This book with CD-ROM introduces the Software ExpDesign Studio for classic and adaptive designs and computer simulations. The book includes step-by-step demos on creating various trial designs, using the automatic outputs to optimize the trial design, and monitoring a clinical trial in progress. While the book emphasizes applications over theory, key mathematic formulations are covered. In addition, ExpDesign software covers and includes SAS and R codes. This is a key reference for pharmaceutical scientists, statisticians, researchers, and others involved in drug development.
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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 Classifi er 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.