The application of real-world evidence in drug regulatory decision-making

This article provides an overview of current applications of RWE in drug regulatory decision-making processes. The potentials of RWE along with the hurdles to be addressed are described and examples of current projects on RWE research for drug regulation are given. The work is based on current international literature as well as examples from international and European initiatives and regulatory practice, which aim to support an increased use of RWD/RWE in regulatory decision-making processes. In order to be able to utilise the potential of RWE even more in the future, it is important to make relevant RWD sources more readily available through research projects and initiatives, to further develop evaluative methods and to establish the significance of RWE.PMID:38214723 | PMC:PMC10834571 | DOI:10.1007/s00103-023-03830-0
Source: Bundesgesundheitsblatt, Gesundheitsforschung, Gesundheitsschutz - Category: International Medicine & Public Health Authors: Source Type: research