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>.

Version: 1.1.4
Depends: R (≥ 3.5.0)
Imports: survival, utils, flexsurv, IPDfromKM
Suggests: knitr, rmarkdown, testthat (≥ 3.0.0)
Published: 2022-09-07
Author: Xiaomeng Yuan [aut, cre], Haitao Pan [aut], Jianrong Wu [aut]
Maintainer: Xiaomeng Yuan <xiaomeng.yuan at stjude.org>
License: GPL (≥ 3)
NeedsCompilation: no
CRAN checks: OneArm2stage results

Documentation:

Reference manual: OneArm2stage.pdf
Vignettes: OneArm2stage

Downloads:

Package source: OneArm2stage_1.1.4.tar.gz
Windows binaries: r-devel: OneArm2stage_1.1.4.zip, r-release: OneArm2stage_1.1.4.zip, r-oldrel: OneArm2stage_1.1.4.zip
macOS binaries: r-release (arm64): OneArm2stage_1.1.4.tgz, r-oldrel (arm64): OneArm2stage_1.1.4.tgz, r-release (x86_64): OneArm2stage_1.1.4.tgz, r-oldrel (x86_64): OneArm2stage_1.1.4.tgz

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