This second edition reflects recent developments and regulatory positions on the use of adaptive designs in clinical trials. It unifies the vast and continuously growing literature and research activities on regulatory requirements, scientific and practical issues, and statistical methodology. This edition significantly updates the chapters on protocol amendment and clinical trial simulation to incorporate the latest changes. It also includes five entirely new chapters on two-stage adaptive design, biomarker adaptive trials, target clinical trials, sample size and power estimation, and regulatory perspectives. INDICE: Chapter 1. Introduction. Chapter 2. Protocol Amendment. Chapter 3.Adaptive Randomization. Chapter 4. Adaptive Hypotheses. Chapter 5. Adaptive Dose-Escalation TrialsChapter 6. Adaptive Group Sequential Design. Chapter 7. Statistical Tests for Seamless Adaptive Designs. Chapter 8. Adaptive Sample Size Adjustment. Chapter 9. Two-Stage Adaptive Design. Chapter 10. Adaptive Treatment Switching. Chapter 11. Bayesian Approach. Chapter 12. Biomarker Adaptive TrialsChapter 13. Target Clinical Trials. Chapter 14. Sample Size and Power Estimation. Chapter 15. Clinical Trial SimulationChapter 16. Regulatory Perspectives - A Review of FDA Draft Guidance. Chapter 17. Case Studies. Bibliography.Index.
- ISBN: 978-1-4398-3987-4
- Editorial: CRC
- Encuadernacion: Cartoné
- Páginas: 358
- Fecha Publicación: 01/01/2012
- Nº Volúmenes: 1
- Idioma: Inglés