| Description |
1 online resource (237 pages) |
| Series |
Chapman and Hall/CRC Biostatistics Ser |
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Chapman and Hall/CRC Biostatistics Ser
|
| Contents |
Cover; Half Title; Series Page; Title Page; Copyright Page; Dedication; Contents; Preface; Acknowledgment; Editors; Contributors; 1. Introduction; 2. Statistical Considerations in Phase I Oncology Trials; 2.1 Introduction; 2.2 Dose Escalation in Phase I Studies; 2.2.1 Operational Aspects; 2.2.2 Statistical Aspects; 2.2.3 Logistic Model for Single-Agent Escalation; 2.2.4 Meta-Analytic-Combined Model for Single-Agent Escalation with Co-Data; 2.2.5 Assessing Effective Sample Size; 2.2.6 Case Study: Ceritinib for Non-Small Cell Lung Cancer; 2.2.6.1 Western Dose Escalation |
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2.2.6.2 Japanese Dose Escalation2.3 Dose Expansion in Phase I Studies; 2.3.1 Dose Expansion for Signal Seeking; 2.3.1.1 Safety Endpoints; 2.3.1.2 Efficacy and Biomarker Endpoints; 2.3.2 Dose Expansion with a Formal Success Criterion for Efficacy; 2.3.2.1 Double Criterion Design; 2.3.2.2 Single-Arm Design with Indirect Comparison to Comparator; 2.3.3 Advanced Designs: Fully Hierarchical Models; 2.4 Conclusion; Acknowledgments; Appendix; References; 3. Exposure-Response Analysis in Oncology Trials; 3.1 Investigation of QT/QTc Prolongation; 3.1.1 Introduction; 3.1.2 Methodology |
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3.1.2.1 Intersection-Union Test3.1.2.2 Exposure-Response Analysis; 3.1.3 Results and Conclusion; 3.2 The BE Study in Cancer Patients Using Group Sequential Design; 3.2.1 Introduction; 3.2.2 Methodology; 3.2.3 Results and Conclusion; 3.3 Exposure-Adjusted Continual Reassessment Method for Dose-Finding Studies; 3.3.1 Introduction; 3.3.2 Methodology; 3.3.3 Results and Conclusion; 3.4 Using Exposure-Safety Response Models for Dose Selection of the Late Phase Pivotal Study; 3.4.1 Introduction; 3.4.2 Methodology; 3.4.3 Results and Conclusion; References |
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4. Statistical Measures of Interaction for Evaluating a Predictive Biomarker4.1 Introduction; 4.2 Methods; 4.3 Binary Outcomes; 4.3.1 Illustrative Example-A Case-Control Study of Melanoma; 4.4 Time-To-Event Outcomes; 4.4.1 Illustrative Example-A Phase III Trial of Metastatic Melanoma; 4.5 Concluding Remarks; Acknowledgment; Computer Programs; 0.1 R Commands for Analyzing the Kricker et al. Melanoma Data with Binary Outcome; 0.2 R Commands for Analyzing the Larkin et al. Metastatic Melanoma Data with Time-To-Event Outcome; References |
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5. Design Considerations for Phase II Oncology Clinical Trials5.1 Introduction; 5.2 Single-Arm Versus Randomized Trials; 5.3 Biomarker-Based Phase II Designs; 5.3.1 Umbrella Trials; 5.3.2 Basket Trials; 5.4 Immunotherapy; 5.5 Discussion; References; 6. Precision Medicine and Associated Challenges; 6.1 Introduction; 6.2 Adaptive Bayesian Clinical Trials; 6.3 Case Studies of Clinical trials; 6.3.1 BATTLE Trial; 6.3.2 I-SPY Trials; 6.4 Challenges in the Implementation of Precision Medicine Trials; 6.4.1 Heterogeneity in Biological Specimens; Acknowledgments; References |
| Notes |
7. Use of Adaptive Design in Late-Stage Oncology Trials |
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Print version record |
| Form |
Electronic book
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| Author |
Lahiri, Soumi
|
| ISBN |
9781351650472 |
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1351650475 |
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