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esDesign (version 1.0.3)

Adaptive Enrichment Designs with Sample Size Re-Estimation

Description

Software of 'esDesign' is developed to implement the adaptive enrichment designs with sample size re-estimation presented in Lin et al. (2021) . In details, three-proposed trial designs are provided, including the AED1-SSR (or ES1-SSR), AED2-SSR (or ES2-SSR) and AED3-SSR (or ES3-SSR). In addition, this package also contains several widely used adaptive designs, such as the Marker Sequential Test (MaST) design proposed Freidlin et al. (2014) , the adaptive enrichment designs without early stopping (AED or ES), the sample size re-estimation procedure (SSR) based on the conditional power proposed by Proschan and Hunsberger (1995), and some useful functions. In details, we can calculate the futility and/or efficacy stopping boundaries, the sample size required, calibrate the value of the threshold of the difference between subgroup-specific test statistics, conduct the simulation studies in AED, SSR, AED1-SSR, AED2-SSR and AED3-SSR.

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Version

Install

install.packages('esDesign')

Monthly Downloads

208

Version

1.0.3

License

GPL-2

Maintainer

Zhao Yang

Last Published

July 13th, 2021

Functions in esDesign (1.0.3)

Conduct the simulation studies of the Adaptive Enrichment Design (Strategy 2) with Sample Size Re-estimation Procedure

Calculate the \(N2\) and the critical value \(C\) in the Adaptive Enrichment Design (Strategy 3) with Sample Size Re-estimation Procedure

AED3_SSR.boundary

Calculate the futility and efficacy stopping boundaries in Adaptive enrichment design (Strategy 3) with Sample Size Re-estimation Procedure for the continuous endpoint

Conduct the simulation studies of the Adaptive Enrichment Design (Strategy 3) with Sample Size Re-estimation Procedure based on Futility and Efficacy Stopping Boundaries for the continuous endpoint

Conduct the simulation studies of the Adaptive Enrichment Design (Strategy 1) with Sample Size Re-estimation Procedure

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

Calculate the conditional power of the Adaptive Enrichment Design with (Strategy 1) Sample Size Re-estimation Procedure

Calculate the futility and efficacy stopping boundaries for Sample Size Re-estimation Procedure based on the conditional error function

Calculate the \(N2\) and the critical value \(C\) in Sample Size Re-estimation Procedure

Calculate the sample size required at the second stage of the adaptive enrichment design (Strategy1) with Sample Size Re-estimation Procedure

Sample size calculation for the standard design with continuous endpoint

Conduct the simulation studies of the Marker Sequential Test design

Calculate the critical value used at the final analysis in AED

Conduct the simulation studies of the Adaptive Enrichment Design without early stopping boundary

Conduct the simulation studies of the standard design

Commonly used \(\alpha\)-spending functions

Conduct the simulation studies using SSR

Calculate the \(N2\) and the critical value \(C\) in the Adaptive Enrichment Design (Strategy 2) with Sample Size Re-estimation Procedure

AED2_SSR.boundary

Calculate the futility and efficacy stopping boundaries of the Adaptive Enrichment Design (Strategy 2) with Sample Size Re-estimation Procedure