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

560 pages | 103 B/W Illus.

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Hardback: 9781138083776
pub: 2019-05-20
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This is a textbook on the design and analysis of cancer clinical trials. It opens with a discussion of the choice of endpoints before moving onto discuss various types of trials across all phases of study, including basket trials, non-inferiority trials and multi-arm trials. It then covers some methodological topics, including missing data and competing risks, before a number of chapters cover aspects of personalized medicine. It includes contributions from various leading teachers and researchers, all thoroughly edited to ensure it is consistent in terms of level and style. It has lots of examples and case studies, and includes exercises to enable use as a course text or for self-study.

Table of Contents

Introduction to Clinical Trials - Susan Halabi, Stefan Michiels

Selection of Endpoints - Katherine S Panageas and Andrea Knezevic

Innovative Phase I Trials - Cody Chiuzan and Nathaniel O’Connell

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

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 Crespi

Statistical Monitoring of Safety and Efficacy - Jay Herson, Chen Hu

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 and Bohdana Ratitch

Developing and Validating Prognostic Models of Clinical Outcomes - Susan Halabi, Lira Pi

High-Dimensional Penalized Regression Models in Time-to-Event Clinical Trials - Federico Rotolo, Nils Ternes, and Stefan Michiels

Sequential Multiple Assignment Randomized Trials - Kelly Speth, Kelley M. Kidwell

Assessing the value of surrogate endpoints - Xavier Paoletti, Federico Rotolo, Stefan Michiels

Competing Risks - Aurelien Latouche, Gang Li and 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

About the Editors

Susan Halabi, Ph.D., is a Professor at the Department of Biostatistics and Bioinformatics at Duke University Durham, NC, USA.

Stefan Michiels, Ph.D., is at the Unit of Biostatistics and Epidemiology, Gustave Roussy; CESP Inserm, University Paris-Sud, University Paris-Saclay, Villejuif, France.

Subject Categories

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