TwoSampleSurvival.NIS: Test for two sample Non-Inferiority/Superiority in...

In TrialSize: R Functions for Chapter 3,4,6,7,9,10,11,12,14,15 of Sample Size Calculation in Clinical Research

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

TrialSize documentation built on July 8, 2020, 7:19 p.m.