In response to the US FDA's Critical Path Initiative, innovative adaptive designs are being used more and more in clinical trials due to their flexibility and efficiency, especially during early phase development. Handbook of Adaptive Designs in Pharmaceutical and Clinical Development provides a comprehensive and unified presentation of the princip
Overview of Adaptive Design Methods in Clinical Trials. Fundamental Theory of Adaptive Designs with Unplanned Design Change in Clinical Trials with Blinded Data. Bayesian Approach for Adaptive Design. The Impact of Protocol Amendments in Adaptive Trial Designs. From Group Sequential to Adaptive Designs. Determining Sample Size for Classical Designs. Sample Size Reestimation Design with Applications in Clinical Trials. Adaptive Interim Analyses in Clinical Trials. Classical Dose-Finding Trial. Improving Dose-Finding: A Philosophic View. Adaptive Dose-Ranging Studies. Seamless Phase I/II Designs. Phase II/III Seamless Designs. Sample Size Estimation/Allocation for Two-Stage Seamless Adaptive Trial Designs. Optimal Response-Adaptive Randomization for Clinical Trials. Hypothesis-Adaptive Design. Treatment Adaptive Allocations in Randomized Clinical Trials: An Overview. Integration of Predictive Biomarker Diagnostics into Clinical Trials for New Drug Development. Clinical Strategy for Study Endpoint Selection. Adaptive Infrastructure. Independent Data Monitoring Committees. Targeted Clinical Trials. Functional Genome-Wide Association Studies of Longitudinal Traits. Adaptive Trial Simulation. Efficiency of Adaptive Designs. Cases Studies in Adaptive Design. Good Practices for Adaptive Clinical Trials. Index.