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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

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

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

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Version

Install

install.packages('rpact')

Monthly Downloads

1,194

Version

3.0.4

License

LGPL-3

Maintainer

Friedrich Pahlke

Last Published

March 2nd, 2021

Functions in rpact (3.0.4)

AccrualTime

Accrual Time
AnalysisResultsGroupSequential

Analysis Results Group Sequential
AnalysisResultsMultiArm

Basic Class for Analysis Results Multi-Arm
AnalysisResultsFisher

Analysis Results Fisher
AnalysisResultsInverseNormal

Analysis Results Inverse Normal
AnalysisResultsMultiArmFisher

Analysis Results Multi-Arm Fisher
AnalysisResultsMultiArmInverseNormal

Analysis Results Multi-Arm Inverse Normal
AnalysisResultsConditionalDunnett

Analysis Results Multi-Arm Conditional Dunnett
AnalysisResultsMultiArmGroupSequential

Analysis Results Multi-Arm Group Sequential
ConditionalPowerResults

Conditional Power Results
AnalysisResults

Basic Class for Analysis Results
AnalysisResults_as.data.frame

Coerce AnalysisResults to a Data Frame
ClosedCombinationTestResults

Analysis Results Closed Combination Test
NumberOfSubjects

Number Of Subjects
ParameterSet

Parameter Set
AnalysisResults_summary

Analysis Results Summary
ParameterSet_as.data.frame

Coerce Parameter Set to a Data Frame
AnalysisResults_names

Names of a Analysis Results Object
ParameterSet_print

Print Parameter Set Values
SimulationResultsSurvival

Class for Simulation Results Survival
SimulationResultsRates

Class for Simulation Results Rates
FieldSet_names

Names of a Field Set Object
FieldSet

Field Set
getAnalysisResults

Get Analysis Results
StageResults_as.data.frame

Coerce Stage Results to a Data Frame
getAccrualTime

Get Accrual Time
StageResultsSurvival

Stage Results of Survival Data
DatasetRates

Dataset of Rates
DatasetMeans

Dataset of Means
PowerAndAverageSampleNumberResult_as.data.frame

Coerce Power And Average Sample Number Result to a Data Frame
SimulationResultsMultiArmRates

Class for Simulation Results Multi-Arm Rates
getDesignConditionalDunnett

Get Design Conditional Dunnett Test
getDesignFisher

Get Design Fisher
SimulationResultsMeans

Class for Simulation Results Means
Dataset

Dataset
SimulationResultsMultiArmMeans

Class for Simulation Results Multi-Arm Means
DatasetSurvival

Dataset of Survival Data
EventProbabilities

Event Probabilities
ParameterSet_summary

Parameter Set Summary
SimulationResults_names

Names of a Simulation Results Object
StageResults

Basic Stage Results
TrialDesignPlanSurvival

Trial Design Plan Survival
getParameterName

Get Parameter Name
TrialDesignPlan_as.data.frame

Coerce Trial Design Plan to a Data Frame
getParameterCaption

Get Parameter Caption
getSampleSizeMeans

Get Sample Size Means
PiecewiseSurvivalTime

Piecewise Exponential Survival Time
StageResults_names

Names of a Stage Results Object
PowerAndAverageSampleNumberResult

Power and Average Sample Number Result
PlotSettings

Plot Settings
getSampleSizeRates

Get Sample Size Rates
SimulationResults

Class for Simulation Results
FieldSet_print

Print Field Set Values
param_allocationRatioPlanned

Parameter Description: Allocation Ratio Planned
param_allocationRatioPlanned_sampleSize

Parameter Description: Allocation Ratio Planned With Optimum Option
param_median2

