The READI European project: Enhancing inclusivity in clinical research

Clinical studies (CS) have often struggled to recruit and retain participants that represent the population who will ultimately receive the treatments. This lack of representation leads to gaps in understanding diseases, preventive factors and the safety and effectiveness of treatments across diverse populations.1 In this way, access to experimental health technologies—such as medicinal drugs, vaccines and medical devices—remains limited to specific populations. Improving inclusiveness and representativeness in clinical studies is not just a matter of equity but a crucial step to ensure the quality and impact of clinical studies.2 Thus, broadening the scope of those who are included in clinical studies can be regarded as an attempt to ensure that innovations in healthcare are accessible to all, reducing disparities not only in Europe but across the globe. This approach will ultimately lead to more reliable data and more effective treatments that truly serve the needs of a diverse population. Various factors are associated with health disparities, including but not limited to demographic characteristics such as ethnicity, sex, gender, socio-economic status or age. Clinical studies must actively consider populations that have historically been underserved (US) and underrepresented (UR) in clinical studies. However, several barriers hinder participation, particularly among US and UR populations. These include geographic limitations, mistrust, restricted access to relevant information, ineffective communication, societal prejudices, financial constraints among other factors.3, 4 Addressing these challenges requires a fundamental transformation in the design and execution of clinical studies to ensure a truly representative patient population is identified and provided with equitable opportunities to participate. To drive this transformation, it is essential that relevant clinical study information is widely distributed and accessible to all populations, that professionals involved are properly trained and empowered to design, develop and manage innovative studies tailored to diverse populations, and that key stakeholders—including patients, caregivers and patient organizations—are actively involved in design, educated and engaged, as their participation is vital to the success of clinical studies.7 In this challenging context, the Research in Europe and Diversity Inclusion (READI) Project aims to create a more integrated and democratic ecosystem for clinical studies by identifying barriers to inclusiveness and representativeness, setting a new standard for equity in clinical studies and fostering the empowerment of all stakeholders. Through this engaged ecosystem, stakeholders can provide and share innovative approaches, tools, training programs and valuable insights to facilitate reach, engagement, recruitment and retention of underserved and underrepresented participants, enhancing inclusiveness and representativeness in CS. The READI Project will further accelerate and sustain its impact through an innovative digital platform designed to enhance access to clinical studies information and strengthen stakeholder connections. By adopting an intersectional and holistic approach, READI will ensure long-term sustainability beyond the project's duration, ultimately transforming the way clinical studies are conducted in Europe. Additionally, READI will align with various global clinical research initiatives, such as the WHO International Clinical Trials Registry Platform (ICTRP)8 and the Vulcan Accelerator,9 among others. To achieve its ambitious objectives, READI has assembled one of the largest consortia ever formed for a European clinical studies initiative.10 Comprising 73 organizations from 18 countries: Belgium, Cyprus, Denmark, France, Germany, Ireland, Italy, Lithuania, Luxembourg, the Netherlands, Portugal, Romania, Spain, Sweden, Switzerland, the United Kingdom, the USA and Brazil (Figure 1). These organizations cover the full range of stakeholders involved in clinical research: patient organizations (with the largest participation ever in such a project), academic research centers, hospitals, technology companies, the European Federation of Pharmaceutical Industries and Associations (EFPIA), regulatory bodies, ethics experts, Health Technology Assessment and clinical research professionals. With a budget of 66.8 million euros, this multidisciplinary consortium fosters cross-collaboration to ensure that all aspects of clinical research—from study design to implementation—reflect the principles of inclusivity and equity, whereby everyone has access to innovation in healthcare. Additionally, the project is structured around 4 main pillars and 10 interconnected work packages (WPs), each addressing a critical component of the project's objectives (Figure 2): Pillar II: Digital platform and tools for clinical studies. This pillar encompasses three work packages: Pillar III: