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Theory and Practice in Complex Dose-Finding Designs

53,49 € Lieferbar ab 29.01.2018


This book deals with advanced methods for complex phase I and phase I/II dose-finding clinical trials with multiple drugs and outcomes in oncology. It provides not only methodological aspects of the dose-finding methods, but also software implementations and practical considerations in applying these complex methods to real cancer clinical trials. Thus, the book aims to furnish researchers in biostatistics and statistical science with a good summary of recent developments of complex dose-finding methods as well as providing practitioners in biostatistics and clinical investigators with advanced materials for designing, conducting, monitoring, and analyzing complex dose-finding trials. The topics in the book are mainly related to cancer clinical trials, but many of those topics are potentially applicable or can be extended to trials for other diseases. The focus is mainly on model-based dose-finding methods for two kinds of phase I trials. One is clinical trials with combinations of two agents. Development of dose-finding methods for two-agent combination trials requires reasonable models that can adequately capture joint toxicity probabilities for two agents, taking into consideration possible interactions of the two agents on toxicity probability such as synergistic or antagonistic effects. Another is clinical trials for evaluating both efficacy and toxicity outcomes in single- and two-agent combination trials. These methods are often applied to the phase I trials including molecularly targeted agents (MTAs) because the toxicity and efficacy for a MTA does not monotonically increase with dose, but the efficacy often increases initially with the dose and then plateaus. Successful software implementations for several dose-finding methods are introduced in the book, and their operating characteristics in practice are discussed. Recent applications of the above-mentioned adaptive dose-finding methods in drug developments are also provided.


Titel: Theory and Practice in Complex Dose-Finding Designs
Autoren/Herausgeber: Akihiro Hirakawa, Takashi Daimon, Hiroyuki Sato, Shigeyuki Matsui
Aus der Reihe: SpringerBriefs in Statistics
Ausgabe: 1st ed. 2018

ISBN/EAN: 9784431555728

Format: 23,5 x 15,5 cm
Produktform: Taschenbuch/Softcover
Gewicht: 0 g
Sprache: Englisch

- Akihiro Hirakawa, Biostatistics and Bioinformatics Section, Center for Advanced Medicine and Clinical Research, Nagoya University Hospital- Takashi Daimon, Division of Biostatistics, Hyogo College of Medicine- Hiroyuki Satom, Biostatistics Group, Center for Product Evaluation, Pharmaceuticals and Medical Devices Agency- Shigeyuki Matsui, Department of Biostatistics, Nagoya University Graduate School of Medicine

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