Lundbeck recently joined the world’s largest federated health data network EHDEN.
Despite our best efforts to provide optimal healthcare to patients, there is still room for improvement across many disease areas. Randomized clinical trials (RCT) are conducted to document efficacy and safety of a new treatment before it can be approved by the regulatory authorities. However, for many good reasons, the RCTs may not provide us all the information we would like to have about a disease or a treatment, for example due to the limited number of participants in RCTs.
Real-world data (RWD) is an enormous resource for healthcare decision makers, regulatory agencies, academia and drug development companies for several purposes, e.g. provide better understanding of diseases, improve clinical practice, generate ideas for new or improved treatments or provide evidence of how an approved medicine is actually used by patients. RWD can come from many various sources such as disease registries, health databases, electronic health records (EHR) and insurance claims data. Both the European Medicine Agency (EMA) and the US Food and Drug Administration (FDA) have ambitious agendas to increase access to and improve the quality of RWD, which can be used in decision-making on the benefits and risks of medicines.
“In response to the need for access to high quality RWD, the European Health Data and Evidence Network (EHDEN) was created as a public-private partnership under the framework of the IMI2 (Innovative Medicines Initiative) starting in 2018.”
In response to the need for access to high quality RWD, the European Health Data and Evidence Network (EHDEN) was created as a public-private partnership under the framework of the IMI2 (Innovative Medicines Initiative) starting in 2018. EHDEN aspires to be the trusted observational research ecosystem to enable better health decisions, outcomes, and care, with a mission to provide a new paradigm for the discovery and analysis of health data in Europe, by building a large-scale, federated network of data sources standardized to a common data model.
EHDEN consists of seven public partners, three SMEs, a European patients organization, and 13 industry partners who combine expertise, resources, and support, creating an ecosystem for working with RWD data across Europe and the rest of the world.
What is the value of a federated data network (FDN)?
By applying novel technology, a FDN enables the conduct of analyses with multiple data sources but without the need to share the data from the individual participant. Individual patient data will therefore not be shared and all GDPR regulations are adhered to. As all data sources are standardized to a common data model, analyses can be conducted across data sources with standardized tools ensuring efficient data handling and analyses.
“A characteristic example being EMA’s choice to base its Data Analysis and Real World Interrogation Network (DARWIN EU) on EHDEN’s learnings and the established infrastructure.”
To date, EHDEN has selected 166 Data Partners in 26 countries with more than 650 million anonymized health records and has already enabled collaborative federated studies aiming to generate reliable RWE in multiple diseases. The extraordinary work of EHDEN has been recognized in several cases. A characteristic example being EMA’s choice to base its Data Analysis and Real World Interrogation Network (DARWIN EU) on EHDEN’s learnings and the established infrastructure.
Last year, Lundbeck joined EHDEN as an industry partner. Lundbeck will work with project partners on health data science, RWE generation, epidemiology, and develop EHDEN’s sustainability. Lundbeck as an organization dedicated to restoring brain health is delighted to contribute to a collaborative international effort that has potential to support data driven health research at scale never encountered before.
“Lundbeck’s efforts will focus on EHDEN’s sustainability via the establishment of a five-year neuroscience research programme.”
Lundbeck’s efforts will focus on EHDEN’s sustainability via the establishment of a five-year neuroscience research programme. A programme aiming to enable neuroscience research having enough granularity and longitudinal power to investigate disease signals and analyze rare conditions that would otherwise require decades of data collection. As part of the research programme’s coordination team, we will contribute with subject matter expertise and support the programme’s aims, shaping a template for future cases of trustworthy RWD-driven patient benefits.
This perspective-article was written by Iannis Drakos, Director and Head of Data Science, H. Lundbeck, for NLS magazine No 04 2022, November 2022