New Targets for Clinical Trials in the European Union

In September 2025, the European Commission (EC), together with the Heads of Medicines Agencies (HMA) and the European Medicines Agency (EMA), revealed two new goals for clinical trials to ensure Europe maintains its leadership in clinical research (1). By 2030, the European Union aims to:

• Increase the number of multinational clinical trials by 100 annually; currently, an average of 900 are authorized each year.
• Increase the speed of patient recruitment in clinical trials; currently, about 50% of trials recruit patients within 200 calendar days or less from the application submission date. The goal is to raise this to two-thirds (66%).

In early 2025, the United Kingdom (UK) government unveiled its plans to speed up clinical trials, unlock National Health System (NHS) data for research, and improve patient access to new treatments earlier (2). The global clinical trial arena is becoming increasingly competitive, serving as a significant revenue generator. According to market research, the global clinical trials market accounted for US$59 billion (€44 billion) in 2024 and is anticipated to grow from US$62.4 billion (€54.35 billion) in 2025 to US$98.9 billion (€86.15 billion) in 2034, growing at a compound annual growth rate of 5.2% (3).

An analysis of clinical trials between 2005 and March 2025 highlights that the United States hosts the majority of clinical trials, followed by China, France, Canada, Turkey, and the UK (Figure 1). The majority of clinical trials were conducted in a limited geographical distribution. Specifically, 26% of clinical trials were conducted in multiple locations, and only 8.2% of the total clinical trials were multinational clinical trials (4). However, market research indicates that the main barriers in clinical trials are due to poor trial design, lack of inclusivity, and inadequate clinical trial infrastructure (5). Therefore, if the EU wants to be a serious contender, it needs to strengthen its clinical trial ecosystem, promote ethical research, encourage stakeholder collaboration, and implement strategic investments.

How is the EU driving innovative clinical research?

These new goals are part of the EU's ongoing effort to create a more supportive environment for clinical research following the launch of the Accelerating Clinical Trials in the EU (ACT EU) initiative in January 2022, a collaboration between EC, HMA, and EMA (6). It also builds on the EU Life Science to enhance public health, create jobs, and foster innovation by 2030, positioning the EU as a global leader (7).

The EU pharmaceutical legislation continues to evolve, and the EC has started a comprehensive review to create an agile, competitive, and equitable regulatory framework. The ACT EU is one of the first steps to strengthen clinical research in Europe (8). The ACT EU initiative has launched a trial map to help patients find nearby clinical trials. Additionally, it provides guidance to clinical trial sponsors on designing effective trials and submitting successful applications for authorisation, including marketing authorization. In addition, they can provide support for the implementation of the revised International Council for Harmonisation (ICH) E6 R3, Good Clinical Practice guideline and assistance for non-commercial sponsors to conduct more multinational trials.

In addition, the EU has several complementary initiatives underway to help the EU meet these targets, including:

• The Clinical Trials Regulation (CTR) Collaborate initiative aims to foster interaction between national authorities and ethics committees to promote harmonized procedures and reduce administrative burden (9).
• The COMBINE initiative aims to understand challenges and obstacles to align the interface between the three frameworks: CTR, In Vitro Diagnostics Regulation (IVDR), and Medical Device Regulation (MDR) (10). In June 2025, the first pilot was launched to coordinate clinical and performance study assessments into a single streamlined process (11).
• The MedEthicsEU is a forum of national representatives from medical research ethics committees, established by the EC, to support discussion and mutual learning between EU/EEA Member States Ethics Committees (12).

Meanwhile, the European Federation of Pharmaceutical Industries and Associations (EFPIA) has been actively promoting innovation in this area. It has launched its Clinical Trials Strategy 2030+ with the goal of re-establishing Europe as a leading hub for faster, smarter, and more patient-centric clinical trials (Figure 2) (13). EFPIA is collaborating closely with other industry associations, patient organizations, academia, and national trade bodies to engage with regulators and policymakers, to help address the challenges in the current legislative framework (e.g., CTR, IVDR, MDR) and proactively proposing solutions (14). They are involved in multiple Innovative Health Initiatives (IHIs) that focus on patient-centred clinical research, aiming to improve trial design and conduct, enhance patient engagement and experience, increase the efficiency of clinical trials, and address health disparities.

