Textbook of Clinical Trials in Oncology: A Statistical Perspective

Author:   Susan Halabi (Duke University) ,  Stefan Michiels
Publisher:   Taylor & Francis Ltd
ISBN:  

9781138083776


Pages:   626
Publication Date:   13 May 2019
Format:   Hardback
Availability:   Not yet available   Availability explained
This item is yet to be released. You can pre-order this item and we will dispatch it to you upon its release.

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Textbook of Clinical Trials in Oncology: A Statistical Perspective


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Overview

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

Full Product Details

Author:   Susan Halabi (Duke University) ,  Stefan Michiels
Publisher:   Taylor & Francis Ltd
Imprint:   CRC Press
Weight:   1.344kg
ISBN:  

9781138083776


ISBN 10:   1138083771
Pages:   626
Publication Date:   13 May 2019
Audience:   College/higher education ,  Tertiary & Higher Education
Format:   Hardback
Publisher's Status:   Active
Availability:   Not yet available   Availability explained
This item is yet to be released. You can pre-order this item and we will dispatch it to you upon its release.

Table of Contents

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

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Author Information

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.

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