rpact

Confirmatory Adaptive Clinical Trial Design, Simulation, and Analysis.

Functional Range

• Sample size and power calculation for
  • means (continuous endpoint)
  • rates (binary endpoint)
  • survival trials with
    • piecewise accrual time and intensity
    • piecewise exponential survival time
    • survival times that follow a Weibull distribution
• Fixed sample design and designs with interim analysis stages
• Simulation tool for means, rates, and survival 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 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")

Documentation

The documentation is hosted at https://www.rpact.org

Vignettes

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

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.

www.rpact.com/contact

About

• rpact is a comprehensive validated[1] R package for clinical research which
  • enables the design and analysis of confirmatory adaptive group sequential designs
  • is a powerful sample size calculator
  • is a free of charge open-source software licensed under LGPL-3
  • particularly, implements the methods described in the recent monograph by Wassmer and Brannath (2016)

For more information please visit www.rpact.org

• RPACT is a company which offers
  • enterprise software development services
  • technical support for the rpact package
  • consultancy and user training for clinical research using R
  • validated software solutions and R package development for clinical research

For more information please visit www.rpact.com

1. The rpact validation documentation is available exclusively for our customers and supporting members. For more information visit www.rpact.com/services/sla