Dose-Finding Designs for Early-Phase Cancer Clinical Trials - Takashi Daimon, Akihiro Hirakawa, Shigeyuki Matsui

Dose-Finding Designs for Early-Phase Cancer Clinical Trials (eBook)

A Brief Guidebook to Theory and Practice

Takashi Daimon, Akihiro Hirakawa, Shigeyuki Matsui (Autoren)

eBook Download: PDF

2019 | 1st ed. 2019
XV, 133 Seiten
Springer Tokyo (Verlag)
978-4-431-55585-8 (ISBN)

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.

Takashi Daimon, Department of Biostatistics, Hyogo College of Medicine

Akihiro Hirakawa, Center for Advanced Medicine and Clinical Research, Nagoya University Graduate School of Medicine

Shigeyuki Matsui, Department of Biostatistics, Nagoya University Graduate School of Medicine

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 bookalso 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.

Erscheint lt. Verlag	21.5.2019
Reihe/Serie	JSS Research Series in Statistics
	JSS Research Series in Statistics
	SpringerBriefs in Statistics
	SpringerBriefs in Statistics
Zusatzinfo	XV, 133 p. 7 illus., 3 illus. in color.
Sprache	englisch
Themenwelt	Mathematik / Informatik ► Mathematik ► Statistik
	Mathematik / Informatik ► Mathematik ► Wahrscheinlichkeit / Kombinatorik
	Medizin / Pharmazie ► Allgemeines / Lexika
Schlagworte	adaptive design • Cancer • Dose Finding • Phase I • Phase I/II
ISBN-10	4-431-55585-4 / 4431555854
ISBN-13	978-4-431-55585-8 / 9784431555858

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