Table of contents:
Introduction. Protocol Amendment. Adaptive Randomization. Adaptive Hypotheses. Adaptive Dose-Escalation Trials. Adaptive Group Sequential Design. Adaptive Sample Size Adjustment. Adaptive Seamless Phase II/III Designs. Adaptive Treatment Switching. Bayesian Approach. Clinical Trial Simulation. Case Studies.
Although adaptive design methods are flexible and useful in clinical research, little or no regulatory guidelines are available. Adaptive Design Methods Clinical Trials provide a comprehensive and unified presentation of the principles and methodologies in adaptive design and analysis with respect to adaptations made to trial and/or statistical procedures based on accrued data of on-going clinical trials. This text also offers a well-balanced summary of current regulatory perspectives and recently developed statistical methods in this area. It fills the need for a comprehensive and updated reference and textbook in the area of adaptive design and analysis in clinical research and development.
Although adaptive design methods are flexible and useful in clinical research, little or no regulatory guidelines are available. Adaptive Design Methods Clinical Trials provide a comprehensive and unified presentation of the principles and methodologies in adaptive design and analysis with respect to adaptations made to trial and/or statistical procedures based on accrued data of on-going clinical trials. This text also offers a well-balanced summary of current regulatory perspectives and recently developed statistical methods in this area. It fills the need for a comprehensive and updated reference and textbook in the area of adaptive design and analysis in clinical research and development.
Introduction. Protocol Amendment. Adaptive Randomization. Adaptive Hypotheses. Adaptive Dose-Escalation Trials. Adaptive Group Sequential Design. Adaptive Sample Size Adjustment. Adaptive Seamless Phase II/III Designs. Adaptive Treatment Switching. Bayesian Approach. Clinical Trial Simulation. Case Studies.
Although adaptive design methods are flexible and useful in clinical research, little or no regulatory guidelines are available. Adaptive Design Methods Clinical Trials provide a comprehensive and unified presentation of the principles and methodologies in adaptive design and analysis with respect to adaptations made to trial and/or statistical procedures based on accrued data of on-going clinical trials. This text also offers a well-balanced summary of current regulatory perspectives and recently developed statistical methods in this area. It fills the need for a comprehensive and updated reference and textbook in the area of adaptive design and analysis in clinical research and development.
Although adaptive design methods are flexible and useful in clinical research, little or no regulatory guidelines are available. Adaptive Design Methods Clinical Trials provide a comprehensive and unified presentation of the principles and methodologies in adaptive design and analysis with respect to adaptations made to trial and/or statistical procedures based on accrued data of on-going clinical trials. This text also offers a well-balanced summary of current regulatory perspectives and recently developed statistical methods in this area. It fills the need for a comprehensive and updated reference and textbook in the area of adaptive design and analysis in clinical research and development.