sargent2stage_pval: p-value for a 2-stage PhII single arm Sargent design

In IDDI-BE/PhIIdesign: Sample Size Calculation for Phase II Designs

Description

This function calculates the p-value for a 2-stage PhII single arm Sargent design In the case of Sargent's 2-stage design, stage-wise ordering means that outcomes observed in the second stage of the trial are more extreme than outcomes observed in the first stage of the trial.

Usage

sargent2stage_pval(n1, n2 = NULL, r1, k, p0)

Arguments

n1	total number of patients in stage1
n2	total number of patients in stage2
r1	critical value for the first stage
k	overall observed responses (must be larger than r1)
p0	true success probability under H0

Value

p-value

References

Simon R. Optimal two-Stage Designs for Phase II Clinical Trials.
Control Clin Trials. 1989;10:1-10; Koyama T and Chen H (2008): Proper inference from Simon's two-stage designs.
Statistics in Medicine, 27(16):3145-3154.

Examples

sargent2stage_pval(n1=15, n2=10, r1=1, k=6, p0=0.1)

IDDI-BE/PhIIdesign documentation built on June 5, 2021, 2:03 p.m.