DARWIN EU is starting to collect more real-world data (RWD) and gain more adherents as an increasing number of regulators and industry groups recognize the value of RWD, Peter Arlett, head of the European Medicine Agency’s data analytics and methods task force, said at DIA Europe 2023.
RWD saw a significant boost from the COVID-19 pandemic, Arlett said. Pre-pandemic, when EMA recommended the establishment of the Data Analysis and Real World Interrogation Network (DARWIN EU) in January 2020, “we had no political support, no legal basis and no funding.”
DARWIN EU aims to provide EMA, the European Commission and national competent authorities in the 27 member states access to the results of analyses of real-world healthcare databases.
EMA and the Heads of Medicines Agencies (HM) Big Data Steering Group released its DARWIN-EU as part of the Big Data Steering Group work plan for 2022-2025.
Real-world evidence (RWE) “really came into its own” during the pandemic, Arlett emphasized. “Many people initially who told us they were skeptical of its value understood that when you wanted to evaluate the safety or the effectiveness of the vaccine in everyday rollouts, it was RWE that was answering the critical questions. And all of a sudden, we were able to secure political support and a legal basis and funding.”
DARWIN EU now is “starting to deliver” in terms of RWD delivery. He said that by 2025, DARWIN EU will deliver 150 RWE studies annually. He stressed that the data will “complement and not replace clinical data.
“We’ve got a really fast-moving environment and DARWIN is upscaling very fast,” he added.
Arlett said RWE can be used to support the approval of orphan drugs, support scientific advice, and support potential expanded indications for approved drugs.
Currently, EMA has partnered with organizations and hospitals in eight countries to supply RWD to DARWIN EU. These countries are the UK, Belgium, France, Spain, Finland, Estonia, the Netherlands and Germany.
The types of studies currently underway vary and include off-the-shelf studies such as population-level epidemiology studies to ascertain the prevalence of rare blood cancers in support of an orphan drug designation decision. Another example is a patient-level drug utilization study of valproate-containing medical products in women of childbearing potential.
Arlett said more data partners in additional countries are expected to come on board very soon. “We are ramping up very quickly.”
More international collaborations
International support for using RWD in decision-making is growing. EMA met with the International Coalition of Medicines Regulatory Authorities (ICMRA) officials in June and agreed to collaborate on RWD efforts.
The meeting identified four areas for regulatory cooperation: the harmonization of terminologies for RWD and RWE; convergence on best practices; addressing public health challenges and emerging health threats; and enabling greater transparency for RWD.
“I think there is a good understanding now of the need for good interoperability of the data,” panel member Peter Rijnbeek the executive director of the DARWIN EU Coordination Center for EMA and professor of medical informatics for Erasmus University Medical Center, said, adding that he is “happy that we are moving forward to harmonize the structure of the data, and the need to standardize the analytics.
“This is a very exciting time for us,” Rijnbeck said.
Need for more patient registries
Panelists at the meeting agreed on need for more patient registries to complement the RWD data.
“I think we have a lot more work to do on registries, Arlett said. “Maybe this year we will have a workshop in Amsterdam on registries. Hopefully, the EMA Quality Working Party will be the catalyst for this.”
Panel member Elizabeth Vroon, president of the Netherlands-based Duchenne Parent Project, said, “we have started to collect data from patients for RWD, patients have to be aware of RWD. Patients can be very involved with this. There is an opportunity to bring in this data. It can be a very rich source of data.”
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