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Estimands in Clinical Trials A Practical Guide /

This book provides a comprehensive, up-to-date, and practical introduction to the estimand framework and its application in clinical trials. Since its introduction by the International Council for Harmonisation (ICH) through the E9(R1) guideline in 2019, the estimand framework has led to a significa...

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Dades bibliogràfiques
Autor corporatiu: SpringerLink (Online service)
Altres autors: Wei, Jiawei (Editor), Meng, Leslie (Editor), Bretz, Frank (Editor), Chen, Feng (Editor), Wang, Jun (Editor)
Format: Electrònic eBook
Idioma:anglès
Publicat: Cham : Springer Nature Switzerland : Imprint: Springer, 2025.
Edició:1st ed. 2025.
Col·lecció:Springer Series in Pharmaceutical Statistics,
Matèries:
Biometry.
Sampling (Statistics).
Clinical medicine > Research.
Biostatistics.
Methodology of Data Collection and Processing.
Clinical Research.
Accés en línia:https://doi.org/10.1007/978-3-032-02192-2
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Taula de continguts:
  • - Part I: Introduction to the Estimand Framework
  • 1. Aligning Trial Planning, Design, Conduct, Analysis, and Interpretation
  • 2. Estimands, Estimators, and Estimates
  • 3. Implementation the Estimand Thinking Process Through Multidisciplinary Collaborations
  • 4. Documentation of Estimands and Reporting of Results
  • 5. Estimands and Causal Inference
  • 6. Global Initiatives Since the Release of ICH E9(R1)
  • Part II: Case Studies Under the Estimand Framework
  • 7. Applying the Estimand Framework: Case Studies in Oncology and Hematology
  • 8. Applying the Estimand Framework: Case Studies in Immunology and Inflammation
  • 9. Applying the Estimand Framework: Case Studies in Neuroscience
  • 10. Applying the Estimand Framework: Case Studies in Cardiology, Respiratory, Infection Diseases and Vaccines
  • Part III: Regulatory Guidelines and Their Relationship to the Estimand Framework
  • 11. ICH Guidelines and Their Relationship to the Estimand Framework
  • 12. EMA Guidelines and Their Relationship to the Estimand Framework
  • 13. FDA Guidelines and Their Relationship to the Estimand Framework
  • 14. NMPA Guidelines and Their Relationship to the Estimand Framework
  • Part IV: Statistical Analysis Under the Estimand Framework
  • 15. Statistical Analysis Under the Estimand Framework: Continuous Endpoints
  • 16. Statistical Analysis Under the Estimand Framework: Binary Endpoints
  • 17. Statistical Analysis Under the Estimand Framework: Recurrent Events
  • 18. Statistical Analysis Under the Estimand Framework: Time-to-Event Endpoints
  • 19. Statistical Analysis Under the Estimand Framework: Principal Stratification
  • 20. Statistical Analysis Under the Estimand Framework: Covariate Adjustment
  • Part V: Leveraging the Estimand Framework in Diverse Clinical Trial Settings
  • 21. Leveraging the Estimand Framework for Integrated Evidence Planning
  • 22. Leveraging the Estimand Framework Across Trial Designs
  • 23. Leveraging the Estimand Framework for Clinical Trial Disruptions.

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