Funding Obstacles to Cross-Border Collaboration
Despite the advantages of multinational clinical trials, just 3% of academic trials (vs. 30% of industry trials) involve more than one country. In Europe, the relative scarcity of multinational academic trials can be explained, in part, by restrictions with current cross-border funding options.
Here, ECRIN and partners 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 2020 (H2020) is the biggest EU Research and Innovation programme ever, with nearly €80 billion of funding available over seven years (2014 to 2020). Multinational clinical trials can seek funding under the H2020 “Health, demographic change and wellbeing” programme. The high number of applicants for funding has meant that only 4% of projects have been awarded funding so far, and many high-quality, worthwhile studies must seek funding elsewhere.
European and Industry Funding Combined
The Innovative Medicines Initiative (IMI) is another source of European funding dedicated to public-private partnership projects. 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.
An alternative strategy of creating a common pot for funding trials has been adopted by the Nordic Trial Alliance (NTA), running from 2013 to 2015 and covering Denmark, Finland, Iceland, Norway, Sweden, the Faroe Islands, Aland Islands and Greenland. The NTA budget comes from Nordforsk and national research councils, and €2M was spent in 2014. Funding supports multinational expansion of clinical studies whose funding is secured in the coordinating country. Supported trials must be run in a minimum of three of the member countries. These approaches have been successful in promoting research and competitiveness for the subset of eligible countries. Nevertheless, a wider reaching solution for a larger number of countries is desirable.
An 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, national agencies fund projects and the Commission supports coordination and evaluation and contributes 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.
Existing ERA-Nets for rare diseases (e.g., E-Rare), cancer (e.g., TRANSCAN) and neurosciences (e.g., NEURON) focus on basic and translational research.
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 multicountry 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.