RPACT Cloud

Interactive Platform for Statistical Methods in Clinical Research

Friedrich Pahlke

RPACT

June 24, 2026

A Journey in Trial Design Software

  • My connection to Takeda goes back to my ADDPLAN years
  • At that time, I worked with Gernot Wassmer on the further development of ADDPLAN — a legacy software that runs only on Windows
  • In my role, I also had insight into how ADDPLAN was used across the pharmaceutical industry, including at Takeda

  • For me, this was the beginning of a long journey: more than 20 years of working at the interface of adaptive design methodology and user-friendly software implementation
  • With rpact and now RPACT Cloud, we continue this work in a modern, open, validated, and web-based environment

RPACT Cloud

Why RPACT Cloud?

What are the advantages of using RPACT Cloud instead of directly using the R package rpact or other software, e.g., ADDPLAN or East?

  • User-friendly graphical user interface: Users do not need to write R code, but can point and click to design their trial
    • 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
  • Web-based: No local installation required, accessible from any device with internet access
  • Free demo available: At rpact.cloud, users can try out RPACT Cloud for free

Why RPACT Cloud? (cont’d)

  • Company installation: Companies can install RPACT Cloud on their own servers, ensuring data security and compliance with internal policies
  • Cost-effective: Installation license with a flat rate per company, no per-user fees, and no hidden costs for updates or included support
  • Continuous development: We are constantly developing and improving RPACT Cloud based on user feedback and the latest methodological research
  • Fully validated: License includes installation qualification tests for the GUI (Shiny test suite), adding on top of the rpact package validation

What can RPACT Cloud be used for?

RPACT Cloud: Trial Designs

  • Fixed sample design
  • Group sequential designs
  • Adaptive designs using the inverse normal and Fisher’s combination test, and conditional error rate principle

RPACT Cloud: Sample Size and Power Calculation

for

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

RPACT Cloud: Simulation Tool

for means, rates, survival data, and count 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 designs
    (planned for late 2026)

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

RPACT Cloud

What does it look like when we use RPACT Cloud?

RPACT Cloud – Basics

RPACT Cloud – Explore Parameter Levels

RPACT Cloud – Settings

RPACT Cloud – Quick Start Menu

RPACT Cloud – Design Tab

RPACT Cloud – Getting Help

RPACT Cloud – Copy And Paste

RPACT Cloud – Plotting

RPACT Cloud – Reporting

RPACT Cloud – Design Comparison

RPACT Cloud – Saving Designs

RPACT Cloud – Enterprise Licensing

Over the past year, four major pharmaceutical companies have licensed RPACT Cloud for internal installation and use on their own servers - fully replacing previous proprietary software.

To support these enterprise deployments, we published extensive documentation covering setup on Posit Connect, configuration, and full qualification/validation:

Internal RPACT Cloud Installation vs. Public Demo Version

Installation and operation of RPACT Cloud on a company server or on an internal Posit Connect environment provides important advantages over using the free public demo version.

Benefit Internal RPACT Cloud Installation Public Demo Version
Dedicated performance
Can be implemented with company-specific resources and scaled for expected usage, including parallel users and computationally intensive simulations. 		✓ ✗
Unlimited simulation iterations
Supports unrestricted simulation settings, subject only to the resources configured in the company environment. 		✓ ✗
Stable company-specific URLs for saved designs
Designs can be shared and revisited via a dedicated company URL; demo URLs may change at any time. 		✓ ✗
Data privacy and compliance control
Company-specific privacy, security, and compliance requirements can only be reliably ensured in an internal environment. The public demo version may use external services such as Google Analytics. 		✓ ✗
Extensive configuration options
Internal deployments can be tailored using environment variables, for example to configure app behavior, reporting, branding, authentication-related settings, and other deployment-specific options. 		✓ ✗
Installation qualification with validation report
A formal installation qualification and corresponding validation report can only be generated for a controlled company installation. 		✓ ✗
Email delivery of reports directly from RPACT Cloud
Reports can be sent directly from the application by email when this feature is configured in the company environment. 		✓ ✗
Earlier access to new features
New features, such as the count data endpoint, are typically made available in company installations months before they are released in the public demo version. 		✓ ✗
Company branding in the app and reports
Company name, logo, and other branding elements can be displayed and flexibly configured in both the application and generated reports. 		✓ ✗

Note

For deployment-specific settings, see the RPACT Cloud documentation on environment variables: https://docs.rpact.cloud/articles/guide-to-environment-variables.html

Summary

  • RPACT Cloud is our web-based graphical user interface for rpact, with a focus on ease of use and accessibility
  • We are continuously developing and improving our software based on user feedback and the latest methodological research
  • This year we are developing “RPACT Code” (working title), a next-generation agentic AI system that helps statisticians design clinical trials using natural language, while ensuring that all results are computed deterministically and reproducibly in R

Thank You