- Full title: EU Patient-Centric Clinical Trial Platform (EU-PEARL)
- Duration: 42 months (1 November 2019 – 30 April 2023)
- Status: ongoing, coordinated by Fundació Hospital Universitari Vall d'Hebrón
- Funding programme: EU-PEARL receives funding from the European Union within the Innovative Medicine Initiative 2 programme, and from the European Federation of Pharmaceutical Industries and Associations.
What will the project do?
- EU-PEARL aims to make clinical trials more efficient and patient friendly. The project will do this by standardising and simplifying trial platforms, to make it easier to enrol enough patients, and ensure that patients have a higher chance of being allocated a promising treatment, rather than the placebo. EU-PEARL will focus on four disease areas – major depressive disorder, tuberculosis, non-alcoholic steatohepatitis (NASH), and neurofibromatosis.
What are the expected outcomes?
- To provide a solution so that more patients find the right trial for their needs, and which is more patient friendly
- To provide a solution that increases the likelihood of patients to be allocated a promising treatment.
- To deliver an adaptive platform which allows multiple companies to test their drugs simultaneously, allow new treatment groups to be added any time, and for dropping ineffective treatments.
- To deliver a tool which will make it possible to set up trial platforms in other disease areas, and which provides a framework from which to address regulatory issues and data governance.
What is EPFs role?
- EPF will contribute to the governance aspects, and will deliver a framework for patient engagement and a patient engagement platform. Through the Patient Advisory Group, we will inform the design of disease specific platforms. Our contribution will bring the patient perspective on aspects related to ethics, legal and non-technical aspects of the platform governance, sustainability and multi-stakeholder collaboration, and will build on the role EPF plays both in PARADIGM and EHDEN.
Impact on the patient community
- Adaptive platform trials have a potential to shorten the time needed for clinical trials. It can be difficult for patients to know where to search for trials, and once they are on them, manage the time commitments, and implications of all trial possibilities. All of these factors can make it more difficult and time-consuming for patients to get access – whether through the trial, or eventually in the market – to essential treatments.
- Making clinical trials more efficient and patient friendly can ensure that individuals find the clinical trial that matches their needs, that companies enrol enough patients, and eventually, that new treatments are evaluated in better ways.
- The EU-PEARL consortium is composed of a wide range of clinical trials stakeholders – universities, research organisations, public bodies, patient organisations, small -to-medium sized enterprises, and companies.
- Universities –Charite – Universitaetsmedizin, Erasmus Universitair Medisch Centrum Rotterdam, Katholieke Universiteit Leuven, King's College London, Ludwig-Maximilians-Universitaet Muenchen, Medizinische Universitaet Wien, The University Of Manchester, Universita Degli Studi Di Milano, Universita Vita-Salute San Raffaele, University Of Newcastle Upon Tyne, University Of Oxford.
- Research Organisations - Institut De Recherches Internationales Servier, Assistance Publique Hopitaux De Paris, Bundesinstitut Fur Impfstoffe Und Biomedizinische Arzneimittel, Eatris Eric, Ecrin European Clinical Research Infrastructure Network, Euroscan International Network Ev, Fundacio Hospital Universitari Vall D'Hebron, Synapse Research Management Partners, The European Institute For Innovation Through Health Data.
- Patient Organisations – European Patients’ Forum (EPF), Children's Tumor Foundation, Global Alliance For Tb Drug Development Non Profit Organisation.
- SMEs – Otsuka Novel Products, Berry Consultants Llp, Custodix Nv, Documental Ou
- Companies – Allergan, Astrazeneca, Janssen Pharmaceutica, Novartis Pharma, Novo Nordisk A/S, Pfizer Limited, Sanofi-Aventis Recherche & Developpement, Teva Pharmaceutical Industries Limited, Springworks Therapeutics In.