D15.1. Database for multicountry clinical research funding opportunities in Europe

This deliverable is an outcome of Task 2B.2.1-Mapping of funding sources available to fund multicountry Investigator Initiated Clinical Studies (IICS) in Europe.

This mapping inventories funding resources available for multinational IICS in Europe, either from public or charity funding organizations.

Purpose and objectives

The main purpose of this deliverable is describing public funding opportunities for IICS in Europe. Specific objectives of this deliverable are:

1. Identify funding organizations capable to fund IICs in Europe

2. Identify potential candidates to join the ERA4Health partnership Phase 2

Intended audience

The deliverable will be made public, as the intended audience will be:

1. General public/clinical research community for objective (1)

2. Current ERA4Health partners for objective (2)

Methodology

In order to identify public and non-for-profit organizations and charities capable to support multicountry IICs in Europe, a survey was designed on the RedCAP platform and divulged to a list of potential funders previously ‘curated’ by reviewers belonging to ERA4Health partnership and ECRIN (European Clinical Research Infrastructure Network) affiliated partners (European Correspondents). An “annotated list of funders” was then constructed based on the replies received from the respondents to the survey. The annotated list of funders contains detailed information about the funding opportunities offered by the targeted organizations, i.e. i) type of clinical research (pre-clinical/clinical or both); ii) funding scheme (national, international); iii) specificities about IICs funding (interventional vs observational); iv) budget/time restrictions.

Results

In total 35 organisations completed the survey, 15 of them are part of the ERA4Health partnership. while 20 are not partners of ERA4Health. The majority, 23, support both pre-clinical and clinical research, while 7 support only clinical research and 5 support only pre-clinical research. Thus, a total of 35 funders funds currently preclinical and/or clinical research and 30 clinical research (IICs). Funds provided by the 30 organizations claiming to support IICs are allocated as follows: 18 can fund only projects, 8 can support IICS through both funding projects and research infrastructures, 2 can support all IICS, RI and other initiatives; 1 by funding only research infrastructures and 1 by other kind of funding initiatives.

The national funding scheme is the most used by the funding organizations participating in the consultation (28), followed by the European funds (17) and the international ones (6). Furthermore, 30 respondents support currently interventional studies and 20 of them also support the non-interventional ones.

A total of 24 organizations have expressed their willingness to fund International Investigator-Initiated Clinical Studies (IICS) under ERA4Health framework, 13 are already part of the consortium while 11 are not. The analysis delved into the preference for various types of clinical studies currently being funded and those that are considered fundable through ERA4Health. The data revealed equal or very similar numbers for low intervention trials (16), proof of concept studies (15), and other studies (10 and 11, funded and fundable). In contrast, other types of trials had a relatively lower representation, especially when comparing the number of studies currently funded with those deemed fundable through ERA4Health. Notably, non-interventional trials were reported as currently funded by 18 responders, while only 11 responders considered them as fundable through the ERA4Health partnership.

Different issues were addressed to the responders in the dedicated survey:

• With regard to specific fundable topic/disease area for IICs, 26 of responders indicated being able to fund any medical field, 5 fund Disease-specific initiatives (2 oncology), 1 funds Technological area, and 1 did not specified.

• As for the grant duration, 14 responders can support IICs lasting for 3-4 years, 1 is available to fund studies for more than 5 years, 4 can fund IICs for less than 3 years, 7 responded that it depends on type of IICs and 4 did not specified the timing.

• Moreover, the availability of funding dedicated to IICS at national level was investigated and for 9 participants it varies depending on the type of IICS while 5 participants indicated the availability of more than 1000K EUR, 5 are willing to commit less than 250k EUR, 3, can commit between 250-500K EUR, 2 can commit an amount in the range of 500-700K EUR and 2 in the range 750-1000K EUR, while 4 participants cannot anticipate the amount.

• Regarding project-based funding, only 11 out of the 30 organizations funding IICs allow cross-border funding, while 19 do not allow it.

Finally, several suggestions have been collected for improving participation in programs from a funder's perspective as well as the perceived gaps and requirements in multi-country IICS funding landscape in Europe: enhancing collaboration, improving funding mechanisms, raising awareness, and streamlining regulatory processes. This can be achieved by promoting collaboration and networking among EU funding organizations, creating a funding platform for small countries with moderate budgets to support small-scale IICS, providing clearer research guidelines on European rules and standards procedures, and utilizing ECfunding to address gaps in multi-country IICS funding at the national level

Conclusion

The results obtained through the survey demonstrated a significant level of engagement of the members of the ERA4Health partnership to fund IICs in the future, but, most importantly, were useful to identify a number of new potential funders of IICs. Moreover, based on the analysis of the data, information regarding which kind of clinical research, the national funding schemes, the budget availability and the duration of granting have been collected. These results will inform ERA4Health partners to prepare the future calls for funding IICs in the framework of the project. EC

can also take advantage of this information to have the correct perspective for the development of forthcoming projects including clinical research.

Main recommendations

These recommendations aim to improve the funding landscape, streamline processes, enhance

collaboration, and facilitate the implementation of International Investigator-Initiated Clinical Studies (IICS) across Europe through the ERA4Health partnership.

Recommendations:

- Promote integration of IICs funders not currently participating in the Partnership.

- Consider funder´s limitations (funding lines, topics and timelines) while establishing the future ERA4Health pilot for IICs.

- Efforts should be made to improve access to information about funding organizations and their criteria for inclusion in funding analysis, funding availability, budget allocation, and duration for IICS. Clarification and better dissemination of this information would benefit researchers seeking funding for IICS.

- Funders show notable preference for supporting intervention trials, comparative effectiveness trials, low-intervention clinical trials, and pilot studies. Aligning funding initiatives with these areas of research and development would increase the chances of setting up a successful call on IICs within the ERA4Health partnership.