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

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

Description

The AED.sim() is used to conduct the simulation studies of the Adaptive Enrichment Design without early stopping boundary. The AED design is quite similar with the AED1_SSR design. But, in the AED design, the futility stopping boundary and the Sample Size Re-estimation Procedure are removed. On the contrary, a fixed sample size is used to replace the sample size re-estimated procedure. In addition, an ε-rule is also introduced to select the subgroup with larger subgroup-specific test statistic.

Usage

AED.sim(
  N1,
  N2,
  rho,
  alpha,
  beta,
  theta,
  theta0,
  K,
  Info,
  epsilon,
  sigma0,
  nSim,
  Seed
)

Arguments

N1	The sample size used at the first stage
N2	The sample size used at the second stage
rho	The proportion of the subgroup 1
alpha	The overall Type I error rate
beta	The (1 - Power)
theta	The sizes of treatment effects in subgroups 1 and 2 among the experimental arm
theta0	The size of treatment effect in standard arm
K	The number of subgroups
Info	The observed information
epsilon	The threshold of difference between the subgroup-specific test statistics
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

• 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

N1 <- 310
N2 <- 310
rho <- 0.5
alpha <- 0.05
beta <- 0.20
theta <- c(0,0)
theta0 <- 0
K <- 2
Info <- 0.5
epsilon <- 0.5
sigma0 <- 1
nSim <- 1000
Seed <- 6
AED.sim(N1 = N1, N2 = N2, rho = rho, alpha = alpha,
        beta = beta, theta = theta, theta0 = theta0,
        K  = K, Info = Info, epsilon = epsilon,
        sigma0 = sigma0, nSim = nSim, Seed = Seed)

Example output

$nTotal
[1] 508

$H00
[1] 0.9

$H01
[1] 1.4

$H02
[1] 2.8

$H0
[1] 5.1

$Enrich01
[1] 36

$Enrich02
[1] 36.8

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