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Textbook of Clinical Trials in Oncology

A Statistical Perspective

Susan Halabi Stefan Michiels



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CRC Press
16 May 2019
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 book's 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
Edited by:   Susan Halabi, Stefan Michiels
Imprint:   CRC Press
Country of Publication:   United Kingdom
Dimensions:   Height: 254mm,  Width: 178mm, 
Weight:   1.329kg
ISBN:   9781138083776
ISBN 10:   1138083771
Pages:   626
Publication Date:   16 May 2019
Audience:   College/higher education ,  Primary
Format:   Hardback
Publisher's Status:   Active
Section I Introduction Introduction to Clinical Trials - Susan Halabi, Stefan Michiels Section II General Issues Selection of Endpoints - Katherine S Panageas and Andrea Knezevic Section III Early Development Innovative Phase I Trials - Cody Chiuzan and Nathaniel O'Connell Section IV Middle Development Current Issues in Phase II Cancer Clinical Trials - Sin-Ho Jung Design and Analysis of Immunotherapy Clinical Trials - Megan Othus Adaptive Designs - William T. Barry Section V Late Phase Clinical Trials Sample Size Calculations for Phase III Trials in Oncology - Koji Oba, Aye Kuchiba Non-inferiority Trial - Keyue Ding, Chris O'Callaghan Design of Multi-arm, Multi-stage Trials in Oncology - James Wason Multiple Comparisons, Multiple Primary Endpoints and Subpopulation Analysis - Ekkehard Glimm, Dong Xi, Paul Gallo Cluster Randomized Trials - Catherine M. Crespi Statistical Monitoring of Safety and Efficacy - Jay Herson, Chen Hu Section VI Personalized Medicine Biomarker-Based Phase II and III Clinical Trials in Oncology - Shigeyuki Matsui, Masataka Igeta, Kiichiro Toyoizumi Genomic Biomarker Clinical Trial Designs - Richard Simon Trial designs for rare diseases and small samples in oncology - Robert A. Beckman, Cong Chen, Martin Posch and Sarah Zohar Statistical Methods for Biomarker and Subgroup Evaluation in Oncology Trials - Ilya Lipkovich, Alex Dmitrienko, Bohdana Ratitch Developing and Validating Prognostic Models of Clinical Outcomes - Susan Halabi, Lira Pi, and Chen-Yen Lin High-Dimensional Penalized Regression Models in Time-to-Event Clinical Trials - Federico Rotolo, Nils Ternes, Stefan Michiels Sequential Multiple Assignment Randomized Trials - Kelly Speth, Kelley M. Kidwell Section VII Advanced Topics Assessing the value of surrogate endpoints - Xavier Paoletti, Federico Rotolo, Stefan Michiels Competing Risks - Aurelien Latouche, Gang Li, Qing Yang Cure models in cancer clinical trials - Catherine Legrand, Aurelie Bertrand Interval Censoring - Yuan Wu Methods for analysis of trials with changes from randomised treatment - Nicholas R. Latimer and Ian R. White The analysis of adverse events in randomized clinical trials - Jan Beyersmann, Claudia Schmoor Analysis of quality of life outcomes in oncology trials - Stephen Walters Missing Data - Stephanie Pugh, James J. Dignam, Juned Siddique

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 Universite 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.

Reviews for Textbook of Clinical Trials in Oncology: A Statistical Perspective

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 Kielkowska, ISCB News, July 2020

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