Simultaneous Global New Drug Development -

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Editeur : Chapman And Hall/Crc

Langue : Anglais

Parution : 01/12/2021

Format : Moyen, de 350g à 1kg

Nombre de pages : 318

Expédition : 621

Dimensions : 24.0 x 16.1 x 2.2

ISBN : 0367565609

Résumé :

This book contains chapters providing interpretations of principles in ICH E17 and new ideas of implementing MRCTs. Authors are from different regions, and from academia and industry. This book will be of particular interest to biostatisticians working in late stage clinical development of medical products.

Sommaire:

1. General Introduction of E17. 2. New Principles in Global development using ICH E 17 guideline. 3. Consideration of Ethnic Factors as Defined in ICH E5 for Drug Development and Application in ICH E17 Guidelines for Conduct of Multiregional Clinical Trials (MRCT). 4. Pooling Strategy. 5. Overall sample size and allocation to regions. 6. Consistency Evaluation in MRCTs. 7. Implementation of the ICH E17 guideline in Japan. 8. ICH E17 and MRCT: Implementation and Regulatory Perspective in China. 9. Lessons Learned from Actual Multi-regional Clinical Trials with Signals of Treatment Effect Heterogeneity. 10. Leveraging Foreign Clinical Data Extrapolation to Accelerate Global Drug Development: A Case Study in Hematological Oncology. 11. Analysis Models for Multi-regional Clinical Trials. 12. Utilization of Robust Estimates of Treatment Effects via Semi-Parametric Models in MRCT. 13. Hierarchical Linear Models for Multi-Regional Clinical Trials. 14. Local Treatment Effect Estimation by Borrowing Information from Similar Regions in Multi-Regional Clinical Trials. 15. Global Drug Development: Multi-Regional Clinical Trials (MRCTs) ? Chin?s Pursuit. 16. Statistical considerations in MRCT design and analysis. 17. Multiple Endpoints in Multiregional Clinical Trials. 18. Multiregional Clinical Trials with Heterogeneous Regional and Treatment Effects. 19. Regional sample size calculation in multiregional equivalence and non-inferiority trials