Classical and Adaptive Clinical Trial Designs Using ExpDesign Studio (eBook)

Mark Chang (Autor)

eBook Download: PDF

2008 | 1. Auflage
280 Seiten
John Wiley & Sons (Verlag)
978-0-470-36997-5 (ISBN)

Infos

ExpDesign Studio facilitates more efficient clinical trial
design

This book introduces pharmaceutical statisticians, scientists,
researchers, and others to ExpDesign Studio software for classical
and adaptive designs of clinical trials. It includes the
Professional Version 5.0 of ExpDesign Studio software that frees
pharmaceutical professionals to focus on drug development and
related challenges while the software handles the essential
calculations and computations. After a hands-on introduction to the
software and an overview of clinical trial designs encompassing
numerous variations, Classical and Adaptive Clinical Trial
Designs Using ExpDesign Studio:

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

* Explains various classical and adaptive designs including
groupsequential, sample-size reestimation, dropping-loser,
biomarker-adaptive, and response-adaptive randomization
designs

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

* Emphasizes applications, yet covers key mathematical
formulations

* Introduces readers to additional toolkits in ExpDesign Studio
that help in designing, monitoring, and analyzing trials, such as
the adaptive monitor, graphical calculator, the probability
calculator, the confidence interval calculator, and more

* Presents comprehensive technique notes for sample-size
calculation methods, grouped by the number of arms, the trial
endpoint, and the analysis basis

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

ERRATUM

Classical and Adaptive Clinical Trial Designs Using
ExpDesign Studio

By Mark Chang

The license for the ExpDesign Studio software on the CD included
with this book is good for one-year after installation of the
software. Prior to the expiration of this period, the software will
generate a reminder about renewal for the license. The user should
contact CTriSoft International (the owners of ExpDesign Studio) at
www.CTriSoft.net or by email at [e-mail], about renewal
for the license.

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

Autor

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.

Rezensionen

"This book has been selected for The First Clinical Research Bookshelf. Essential reading for clinical research professionals" (Journal of Clinical Research Best Practices, June 2009)

Produkt-Details

• Erscheint lt. Verlag: 15.8.2008
• Sprache: englisch
• Themenwelt: Medizin / Pharmazie
• Themenwelt: Naturwissenschaften ► Chemie
• Schlagworte: Chemie • Chemistry • Clinical Trials • Drug Discovery & Development • Klinische Studien • Medical Science • Medizin • Pharmacology & Pharmaceutical Medicine • Pharmakologie u. Pharmazeutische Medizin • Statistics • Statistik • Wirkstoffforschung u. -entwicklung
• ISBN-10: 0-470-36997-3 / 0470369973
• ISBN-13: 978-0-470-36997-5 / 9780470369975