generateSP23Design: Generate a seamless Phase II-III design object given some the...

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

Generate a seamless Phase II-III design object given some the true parameters and clinical trial parameters

Description

Generate a seamless Phase II-III design object given some the true parameters and clinical trial parameters

Usage

generateSP23Design(trueParameters, trialParameters)

Arguments

trueParameters

A list constisting of several components including p0, the true probability of response under control, p1, the true probability of response under treatment, theta, a list of three items (α,β,γ), baselineLambda, the base line hazard rate (constant for now), etaHyp, the hypothesized non-null hazard d.

trialParameters

A list constisting of several components including numberRecruitedEachYear, a vector of recruitment numbers for each year, interimLookTime, the calendar interim look times, followupTime, the follow-up time, adminCensoringTime, the administrative censoring time, glrBoundarySidedness, either one or two-sided generalized likelihood ratio boundaries, default one-sided, typeIError, the type I error desired, type2Error, the type II error desired, used only for computing futility boundaries (only nominally used; need to clarify), epsTypeI, the fraction to spend in interim looks for the modified Haybittle-Peto boundaries, epsTypeII, the fraction to spend in interim looks for the modified Haybittle-Peto boundaries.

Details

Generates a design object that is used throughout the simulation or an actual analysis.

Value

An informal sp23Design object, a list of four items

trueParameters	exactly the input above
trialParameters	exactly the input above
glrBoundary	a matrix of dimension number of interim looks by 4, containing the boundaries for futility and efficacy for both response and survival
interimLookHistoryDF	A data frame as described in exploreSP23Design.

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.

See Also

exploreSP23Design and examples in the examples subdirectory of this package

Examples

## trial parameters in paper
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)

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