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Textbook of Clinical Trials in Oncology: A Statistical Perspective [Kietas viršelis]

Edited by (Duke University), Edited by
  • Formatas: Hardback, 626 pages, aukštis x plotis: 254x178 mm, weight: 1360 g, 73 Tables, black and white; 103 Line drawings, black and white; 103 Illustrations, black and white
  • Išleidimo metai: 16-May-2019
  • Leidėjas: CRC Press
  • ISBN-10: 1138083771
  • ISBN-13: 9781138083776
Kitos knygos pagal šią temą:
  • Formatas: Hardback, 626 pages, aukštis x plotis: 254x178 mm, weight: 1360 g, 73 Tables, black and white; 103 Line drawings, black and white; 103 Illustrations, black and white
  • Išleidimo metai: 16-May-2019
  • Leidėjas: CRC Press
  • ISBN-10: 1138083771
  • ISBN-13: 9781138083776
Kitos knygos pagal šią temą:
There is an increasing need for educational resources for statisticians and investigators. Reflecting this, the goal of this book is to provide readers with a sound foundation in the statistical design, conduct, and analysis of clinical trials. Furthermore, it is intended as a guide for statisticians and investigators with minimal clinical trial experience who are interested in pursuing a career in this area. The advancement in genetic and molecular technologies have revolutionized drug development. In recent years, clinical trials have become increasingly sophisticated as they incorporate genomic studies, and efficient designs (such as basket and umbrella trials) have permeated the field. This book offers the requisite background and expert guidance for the innovative statistical design and analysis of clinical trials in oncology.

Key Features:











Cutting-edge topics with appropriate technical background





Built around case studies which give the work a "hands-on" approach





Real examples of flaws in previously reported clinical trials and how to avoid them





Access to statistical code on the books website





Chapters written by internationally recognized statisticians from academia and pharmaceutical companies





Carefully edited to ensure consistency in style, level, and approach





Topics covered include innovating phase I and II designs, trials in immune-oncology and rare diseases, among many others

Recenzijos

"This highly anticipated book focuses on clinical trials in oncology, ranging from early, middle, and late phase trials to advanced topics such as precision medicine and immunotherapy. This textbook is expected to be extremely useful for statisticians and investigators who have been doing clinical trials for years, and for future clinical researchers and statisticians who are eager to learn about the design, conduct, analysis, and interpretation of clinical trials in oncology.

We strongly recommend this textbook for four reasons. First, it covers multiple stages of clinical trials in oncology, from early, middle, to late development. Second, it examines various designs of clinical trials, including traditional study designs, flexible designs, and SMART (Sequential Multiple Assignment Randomized Trials) designs. Third, it gives insights into unique aspects of clinical trials in oncology compared with other therapeutic areas, such as time-to-event endpoints and censoring. Fourth, it consists of different types of materials that are suitable to different groups of readers, with some materials for readers who like to have an aerial view of the practical considerations and the other materials for readers who like to have deep understanding to motivate their theoretical research. In the following, we explain these four reasons in detail...To summarize, because of the above four reasons, we strongly recommend this book to clinical researchers and statisticians who are interested in the development, design, conduct and analysis of oncology clinical trials. This book is well-balanced between practical considerations and statistical theories involved in oncology clinical trials. We believe that this book will help advance the design and analysis of oncology clinical trials with the ultimate goal to improve the care of oncology patients and their quality of life." - Man Jin and Yixin Fang, Journal of Biopharmaceutical Statistics, November 2019 "This highly anticipated book focuses on clinical trials in oncology, ranging from early, middle, and late phase trials to advanced topics such as precision medicine and immunotherapy. This textbook is expected to be extremely useful for statisticians and investigators who have been doing clinical trials for years, and for future clinical researchers and statisticians who are eager to learn about the design, conduct, analysis, and interpretation of clinical trials in oncology.

We strongly recommend this textbook for four reasons. First, it covers multiple stages of clinical trials in oncology, from early, middle, to late development. Second, it examines various designs of clinical trials, including traditional study designs, flexible designs, and SMART (Sequential Multiple Assignment Randomized Trials) designs. Third, it gives insights into unique aspects of clinical trials in oncology compared with other therapeutic areas, such as time-to-event endpoints and censoring. Fourth, it consists of different types of materials that are suitable to different groups of readers, with some materials for readers who like to have an aerial view of the practical considerations and the other materials for readers who like to have deep understanding to motivate their theoretical research. In the following, we explain these four reasons in detail...To summarize, because of the above four reasons, we strongly recommend this book to clinical researchers and statisticians who are interested in the development, design, conduct and analysis of oncology clinical trials. This book is well-balanced between practical considerations and statistical theories involved in oncology clinical trials. We believe that this book will help advance the design and analysis of oncology clinical trials with the ultimate goal to improve the care of oncology patients and their quality of life." - Man Jin and Yixin Fang, Journal of Biopharmaceutical Statistics, November 2019

