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?
The determination of an "adequate" sample size is an essential part of the statistical planning process. Depending on your type of non-interventional study design and your specific study objectives, there are different approaches for the planning of your sample size [...]
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. [...]
The mean value of numerical data is without a doubt the most commonly used statistical measure. Anyone who has a basic statistical background knows how to calculate the (arithmetic) mean. However, sometimes the median is used as an alternative to the mean. [...]
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.