SimonAnalysis {UnplanSimon}R Documentation

Post-Trial Inference for ATS and ATSS Simon Designs

Description

SimonAnalysis( ) can be used to calculate the Uniformly minimum-variance unbiased estimator (UMVUE), Confidence Intervals (Clopper-Pearson, Jung exact, and Mid-p) and p-Value given the design parameters obtained from the Adaptive Threshold Simon Design (ATS Simon) design and Adaptive Threshold and Sample Simon Design (ATSS Simon) design using ATS_Design( ), ATSS_Design_Stage1( ) and ATSS_Design_Stage2( ).

Usage

SimonAnalysis(m, s, n1, n2, r1, r, alpha, quantile, CI_option, p0)

Arguments

m

Stopping stage of the ATS or ATSS Simon Designs

s

The number of responses observed in total

n1

The actual number of patients in stage 1

n2

The actual total number of patients in stages 1 and 2

r1

The design threshold in stage 1

r

The design threshold in stage 2

alpha

Type-I error rate

quantile

Two tails probability of the confidence interval

CI_option

The type of confidence interval, the character can be typed by "CP", "Jung" or "MIDp" corresponding to the Clopper-Pearson, Jung exact, or Midp confidence intervals

p0

Unacceptable efficacy rate

Value

a data frame includes the Uniformly minimum-variance unbiased estimator (UMVUE), chosen Confidence Interval and p-Value

References

Jung, S. H., & Kim, K. M. (2004). On the estimation of the binomial probability in multistage clinical trials. Statistics in medicine, 23(6), 881-896, doi:10.1002/sim.1653.
Clopper, C. J., & Pearson, E. S. (1934). The use of confidence or fiducial limits illustrated in the case of the binomial. Biometrika, 26(4),404-413, doi:10.2307/2331986.
Porcher, R., & Desseaux, K. (2012). What inference for two-stage phase II trials?. BMC medical research methodology, 12, 1-13, doi:10.1186/1471-2288-12-117.
Jung, S. H., Owzar, K., George, S. L., & Lee, T. (2006). P-value calculation for multistage phase II cancer clinical trials. Journal of Biopharmaceutical Statistics, 16(6), 765-775, doi:10.1080/10543400600825645.

Examples

# Post-Trial inference for ATS or ATSS Simon Designs case 1
SimonAnalysis(2,7,13,30,3,12,0.05,c(0.025,0.975),"MIDp",0.40)
# Analysis Plan
#                      UMVUE CI(lower) CI(upper) p_Val
# Post-Trial Inference 0.322     0.108     0.538 0.831

# Post-Trial inference for ATS or ATSS Simon Designs case 2
SimonAnalysis(2,16,11,28,2,13,0.077,c(0.025,0.975),"Jung",0.25)
# Analysis Plan
#                     UMVUE CI(lower) CI(upper) p_Val
# Post-Trial Inference 0.429     0.257     0.568 0.019


[Package UnplanSimon version 0.1.0 Index]