What are the implications of new clinical trial targets for pharma?

These new EC trial targets present new opportunities for the pharmaceutical industry to expand the number of multinational trials, provided they can meet patient recruitment timelines and comply with the CTR. It could catalyse changes in how clinical trials are conducted and managed in the EU, and allow sponsors to include more flexible trial design and market access strategies. This will help to increase speed to market and enable European patients to receive new therapies more quickly. The EU continues to streamline the trial process and reduce administrative burdens. Pharma companies must proactively engage with regulators and stakeholders to capitalize on the EU's strategy and strengthen their position in this multi-billion-dollar arena.

References

1. EMA. New Targets for Clinical Trials in Europe. Press Release. 23 Sept 2025. https://www.ema.europa.eu/en/news/new-targets-clinical-trials-europe
2. Wise, J. UK Launches Plan to Speed Up Clinical Trials and Improve Access to New Treatments BMJ 2025; 390:r1510 DOI:10.1136/bmj.r1510
3. Global Market Insights Clinical Trials Market Size & Share Report, 2025 – 2034. February 2025. Clinical Trials Market Size & Share Report, 2025 – 2034
4. Joshi, G.; et al. The Current Landscape of Clinical Trials. J Clin Med. 2025 Apr 7;14(7):2519. DOI: 10.3390/jcm14072519.
5. The Lancet. Clinical Trials in Global Health 2025. 25 Mar 2025. https://www.thelancet.com/series-do/clinical-trials
6. EU. Accelerating Clinical Trials in the EU (ACT EU) EC.europa.eu. https://accelerating-clinical-trials.europa.eu/about/initiative_en (accessed 15 Oct 2025).
7. Barton, C. European Union Life Science Strategy. PharmTech.com. 14 Oct. 2025.
8. Osborne Clarke. EU Regulatory Activity is Driving Comprehensive Reforms for Pharma in 2025. 25 Mar. 2025. https://www.osborneclarke.com/insights/eu-regulatory-activity-driving-comprehensive-reforms-pharma-2025
9. EC. Clinical Trials Regulation (EU) 536/2014. EC.europa.eu. 16 Apr. 2014. https://eur-lex.europa.eu/eli/reg/2014/536/oj
10. EC. ‘COMBINE’ Initiative–The Regulatory Landscape for Combined Studies on the IVDR/MDR/CTR Interface. EC.europa.eu. December 2024. https://health.ec.europa.eu/document/download/44bbffa5-e61e-4056-bfaf-50a46eeecb7b_en?filename=md_combine_presentation_en.pdf
11. EC. COMBINE Programme Launched a Pilot Coordinated Assessment for Clinical Trials and Performance Studies. EC.europa.eu. 11 June 2025. https://ec.europa.eu/newsroom/sante/newsletter-archives/64447
12. EC.Clinical Trials–MedEthicsEU–Group of National Representatives of Medical Research Ethics Committees. EC.europa.eu (accessed 15 Oct 2025). https://health.ec.europa.eu/medicinal-products/clinical-trials/medethicseu_en
13. EFPIA. Clinical Trials Strategy 2030+. efpia.eu. 2024. clinical-trial-strategy-in-a-snapshot.pdf
14. EFPIA. Improving EU Clinical Trials: Proposals to Overcome Current Challenges and Strengthen the Ecosystem. efpia.eu. 15 Apr 2025. efpias-list-of-proposals-clinical-trials-15-apr-2025.pdf

About the author

Cheryl Barton, PhD, is founder and director of PharmaVision, Pharmavision.co.uk.