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Dose-Finding Designs for Early-Phase Cancer Clinical Trials

A Brief Guidebook to Theory and Practice

  • Book
  • © 2019

Overview

  • Serves as an excellent resource in the design and analysis of early phase dose-finding trials
  • Covers a wide range of various methods for designing early phase dose-finding clinical trials in oncology and other areas
  • Provides an overview of complex designs for researchers in biostatistics and statistical science

Part of the book series: SpringerBriefs in Statistics (BRIEFSSTATIST)

Part of the book sub series: JSS Research Series in Statistics (JSSRES)

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Table of contents (6 chapters)

Keywords

About this book

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.

Reviews

“The book under review is intended to serve as a brief handbook for graduate students and biostatistics, as well as for oncologists who are involved in the analysis of methods for developing optimal doses for treating cancer in the early stages.” (Fatima T. Adylova, zbMATH 1427.92001, 2020)

Authors and Affiliations

  • Department of Biostatistics, Hyogo College of Medicine, Nishinomiya, Hyogo, Japan

    Takashi Daimon

  • Department of Biostatistics and Bioinformatics, Graduate School of Medicine, The University of Tokyo, Tokyo, Japan

    Akihiro Hirakawa

  • Graduate School of Medicine, Nagoya University, Nagoya, Japan

    Shigeyuki Matsui

About the authors

Takashi Daimon, Department of Biostatistics, Hyogo College of MedicineAkihiro 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

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