| gen2simon {gen2stage} | R Documentation |
Generalized Simon's 2-stage phase II design
Description
Calculates generalized optimal and minimax 2-stage phase II designs based on the R function ph2simon.
Usage
gen2simon(pu, pa, ep1, ep2, nmax=100)
## S3 method for class 'gen2simon'
print(x, ...)
## S3 method for class 'gen2simon'
plot(x, ...)
Arguments
pu |
unacceptable response/toxicity rate |
pa |
response/toxicity rate that is desirable |
ep1 |
threshold for the probability of declaring drug/treatment desirable under p0 |
ep2 |
threshold for the probability of rejecting the drug/treatment under p1 |
nmax |
maximum total sample size (default 100; can be at most 500) |
x |
object returned by gen2simon |
... |
arguments to be passed onto plot and print commands called within |
Value
gen2simon returns a list with pu, pa, alpha, beta and nmax as above and:
out |
matrix of best 2 stage designs for each value of total sample size n. The 6 columns are: r1, n1, r, n, EN(p0), PET(p0), alpha, beta |
The "print" method formats and returns the minimax and optimal designs. The "plot" plots the expected sample size agains the maximum sample size as in Jung et al., 2001
References
Kim S and Wong WK. Phase II Two-Stage Single-Arm Clinical Trials for Testing Toxicity Levels. Commun Stat Appl Methods. 2019 Mar;26(2):163-173. https://www.ncbi.nlm.nih.gov/pubmed/31106162.
Jung SH, Carey M and Kim KM. (2001). Graphical Search for Two-Stage Designs for Phase II Clinical Trials. Controlled Clinical Trials 22, 367-372.
Simon R. (1989). Optimal Two-Stage Designs for Phase II Clinical Trials. Controlled Clinical Trials 10, 1-10.
See Also
Examples
# Two-stage safety design with pu (p0) = 0.33 vs. pa (p1) = 0.20
gen2simon(0.33, 0.20, 0.05, 0.20)
gen2simon(0.33, 0.20, 0.05, 0.10, nmax=150)
# Two-stage efficacy design with pu (p0) = 0.67 vs. pa (p1) = 0.80
gen2simon(0.67, 0.80, 0.05, 0.20)
gen2simon(0.67, 0.80, 0.05, 0.10, nmax=150)
# save, print and plot
safety2 = gen2simon(0.33, 0.20, 0.05, 0.20)
print(safety2)
plot(safety2)