TrialSize (version 1.4)

ISCV.NIS: Test for Non-Inferiority/Superiority of Intra-Subject CVs

Description

H0: CVr - CVt < \(\delta\)

Ha: CVr - CVt \( \ge \delta \)

if \(\delta\) > 0, the rejection of Null Hypothesis indicates the superiority of the test drug over the reference;

if \(\delta\) < 0, the rejection of the null hypothesis implies the non-inferiority of the test drug against the reference.

Usage

ISCV.NIS(alpha, beta, CVt, CVr, m, margin)

Arguments

alpha

significance level

beta

power = 1-beta

CVt

Coefficient Of Variation for treatment T

CVr

Coefficient Of Variation for treatment R

m

for each subject, there are m replicates.

margin

margin=delta,

References

Chow SC, Shao J, Wang H. Sample Size Calculation in Clinical Research. New York: Marcel Dekker, 2003

Examples

# NOT RUN {
Example.9.2.1<-ISCV.NIS(0.05,0.2,0.7,0.5,2,0.1)
Example.9.2.1

# }