The Evaluation of Surrogate Endpoints

The Evaluation of Surrogate Endpoints
Author: Geert Molenberghs
Publisher: Springer Science & Business Media
Total Pages: 440
Release: 2005-02-28
Genre: Mathematics
ISBN: 9780387202778

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Covers the latest research on a sensitive and controversial topic in a professional and well researched manner. Provides practical outlook as well as model guidelines and software tools that should be of interest to people who use the software tools described and those who do not. Related title by Co-author Geert Molenbergh has sold more than 3500 copies world wide. Provides dual viewpoints: from scientists in the industry as well as regulatory authorities.

The Evaluation of Surrogate Endpoints

The Evaluation of Surrogate Endpoints
Author: Tomasz Burzykowski
Publisher: Springer Science & Business Media
Total Pages: 417
Release: 2005-11-24
Genre: Medical
ISBN: 0387270809

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Covers the latest research on a sensitive and controversial topic in a professional and well researched manner. Provides practical outlook as well as model guidelines and software tools that should be of interest to people who use the software tools described and those who do not. Related title by Co-author Geert Molenbergh has sold more than 3500 copies world wide. Provides dual viewpoints: from scientists in the industry as well as regulatory authorities.

Clinical Trials in Oncology, Third Edition

Clinical Trials in Oncology, Third Edition
Author: Stephanie Green
Publisher: CRC Press
Total Pages: 266
Release: 2012-05-09
Genre: Mathematics
ISBN: 1439814481

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The third edition of the bestselling Clinical Trials in Oncology provides a concise, nontechnical, and thoroughly up-to-date review of methods and issues related to cancer clinical trials. The authors emphasize the importance of proper study design, analysis, and data management and identify the pitfalls inherent in these processes. In addition, the book has been restructured to have separate chapters and expanded discussions on general clinical trials issues, and issues specific to Phases I, II, and III. New sections cover innovations in Phase I designs, randomized Phase II designs, and overcoming the challenges of array data. Although this book focuses on cancer trials, the same issues and concepts are important in any clinical setting. As always, the authors use clear, lucid prose and a multitude of real-world examples to convey the principles of successful trials without the need for a strong statistics or mathematics background. Armed with Clinical Trials in Oncology, Third Edition, clinicians and statisticians can avoid the many hazards that can jeopardize the success of a trial.

Survival Analysis with Correlated Endpoints

Survival Analysis with Correlated Endpoints
Author: Takeshi Emura
Publisher: Springer
Total Pages: 118
Release: 2019-03-25
Genre: Medical
ISBN: 9811335168

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This book introduces readers to advanced statistical methods for analyzing survival data involving correlated endpoints. In particular, it describes statistical methods for applying Cox regression to two correlated endpoints by accounting for dependence between the endpoints with the aid of copulas. The practical advantages of employing copula-based models in medical research are explained on the basis of case studies. In addition, the book focuses on clustered survival data, especially data arising from meta-analysis and multicenter analysis. Consequently, the statistical approaches presented here employ a frailty term for heterogeneity modeling. This brings the joint frailty-copula model, which incorporates a frailty term and a copula, into a statistical model. The book also discusses advanced techniques for dealing with high-dimensional gene expressions and developing personalized dynamic prediction tools under the joint frailty-copula model. To help readers apply the statistical methods to real-world data, the book provides case studies using the authors’ original R software package (freely available in CRAN). The emphasis is on clinical survival data, involving time-to-tumor progression and overall survival, collected on cancer patients. Hence, the book offers an essential reference guide for medical statisticians and provides researchers with advanced, innovative statistical tools. The book also provides a concise introduction to basic multivariate survival models.

Evaluation of Biomarkers and Surrogate Endpoints in Chronic Disease

Evaluation of Biomarkers and Surrogate Endpoints in Chronic Disease
Author: Institute of Medicine
Publisher: National Academies Press
Total Pages: 335
Release: 2010-06-25
Genre: Medical
ISBN: 0309157277

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Many people naturally assume that the claims made for foods and nutritional supplements have the same degree of scientific grounding as those for medication, but that is not always the case. The IOM recommends that the FDA adopt a consistent scientific framework for biomarker evaluation in order to achieve a rigorous and transparent process.

