Design and Analysis of Subgroups with Biopharmaceutical Applications

This book provides an overview of the theories and applications on subgroups in the biopharmaceutical industry. Drawing from a range of expert perspectives in academia and industry, this collection offers an overarching dialogue about recent advances in biopharmaceutical applications, novel statisti...

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Bibliographic Details
Other Authors: Ting, Naitee (Editor), Cappelleri, Joseph C. (Editor), Ho, Shuyen (Editor), Chen, (Din) Ding-Geng (Editor)
Format: eBook
Language:English
Published: Cham Springer International Publishing 2020, 2020
Edition:1st ed. 2020
Series:Emerging Topics in Statistics and Biostatistics
Subjects:
Online Access:
Collection: Springer eBooks 2005- - Collection details see MPG.ReNa
Table of Contents:
  • 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 Therapies: 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