Versorgungsnahe Daten und agiles Projekt- management – was hat das miteinander zu tun?

Cochrane postulates that ‚the best available evidence‘ (www.cochrane.org) must be the basis for medical decisions and that the quality of the study design is therefore crucial. From this it can be concluded that, in addition to randomised controlled trials (RCTs), healthcare-related data can also be used. Questions relating to particularly rare diseases, which increasingly include ever smaller subgroups of common diseases (individualised therapies, e.g. based on certain genetic characteristics), as well as increasingly important endpoints such as Patient-Reported Outcome Measures (PROMs) and Patient-Reported Experience Measures (PREMs) cannot be clarified in an RCT. Instead of a specific study design, the focus should be on the quality of studies. It is therefore by no means a question of weakening requirements, but rather of consistently increasing the quality of studies in which new data sources can also be included. The following text is a reflection on the workshop ‚RWE - Fit-for-purpose‘ at the MSD Health Forum 2023, on the one hand, and some thoughts on the undogmatic handling of data sources based on ideas from management theory, on the other.