16 January, 2025 — The pioneering project READI — Research in Europe and Diversity Inclusion — a public-private partnership funded by the Horizon Europe Innovative Health Initiative (IHI) and driven by meaningful co-leadership with patients, officially launches today.
Its purpose is to promote a less fragmented and more democratic ecosystem for clinical studies by engaging key stakeholders in the process of including underserved and underrepresented populations in clinical studies.
The consortium is coordinated by the Servicio Madrileño de Salud (SERMAS), through Hospital Universitario La Paz, as the Project Coordinator, Novartis as the Project Lead, and supported by The Synergist as the Digital & Sustainability Coordinator. This project brings together a highly multidisciplinary consortium of 73 organisations from 18 different countries, including Penta. The six-year project will have a budget of €66.8 million, of which €31.5 million is requested to be funded by IHI, and €34.2 million is committed by industry and contributing partners.
READI’s main objective is to enhance the representativeness of underserved populations in clinical studies by fostering a more cohesive and integrated clinical study ecosystem, with the ambition of achieving full inclusion by placing the patient at the center. It will actively connect key stakeholders involved with underserved and underrepresented communities, and equip them with the necessary tools, training programs, and strategies essential for recruiting and retaining underserved and underrepresented patients in clinical studies. To demonstrate READI’s capacity to broaden representation in clinical research, the approaches will be tested in real-world pilot clinical and non-clinical use cases, supported by industry partners.
The work will include mapping the characteristics of these populations using Real-World Data, developing standardised descriptors for their inclusion, collecting insights and informing regulatory and Health Technology Assessment policies to enhance representativeness in clinical studies.
Drawing on its expertise in child health research, Fondazione Penta ETS will be a key contributor to the READI initiative. With a strong track record in fostering global partnerships with clinical sites, engaging underserved communities in research and developing innovative training programmes tailored to diverse populations, particularly in the field of infectious diseases affecting children and in pregnancy, Fondazione Penta is committed to advancing health equity.
Penta’s role in the project will focus on bridging gaps between stakeholders, ensuring the effective implementation of tools and strategies and evaluating the real-world impact of these approaches in studies, all while prioritising the needs of children, pregnant people and diverse populations in research.
READI will help underserved and underrepresented communities overcome barriers to clinical study participation, such as lack of information or awareness, mistrust, poor communication, geographic limitations, and prejudice. In addition, READI will design and implement a patient-centred, open, and innovative digital platform to improve access to clinical study information and READI tools, while fostering patient connections with established communities.
Ultimately, this initiative will lead to more innovative science and will improve inclusive participation in clinical trial research thereby promoting health equity in Europe.
The expertise behind READI
The READI project is supported by a consortium of 73 organisations (click to see the complete list), drawing together expertise from clinical research, patient advocacy, digital health, and regulatory affairs. Collectively, they contribute to READI’s mission of fostering inclusive clinical studies across Europe, addressing health disparities, and expanding patient access to innovative treatments.
The project is coordinated by SERMAS (Servicio Madrileño de Salud), through Hospital Universitario La Paz in Spain; Novartis in Switzerland; and supported by The Synergist in Belgium.
Contacts:
- For more information about the READI project, visit: https://ihi-readi.org/
- Follow READI on LinkedIn, X and subscribe to the YouTube Channel
Media contacts:
- Nora Franco – nfranco@zabala.es – Dissemination & Communication Manager
- Bea Quintillá – bquintilla@zabala.es – Dissemination & Communication Manager
The project is supported by the Innovative Health Initiative Joint Undertaking (IHI JU) under grant agreement No 101166227. The JU receives support from the European Union’s Horizon Europe research and innovation programme and COCIR, EFPIA, Europa Bío, MedTech Europe, Vaccines Europe and Medicines and Healthcare Products Regulatory Agency and Breakthtough T1D. UKRI UK Research and Innovation also supports this project.
