| TwoSampleSurvival.NIS {TrialSize} | R Documentation |
Test for two sample Non-Inferiority/Superiority in exponential model for survival data
Description
margin=lamda1-lamda2, the true difference of hazard rates between control group lamda1 and a test drug group lamda2
H0: margin <= delta
Ha: margin > delta
if delta >0, the rejection of Null Hypothesis indicates the superiority of the test drug over the control;
if delta <0, the rejection of the null hypothesis implies the non-inferiority of the test test drug against the control.
Usage
TwoSampleSurvival.NIS(alpha, beta, lam1, lam2, k, ttotal, taccrual, gamma,margin)
Arguments
alpha |
significance level |
beta |
power = 1-beta |
lam1 |
the hazard rates of control group |
lam2 |
the hazard rates of a test drug |
k |
k=n1/n2 sample size ratio |
ttotal |
Total trial time |
taccrual |
accrual time period |
gamma |
parameter for exponential distribution. Assume Uniform patient entry if gamma =0 |
margin |
margin=lamda1-lamda2, the true difference of hazard rates between control group lamda1 and a test drug group lamda2 |
References
Chow SC, Shao J, Wang H. Sample Size Calculation in Clinical Research. New York: Marcel Dekker, 2003
Examples
Example.7.2.4<-TwoSampleSurvival.NIS(0.05,0.2,1,2,1,3,1,0.00001,0.2)
Example.7.2.4