Ess_multiple_tte {drugdevelopR} | R Documentation |
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_tte()
function
Usage
Ess_multiple_tte(HRgo, n2, alpha, beta, 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 |
alpha |
one- sided significance level |
beta |
|
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 |
id2 |
amount of information for |
fixed |
choose if true treatment effects are fixed or random |
rho |
correlation between the two endpoints |
Value
the output of the function Ess_multiple_tte()
is the expected number of participants in phase III