AED1_SSR.boundary: Calculate the critical value used at the final analysis of...

In esDesign: Adaptive Enrichment Designs with Sample Size Re-Estimation

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

AED1_SSR.boundary(rho = 0.5, alpha = 0.05, pstar = 0.2, Info = 0.5, epsilon = 0.5)

Example output

[1] 2.212965

esDesign documentation built on July 13, 2021, 9:06 a.m.