Biomarker Analysis in Clinical Trials with R

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