Classical and Adaptive Clinical Trial Designs Using ExpDesign Studio [NOOK Book]

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Overview

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 ...
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Classical and Adaptive Clinical Trial Designs Using ExpDesign Studio

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Overview

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 group sequential, 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), andregulatory bodies. It's also a go-to reference for biostatisticians, pharmacokinetic specialists, and principal investigators involved in clinical trials.

About the Author:
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

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Editorial Reviews

From the Publisher

“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)

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Product Details

  • ISBN-13: 9780470438565
  • Publisher: Wiley, John & Sons, Incorporated
  • Publication date: 6/15/2010
  • Sold by: Barnes & Noble
  • Format: eBook
  • Edition number: 1
  • Pages: 260
  • File size: 551 KB

Meet the Author

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.

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Table of Contents

Self-Study and Practice Guide

1 ExpDesign Studio 1

2 Clinical Trial Design 14

3 Classical Trial Design 27

4 Group Sequential Trial Design 51

5 Adaptive Trial Design 75

6 Adaptive Trial Monitoring 103

7 Oncology Adaptive Trial Design 123

8 Adaptive Trial Simulator 149

9 Further Assistance from ExpDesign Studio 172

10 Classical Design Method Reference 187

Afterword 214

Appendix A Validation of ExpDesign Studio 215

Appendix B Sample-Size Calculation Methods: Classical Design 235

References 240

Index 251

System Requirements, Software Installation, and Software License Agreement 259

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    Blindwind

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    Posted January 10, 2013

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