gen2single: Generalized exact single stage phase II design

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

Description

Calculates the generalized exact one stage phase II design based on the R function ph2single.

Usage

gen2single(pu,pa,ep1,ep2,nsoln=5)
## S3 method for class 'gen2single'
print(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
nsoln	number of designs with given alpha and beta
x	object returned by gen2single
...	arguments to be passed onto print command called within

Value

gen2single returns the optimal design with pu, pa, alpha, and beta as above and:

out	matrix of the single-stage designs up to nsoln. The 4 columns are: r, n, alpha (type I error), beta (type II erro)

The "print" method formats and returns the optimal design.

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.

See Also

gen2simon

Examples

  # Single-stage safety design with pu (p0) = 0.33 vs. pa (p1) = 0.20
  gen2single(0.33, 0.20, 0.05, 0.20)

  # Single-stage efficacy design with pu (p0) = 0.67 vs. pa (p1) = 0.80
  gen2single(0.67, 0.80, 0.05, 0.20)

  # save and print
  safety1 = gen2single(0.33, 0.20, 0.05, 0.20)
  print(safety1)

Example output

Loading required package: clinfun

 Generalized 1-stage Phase II design 

Unacceptable response/toxicity rate:  0.33 
Desirable response/toxicity rate:  0.2 
Error rates: alpha =  0.05 ; beta =  0.2 

         n  r Type I error Type II error
Optimal 73 18      0.04747        0.1957


 Generalized 1-stage Phase II design 

Unacceptable response/toxicity rate:  0.67 
Desirable response/toxicity rate:  0.8 
Error rates: alpha =  0.05 ; beta =  0.2 

         n  r Type I error Type II error
Optimal 73 55      0.04747        0.1957


 Generalized 1-stage Phase II design 

Unacceptable response/toxicity rate:  0.33 
Desirable response/toxicity rate:  0.2 
Error rates: alpha =  0.05 ; beta =  0.2 

         n  r Type I error Type II error
Optimal 73 18      0.04747        0.1957

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