Ess_multiple_normal: Expected sample size for phase III for multiple endpoints...

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

Expected sample size for phase III for multiple endpoints with normally distributed outcomes

Description

Given phase II results are promising enough to get the "go"-decision to go to phase III this function now calculates the expected sample size for phase III. The results of this function are necessary for calculating the utility of the program, which is then in a further step maximized by the optimal_multiple_normal() function

Usage

Ess_multiple_normal(
  kappa,
  n2,
  alpha,
  beta,
  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
alpha	significance level
beta	1-beta power for calculation of sample size for phase III
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 Ess_multiple_normal is the expected number of participants in phase III

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