EU-PEARL has the ambition of transforming 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.
EU-PEARL is engaging with patients from the start to co-design the platform trial framework, and in that way, bring on board more patient-relevant outcomes. EATG’s role in the project Is to coordinate the Patients Advisory Group (PAG) and monitor patients Involvement throughout various work packages.
One of the ways we are ensuring that patients are real partners in the project is by inaugurating two consultative bodies – a Patient Advisory Group (PAG), and an Expert Advisory Group (EAG). The PAG is coordinated by the European AIDS Treatment Group (EATG), which is an external partner to the EU PEARL project, brought on board to support in coordinating the PAG. The PAG comprises representatives per EU PEARL disease area, and two additional representatives from patient organisations. The PAG will bring the patient perspective to the work of the project, and will consult on the work of EU PEARL and the design of the platform, ensuring these are as patient friendly as possible.
The main objectives of EU-PEARL are: (1) 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; (2) 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; (3) 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 (4) 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).
|EATG contact person(s):||Fiona Greenhalgh – firstname.lastname@example.org|
|Duration of the project/initiative:||42 months (started in November 2019)|
|Project/Initiative Leader:||VALL D’HEBRON – INSTITUT DE RECERCA (VHIR), Industry co-leader: Janssen and Novartis|
|Project/initiative Main Partner(s):||36 public and private partners|
|Main Funding Sources:||IMI (Innovative Medicines Initiative 2 programme): European Union and the European Federation of Pharmaceutical Industries Association (EFPIA)|
|Communication Disclaimer:||EU-PEARL has received funding from the Innovative Medicines Initiative 2 Joint Undertaking under grant agreement No 853966-2. This Joint Undertaking receives support from the European Union’s Horizon 2020 research and innovation programme and EFPIA|
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