Community Connectivity and Capacity Building. This pillar includes two work packages: All these work packages progress in parallel and are led by a combination of academic institutions, patient representatives, civil society and EFPIA members, ensuring a balanced collaboration between the public and private sectors (Table 1), all of them participating in the Steering Committee. The overall coordination of the project is managed by Alberto Borobia (SERMAS) as Coordinator and Juliette Guillot (Novartis) as Project Leader, with the support of Amanda Bok (The Synergist) as Digital and Sustainability Coordinator. This structure ensures the proper development, WP interconnection and collaborative work among all project partners, guaranteeing the success and achievement of its objectives. ITTM: Andreas Kremer, Gabriel Sieglerschmidt Synergist: Nersey Rastan AZ: John Rivers J&J BREAKTHROUGHT1D: Carmen Hurtado del Pozo TPIZ: Akiko Otani, Adam MacNeill As reflected in the previous lines, the READI project will transform the way clinical studies are conducted in Europe. It is designed to transform clinical trial ecosystems and capabilities, with patients at the center, and key stakeholders collaborating from the design phase to the delivery phase. In this way, the knowledge generated will not only be beneficial by itself, but also useful for making recommendations to advance inclusive representation in CS and develop ethical standards. It will provide an innovative methodology to recruit underserved and underrepresented populations, as well as a change in CS communication by expanding a network of sites capable of conducting CS across Europe, by equipping diverse entities with the necessary capabilities to recruit and retain US and UR populations. Specifically, it is expected to expand the understanding of underserved and underrepresented populations, leading to a 60% increase in CS recruitment representativeness compared to historical data. In doing so, an agreed set of data standards for demographic descriptors will be developed, along with a toolbox for patient recruitment that includes digital platforms reaching at least 100 organizations. Testing these tools is crucial, so at least four clinical use cases will be developed to demonstrate their impact and effectiveness. The READI project addresses critical systemic barriers to inclusivity in clinical studies, such as geographical limitations or mistrust. By leveraging a holistic, intersectional approach, READI aims to democratize access to clinical studies and enhance the representation of US and UR populations in CS. Key innovations, such as the AI-powered digital platform and the development of a standardized set of descriptors for US and UR populations, will enhance recruitment efficiency, improve retention rates, and increase the generalizability of clinical study findings. To further support patient engagement, community clusters and targeted educational activities will help address participation barriers. Additionally, the focus on capacity building ensures that clinical sites across Europe are equipped with the necessary skills and tools to reach and engage with US and UR populations effectively. The implementation of use cases provides a practical framework for validating these innovations and generating actionable insights that will support long-term sustainability. The READI project represents a paradigm shift in the conduct of clinical research in Europe, enhancing inclusivity and equity. By addressing the systemic barriers that limit the participation of underserved and underrepresented populations, READI has the potential to transform clinical studies into being more representative and impactful. The outcomes of this project will not only help establish ethical, effective and inclusive CS practices across Europe and beyond, but also enhance access to innovations in healthcare. Future research should build on these achievements to refine methodologies and promote global adoption of inclusive CS standards. Alberto M. Borobia: Project coordination, conceptualization, supervision of manuscript preparation and critical review. Juliette Guillot: Project leadership, consortium coordination and drafting of key sections. Amanda Bok, Léa Proulx, Ron Hillel, Bruno Jolain, Sandra Pla, Mónica García, Paloma Moraga, Jose Luis Narro, and Silvia Bornengo: Provided content expertise, contributed to writing and reviewing specific sections related to their institutional work packages. All authors contributed to the manuscript, reviewed the final version and approved it for submission. We extend our sincere gratitude to all READI Consortium Members, whose commitment and expertise have been instrumental in shaping this project. Special thanks to the coordinating institutions, SERMAS (Hospital Universitario La Paz, Spain), Novartis (Switzerland) and The Synergist (Belgium), for their leadership and strategic vision. We also acknowledge the invaluable contributions of the Work Package (WP) Leaders, including