Description Usage Arguments Value Examples
Simulates replicates from a Sub-TITE trial with user specified true toxicity time distributions for different doses and subgroups and returns average summary statistics of the trial.
1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 | SimTrial(
nSims,
Nmax,
T1,
Target,
Dose,
DoseStart,
Upper,
Accrue,
groupprob,
meanmu,
meanslope,
MeanInts,
MeanSlopes,
VarInt,
VarSlope,
phetero,
Family,
SimTruth,
NSep,
NBorrow,
cohort,
FULL
)
|
nSims |
Number of Trials to Simulate. |
Nmax |
Maximum Number of Patients to enroll in the trial. |
T1 |
Reference time for toxicity. |
Target |
Target cumulative toxicity probability (or subgroup specific vector) at time T1. |
Dose |
Standardized vector of doses to try. |
DoseStart |
Dose (or vector of Doses) to enroll the first patient in each subgroup at. |
Upper |
Cutoff values used to determine if accrual in a subgroup should be suspended. |
Accrue |
Expected montly patient accrual rate. |
groupprob |
Probability vector of subgroup assignment. |
meanmu |
Prior mean of the baseline intercept parameter. |
meanslope |
Prior mean of the baseline slope parameter. |
MeanInts |
G-1 length vector of subgroup specific prior intercept means. |
MeanSlopes |
G-1 length vector of subgroup specific prior slope means. |
VarInt |
Prior Variance of Intercept Parameters. |
VarSlope |
Prior Variance of Slope Parameters. |
phetero |
Prior probability of clustering |
Family |
What distribution Family to simulate from. Options include: Exponential,Gamma, Lognormal, Uniform, Weibull. |
SimTruth |
List of 2 #Groups by #Doses matrices containing the true parameter values needed for simulating from different true time to toxicity distributions. When a Uniform distribution is chosen, the user will instead supply the true toxicity probabilities for each dose/subgroup combination in both list entries. For a gamma distribution, the user will supply a matrix for the shape parameters for each dose and subgroup, and a second matrix for the rate parameters of each dose and subgroup. |
NSep |
Number of patients to assign based on no borrowing. |
NBorrow |
Number of patients to assign based on no clustering |
cohort |
Number of patients to enroll before escalating. |
FULL |
Do we have to fully evaluate a cohort before escalating? |
A list with first entry corresponding to summaries of the operating characteristics of the design including
1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 29 30 31 32 33 34 35 36 37 38 39 40 41 42 43 44 45 46 47 48 49 50 | ##Note: nSims should be set larger than the example below.
nSims=1
###TRIAL PARAMETERS###
##Specify reference toxicity time and target
T1=6
Target=.3
##Number of Groups
##Specify upper bound for determining if the lowest dose is too toxic in a subgroup
Upper=c(.95,.95)
#' ##Standardized Dose Values and starting dose index
Dose=sort(rnorm(5))
DoseStart=1
##Maximum Sample Size
Nmax=25
##Number of patients to run separately
NSep=0
##Number of patients to borrow, but NOT cluster
NBorrow=0
##Number of patients to fully evaluate or TREAT before ESCALATING
cohort=3
##Do we fully evaluate a cohort before escalating?
FULL=0
#HYPERPARAMETERS#
##Hypermeans for baseline terms
meanmu=2.21
meanslope=-.57
##Hypervectors for subgroup specific terms
MeanInts = c(0,.46)
MeanSlopes = c(0,.04)
##Hypervariances
VarInt=5
VarSlope=1
######SIMULATION TRUTH####
##True Accrual Rate
Accrue=2
##True Distribution of subgroups
groupprob=c(.5,.5)
##True Group Toxicity probabilities at each dose level
GroupProb =matrix(c(.05,.3,.6,.7,.8,.01,.02,.13,.27,.5),nrow=2,byrow=TRUE)
##True Simulation distribution
Family="Uniform"
SimTruth = as.list(c(0,0))
SimTruth[[1]]=GroupProb
SimTruth[[2]]=GroupProb
phetero=.9
RESULTS=SimTrial(nSims,Nmax,T1,Target,Dose,DoseStart,
Upper,Accrue,groupprob,meanmu,meanslope,
MeanInts,MeanSlopes,VarInt,VarSlope,phetero,
Family,SimTruth,NSep,NBorrow,cohort,FULL)
RESULTS[[1]]
|
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