drugdevelopR (version 1.0.2)

pgo_multiple_normal: 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
)

Value

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

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