce valid qualitative results backed by rigorous statistical methods ; - Contains an introduction and summary in each chapter to reinforce key points ; - Includes discussion questions to stimulate critical thinking and help readers understand how they can apply their newfound knowledge ; - Provides extensive references to direct readers to the most recent literature ; - Includes numerous new or revised exercises throughout.

Mathematical statistics --- Pharmacology. Therapy --- Clinical trials --- Clinical Trials as Topic --- Research Design. --- Statistics as Topic --- Essais cliniques des médicaments --- Études cliniques --- Statistical methods. --- methods. --- Méthodologie. --- Statistical methods --- Clinical trials - Statistical methods --- Research Design --- methods --- Research - methods --- Statistics as Topic - methods