EU-PEARL (EU Patient- cEntric clinicAl tRial pLatform)
|Funding Program||Horizon 2020 & Innovative Medicines Initiative (IMI)|
|Coordinator||Vall d'Hebron/EATRIS-ERIC (co-coordinator)|
EU-PEARL is an IMI 2 funded project, which launched in November 2019 in Barcelona, Spain. The project is one of the EATRIS flagship initiatives with an overall budget of more than 26 million euros . The project will run for 42 months, until April 2023. EU-PEARL will deliver a trusted sustainable entity ready to set up and coordinate the operation of Integrated Research Platforms (IRPs) in any disease. A Clinical Trial Platform Framework that can be used for any disease, plus four disease clinical trial platforms ready to operate at the end of the project (in Major Depressive Disorder, Tuberculosis, Non-Alcoholic Steatohepatitis (NASH), and Neurofibromatosis).
What is the goal of the project?
EU-PEARL aims to create a framework for patient-centric IRPs, through which novel techniques and treatments developed by multiple companies and organisations are
tested in a platform trial. This is a more efficient, accelerated method to bring new, effective treatments to patients.
An IRP is a novel clinical development concept which centres around a master trial protocol. It can accommodate multisourced interventions using the existing infrastructure of hospitals and federated patient data in design, planning and execution. An optimised registration pathway for these novel treatments has been established.
EU-PEARL will deliver a trusted sustainable entity ready to set up and coordinate the operation of IRPs in any disease. A Clinical Trial Platform Framework that can be used for any disease, will include four disease clinical trial platforms ready to operate at the end of the project (Major Depressive Disorder, Tuberculosis, Non-Alcoholic Steatohepatitis (NASH), and Neurofibromatosis).
Why is this so important?
There is a clinical need to find newer treatments, faster, for a variety of diseases. In this sense, recent developments in scientific research, technological innovation and advances on big data analysis open a new world of opportunities for clinical research. Based on this new reality, EU-PEARL intends to transform the way clinical trials are conducted with the aim of improving and accelerating drug development processes.
The innovative framework of Integrated Research Platforms EU-PEARL is set to bring more efficiency to the design and implementation of clinical trial protocols, potentially improving the speed of making new drugs available to patients.
What is the added value of the project for patients?
EU-PEARL is engaging with patients from the start to co-design the platform trial framework, thus bringing on board more patient-relevant outcomes. Patients and their relatives/carers will play a central role in trial designs as their perspective on inputs and views on outcomes will be consistently incorporated. Platform trials will:
• Increase patients’ prospects of receiving novel techniques
and treatments during the clinical trial, rather than a
placebo or standard of care; and
• Promote efficiencies in the clinical development process,
potentially resulting in faster access for patients to more
effective and personalised techniques and treatments.
The EU-PEARL framework will support better health and care for patients by promoting a ground-breaking collaborative paradigm.
How is EATRIS involved in this project?
EATRIS is involved in several ways. It was one of the initiators of the consortium and the development of the project proposal. EATRIS is also Co-Coordinator of EU-PEARL, with Vall d’Hebron Research Institute (VHIR). As a result, EATRIS has a seat on the project’s Executive Committee.