Survival Analysis

Survival Analysis
Author: David Machin
Publisher: John Wiley & Sons
Total Pages: 278
Release: 2006-03-30
Genre: Medical
ISBN: 0470870419

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Well received in its first edition, Survival Analysis: A Practical Approach is completely revised to provide an accessible and practical guide to survival analysis techniques in diverse environments. Illustrated with many authentic examples, the book introduces basic statistical concepts and methods to construct survival curves, later developing them to encompass more specialised and complex models. During the years since the first edition there have been several new topics that have come to the fore and many new applications. Parallel developments in computer software programmes, used to implement these methodologies, are relied upon throughout the text to bring it up to date.

Statistical Methods for Survival Trial Design

Statistical Methods for Survival Trial Design
Author: Jianrong Wu
Publisher: CRC Press
Total Pages: 243
Release: 2018-06-14
Genre: Mathematics
ISBN: 0429892934

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Statistical Methods for Survival Trial Design: With Applications to Cancer Clinical Trials Using R provides a thorough presentation of the principles of designing and monitoring cancer clinical trials in which time-to-event is the primary endpoint. Traditional cancer trial designs with time-to-event endpoints are often limited to the exponential model or proportional hazards model. In practice, however, those model assumptions may not be satisfied for long-term survival trials. This book is the first to cover comprehensively the many newly developed methodologies for survival trial design, including trial design under the Weibull survival models; extensions of the sample size calculations under the proportional hazard models; and trial design under mixture cure models, complex survival models, Cox regression models, and competing-risk models. A general sequential procedure based on the sequential conditional probability ratio test is also implemented for survival trial monitoring. All methodologies are presented with sufficient detail for interested researchers or graduate students.

Applied Surrogate Endpoint Evaluation Methods with SAS and R

Applied Surrogate Endpoint Evaluation Methods with SAS and R
Author: Ariel Alonso
Publisher: CRC Press
Total Pages: 396
Release: 2016-11-30
Genre: Mathematics
ISBN: 1482249375

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An important factor that affects the duration, complexity and cost of a clinical trial is the endpoint used to study the treatment’s efficacy. When a true endpoint is difficult to use because of such factors as long follow-up times or prohibitive cost, it is sometimes possible to use a surrogate endpoint that can be measured in a more convenient or cost-effective way. This book focuses on the use of surrogate endpoint evaluation methods in practice, using SAS and R.

Perspectives on Biomarker and Surrogate Endpoint Evaluation

Perspectives on Biomarker and Surrogate Endpoint Evaluation
Author: Institute of Medicine
Publisher: National Academies Press
Total Pages: 141
Release: 2011-01-12
Genre: Medical
ISBN: 0309187001

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In 2010 the Institute of Medicine (IOM) recommended a framework for the evaluation of biomarkers in the chronic disease setting. Published in the book Evaluation of Biomarkers and Surrogate Endpoints in Chronic Disease, the framework is intended to bring consistency and transparency to the previously disparate process of biomarker evaluation. Following the book's release, the IOM convened a 2-day discussion forum in Washington, DC, in order to provide an opportunity for stakeholders to learn about, react to, and discuss the book. Presentations reviewed the authoring committee's work process, recommendations, and provided perspectives on the book from the point of view of participants. Thomas Fleming, professor of biostatistics and statistics at the University of Washington, gave a keynote presentation on the critical issues in the validation of surrogate endpoints, a specific use of a biomarker. The present volume recounts the discussion forum proceedings, focusing in turn on each represented sector. A summary of Dr. Fleming's presentation then sets the committee's recommendations within the context of biomarker utilization. Lastly, this summary examines the main themes raised by stakeholders, and the challenges and opportunities presented to stakeholders by the book's recommendations.