EU clinical trials decline 13.5% as academic sponsors pull back

Clinical trials authorised in the European Union and the European Economic Area dropped 13.5% when pandemic years are excluded, and the EU clinical trials decline is concentrated in the sponsors least able to absorb it. An analysis published in The Lancet Regional Health – Europe reviewed 25,320 trials authorised in at least one EU or EEA member state from 2013 through 2025. The work relied on both European registries.

Trials averaged 1,989 a year from 2013 to 2019. Authorisations reached a peak of 2,364 in 2021, then averaged 1,721 a year from 2022 to 2025. That represents a loss of 269 trials annually. The authors left out phase I trials run only in adults, since the old Clinical Trials Directive did not publish them, and they excluded trials run only in the United Kingdom to keep the 13-year span comparable.

The dataset was extracted on 13 January 2026. The team collected 55,052 trial records, 10,686 from the Clinical Trials Information System (CTIS) and 44,366 from EudraCT. The EudraCT portion came from 117,725 national entries because multinational trials appear once per country. Eligibility screening removed 29,905 records. Another 173 authorised trials remained hidden from public view for confidentiality reasons and were supplied from internal European Medicines Agency data. This left 8,813 CTIS trials and 16,507 EudraCT trials.

EU clinical trials decline hits non-commercial sponsors hardest

Commercial sponsors ran an average of 1,024 trials a year from 2013 to 2019 and 941 a year from 2022 to 2025, an 8.1% drop. Non-commercial sponsors fell from 956 to 778, down 18.6%. Phase IV studies, the post-approval work that follows a medicine to market, slipped from about 20.5% of authorisations to 13.7%.

The mix shifted in other ways. Multi-phase designs, meaning phase I to II, II to III and III to IV, rose from roughly 8.9% to 16.5% of authorisations. Phase II remained the largest single category at about 37% in both periods, with phase III at 32%. In CTIS alone, phase I trials accounted for 17.8% of authorisations, or 26.9% once phase I to II studies are counted, against roughly 40% of global trial starts in 2024.

Cross-border work grew. Trials authorised in more than one EU or EEA state rose from 42.4% to 46.4%, and trials authorised in more than one country anywhere rose from 49.8% to 53.2%. The average number of member states involved went from 5.4 to 6.0. Commercial sponsors ran 70.1% of their trials across multiple European countries in 2013 and 77.2% in 2025, while the academic multinational share stayed near 9%.

Biologics moved to the centre of the portfolio. They featured in 35.1% of trials in 2013 and 49.1% in 2025. Advanced therapy medicinal products grew from 3.2% of trials to 4.0%, with gene therapy the largest and fastest-growing modality.

Cancer still dominates, immunology climbs

Cancer accounted for 25.2% of all authorised trials, ahead of nervous system diseases at 7.5% and cardiovascular disease at 6.5%. Immune system diseases almost tripled, from 3.3% in 2013 to 9.4% in 2025, and have been the second most studied area since 2024. Viral disease trials, normally 3% to 4% of annual activity, reached 14.5% in 2020 and 8.3% in 2021 before returning to baseline, while respiratory trials peaked at 7.6% in 2020. Rare disease research rose from 17.1% to 20.3%. The share of trials open to children held steady near 15%, while trials enrolling people over 65 climbed from 68.7% in 2013 to 81.4% in 2025.

Why the numbers fell

The authors point to several forces acting at once: the pandemic correction after the 2020 and 2021 surge, the regulatory transition to the Clinical Trials Regulation (Regulation (EU) No 536/2014), which became applicable in 2022, a global redistribution of research toward Asia, and a post-pandemic contraction in biopharma capital markets. Growth in real-world data studies, particularly after approval, may also move research out of trial registries altogether.

They caution that trial counts are an imperfect measure. Fewer, larger studies may carry the same research load, and the rise in multi-phase applications may mean several objectives are now bundled into one registration.

What ACT EU is trying to fix

The Accelerating Clinical Trials in the EU initiative has set two targets: 500 additional multinational trials authorised over five years, and at least two thirds of trials reaching first patient recruited within 200 days. The Heads of Medicines Agencies launched FAST-EU in January 2026 as a fast-track route for those authorisations. The authors argue the targets will be hard to reach without dedicated support for academic sponsors, who face fragmented funding, compliance burden, thin operational infrastructure and difficulty sourcing investigational products.

Limitations

Excluding adult phase I trials leaves the overall count incomplete, though an unpublished analysis that included non-public phase I data corroborated the downward trend. MeSH coding fragments some conditions across categories, definitions differed between the two databases, and the figures depend on metadata that sponsors submit.

The team released its method as a reproducible framework built on public registry data, and argues that continuous monitoring of this kind should inform EU policy as the revised pharmaceutical legislation and the European Biotech Act take shape.

Source: Machado et al., The Lancet Regional Health – Europe, 2026