Summary
At present, many groups in Europe are not adequately represented in clinical research. These underserved and underrepresented populations may include ethnicities, LGBTQ+ individuals, older adults, and those from socioeconomically disadvantaged backgrounds, among others. This lack of representation has two major consequences. First, it leads to significant gaps in our understanding of various diseases and the most effective ways to prevent and treat them across different demographic groups. Second, it means that people from these communities miss out on access to experimental health technologies, such as new medicines, vaccines, and medical devices.
Improving inclusiveness and representation in clinical studies will lead to more equitable healthcare access, help address existing health disparities and enhance the quality of clinical research.
However, numerous systemic barriers hamper the greater involvement of underserved and underrepresented communities in clinical studies. These barriers include geographic limitations, mistrust, poor communication, and prejudice.
The aim of READI is to foster a more holistic, integrated system around clinical studies that will support the inclusion of patients usually underserved and underrepresented, and ultimately transform the way clinical studies are carried out in Europe. The project brings together experts from various fields, such as clinical studies, public health, multistakeholder collaboration, and patient engagement as well patient representatives themselves.
One of the project’s first tasks will be to understand and characterise, at a country level, underserved and underrepresented populations in Europe and generate strategies to boost their involvement in clinical studies. Additionally, the project will co-create new methodological approaches, resources, training programs, and tools to design and conduct inclusive clinical studies.
A key outcome of the project will be the development of an open, patient-centric digital platform for clinical studies. This innovative platform will bring together in one place resources, data, and information about clinical studies, driving the evolution of more inclusive clinical research. Finally, at least four clinical studies will be used to test the effectiveness of the tools and approaches developed.
Ultimately, READI will usher in a more inclusive approach to conducting clinical trials, benefiting underserved and underrepresented groups and enhancing the quality of clinical research in Europe.
Participants
Show participants on mapUniversities, research organisations, public bodies, non-profit groups
- Aarhus Universitet, Aarhus C, Denmark
- Aarhus Universitetshospital, Aarhus, Denmark
- Digestive Cancers Europe Dice, Brussels, Belgium
- Ecrin European Clinical Research Infrastructure Network, Paris, France
- Edex - Educational Excellence Corporation Limited, Nicosia, Cyprus
- European University - Cyprus LTD, Nicosia, Cyprus
- Fondazione PENTA - for the treatment and care of children with HIV-ONLUS, Padova, Italy
- Fundacio Privada Per A La Recerca I La Docencia Sant Joan De Deu, Esplugues de Llobregat, Spain
- Fundacion 29 De Febrero, Pozuelo De Alarcon Madrid, Spain
- Fundacion Para El Fomento De La Investigacion Sanitaria Y Biomedica De La Comunitat Valenciana, Valencia, Spain
- Fundatia Youth Cancer Europe, Cluj-Napoca, Romania
- Global Heart Hub Company Limited By Guarantee, Galway, Ireland
- Hl7 International Fondation, Brussels, Belgium
- Klinikum Der Universitaet Zu Koeln, Cologne, Germany
- Midtjyllands Eu Kontor Forening, Viborg, Denmark
- Nacionalinis Vezio Institutas, Vilnius, Lithuania
- National Institute For Health And Care Excellence, Manchester, United Kingdom
- Pagalbos Onkologiniams Ligoniams Asociacija, Kaunas, Lithuania
- Servicio Madrileno De Salud, Madrid, Spain
- Stichting Eupati Foundation, Utrecht, Netherlands
- Stichting Vu, Amsterdam, Netherlands
- The University Court Of The University Of Aberdeen, Aberdeen, United Kingdom
- Trial Nation, Copenhagen, Denmark
- Universitair Medisch Centrum Utrecht, Utrecht, Netherlands
Small and medium-sized enterprises (SMEs) and mid-sized companies (<€500 m turnover)
- Cdisc Europe Foundation Fondation, Brussels, Belgium
- Curewiki, Brussels, Belgium
- Esperity, Bruxelles / Brussel, Belgium
- Fundacion Centro De Tecnologias De Interaccion Visual Y Comunicaciones Vicomtech, Donostia San Sebastian, Spain
- Information Technology For Translational Medicine (Ittm) SA, Esch-sur-Alzette, Luxembourg
- Shine 2europe Lda, Coimbra, Portugal
