The overall aim of the group will be to raise awareness and improve understanding of diversity, as well as the characteristics of underrepresented and underserved communities across Europe. Credit: Shutterstock / New Africa

A new pan-European initiative aimed at creating a new less fragmented and more democratic ecosystem for clinical trials across the continent has been launched.

Dubbed Research in Europe and Diversity Inclusion (READI), the new consortium, backed by a consortium of 73 continental healthcare entities, is led by the Servicio Madrileño de Salud (SERMAS) based out of the Spanish University Hospital of La Paz. It also has the backing of industry players ranging from biopharmaceutical giants such as Novo Nordisk, AbbVie and Roche, through to healthcare regulatory bodies such as the UK’s Medicines and Healthcare Products Regulatory Agency (MHRA) or Denmark’s Midtjyllands EU Kontor Forening (CDEU). It also comprises hospital sites and clinical research organisations (CROs) across the continent.

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The overall aim of the group will be to raise awareness and improve understanding of diversity, as well as the characteristics of underrepresented and underserved communities across Europe, by promoting population representativeness in clinical research. The hope is that this will encourage researchers and research organisations to alter their study designs in the future and help certain groups to feature more prominently across the clinical trials space.

Alongside SERMAS, the group will be led by Swiss pharma giant Novartis, which will be acting as project lead alongside non-profit organisation, Synergist, as the digital & sustainability coordinator. The six-year project is set to have a budget of €66.8m, €31.5m of which is to be provided by the European Union’s Horizon Europe Innovative Health Initiative.

In a statement released alongside the announcement, the group said: “The work will include mapping the characteristics of these populations using real-world data (RWD), developing standardised descriptors for their inclusion, collecting insights and informing regulatory and Health Technology Assessment (HTA) policies to enhance representativeness in clinical studies.

“READI will help underserved and underrepresented communities overcome barriers to clinical study participation, such as lack of information or awareness, mistrust, poor communication, geographic limitations, and prejudice. In addition, READI will design and implement a patient-centred, open, and innovative digital platform. This platform will improve access to clinical study information and READI tools while fostering patient connections with established communities.”

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The announcement follows after stakeholders at a conference in Vienna last year urged regulators, governments and healthcare firms in the EU to form more united and singular groups in order to tackle several rising issues across the continent, lack of diversity in trials among them. Away from the EU, the World Health Organisation (WHO) has launched guidance urging a greater rate of diversity in clinical trials.