Dose-Finding Designs for Early-Phase Cancer Clinical Trials

A Brief Guidebook to Theory and Practice

  • Takashi Daimon
  • Akihiro Hirakawa
  • Shigeyuki Matsui

Part of the SpringerBriefs in Statistics book series (BRIEFSSTATIST)

Also part of the JSS Research Series in Statistics book sub series (JSSRES)

Table of contents

  1. Front Matter
    Pages i-xv
  2. Takashi Daimon, Akihiro Hirakawa, Shigeyuki Matsui
    Pages 1-8
  3. Takashi Daimon, Akihiro Hirakawa, Shigeyuki Matsui
    Pages 9-32
  4. Takashi Daimon, Akihiro Hirakawa, Shigeyuki Matsui
    Pages 33-79
  5. Takashi Daimon, Akihiro Hirakawa, Shigeyuki Matsui
    Pages 81-94
  6. Takashi Daimon, Akihiro Hirakawa, Shigeyuki Matsui
    Pages 95-120
  7. Takashi Daimon, Akihiro Hirakawa, Shigeyuki Matsui
    Pages 121-133

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 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.


Adaptive Design Cancer Dose Finding Phase I Phase I/II

Authors and affiliations

  • Takashi Daimon
    • 1
  • Akihiro Hirakawa
    • 2
  • Shigeyuki Matsui
    • 3
  1. 1.Department of BiostatisticsHyogo College of MedicineNishinomiya, HyogoJapan
  2. 2.Department of Biostatistics and Bioinformatics, Graduate School of MedicineThe University of TokyoTokyoJapan
  3. 3.Graduate School of MedicineNagoya UniversityNagoyaJapan

Bibliographic information

  • DOI
  • Copyright Information The Author(s), under exclusive licence to Springer Japan KK 2019
  • Publisher Name Springer, Tokyo
  • eBook Packages Mathematics and Statistics
  • Print ISBN 978-4-431-55584-1
  • Online ISBN 978-4-431-55585-8
  • Series Print ISSN 2191-544X
  • Series Online ISSN 2191-5458
  • Buy this book on publisher's site
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