Real-world data (RWD) are routinely-collected data relating to patient health status and/or the delivery of health care routinely collected from a variety of sources, and real-world evidence (RWE) is evidence derived from the analysis of RWD. RWD is collected in many forms and in various ways and needs to be harmonised before it can be used effectively.
EHDEN
EHDEN has been an impactful project by harmonising and standardising close to 200 data sources from 29 into the OMOP Common Data Model, delivering a vital resource to health researchers in a first step towards the vision of the European Health Data Space. EHDEN demonstrated that improving the syntactic and semantic interoperability of data enables the use of standardised analytics for generating real world evidence at scale. The EHDEN Foundation has been established as a non-for-profit organization with the mission to operationalize the new paradigm for discovery and analysis of health data created by EHDEN, providing continuity to the large-scale federated network of Data Partners.
The EHDEN project demonstrates how large-scale public-private partnerships can have transformative impact by embedding standards, practises and trust in all actors in the health ecosystem: companies, SMEs, regulatory bodies and healthcare providers.
SYNAPSE is a proud member of EHDEN, having been involved from its definition and being a key partner in several pillars of the Project, from leading the Sustainability development and Project Management to the Community Management acting as central point of contact with all network members.
DARWIN EU®
European Medicines Agency (EMA) representatives at the workshop also highlighted the IMI project EHDEN as an example of a public-private partnership that provides results that regulators can use. Leveraging this extensive work done, EMA’s DARWIN EU enables the conduction of studies to generate real-world evidence for EMA. The EMA is systematically growing and publicly sharing the experience with real-world evidence used for answering questions in medicine development, assessment and use, such as disease epidemiology, clinical management and drug utilisation to support the design and feasibility of studies, evaluate the representativeness and validity of completed studies, and investigate effectiveness and safety studies as well as the impact of regulatory actions about DARWIN EU®.
SYNAPSE is contributing in DARWIN EU® as part of the Coordination Centre running the Management pillar of the initiative.
CLAIMS
Several IHI and IMI projects are investigating how AI and real-world data could yield insights so that doctors can deliver more personalised prognoses and treatment plans to patients. During the event, the IHI CLAIMS project (on Multiple sclerosis, MS) was presented, which is developing a platform based on real-world data and AI models seeking to predict how a person’s multiple sclerosis will progress depending on which treatments are administered. This is a step towards more personalised care for people with MS, and it will help clinicians to make better, evidence-based decisions regarding treatment plans. It will also feed into the goals of the European Health Data Space. SYNAPSE is leading the management and communication work packages within this initiative.
These initiatives underscore SYNAPSE's commitment to advancing digital health solutions and real-world data applications to improve patient care and outcomes across various medical domains.
Read the full event report here.
