esDesign (version 1.0.3)

AED1_SSR.boundary: Calculate the critical value used at the final analysis of the Adaptive Enrichment Design (Strategy 1) with Sample Size Re-estimation Procedure

Description

The AED1_SSR.boundary() is used to calculate the critical value required at the final analysis of the Adaptive Enrichment Design (Strategy 1) with sample size re-estimation procedure. In the AED1-SSR design, the adaptive enrichment strategy is guided by a pre-specified futility stopping boundary and a threshold of the difference between the subgroup-specific test statistics.

Usage

AED1_SSR.boundary(rho, alpha, pstar, Info, epsilon)

Arguments

rho

The proportion of subgroup 1.

alpha

The overall Type I error rate.

pstar

The (1 - power) of accepting the null hypothesis at the interim analysis.

Info

The observation information, which is commonly calculated through the sample size used at each stage of the trial.

epsilon

The threshold of the difference between subgroup-specific test statistics.

References

• Lin, R., Yang, Z., Yuan, Y. and Yin, G., 2021. Sample size re-estimation in adaptive enrichment design. Contemporary Clinical Trials, 100, p.106216. <doi: 10.1016/j.cct.2020.106216>

Examples

# NOT RUN {
AED1_SSR.boundary(rho = 0.5, alpha = 0.05, pstar = 0.2, Info = 0.5, epsilon = 0.5)
# }