ph2hetero (version 1.0.2)

design.parashar: Parashar's 2-stage Phase II design

Description

Calculates Optimal 2-stage Phase II designs given by Deepak Parashar (2016).

Usage

design.parashar(alpha=0.05,beta=0.2,p0,p1n,p1p,Nmax=100,NumThreads=1)

Arguments

alpha

Type I error.

beta

Type II error.

p0

Max unacceptable response rate.

p1n

Min acceptable response rate for "negative" subgroup.

p1p

Min acceptable response rate for "positive" subgroup.

Nmax

Maximum sample size.

NumThreads

Number of threads used for parallel compilation.

Value

Returns a data.frame object which components are :

alpha

Type I error probability of the optimal design.

power

Power of the optimal design.

p0

Max unacceptable response rate.

p1n

Min acceptable response rate for "negative" subgroup.

p1p

Min acceptable response rate for "positive" subgroup.

PET

Overall probability of early termination.

EN

Expected sample size.

k1n

Minimum number of responses in marker negative subjects to go into the unselected population during stage 2.

k1p

Minimum number of responses in the marker positive subjects.

N1n

Number of marker negative subjects enrolled during the first stage.

N1p

Number of marker positive subjects enrolled during the first stage.

kep

Minimum number of responses in the enrichment population.

Nep

Number of subjects in the enrichment population.

kn

Total number of response required during stage 1 and stage 2 combined in the negative sample to conclude efficacy in the unselected population.

kp

Total number of response required during stage 1 and stage 2 combined in the amplified sample to conclude efficacy in this population when preliminary efficacy is unselected.

Nn

Number of marker negative subjects enrolled during the first stage and the second stage.

N2p

Number of marker positive subjects enrolled during the first stage and the second stage.

References

Parashar D, Bowden J, Starr C, Wernisch L and Mander A (2016).An optimal stratified Simon two-stage design. Pharmaceutical statistics 15(4) 333-40.

Examples

Run this code
# NOT RUN {
out.parashar<-design.parashar(alpha=0.05,
                              beta=0.2,
                              p0=0.03,
                              p1n=0.25,
                              p1p=0.40,
                              Nmax=30)

# }

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