Evidence map›Paper›PMID 42861283›Full record

ArticleThe Lancet regional health. Europe2026

Clinical trials on medicinal products in the EU/EEA, 2013-2025: a cross-sectional analysis of CTIS and EudraCT data.

Tiago Machado, Giacomo Capone, IJsbrand den Rooijen, Felix Bindt, Marta Marcelino, Jacobus van Wyk, Ana Zanoletty Perez, Laura Pioppo, Rui Santos Ivo, Peter Arlett

Abstract read
In one paragraph

Article in The Lancet regional health. Europe, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Not yet cited in PubMed.

0numbers the graph read from it
0cells of the map it votes in
0citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

0 citing papers in PubMed.

No citing paper in PubMed yet.

4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

10 authors.

Tiago MachadoINFARMED - Autoridade Nacional do Medicamento e Produtos de Saúde, I.P., Lisbon, 1749-004, Portugal.
Giacomo CaponeEuropean Medicines Agency, Amsterdam, 1083 HS, the Netherlands.
IJsbrand den RooijenEuropean Medicines Agency, Amsterdam, 1083 HS, the Netherlands.
Felix BindtEuropean Medicines Agency, Amsterdam, 1083 HS, the Netherlands.
Marta MarcelinoINFARMED - Autoridade Nacional do Medicamento e Produtos de Saúde, I.P., Lisbon, 1749-004, Portugal.
Jacobus van WykEuropean Medicines Agency, Amsterdam, 1083 HS, the Netherlands.
Ana Zanoletty PerezEuropean Medicines Agency, Amsterdam, 1083 HS, the Netherlands.
Laura PioppoEuropean Medicines Agency, Amsterdam, 1083 HS, the Netherlands.
Rui Santos IvoINFARMED - Autoridade Nacional do Medicamento e Produtos de Saúde, I.P., Lisbon, 1749-004, Portugal.
Peter ArlettEuropean Medicines Agency, Amsterdam, 1083 HS, the Netherlands.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Background: The global clinical trial landscape and the European regulatory environment have both undergone substantial change over the past decade. We describe trends in clinical trials on medicinal products in the EU/EEA from 2013 to 2025. Methods: We conducted a cross-sectional descriptive analysis of public data from EU clinical trial registries (Clinical Trials Information System, CTIS, and EU Drug Regulating Authorities Clinical Trials Database, EudraCT). All clinical trials on medicinal products authorised in at least one EU/EEA Member State between 2013 and 2025 were included, except phase I trials conducted solely on adults and trials conducted exclusively in the United Kingdom. Findings: Of 25,320 authorised trials, annual counts decreased by 13.5%, from an average of 1989 trials in the pre-pandemic period (2013-2019) to 1721 trials in 2022-2025. This decline was predominantly observed in non-commercial and phase IV trials. Adoption of multi-phase designs increased. The proportion of trials involving biologic medicinal products rose to nearly half (49.1% in 2025), accompanied by growth in advanced therapy medicinal products. Multinational trials showed a modest rise, with non-commercial trials remaining predominantly mononational. Interpretation: The number of clinical trials in the EU/EEA has declined, with the sharpest reductions in non-commercial and phase IV trials. Simultaneously, the trials landscape has shifted toward multi-phase, multinational and biologic-focused research. Our findings highlight the need for targeted policy support, particularly for academic research. The publicly available data from trial registries provide a foundation for continuous, evidence-based monitoring of the EU/EEA clinical trial landscape. Funding: This research received no specific funding.

Indexed as

Clinical trials

Identifiers

PMID42861283
PMCPMC13654569

What OpenQuestion holds

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Registered trials

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Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.