The Innovative Medicines Initiative has approved a 26 million euros project to advance in the development of a framework for platform trials.
EU-PEARL aims to improve health outcomes for patients by transforming the way clinical trials are conducted. To this end, a strategic alliance between the public and private sector composed of 36 partners will drive forward patient-centric, cross-company, multi-compound platforms trials in any disease area.
By its completion in April 2023, EU-PEARL will lead to a tested and trusted framework of IRPs (Integrated Research Platforms) which will promote cooperation amongst pharmaceutical companies, clinicians, patients and researchers and will encourage knowledge sharing and open discussion amongst all stakeholders, including regulators.
This sustainable and replicable systematic approach to platform trials conceived to test multisource compounds, will be supported by a management structure able to meet complex regulatory, ethical, legal, statistical and data requirements.
Project results are to be disseminated and exploited to the highest standards, with trial-ready networks for Major Depressive Disorder, Tuberculosis, Non-Alcoholic Steatohepatitis (NASH) and Neurofibromatosi.
EU PEARL has set itself four objectives:
- Create a trusted, sustainable and replicable entity, ready to setup and coordinate the operation of IRPs in any disease area with unmet needs.
- Set up an open, dynamic and patient inclusive IRP Governance structure to manage regulatory, ethical, legal, statistical and data requirements.
- Disseminate and exploit the EU PEARL paradigm by providing the necessary common tools, procedures, expertise and operational skills that meet the highest scientific, regulatory and ethical standards and best practices. These are to be developed jointly by public and industry partners in a consensus-based approach.
- Create trial ready IRP networks to operate on Major Depressive Disorder, Tuberculosis, Non-Alcoholic Steatohepatitis (NASH)and Neurofibromatosis.