商品描述
Single-Arm Phase II Survival Trial Design provides a comprehensive summary to the most commonly- used methods for single-arm phase II trial design with time-to-event endpoints. Single-arm phase II trials are a key component for successfully developing advanced cancer drugs and treatments, particular for target therapy and immunotherapy in which time-to-event endpoints are often the primary endpoints. Most test statistics for single-arm phase II trial design with time-to-event endpoints are not available in commercial software.
Key Features:
- Covers the most frequently used methods for single-arm phase II trial design with time-to-event endpoints in a comprehensive fashion.
- Provides new material on phase II immunotherapy trial design and phase II trial design with TTP ratio endpoint.
- Illustrates trial designs by real clinical trial examples
- Includes R code for all methods proposed in the book, enabling straightforward sample size calculation.
作者簡介
Jianrong (John) Wu is a professor in the Division of Cancer Biostatistics, Department of Internal Medicine, University of Kentucky; Biostatistics and Bioinformatics Shared Resource, Markey Cancer Center. Dr. Wu has more than 20 years' experience of designing and conducting cancer clinical trials at St. Jude Children's Research Hospital and Markey Cancer Center and has developed many novel statistical methods for designing and monitoring single-arm phase II and randomized phase III trial design with time-to-event endpoints.
作者簡介(中文翻譯)
吳建榮（John Wu）是肯塔基大學內科學系癌症生物統計學部門的教授，同時也是馬基癌症中心的生物統計學和生物信息學共享資源的成員。吳博士在聖裘德兒童研究醫院和馬基癌症中心擁有超過20年的癌症臨床試驗設計和執行經驗，並開發了許多新穎的統計方法，用於設計和監測單臂II期和隨機III期試驗，其中包括時間至事件結束點。
