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getSimulationCounts()
can be used to
perform power simulations for clinical trials with negative binomial
distributed count data. The function returns the simulated power,
stopping probabilities, conditional power, and expected sample size for
testing mean rates for negative binomial distributed event numbers in
the two treatment groups testing situation.getDesignGroupSequential()
,
getDesignInverseNormal()
, and
getDesignFisher()
now support the argument
directionUpper
to specify the direction of the alternative
for one-sided testing early at the design phase, see enhancement #26getSampleSizeCounts()
and getPowerCounts()
output boundary values also on the treatment effect scale, see
enhancement #40fetch()
and obtain()
functions can be
used to extract multiple parameters from an rpact result object and
support various output formatskable()
for rpact result objects marked
as deprecated, as the formatting and display will be handled
automatically by rpactggplot2
changed
from 2.2.0 to 3.2.0directionUpper = FALSE
has no influence
in simulation for testing rates in one-sample situationgetPerformanceScore()
for
sample size recalculation rules to the setting of binary endpoints
according to Bokelmann et
al. (2024)getSimulationMultiArmMeans()
,
getSimulationMultiArmRates()
, and
getSimulationMultiArmSurvival()
functions now support an
enhanced selectArmsFunction
argument. Previously, only
effectVector
and stage
were allowed as
arguments. Now, users can optionally utilize additional arguments for
more powerful custom function implementations, including
conditionalPower
, conditionalCriticalValue
,
plannedSubjects/plannedEvents
,
allocationRatioPlanned
, selectedArms
,
thetaH1
(for means and survival), stDevH1
(for
means), overallEffects
, and for rates additionally:
piTreatmentsH1
, piControlH1
,
overallRates
, and overallRatesControl
.getSimulationEnrichmentMeans()
,
getSimulationEnrichmentRates()
, and
getSimulationEnrichmentSurvival()
. Specifically, support
for population selection with selectPopulationsFunction
argument based on predictive/posterior probabilities added (see #32)fetch()
and obtain()
functions can be
used to extract a single parameter from an rpact result object, which is
useful for writing pipe-operator linked commands.parameterNames
and
.parameterFormatFunctions
were removed from all rpact
result objects in favor of a more efficient solutiongetSampleSizeSurvival()
/
getPowerSurvival()
:
eventsPerStage
replaced by
cumulativeEventsPerStage
singleEventsPerStage
addedgetSimulationSurvival()
:
eventsPerStage
replaced by
singleEventsPerStage
overallEventsPerStage
replaced by
cumulativeEventsPerStage
getSimulationMultiArmSurvival()
:
eventsPerStage
replaced by
cumulativeEventsPerStage
singleNumberOfEventsPerStage
replaced by
singleEventsPerArmAndStage
singleEventsPerStage
addedgetSimulationEnrichmentSurvival()
:
singleNumberOfEventsPerStage
replaced by
singleEventsPerSubsetAndStage
covr
and uploads the results to codecov.iogetSampleSizeCounts()
and
getPowerCounts()
can be used to perform sample size
calculations and the assessment of test characteristics for clinical
trials with negative binomial distributed count data. This is possible
for fixed sample size and group sequential designs. For the latter, the
methodology described in Muetze et al. (2019) is implemented. These
functions can also be used to perform blinded sample size reassessments
according to Friede and Schmidli (2010).mvnprd
, mvstud
,
as251Normal
, and as251StudentT
mnormt
dependency has been removedtheta
can be used for plotting of sample size
and power resultsgetPerformanceScore()
calculates the
conditional performance score, its sub-scores and components according
to Herrmann et al. (2020)
for a given simulation result from a two-stage designallocationRatioPlanned
for simulating multi-arm and
enrichment designs can be a vector of length kMax, the number of
stagesgetObjectRCode()
(short: rcmd()
): with the
new arguments pipeOperator
and output
many new
output variants can be specified, e.g., the native R pipe operator or
the magrittr pipe operator can be usedknitr::knit_print
for all result
objects implemented and automatic code chunk option
results = 'asis'
activateddf <= 500
because of erroneous results in mnormt
package otherwise.
