Introduction: A New Era Begins
Recently, EMA (with the European Commission and Heads of Medicines Agencies) set out new targets intended to make the Europe a more attractive site for clinical research, while improving patient access to innovative medicines.
The introduction of the EU Clinical Trials Regulation (CTR) and the Clinical Trials Information System (CTIS) is more than an administrative upgrade. It represents a turning point that is reshaping Europe’s medical research landscape. Sponsors can now submit a single application through CTIS that covers up to 30 European countries at once.
So, what has the wealth of data collected during this three-year transition period revealed? Are there surprising patterns hidden within it?
Let’s explore the five most striking, counterintuitive, and influential findings
The full report is available on the ACT EU website
1. A Surprisingly High Success Rate: Over 98% of Applications Approved
Out of 8,661 clinical trial applications submitted via CTIS with a final decision, 8,521 were approved—an astonishing 98.4% approval rate.
This suggests the new regulatory system acts less as a barrier and more as an efficient pathway for well-prepared applications. Contrary to the common assumption that stricter regulations create more hurdles, CTR and CTIS appear to have streamlined approval processes.
However, there’s important context: around 1,200 applications never reached a final decision due to incomplete submissions or falling outside the CTR’s scope. These were rejected, withdrawn, or deemed invalid. This means the high approval rate reflects both the sponsors’ growing adaptability and the critical importance of thorough preparation from the outset.
With CTR and CTIS now fully implemented, the EU has laid the foundation for a more transparent, efficient, and collaborative clinical trial ecosystem.
2. Two Worlds Apart: Commercial vs. Non-Commercial Sponsors
The data clearly shows that strategies differ sharply depending on the type of sponsor:
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Non-commercial sponsors (universities, research institutions): 85.6% of approved trials were mononational, conducted within a single country.
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Commercial sponsors (pharmaceutical companies): 71.5% of approved trials were multinational, spanning multiple countries.
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| Source: EU clinical trials during the 3-year CTR transition period. page 9 |
The contrast reflects different priorities. Non-commercial sponsors often focus on academic questions or public health challenges within a single country. Commercial sponsors, meanwhile, pursue broader market access and diverse patient populations, following global strategies.
3. The Deadline Effect: A Rush of Transition Applications
Sponsors were given three years to transition trials from the old Clinical Trials Directive (CTD) to the new CTR. But submissions weren’t evenly spread.
Of the 5,088 transition applications:
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84.6% (4,303) came in the final year, 2024.
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Another 3.0% (154) arrived in the last 30 days before the final deadline of January 30, 2025.
Even major pharmaceutical firms and large research institutions scrambled near the deadline. This reveals both the universal tendency to procrastinate and the heavy burden posed by complex regulatory transitions.
4. A Win for Gender Inclusivity: 90% of Trials Include Both Men and Women
One of the most encouraging findings is the strong inclusion of both genders in clinical trial design. Nearly 90% of approved trials enrolled both male and female participants.
Interestingly, trials limited to only women (5.1%) and only men (5.8%) were nearly equal in share, showing no gender bias in study focus. This points to a cultural shift in the EU’s trial environment, where inclusivity is embedded from the design stage, ultimately ensuring treatments are safer and more effective across populations.
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| Source: EU clinical trials during the 3-year CTR transition period. page 32 |
5. Academia’s Quiet Strength: Driving Low-Intervention Trials
“Low-intervention trials” use authorized medicines within their approved indications or supported by scientific evidence, meaning participants face minimal additional risk.
In this space, non-commercial sponsors dominate. Of 730 low-intervention trial submissions, 94.4% (693) came from academic and non-profit institutions.
This underscores the vital role of academia in pursuing knowledge-driven or public health-focused research rather than profit-oriented studies. Universities and non-commercial organizations keep the clinical research ecosystem diverse and robust.
Conclusion: The Future Written in Data
Over the past three years, the EU’s new clinical trial system has taken root successfully. The data reveals not just system efficiency, but also deeper patterns: stark contrasts between commercial and non-commercial strategies, major advances in gender inclusivity, and the very human tendency to push deadlines.
The divergence between commercial sponsors (favoring multinational trials) and non-commercial sponsors (favoring mononational studies) raises an important question: As CTIS matures, will its efficiency and transparency encourage academia to expand into more multinational collaborations, bridging the gap? Or will resource constraints keep the divide intact, solidifying distinct roles within Europe’s research ecosystem?
One thing is certain: the data will keep prompting new and thought-provoking questions.
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