Design and Analysis of Subgroups with Biopharmaceutical Applications. 1st ed. 2020

フォーマット:

電子ブック

責任表示:

edited by Naitee Ting, Joseph C. Cappelleri, Shuyen Ho, (Din) Ding-Geng Chen

言語:

英語

出版情報:

Cham : Springer International Publishing : Imprint: Springer, 2020

形態:

XVIII, 400 p. 61 illus., 43 illus. in color : online resource

著者名:

• Ting, Naitee
• Cappelleri, Joseph C.
• Ho, Shuyen
• Chen, (Din) Ding-Geng
• SpringerLink (Online service)

シリーズ名:

Emerging Topics in Statistics and Biostatistics ;

目次情報:

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

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

続きを見る

書誌ID:

IT00015290

ISBN:

9783030401054 [3030401057]      
9783030401078 [3030401073]