rpact

Confirmatory Adaptive Clinical Trial Design, Simulation, and Analysis.

Functional Range

• Fixed sample design and designs with interim analysis stages
• Sample size and power calculation for
  • means (continuous endpoint)
  • rates (binary endpoint)
  • survival trials with flexible recruitment and survival time options
  • count data
• Simulation tool for means, rates, survival data, and count data
  • Assessment of adaptive sample size/event number recalculations based on conditional power
  • Assessment of treatment selection strategies in multi-arm trials
• Adaptive analysis of means, rates, and survival data
• Adaptive designs and analysis for multi-arm trials
• Adaptive analysis and simulation tools for enrichment design testing means, rates, and hazard ratios
• Automatic boundary recalculations during the trial for analysis with alpha spending approach, including under- and over-running

Installation

Install the latest CRAN release via

install.packages("rpact")

Development version

To use a feature from the development version, you can install the development version of rpact from GitHub.

# install.packages("pak")
pak::pak("rpact-com/rpact")

Documentation

The documentation is hosted at www.rpact.org

Vignettes

The vignettes are hosted at www.rpact.org/vignettes

Issues and Feature Requests

Please use GitHub issues to report bugs or suggest improvements for rpact.

• 🐞 Report a bug
  Please include a minimal reproducible R example, or a runnable R Markdown (.Rmd) or Quarto (.qmd) document.

• ✨ Request a feature
  Please describe the use case, affected function(s), and the expected benefit.

Before opening a new issue, please search existing issues to avoid duplicates.

Please do not include confidential, customer-specific, personal, regulated, or security-sensitive information in public issues.

RPACT Cloud

RPACT Cloud is a web-based graphical user interface for rpact.

It provides guided, browser-based access to selected rpact functionality, including study design, sample size calculation, simulation, and reporting, without requiring users to write R code.

rpact.cloud

RPACT Connect

Connecting you to insights, downloads, and premium support: connect.rpact.com

The RPACT User Group

The rpact project has an active user group consisting of decision-makers and users from the pharmaceutical industry and CROs, who meet regularly and, e.g., discuss best practices.

We invite you to be part of the RPACT User Group: benefit from know-how, shape open source development in Pharma!

Use on corporate computer systems

Please contact us to learn how to use rpact on FDA/GxP-compliant validated corporate computer systems and how to get a copy of the formal validation documentation that is customized and licensed for exclusive use by your company, e.g., to fulfill regulatory requirements. The validation documentation contains the personal access data for performing the installation qualification with testPackage().

www.rpact.com/contact

About

• rpact is a comprehensive, validated¹ R package for clinical trial planning, design, simulation, and analysis.

  It supports classic fixed designs, adaptive group sequential designs, sample size and power calculations, simulation-based operating characteristics, and confirmatory trial analysis with flexible interim decision rules.

  rpact is free of charge and open source, licensed under LGPL-3, and implements a broad range of methods described in the monograph by Wassmer and Brannath (2025).

For more information, please visit www.rpact.org

• RPACT develops Statistical Tools for Drug Development.

  We build and support open-source and commercial software solutions for clinical research, including R packages, Shiny applications, validated workflows, and cloud-based tools for trial planning, simulation, dose finding, analysis, and reporting.

  RPACT is the team behind tools such as rpact, crmPack, and RPACT Cloud.

For more information, please visit www.rpact.com