For df > 500
, multivariate normal distribution is
usedomega
to chi
in class
TrialDesignPlanSurvival
sapply
removed from C++ code to
stop deprecated warnings on r-devel-linux-x86_64-fedora-clangallocationRatioPlanned
for simulating means and rates
for a two treatment groups design can be a vector of length kMax, the
number of stagescalcSubjectsFunction
can be used in C++ version for
simulating means and ratescalcEventsFunction
added in
getSimulationSurvival()getPerformanceScore()
added: calculates the performance
score for simulation means results (1 and 2 groups; 2 stages)getDataset()
to enable
pipe syntax for analysis, e.g.,
getDesignGroupSequential() |> getDataset(dataMeans) |> getAnalysisResults()
SystemRequirements: C++11
added to DESCRIPTION to
enable C++ 11 compilation on R 3.xbetaAdjustment
can also be used in
getDesignInverseNormal()
subsets
removed from result of
getWideFormat()
for non-enrichment datasetspopulations
in
getSimulationEnrichmentMeans()
,
getSimulationEnrichmentRates()
, and
getSimulationEnrichmentSurvival()
has been removed since it
is always derived from effectList
getSimulationEnrichmentRates()
for
calculated non-integer number of subjectsgetRawData()
: the resulting data.frame
now
contains the correct stopStage
and
lastObservationTime
(formerly
observationTime
)deltaWT
is provided with three decimal points for
typeOfDesign = “WToptimum”as.data.frame
functions improvedgetSimulationMultiArmSurvival()
: single stage treatment
arm specific event numbers account for selection proceduregetSimulationEnrichmentRates()
and
getSimulationEnrichmentSurvival()
getDesignCharacteristics()
getSimulationSurvival()
: the result object now contains
the new parameter overallEventsPerStage
, which contains the
values previously given in eventsPerStage
(it was
“cumulative” by mistake); eventsPerStage
contains now the
non-cumulative values as expectedstats::qnorm(1e-323)
to
stats::qnorm(1e-100)
getAnalysisResults()
: issue with zero values in the
argument ‘userAlphaSpending’ fixedgetSimulationEnrichmentMeans()
,
getSimulationEnrichmentRates()
,
getSimulationEnrichmentSurvival()
available for simulation
of enrichment designs; note that this is a novel implementation, hence
experimentalgetDesignGroupSequential()
/
getDesignInverseNormal()
: new typeOfDesign =
“noEarlyEfficacy” addedgetSimulationSurvival()
: bug fixed for
accruallIntensity = 0 at some accrual intervalsgetSimulationMultiArmMeans()
,
getSimulationMultiArmRates()
, and
getSimulationMultiArmSurvival()
testPackage()
: a problem with downloading full
set of unit tests under Debian/Linux has been fixedkable()
improved: optional
knitr::kable arguments enabled, e.g., formatqnorm()
calculations
improvedas.data.frame()
getAnalysisResults()
generalized
for enrichment designs; function getDataset()
generalized
for entering stratified data; manual extended for enrichment
designsgetAnalysisResults()
getObjectRCode()
(short:
rcmd()
) returns the original R command which produced any
rpact result object, including all dependenciesgetWideFormat()
and getLongFormat()
return
a dataset object in wide format (unstacked) or long format (narrow,
stacked)kable()
returns the output of an rpact
result object formatted in Markdown.t()
returns the transpose of an rpact
result objectgetDesignFisher()
fixed:
getDesignFisher(method = "noInteraction", kMax = 3)
and
getDesignFisher(method = "noInteraction")
produced
different resultstestPackage()
: the default call is now running only a
small subset of all available unit tests; with the new argument
‘connection’ the owners of the rpact validation documentation can enter
a ‘token’ and a ‘secret’ to get full access to all unit testsgetSampleSizeSurvival()
,
getSimulationSurvival()
,
getNumberOfSubjects()
, and
getEventProbabilities()
getParameterCaption()
and
getParameterName()
implementedas.matrix()
improved for several
result objectsgetAvailablePlotTypes()
for sample size and
power results fixedgetDesignFisher(kMax = 1)
in
getSimulationMultiArm...()
fixedgetSimulationMultiArmSurvival()
: correlation of
log-rank statistics revised and improvedgetSimulationMultiArmMeans()
: name of the first
effectMeasure option “effectDifference” changed to “effectEstimate”getSimulation[MultiArm][Means/Rates/Survival]()
:
argument ‘showStatistics’ now works correctly and is consistently FALSE
by default for multi-arm and non-multi-armgetSimulation[MultiArm]Survival()
: generic function
summary()
improvedgetAnalysisResults()
: generic function
summary()
improvedgetAccrualTime()
: improved and new argument
