pgo_multiple_tte: Probability to go to phase III for multiple endpoints in the...

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

Probability to go to phase III for multiple endpoints in the time-to-event setting

Description

This function calculates the probability that we go to phase III, i.e. that results of phase II are promising enough to get a successful drug development program. Successful means that at least one endpoint shows a statistically significant positive treatment effect in phase III.

Usage

pgo_multiple_tte(HRgo, n2, 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
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 pgo_multiple_tte() is the probability to go to phase III.

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