Features
•Presents state-of-the-art approaches to the design and analysis of cancer clinical trials, such as adaptive designs, biomarker-based trials, and dynamic treatment regimes
•Explains the importance of the selection of endpoints, use of historical data, multiplicity, analysis of safety data, discovery and validation of predictive signatures, dose-finding, sample size, and non-inferiority designs
•Includes contributions from top researchers in academia, government, and the industry
•Contains many examples drawn from real cancer clinical trials

Summary

Cancer Clinical Trials: Current and Controversial Issues in Design and Analysis provides statisticians with an understanding of the critical challenges currently encountered in oncology trials. Well-known statisticians from academic institutions, regulatory and government agencies (such as the U.S. FDA and National Cancer Institute), and the pharmaceutical industry share their extensive experiences in cancer clinical trials and present examples taken from actual trials.


The book covers topics that are often perplexing and sometimes controversial in cancer clinical trials. Most of the issues addressed are also important for clinical trials in other settings. After discussing general topics, the book focuses on aspects of early and late phase clinical trials. It also explores personalized medicine, including biomarker-based clinical trials, adaptive clinical trial designs, and dynamic treatment regimes.

General Issues
Endpoints for Cancer Clinical Trials
Stephen L. George, Xiaofei Wang, and Herbert Pang

Use of Historical Data
Simon Wandel, Heinz Schmidli, and Beat Neuenschwander

Multiplicity
Dong Xi, Ekkehard Glimm, and Frank Bretz

Analysis of Safety Data
Steven Snapinn and Qi Jiang


Early Phase Clinical Trials
Development and Validation of Predictive Signatures
Michael C. Sachs and Lisa M. McShane

Phase I Trials and Dose-Finding
Mark R. Conaway and Nolan A. Wages

Design and Analysis of Phase II Cancer Clinical Trials
Sin-Ho Jung


Late Phase Clinical Trials
Sample Size for Survival Trials in Cancer
Edward Lakatos

Non-Inferiority Trials
Rajeshwari Sridhara and Thomas Gwise

Quality of Life
Diane Fairclough


Personalized Medicine
Biomarker-Based Clinical Trials
Edward L. Korn and Boris Freidlin

Adaptive Clinical Trial Designs in Oncology
J. Jack Lee and Lorenzo Trippa

Dynamic Treatment Regimes
Marie Davidian, Anastasios (Butch) Tsiatis, and Eric Laber


Index