simon2stage_pval.RdThis function calculates the p-value for a 2-stage PhII single arm Simon design. In the case of Simon’s 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.
simon2stage_pval(n1, n2 = NULL, r1, k, p0)| 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 |
p-value
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.
simon2stage_pval(n1=15, n2=10, r1=1, k=6, p0=0.1)
#> [1] 0.03280867