OneArm2stage: Optimal One-Arm Two-Stage Phase II Design with Survival Endpoint
The proposed two-stage design can be used for single-arm phase II trial designs with
time-to-event endpoints, which is desirable for clinical trials on immunotherapies
among cancer patients. There're two advantages of the proposed approach: 1) It provides
flexible choices of four underlying survival distributions and 2) the power of the design
is more accurately calculated using exact variance in one-sample log-rank test. The package
can be used for 1) planning the sample size; 2) conducting the interim and final analyses for
the Go/No-go decisions. More details about the design method can be found in the paper:
Wu, J, Chen L, Wei J, Weiss H, Chauhan A. (2020). <doi:10.1002/pst.1983>.
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