EMA Releases Draft Guidance on Using Registry-Based Studies
The European Medicines Agency (EMA) has released a draft guidance document on how best to use registries as a source of real-world evidence to support clinical trials. Detailed advice is provided on the use of disease registries or condition registries to evaluate the safety and efficacy of therapeutic agents during pre- and post-authorization phases.
In the guidance, recommendations address methodological considerations as well as legal and operational aspects involved in using registry-based studies to assist regulatory decisionmaking.
Recommendations are also provided on how to establish and manage patient registries, how to align regulatory requirements with designing a registry-based study protocol, how to manage data collection and how to address missing data.
The guideline draft has been published for a three-month public consultation period, allowing stakeholders to submit their comments by Dec. 31.
Read the EMA guidance here: https://bit.ly/308v1rs.