Buch, Englisch, 280 Seiten, Format (B × H): 163 mm x 235 mm, Gewicht: 544 g
ISBN: 978-0-470-27612-9
Verlag: Turner Publishing Company
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), and regulatory bodies. It's also a go-to reference for biostatisticians, pharmacokinetic specialists, and principal investigators involved in clinical trials.
Autoren/Hrsg.
Fachgebiete
Weitere Infos & Material
Preface.
Self-Study and Practice Guide.
1 ExpDesign Studio.
1.1 Introduction.
1.2 How to Design a Trial Using ExpDesign Studio.
1.3 ExpDesign Menus.
2 Clinical Trial Design.
2.1 Introduction.
2.2 Classical Clinical Trial Design.
2.3 Selection of a Trial Design.
2.4 Adaptive Clinical Trial Design.
3 Classical Trial Design.
3.1 Introduction.
3.2 How to Calculate Sample Size Using ExpDesign.
3.3 Mathematical Notes on Classical Design.
4 Group Sequential Trial Design.
4.1 Introduction.
4.2 Basics of Group Sequential Design.
4.3 How to Design Sequential Trials Using ExpDesign.
4.4 How to Monitor a Group Sequential Trial Using ExpDesign.
4.5 Mathematical Notes on Sequential Trial Design.
5 Adaptive Trial Design.
5.1 Introduction.
5.2 Basics of Adaptive Design Methods.
5.3 How To Design a Sample-Size Reestimation Trial Using ExpDesign.
5.4 How to Design a Drop-Loser Trial Using ExpDesign.
5.5 How to Design a Trial Using a Classifier Biomarker.
5.6 How to Design a Play-the-Winner Trail Using ExpDesign.
6 Adaptive Trial Monitoring.
6.1 Introduction.
6.2 Error-Spending Approach.
6.3 How to Recalculate Stopping Boundaries Using ExpDesign.
6.4 Conditional Power and the Futility Index.
6.5 How to Reestimate Sample Size Using ExpDesign.
6.6 Trial Examples.
7 Oncology Adaptive Trial Design.
7.1 Multistage Trial Design.
7.2 Dose-Escalation Trial Design.
7.3 Dose-Escalation Trial Monitoring Using CRM.
7.4 Mathematical Notes on Multistage Design.
7.5 Mathematical Notes on the CRM.
8 Adaptive Trial Simulator.
8.1 Adjusting the Critical Region Method.
8.2 Classical Design with Two Parallel Treatment Groups.
8.3 Flexible Design with Sample-Size Reestimation.
8.4 Design with Random-Play-the-Winner Randomization.
8.5 Group Sequential Design with One Interim Analysis.
8.6 Design Permitting Early Stopping and Sample-Size Reestimation.
8.7 Classical Design with Multiple Treatment Groups.
8.8 Multigroup Trial with Response-Adaptive Randomization.
8.9 Adaptive Design Featuring Dropping Losers.
8.10 Dose-Response Trial Design.
8.11 Dose-Escalation Design for an Oncology Trial.
9 Further Assistance from ExpDesign Studio.
9.1 ExpDesign Probability Functions.
9.2 Virtual Trial Data Generation Using ExpDesign Randomizor.
9.3 ExpDesign Toolkits.
10 Classical Design Method Reference.
10.1 Single-Group Design.
10.2 Two-Group Design.
10.3 Multigroup Trial Design.
Afterword.
Appendix A: Validation of ExpDesign Studio.
A.1 Validation Process for ExpDesign Studio.
A.2 Validation of the Classical Design Module.
A.3 Validation of the Group Sequential Design Module.
A.4 Validation of the Adaptive Design Module.
A.5 Validation of the Multistage Design Module.
A.6 Validation of the Traditional Dose-Escalation Design Module.
A.7 Validation of the Trial Simulation Module.
A.8 Validation of the Randomizor.
A.9 Validation of the ExpDesign Toolkits.
A.10 Computer Programs for Validations.
Appendix B: Sample-Size Calculation Methods: Classical Design.
References.
Index.
System Requirements, Software Installation, and Software License Agreement.
