EMA, HMA outline evolution of DARWIN EU real-world database

Regulatory NewsRegulatory News | 02 August 2022 |  By 

The European Medicines Agency (EMA) and the Heads of Medicines Agencies (HMA) plan to launch an ambitious new database to collect real-world data (RWD) from a slew of studies that reviewers can reference for their regulatory decision-making.
Their joint Big Data Steering Group’s third workplan lays out a timeline to develop the Data Analysis and Real World Interrogation Network (DARWIN EU). According to the plan, by the end of this year, the research database will initiate four studies with the help of 10 research partners to gather real-world evidence (RWE). By the end of 2025, that is slated to grow exponentially, resulting in collection from 100 studies with the help of 40 partners.
“The new workplan will allow to further enhance the efficient integration of data analysis into the evaluation of medicinal products by regulators,” EMA said in a 28 July statement. “Using novel technologies and the evidence generated from big data will benefit public health by accelerating medicine development, improving treatment outcomes and facilitating earlier patient access to new treatments.”
After establishing the DARWIN EU Coordination Centre in 2022, the plan aims to focus on onboarding various research partners and initiating studies to aggregate RWD. Ultimately, the pilot activities of the project is meant to expand and support the European Centre for Disease Prevention and Control (ECDC) and bodies responsible for Health Technology Assessments (HTA) as well as payers.
The workplan also outlines timeframes for several other topics that will be addressed in parallel to help regulators use RWE in their decision-making using the DARWIN EU database. They include creating a framework for data quality, addressing data discoverability, addressing skills and processes needed to properly use the data, a governance framework, and promoting stakeholder engagement.
When it comes to data quality, the EMA and HMA say that engaging stakeholders and leveraging the work of external parties are key to ensuring that data is high quality and that it is representative.
“Therefore, collaboration will continue with the joint action ‘Towards A European Health Data Space – TEHDAS’ dedicated to the technical and scientific aspects of data quality,” the workplan said. “Following the analysis and exchanges on data quality with a wide range of stakeholders the first version of a data quality framework for the EU Regulatory Network will be delivered in late 2022, followed by work in the coming years to strengthen the EMA data qualifications process and further collaboration with the [European Health Data Space].”
The workplan also says regulators expect to publish a good practice guide on real-world metadata and a public catalog of European real-world data to help with making the data more discoverable by researchers, regulators and other stakeholders. Analytics tools and standardized clinical trial protocols are also expected to help with data discoverability.
The workplan recognizes that regulators will need to be trained in biostatistics, pharmacoepidemiology, genomics data and data science for them to effectively use the data generated by DARWIN EU. Over the next couple of years, regulators plan to develop curricula on those topics and some of them will even be available to other stakeholders including patients, healthcare professionals and academics.
“Reports on pilot studies on the use of real world evidence (RWE) by EMA scientific committees will be published incrementally and concluded in 2025 with a report on RWE in regulatory decision-making,” the workplan states in terms of how regulators intend to incorporate RWE processes into their decision-making. “A portfolio of RWE use cases will be published to support uptake of RWE by the [European Medicines Regulatory Network].”
The Big Data Steering Group will organize an annual forum, hold topic-specific meetings and workshops, and convene biannual industry meetings to address RWE data, according to the workplan.


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