Practical Considerations for Adaptive Trial Design and Implementation

• Συγγραφή απο Οργανισμό/Αρχή: SpringerLink (Online service)
• Άλλοι συγγραφείς: He, Weili (Επιμελητής έκδοσης), Pinheiro, José (Επιμελητής έκδοσης), Kuznetsova, Olga M. (Επιμελητής έκδοσης)
• Μορφή: Ηλεκτρονική πηγή Ηλ. βιβλίο
• Γλώσσα: English
• Έκδοση: New York, NY : Springer New York : Imprint: Springer, 2014.
• Σειρά: Statistics for Biology and Health,
• Θέματα: Statistics.; Pharmacy.; Biostatistics.; Statistics for Life Sciences, Medicine, Health Sciences.; Drug Safety and Pharmacovigilance.; Statistical Theory and Methods.

This edited volume is a definitive text on adaptive clinical trial designs from creation and customization to utilization. As this book covers the full spectrum of topics involved in the adaptive designs arena, it will serve as a valuable reference for researchers working in industry, government and...

Πίνακας περιεχομένων:

• Preface
• The Need for and the Future of Adaptive Designs in Clinical Development
• Regulatory Guidance Documents on Adaptive Designs: an Industry Perspective
• A Commentary on the U.S. FDA Adaptive Design Draft Guidance and EMA Reflection Paper from a Regulatory Perspective and Regulatory Experiences
• Considerations and optimization of adaptive trial design in clinical development programs
• Optimal Cost-effective Go-No Go Decisions in Clinical Development
• Timing and frequency of interim analyses in confirmatory trials
• Approaches for optimal dose selection for adaptive design trials
• A Review of Available Software and Capabilities for Adaptive Designs
• Randomization Challenges in Adaptive Design Studies
• Response-adaptive randomization for clinical trials
• Implementing Adaptive Designs: Operational Considerations, Putting it all together
• Implementation Issues in Adaptive Design Trials
• Implementing Adaptive Designs; Using Technology to Protect Trial Integrity, Reduce Operational Bias, and Build Regulatory Trust
• Considerations for Interim Analyses in Adaptive Trials, and Perspectives on the Use of DMCs
• Approaches for Clinical Supply Modelling and Simulation
• Approaches for Patient Recruitment Modeling and Simulation
• A case study for adaptive trial design consideration and implementation
• Design Considerations for a Phase Ib Randomized, Placebo-Controlled, 4-Period Cross-over Adaptive Dose-Finding Clinical Trial
• Continual Reassessment Method for a First-In-Human Trial: From Design to Trial Implementation
• Practical Considerations for a Two-Stage Confirmatory Adaptive Clinical Trial Design and its Implementation: ADVENT Trial.