Capabilities of RPACT

Friedrich Pahlke

April 26, 2024

The R Package rpact – Functional Range

Trial Design

Fixed sample design and designs with interim analysis stages

  • Group sequential designs
  • Adaptive designs through use of inverse normal and Fisher’s combination test and conditional error rate principle

Easy to understand R commands:

getDesignGroupSequential()
getDesignInverseNormal()
getDesignFisher()
getDesignConditionalDunnett()

Sample size and power calculation

for

  • means (continuous endpoint)
  • rates (binary endpoint)
  • survival trials with flexible recruitment and survival time options
  • count data

Easy to understand R commands:

getSampleSizeMeans()
getPowerMeans()

…

Adaptive Analysis

for testing means, rates, and survival data

  • Calculates adjusted point estimates and confidence intervals
  • Some highlights:
    • Automatic boundary recalculations during the trial for analysis with alpha spending approach, including under- and over-running
    • Adaptive analysis tools for multi-arm trials
    • Adaptive analysis tools for enrichment design

Easy to understand R commands:

getSimulationMultiArmMeans()
getPowerMultiArmMeans()

…

Simulation Tool

for means, rates, and survival data

  • Assessment of adaptive sample size/event number recalculation strategies
  • Assessment of treatment selection strategies in multi-arm trials
  • Assessment of population selection strategies in enrichment trials

Easy to understand R commands:

getSimulationMeans()
getSimulationMultiArmMeans()

…

  • Simulation of count data is coming this year

\(\rightarrow\) rpact useful for conducting flexible simulations in clinical trial planning

The R Package rpact

Further information, installation, and usage:

RPACT Vignettes

RPACT Cloud

RPACT Cloud – Introduction

  • Graphical user interface
  • Web based usage without local installation on nearly any device
  • Provides an easy entry to rpact
  • Starting point for your R Markdown or Quarto reports
  • Helpful to learn/demonstrate the usage of rpact in a user friendly and intuitive way
  • Online available at cloud.rpact.com

RPACT Cloud – Start Page

RPACT Cloud – Design

RPACT Cloud – Reporting

RPACT Cloud – Export

RPACT Cloud – Design Comparison

The RPACT User Group

  • Boehringer Ingelheim
  • Metronomia Clinical Research
  • F. Hoffmann-La Roche
  • Excelya
  • Dr. Willmar Schwabe
  • Bayer
  • Merck
  • AbbVie
  • Dr. Falk Pharma
  • Klifo
  • FGK Clinical Research
  • UCB
  • GKM
  • Parexel
  • Nestlé
  • Janssen (Johnson & Johnson)
  • Novartis
  • PPD (Thermo Fisher Scientific)
  • Sanofi
  • Solara Consulting
  • Pfizer

What Our Users Say About RPACT

  • “One of the best software and team in the field of adaptive design!”
    (Senior Director of Statistics)
  • “rpact is by far the easiest to use.”
    (Professor, Human-Technology Interaction Group)
  • “RPACT is just amazing.” (Biostatistician)
  • “We are impressed by the high quality of the package and the excellent support by rpact.” (Biostatistics director of a pharmaceutical company)
  • “[We] exclusively uses rpact, complemented with a huge internal webportal of supporting code, documentation, internal case studies, repository of health authority questions, etc. for all clinical trial design purposes” (see DOI)
  • “Excellent package! Many thansk.” (Biostatistician)