Design and Analysis of Clinical Trials with Time-to-Event Endpoints

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Release : 2009-04-23
Genre : Mathematics
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Book Rating : 404/5 ( reviews)

Design and Analysis of Clinical Trials with Time-to-Event Endpoints - read free eBook in online reader or directly download on the web page. Select files or add your book in reader. Download and read online ebook Design and Analysis of Clinical Trials with Time-to-Event Endpoints write by Karl E. Peace. This book was released on 2009-04-23. Design and Analysis of Clinical Trials with Time-to-Event Endpoints available in PDF, EPUB and Kindle. 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 o

Design and Analysis of Clinical Trials for Predictive Medicine

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Release : 2015-03-19
Genre : Mathematics
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Book Rating : 164/5 ( reviews)

Design and Analysis of Clinical Trials for Predictive Medicine - read free eBook in online reader or directly download on the web page. Select files or add your book in reader. Download and read online ebook Design and Analysis of Clinical Trials for Predictive Medicine write by Shigeyuki Matsui. This book was released on 2015-03-19. Design and Analysis of Clinical Trials for Predictive Medicine available in PDF, EPUB and Kindle. 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

Design and Analysis of Clinical Trials

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Release : 2008-12-04
Genre : Mathematics
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Book Rating : 294/5 ( reviews)

Design and Analysis of Clinical Trials - read free eBook in online reader or directly download on the web page. Select files or add your book in reader. Download and read online ebook Design and Analysis of Clinical Trials write by Shein-Chung Chow. This book was released on 2008-12-04. Design and Analysis of Clinical Trials available in PDF, EPUB and Kindle. Praise for the First Edition of Design and Analysis of Clinical Trials "An excellent book, providing a discussion of the clinical trial process from designing the study through analyzing the data, and to regulatory requirement . . . could easily be used as a classroom text to understand the process in the new drug development area." –Statistical Methods in Medicine A complete and balanced presentation now revised, updated, and expanded As the field of research possibilities expands, the need for a working understanding of how to carry out clinical trials only increases. New developments in the theory and practice of clinical research include a growing body of literature on the subject, new technologies and methodologies, and new guidelines from the International Conference on Harmonization (ICH). Design and Analysis of Clinical Trials, Second Edition provides both a comprehensive, unified presentation of principles and methodologies for various clinical trials, and a well-balanced summary of current regulatory requirements. This unique resource bridges the gap between clinical and statistical disciplines, covering both fields in a lucid and accessible manner. Thoroughly updated from its first edition, the Second Edition of Design and Analysis of Clinical Trials features new topics such as: Clinical trials and regulations, especially those of the ICH Clinical significance, reproducibility, and generalizability Goals of clinical trials and target population New study designs and trial types Sample size determination on equivalence and noninferiority trials, as well as comparing variabilities Also, three entirely new chapters cover: Designs for cancer clinical trials Preparation and implementation of a clinical protocol Data management of a clinical trial Written with the practitioner in mind, the presentation assumes only a minimal mathematical and statistical background for its reader. Instead, the writing emphasizes real-life examples and illustrations from clinical case studies, as well as numerous references-280 of them new to the Second Edition-to the literature. Design and Analysis of Clinical Trials, Second Edition will benefit academic, pharmaceutical, medical, and regulatory scientists/researchers, statisticians, and graduate-level students in these areas by serving as a useful, thorough reference source for clinical research.

Statistical Issues in the Design and Analysis of Clinical Trials

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Release : 2017-01-11
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Book Rating : 543/5 ( reviews)

Statistical Issues in the Design and Analysis of Clinical Trials - read free eBook in online reader or directly download on the web page. Select files or add your book in reader. Download and read online ebook Statistical Issues in the Design and Analysis of Clinical Trials write by Yanning Liu. This book was released on 2017-01-11. Statistical Issues in the Design and Analysis of Clinical Trials available in PDF, EPUB and Kindle.

Planning and Analyzing Clinical Trials with Composite Endpoints

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Release : 2018-05-22
Genre : Medical
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Book Rating : 708/5 ( reviews)

Planning and Analyzing Clinical Trials with Composite Endpoints - read free eBook in online reader or directly download on the web page. Select files or add your book in reader. Download and read online ebook Planning and Analyzing Clinical Trials with Composite Endpoints write by Geraldine Rauch. This book was released on 2018-05-22. Planning and Analyzing Clinical Trials with Composite Endpoints available in PDF, EPUB and Kindle. 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. Composite endpoints are often used as primary efficacy variables for clinical trials, particularly in the fields of oncology and cardiology. These endpoints combine several variables of interest within a single composite measure, and as a result, all variables that are of major clinical relevance can be considered in the primary analysis without the need to adjust for multiplicity. Moreover, composite endpoints are intended to increase the size of the expected effects thus making clinical trials more powerful. The book offers practical advice for statisticians and medical experts involved in the planning and analysis of clinical trials. For readers who are mainly interested in the application of the methods, all the approaches are illustrated with real-world clinical trial examples, and the software codes required for fast and easy implementation are provided. The book also discusses all the methods in the context of relevant guidelines related to the topic. To benefit most from the book, readers should be familiar with the principles of clinical trials and basic statistical methods.