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
Biography
Nusrat Rabbee is a biostatistician and data scientist at Rabbee & Associates, where she creates innovative solutions to help companies accelerate drug and diagnostic development for patients. Her research interest lies in the intersection of data science and personalized medicine. She has extensive experience in bioinformatics, clinical statistics and high-dimensional data analyses. She has co-discovered the RLMM algorithm for genotyping Affymetrix SNP chips and co-invented a high-dimensional molecular signature for cancer. She has spent over 17 years in the pharmaceutical and diagnostics industry focusing on biomarker development. She has taught statistics at UC Berkeley for 4 years.
