Planning and Analyzing Clinical Trials with Composite Endpoints, Geraldine Rauch; Svenja Sch?ler; Meinhard Kieser
Автор: Takashi Sozu; Tomoyuki Sugimoto; Toshimitsu Hamasa Название: Sample Size Determination in Clinical Trials with Multiple Endpoints ISBN: 3319220047 ISBN-13(EAN): 9783319220048 Издательство: Springer Рейтинг: Цена: 46570.00 T Наличие на складе: Есть у поставщика Поставка под заказ. Описание:
1.Introduction.- 2.Continuous Co-primary Endpoints.- 3.Binary Co-primary Endpoints.- 4.Convenient Sample Size Formula.- 5.Continuous Primary Endpoints.- 6. Further Developments.- A.Sample Size Calculation Using other Contrasts for Binary Endpoints.- B.Empirical Power for Sample Size Calculation for Binary Co-primary Endpoints.- C.Numerical Tables for Ck in the Convenient Sample Size Formula for the Three Co-primary Continuous Endpoints Cace.- D.Software Programs for Sample Size Calculation for Continuous Co-primary Endpoints.- References.
Автор: Rauch Название: Planning and Analyzing Clinical Trials with Composite Endpoints ISBN: 3319737694 ISBN-13(EAN): 9783319737690 Издательство: Springer Рейтинг: Цена: 130430.00 T Наличие на складе: Есть у поставщика Поставка под заказ. Описание: This book addresses the most important aspects of how to plan and evaluate clinical trials with a composite primary endpoint to guarantee a clinically meaningful and valid interpretation of the results.
Автор: Takeshi Emura; Shigeyuki Matsui; Virginie Rondeau Название: Survival Analysis with Correlated Endpoints ISBN: 981133515X ISBN-13(EAN): 9789811335150 Издательство: Springer Рейтинг: Цена: 55890.00 T Наличие на складе: Есть у поставщика Поставка под заказ. Описание: This book introduces readers to advanced statistical methods for analyzing survival data involving correlated endpoints. Hence, the book offers an essential reference guide for medical statisticians and provides researchers with advanced, innovative statistical tools.
Using time-to-event analysis methodology requires careful definition of the event, censored observation, provision of adequate follow-up, number of events, and independence or noninformativeness of the censoring mechanisms relative to the event. Design and Analysis of Clinical Trials with Time-to-Event Endpoints provides a thorough presentation of the design, monitoring, analysis, and interpretation of clinical trials in which time-to-event is of critical interest.
After reviewing time-to-event endpoint methodology, clinical trial issues, and the design and monitoring of clinical trials, the book focuses on inferential analysis methods, including parametric, semiparametric, categorical, and Bayesian methods; an alternative to the Cox model for small samples; and estimation and testing for change in hazard. It then presents descriptive and graphical methods useful in the analysis of time-to-event endpoints. The next several chapters explore a variety of clinical trials, from analgesic, antibiotic, and antiviral trials to cardiovascular and cancer prevention, prostate cancer, astrocytoma brain tumor, and chronic myelogonous leukemia trials. The book then covers areas of drug development, medical practice, and safety assessment. It concludes with the design and analysis of clinical trials of animals required by the FDA for new drug applications.
Drawing on the expert contributors' experiences working in biomedical research and clinical drug development, this comprehensive resource covers an array of time-to-event methods and explores an assortment of real-world applications.
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