A groundbreaking pan-European initiative has been launched to transform the clinical trials landscape by addressing the critical issue of participant diversity across the continent. The Research in Europe and Diversity Inclusion (READI) consortium brings together 73 healthcare organizations in an unprecedented collaboration to create a more inclusive and representative clinical research ecosystem.
Strategic Leadership and Industry Support
The initiative is spearheaded by the Servicio Madrileño de Salud (SERMAS), operating from the Spanish University Hospital of La Paz, with pharmaceutical giant Novartis serving as project lead. The consortium has garnered support from major industry players including Novo Nordisk, AbbVie, and Roche, alongside regulatory authorities such as the UK's Medicines and Healthcare Products Regulatory Agency (MHRA) and Denmark's Midtjyllands EU Kontor Forening (CDEU).
Comprehensive Funding and Timeline
The ambitious project has secured substantial financial backing, with a total budget of €66.8 million, including €31.5 million from the European Union's Horizon Europe Innovative Health Initiative. The initiative is structured as a six-year program to ensure sustainable impact and meaningful change in clinical trial diversity.
Core Objectives and Implementation Strategy
READI's mission focuses on several key areas to enhance diversity in clinical research:
- Mapping population characteristics using real-world data
- Developing standardized inclusion descriptors
- Informing regulatory and Health Technology Assessment policies
- Addressing participation barriers for underserved communities
- Creating an innovative digital platform for improved access to clinical study information
The consortium will tackle various obstacles that traditionally prevent underserved communities from participating in clinical studies, including:
- Information and awareness gaps
- Trust issues
- Communication barriers
- Geographic limitations
- Systemic prejudice
Digital Innovation for Patient Engagement
A cornerstone of the initiative is the development of a patient-centered digital platform. This tool will serve as a comprehensive resource for clinical study information and READI-specific tools, while also facilitating connections between patients and established research communities.
Alignment with Global Health Initiatives
The formation of READI comes at a crucial time, following recent stakeholder discussions in Vienna that emphasized the need for unified approaches to address European healthcare challenges. The initiative also aligns with the World Health Organization's guidance on increasing diversity in clinical trials, demonstrating a coordinated global effort to make clinical research more representative and inclusive.
