ISCV.NIS {TrialSize} | R Documentation |
H0: CVr - CVt < δ
Ha: CVr - CVt ≥ δ
if δ > 0, the rejection of Null Hypothesis indicates the superiority of the test drug over the reference;
if δ < 0, the rejection of the null hypothesis implies the non-inferiority of the test drug against the reference.
ISCV.NIS(alpha, beta, CVt, CVr, m, margin)
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, |
Chow SC, Shao J, Wang H. Sample Size Calculation in Clinical Research. New York: Marcel Dekker, 2003
Example.9.2.1<-ISCV.NIS(0.05,0.2,0.7,0.5,2,0.1) Example.9.2.1