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>.
