EMA has published its draft Guideline on registry-based studies for a three-month public consultation today. The new draft guidance aims to optimise the use of registry-based studies as a source of real-world evidence.
Patient registries are databases containing quantitative and qualitative data about patients who are affected by a particular condition.
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 by 31 December 2020.
More information: https://www.ema.europa.eu/en/news/guideline-registry-based-studies-launch-public-consultation
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