- Socialit Software E Consulting SRL, Trento, Italy
- Synapse Research Management Partners SL, Barcelona, Spain
- Synergist Services, Bruxelles, Belgium
- The Synergist, Bruxelles, Belgium
Patient organisations
- European Aids Treatment Group Ev, Duesseldorf, Germany
- Forum Des Patients Europeens, 1040, Belgium
- Irish Platform For Patients' Organisations Science And Industry Limited By Guarantee, Dublin, Ireland
Third parties
- Fundacio De Recerca Clinic Barcelona-Institut D Investigacions Biomediques August Pi I Sunyer, Barcelona, Spain
- Fundacion Para La Investigacion Biomedica Del Hospital Universiatrio La Paz, Madrid, Spain
- Fundacion Para La Investigacion Biomedica Del Hospital Universitario De Getafe, Madrid, Spain
- Janssen-Cilag GMBH, Neuss, Germany
- Janssen Biologics BV, Leiden, Netherlands
- Janssen Pharmaceutica Nv, Beerse, Belgium
Private companies
- Zabala Innovation Consulting SA, Mutilva Alta Navarra, Spain
IHI industry partners
- Abbvie Inc, North Chicago, Illinois, United States
- Ablynx Nv, Zwijnaarde, Belgium
- Almirall SA, Barcelona, Spain
- Astrazeneca AB, Södertälje, Sweden
- Boehringer Ingelheim B.V., amsterdam, Netherlands
- Boehringer Ingelheim Internationalgmbh, Ingelheim, Germany
- Bristol-Myers Squibb Company Corp, Princeton, NJ, United States
- Chiesi Farmaceutici S.A, Parma, Italy
- Eli Lilly And Company, Indianapolis, United States
- Eli Lilly And Company LTD, Basingstoke, United Kingdom
- F. Hoffmann-La Roche AG, Basel, Switzerland
- Glaxosmithkline Research & Development Limited, Brentford, Middlesex, United Kingdom
- Janssen Cilag Limited, High Wycombe, United Kingdom
- Lilly Deutschland GmbH, Bad Homburg, Germany
- Novartis Pharma AG, Basel, Switzerland
- Novo Nordisk A/S, Bagsvaerd, Denmark
- Pfizer Inc, New York City, United States
- Pfizer Polska Sp. z o.o., Warsaw, Poland
- Pfizer R&D UK Limited, Sandwich, United Kingdom
- Sanofi, Bridgewater, United States
- Sanofi-Aventis Recherche & Developpement, Chilly Mazarin, France
- Sanofi Medley Farmacêutica Ltda, São Paulo, Brazil
- Sanofi Pasteur SA, Lyon, France
- Sanofi Winthrop Industrie, Gentilly, France
- Takeda Pharmaceuticals International AG, Glattpark-Opfikon (Zurich), Switzerland
- UCB Biopharma, Brussels, Belgium
- Viiv Healthcare Uk LTD, Brentford, United Kingdom
Contributing partners
- Breakthrough T1d, New York, United States
- Medicines And Healthcare Products Regulatory Agency, London, United Kingdom
Participants | |
---|---|
Name | EU funding in € |
Aarhus Universitet | 156 280 |
Aarhus Universitetshospital | 530 200 |
Cdisc Europe Foundation Fondation | 362 450 |
Curewiki | 815 950 |
Digestive Cancers Europe Dice | 241 250 |
Ecrin European Clinical Research Infrastructure Network | 890 825 |
Esperity | 258 950 |
European Aids Treatment Group Ev | 581 950 |
European University - Cyprus LTD | 1 228 825 |
Fondazione PENTA - for the treatment and care of children with HIV-ONLUS | 854 500 |
Forum Des Patients Europeens | 627 200 |
Fundacio Privada Per A La Recerca I La Docencia Sant Joan De Deu | 258 950 |
Fundacion 29 De Febrero | 100 250 |
Fundacion Centro De Tecnologias De Interaccion Visual Y Comunicaciones Vicomtech | 973 930 |
Fundacion Para El Fomento De La Investigacion Sanitaria Y Biomedica De La Comunitat Valenciana | 564 700 |
Fundatia Youth Cancer Europe | 443 950 |
Global Heart Hub Company Limited By Guarantee | 345 200 |
Hl7 International Fondation | 362 450 |
Information Technology For Translational Medicine (Ittm) SA | 2 337 525 |
Irish Platform For Patients' Organisations Science And Industry Limited By Guarantee | 788 950 |
Klinikum Der Universitaet Zu Koeln | 1 340 950 |
Midtjyllands Eu Kontor Forening | 172 700 |
Nacionalinis Vezio Institutas | 155 450 |
Pagalbos Onkologiniams Ligoniams Asociacija | 547 450 |
Servicio Madrileno De Salud | 1 250 625 |
Shine 2europe Lda | 478 450 |
Socialit Software E Consulting SRL | 155 450 |
Stichting Eupati Foundation | 1 291 325 |
Stichting Vu | 747 550 |
Synapse Research Management Partners SL | 1 223 450 |
Synergist Services | 3 590 890 |
The Synergist | 978 910 |
Trial Nation | 362 450 |
Universitair Medisch Centrum Utrecht | 1 000 750 |
Zabala Innovation Consulting SA | 796 280 |
Third parties | |
Name | Funding in € |
Fundacio De Recerca Clinic Barcelona-Institut D Investigacions Biomediques August Pi I Sunyer | 51 750 |
Fundacion Para La Investigacion Biomedica Del Hospital Universiatrio La Paz | 4 027 385 |
Fundacion Para La Investigacion Biomedica Del Hospital Universitario De Getafe | 641 900 |
Total Cost | 31 538 000 |