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SimNPH

SimulateNonProportionalHazards

This package provides several functions to simulate survival datawith non proportional hazards using the general purpose simulationpackageSimDesign.

This package follows the structure of SimDesing and providesfunctions that can readily be used asgenerate,analyse andsummarise arguments inSimDesign’srunSimulation function.

Usage

Installation

The current development version can be installed with:

remotes::install_git("https://github.com/SimNPH/SimNPH.git")

Getting Started

Documentation for all functions can be found in the respective helptopics in the package after installation orhere

Some examples of data generation, testing and estimation can be foundin thisvignette.

Results of the SimulationStudy

The results of the simulation study done by the CONFIRMS consortiumin the course of the EMA tender are published in the paperA Comparison of StatisticalMethods for Time-To-Event Analyses in Randomized Controlled Trials UnderNon-Proportional Hazards, Klinglmüller et al. (2025) and arepresented in ashinyliveApp.

Reproducing theResults of the Simulation study

The parameters for the simulations were set using the followingscripts:

• scripts/set_parameters_delayed_effect.R
• scripts/set_parameters_crossing_hazards.R
• scripts/set_parameters_subgroup.R
• scripts/set_parameters_progression.R

The simulations were then run using the following scripts:

• scripts/run_simulations_delayed_effect.R
• scripts/run_simulations_crossing_hazards.R
• scripts/run_simulations_subgroup.R
• scripts/run_simulations_progression.R

Which in turn usescripts/run_simulations_common.R.

All scripts are executed with the base directory of this repositoryas working directory.

Changes since the conduct of the simulation study:

• The version number of SimNPH was increased, to reproduce thesimulation study, remove the check fromrun_simulations_...
• Simulation parameters and results were previously stored in thefolderdata. This folder was renamed todata_sim_study becausedata is reserved forthe use in R packages. Change the paths accordingly.
• Therun_simulations_... scripts use the parameters froma specified data. If you want to use parameter-values you generatedyourself, update the path accordingly.

Re-Using the Scenarios

If you want to re-use the scenarios from the simulation study toinvestigate additional methods, use the scripts and documentationprovided in theSimTemplate githubrepository. Also refer to the documentation oncontributing.If you do so please cite the simulation study, you can get a bibtexentry withcitation(package="SimNPH").