Patient registries are where big data meets new and exciting regulatory opportunities in pharma, and regulators are keen to address the gaps between regulation and innovation in this space. The European Medicines Agency (EMA) has published its new draft guidelines on registry-based studies (Guidelines) for a three-month public consultation period. The Guidelines make the case for optimising the use of registry-based studies as a source of real-world evidence.
Studies based on patient registries generate real-world evidence that can complement the knowledge gained through pre-clinical studies and clinical trials during the development of a medicine. Studies derived from patient registries can also provide information that is critical to understanding the benefits and risks of medicines in everyday use by patients and healthcare professionals.