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60 black & white illustrations, 39 black & white tables
Herbert Pang, Stephen L. George, Xiaofei Wang
Table Of Contents
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
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.