Modern Dose-Finding Designs for Cancer Phase I Trials: Drug Combinations and Molecularly Targeted Agents (eBook)
XIII, 89 Seiten
Springer Tokyo (Verlag)
978-4-431-55573-5 (ISBN)
- 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
This book deals with advanced methods for adaptive phase I dose-finding clinical trials for combination of two agents and molecularly targeted agents (MTAs) 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 adaptive dose-finding methods as well as providing practitioners in biostatistics and clinical investigators with advanced materials for designing, conducting, monitoring, and analyzing adaptive 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 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 advance of the adaptive dose-finding methods in drug developments are also provided.
- Akihiro Hirakawa, Department of Biostatistics and Bioinformatics, Graduate School of Medicine, The University of Tokyo- 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
1. Introduction.- 2. Phase I Trials for Drug Development in Oncology.- 3. A Summary of Dose.- Finding Methods in Standard Phase I Trials .- 4. Phase I Trials for Combination of Two Agents.- 5. Phase I Trials for Joint Assessment of Both Efficacy and Toxicity.- 6. Additional Topics on Adaptive Dose.- Finding Methods.
| Erscheint lt. Verlag | 30.1.2018 |
|---|---|
| Reihe/Serie | JSS Research Series in Statistics |
| JSS Research Series in Statistics | |
| SpringerBriefs in Statistics | SpringerBriefs in Statistics |
| Zusatzinfo | XIII, 89 p. 3 illus. |
| Verlagsort | Tokyo |
| Sprache | englisch |
| Themenwelt | Mathematik / Informatik ► Mathematik ► Statistik |
| Mathematik / Informatik ► Mathematik ► Wahrscheinlichkeit / Kombinatorik | |
| Medizin / Pharmazie ► Medizinische Fachgebiete ► Onkologie | |
| Medizin / Pharmazie ► Medizinische Fachgebiete ► Pharmakologie / Pharmakotherapie | |
| Schlagworte | adaptive design • Cancer • Dose Finding • Phase I • Phase I/II |
| ISBN-10 | 4-431-55573-0 / 4431555730 |
| ISBN-13 | 978-4-431-55573-5 / 9784431555735 |
| Haben Sie eine Frage zum Produkt? |
PDF (Wasserzeichen)Größe: 1,6 MB
DRM: Digitales Wasserzeichen
Dieses eBook enthält ein digitales Wasserzeichen und ist damit für Sie personalisiert. Bei einer missbräuchlichen Weitergabe des eBooks an Dritte ist eine Rückverfolgung an die Quelle möglich.
Dateiformat: PDF (Portable Document Format)
Mit einem festen Seitenlayout eignet sich die PDF besonders für Fachbücher mit Spalten, Tabellen und Abbildungen. Eine PDF kann auf fast allen Geräten angezeigt werden, ist aber für kleine Displays (Smartphone, eReader) nur eingeschränkt geeignet.
Systemvoraussetzungen:
PC/Mac: Mit einem PC oder Mac können Sie dieses eBook lesen. Sie benötigen dafür einen PDF-Viewer - z.B. den Adobe Reader oder Adobe Digital Editions.
eReader: Dieses eBook kann mit (fast) allen eBook-Readern gelesen werden. Mit dem amazon-Kindle ist es aber nicht kompatibel.
Smartphone/Tablet: Egal ob Apple oder Android, dieses eBook können Sie lesen. Sie benötigen dafür einen PDF-Viewer - z.B. die kostenlose Adobe Digital Editions-App.
Buying eBooks from abroad
For tax law reasons we can sell eBooks just within Germany and Switzerland. Regrettably we cannot fulfill eBook-orders from other countries.
aus dem Bereich
