Practical considerations for adaptive trial design and implementation [electronic resource] / Weili He, José Pinheiro, Olga M. Kuznetsova, editors.

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A Commentary on the U.S. FDA Adaptive Design Draft Guidance and EMA Reflection Paper from a Regulatory Perspective and Regulatory Experiences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.