Background: Adaptive designs refer to
actions taken during the running of a clinical study. This means that in
addition to making a final analysis of all data, one makes one or more interim analyses
based in the data available at that time and use this for making some decision
on how to continue the study. In the most simple case, this means early
stopping for efficacy (meaning that the drug has a persuading positive effect)
or for futility (meaning there is no or only a small effect, so the drug is not
relevant for use under the circumstances studied). With a simple endpoint this
is covered by the group sequential methods, which are based on refined
probability calculations that use that different patients are independent.
However, the typical study design in modern clinical trials is of the repeated
measurements type (meaning that patients are measured at several time points).
As some patients contribute only with a part of the data at the interim
analysis, the independence assumption is no longer satisfied.
The project consists of studying the
consequences of this dependence and considering ways of accounting for it.
Studies at Lundbeck have a typical treatment period of 8 weeks in case of
depression and 24 weeks in case of Alzheimer’s disease.