Real-World Evidence Makes Further Headway in Europe’s Healthcare Planning

Europe’s bid to make better use of data in drug research took a step forward late this month with the announcement that the first data partners had been signed up to the new data network of the European Medicines Agency (EMA), DARWIN-EU. Half-a-dozen hospitals, registries, and universities from Finland, France, Estonia, Spain, Netherlands, and the UK have been selected to collaborate in this emerging Data Analysis and Real World Interrogation Network.

The data that DARWIN will be collecting is to be used for studies to generate real-world evidence (RWE) to support scientific evaluations and regulatory decision-making. All the selected partners have access to real-world healthcare data, and will provide DARWIN with results of analyses of these data.

The move enables EMA to initiate the launch of the first three studies to be provided by DARWIN, on blood cancers, on valproate, and on antimicrobial resistance. These studies mark the start of a new phase designed to support regulatory decision-making. The aim is to have 150 such RWE studies per year by 2025. The number of data partners will increase, with a target of adding at least 10 new partners every year.

DARWIN is a federated network that will provide the European medicines regulatory network with access to results from analysis of data from real-world healthcare databases across the EU whenever needed, to support decision-making throughout the life-cycle of a medicine. The network is seen as a pathfinder for the proposed European regulation on health data.

Coincidentally but separately, a drug industry-backed coalition of European health technology assessment (HTA) bodies announced the same day a push for wider use of RWE to support the introduction of new products, particularly cancer treatments and advanced therapies.

At a symposium in Brussels last week, the RWE4Decisions network set out its priorities for expanding RWE use by HTA bodies and payers. Its aim is to promote the sharing of experience of using real-world data (RWD) in outcomes-based managed entry agreements and similar conditional reimbursement processes.