Описание: This book provides an overview of current available biomarkers and human biomonitoring programs in environmental health, addressing current concerns regarding adverse health effects from environmental exposures.
Описание: Presents a range of solutions to analytic issues. This title reflects developments in methodology with coverage of mixture models and a dataset example. It implements examples using SAS and R code and incorporates a number of examples from real QoL clinical trials to illustrate design and analysis methods.
Автор: Matsui Shigeyuki Название: Design and Analysis of Clinical Trials for Predictive Medicine ISBN: 1466558156 ISBN-13(EAN): 9781466558151 Издательство: Taylor&Francis Рейтинг: Цена: 17609.00 р. Наличие на складе: Есть у поставщика Поставка под заказ.
Описание:
Design and Analysis of Clinical Trials for Predictive Medicine provides statistical guidance on conducting clinical trials for predictive medicine. It covers statistical topics relevant to the main clinical research phases for developing molecular diagnostics and therapeutics--from identifying molecular biomarkers using DNA microarrays to confirming their clinical utility in randomized clinical trials.
The foundation of modern clinical trials was laid many years before modern developments in biotechnology and genomics. Drug development in many diseases is now shifting to molecularly targeted treatment. Confronted with such a major break in the evolution toward personalized or predictive medicine, the methodologies for design and analysis of clinical trials is now evolving.
This book is one of the first attempts to contribute to this evolution by laying a foundation for the use of appropriate statistical designs and methods in future clinical trials for predictive medicine. It is a useful resource for clinical biostatisticians, researchers focusing on predictive medicine, clinical investigators, translational scientists, and graduate biostatistics students.
Описание: This book provides statisticians with an understanding of the critical challenges currently encountered in oncology trials. The book covers state-of-the-art approaches to the design and analysis of cancer clinical trials, such as adaptive designs, biomarker-based trials, and dynamic treatment regimes.
Автор: Mallinckrodt, Craig Molenberghs, Geert Lipkovich, Ilya (quintiles, Durham, North Carolina, Usa) Ratitch, Bohdana (eli Lilly Cananda, Ontario, Canada) Название: Estimands, estimators and sensitivity analysis in clinical trials ISBN: 1138592501 ISBN-13(EAN): 9781138592506 Издательство: Taylor&Francis Рейтинг: Цена: 17609.00 р. Наличие на складе: Есть у поставщика Поставка под заказ.
Описание: This book will use the new guidance as a framework for developing and implementing comprehensive analysis plans for clinical trials that support the development and approval of medical interventions.
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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