EU-backed scientists explore why we need to support multinational clinical studies carried out by independent researchers, and how to do it.
A new paper published in the journal ‘Trials’ takes a close look at investigator-initiated clinical studies (IICSs), non-commercial studies conducted by independent clinicians and researchers with the ultimate goal of improving healthcare. The result of work carried out under the EU-funded ERA4Health project, the paper discusses why we need to support multinational IICSs, what their objectives should be, the main barriers to implementation and current funding mechanisms in Europe.
The pros of multinational research
Unlike industry-funded studies, which usually research products that can generate revenue for companies, IICSs – including investigator-initiated clinical trials (IICTs) – tackle important research questions usually neglected by industry. However, even though they account for almost half of current clinical research in Europe, IICTs are mostly carried out in a single country. So, what would happen if scientists took advantage of Europe’s huge population size, medical expertise, high-quality healthcare systems and scientific potential through multinational cooperation in clinical studies? As stated in the paper, it “would boost clinical research and its impact in Europe,” fostering rapid patient recruitment and spreading best practice. “Multinational IICSs increase the scientific quality of the data by exchange of research ideas, scientific techniques and tools,” the authors report, adding: “Participation of patients from different geographical, social and ethnic backgrounds equally adds to the value of study results and yields more generalisable evidence than a study confined to a single geographical location.”
Public funding barriers
Clinical studies should focus on developing innovative health products, identifying new uses for approved medicines and comparing treatments with the goal of optimising them. They therefore need to be funded through well-financed multinational programmes. However, current multinational IICSs are usually sponsored by academic organisations and publicly funded, which is a key barrier to carrying out multinational IICSs, and especially IICTs. The main challenges identified include budget limitations and grant durations, lack of flexibility to move funds transnationally, tendering rules and the complexity in the reporting of eligible costs to funders. According to the authors, strategies for funding multinational IICSs should evolve to diminish the barriers outlined. This could be achieved by prioritising public funding towards multinational IICS objectives, by implementing flexible public funding across borders, and by sustaining clinical research infrastructures and networks. This could help promote research into important healthcare issues that are less likely to be tackled by the pharmaceutical and medical device industries. Some of the topics described in the paper were discussed in an earlier workshop hosted by project partner European Clinical Research Infrastructure Network, France. The workshop focused on funding mechanisms for multinational IICSs through joint transnational calls and served as a platform for stakeholders to exchange ideas, explore innovative funding solutions and lay the groundwork for better multinational IICS support. The ERA4Health (Fostering a European Research Area for Health Research) project has also recently published a Joint Transnational Call for Investigator-Initiated Clinical Studies, JTC IICS, 2025, titled “Fostering Pragmatic Comparative-Effectiveness Trials in Non-communicable Diseases” (EffecTrial). The deadline for submission of pre-proposals is 28 January.
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