lrstat: Power and Sample Size Calculation for Non-Proportional Hazards and Beyond

Performs power and sample size calculation for non-proportional hazards model using the Fleming-Harrington family of weighted log-rank tests. The sequentially calculated log-rank test score statistics are assumed to have independent increments as characterized in Anastasios A. Tsiatis (1982) <doi:10.1080/01621459.1982.10477898>. The mean and variance of log-rank test score statistics are calculated based on Kaifeng Lu (2021) <doi:10.1002/pst.2069>. The boundary crossing probabilities are calculated using the recursive integration algorithm described in Christopher Jennison and Bruce W. Turnbull (2000, ISBN:0849303168). The package can also be used for continuous, binary, and count data. For continuous data, it can handle missing data through mixed-model for repeated measures (MMRM). In crossover designs, it can estimate direct treatment effects while accounting for carryover effects. For binary data, it can design Simon's 2-stage, modified toxicity probability-2 (mTPI-2), and Bayesian optimal interval (BOIN) trials. For count data, it can design group sequential trials for negative binomial endpoints with censoring. Additionally, it facilitates group sequential equivalence trials for all supported data types. Moreover, it can design adaptive group sequential trials for changes in sample size, error spending function, number and spacing or future looks. Finally, it offers various options for adjusted p-values, including graphical and gatekeeping procedures.

Version: 0.2.7
Depends: R (≥ 2.10)
Imports: Rcpp (≥ 1.0.9), mvtnorm (≥ 1.1-3), lpSolve (≥ 5.6.1), shiny (≥ 1.7.1)
LinkingTo: Rcpp
Suggests: knitr, rmarkdown, testthat (≥ 3.0.0), dplyr, tidyr, survival
Published: 2024-06-13
Author: Kaifeng Lu ORCID iD [aut, cre]
Maintainer: Kaifeng Lu <kaifenglu at gmail.com>
License: GPL-2 | GPL-3 [expanded from: GPL (≥ 2)]
NeedsCompilation: yes
Materials: README NEWS
CRAN checks: lrstat results [issues need fixing before 2024-06-27]

Documentation:

Reference manual: lrstat.pdf
Vignettes: Comparing Direct Approximation and Schoenfeld Methods
Sample Size Calculation With Fixed Follow-up
Multiplicity Adjustment for Group Sequential Designs
Simulation for Group Sequential Trials
Power Calculation Using Max-Combo Tests
Sample Size Calculation Under Non-Proportional Hazards
Power Calculation With Stratification Variables

Downloads:

Package source: lrstat_0.2.7.tar.gz
Windows binaries: r-devel: lrstat_0.2.6.zip, r-release: lrstat_0.2.6.zip, r-oldrel: lrstat_0.2.6.zip
macOS binaries: r-release (arm64): lrstat_0.2.7.tgz, r-oldrel (arm64): lrstat_0.2.7.tgz, r-release (x86_64): lrstat_0.2.7.tgz, r-oldrel (x86_64): lrstat_0.2.7.tgz
Old sources: lrstat archive

Linking:

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