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.
Funding from central, European Budget
Horizon Europe is the EU’s key funding programme for research and innovation with a budget of €95,5 billion of funding available. In Pillar 2, Cluster 1, we can find more information for life science research and clinical research opportunities. Areas of intervention are ‘Health throughout the life course’, ‘environmental and social health determinants’, ‘non-communicable and rare diseases’, ‘infectious diseases including poverty-related and neglected diseases’, ‘tools, technologies and digital solutions for health and care including personalised medicine’, and ‘health care systems’.
European and Industry Funding Combined
The Innovative Health Initiative (IHI) 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.
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 (€683M, €683M and €500M respectively for 2014-2024). 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.
In general, national funding agencies do not accept funding crossing borders, inhibiting international collaboration. Notable exceptions include Innovation Fund Denmark, which has a total budget of 144M€, including 17M€ for projects on “individuals, diseases and society”. Funding is available for clinical trials (about 20M€ over 7 years) with a significant share (12%) for international partners.
Other countries have limited cross-border funding such as Germany where the German Research Foundation (DFG) considers provision of a maximum of 20% of a clinical trial budget to sites in Austria, Luxembourg and Switzerland.
ERA-Net as a Funding Mechanism
Since cross-border funding is not possible for most funding agencies, countries have begun to join forces by coordinating national sources to fund multinational projects using a European Research Area Network (ERA-Net), an instrument created by the European Commission. In an ERA-Net, the combination of national agencies fund projects and the European Commission support the coordination, evaluation and contribution to funding. An ERA-Net can cover a large number of diverse countries and combine national sources, with each country supporting the aspects of the trial that occur nationally.
ECRIN and partners consider that the possibility of a cross-disciplinary ERA-Net for multinational clinical trials is an optimal solution for near-future financing of multi-country trials. In this model, proposals would be evaluated by a panel that would review the medical relevance and methodology of the trial protocol. The funding agencies would contribute a funding volume adapted to the cost of the trial. Moreover, the ERA-Net would allow expansion to countries outside Europe, creating an instrument with global potential.