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

In Sterniii3/drugdevelopR: Utility-Based Optimal Phase II/III Drug Development Planning

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)

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

Value

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

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)

Sterniii3/drugdevelopR documentation built on Jan. 26, 2024, 6:17 a.m.