Registries are study types which are closely linked to non-interventional studies. However, the main difference is
that registries will aim at complete documentation of all patients (in a defined area, in a defined period
Registries may be drug-based (all patients exposed to a defined drug) or population-based (all patients with a
defined indication, regardless of the applied treatment). Registries may be small in rare indications or large in
Registries are a rare design for the generation of clinical knowledge, but may become of greater importance in the
near future. Registry studies can provide long term experience and / or safety data at a significantly reduced
cost per patient.
SIRO has gained experience with national and global registry programs. One major registry program has involved
thousands of patients from a large number of sites across Europe.