Fewer academic trials in Europe: four levers to reverse the trend

The number of authorised clinical trials in the EU has fallen significantly, with trials from universities and university hospitals particularly affected. The European Medicines Agency (EMA) and the Heads of Medicines Agencies (HMA) have published a comprehensive analysis in The Lancet Regional Health – Europe. The KKS Network (KKSN) puts the findings into context for academic clinical research and sets out what is needed.

The analysis covers around 25,300 clinical trials of medicinal products authorised in the EU/EEA between 2013 and 2025. Before the pandemic (2013–2019), an average of 1,989 trials were authorised each year; between 2022 and 2025, the figure was only 1,721. This represents a decline of 13.5%. The decline mainly affects non-commercial trials and phase IV trials, which take place after a medicinal product has been authorised. Both are core areas of academic clinical research. The number of multinational academic trials also remains low.

Why this matters for patient care

Academic trials, initiated by universities and university hospitals, are mostly publicly funded. They answer questions that commercial sponsors often do not ask. What dose is sufficient? Which of two established therapies works better? How can a treatment be adapted for older patients or those with multiple conditions? How is a rare disease best treated? These questions shape how patients are cared for in everyday practice.

When academic trials decline, healthcare loses an essential part of its evidence base. The decline is therefore not a marginal issue for research, but affects the quality of care as a whole.

What lies behind the decline

The authors of the analysis interpret the disproportionate decline as an indication of specific capacity gaps in the academic sector. They see regulatory requirements, infrastructure and funding as starting points for addressing them.

The KKS Network shares this assessment and sees several causes. A key factor is funding: academic sponsors depend heavily on public funding. Without it, trials do not get off the ground.

The decline also coincides with the introduction of the EU Clinical Trials Regulation (CTR) and the EU portal CTIS. New procedures, a new portal and the transition of ongoing trials to the new system have tied up additional resources. Academic sponsors had to manage this effort with far fewer resources than pharmaceutical companies, although they bear the same regulatory responsibility.

Multinational trials face hurdles of their own. Even under the CTR, each Member State continues to assess parts of the application nationally, for example on informed consent, insurance or data protection. At the same time, funding is mostly organised nationally, so resources for cross-border collaboration are lacking.

What academic clinical research needs now

In the view of the KKS Network, four levers are decisive: reliable framework conditions and adequate funding, but also strong teams at the trial sites and trust in clinical research.

1. Harmonised and reliable framework conditions
Anyone planning a trial needs planning certainty. Requirements must be consistent, transparent and predictable, both nationally and internationally. New regulations should noticeably reduce the effort required for applications and approvals rather than adding new documentation obligations. A risk-based approach must not remain a mere demand placed on sponsors. It must apply equally to authorities and ethics committees. Particularly for trials involving authorised medicinal products with a known safety profile, the effort required should reflect the actual risk.

2. Adequate project funding
There is no shortage of ideas and structures. This year’s funding call by the German Federal Ministry of Research, Technology and Space (BMFTR) has once again demonstrated this impressively. At the same time, trials are becoming increasingly demanding: designs are more complex, patients are involved from the outset, decentralised elements are being added and data are to be made available for secondary use. Trial budgets, however, have not kept pace with these requirements. Alongside infrastructure, we therefore need targeted, adequately resourced project funding that reflects the true effort of modern clinical trials. This applies in particular to multinational trials, which can hardly be carried out without appropriate resources.

3. Sufficient and qualified staff at trial sites
Studien werden vor Ort durchgeführt. An den Standorten braucht es qualifiziertes und vor allem ausreichendes Personal. Befristete, projektgebundene Stellen führen dazu, dass erfahrene Mitarbeiter:innen nach Studienende gehen und ihr Wissen mitnehmen. Notwendig sind attraktive, verlässliche Stellen und gezielte Qualifizierung, damit Erfahrung an den Standorten gehalten und weitergegeben wird.

3. Sufficient and qualified staff at trial sites
Clinical trials are not an end in themselves but an integral part of good healthcare. This message must reach the public, policymakers, hospitals and medical practices more effectively. Reservations also have to be addressed: the image of trial participants as “guinea pigs” still persists. Academic research is called upon to promote trials jointly, to counter prejudice with clear information and to make their benefit for patients visible.

Conclusion

The decline in non-commercial trials is a warning sign, but not a development we have to accept. The expertise and commitment in academic research are there. To turn them into more trials again, we need consistent and proportionate rules, budgets that cover the real effort, well-equipped trial sites and a broad understanding of the value of clinical research.

The KKS Network contributes the perspective of the academic trial centres to this process and is available to policymakers, authorities and funders as a partner for dialogue.

Source: Clinical trials on medicinal products in the EU/EEA, 2013–2025: a cross-sectional analysis of CTIS and EudraCT data. The Lancet Regional Health – Europe