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

There are many important and controversial topics in the design and analysis of cancer clinical trials, such as adaptive design and biomarker-integrated designs and analyses. This book provides readers a current understanding of the critical issues in these topics with state-of-the-art approaches and deepens the ongoing discussion in a well-informed and balanced fashion.

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 involved in the design, monitoring, and analysis of cancer clinical trials, translational, and big data-omics research in cancer for CALGB, Alliance SDC, DCI, and LKSFM. He has served on the editorial board of the Journal of Clinical Oncology and has received several honors, including the U.S. Chinese Anti-Cancer Association-Asian Fund for Cancer Research Scholar Award. He obtained his Ph.D. in biostatistics from Yale University and B.A. in mathematics and computer science from the University of Oxford.