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

Authors

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

Published in

The Lancet regional health. Europe. Volume 71. Pages 101884. Epub Sep 29, 2026.

Abstract

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.
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.
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.
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.
This research received no specific funding.

PMID:
42861283
Bibliographic data and abstract were imported from PubMed on 12 Oct 2026.

Read full publication at:
Please sign in to see all details.

Stats

1-terrible, 9-excellent. How would you rate this publication? Sign in in to submit your rating.

Post a comment

You need to be signed in to post comments. You can sign in here.

Comments

There are no comments yet.