Parameter Description: Median (2)
getEventProbabilities

Get Event Probabilities
TrialDesignPlanRates

Trial Design Plan Rates
getConditionalPower

Get Conditional Power
getClosedConditionalDunnettTestResults

Get Closed Conditional Dunnett Test Results
getDesignSet

Get Design Set
TrialDesignCharacteristics

Trial Design Characteristics
TrialDesignPlanMeans

Trial Design Plan Means
TrialDesign

Basic Trial Design
FrameSet_as.matrix

Coerce Frame Set to a Matrix
getRepeatedConfidenceIntervals

Get Repeated Confidence Intervals
StageResultsRates

Stage Results of Rates
SimulationResultsMultiArmSurvival

Class for Simulation Results Multi-Arm Survival
TrialDesignConditionalDunnett

Conditional Dunnett Design
TrialDesignCharacteristics_as.data.frame

Coerce TrialDesignCharacteristics to a Data Frame
plotTypes

Get Available Plot Types
StageResultsMeans

Stage Results of Means
TrialDesignInverseNormal

Inverse Normal Design
TrialDesignPlan

Basic Trial Design Plan
TrialDesignGroupSequential

Group Sequential Design
TrialDesignFisher

Fisher Design
getClosedCombinationTestResults

Get Closed Combination Test Results
SummaryFactory

Summary Factory
TrialDesignSet

Class for trial design sets.
TrialDesignSet_length

Length of Trial Design Set
TrialDesignSet_as.data.frame

Coerce Trial Design Set to a Data Frame
getDesignInverseNormal

Get Design Inverse Normal
getDesignGroupSequential

Get Design Group Sequential
getFinalConfidenceInterval

Get Final Confidence Interval
Trial_Design_Set_summary

Trial Design Set Summary
TrialDesignSet_names

Names of a Trial Design Set Object
TrialDesign_as.data.frame

Coerce TrialDesign to a Data Frame
getTestActions

Get Test Actions
param_accrualIntensity

Parameter Description: Accrual Intensity
getFinalPValue

Get Final P Value
param_minNumberOfEventsPerStage

Parameter Description: Min Number Of Events Per Stage
getDataset

Get Dataset
getRepeatedPValues

Get Repeated P Values
getPowerAndAverageSampleNumber

Get Power And Average Sample Number
getConditionalRejectionProbabilities

Get Conditional Rejection Probabilities
getData

Get Simulation Data
getLambdaStepFunction

Get Lambda Step Function
getPiecewiseSurvivalTime

Get Piecewise Survival Time
getSampleSizeSurvival

Get Sample Size Survival
getPowerMeans

Get Power Means
getLogLevel

Get Log Level
getSimulationMeans

Get Simulation Means
param_design_with_default

Parameter Description: Design with Default
param_digits

Parameter Description: Digits
param_alternative

Parameter Description: Alternative
param_alpha

Parameter Description: Alpha
getDesignCharacteristics

Get Design Characteristics
getOutputFormat

Get Output Format
getPowerSurvival

Get Power Survival
getNumberOfSubjects

Get Number Of Subjects
param_conditionalPower

Parameter Description: Conditional Power
getSimulationMultiArmSurvival

Get Simulation Multi-Arm Survival
getSimulationRates

Get Simulation Rates
param_pi2_rates

Parameter Description: Pi (2) for Rates
getPowerRates

Get Power Rates
param_pi2_survival

Parameter Description: Pi (2) for Survival Data
getSimulationMultiArmMeans

Get Simulation Multi-Arm Means
param_accrualIntensityType

Parameter Description: Accrual Intensity Type
getRawData

Get Simulation Raw Data for Survival
getSimulationMultiArmRates

Get Simulation Multi-Arm Rates
param_accrualTime

Parameter Description: Accrual Time
param_bindingFutility

Parameter Description: Binding Futility
param_selectArmsFunction

Parameter Description: Select Arms Function
getSimulationSurvival

Get Simulation Survival
param_beta

Parameter Description: Beta
param_conditionalPowerSimulation

Parameter Description: Conditional Power
param_showSource

Parameter Description: Show Source
getStageResults

Get Stage Results
param_activeArms

Parameter Description: Active Arms
param_intersectionTest

Parameter Description: Intersection Test
param_groups

Parameter Description: Number Of Treatment Groups
param_hazardRatio

Parameter Description: Hazard Ratio
param_adaptations

Parameter Description: Adaptations
param_dropoutRate1

Parameter Description: Dropout Rate (1)
param_nPlanned

Parameter Description: N Planned
param_directionUpper

Parameter Description: Direction Upper
param_kMax

Parameter Description: Maximum Number of Stages
param_three_dots

Parameter Description: "..."
param_niceColumnNamesEnabled

Parameter Description: Nice Column Names Enabled
plot.StageResults

Stage Results Plotting
plot.TrialDesign

Trial Design Plotting
param_epsilonValue

Parameter Description: EpsilonValue
param_three_dots_plot

Parameter Description: "..." (optional plot arguments)
param_dataInput

Parameter Description: Data Input
writeDatasets

Write Multiple Datasets
param_stDevH1

Parameter Description: Standard Deviation Under Alternative
param_includeAllParameters

