generateInterimData: Generate interim data for a clinical trial from a data set.

In sp23design: Design and Simulation of Seamless Phase II-III Clinical Trials

Generate interim data for a clinical trial from a data set.

Description

Generate interim data at a given time from a dataset

Usage

generateInterimData(clinicalTrialDF, interimTime, administrativeCensoringTime)

Arguments

clinicalTrialDF	The data frame from which to generate the interim data. It is assumed that the variables entryTime, responseIndicator, treatmentIndicator and timeToEvent are present
interimTime	the interim time for which the data is to generated
administrativeCensoringTime	The administrative censoring time when the study concludes

Details

As it stands this function also is geared towards the simulation scenario. Needs to be cleaned up a bit.

Value

Returns a subset of the input data frame with the following additional variables.

delta	the event indicator
eventTime	calendar event time

Furthermore, the timeToEvent variable is appropriately calculated

Author(s)

Mei-Chiung Shih, Balasubramanian Narasimhan, Pei He

References

Lai, Tze Leung and Lavori, Philip W. and Shih, Mei-Chiung. Sequential Design of Phase II-III Cancer Trials, Statistics in Medicine, Volume 31, issue 18, p.1944-1960, 2012.

Examples

  trialParameters <- list(minimumNumberOfEvents = 20,
                              minimumIncreaseInV = 0.2,
                              numberRecruitedEachYear = c(80, 120, 160, 160),
                              followupTime = 3,
                              adminCensoringTime = 7,
                              interimLookTime = c(1, 2, 3, 5, 7),
                              type1ErrorForResponse = 0.05,
                              type2ErrorForResponse = 0.01,
                              glrBoundarySidedness = "one", # one sided or two-sided
                              type1Error = 0.05,
                              type2Error = 0.10,
                              epsType1 = 1/3,
                              epsType2 = 1/3)

  trueParameters <- list(p0 = 0.3,
                             p1 = 0.3,
                             pdiffHyp=0.3,
                             theta = list(
                                     alpha = 0,
                                     beta = 0,
                                     gamma = 0),
                             baselineLambda = 0.35,
                             etaHyp = 0.25)
  rngSeed <- 9872831

  d <- generateClinicalTrialData(nRec = trialParameters$numberRecruitedEachYear,
                                     nFUp = trialParameters$followupTime,
                                     pi0 = trueParameters$p0,
                                     pi1 = trueParameters$p1,
                                     theta = trueParameters$theta,
                                     lambda0 = trueParameters$baselineLambda)
  dInterim <- generateInterimData(d, trialParameters$interimLookTime[2],
                                     trialParameters$adminCensoringTime)

sp23design documentation built on April 19, 2022, 5:08 p.m.