EPsProg_multiple_tte: Expected probability of a successful program for multiple...

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

Expected probability of a successful program for multiple endpoints in a time-to-event setting

Description

This function calculates the probability that our drug development program is successful. Successful is defined as at least one endpoint showing a statistically significant positive treatment effect in phase III.

Usage

EPsProg_multiple_tte(
  HRgo,
  n2,
  alpha,
  beta,
  ec,
  hr1,
  hr2,
  id1,
  id2,
  step1,
  step2,
  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	significance level
beta	1-beta power for calculation of sample size for phase III
ec	control arm event rate for phase II and III
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 sample size
id2	amount of information for hr2 in terms of sample size
step1	lower boundary for effect size
step2	upper boundary for effect size
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 EPsProg_multiple_tte() is the expected probability of a successful program, when going to phase III.

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