Creating an Inclusive European Clinical Trials Ecosystem That Values Every Individual’s Health Journey

READI is an IHI-funded project aimed at fostering a more cohesive and integrated clinical studies ecosystem for underserved (US) and underrepresented (UR) communities.

This pioneering project is a public-private partnership formed by a multi-stakeholder consortium of 73 organizations; supported by €66.8 million in funding from the Innovative Health Initiative Joint Undertaking (IHI JU) and contributing industry partners from 18 countries.

WHY IS READI NECCESSARY AND VALUABLE FOR CITIZENS ACROSS EUROPE?

Did you know that clinical trials in Europe fail to include/leave out many population groups in Europe?

That leads to gaps in knowledge that affect all of us

Underrepresented and underserved groups, such as ethnic, sexual and gender minorities, age or socioeconomically disadvantaged groups, are often left out of crucial clinical research. Geographical limitations, lack of trust and poor access to information lead to many barriers that limit these people's access to trials. This creates significant knowledge gaps in understanding how diseases and treatments affect diverse groups, while also limiting access to new health innovations for many.

The READI Project embarks on the mission to address this imbalance by breaking down barriers to participation and creating a more equitable, inclusive clinical research ecosystem. By empowering all stakeholders - patients, caregivers, healthcare professionals and patient organizations - with tools, training, and improved communication, READI ensures that everyone has a fair chance to participate in clinical studies.

We take a critical step forward in transforming clinical research in Europe - making it more representative and impactful for all communities, regardless of people's background, geographical location or circumstances.

Together, we shape a better healthcare for tomorrow, closing the gaps and ensuring that nobody is left behind/setting a new standard for equity in clinical research.

OBJECTIVES

The main goal of READI is to enhance the representativeness of underserved (US) and underrepresented (UR) populations in clinical studies by fostering a more cohesive and integrated clinical study ecosystem.

READI will help US/UR communities overcome barriers to clinical study participation, such as lack of information or awareness, mistrust, poor communication, geographic limitations, and prejudice. In turn, this will enhance research on many diseases and conditions, improve preventative care and treatment effectiveness across diverse demographic groups, and better serve society.

IMPACT

READI will transform the way clinical studies are conducted in Europe:

READI will raise awareness and improve understanding of diversity, as well as the characteristics of Underrepresented (UR) and Underserved (US) communities across Europe, by promoting population representativeness in clinical research.

Researchers and industry stakeholders will enhance their understanding of the impact of study design and execution on patient recruitment in future clinical studies, through use cases.

READI will lead to improved research on various diseases and conditions, better care, and more effective treatments across different demographic groups, thereby serving society more effectively.

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PRESS RELEASE

THE EXPERTISE BEHIND - CONSORTIUM

SERMAS (Servicio Madrileño de Salud) , through Hospital Universitario La Paz in Spain, Novartis in Switzerland, and supported by The Synergist in Belgium.

Consortium include:

AbbVie - Aarhus Universitet (AU) - 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 Patients' Organisations 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 Institute (NCI) - National Institute for Health and Care Excellence (NICE) - Novo Nordisk A/S - Pagalbos Onkologiniams Ligoniiams Asociacija (POLA) - Penta Foundation (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) - Zabala Innovation Consulting SA (ZABALA) -

CONTACT US

This project 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).