ph2hetero (version 1.0.2)

design.jones: Jones 2-stage Phase II design

Description

Calculates Optimal 2-stage Phase II designs given by Cheryl L. Jones (2007).

Usage

design.jones(alpha=0.05,beta=0.2,p0,p1n,p1p,Nmax=100,Ppos=0.5,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.

Ppos

Prevalence of "biomarker-positive" subjects.

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.

k2p

Total number of response required during stage 1 and stage 2 combined in the amplified when preliminary efficacity is in the amplified subgroup.

N2p

Number of amplified subjects enrolled during the second stage if preliminary evidence of efficacy leads to this path.

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.

N2un

Number of unselected subjects enrolled during the second stage if preliminary evidence of efficacy leads to this path.

References

Jones CL, Holmgren E (2007).An adaptive Simon Two-Stage Design for Phase 2 studies of targeted therapies. Contemporary Clinical Trials 28 654-661.

Examples

# NOT RUN {
out.jones<-design.jones(alpha=0.05,
                        beta=0.2,
                        p0=0.03,
                        p1n=0.10,
                        p1p=0.15,
                        Nmax=150,
                        Ppos=0.40)
# }

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