OneArm2stage: Phase II Single-Arm Two-Stage Designs with Time-to-Event Outcomes

Two-stage design for single-arm phase II trials with time-to-event endpoints (e.g., clinical trials on immunotherapies among cancer patients) can be calculated using this package. Two notable advantages of the package: 1) It provides flexible choices from three design methods (optimal, minmax, and admissible), and 2) the power of the design is more accurately calculated using the exact variance in the one-sample log-rank test. The package can be used for 1) planning the sample sizes and other design parameters, and 2) conducting the interim and final analyses for the Go/No-go decisions. More details about the design method can be found in: Wu, J, Chen L, Wei J, Weiss H, Chauhan A. (2020). <doi:10.1002/pst.1983>.

install.packages("OneArm2stage")

Try the OneArm2stage package in your browser