os_tte: Probability that endpoint OS significant

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

Probability that endpoint OS significant

Description

This function calculate the probability that the endpoint OS is statistically significant. In the context of cancer research OS stands for overall survival, a positive treatment effect in this endpoints is thus sufficient for a successful program.

Usage

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

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
rsamp	sample data set for Monte Carlo integration

Value

The output of the function os_tte() is the probability that endpoint OS significant.

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