Funding for multinational clinical trials
Despite the advantages of multinational clinical trials, just 3% of academic trials involve more than one country. To put this into perspective, for industry sponsored trials this is up to 30%. In Europe, the relative scarcity of multinational academic trials can be explained, in part, by restrictions with current cross-border funding options. Below we detail the current funding options for multinational academic clinical trials in Europe, and outline promising mechanisms for the future.
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Funding from central, European Budget
Horizon Europe (HE) is the current EU’s key funding programme for research and innovation with a budget of €95,5 billion of funding available. In HE Pillar 2, Cluster 1 (Health), we can find more information for life science research and clinical research opportunities. Cluster Health is built around six strategic destinations, each addressing a major health policy objective.
Cluster Health Destinations
| Destination | Main focus |
|---|---|
| 1. Staying healthy in a rapidly changing society | Prevention, health promotion, healthy lifestyles, resilience, mental health, ageing, population health |
| 2. Living and working in a health-promoting environment | Environmental determinants of health, climate change, pollution, occupational health, One Health, exposome |
| 3. Tackling diseases and reducing disease burden | Prevention, diagnosis and treatment of communicable and non-communicable diseases, rare diseases, cancer, infectious diseases |
| 4. Ensuring equal access to innovative, sustainable and high-quality healthcare | Healthcare systems, health equity, integrated care, personalised medicine, implementation research |
| 5. Developing and using new tools, technologies and digital solutions for a healthy society | AI, digital health, medical technologies, omics, diagnostics, data infrastructures, advanced therapeutics |
| 6. Maintaining an innovative, sustainable and competitive EU health industry | Translation to market, manufacturing, regulatory science, resilience of the European health innovation ecosystem |
One of the defining features of Horizon Europe Cluster 1 is that it funds multinational collaborative research, including multinational clinical trials / studies. The programme generally supports studies that generate evidence with high public health value rather than those aimed solely at obtaining market authorisation for a single product.
Research and Innovation Actions (RIAs) | Many clinical trial topics are funded as RIAs, covering activities from protocol development through trial implementation, data analysis, and dissemination.
Integration of research infrastructures | Projects are encouraged to use European clinical research infrastructures, biobanks, registries, and health data platforms to improve efficiency and interoperability.
Typical clinical study topics
Cluster Health funds multinational studies in areas such as:
- novel therapies for cancer and rare diseases
- prevention and treatment of infectious diseases
- antimicrobial resistance
- advanced therapy medicinal products (ATMPs)
- personalised medicine
- mental health interventions
- medical devices and digital health technologies
- comparative effectiveness of existing interventions
- implementation and pragmatic clinical trials in healthcare settings
The exact topics change with each Work Programme, but the emphasis is consistently on generating evidence that addresses important health challenges at the European level.
European and Industry Funding Combined
The Innovative Health Initiative (IHI), an institutionalised Partnership, is another source of European funding dedicated to public-private partnership projects under Horizon Europe. Non-industry partners in consortia receive public funding, while companies contribute to the projects through in-kind contributions.
It accelerates the development of innovative health technologies, medicines, diagnostics, medical devices, and digital health solutions through collaboration between the European Commission and the life sciences industry.
Joint Transnational Calls from European Partnerships
Since cross-border funding is not possible for most funding agencies, countries have joined forces by coordinating national sources to fund multinational projects using European Partnerships, an instrument created by the European Commission.
In a European Partnership, the combination of both Horizon Europe and national research agencies funding organisations supports the call launch, coordination, evaluation and funding of transnational projects through Joint Transnational Calls (JTCs).
A JTC is a coordinated effort among multiple countries or regions to fund collaborative research projects in a specific field or topic. Typically, each participating country or region contributes funds to support researchers from their respective areas who collaborate on a shared research project.
The EC co-financing rate is typically 30% (and can be up to 50% in exceptional cases).
| European Partnership | Partnership model | Main focus |
|---|---|---|
| European Rare Diseases Research Alliance (ERDERA) | EC–National funding organisations (Co-funded partnership) | Coordinates European research on rare diseases by supporting multinational collaborative research, clinical studies, data sharing, and the development of diagnostics and therapies to improve patient outcomes. |
| ERA4Health | EC–National funding organisations (Co-funded partnership) | Coordinates national and regional research funding programmes to support transnational research on prevention, personalised medicine, clinical studies, and health care systems, fostering collaboration and reducing fragmentation across Europe. |
Other models of pooled public funding for multinational academic trials in Europe
NordForsk community research
Founded by the Nordic Council of Ministers, NordForsk funds clinical studies, including clinical trials, following both the “virtual and real common pot” models or a mixed model, combining both. NordForsk can enter into collaboration with funding organisations/institutions outside the Nordic Region when this is expected to result in high scientific quality and Nordic added value. The virtual common pot model is the preferred funding model for partners from outside the Nordics where NordForsk can act as a broker between national funding organisations in the Nordics and organisations outside the Nordics.
BeNeFIT programme: BeNeFIT calls for comparative effectiveness
Since 2017, KCE (a department of the Belgian Health Care Knowledge Centre) and ZonMw (he public funder of clinical research in the Netherlands) have collaborated through the BeNeFIT programme funding non-commercial comparative-effectiveness trials, for a total budget of 9 million € per call. Both organisations had to work outside of their usual procedures for the success of the programme.
Although the programme does not allow cross-border funding, the BeNeFIT model relies on a strong feasibility evaluation and follow-up of selected projects. Three BeNeFIT calls have been organised so far.
Central and National Funding Combined
The European and Developing Countries Clinical Trial Partnership (EDCTP) is an example of a funding programme based on a combination of central, European funding and national sources. The budget comes from the European Commission, national member countries, and third parties such as private sector and other international partners.
The programme funds trials addressing malaria, tuberculosis, and HIV, as well as other poverty-related and neglected diseases in developing countries. All European and sub-Saharan African countries are eligible for funding, and partnership with private funders is possible. Proposed clinical trials should involve at least two European and one sub-Saharan country.