The Innovative Health Initiative (IHI) RealiseD project (compRehensive mEthodological and operational Approach to cLinical trIalS in ultra rarE Diseases) has been officially launched, bringing together nearly 40 public and private partners to revolutionise clinical trials for rare and ultra-rare diseases. The initiative, under the leadership of Sigmund Freud Private University and AstraZeneca, aims to optimise and accelerate the development of treatments for over 30 million people living with rare diseases across Europe, the majority of whom suffer from ultra-rare conditions with no available treatment options.
What is it?
RealiseD unites nearly 40 partners from academia, regulatory bodies, clinical research institutes and hospitals, patient organisations, pharmaceutical companies or European Research Infrastructures to establish new gold standards for clinical trials in rare and ultra-rare diseases. Sigmund Freud Private University and AstraZeneca lead this project, which is funded by the Innovative Health Initiative (IHI) and will run until 2029.
What are the objectives of RealiseD?
By bringing together experts from various fields, 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.
- 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.
Building on advancements and outputs from prior and ongoing public private partnerships like EU-PEARL or Screen4Care and other relevant initiatives, such as ERICA, RD Moonshot, IDeAl or ERDERA, the RealiseD Consortium will co-create tools, methodologies and standards, to enhance innovative clinical trial designs, incorporating new methods like Real World Evidence and digital health technologies. These solutions will result in easy-to-use playbooks and digital tools for planning and running clinical trials.