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Planning and Analyzing Clinical Trials with Composite Endpoints

BuchGebunden
255 Seiten
Englisch
Springererschienen am31.05.20181st ed. 2017
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.mehr
Verfügbare Formate
BuchGebunden
EUR149,79
BuchKartoniert, Paperback
EUR149,79
E-BookPDF1 - PDF WatermarkE-Book
EUR139,09

Produkt

KlappentextThis 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.
Zusammenfassung
Discusses methods for planning and evaluating clinical trials with a composite primary endpoint

Offers software codes for the implementation of methods

Summarizes current medical and methodology guideline documents on composite endpoints

Includes recommendations and guidance for planning clinical trials with composite endpoints

Provides numerous examples from clinical trials illustrating the different methods
Details
ISBN/GTIN978-3-319-73769-0
ProduktartBuch
EinbandartGebunden
Verlag
Erscheinungsjahr2018
Erscheinungsdatum31.05.2018
Auflage1st ed. 2017
ReiheSpringer Series in Pharmaceutical Statistics
Seiten255 Seiten
SpracheEnglisch
Gewicht566 g
IllustrationenXVI, 255 p. 9 illus., 2 illus. in color.
Artikel-Nr.44013644
Rubriken
GenreMedizin

Inhalt/Kritik

Inhaltsverzeichnis
Preface.- Contents.- Part I General Introduction to Composite Endpoints.- 1 Definition and Rationale.- 2 Challenges of Composite Endpoints.- 3 Guideline View - Recommendations and Requirements.- 4 Clinical Trial Examples.- Part II Confirmatory Test Problem for a Single (Composite) Endpoint.- 5 The Single-Stage Design.- 6 Group-Sequential and Adaptive Designs.- 7 Related Software Code.- Part III Confirmatory Multiple Test Problem.- 8 Correlation Between Test Statistics.- 9 The Single-Stage Design.- 10 Group-Sequential and Adaptive Designs.- 11 Related Software Code.- Part IV Confirmatory Test Problem for a Weighted Composite Endpoint.- 12 Weighted Binary Composite Endpoint.- Weighted Time-to-Event Composite Endpoint.- 14 OtherWeighted Effect Measures.- 15 Related Software Code.- Part V Descriptive and Confirmatory Evaluation of the Components.- 16 Descriptive Analysis of the Components.- 17 Supplementary Confirmatory Analyses of the Components.- 18 Related Software Code.- Part VI Illustrating Clinical Trial Examples.- 19 Clinical Trial Examples with Binary (Composite) Endpoints.- 20 Clinical Trial Examples with (Composite) Time-to-Event Endpoints.mehr

Autor


Since 2017, Prof. Dr. Geraldine Rauch has been a professor of Medical Biometry and Director of the Institute of Biometry and Clinical Epidemiology at the Charité Universitätsmedizin Berlin. Prior to that, she had a professorship at the University Medical Center Hamburg-Eppendorf. From 2009 to 2016, she worked at the Institute of Medical Biometry and Informatics, Heidelberg, where she finished her habilitation thesis in 2015. She studied Mathematics at the University of Bremen, and prepared her PhD thesis at Roche Diagnostics GmbH in Penzberg.
Prof. Dr. Meinhard Kieser studied Mathematics at the University of Heidelberg and received his PhD in Medical Biometry in 1992. After that, he worked for more than 15 years as a biostatistician and Head of Biometrics in the pharmaceutical industry. In 2001, he completed his habilitation thesis. Since 2008, he has been a professor of Medical Biometry and Director of the Institute of Medical Biometry and Informatics at the University of Heidelberg.
Svenja Schüler studied Mathematics at the University of Kiel and graduated in 2013. Since then, she has been working as a research fellow at the Institute of Medical Biometry and Informatics at the University of Heidelberg. In her doctorial thesis, funded by the German Research Foundation, she is developing statistical methods for the analysis of composite endpoints.
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