Calculates Optimal and Minimax 2-stage Phase II designs given by
Richard Simon

Usage

ph2simon(pu, pa, ep1, ep2, nmax=100)
# S3 method for ph2simon
print(x, …)
# S3 method for ph2simon
plot(x, …)

Arguments

pu

unacceptable response rate

pa

response rate that is desirable

ep1

threshold for the probability of declaring drug desirable
under p0

ep2

threshold for the probability of rejecting the drug under
p1

nmax

maximum total sample size (default 100; can be at most
500)

x

object returned by ph2simon

...

arguments to be passed onto plot and print commands called
within

Value

ph2simon 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)

Trial is stopped early if <= r1 responses are seen in the first stage
and treatment is considered desirable only when >r responses seen.

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

Simon R. (1989). Optimal Two-Stage Designs for Phase II Clinical
Trials. Controlled Clinical Trials 10, 1-10.

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.