Design and Analysis of Subgroups with Biopharmaceutical Applications

by Naitee Ting (Editor)

1. Data-driven and Confirmatory Subgroup Analysis in Clinical Trials.- 2. Subgroup Analysis - A View from Industry.- 3. Biomarker-Targeted Confirmatory Trials.- 4. Considerations on Subgroup Analysis in Design and Analysis of Multi-Regional Clinical Trials.- 5. Practical Subgroup Identification Strategies in Late-stage Clinical Trials.- 6. Exploratory Subgroup Identification for Biopharmaceutical Development.- 7. Logical Inference on Treatment Efficacy When Subgroup Exists.- 8. The GUIDE Approach to Subgroup Identification and Inference.- 9. Use of the VG (Virtual Twins Combined with GUIDE) Method in the Development of Precision Medicines.- 10. Subgroups Identification for Tailored a System of Methods, a Framework for Consistent Methodology Evaluation, and an Integrated Learn-and-confirm Approach.- 11. Developing and Validating Predictive Classifiers in Randomized Clinical Trials.- 12. Issues Related to Subgroup Analysis.- 13. Subgroup Analysis with Partial Linear Model.- 14.  Subgroup Analysis in the 21st Century.- 15. Power of Statistical Tests for Subgroup Analysis in Meta-Analysis.- 16. Heterogeneity and Subgroup Analysis in Network Meta-Analysis.

420 pages, Paperback

Published May 16, 2020