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Scope
After defining the research question, we develop a study design with a statistical analysis plan to eliminate bias by adjusting for confounding variables under everyday conditions. This involves determining how the study population is defined, how exposure, endpoint, and concomitant variables are determined, and which procedure will be used for analysis. Sensitivity analyses can help to assess the robustness of the chosen procedure. A final (technical) report summarizes the results and interpretation of the work performed.
Mission
Adequate statistical methods can be used to gather robust evidence on the effectiveness and safety of drugs under everyday conditions which in turn support therapy decisions, e. g. in the form of treatment comparisons.
Background
Data on drug use under everyday conditions contain comprehensive information on effectiveness and safety within a healthcare system. This source can be used to determine the everyday benefits of therapies and compare them to alternatives that were not or could not be considered in controlled clinical trials.
