exploreSP23Design: Explore a specified design by simulation

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

Explore a specified design by simulation

Description

Explore a chosen design by generating simulated datasets and storing data from simulations for further analysis

Usage

exploreSP23Design(sp23Design, numberOfSimulations = 25, rngSeed = 12345,
showProgress = TRUE)

Arguments

sp23Design	A design object typically created by the function generateSP23Design
numberOfSimulations	The number of simulations to use, default 25
rngSeed	A seed for the random number generator for reproducibility
showProgress	A flag (default TRUE) to show progress or not

Details

This function is used while exploring the characteristics of a design. Results are accumulated and can be fed into analysis functions to inform choices.

Value

A list of length numberOfSimulations where each entry is a data frame with number of interim looks rows and the following variables in the column.

m0	number on control arm
m1	number on treatment arm
y0	number of responses in control
y1	number of responses in treatment
pi0Hat	estimate of the proportion of responders among control
pi1Hat	estimate of the proportion of responders among treatment
pi0HatH0	estimate of the proportion of responders among control under H_0
pi1HatH0	estimate of the proportion of responders among control under H_0
pi0HatH1	estimate of the proportion of responders among control under H_1
pi1HatH1	estimate of the proportion of responders among control under H_1
glrRespH0	estimate of the generalized likelihood ratio statistic for response under H_0
glrRespH1	estimate of the generalized likelihood ratio statistic for response under H_1
glrSurvH0	estimate of the generalized likelihood ratio statistic for survival under H_0
glrSurvH1	estimate of the generalized likelihood ratio statistic for survival under H_1
alphaHat	the estimate of α
alphaHatH0	the estimate of α under H_0
alphaHatH1	the estimate of α under H_1
betaHat	the estimate of β
betaHatH0	the estimate of β under H_0
betaHatH1	the estimate of β under H_1
gammaHat	the estimate of γ
gammaHatH0	the estimate of γ under H_0
gammaHatH1	the estimate of γ under H_1
hazard	the estimate of d
v	the estimate of Γ_t
rejectH0R	a flag indicating if $H_0^R$ was rejected at the interim look
acceptH0R	a flag indicating if $H_0^R$ was accepted (futility) at the interim look
rejectH0S	a flag indicating if $H_0^S$ was rejected at the interim look
acceptH0S	a flag indicating if $H_0^S$ was accepted (futility) at the interim look
b.metas.Last	the last Haybittle-Peto boundary for the survival end-point, if computed

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, 2011, (submitted).

Examples

## Not run: 
  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)

  ## Case C of table 1 in paper
  caseC.TrueParameters <- list(p0 = 0.3,
                               p1 = 0.6,
                               pdiffHyp=0.3,
                               theta = list(
                                   alpha = 0,
                                   beta = 0,
                                   gamma = 0),
                               baselineLambda = 0.35,
                               etaHyp = 0.25)
  ## Do case C as example
  sp23Design <- generateSP23Design(caseC.TrueParameters, trialParameters)
  trialHistory <- exploreSP23Design(sp23Design, numberOfSimulations=25, rngSeed=2387487)

## End(Not run)

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