Single-Arm Phase II Survival Trial Design

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.

Author Biography

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.