The Evaluation of Surrogate Endpoints (eBook)

eBook Download: PDF
2005 | 2005
XXIV, 410 Seiten
Springer New York (Verlag)
978-0-387-27080-7 (ISBN)

Lese- und Medienproben

The Evaluation of Surrogate Endpoints -
Systemvoraussetzungen
117,69 inkl. MwSt
  • Download sofort lieferbar
  • Zahlungsarten anzeigen

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.


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 general strategy that has stimulated both enthusiasm and skepticism. Surrogate endpoints are useful when they can be measured earlier, more conveniently, or more frequently than the "e;true"e; endpoints of primary interest. Regulatory agencies around the globe, particularly in the United States, Europe, and Japan, are introducing provisions and policies relating to the use of surrogate endpoints in registration studies. But how can one establish the adequacy of a surrogate? What kind of evidence is needed, and what statistical methods portray that evidence most appropriately? This book offers a balanced account on this controversial topic. The text presents major developments of the last couple of decades, together with a unified, meta-analytic framework within which surrogates can be evaluated from several angles. Methodological development is coupled with perspectives on various therapeutic areas. Academic views are juxtaposed with standpoints of scientists working in the biopharmaceutical industry as well as of colleagues from the regulatory authorities.Tomasz Burzykowski is Assistant Professor of Biostatistics at the Limburgs Universitair Centrum in Belgium. Dr. Burzykowski has published methodological work on the analysis of survey data, meta-analyses of clinical trials, and validation of surrogate endpoints. He is a co-author of numerous papers applying statistical methods to clinical data in different disease areas (cancer, cardiovascular diseases, dermatology, orthodontics).Geert Molenberghs is Professor of Biostatistics at the Limburgs Universitair Centrum in Belgium. Dr. Molenberghs published methodological work on surrogate markers in clinical trials, categorical data, longitudinal data analysis, and on the analysis of non-response in clinical and epidemiological studies. He serves as Joint Editor for Applied Statistics (2001-2004) and is President of the International Biometric Society (2004-2005). He was elected Fellow of the American Statistical Association and received the Guy Medal in Bronze from the Royal Statistical Society. Marc Buyse founded the International Drug Development Institute in 1991. He is Past President of the International Society for Clinical Biostatistics, Past President of the Quetelet Society, and Past Board Member of the Society for Clinical Trials. He is currently the Executive Director of IDDI (International Drug Development Institute) and Associate Professor of biostatistics at the Limburgs Universitair Centrum, Center for Statistics, Diepenbeek, Belgium. He has published extensively in the fields of biostatistics and oncology. His research interests include meta-analysis, surrogate endpoints, statistical detection of fraud, and the design and statistical analysis of clinical trials.From the reviews:"e;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..."e; Journal of Biopharmaceutical Statistics, 2006"e;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."e; Debajyoti Sinha for the Journal of the American Statistical Association, December 2006"e;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."e; Hans C. Van Houwelingen for Bioometrics, September 2006

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

Erscheint lt. Verlag 24.11.2005
Reihe/Serie Statistics for Biology and Health
Statistics for Biology and Health
Zusatzinfo XXIV, 410 p.
Verlagsort New York
Sprache englisch
Themenwelt Mathematik / Informatik Mathematik Wahrscheinlichkeit / Kombinatorik
Medizin / Pharmazie Allgemeines / Lexika
Medizin / Pharmazie Medizinische Fachgebiete Allgemeinmedizin
Schlagworte Cancer • Data Analysis • Dermatology • Diseases • Oncology • Statistics • therapy
ISBN-10 0-387-27080-9 / 0387270809
ISBN-13 978-0-387-27080-7 / 9780387270807
Haben Sie eine Frage zum Produkt?
PDFPDF (Wasserzeichen)
Größe: 4,3 MB

DRM: Digitales Wasserzeichen
Dieses eBook enthält ein digitales Wasser­zeichen und ist damit für Sie persona­lisiert. Bei einer missbräuch­lichen Weiter­gabe des eBooks an Dritte ist eine Rück­ver­folgung an die Quelle möglich.

Dateiformat: PDF (Portable Document Format)
Mit einem festen Seiten­layout eignet sich die PDF besonders für Fach­bücher mit Spalten, Tabellen und Abbild­ungen. Eine PDF kann auf fast allen Geräten ange­zeigt werden, ist aber für kleine Displays (Smart­phone, eReader) nur einge­schränkt geeignet.

Systemvoraussetzungen:
PC/Mac: Mit einem PC oder Mac können Sie dieses eBook lesen. Sie benötigen dafür einen PDF-Viewer - z.B. den Adobe Reader oder Adobe Digital Editions.
eReader: Dieses eBook kann mit (fast) allen eBook-Readern gelesen werden. Mit dem amazon-Kindle ist es aber nicht kompatibel.
Smartphone/Tablet: Egal ob Apple oder Android, dieses eBook können Sie lesen. Sie benötigen dafür einen PDF-Viewer - z.B. die kostenlose Adobe Digital Editions-App.

Buying eBooks from abroad
For tax law reasons we can sell eBooks just within Germany and Switzerland. Regrettably we cannot fulfill eBook-orders from other countries.

Mehr entdecken
aus dem Bereich
Quellen der Erkenntnis oder digitale Orakel?

von Bernd Simeon

eBook Download (2023)
Springer Berlin Heidelberg (Verlag)
16,99
Klartext für Nichtmathematiker

von Guido Walz

eBook Download (2021)
Springer Fachmedien Wiesbaden (Verlag)
4,48