Which Countries Produce the most Clinical Trials?

Clinical trials are a vital component of medical research, enabling the development, evaluation, and approval of new treatments, vaccines, and diagnostic methods. Their complexity stems from the need to balance scientific rigor with patient safety, regulatory compliance, and logistical coordination across multiple sites and stakeholders. Trials often span years, require significant funding, and must navigate ethical considerations, strict protocols, and evolving regulatory frameworks. As healthcare becomes increasingly globalised, many trials are now conducted across multiple countries.

The geographical distribution of clinical trials has evolved in response to both scientific and strategic priorities. While clinical research is very much concentrated in North America and Western Europe, advances in healthcare infrastructure, regulatory harmonisation, and data management technologies have enabled countries in other continents to become more involved.

Top 5 countries running the most clinical trials

As of 2025, the global landscape of clinical trials is led by the following five countries, each demonstrating significant contributions to medical research:

1. United States: With 4,034 active clinical trials, the U.S. maintains its leadership position in clinical research. Its dominance is underpinned by a vast pharmaceutical industry, advanced research infrastructure, and a large, diverse patient population. The U.S. also benefits from a long history of clinical research and a robust regulatory environment that encourages innovation and investment.
2. China: China has rapidly ascended in clinical research, now ranking second globally. The country’s growth is driven by streamlined regulatory procedures, cost-effective trial operations, and access to a massive patient pool. China’s share of global commercial clinical trials has doubled since 2018, reflecting significant investment and policy support.
3. France: France is a European leader, with 910 clinical trials. The country excels particularly in oncology research, supported by government incentives such as generous R&D tax credits and a strong tradition of collaboration between academia, industry, and public health institutions.
4. United Kingdom: The UK continues to be a major hub, with robust clinical trial activity supported by government initiatives to accelerate trial setup and enhance access to NHS data. The country’s established healthcare infrastructure and regulatory expertise make it a preferred destination for global sponsors.
5. Spain: Spain has become increasingly attractive for clinical research, recently overtaking Germany in the number of annual trial starts. Factors contributing to Spain’s rise include an efficient regulatory framework, strong healthcare system, and effective collaboration between commercial and non-commercial trial sponsors. Barcelona, in particular, has emerged as a key clinical research center in Southern Europe.

Europe punches above its weight on clinical trials per head

Europe remains a powerhouse for clinical research, not only in absolute numbers but also when adjusted for population size. Countries like France, the UK, Spain, and Germany consistently rank among the global leaders, and several smaller European nations surpass larger countries on a per-capita basis. This high density of trials per 100,000 people is a testament to Europe’s robust regulatory frameworks, established healthcare infrastructure, and extensive collaboration between academic institutions, government agencies, and pharmaceutical companies.

The European Medicines Agency (EMA) and national regulators provide harmonised guidance, facilitating multi-country trials and encouraging continued investment. While the U.S. leads in total trial numbers, its per-capita rate is lower than that of several European countries, highlighting Europe’s efficiency and accessibility in clinical research.

Denmark and Belgium run a lot of trials for their size

Despite their relatively small populations, Denmark and Belgium lead the way in clinical trial activity on a per-capita basis. Denmark runs an impressive 46.31 trials per 100,000 people, while Belgium follows closely with 37.41.

Both countries also benefit from close collaboration between academic centres, hospitals, and industry partners, as well as government incentives that encourage clinical innovation.

What are the data implications of clinical trials?

The success of clinical trials hinges on rigorous data management practices that ensure the integrity, traceability, and accessibility of research data throughout the trial lifecycle. The explosion of digital data-from electronic data capture (EDC) systems, imaging, genomics, and wearable devices-has created new challenges, including inconsistent metadata, file-format obsolescence, and fragmented storage across platforms.

Key data management challenges include:

• Data quality and consistency: Incomplete or inconsistent data can delay trials, increase costs, and jeopardise regulatory approval.
• Integration of diverse data sources: Trials now collect information from EHRs, wearables, mobile apps, and lab systems, requiring harmonisation and standardisation to avoid data silos and ensure reliable analysis.
• Regulatory compliance and security: Adherence to Good Clinical Practice (GCP), GDPR, and other regulations is essential. Systems must provide robust encryption, audit trails, and user authentication.
• Long-term data preservation: Clinical data must be archived and remain accessible and human-readable for decades, often requiring migration to new formats as technology evolves.

Modern platforms, such as those developed by Arkivum, address these challenges by automating data integrity checks, enforcing standardised metadata, and supporting a wide range of file formats. These solutions enable research teams to consolidate datasets, maintain regulatory compliance, and ensure inspection readiness, ultimately supporting better patient outcomes.

Frequently Asked Questions:

What is a clinical trial?
A clinical trial is a research study that tests new medicines, treatments, or medical devices in people to determine their safety and effectiveness. Participants typically include volunteers who meet specific criteria, such as having a particular condition or being healthy. Clinical trials are essential for developing new therapies and improving healthcare. They usually progress through several phases to gather detailed information about the treatment.

What is a randomised clinical trial?
In a randomised clinical trial, participants are randomly assigned to different groups such as receiving the new treatment or a placebo/standard therapy. Randomisation helps ensure the groups are comparable, reducing bias and increasing the reliability of the results. This approach allows researchers to confidently attribute any differences in outcomes to the treatment itself rather than other factors.

How do clinical trials get approved?
Before a clinical trial can start, it must be reviewed and approved by regulatory agencies like the FDA (U.S.), EMA (Europe) or MHRA (UK) to ensure it meets safety and scientific standards. Additionally, ethics committees or Institutional Review Boards (IRBs) review the study protocol to protect participant rights and welfare. Sponsors must submit detailed information about the trial design, risks, benefits, and how participants will be informed and protected.

How are clinical trials monitored?
Clinical trials are monitored through:

• Sponsor oversight (pharmaceutical company or research institution)
• Regular site visits by trained monitors checking data accuracy and protocol compliance
• Independent safety monitoring boards reviewing data periodically
• Regulatory inspections
• Mandatory adverse event reporting
• Quality assurance audits

Monitoring frequency varies based on trial complexity and risk level.

What is the clinical trial process?
Clinical trials typically progress through several phases:

• Preclinical: Laboratory and animal studies to gather initial safety data.
• Phase I: Tests safety and dosage in a small group of healthy volunteers or patients.
• Phase II: Explores effectiveness and side effects in a larger patient group.
• Phase III: Confirms effectiveness, monitors side effects, and compares to standard treatments in large populations.
• Phase IV: Post-marketing studies to gather long-term safety and effectiveness data after approval.

Do clinical trials need to be run in every country?
Not necessarily. While some trials are conducted globally to ensure diverse populations and faster recruitment, others are limited to specific regions. Multinational trials can provide broader data but come with higher costs and regulatory complexity. Running trials in multiple countries helps assess how treatments perform across different genetic backgrounds and healthcare settings.