"This book offers a comprehensive presentation of the statistical methods and issues connected with clinical trials in oncology...I would recommend this book to those who are new to the field of clinical trials in oncology and those who would like to learn about its specifics. The book covers a vast range of topics, which on its own illustrates how broad and dynamic the statistical methodology applied in oncology is...Individual chapters of the book are written by different authors. Therefore, each chapter is written by someone who is an expert in their field and can enrich the description of the methods with much appreciated insight on what is really used in practice and what the advantages and disadvantages of the methods are...Struggling with understanding some medical terms I found using the National Cancer Institute Dictionary of Cancer Terms very helpful when reading the book." - Eva Kielkowskį, ISCB News, July 2020

Acknowledgment xi
Editors xiii
Contributors xv
1 Introduction to Clinical Trials 1(8)
Susan Halabi
Stefan Michiels
Section I Early to Middle Development
2 Selection of Endpoints
9(18)
Katherine S. Panageas
Andrea Knezevic
3 Innovative Phase I Trials
27(26)
Cody Chiuzan
Nathaniel O'Connell
4 Current Issues in Phase II Cancer Clinical Trials
53(34)
Sin-Ho Jung
5 Design and Analysis of Immunotherapy Clinical Trials
87(6)
Megan Othus
6 Adaptive Designs
93(20)
William T. Barry
Section II Late Phase Clinical Trials
7 Sample Size Calculations for Phase III Trials in Oncology
113(20)
Koji Oba
Aya Kuchiba
8 Non-inferiority Trial
133(22)
Keyue Ding
Chris O'Callaghan
9 Design of Multi-Arm, Multi-Stage Trials in Oncology
155(28)
James Wason
10 Multiple Comparisons, Multiple Primary Endpoints and Subpopulation Analysis
183(20)
Ekkehard Glimm
Dong Xi
Paul Gallo
11 Cluster Randomized Trials
203(36)
Catherine M. Crespi
12 Statistical Monitoring of Safety and Efficacy
239(22)
Jay Herson
Chen Hu
Section III Personalized Medicine
13 Biomarker-Based Phase II and III Clinical Trials in Oncology
261(28)
Shigeyuki Matsui
Masataka Igeta
Kiichiro Toyoizumi
14 Genomic Biomarker Clinical Trial Designs
289(8)
Richard Simon
15 Trial Designs for Rare Diseases and Small Samples in Oncology
297(20)
Robert A. Beckman
Cong Chen
Martin Posch
Sarah Zohar
16 Statistical Methods for Biomarker and Subgroup Evaluation in Oncology Trials
317(30)
Ilya Lipkovich
Alex Dmitrienko
Bohdana Ratitch
17 Developing and Validating Prognostic Models of Clinical Outcomes
347(28)
Susan Halabi
Lira Pi
Chen-Yen Lin
18 High-Dimensional, Penalized-Regression Models in Time-to-Event Clinical Trials
375(24)
Federico Rotolo
Nils Ternes
Stefan Michiels
19 Sequential, Multiple Assignment, Randomized Trials
399(28)
Kelly Speth
Kelley M. Kidwell
Section IV Advanced Topics
20 Assessing the Value of Surrogate Endpoints
427(20)
Xavier Paoletti
Federico Rotolo
Stefan Michiels
21 Competing Risks
447(18)
Aurelien Latouche
Gang Li
Qing Yang
22 Cure Models in Cancer Clinical Trials
465(28)
Catherine Legrand
Aurelie Bertrand
23 Interval Censoring
493(18)
Yuan Wu
Susan Halabi
24 Methods for Analysis of Trials with Changes from Randomized Treatment
511(26)
Nicholas R. Latimer
Ian R. White
25 The Analysis of Adverse Events in Randomized Clinical Trials
537(22)
Jan Beyersmann
Claudia Schmoor
26 Analysis of Quality of Life Outcomes in Oncology Trials
559(28)
Stephen Walters
27 Missing Data
587(18)
Stephanie Pugh
James J. Dignam
Juned Siddique
Index 605
Susan Halabi, Ph.D. is Professor of Biostatistics and Bioinformatics, Duke University, USA. She has extensive experience in the design and analysis of clinical trials in oncology. Dr. Halabi is a fellow of the American Statistical Association, the Society of Clinical Trials, and the American Society of Clinical Oncology. She serves on the Oncologic Drugs Advisory Committee for the Food and Drug Administration.

Stefan Michiels, Ph.D. is Head of the Oncostat team of the Center for research in epidemiology and population health (INSERM U1018, University Paris-Saclay, University Paris-Sud) at Gustave Roussy, Villejuif, France. His areas of expertise are clinical trials, meta-analyses and prediction models in oncology. Stefan is the currently the chair of the biostatisticians at Unicancer, a French collaborative cancer clinical trials group. Stefan holds a PhD in Biostatistics from the School of Public Health at the University Paris-Sud and Master Degrees in Statistics and in Applied Mathematics from the University of Leuven. His previous positions include the Université Libre de Bruxelles- Institut Jules Bordet (Belgium), the National Cancer Institute (France) and the University of Leuven (Belgium). He is currently member of the editorial board of the Journal of the National Cancer Institute and Annals of Oncology.