sp23design-package: sp23design: A package for the design, exploration and...

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

sp23design: A package for the design, exploration and execution of seamless Phase II-II clinical trials

Description

This package implements the methodology described in the paper below

Details

Package:	sp23design
Type:	Package
Version:	1.0
Date:	2011-05-05
License:	LGPL?
LazyLoad:	yes

The most important functions in this package are generateSP23Design, exploreSP23Design, executeSP23Design, and analyzeSP23Design

Author(s)

Mei-Chiung Shih, Balasubramanian Narasimhan, Pei He

Maintainer: Balasubramanian Narasimhan <[e-mail]>

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

## Not run: 
  catn <- function(...) cat(..., "\n")

  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)
  print(sp23Design)
  trialHistory <- exploreSP23Design(sp23Design, numberOfSimulations=25, rngSeed=rngSeed)
  result <- analyzeSP23Design(sp23Design, trialHistory)$designSummary
  catn("numberOfTimesH0RIsRejectedAtFirstLook", result[["numberOfTimesH0RIsRejectedAtFirstLook"]])
  catn("numberOfTimesH0RIsRejected", result[["numberOfTimesH0RIsRejected"]])
  catn("numberOfTimesStoppedForFutility", result[["numberOfTimesStoppedForFutility"]])
  catn("numberOfTimesH0SIsAccepted", result[["numberOfTimesH0SIsAccepted"]])
  catn("numberOfTimesH0SIsRejected", result[["numberOfTimesH0SIsRejected"]])
  catn("numberOfTimesFutilityDecidedAtLastLook",result[["numberOfTimesFutilityDecidedAtLastLook"]])
  catn("numberOfTimesTrialEndedAtLook", result[["numberOfTimesTrialEndedAtLook"]])
  catn("avgExitTime", result[["avgExitTime"]])

## End(Not run)

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