Package: gsDesign2 1.2.0.9003

Yujie Zhao

gsDesign2: Group Sequential Design with Non-Constant Effect

The goal of 'gsDesign2' is to enable fixed or group sequential design under non-proportional hazards. To enable highly flexible enrollment, time-to-event and time-to-dropout assumptions, 'gsDesign2' offers piecewise constant enrollment, failure rates, and dropout rates for a stratified population. This package includes three methods for designs: average hazard ratio, weighted logrank tests in Yung and Liu (2019) <doi:10.1111/biom.13196>, and MaxCombo tests. Substantial flexibility on top of what is in the 'gsDesign' package is intended for selecting boundaries.

Authors:Keaven Anderson [aut], Yujie Zhao [aut, cre], Yilong Zhang [aut], John Blischak [aut], Yihui Xie [aut], Nan Xiao [aut], Jianxiao Yang [aut], Amin Shirazi [ctb], Ruixue Wang [ctb], Yi Cui [ctb], Ping Yang [ctb], Xin Tong Li [ctb], Chenxiang Li [ctb], Hiroaki Fukuda [ctb], Hongtao Zhang [ctb], Yalin Zhu [ctb], Shiyu Zhang [ctb], Dickson Wanjau [ctb], Merck & Co., Inc., Rahway, NJ, USA and its affiliates [cph]

# Install 'gsDesign2' in R:

install.packages('gsDesign2', repos = c('https://merck.r-universe.dev', 'https://cloud.r-project.org'))

Bug tracker:https://github.com/merck/gsdesign2/issues

Pkgdown/docs site:https://merck.github.io

Uses libs:

c++– GNU Standard C++ Library v3

On CRAN:

cpp

9.19 score 34 stars 260 scripts 856 downloads 50 exports 75 dependencies

Last updated from:29eb615576. Checks:15 OK. Indexed: yes.

Target	Result	Time
linux-devel-arm64	OK	248
linux-devel-x86_64	OK	257
source / vignettes	OK	220
linux-release-arm64	OK	238
linux-release-x86_64	OK	292
macos-release-arm64	OK	277
macos-release-x86_64	OK	578
macos-oldrel-arm64	OK	288
macos-oldrel-x86_64	OK	428
windows-devel-arm64	OK	360
windows-devel-x86_64	OK	325
windows-release-arm64	OK	381
windows-release-x86_64	OK	239
windows-oldrel-x86_64	OK	194
wasm-release	OK	139

Exports:ahr ahr_blinded as_gt as_rtf define_enroll_rate define_fail_rate expected_accrual expected_event expected_time fixed_design_ahr fixed_design_fh fixed_design_lf fixed_design_maxcombo fixed_design_mb fixed_design_milestone fixed_design_rd fixed_design_rmst gs_b gs_bound_summary gs_cp gs_cp_simple gs_create_arm gs_design_ahr gs_design_combo gs_design_npe gs_design_rd gs_design_wlr gs_info_ahr gs_info_combo gs_info_rd gs_info_wlr gs_power_ahr gs_power_combo gs_power_npe gs_power_rd gs_power_wlr gs_spending_bound gs_spending_combo gs_update_ahr lt ppwe pw_info s2pwe sequential_pval text_summary to_integer wlr_weight_1 wlr_weight_fh wlr_weight_mb wlr_weight_n

Dependencies:base64enc bigD bitops bslib cachem cli commonmark corpcor cpp11 curl data.table digest dplyr evaluate farver fastmap fontawesome fs generics ggplot2 glue gsDesign gt gtable highr htmltools htmlwidgets isoband jquerylib jsonlite juicyjuice knitr labeling lattice lifecycle litedown lt magrittr markdown Matrix memoise mime mvtnorm npsurvSS pillar pkgconfig purrr r2rtf R6 rappdirs RColorBrewer Rcpp reactable reactR rlang rmarkdown S7 sass scales stringi stringr survival tibble tidyr tidyselect tinytex utf8 V8 vctrs viridisLite withr xfun xml2 xtable yaml

Quick start for NPH sample size and power

Rendered fromgsDesign2.Rmdusingknitr::rmarkdown

Last update: 2026-08-28
Started: 2023-03-02

Help page	Topics
Average hazard ratio under non-proportional hazards	ahr
Blinded estimation of average hazard ratio	ahr_blinded
Convert summary table of a fixed or group sequential design object to a gt object	as_gt as_gt.fixed_design_summary as_gt.gs_design_summary
Write summary table of a fixed or group sequential design object to an RTF file	as_rtf as_rtf.fixed_design_summary as_rtf.gs_design_summary
Define enrollment rate	define_enroll_rate
Define failure rate	define_fail_rate
Piecewise constant expected accrual	expected_accrual
Expected events observed under piecewise exponential model	expected_event
Predict time at which a targeted event count is achieved	expected_time
Fixed design under non-proportional hazards	fixed_design_ahr fixed_design_fh fixed_design_lf fixed_design_maxcombo fixed_design_mb fixed_design_milestone fixed_design_rd fixed_design_rmst
Default boundary generation	gs_b
Bound summary table	gs_bound_summary
Conditional power computation with non-constant effect size for (non-)crossing an upper/lower boundary at future analyses given Z value at analysis i	gs_cp
Simple conditional power computation with non-constant effect size	gs_cp_simple
Create npsurvSS arm object	gs_create_arm
Calculate sample size and bounds given targeted power and Type I error in group sequential design using average hazard ratio under non-proportional hazards	gs_design_ahr
Group sequential design using MaxCombo test under non-proportional hazards	gs_design_combo
Group sequential design computation with non-constant effect and information.	gs_design_npe gs_power_design_npe gs_power_npe
Group sequential design of binary outcome measuring in risk difference	gs_design_rd
Group sequential design using weighted log-rank test under non-proportional hazards	gs_design_wlr
Information and effect size based on AHR approximation	gs_info_ahr
Information and effect size for MaxCombo test	gs_info_combo
Information and effect size under risk difference	gs_info_rd
Information and effect size for weighted log-rank test	gs_info_wlr
Group sequential design power using average hazard ratio under non-proportional hazards	gs_power_ahr
Group sequential design power using MaxCombo test under non-proportional hazards	gs_power_combo
Group sequential design power of binary outcome measuring in risk difference	gs_power_rd
Group sequential design power using weighted log rank test under non-proportional hazards	gs_power_wlr
Derive spending bound for group sequential boundary	gs_spending_bound
Derive spending bound for MaxCombo group sequential boundary	gs_spending_combo
Group sequential design using average hazard ratio under non-proportional hazards	gs_update_ahr
Create an lt table from a design summary	lt-methods lt.fixed_design_summary lt.gs_design_summary
Piecewise exponential cumulative distribution function	ppwe
Average hazard ratio under non-proportional hazards	pw_info
Approximate survival distribution with piecewise exponential distribution	s2pwe
Sequential p-value computation for gsDesign2	sequential_pval
Summary for fixed design or group sequential design objects	summary.fixed_design summary.gs_design
Generates a textual summary of a group sequential design using the AHR method.	text_summary
Round sample size and events	to_integer to_integer.fixed_design to_integer.gs_design
Weight functions for weighted log-rank test	wlr_weight wlr_weight_1 wlr_weight_fh wlr_weight_mb wlr_weight_n

Package: gsDesign2 1.2.0.9003

gsDesign2: Group Sequential Design with Non-Constant Effect

Citation

Development and contributors

Readme and manuals

Help Manual

Usage by other packages (reverse dependencies)