EMA has published the draft Guideline on registry-based studies for a three-month public consultation. The new draft guidance aims to optimise the use of registry-based studies as a source of real-world evidence.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. The guideline addresses methodological, legal and operational aspects in the use of registry-based studies to support regulatory decision-making.
Stakeholders are invited to send their comments via an online form (available at this link) by 31 December 2020.
As part of the consultation process, EMA is hosting a virtual workshop on 19 October 2020 to present the draft guideline to key stakeholders. The workshop provides an opportunity to discuss questions, perspectives on the usefulness of the document and recent experience on methodological aspects of registry-based studies.
Participation in the virtual meeting room is limited and requires pre-registration through the electronic form.