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gsDesignNB: Sample Size and Simulation for Negative Binomial Outcomes

Provides tools for planning and simulating recurrent event trials with overdispersed count endpoints analyzed using negative binomial (or Poisson) rate models. Implements sample size and power calculations for fixed designs with variable accrual, dropout, maximum follow-up, and event gaps, including methods of Zhu and Lakkis (2014) <doi:10.1002/sim.5947> and Friede and Schmidli (2010) <doi:10.3414/ME09-02-0060>. Supports group sequential designs by adding calendar-time analysis schedules compatible with the 'gsDesign' package and by estimating blinded information at interim looks. Includes simulation utilities for recurrent events (including seasonal rates), interim data truncation, and Wald-based inference for treatment rate ratios.

Version: 0.2.6
Depends: R (≥ 3.5.0)
Imports: data.table, gsDesign, simtrial, stats, MASS
Suggests: testthat (≥ 3.0.0), knitr, rmarkdown, ggplot2, dplyr, gt, scales
Published: 2026-02-16
DOI: 10.32614/CRAN.package.gsDesignNB
Author: Keaven Anderson [aut, cre], Nan Xiao [ctb], Hongtao Zhang [ctb], Merck & Co., Inc., Rahway, NJ, USA and its affiliates ROR ID [cph]
Maintainer: Keaven Anderson <keaven_anderson at merck.com>
BugReports: https://github.com/keaven/gsDesignNB/issues
License: GPL (≥ 3)
URL: https://keaven.github.io/gsDesignNB/, https://github.com/keaven/gsDesignNB
NeedsCompilation: no
Materials: README, NEWS
CRAN checks: gsDesignNB results

Documentation:

Reference manual: gsDesignNB.html , gsDesignNB.pdf
Vignettes: Diagnosing Blinded Information Calculation Issues (source, R code)
Group sequential simulation with completers analysis (source, R code)
Group sequential design and simulation (source, R code)
Non-inferiority and super-superiority designs (source, R code)
Sample size calculation for negative binomial outcomes (source, R code)
Seasonal event simulation (source, R code)
Simulation of recurrent events (source, R code)
Sample size re-estimation example (source, R code)
Verification of sample size calculation via simulation (source, R code)

Downloads:

Package source: gsDesignNB_0.2.6.tar.gz
Windows binaries: r-devel: gsDesignNB_0.2.6.zip, r-release: gsDesignNB_0.2.6.zip, r-oldrel: gsDesignNB_0.2.6.zip
macOS binaries: r-release (arm64): gsDesignNB_0.2.6.tgz, r-oldrel (arm64): gsDesignNB_0.2.6.tgz, r-release (x86_64): gsDesignNB_0.2.6.tgz, r-oldrel (x86_64): not available

Linking:

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These binaries (installable software) and packages are in development.
They may not be fully stable and should be used with caution. We make no claims about them.
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