Description Usage Arguments Value Author(s) References Examples
Calculates Optimal 2-stage Phase II designs given by Cheryl L. Jones (2007).
1 | design.jones(alpha=0.05,beta=0.2,p0,p1n,p1p,Nmax=100,Ppos=0.5,NumThreads=1)
|
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. |
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. |
Patrick Sfumato and Bastien Cabarrou.
Jones CL, Holmgren E (2007).An adaptive Simon Two-Stage Design for Phase 2 studies of targeted therapies. Contemporary Clinical Trials 28 654-661.
1 2 3 4 5 6 7 | 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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