Netwerkvorming Europe

IKNL data partner in DARWIN EU® network of the European Medicines Agency

The European Medicines Agency (EMA) has selected the first data partners to collaborate with the international DARWIN EU® network. IKNL is one of the organizations that has been approached and selected for this, through the Erasmus University Medical Center in the Netherlands, which has been appointed as the DARWIN EU® Coordination Center. DARWIN EU® is an EU-wide federated network of high-quality observational healthcare databases across Europe, that provides expertise and services to support regulatory decision-making throughout the lifecycle of a medicinal product.

Commercialisation authorization of new drugs is done after running controlled clinical trials with a limited number of patients and within a limited period of time that allow to secure safety and effectiveness data but only observe the more frequent adverse effects. However, different source systems such as electronic health records or claims data, like the Netherlands Cancer Registry (NCR), collect information on the effectiveness and safety of medicines in real-world datasets. These real-world data are routinely collected and relate to a patient's health status or healthcare delivery from sources other than clinical trials. These datasets are much larger in number of patients and longer in the recording period, allowing the identification of additional information in them, for example about side effects after 20 years, which you do not see in trials. That's why the DARWIN EU® was started and why IKNL is happy to join.

Different partners, different data registration, a challenge

The selected partners include both public and private organizations. The common feature is that they all access real-world-health care data from one or more sources, such as hospitals, primary care, health insurance, biobanks, or disease-specific patient registries such as the NCR. The data partners will provide the DARWIN EU® Coordination Center with results of analyses of their data. The challenge is that the data is registered in different ways among different data bases and that unambiguous analysis is therefore difficult.

A solution for standardized data and international analysis

That's why OHDSI – a collaborative to bring out the value of health data through large-scale analytics – has developed a data model to enable standardized data analysis, the so-called OMOP-Common Data Model. Hundreds of organizations around the world have already converted their data to it, including IKNL, so that the analysis script supplied by DARWIN EU® can be run on it. The advantage of this is that IKNL can keep its own data and only share aggregated results. This creates many opportunities to collaborate internationally in research.

First three international studies launched

With data partner onboarding, EMA has begun the launch of the first three studies to be provided by the DARWIN EU® network. One study focuses on the epidemiology of rare blood cancers to obtain information about their prevalence in Europe. The second study looks at the drug use of valproate and the third investigates the use of antibiotics to inform future work on antimicrobial resistance. These studies mark the beginning of a rapid increase in the number of studies conducted to support decision-making in European medicine regulation. The goal is for DARWIN EU® to deliver approximately 150 real-world evidence studies per year by 2025 with an increasing number of EU data partners.