Theodore Lytras, Zoi-Dorothea Pana, Rachael Williams, Solomon Makgoeng, Andreas Kremer, Brian Goodman, Nersey Rastan, John Rivers, Lars Hulstaert, Amelie Michon, Bruno Jolain, Maria Dutarte, Michel Reid, Oliver Andreas Cornely, Kerstin Albus, Sasha Tyndale, Derick Mitchell, Lea Proulx, Barbara Valastro, Irene Garcia, Juliette Guillot, Leo Russo, Cristina Murano, Monique Adams, Susan Tio, Carmen Hurtado del Pozo, Akiko Otani, Adam MacNeill, Alberto M. Borobia and Ron Hillel, whose efforts have been essential in structuring and executing this initiative. Finally, we extend our appreciation to all members who reviewed the manuscript and provided valuable feedback: Kerstin Albus, Hilda Ahnstedt, Ulrik Bak, Nadine Boesten, Solange Corriol-Rohou, Carina Dantas, Maria Dutarte, Rhonda Facile, Talita Honorato, Irene García, Shatyam Issur, Bruno Jolain, Apostolos Kalagionnes, Urska Kosir, Olga Laosa, Claudia Louati, Reamonn Madden, Salma Malik, Cristina Marián, Julia Mollá, María Cristina Murano, Begonya Nafria, Sanne Peters, Carina Pittens, Lea Proulx, Kavita Ramji, Shaun Treweek, Barbara Valastro, Robina Weermeijer, Rachael Williams, Mira Zuidgeest. READI Consortium Members: The consortium is led by SERMAS (Servicio Madrileño de Salud), through Hospital Universitario La Paz in Spain, Novartis in Switzerland, and supported by The Synergist in Belgium. Consortium includes AbbVie, Aarhus Universitet (AU) and Aarhus Universitetshospital (AUH), Almirall SA (ALM), AstraZeneca AB (AZ), Boehringer Ingelheim, Breakthrough T1D, (BREAKTHROUGH1D) Bristol-Myers Squibb Company Corp (BMS), CDISC Europe Foundation (CDISC), Chiesi Group, Curewiki, Digestive Cancers Europe (DiCE), Eli Lilly and Company (Lilly), Esperity (CT.be), European AIDS Treatment Group (EATG), European University Cyprus (EUC), ECRIN European Clinical Research Infrastructure Network (ECRIN), F. Hoffmann-La Roche AG (Roche), FIBHUG (Fundación para la Investigación Biomédica del Hospital Universitario de Getafe), Fundación para la Investigación Biomédica del Hospital Universitario la Paz (FIBHULP), FISABIO (Fundacion para el Fomento de la Investigación Sanitaria y Biomédica de la Comunitat Valenciana), Forum des Patients Européens (EPF), Fundación 29 de Febrero, Fundació Privada per a la Recerca i la Docència Sant Joan de Déu (FSJD), GlaxoSmithKline Research & Development Limited (GSK), Global Heart Hub (GHH), HL7 International Fondation, Information Technology for Translational Medicine (ITTM) SA, Irish Platform for Patient Organizations Science and Industry (IPPOSI), Janssen-Cilag Limited, a Johnson & Johnson company, Klinikum der Universität zu Köln (UHC), Medicines and Healthcare Products Regulatory Agency (MHRA), Midtjyllands EU Kontor Forening (CDEU), National Cancer Center of Vilnius University Hospital Santaros Clinics (NCI), National Institute for Health and Care Excellence (NICE), Novo Nordisk A/S, Pagalbos Onkologiniams Ligoniiams Asociacija (POLA), Fondazione Penta ETS (PENTA) Pfizer Inc. (Pfizer), Sanofi, SHINE 2Europe, Lda (SHINE), Socialit Software e Consulting Srl (SIT), Stichting EUPATI Foundation (EUPATI) Stichting VU, Synapse Research Management Partners SL (Synapse), Synergist Services (Synerserv), Takeda Pharmaceuticals International AG (TPIZ), The August Pi i Sunyer Biomedical Research Institute (IDIBAPS), Trial Nation (TrialNation), UCB Biopharma (UCB), Universitair Medisch Centrum Utrecht (UMCU), University of Nicosia (UNIC), University Court of the University of Aberdeen (UoA), Vicomtech, ViiV Healthcare UK LTD, VU University Medical Center (VU), Youth Cancer Europe (YCE) and Zabala Innovation Consulting SA (ZABALA). The project leading to this publication 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, EuropaBio, MedTech Europe, Vaccines Europe, and Medicines and Healthcare products Regulatory Agency and Breakthrough T1D. This project is also supported by UKRI (UK Research and Innovation) grant agreement No 10152425 for National Institute for Health and Care Excellence and grant agreement No 31052024 for The University Court of the University of Aberdeen. Webpage: https://ihi-readi.org. The authors declared no competing interests for this work. This publication is organized and funded by the IHI READI consortium members. This publication is intended for non promotional scientific purposes only and may contain information on products or indications currently under investigation and/or that have not been approved by the regulatory authorities. This publication is accurate at the time of presentation. The content of this publication is not intended to establish any legally enforceable rights, obligations or commitments on the IHI READI consortium members. The data presented in this article are based on project documentation and consortium contributions from the READI European initiative. Data supporting the findings are available from the corresponding author upon reasonable request. Due to privacy and consortium agreements, some datasets are not publicly available.