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.

EU Regulations on medical devices (MDs), in-vitro diagnostics, and Health Technology Assessment envisage a harmonised lifecycle approach for clinical evidence generation of MDs. To be effective this approach requires evidence generation plan to be developed since early stages of product development, by engaging all relevant stakeholders. At present, in the EU there are no standardized procedural frameworks/guidelines/common reference standards for Early Feasibility Studies (EFS), clinical investigations allowed by ISO 14155:2020 conducted early in the development aiming to inform the product development. The ambition of the HEU-EFS project is to develop a harmonised framework for the EU EFS Program, as one integrated step of evidence generation cycle. Project objectives include: (1) conducting research/analysis on state of play (i.e., characteristics, challenges, impacts) of pre-market programs for MDs, including EFS; (2) building a sustainable network of stakeholders at EU/national level to promote/support EFS implementation; (3) developing a sound, widely applicable, harmonised EU methodology and formulating recommendations to uptake EFS; (4) undertaking pilots to test the proposed framework; (5) developing instruments to monitor the EFS performance; and (6) implementing a dedicated, sustainable, open access online portal dedicated to EFS methodological framework, best practices and network. To achieve these goals, the HEU-EFS consortium has been designed including a wide range of relevant stakeholders: research organisations, HTA bodies, patient organizations, healthcare providers, SMEs (including health technology developers, legal experts, and a CRO), and 6 major private companies that are part of a pre-identified industry consortium. An Advisory Board made of competent authorities, notified bodies, medical and biomedical engineering professional associations, networks and industry trade association will collaborate to the success of the initiative.