pgo_multiple_normal: Probability to go to phase III for multiple endpoints with...

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

Probability to go to phase III for multiple endpoints with normally distributed outcomes

Description

This function calculated 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 both endpoints show a statistically significant positive treatment effect in phase III.

Usage

pgo_multiple_normal(
  kappa,
  n2,
  Delta1,
  Delta2,
  in1,
  in2,
  sigma1,
  sigma2,
  fixed,
  rho,
  rsamp
)

Arguments

kappa	threshold value for the go/no-go decision rule; vector for both endpoints
n2	total sample size for phase II; must be even number
Delta1	assumed true treatment effect given as difference in means for endpoint 1
Delta2	assumed true treatment effect given as difference in means for endpoint 2
in1	amount of information for Delta1 in terms of sample size
in2	amount of information for Delta2 in terms of sample size
sigma1	standard deviation of first endpoint
sigma2	standard deviation of second endpoint
fixed	choose if true treatment effects are fixed or random, if TRUE Delta1 is used as fixed effect
rho	correlation between the two endpoints
rsamp	sample data set for Monte Carlo integration

Value

The output of the function pgo_multiple_normal() is the probability to go to phase III.

Sterniii3/drugdevelopR documentation built on Jan. 14, 2025, 7:50 p.m.