
Getting started with rpact
Friedrich Pahlke and Gernot Wassmer
2025-03-25
Source:vignettes/rpact_getting_started.Rmd
rpact_getting_started.Rmd
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
Learn to use rpact
We recommend three ways to learn how to use rpact
:
- Use the Shiny app: shiny.rpact.com
- Use the Vignettes: www.rpact.org/vignettes
- Book a training: www.rpact.com
Vignettes
The vignettes are hosted at www.rpact.org/vignettes and cover the following topics:
- Defining Group Sequential Boundaries with rpact
- Designing Group Sequential Trials with Two Groups and a Continuous Endpoint with rpact
- Designing Group Sequential Trials with a Binary Endpoint with rpact
- Designing Group Sequential Trials with Two Groups and a Survival Endpoint with rpact
- Simulation-Based Design of Group Sequential Trials with a Survival Endpoint with rpact
- An Example to Illustrate Boundary Re-Calculations during the Trial with rpact
- Analysis of a Group Sequential Trial with a Survival Endpoint using rpact
- Defining Accrual Time and Accrual Intensity with rpact
- How to use R Generics with rpact
- How to Create Admirable Plots with rpact
- Comparing Sample Size and Power Calculation Results for a Group Sequential Trial with a Survival Endpoint: rpact vs. gsDesign
- Supplementing and Enhancing rpact’s Graphical Capabilities with ggplot2
- Using the Inverse Normal Combination Test for Analyzing a Trial with Continuous Endpoint and Potential Sample Size Re-Assessment with rpact
- Planning a Trial with Binary Endpoints with rpact
- Planning a Survival Trial with rpact
- Simulation of a Trial with a Binary Endpoint and Unblinded Sample Size Re-Calculation with rpact
- How to Create Summaries with rpact
- How to Create One- and Multi-Arm Analysis Result Plots with rpact
- How to Create One- and Multi-Arm Simulation Result Plots with rpact
- Simulating Multi-Arm Designs with a Continuous Endpoint using rpact
- Analysis of a Multi-Arm Design with a Binary Endpoint using rpact
- Step-by-Step rpact Tutorial
- Planning and Analyzing a Group-Sequential Multi-Arm Multi-Stage
Design with Binary Endpoint using rpact
- Two-arm Analysis for Continuous Data with Covariates from Raw Data using rpact (exclusive)
- How to Install the Latest rpact Developer Version (exclusive)
- Delayed Response Designs with rpact
- Sample Size Calculation for Count Data
User Concept
Workflow
- Everything is starting with a design, e.g.:
design <- getDesignGroupSequential()
- Find the optimal design parameters with help of
rpact
comparison tools:getDesignSet
- Calculate the required sample size, e.g.:
getSampleSizeMeans()
,getPowerMeans()
- Simulate specific characteristics of an adaptive design, e.g.:
getSimulationMeans()
- Collect your data, import it into R and create a dataset:
data <- getDataset()
- Analyze your data:
getAnalysisResults(design, data)
Focus on Usability
The most important rpact
functions have intuitive
names:
-
getDesign
[GroupSequential
/InverseNormal
/Fisher
]()
getDesignCharacteristics()
-
getSampleSize
[Means
/Rates
/Survival
/Counts
]()
-
getPower
[Means
/Rates
/Survival
/Counts
]()
-
getSimulation
[MultiArm
/Enrichment
]`[
Means/
Rates/
Survival]
()` getDataSet()
getAnalysisResults()
getStageResults()
RStudio/Eclipse: auto code completion makes it easy to use these functions.
R generics
In general, everything runs with the R standard functions which are
always present in R: so-called R generics, e.g., print
,
summary
, plot
, as.data.frame
,
names
, length
Utilities
Several utility functions are available, e.g.
getAccrualTime()
getPiecewiseSurvivalTime()
getNumberOfSubjects()
getEventProbabilities()
getPiecewiseExponentialDistribution()
- survival helper functions for conversion of
pi
,lambda
andmedian
, e.g.,getLambdaByMedian()
-
testPackage()
: installation qualification on a client computer or company server (via unit tests)
Validation
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.
RPACT Connect
Connecting you to insights, downloads, and premium support: connect.rpact.com
About
-
rpact is a comprehensive validated1 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