Zero early weighting function
Arguments
- early_period
The initial delay period where weights increase; after this, weights are constant at the final weight in the delay period.
- fail_rate
Failure rate
References
Xu, Z., Zhen, B., Park, Y., & Zhu, B. (2017). "Designing therapeutic cancer vaccine trials with delayed treatment effect."
Examples
library(gsDesign2)
# Example 1: Unstratified ----
sim_pw_surv(n = 200) |>
cut_data_by_event(125) |>
wlr(weight = early_zero(early_period = 2))
#> $method
#> [1] "WLR"
#>
#> $parameter
#> [1] "Xu 2017 with first 2 months of 0 weights"
#>
#> $estimate
#> [1] -18.90851
#>
#> $se
#> [1] 4.779634
#>
#> $z
#> [1] -3.956058
#>
# Example 2: Stratified ----
n <- 500
# Two strata
stratum <- c("Biomarker-positive", "Biomarker-negative")
prevalence_ratio <- c(0.6, 0.4)
# Enrollment rate
enroll_rate <- define_enroll_rate(
stratum = rep(stratum, each = 2),
duration = c(2, 10, 2, 10),
rate = c(c(1, 4) * prevalence_ratio[1], c(1, 4) * prevalence_ratio[2])
)
enroll_rate$rate <- enroll_rate$rate * n / sum(enroll_rate$duration * enroll_rate$rate)
# Failure rate
med_pos <- 10 # Median of the biomarker positive population
med_neg <- 8 # Median of the biomarker negative population
hr_pos <- c(1, 0.7) # Hazard ratio of the biomarker positive population
hr_neg <- c(1, 0.8) # Hazard ratio of the biomarker negative population
fail_rate <- define_fail_rate(
stratum = rep(stratum, each = 2),
duration = c(3, 1000, 4, 1000),
fail_rate = c(log(2) / c(med_pos, med_pos, med_neg, med_neg)),
hr = c(hr_pos, hr_neg),
dropout_rate = 0.01
)
# Simulate data
temp <- to_sim_pw_surv(fail_rate) # Convert the failure rate
set.seed(2023)
sim_pw_surv(
n = n, # Sample size
# Stratified design with prevalence ratio of 6:4
stratum = data.frame(stratum = stratum, p = prevalence_ratio),
# Randomization ratio
block = c("control", "control", "experimental", "experimental"),
enroll_rate = enroll_rate, # Enrollment rate
fail_rate = temp$fail_rate, # Failure rate
dropout_rate = temp$dropout_rate # Dropout rate
) |>
cut_data_by_event(125) |>
wlr(weight = early_zero(early_period = 2, fail_rate = fail_rate))
#> $method
#> [1] "WLR"
#>
#> $parameter
#> [1] "Xu 2017 with first 2 months of 0 weights"
#>
#> $estimate
#> [1] 1.207753
#>
#> $se
#> [1] 1.133941
#>
#> $z
#> [1] 1.065093
#>