The Evaluation Of Surrogate Endpoints

Hardcover | February 28, 2005

EditorTomasz Burzykowski, Geert Molenberghs, Marc Buyse

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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.

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From the Publisher

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...

From the Jacket

Both humanitarian and commercial considerations have spurred intensive search for methods to reduce the time and cost required to develop new therapies. The identification and use of surrogate endpoints, i.e., measures that can replace or supplement other endpoints in evaluations of experimental treatments or other interventions, is a ...

Format:HardcoverDimensions:434 pages, 9.25 × 6.1 × 0.27 inPublished:February 28, 2005Publisher:Springer New YorkLanguage:English

The following ISBNs are associated with this title:

ISBN - 10:0387202773

ISBN - 13:9780387202778

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Extra Content

Table of Contents

Introduction * Setting the Scene * Regulatory Aspects in Using Surrogate Markers in Clinical Trials * Notation and Motivating Studies * The History of Surrogate Marker Validation * Validation Using Single-Trial Data: Mixed Binary and Continuous Outcomes * A Meta-Analytic Validation Framework for Contiuous Outcomes * The Choice of Units * Extensions of the Meta-Analytic Approach to Surrogate Endpoints * Meta-Analytic Validation with Binary Outcomes * Validation in the Case of Two Failure-Time Endpoints * An Ordinal Surrogate for a Survival True Endpoint * A Combination of Longitudinal and Survival Endpoints * Repeated Measures and Surrogate Marker Validation * Bayesian Evaluation of Surrogate Endpoints * Surrogate Marker Validation in Mental Health * The Evaluation of Surrogate Endpoints in Practice: Experience in HIV * An Alternative Measure for Meta-Analytic Surrogate Marker Validation * Discussion: Surrogate Endpoint Definition and Evaluation *The Promise and Peril of Surrogate End Points in Cancer Research

Editorial Reviews

From the reviews:"A strength of this book is its comprehensive and up-to-date presentation of issues pertinent to the evaluation of surrgoate endpoints...This book makes an important contribution to the clinical trials literature..." Journal of Biopharmaceutical Statistics, 2006"Many of the chapters deal with real-life data examples and studies involving surrogate outcomes, many written by authors who were directly involved in these studies...The editors have written nice background sections...until a more concise manuscript on this topic is written, this book will remain the most important resource for biostatisticians and researchers in this area." Debajyoti Sinha for the Journal of the American Statistical Association, December 2006"This book is a reflection of the ongoing debate on the definition and use of surrogate markers...I see the book as an invitation to join the debate. There is much work to be done and reading the book might inspire many to participate. It will be useful for researchers in this and related fields, such as joint modeling of longitudinal and survival data and multivariate meta-analysis. The book is well organized, is a pleasure to read, and is very well documented with up-to-date references." Hans C. Van Houwelingen for Bioometrics, September 2006"This edited volume deals with a topic that has been the subject of much debate since publication of Prentice's 1989 attempt to formalize the definition of a surrogate marker or endpoint. . This work focuses on evaluation of a surrogate endpoint. . an attempt has been made to maintain common notations whenever possible. The editors have succeeded in producing a very useful book." (V. T. Farewell, Short Book Reviews, Vol. 25 (2), 2005)"I enjoyed readhing the book and I certainly learned a lot about these fascinating areas. The book is suitable as a textbook for a postgraduate course in statistics but is also an invaluable reference for the applied statisticians working in industry, academia, or regulatory authority."  (ISCB News Book Reviews, 2008)