Chang Classical and Adaptive Clinical Trial Designs Using ExpDesign Studio

1. Auflage 2008
ISBN: 978-0-470-36997-5
Verlag: John Wiley & Sons
Format: PDF
Kopierschutz: Adobe DRM (»Systemvoraussetzungen)

E-Book, Englisch, 280 Seiten, E-Book

ExpDesign Studio facilitates more efficient clinical trialdesign

This book introduces pharmaceutical statisticians, scientists,researchers, and others to ExpDesign Studio software for classicaland adaptive designs of clinical trials. It includes theProfessional Version 5.0 of ExpDesign Studio software that freespharmaceutical professionals to focus on drug development andrelated challenges while the software handles the essentialcalculations and computations. After a hands-on introduction to thesoftware and an overview of clinical trial designs encompassingnumerous variations, Classical and Adaptive Clinical TrialDesigns Using ExpDesign Studio:

* Covers both classical and adaptive clinical trial designs,monitoring, and analyses

* Explains various classical and adaptive designs includinggroupsequential, sample-size reestimation, dropping-loser,biomarker-adaptive, and response-adaptive randomizationdesigns

* Includes instructions for over 100 design methods that havebeen implemented in ExpDesign Studio and step-by-step demos as wellas real-world examples

* Emphasizes applications, yet covers key mathematicalformulations

* Introduces readers to additional toolkits in ExpDesign Studiothat help in designing, monitoring, and analyzing trials, such asthe adaptive monitor, graphical calculator, the probabilitycalculator, the confidence interval calculator, and more

* Presents comprehensive technique notes for sample-sizecalculation methods, grouped by the number of arms, the trialendpoint, and the analysis basis

Written with practitioners in mind, this is an ideal self-studyguide for not only statisticians, but also scientists, researchers,and professionals in the pharmaceutical industry, contract researchorganizations (CROs), and regulatory bodies. It's also a go-toreference for biostatisticians, pharmacokinetic specialists, andprincipal investigators involved in clinical trials.

ERRATUM

Classical and Adaptive Clinical Trial Designs UsingExpDesign Studio

By Mark Chang

The license for the ExpDesign Studio software on the CD includedwith this book is good for one-year after installation of thesoftware. Prior to the expiration of this period, the software willgenerate a reminder about renewal for the license. The user shouldcontact CTriSoft International (the owners of ExpDesign Studio) atwww.CTriSoft.net or by email at [e-mail], about renewalfor the license.

This should have been made clear in the first printing of thisbook. We apologize for this error.

Autoren/Hrsg.

Chang, Mark

Über Autor(innen)

Mark Chang, PHD, is a Scientific Fellow at Millennium Pharmaceuticals. He has extensive experience with IND and NDA submissions. His involvement in drug development includes both strategic and methodological aspects. Dr. Chang is an Associate Editor for the Journal of Biopharmaceutical Statistics.