Modern Adaptive Randomized Clinical Trials: Statistical and Practical Aspects

This book aids in identifying when to apply adaptive randomization designs in practice. Featuring contributions from statisticians, clinical trialists, and subject-matter experts in academia and industry, the text discusses restricted, covariate-adaptive, response-adaptive, and covariate-adjusted response-adaptive randomization designs, as well as randomized designs with treatment selection. It describes a successful implementation of a single pivotal phase II/III adaptive trial in infants with proliferating hemangioma, addresses practical aspects of phase II dose-ranging studies, and examines statistical monitoring and interim analysis issues in response-adaptive randomized clinical trials.