ReturnOCS {Phase123}

Gives operating characteristics of phase 123 and conventional design.

Description

Returns the probability of selecting the optimal dose, type I error, generalized power, probability of making the best decision, average number of patients treated and average trial duration.

Usage

ReturnOCS(Results, Means, CMu, Delta, Hyp)

Arguments

Results

List containing phase 123 and conventional design results.

Means

True mean survival times for experimental agents at each dose.

CMu

Mean survival time for the control therapy.

Delta

Desired improvement in survival.

Hyp

Null=0 or alternative=1 hypthesis

References

[1] Chapple and Thall (2018). A Hybrid Phase 12/3 Clinical Trial Design Allowing Dose-Re-Optimization in Phase 3 Biometrics. Under Review.

Examples

##True Mean Control
CMu=24
##True Means Agent
Means = c(27,32,38,42,28)
##Desired improvement in mean survival
Delta=12
##Random Trial results
 Results=as.list(c(0,0))
 nSims=5
 X=matrix(rep(NA,nSims*4),nrow=nSims)
 ##DoseSelected
 X[,1]=c(2,3,4,4,3)
 X[,2]=c(0,1,1,1,1)
 X[,3]=c(270,500,500,420,400)
 X[,4]=c(70,85,88,70,88)
 Results[[1]]=X
 X[,1]=c(2,3,5,4,2)
 X[,2]=c(0,1,0,1,0)
 X[,3]=c(270,500,450,420,415)
 X[,4]=c(70,82,80,70,79)
Results[[2]]=X
Hyp=1
ReturnOCS(Results,Means,CMu,Delta,Hyp)