PASS-studies

The Danish Multiple Sclerosis Registry (DMSR) is a resource for post marketing authorization safety and effectiveness studies (i.e. phase IV). The studies are conducted by utilizing its prospectively collected safety data and linkage to independent secondary data information from several population-based registries, such as The National Patient Registry, The National Prescription Database, The Registry of causes of death and The Cancer Registry.

By linkage of the DMSR to nationwide population based reproductive registries we are able to evaluate the association between exposure to a specific drug and different pregnancy and perinatal outcomes. Currently the DMSR is involved in several multi-country cohort post authorization pregnancy safety studies. Such studies are also conducted at national level if the sample size allows sufficient statistical power.