Differences between and characteristics of the Intention-To-Treat (ITT) vs. Per Protocol (PP) principles: which is the method of choice for the primary analysis of your clinical trial?
If you are thinking of a clinical trial, you might ask yourself why and how data review for interim analysis can be a topic for a whole article. However, in a non-interventional study there are certain challenges [...]
Your results on the overall patient level contradict results on the subgroup level? There is no need to panic. With a deeper look into the data, one can get to the bottom of this observation. [...]
In this article we would like to address the question whether it is useful to perform statistical testing in the context of a NIS, as it is often requested by the sponsor, and why, if tests are performed, we should handle their results with caution.
Die Medizinproduktestudie als Variation der Arzneimittelstudie? Im Detail zeigen sich Unterschiede, die sich grundlegend auf Design und Auswertung einer Medizinproduktstudie auswirken können.