SampleSize4ClinicalTrials

[venkymd]

ssc_propcomp(design = 3L, ratio = 1, alpha = 0.05, power = 0.8, p1 = 0.65, p2 = 0.65, delta = 0.15)

Can you please help with non-inferiority trial sample size calculation with "SampleSize4ClinicalTrials" package?
Is the alpha one-sided or two-sided in the package?
What will be the input for alpha in the following scenarios? 1. One-sided alpha 0.025 and 2. two-sided alpha 0.05

[technocrat]

The documentation doesn't specify. View the code for the function with

ssc_precomp

(without the following ())

or look at it below

ssc_precomp <- function (design = c(1L, 2L, 3L, 4L), ratio = 1, alpha = 0.05, 
    power = 0.8, p1 = NULL, p2 = NULL, delta = NULL) 
{
    if (!(design %in% 1L:4L)) 
        stop("Unrecognized study design, 1: Test for equility, 2: Superiority trial,\n         3: Non-inferiority trial, 4: Equivalence trial")
    if (design == 1L) {
        numerator <- (abs(qnorm(alpha/2)) + abs(qnorm(1 - power)))^2 * 
            (p1 * (1 - p1)/ratio + p2 * (1 - p2))
    }
    if (design %in% 2L:3L) {
        numerator <- (abs(qnorm(alpha)) + abs(qnorm(1 - power)))^2 * 
            (p1 * (1 - p1)/ratio + p2 * (1 - p2))
    }
    if (design == 4L) {
        numerator <- (abs(qnorm(alpha)) + abs(qnorm((1 - power)/2)))^2 * 
            (p1 * (1 - p1)/ratio + p2 * (1 - p2))
    }
    if (design == 1L) {
        denom <- (p1 - p2)^2
    }
    if (design %in% 2L:3L) 
        denom <- ((p1 - p2) - delta)^2
    if (design == 4L) 
        denom <- (delta - abs(p1 - p2))^2
    n4 <- ceiling(numerator/denom)
    n3 <- ratio * n4
    samplesize <- data.frame(Treatment = n3, Control = n4)
    return(samplesize)
}