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This book provides a comprehensive introduction to statistical
methods for designing early phase dose-finding clinical trials. It
will serve as a textbook or handbook for graduate students and
practitioners in biostatistics and clinical investigators who are
involved in designing, conducting, monitoring, and analyzing
dose-finding trials. The book will also provide an overview of
advanced topics and discussions in this field for the benefit of
researchers in biostatistics and statistical science. Beginning
with backgrounds and fundamental notions on dose finding in early
phase clinical trials, the book then provides traditional and
recent dose-finding designs of phase I trials for, e.g., cytotoxic
agents in oncology, to evaluate toxicity outcome. Included are
rule-based and model-based designs, such as 3 + 3 designs,
accelerated titration designs, toxicity probability interval
designs, continual reassessment method and related designs, and
escalation overdose control designs. This book also covers more
complex and updated dose-finding designs of phase I-II and I/II
trials for cytotoxic agents, and cytostatic agents, focusing on
both toxicity and efficacy outcomes, such as designs with
covariates and drug combinations, maximum tolerated dose-schedule
finding designs, and so on.
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