AED1_SSR.sim: Conduct the simulation studies of the Adaptive Enrichment...

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

Description

The AED1_SSR.sim() is used to conduct the simulation study of the Adaptive Enrichment Design (Strategy 1) with Sample Size Re-estimation procedure

Usage

AED1_SSR.sim(
  N1,
  rho,
  alpha,
  beta,
  pstar,
  theta,
  theta0,
  Info,
  K = 2,
  epsilon,
  sigma0,
  nSim,
  Seed
)

Arguments

N1	The sample size used at the first stage
rho	The proportion of subgroup 1 among the overall patients
alpha	The overall Type I error rate
beta	The (1 - Power)
pstar	The (1 - power) of accepting the null hypothesis at the interim analysis.
theta	The sizes of the treatment effect in subgroups 1 and 2 with the experimental arm
theta0	The size of the treatment effect in standard arm
Info	The observation information
K	The number of subgroups. The default value is K = 2
epsilon	The threshold of the difference between the subgroup-specific test statistic
sigma0	The variance of the treatment effect
nSim	The number of simulated studies
Seed	The random seed

Value

A list contains

• nTotal The average expected sample size

• H00 The probability of rejecting the null hypothesis of H_{00}

• H01 The probability of rejecting the null hypothesis of H_{01}

• H02 The probability of rejecting the null hypothesis of H_{02}

• H0 The probabilities of rejecting at least one of the null hypothesis

• ESF The probability of early stopping for futility

• ESE The probability of early stopping for efficacy

• Enrich01 The prevalence of adaptive enrichment of subgroup 1

• Enrich02 The prevalence of adaptive enrichment of subgroup 2

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

res <- AED1_SSR.sim(
  N1 = 310, rho = 0.5,
  alpha = 0.05, beta = 0.2, pstar = 0.2,
  theta = c(0,0), theta0 = 0, Info = 0.5,
  epsilon = 0.5, sigma0 = 1, nSim = 1000, Seed = 6)

Example output

## Summary of AED1-SSR:    


The expected sample size and overall power: 
  ESS  H0 H00 H01 H02
% 611 4.9 0.4   2 2.5

Pr(Early stopping for futility) =  62.4 %.
Pr(Early stopping for efficacy) =  2.5 %.
Pr(Enrich subgroup 1) =  13.6 %.
Pr(Enrich subgroup 2) =  18 %.

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