View source: R/functions_multitrial.R
EPsProg23 | R Documentation |
The function EPsProg23()
calculates the expected probability of a successful program
in a time-to-event setting. This function follows a special decision rule in order to determine
whether two or three phase III trials should be conducted. First, two phase III trials are performed. Depending
on their success, the decision for a third phase III trial is made:
If both trials are successful, no third phase III trial will be conducted.
If only one of the two trials is successful and the other trial has a treatment effect that points in the same direction,
a third phase III trial will be conducted with a sample size of N3 = N3(ymin), which depends on an assumed minimal clinical relevant effect (ymin
).
The third trial then has to be significant at level alpha
If only one of the two trials is successful and the treatment effect of the other points in opposite direction or if none of the two trials are successful, then no third trial is performed and the drug development development program is not successful. In the utility function, this will lead to a utility of -9999.
EPsProg23(HRgo, d2, alpha, beta, w, hr1, hr2, id1, id2, case, size, ymin)
HRgo |
threshold value for the go/no-go decision rule |
d2 |
total number of events in phase II |
alpha |
significance level |
beta |
|
w |
weight for mixture prior distribution |
hr1 |
first assumed true treatment effect on HR scale for prior distribution |
hr2 |
second assumed true treatment effect on HR scale for prior distribution |
id1 |
amount of information for |
id2 |
amount of information for |
case |
choose case: "at least 1, 2 or 3 significant trials needed for approval" |
size |
size category |
ymin |
assumed minimal clinical relevant effect |
The output of the function EPsProg23()
is the expected probability of a successful program.
res <- EPsProg23(HRgo = 0.8, d2 = 50, alpha = 0.025, beta = 0.1,
w = 0.3, hr1 = 0.69, hr2 = 0.81,
id1 = 280, id2 = 420, case = 2, size = "small",
ymin = 0.5)
Add the following code to your website.
For more information on customizing the embed code, read Embedding Snippets.