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