Protocol amendment -- Adaptive randomization -- Adaptive hypotheses -- Adaptive dose-escalation trials -- Adaptive group sequential design -- Statistical tests for adaptive seamless designs -- Adaptive sample size adjustment -- Two-stage adaptive design -- Adaptive treatment switching -- Bayesian approach -- Biomarker adaptive trials -- Target clinical trials -- Sample size and power estimation -- Clinical trial simulation -- Regulatory perspectives : a review of FDA draft guidance
Summary
With new statistical and scientific issues arising in adaptive clinical trial design, including the U.S. FDA's recent draft guidance, a new edition of one of the first books on the topic is needed. Adaptive Design Methods in Clinical Trials, Second Edition reflects recent developments and regulatory positions on the use of adaptive designs in clinical trials. It unifies the vast and continuously growing literature and research activities on regulatory requirements, scientific and practical issues, and statistical methodology. New to the Second Edition Along with revisions throughout the text
