Cancer Clinical Trials : Current and Controversial Issues in Design and Analysis

This book provides statisticians with an understanding of the critical challenges currently encountered in oncology trials. Top researchers in academia, government, and the industry present many examples drawn from real trials. The book covers 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. It also 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.

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.