drugdevelopR (version 1.0.2)

Ed3_tte: Expected sample size for phase III for time-to-event outcomes

Description

Expected sample size for phase III for time-to-event outcomes

Usage

Ed3_tte(HRgo, d2, alpha, beta, w, hr1, hr2, id1, id2, fixed)

Value

The output of the the functions Ed3_tte is the expected number of events in phase III.

Arguments

HRgo

threshold value for the go/no-go decision rule

d2

total events for phase II; must be even number

alpha

significance level

beta

1-beta power for calculation of sample size for phase III

w

weight for mixture prior distribution

hr1

first assumed true treatment effect on HR scale for prior distribution

hr2

second assumed true treatment effect on HR scale for prior distribution

id1

amount of information for hr1 in terms of number of events

id2

amount of information for hr2 in terms of number of events

fixed

choose if true treatment effects are fixed or random, if TRUE hr1 is used as fixed effect

Examples

res <-  Ed3_tte(HRgo = 0.8, d2 = 50,
                        alpha = 0.025, beta = 0.1, w = 0.3, 
                        hr1 =  0.69, hr2 = 0.81, 
                        id1 = 280, id2 = 420, fixed = FALSE)