executeSP23Design | R Documentation |
This function is designed to be used in the field. Assuming a particular design is chosen, it conducts the interim analysis for a specific calendar time and provides the means for deciding whether to stop for futility or efficacy.
executeSP23Design(sp23DesignObject, data, currentCalendarTime)
sp23DesignObject |
A seamless phase II-III design object, typically one produced by the
|
data |
The interim data, something akin to that produced by the function
|
currentCalendarTime |
The current calendar time of the interim data. This better be one of the specified interim looks, or the function stops. |
This function is designed to be used in the field, although there are parts of it that are currently problematic. For example, in the field, there is typically no inkling of a responder or non-responder and yet the function as it currently stands is too wedded to the simulation scenario. Not hard to fix though.
A vector of quantities is returned.
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 |
Mei-Chiung Shih, Balasubramanian Narasimhan, Pei He
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.
## 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) 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 sp23Design <- generateSP23Design(trueParameters, trialParameters) d <- generateClinicalTrialData(nRec = trialParameters$numberRecruitedEachYear, nFUp = trialParameters$followupTime, pi0 = trueParameters$p0, pi1 = trueParameters$p1, theta = trueParameters$theta, lambda0 = trueParameters$baselineLambda) result <- executeSP23Design(sp23Design, d, trialParameters$interimLookTime[2]) ## End(Not run)
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