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Section I Pharmacodynamic Biomarkers 1. Introduction 2. Toxicology Studies 3. Bioequivalence Studies 4. Cross-Sectional Profile of Pharmacodynamics Biomarkers 5. Timecourse Profile of Pharmacodynamics Biomarkers 6. Evaluating Multiple Biomarkers Section II Predictive Biomarkers 7. Introduction 8. Operational Characteristics of Proof-of-Concept Trials with Biomarker-Positive and -Negative Subgroups 9. A Framework for Testing Biomarker Subgroups in Confirmatory Trials 10. Cutoff Determination of Continuous Predictive Biomarker for a Biomarker-Treatment Interaction 11. Cutoff Determination of Continuous Predictive Biomarker Using Group Sequential Methodology 12. Adaptive Threshold Design 13. Adaptive Seamless Design (ASD) Section III Surrogate Endpoints 14. Introduction 15. Requirement # 1: Trial Level
Correlation Between Hazard Ratios in Progression-Free Survival and Overall Survival Across Trials 16. Requirement # 2: Individual Level
Assess the Correlation Between the Surrogate and True Endpoints After Adjusting for Treatment (R2 indiv) 17. Examining the Proportion of Treatment Effect in AIDS Clinical Trials 18. Concluding Remarks Section IV Combining Multiple Biomarkers 19. Introduction 20. Regression-Based Models 21. Tree-Based Models 22. Cluster Analysis 23. Graphical Models Section V Biomarker Statistical Analysis Plan.
Correlation Between Hazard Ratios in Progression-Free Survival and Overall Survival Across Trials 16. Requirement # 2: Individual Level
Assess the Correlation Between the Surrogate and True Endpoints After Adjusting for Treatment (R2 indiv) 17. Examining the Proportion of Treatment Effect in AIDS Clinical Trials 18. Concluding Remarks Section IV Combining Multiple Biomarkers 19. Introduction 20. Regression-Based Models 21. Tree-Based Models 22. Cluster Analysis 23. Graphical Models Section V Biomarker Statistical Analysis Plan.