Practical Considerations for Adaptive Trial Design and Implementation

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Guidance Documents on Adaptive Designs: an Industry Perspective.- A Commentary on the U.S. FDA Adaptive Design Draft Guidance and EMA Reflection Paper from a Regulatory Perspective and Regulatory Experiences.- Considerations and optimization of adaptive trial design in clinical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.