Cancer Clinical Trials Current and Controversial Issues in Design and Analysis Chapman & Hall/CRC Biostatistics Series

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. Early Phase Clinical Trials. Late Phase Clinical Trials. Personalized Medicine. Index.

Stephen L. George, Ph.D., is professor emeritus of biostatistics in the Department of Biostatistics and Bioinformatics at the Duke University School of Medicine. For more than 20 years, he was director of biostatistics in the Duke Comprehensive Cancer Center and director of the Statistical Center of the Cancer and Leukemia Group B (CALGB). He has been closely involved in the design, conduct, and analysis of cancer clinical trials and other research projects in cancer throughout his career. He has served on and chaired data monitoring committees for treatment and prevention trials in cancer and other diseases. Dr. George is a fellow of the American Statistical Association and the Society for Clinical Trials. He also served as treasurer and member of the executive committee of the International Biometric Society, president of the Society for Clinical Trials, and biostatistician for the Oncologic Drugs Advisory Committee of the U.S. FDA.

Xiaofei Wang, Ph.D., is an associate professor of biostatistics and bioinformatics at the Duke University School of Medicine, a member of Duke Cancer Institute (DCI), and the director of statistics for the Alliance Statistics and Data Center (Alliance SDC). He has been involved in the design and analysis of cancer clinical trials and translational studies and served on special emphasis panels for NIH and FDA grants. His methodology research focuses on the development of novel designs and methods for biomarker-integrated clinical studies and methods for analyzing patient data from multiple sources. He obtained his Ph.D. in biostatistics from the University of North Carolina at Chapel Hill.

Herbert Pang, Ph.D., is an assistant professor in the School of Public Health, Li Ka Shing Faculty of Medicine (LKSFM) at the University of Hong Kong. Dr. Pang also holds an adjunct faculty position in the Department of Biostatistics and Bioinformatics at Duke University. He has been i