Convergence: DARWIN EU real-world research network takes first steps

Regulatory NewsRegulatory News | 19 September 2022 |  By 

PHOENIX, AZ – DARWIN EU, the Data Analysis and Real World Interrogation Network formed by the European Medicines Agency (EMA), is taking its first steps as a sustainable network for the generation of real-world evidence to support regulatory decision making in the European Union.

“Currently, we are onboarding the data partners and working on the protocols and initiation of the first studies,” Andrej Segec, the DARWIN EU project manager at the EMA, told attendees at RAPS Convergence 2022.

Segec outlined how DARWIN EU will operate and its implementation timeline. The creation of DARWIN-EU was part of the EMA-Heads of Medicines Agencies (HMA) Big Data Steering Group workplan 2022-2025 (RELATED: EMA, HMA outline evolution of DARWIN EU real-world database, Regulatory Focus 02 August 2022).

How it works
 

“DARWIN EU is a federated network of data, expertise, and services that will support better decision making throughout a medicine product’s lifecycle by generating reliable evidence from real-world health care data,” Segec said.

The network will provide expertise in formulating and executing studies and analyses, maintain a catalogue of relevant data holders, conduct scientific studies and analyses on behalf of the European medicines regulatory network and the EMA scientific committees, and deliver training services.

DARWIN EU includes a coordination center run by Erasmus University Medical Center in Rotterdam, Netherlands, which will receive aggregated data from several local data partners. Individual data partners will use the Observational Medical Outcomes Partnership (OMOP) common data model to hold and perform studies, and the data will remain local. “This is a privacy by design approach, which is compliant with the data protection requirements in the EU,” Segec said, adding that the approach also reduces the complexity of sharing the raw data.

DARWIN will deliver four types of observational analyses and studies:
  • Routine repeated analyses. These analyses, based on a generic study protocol, could include periodic estimation of drug utilization, safety monitoring of a drug product, or estimation of the incidence of a series of adverse events.
  • Off-the-shelf studies. These studies will take a generic protocol and adapt it to a specific research question, such as estimating the prevalence or characteristics of exposures.
  • Complex studies. These studies require the development or customization of specific study designs, protocols, and Statistical Analysis Plans with extensive collection or extraction of data. For example, studies that look at associations between exposures and outcomes while adjusting for confounding factors.
  • Very complex studies. These studies require complex methodological work and would rely on more than just an electronic health care database source.
The process for conducting DARWIN EU studies will begin with a research question from the EMA or National Competent Authority (NCA) committees, Segec explained. Once the EMA or NCA committees define the research questions and evaluate the feasibility, the DARWIN coordinating center creates the protocol and code, and contacts the data partners. The data partners then receive and run the code on their own databases and send the aggregated information to the coordinating center. The coordinating center checks and analyses the aggregated data and compiles the results in a study report that is sent on to the NCA or EMA committee to inform regulatory decision making.

The real-world data sources for DARWIN EU will include data on primary and specialist care, hospital care electronic health records, claims databases, disease registries, patient-reported outcomes, and drug prescription and dispensing data.

Real-world analyses generated by the network are expected to aid in regulatory decision making by supporting the planning and validity of applicant studies, helping committee members understand the clinical context, and providing data on drug associations and impact.
DARWIN EU can also be a tool in a potential future health crisis, Segec said, by helping predict drug shortages and providing evidence for the repurposing of existing medicines, as well as monitoring the safety and effectiveness of vaccines and therapeutics.

Timeline

DARWIN EU is wrapping up the first year of a two-year establishment period. So far in 2022, they have worked on the set up of the coordination center, establishing templates and performing data protection analyses, and have begun recruiting and onboarding data partners.

The network is also starting to run the first pilot studies to support the EMA committees, Segec said.

In 2024, the first year of operation, DARWIN EU will ramp up its capacity to routinely support EMA and NCA committees by delivering studies and maintaining data sources. “We expect upwards of 70 studies in this year,” Segec said.

The network will be fully operational by 2025/2026 and will be integrated with the European Health Data Space. Over the first five years of the network, they expect to conduct about 380 scientific studies. 

Benefits

Once the off the ground, DARWIN EU offers potential benefits for regulators across the medicine lifecycle, from drug development through post authorization, Segec said. “For regulators, the DARWIN EU network will increase our capacity to undertake high-quality studies based on real-world data and reduce the time and cost per study,” he said.

But the network will also have benefits for researchers, payers, industry, and patients, he said. For industry, Segec said it will likely “increase the use and receptiveness for real-world evidence in medicines regulation and reduce the time and cost of drug development.”
 

 

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