National Summary of Clinical Trials in Human Medicines Based on CTIS Data

Clinical Studies Sweden has compiled new statistics on clinical trials in human medicines using data from the EU’s Clinical Trials Information System (CTIS). The report provides a national overview of approved trials involving at least one Swedish trial site. It offers a shared factual foundation to strengthen the conditions for clinical research within Swedish healthcare.

Background

With the introduction of the EU Clinical Trials Regulation (CTR), CTIS became the central system for all clinical trials in human medicines across the EU and EEA. The database includes information on trials conducted by both commercial and non-commercial sponsors, enabling the production of structured and comparable statistics.

Clinical Studies Sweden has analysed CTIS data and categorised trials by sponsor type, trial phase, and therapy area. The aim is to provide a comprehensive national overview that can be used by stakeholders in healthcare, academia, industry, and government.

“We are seeing a growing need for data-driven and fact-based dialogue between healthcare, academia, and industry. These statistics give us a reliable common ground to track developments over time and build more nuanced analyses,” says Helen Fagerlind, strategist at Gothia Forum and project manager for the report.

Key Findings

The report highlights several clear patterns:

• Strong role of non-commercial actors: Almost one quarter of approved clinical trials in human medicines (200 out of 847) are led by Swedish regions, institutes, or universities. Another 93 trials are run by international non-commercial actors, while commercial sponsors account for 65% of all trials.
• Phase III dominates: Phase III trials are the most common, showing that Swedish healthcare is heavily involved in studies close to clinical implementation.
• Oncology leads the way: Oncology is the largest therapy area, with 317 trials. Nearly two-thirds are conducted by commercial sponsors. While commercial actors dominate across most therapy areas, Swedish trial activity spans a wide range of medical fields.
• Collaboration across regions: More than half of all trials involve sites in two to six healthcare regions, demonstrating Sweden’s strong capacity for interregional collaboration.

How the Statistics Can Be Used

This initial national overview serves multiple purposes:

• Tracking developments over time
• Supporting planning of national initiatives for clinical trials in human medicines
• Strengthening support structures within healthcare
• Facilitating dialogue with industry and trial networks

“Instead of relying on individual experiences, we now have a shared factual base for planning initiatives and investments. This helps ensure correct prioritisation at both national and regional levels and strengthens healthcare’s ability to participate in clinical trials in human medicines,” says Ann Tronde, Chair of Clinical Studies Sweden.

Next Steps

Clinical Studies Sweden will continue to:

• Analyse developments over time
• Establish routines for regular follow-ups of approved trials
• Break down broad therapy areas into diagnosis groups to identify healthcare research strengths
• Compare academic and commercial principal investigator networks to highlight implementation capacity and guide participation in company-initiated trials

This work is carried out in close dialogue with national stakeholders to ensure a coordinated, high-quality approach to follow-up and statistics. Together, these efforts aim to make the trial landscape more transparent and strengthen Sweden’s position in clinical trials in human medicines.

Download the full report (PDF)

Overview of Clinical Trials in Human Medicines in Sweden Approved under EU Regulation 536/2014 (in Swedish) pdf, 3 MB. (pdf, 3 MB)

Contact

For questions about the report or Clinical Studies Sweden’s ongoing work with statistics, email info@kliniskastudier.se.