Ess_multiple_tte: Expected sample size for phase III for multiple endpoints...

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

Expected sample size for phase III for multiple endpoints with normally distributed outcomes

Description

Given phase II results are promising enough to get the "go"-decision to go to phase III this function now calculates the expected sample size for phase III. The results of this function are necessary for calculating the utility of the program, which is then in a further step maximized by the optimal_multiple_tte() function

Usage

Ess_multiple_tte(HRgo, n2, alpha, beta, hr1, hr2, id1, id2, fixed, rho)

Arguments

HRgo	threshold value for the go/no-go decision rule;
n2	total sample size for phase II; must be even number
alpha	one- sided significance level
beta	1-beta power for calculation of the number of events for phase III by Schoenfeld (1981) formula
hr1	assumed true treatment effect on HR scale for endpoint OS
hr2	assumed true treatment effect on HR scale for endpoint PFS
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
rho	correlation between the two endpoints

Value

the output of the function Ess_multiple_tte() is the expected number of participants in phase III

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