‘accrualIntensityType’ addedgetSampleSizeSurvival()
: field ‘studyDurationH1’ in
result object was replaced by ‘studyDuration’, i.e., ‘studyDurationH1’
is deprecated and will be removed in future versionsgetSimulationMultiArmSurvival()
: plannedEvents
redefined as overall events over treatment armsgetStageResults()
: element overallPooledStDevs added;
print output improvedgetSampleSizeSurvival()
with user
defined lambdas with different lengths: issue fixedsummary()
improved for several result
objectstestPackage()
improvedgetSimulationMultiArm[Means/Rates/Survival]()
: stage
index corrected for user defined calcSubjectsFunction or
calcEventsFunctiongetSimulationMultiArmRates()
: adjustment for identical
simulated rates to account for tiesgetSimulationMultiArmSurvival()
: corrected correlation
of test statisticsgetSimulationRates()
: exact versions for testing a rate
(one-sample case) and equality of rates (two-sample case)getEventProbabilities()
: plot of result objectgetNumberOfSubjects()
: plot of result objectplot(design1, design2)
getSimulationMeans()
: thetaH1 and stDevH1 can be
specified for assessment of sample size recalculation (replaces
thetaStandardized)getSimulationSurvival()
: separate p-values added to the
aggregated simulation data for Fisher designsgetSimulationMeans()
,
getSimulationRates()
: Cumulated number of subjects
integrated in getData objectgetSimulation[MultiArm][Means/Rates/Survival]()
: new
logical argument ‘showStatistics’ addedplot(x, type = "all")
plot(x, type = c(1, 3))
plot(x, grid = 1)
: new plot argument ‘grid’ enables the
plotting of 2 or more plots in one graphicgetAnalysisResults()
: list output implemented analogous
to the output of all other rpact objectsgetAnalysisResults()
: the following stage result
arguments were removed from result object because they were redundant:
effectSizes, testStatistics, and pValues. Please use the ‘.stageResults’
object to access them, e.g., results$.stageResults$effectSizesgetAnalysisResults()
: the following design arguments
were removed from result object because they were redundant: stages,
informationRates, criticalValues, futilityBounds, alphaSpent, and
stageLevels. Please use the ‘.design’ object to access them, e.g.,
results$.design$informationRatesplot(x, showSource = TRUE)
improved for all rpact
result objects xgetSimulationRates()
: issue for futility stopping for
Fisher’s combination test fixedgetSimulationSurvival()
: issue for expected number of
events fixedgetSimulationSurvival()
: if eventsNotAchieved > 0,
rejection/futility rate and analysis time is estimated for valid
simulation runsgetSimulationSurvival()
: output improved for
lambda1/median1/hazardRatio with length > 1getSampleSizeSurvival()
: calculation of the maximum
number of subjects given the provided argument ‘followUpTime’
improvedgetPiecewiseSurvivalTime()
: delayed response via
list-based piecewiseSurvivalTime definition enabledgetAccrualTime()
/
getSimulationSurvival()
: issue with the calculation of
absolute accrual intensity by given relative accrual intensity
fixedgetRawData()
: issue for multiple pi1 solvedgetAnalysisSurvival()
: calculation of stage wise
results not more in getStageResultsgetStageResults()
: the calculation of ‘effectSizes’ for
survival data and thetaH0 != 1 was correctedgetDataset()
of survival data: issue with the internal
storage of log ranks fixedgetSampleSizeSurvival()
with piecewise survival time:
issue with calculation of ‘maxNumberOfSubjects’ for given ‘followUpTime’
fixedsummary()
improvedgetSampleSizeSurvival()
with given
maxNumberOfSubjects improvedget[SampleSize/Power]Survival()
for Kappa !=
1 improvedsummary()
for getDesign[...]()
fixedsummary()
fixed for
getSampleSize[...]()
and getPower[...]()
summary()
implemented for
getDesign[...]()
, getSampleSize[...]()
,
getPower[...]()
, and getSimulation[...]()
results: a simple boundary summary will be displayedgetDesign[...]()
, getSampleSize[...]()
,
getPower[...]()
, and getSimulation[...]()
resultsgetStageResults()
improvedgetAccrualTime()
improvedgetSampleSizeSurvival()
improved: numeric
search for accrualTime if followUpTime is givenset.seed()
calls ‘kind’ and ‘normal.kind’ were
specified as follows: kind = “Mersenne-Twister”, normal.kind =
“Inversion”readDatasets()
fixed: variable names ‘group’ and
‘groups’ are now acceptedgetSampleSizeSurvival()
: argument ‘maxNumberOfPatients’
was renamed in ‘maxNumberOfSubjects’These binaries (installable software) and packages are in development.
They may not be fully stable and should be used with caution. We make no claims about them.