EU-PEARLEU Patient cEntric clinicAl tRial pLatform
Funding programme: Innovative Medicines Initiative & Horizon 2020 (N 853966-2)
Duration: 3.5 years (Nov 2019 - Apr 2023)
EU-PEARL aims to transform the current approach of conducting single-compound clinical trials into the use of cross-company Integrated Research Platforms (IRPs), taking into consideration both patients’ interests and the opportunities from novel molecules for addressing medical needs. Patient-centric data and knowledge sharing have the potential to accelerate the development of new treatments and reduce the operational costs of clinical trials.
EU-PEARL will improve clinical effectiveness, patients’ satisfaction and societal access to timely and affordable medicines and it will shape the clinical trials of the future. This will change the industry paradigm from competition to cooperation in four disease areas and provide the framework for designing IRPs in other disease areas.
The main objectives of EU-PEARL are:
- To create a reusable, accessible and sustainable modular IRP for the design and execution of patient-centric, cross company IRP in any disease area with unmet needs;
- To set up the open, dynamic, patient inclusive IRP governance structure that will manage the appropriate regulatory, ethical, legal, statistical and data utilisation requirements of the IRP;
- To disseminate and exploit the EU-PEARL paradigm through the provision of the necessary common tools, procedures, expertise and operational skills working to the highest scientific, regulatory and ethical standards and best practices, developed jointly by public and industry partners in a consensus-based approach; and
- To create trial-ready IRP networks in the four disease areas of Major Depressive Disorder (MDD), Tuberculosis (TB), Non-Alcoholic Steatohepatitis (NASH) and Neurofibromatosis (NF).
The project kick-off was held from 21-22 November 2019; the scheduled duration of the project is 42 months.
EU-PEARL is funded by Horizon 2020 and the Innovative Medicines Initiative (IMI) under grant agreement number 853966-2.