Parameter Description: Include All Parameters
param_grid

Parameter Description: Grid (Output Specification Of Multiple Plots)
param_informationRates

Parameter Description: Information Rates
param_stDevSimulation

Parameter Description: Standard Deviation for Simulation
param_gED50

Parameter Description: G ED50
param_maxNumberOfSubjects

Parameter Description: Maximum Number Of Subjects
param_calcEventsFunction

Parameter Description: Calculate Events Function
param_threshold

Parameter Description: Threshold
param_design

Parameter Description: Design
param_pi1_rates

Parameter Description: Pi (1) for Rates
param_rValue

Parameter Description: RValue
plot.AnalysisResults

Analysis Results Plotting
param_seed

Parameter Description: Seed
param_pi1_survival

Parameter Description: Pi (1) for Survival Data
param_maxNumberOfSubjectsPerStage

Parameter Description: Maximum Number Of Subjects Per Stage
plot.EventProbabilities

Event Probabilities Plotting
param_tolerance

Parameter Description: Tolerance
param_eventTime

Parameter Description: Event Time
param_effectMatrix

Parameter Description: Effect Matrix
param_calcSubjectsFunction

Parameter Description: Calculate Subjects Function
plot.NumberOfSubjects

Number Of Subjects Plotting
param_kappa

Parameter Description: Kappa
param_normalApproximation

Parameter Description: Normal Approximation
param_slope

Parameter Description: Slope
param_lambda1

Parameter Description: Lambda (1)
param_effectMeasure

Parameter Description: Effect Measure
param_palette

Parameter Description: Palette
param_dropoutRate2

Parameter Description: Dropout Rate (2)
param_maxNumberOfEventsPerStage

Parameter Description: Max Number Of Events Per Stage
plot.Dataset

Dataset Plotting
plot.SimulationResults

Simulation Results Plotting
plot.ParameterSet

Parameter Set Plotting
setOutputFormat

Set Output Format
param_maxNumberOfIterations

Parameter Description: Maximum Number Of Iterations
resetLogLevel

Reset Log Level
readDatasets

Read Multiple Datasets
param_stage

Parameter Description: Stage
param_stageResults

Parameter Description: Stage Results
param_plotPointsEnabled

Parameter Description: Plot Points Enabled
param_nMax

Parameter Description: N_max
param_plannedSubjects

Parameter Description: Planned Subjects
param_minNumberOfSubjectsPerStage

Parameter Description: Minimum Number Of Subjects Per Stage
param_stDev

Parameter Description: Standard Deviation
param_dropoutTime

Parameter Description: Dropout Time
printCitation

Print Citation
param_typeOfSelection

Parameter Description: Type of Selection
param_theta

Parameter Description: Theta
param_typeOfShape

Parameter Description: Type Of Shape
param_successCriterion

Parameter Description: Success Criterion
testPackage

Test Package
utilitiesForPiecewiseExponentialDistribution

The Piecewise Exponential Distribution
param_lambda2

Parameter Description: Lambda (2)
param_showStatistics

Parameter Description: ShowStatistics
param_thetaH0

Parameter Description: Theta H0
param_maxNumberOfSubjects_survival

Parameter Description: Maximum Number Of Subjects For Survival Endpoint
param_median1

Parameter Description: Median (1)
param_legendPosition

Parameter Description: Legend Position On Plots
param_thetaH1

Parameter Description: Effect Under Alternative
param_plannedEvents

Parameter Description: Planned Events
param_piecewiseSurvivalTime

Parameter Description: Piecewise Survival Time
param_sided

Parameter Description: Sided
[,TrialDesignSet-method

Access Trial Design by Index
readDataset

Read Dataset
rpact

rpact - Confirmatory Adaptive Clinical Trial Design and Analysis
setLogLevel

Set Log Level
param_varianceOption

Parameter Description: Variance Option
param_userAlphaSpending

Parameter Description: User Alpha Spending
plot.TrialDesignSet

Trial Design Set Plotting
param_typeOfDesign

Parameter Description: Type of Design
utilitiesForSurvivalTrials

Survival Helper Functions for Conversion of Pi, Lambda, Median
plot.TrialDesignPlan

Trial Design Plan Plotting
writeDataset

Write Dataset
param_typeOfComputation

Parameter Description: Type Of Computation