What RealiseD represents
This project is supported by the Innovative Health Initiative Joint Undertaking (IHI JU). The JU receives support from the European Union’s Horizon Europe research and innovation programme and COCIR, EFPIA, Europa Bío, MedTech Europe, and Vaccines Europe.
How many people are affected?
Ambition
improve the lives of millions of people living with a rare and ultra-rare disease across Europe and beyond by developing cutting-edge operational and methodological tools and resources that can dramatically advance the evaluation of new treatments
RealiseD will:
Generate cutting-edge operational and methodological tools and resources:
through a co-creation process involving clinicians, methodologists, pharmaceutical industry researchers, representatives from patient organisations, regulatory agencies and HTA bodies.
Collaborate with European Reference Networks (ERNs):
to create a network of clinical trial sites across Europe and streamline the process of finding and enrolling patients in clinical trials. ERNs will also test RealiseD solutions in four areas – paediatric epilepsy, bone disorders, eye disease, and haematology.
Accelerate therapeutic development and improve patient outcomes:
for over 30 million people living with rare diseases in Europe, most of whom suffer from ultra-rare diseases and have no treatment options.
Establish new gold standards for clinical trials:
in rare and ultra-rare diseases through a partnership of nearly 40 public and private organisations.
ERKNET is crucially involved in following key activities
Establish a European Clinical Trial Network: ERKNet, along with other ERNs (like Epicare, Bond, MetabERN, EuroBloodNet, and ERN-EYE), will contribute to building a network of top-tier clinical trial sites across Europe.
Create an Efficient Patient Referral System: By leveraging its network of expert hospital centers across Europe, ERKNet will help streamline the identification and enrollment of patients with rare and ultra-rare kidney diseases into appropriate clinical trials.
Support Development and Acceptance of Innovative Methodologies: ERKNet’s clinical partners will participate in the co-creation of new clinical trial methodologies and tools tailored for small patient populations. This includes facilitating regulatory acceptance and ensuring patient-relevant outcomes are central to decision-making.