READI Project kicks off to enhance Patient Representativeness and Inclusion in European Clinical Research

In a context where certain European communities remain neglected and underrepresented in clinical studies, READI emerges, an initiative that seeks to foster a more integrated and equitable ecosystem. It aims to strengthen the inclusion of these populations by involving key stakeholders in the process.

READI aims to promote a less fragmented and more democratic ecosystem for clinical trials / studies (CS) by involving key stakeholders in the process of inclusion of underserved and underrepresented populations (UnderServed US / UnderRepresented UR).

Vicomtech participates as a technical partner contributing to the development of a patient-focused digital and AI platform, defining the functional and non-functional requirements and specifications of the digital platform and its subsequent implementation. Also, Vicomtech is leading a task that has as main objective to provide structured, standardized and enriched data to simplify the process of identifying candidates for Clinical Trials from underserved and underrepresented populations and matching them with relevant Clinical Trials.

To demonstrate READI's ability to broaden representation in clinical research, pilot testing will be conducted in clinical and non-clinical use cases within real-world settings, supported by industry partners.

The project will include the mapping of the characteristics of these populations from real-world data (RWD), the development of standardized descriptors for their inclusion, as well as the collection of knowledge and analysis of regulatory policies and Health Technology Assessment (HTA), with the aim of improving representativeness in clinical studies.

The consortium, coordinated by the Madrid Health Service (SERMAS) through the Hospital Universitario La Paz, has Novartis as Project Leader and The Synergist as Digital and Sustainability Coordinator. It brings together 73 organizations from 18 countries and will last six years, with a budget of 66.8 million euros, of which 31.5 million are financed by IHI and 34.2 million by industry and contributing partners.