Search Results for design-and-analysis-of-clinical-experiments

199 for arbitrary design, 208-210 vs. blocking, I86 on change, 200-202 components of treatment sum of squares. 2I7 estimated slope in. ... 274-275. 287 with historical 423 The Design and Analysis of Clinical Experiments: SUBJECT INDEX.

Author: Joseph L. Fleiss

Publisher: John Wiley & Sons

ISBN: 9781118031179

Category: Mathematics

Page: 448

View: 757

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First published in 1986, this unique reference to clinical experimentation remains just as relevant today. Focusing on the principles of design and analysis of studies on human subjects, this book utilizes and integrates both modern and classical designs. Coverage is limited to experimental comparisons of treatments, or in other words, clinical studies in which treatments are assigned to subjects at random.
2011-01-25 By Joseph L. Fleiss

Guidance for Industry—Computerized System Used in Clinical Trials. ... Draft Guidance on Developing Medical Imaging Drugs and Biological Products, Part 3: Design, Analysis and Interpretation of Clinical Studies.

Author: Shein-Chung Chow

Publisher: John Wiley & Sons

ISBN: 9780471473299

Category: Mathematics

Page: 752

View: 874

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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.
2008-12-04 By Shein-Chung Chow

... Controversial Statistical Issues in Clinical Trials Shein-Chung Chow Data Analysis with Competing Risks and Intermediate States Ronald B. Geskus Data and Safety Monitoring Committees in Clinical Trials Jay Herson Design and Analysis ...

Author: Weichung Joe Shih

Publisher: CRC Press

ISBN: 9781482250503

Category: Mathematics

Page: 244

View: 187

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Statistical Design and Analysis of Clinical Trials: Principles and Methods concentrates on the biostatistics component of clinical trials. Developed from the authors' courses taught to public health and medical students, residents, and fellows during the past 15 years, the text shows how biostatistics in clinical trials is an integration of many fu
2015-07-28 By Weichung Joe Shih

... Issues in Clinical Trials Shein-Chung Chow Data and Safety Monitoring Committees in Clinical Trials Jay Herson Design and Analysis of Animal Studies in Pharmaceutical Development Shein-Chung Chow and Jen-pei Liu Design and Analysis ...

Author: Shigeyuki Matsui

Publisher: CRC Press

ISBN: 9781466558168

Category: Mathematics

Page: 400

View: 535

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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.
2015-03-19 By Shigeyuki Matsui

Design and Analysis of Animal Studies in Pharmaceutical Development, Shein-Chung Chow and Jen-pei Liu 2. Basic Statistics and Pharmaceutical ... Statistical Methods for Clinical Trials, Mark X. Norleans 9. Causal Analysis in Biomedicine ...

Author: Karl E. Peace

Publisher: CRC Press

ISBN: 9781420066401

Category: Mathematics

Page: 616

View: 571

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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.
2009-04-23 By Karl E. Peace

Published Titles DNA Microarrays and Related Genomics Techniques: Design, Analysis, and Interpretation of Experiments David B. Allison, Grier P. Page, T. Mark Beasley, and Jode W. Edwards Dose Finding by the Continual Reassessment ...

Author: Iftekhar Khan

Publisher: CRC Press

ISBN: 9781466505483

Category: Mathematics

Page: 339

View: 761

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Economic evaluation has become an essential component of clinical trial design to show that new treatments and technologies offer value to payers in various healthcare systems. Although many books exist that address the theoretical or practical aspects of cost-effectiveness analysis, this book differentiates itself from the competition by detailing
2015-11-11 By Iftekhar Khan

Focusing on the principles of design and analysis of studies on human subjects, this book utilizes and integrates both modern and classical designs.

Author: Joseph L. Fleiss

Publisher: Wiley-Interscience

ISBN: UOM:39015053540228

Category: Mathematics

Page: 460

View: 301

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First published in 1986, this unique reference to clinical experimentation remains just as relevant today. Focusing on the principles of design and analysis of studies on human subjects, this book utilizes and integrates both modern and classical designs. Coverage is limited to experimental comparisons of treatments, or in other words, clinical studies in which treatments are assigned to subjects at random.
1986-03-06 By Joseph L. Fleiss

Author: Harland Sather

Publisher:

ISBN: 8849106793

Category: Medical

Page: 128

View: 312

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1992 By Harland Sather

... Issues in Clinical Trials Shein-Chung Chow Data and Safety Monitoring Committees in Clinical Trials Jay Herson Design and Analysis of Animal Studies in Pharmaceutical Development Shein-Chung Chow and Jen-pei Liu Design and Analysis ...

Author: Tie-Hua Ng

Publisher: CRC Press

ISBN: 9781466561496

Category: Mathematics

Page: 208

View: 797

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Take Your NI Trial to the Next Level Reflecting the vast research on noninferiority (NI) designs from the past 15 years, Noninferiority Testing in Clinical Trials: Issues and Challenges explains how to choose the NI margin as a small fraction of the therapeutic effect of the active control in a clinical trial. Requiring no prior knowledge of NI testing, the book is easily accessible to both statisticians and nonstatisticians involved in drug development. With over 20 years of experience in this area, the author introduces the basic elements of the NI trials one at a time in a logical order. He discusses issues with estimating the effect size based on historical placebo control trials of the active control. The book covers fundamental concepts related to NI trials, such as assay sensitivity, constancy assumption, discounting, and preservation. It also describes patient populations, three-arm trials, and the equivalence of three or more groups.
2014-12-01 By Tie-Hua Ng

Design: Analysis. Plans. 12.1 Introduction The analysis plan is an essential part of any randomized clinical trial. ... For example, clinical trials of treatments for cancer have a primary and one to two secondary endpoints, ...

Author: Diane L. Fairclough

Publisher: CRC Press

ISBN: 9781420035438

Category: Mathematics

Page: 328

View: 802

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More and more frequently, clinical trials include the evaluation of Health-Related Quality of Life (HRQoL), yet many investigators remain unaware of the unique measurement and analysis issues associated with the assessment of HRQoL. At the end of a study, clinicians and statisticians often face challenging and sometimes insurmountable analytic problems. Design and Analysis of Quality of Life Studies in Clinical Trials details these issues and presents a range of solutions. Written from the author's extensive experience in the field, it focuses on the very specific features of QoL data: its longitudinal nature, multidimensionality, and the problem of missing data. The author uses three real clinical trials throughout her discussions to illustrate practical implementation of the strategies and analytic methods presented. As Quality of Life becomes an increasingly important aspect of clinical trials, it becomes essential for clinicians, statisticians, and designers of these studies to understand and meet the challenges this kind of data present. In this book, SAS and S-PLUS programs, checklists, numerous figures, and a clear, concise presentation combine to provide readers with the tools and skills they need to successfully design, conduct, analyze, and report their own studies.
2002-03-28 By Diane L. Fairclough