Textbook of Clinical Trials in Oncology: A Statistical Perspective, 1st Edition (Hardback) book cover

Textbook of Clinical Trials in Oncology

A Statistical Perspective, 1st Edition

Edited by Susan Halabi, Stefan Michiels

Chapman and Hall/CRC

626 pages | 103 B/W Illus.

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pub: 2019-05-16
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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

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

About the Editors

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.

Subject Categories

BISAC Subject Codes/Headings:
MATHEMATICS / Probability & Statistics / General
MEDICAL / Pharmacology
MEDICAL / Biostatistics