FarringtonManning-class {blindrecalc} | R Documentation |
Farrington Manning test
Description
This class implements a Farrington-Manning test for non-inferiority
trials. A trial with binary outcomes in two groups E
and
C
is assumed. The null and alternative hypotheses for the
non-inferiority of response probabilities are:
where denotes the non-inferiority margin.
The function setupFarringtonManning
creates an object of
FarringtonManning
.
Usage
setupFarringtonManning(alpha, beta, r = 1, delta, delta_NI, n_max = Inf, ...)
Arguments
alpha |
One-sided type I error rate. |
beta |
Type II error rate. |
r |
Allocation ratio between experimental and control group. |
delta |
Difference of effect size between alternative and null hypothesis. |
delta_NI |
Non-inferiority margin. |
n_max |
Maximal overall sample size. If the recalculated sample size
is greater than |
... |
Further optional arguments. |
Details
The nuisance parameter is the overall response probability .
In the blinded sample size recalculation procedure it is blindly estimated
by:
where
and
are the numbers of responses and
and
are the sample sizes of the respective group after the first stage.
The event rates in both groups under the alternative hypothesis can then be
blindly estimated as:
where is the difference in
response probabilities under the alternative hypothesis and r is the
allocation ratio of the sample sizes in the two groups.
These blinded estimates can then be used to re-estimate the sample
size.
Value
An object of class FarringtonManning
.
References
Friede, T., Mitchell, C., & Mueller-Velten, G. (2007). Blinded sample size
reestimation in non-inferiority trials with binary endpoints.
Biometrical Journal, 49(6), 903-916.
Kieser, M. (2020). Methods and applications of sample size calculation and
recalculation in clinical trials. Springer.
Examples
design <- setupFarringtonManning(alpha = .025, beta = .2, r = 1, delta = 0,
delta_NI = .15)