Both in Germany and internationally, the use of real-world evidence (RWE) as a basis for decisions in the healthcare sector is being discussed. That discussion focuses on the need to capture and reflect the everyday healthcare environment in studies, because results from clinical regulatory studies—which follow an experimental and controlled design—only allow limited conclusions on day-to-day healthcare issues. For example, the assessment of the efficacy of a therapy under everyday conditions is a central topic.

When designing RWE studies, stringent requirements are necessary for the selection of databases, as well as the study design.