gen2simon: Generalized Simon's 2-stage phase II design

In gen2stage: Generalized Two-Stage Designs for Phase II Single-Arm Studies

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

oc.gentwostage.bdry

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)

gen2stage documentation built on June 3, 2019, 5:04 p.m.