generateClinicalTrialData: A function to generate some clinical trial data according the...

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

A function to generate some clinical trial data according the joint model of response and survival for simulations

Description

The data is generated according to the model specified in the reference below, specifically,

λ(t \mid Y,Z)=λ_0(t) \exp(α Y + β Z + γ Y Z)

Usage

generateClinicalTrialData(nRec, nFUp, pi0, pi1, theta, lambda0, blockSize = 10)

Arguments

nRec	the number of patients recruited every year. Length(nRec) is the number of years of recruitment
nFUp	the number of additional years of followup
pi0	the probability of response under control arm
pi1	the probability of response under treatment arm
theta	the three dimensional parameter (α, β, γ) of the joint response/survival model
lambda0	the baseline hazard rate
blockSize	the size of the blocks for randomization of the treatment/control; we use block randomization

Details

Generates data from an exponentail distribution according to the model and adhering to the recruitment goals for each calendar year

Value

A data frame consisting of the following variables.

entryTime	entry time of the patient into the trial
responseIndicator	an indicator of patient being a responder or not
treatmentIndicator	an indicator of patient being in treatment arm or control
timeToEvent	the time to event or death in the language of the paper

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)

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