A modular R package for simulating realistic clinical trial datasets, including patient generation, treatment allocation, outcomes (continuous, binary, ordinal, longitudinal), survival, dropout, adverse events, and ADaM-compatible export.

🚀 Features 📋 Patient simulation with demographic and stratified characteristics

⚖️ Flexible treatment allocation with customizable randomization ratios

📈 Outcome simulation: continuous, binary, ordinal, and longitudinal

💀 Survival endpoint generation with censoring

🚪 Dropout modeling, including AE-related dropout logic

❗ Adverse event simulation by treatment arm and severity

🌍 Multilevel support (e.g., site, region, or country-level simulation)

📤 Export to CDISC ADaM-like ADSL format

🧪 Analysis flags: ITT, SAF, PPS

📦 Designed for SAP prototyping, training, and simulation-based power analysis

📦 Installation Install from GitHub using devtools:

install.packages(“devtools”)

devtools::install_github("JorAlEs/clinicalTrialSimulator")

🔧 Requirements R version ≥ 4.1.0

Suggested packages:

tidyverse

survival

lubridate

data.table

glue

testthat (for unit testing)

roxygen2, devtools, pkgdown (for development)

Install dependencies with:

install.packages(c("tidyverse", "survival", "lubridate", "data.table", "glue"))

🧰 Main Functions Function Purpose simulate_patients() Generate baseline demographic data (age, sex, stratification, site) simulate_allocation() Assign treatments with ratio and stratification simulate_outcomes() Simulate outcomes (continuous, binary, ordinal, longitudinal) simulate_survival() Generate survival times and censoring simulate_dropout() Assign dropout flags and dropout times simulate_adverse_events() Simulate adverse events per arm and severity simulate_post_dropout_followup() Generate visit windows post-dropout or censoring export_adam_format() Export dataset in ADaM-like ADSL format

📖 Vignette See the full simulation workflow in the package vignette:

vignette("clinicalTrialSimulator_workflow")

Includes:

Full pipeline from patient generation to ADSL export

Longitudinal outcome simulation

AE-triggered dropout scenarios

Site-level simulation

🧪 Testing Unit tests are included using testthat. To run all tests:

devtools::test()

🛠 Roadmap Planned features for v1.1 and beyond:

Export to additional ADaM domains (ADAE, ADLB, ADVS)

Integration with Shiny for interactive simulation

Quarto reporting templates

AE-based discontinuation logic

GUI-powered parameter input for non-programmers

📜 License This package is released under the MIT License. Feel free to use, modify, and distribute with attribution.

🙋 Contributing & Feedback I welcome suggestions, feature requests, and collaborators!

🔗 Citation (example) Alcántara J. (2025). clinicalTrialSimulator: Modular Clinical Trial Data Simulation in R. Version 1.0. https://github.com/JorAlEs/clinicalTrialSimulator