Addressing the many challenges that have arisen since the publication of its predecessor, this third edition covers the newest developments involved in the design and analysis of cancer clinical trials. Accessible to statisticians in clinical trials as well as oncologists interested in clinical trial methodology, the book presents up-to-date statistical approaches to the design and analysis of oncology clinical trials. New topics in this edition include trial designs for targeted agents, Bayesian trial design, and the inclusion of high-dimensional data and imaging techniques. This edition also contains numerous figures and examples to better explain concepts.

part Part I|106 pages

Phase I Trials

chapter 1|18 pages

Choosing a Phase I Design

ByBarry E. Storer

chapter 2|31 pages

Dose-Finding Designs Based on the Continual Reassessment Method

ByJohn O’Quigley, Alexia Iasonos

chapter 3|20 pages

Pharmacokinetics in Clinical Oncology Statistical Issues

ByGary L. Rosner, Peter Müller, Simon Lunagomez

chapter 4|11 pages

Statistics of Phase 0 Trials

ByLarry Rubinstein

chapter 5|11 pages

CRM Trials for Assessing Toxicity and Efficacy

BySumithra J. Mandrekar, Daniel J. Sargent

chapter 6|10 pages

Seamless Phase I/II Trial Design for Assessing Toxicity and Efficacy for Targeted Agents

ByAntje Hoering, Michael LeBlanc, John J. Crowley

part Part II|76 pages

Phase II Trials

chapter 7|15 pages

Overview of Phase II Clinical Trials

ByStephanie Green

chapter 8|14 pages

Designs Based on Toxicity and Response

ByGina R. Petroni, Mark R. Conaway

chapter 9|12 pages

Designs Using Time-to-Event Endpoints/Single-Arm versus Randomized Phase II Designs

ByCatherine M. Tangen, John J. Crowley

chapter 10|11 pages

Phase II Selection Designs

ByP.Y. Liu, James Moon, Michael LeBlanc

chapter 11|12 pages

Phase II with Multiple Subgroups

Designs Incorporating Disease Subtype or Genetic Heterogeneity
ByMichael LeBlanc, Cathryn Rankin, John J. Crowley

chapter 12|8 pages

Phase II/III Designs

BySally Hunsberger

part Part III|230 pages

Phase III Trials

chapter 13|13 pages

Use of Covariates in Randomization and Analysis of Clinical Trials

ByGarnet L. Anderson, Michael LeBlanc, P.Y. Liu, John J. Crowley

chapter 14|11 pages

Factorial Designs with Time-to-Event Endpoints

ByStephanie Green

chapter 15|17 pages

Early Stopping of Clinical Trials

ByMary W. Redman

chapter 16|21 pages

Noninferiority Trials

ByKenneth J. Kopecky, Stephanie Green

chapter 17|14 pages

Phase II Trials for Targeted Agents

ByAntje Hoering, Michael LeBlanc, John J. Crowley

chapter 18|27 pages

Adaptive Trial Designs

ByBrian P. Hobbs, J. Jack Lee

chapter 20|19 pages

Software for Design and Analysis of Clinical Trials

ByJ. Jack Lee, Nan Chen

chapter 21|13 pages

Cure-Rate Survival Models in Clinical Trials

ByMegan Othus, John J. Crowley, Bart Barlogie

chapter 22|29 pages

Design and Analysis of Quality-of-Life Data

ByAndrea B. Troxel, Carol M. Moinpour

chapter 23|18 pages

Economic Analyses alongside Cancer Clinical Trials

ByDean A. Regier, Scott D. Ramsey

chapter 24|26 pages

Structural and Molecular Imaging in Cancer Therapy Clinical Trials

ByBrenda F. Kurland, David A. Mankoff

part Part IV|205 pages

Exploratory and High-Dimensional Data Analyses

chapter 25|55 pages

Prognostic Factor Studies

ByMartin Schumacher, Norbert Holländer, Guido Schwarzer, Harald Binder, Willi Sauerbrei

chapter 26|15 pages

Predictive Modeling of Gene Expression Data

ByAlexander Hapfelmeier, Waheed Babatunde Yahya, Robert Rosenberg, Kurt Ulm

chapter 27|17 pages

Explained Variation and Explained Randomness for Proportional Hazards Models

ByJohn O’Quigley, Ronghui Xu

chapter 28|24 pages

Prognostic Groups by Tree-Based Partitioning and Data Refinement Methods

ByMichael LeBlanc, John J. Crowley

chapter 29|25 pages

Risk Calculators

ByDonna Pauler Ankerst, Yuanyuan Liang

chapter 30|14 pages

Developing a Score Based upon Gene Expression Profiling and Validation

ByPingping Qu, John D. Shaughnessy, Bart Barlogie, John J. Crowley

chapter 31|21 pages

Analysis of DNA Microarrays

ByShigeyuki Matsui, Hisashi Noma

chapter 32|13 pages

Methods for SNP Regression Analysis in Clinical Studies

Selection, Shrinkage, and Logic
ByMichael LeBlanc, Bryan Goldman, Charles Kooperberg

chapter 33|13 pages

Forensic Bioinformatics

ByKeith A. Baggerly, Kevin R. Coombes