The public-private partnership, READI, seeks to help clinical studies (CS) to finally serve the complete general population, and therefore more patients. To date CS have struggled to recruit and retain participants from diverse backgrounds and communities, such as marginalized or disadvantaged groups (e.g., sexual, gender, age, cultural, and socioeconomic cohorts). The resulting knowledge gaps entrench or increase health disparities. The READI consortium strives to tackle these challenges by fostering a more cohesive and integrated CS ecosystem for underserved (US) and underrepresented (UR) communities. It will actively connect all key stakeholders who can facilitate access to a wide range of patient populations. It will provide these stakeholders with the necessary tools, training programs, and approaches essential for the recruitment and retention of US/UR patients in CS. In addition, it will design, build and implement a digital platform which is patient-centred, sustainable, open and innovative. This will foster improved access to CS information and READI tools, while also supporting patient connections with the created communities. Finally, at least 4 CS will be used for testing the effectiveness of the developed tools and approaches. READI has a three-fold objective: to help US/UR communities overcome CS participation barriers (e.g., lack of information/awareness, mistrust, poor communication, geographic limitations, prejudice), which in turn will improve research of many diseases and conditions, preventative care and treatment effectiveness in different demographic groups, and better serve society. READI’s success will draw from its interdisciplinary, multi-stakeholder, consortium composition of 73 organizations from 18 countries, with key expertise in drug development and CS (design and operations), engagement strategies for US/UR populations, digital platform development, training and capability building initiatives, effective communication and dissemination, long-term sustainability, ethics and regulatory affairs.

In the first five years of operations, EATRIS has shown strong proof of concept of the value of the services portfolio, with users ranging from academia, SMEs, large pharma, to biotech and research funding organisations. The overarching aim of EATRIS-Plus is to support the long-term sustainability (LTS) of EATRIS by delivering innovative scientific tools to the research community, strengthening the infrastructure’s financial model and reinforcing EATRIS leadership in the European Research Area (ERA), particularly in the field of Personalised Medicine (PM) research and development. Specific objectives are: (i) To consolidate EATRIS capacities in the field of PM to better serve academia and industry and augment the number of EATRIS Innovation Hubs with large pharma; (ii) To further strengthen the LTS of EATRIS financial model; (iii) To drive patient empowerment through active involvement in the infrastructure’s operations; (iv) To expand strategic partnerships with Research Infrastructures and other relevant stakeholders. The proposal relies on a scientific and technological programme combined with capacity-building activities across 16 EU countries, with the support of two umbrella organisations representing patient organisations and SMEs. EATRIS-Plus will help pooling and exploiting the translational academic capacities of the infrastructure in omic technologies to enable researchers to better address the scientific and societal challenge of PM. Additionally, the coordination office and 13 existing national nodes of the infrastructure will participate in implementing joint outreach, training, industry engagement and international collaboration activities to further build national capacity, increase users’ trust and strengthen EATRIS and the ERA global scientific leadership.