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.