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