OneArm2stage
CRANOneArm2stageMaRDI QIDQ86702FDOQ86702
Phase II Single-Arm Two-Stage Designs with Time-to-Event Outcomes
Jianrong Wu, Haitao Pan, Xiaomeng Yuan
Last update: 9 October 2023
Copyright license: GNU General Public License
Software version identifier: 1.1.5, 1.1.4, 1.2.1
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 ofthe design is more accurately calculated using the exact variance in theone-sample log-rank test. The package can be used for 1) planning the samplesizes and other design parameters, and 2) conducting the interim and finalanalyses for the Go/No-go decisions. More details about the design methodcan be found in: Wu, J, Chen L, Wei J, Weiss H, Chauhan A. (2020).<doi:10.1002/pst.1983>.
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