Spain has become a prime destination for clinical trials in the pharmaceutical and biotech industries due to its robust healthcare infrastructure, diverse patient population, skilled professionals, and favorable regulatory environment.
The country boasts a high-quality public and private healthcare system, enabling efficient patient recruitment and trial execution.
Spain’s diverse population offers an advantage for conducting studies across a wide range of medical conditions and demographics, enhancing the generalizability of trial results.
Moreover, Spain’s regulatory processes are harmonized with European Union standards, ensuring streamlined approvals for clinical studies.
The country also supports strong public-private collaborations, fostering innovation and expediting trial timelines.
Madrid and Catalonia are particularly prominent hubs for clinical research, housing leading hospitals and research institutes that facilitate cutting-edge studies.
These factors, combined with Spain’s reputation for high research ethics and quality data, make it a strategic choice for global pharmaceutical and biotech companies seeking to advance their research and development efforts.
Key Advantages of Spain for Clinical Trials
Here are the key advantages that make Spain an excellent choice for clinical trials:
- Modern Healthcare Infrastructure
Spain boasts a well-established and modern healthcare system that ranks among the best in the world.
Its hospitals and research centers are equipped with state-of-the-art technology and adhere to international quality standards, ensuring the reliability and accuracy of clinical data.
- Diverse and Accessible Patient Pool
With a population exceeding 47 million people, Spain provides a diverse patient demographic, including varying genetic, cultural, and lifestyle factors.
This diversity facilitates the recruitment of participants for various therapeutic areas, improving the generalizability of study results.
Moreover, Spain has a strong culture of volunteer participation in clinical trials, ensuring timely patient recruitment.
- Skilled Medical Professionals
Spain has a high concentration of experienced clinicians and researchers trained in Good Clinical Practice (GCP) guidelines.
The country’s universities and medical schools are globally recognized, contributing to a well-educated workforce that enhances the quality of clinical trial execution.
- Supportive Regulatory Environment
Spain has streamlined regulatory processes for clinical trials, enabling faster approval timelines compared to many other European countries.
The Spanish Agency of Medicines and Medical Devices (AEMPS) oversees the approval and monitoring of trials, ensuring compliance with EU regulations while maintaining efficiency.
- Cost-Effectiveness
Conducting clinical trials in Spain is often more cost-effective compared to other Western European countries.
Competitive operational costs, coupled with high-quality services, make Spain an attractive destination for research sponsors looking to optimize their budgets.
- Integration into the European Network
As a member of the European Union, Spain complies with EU clinical trial regulations, offering seamless integration with broader European research initiatives.
This facilitates multicenter trials and ensures that data generated in Spain is readily accepted by European regulatory authorities.
- Advanced Research Ecosystem
Spain is home to numerous research institutes and clinical trial networks, fostering innovation and collaboration.
The country’s focus on translational medicine and partnerships between academic institutions, hospitals, and industry players drives progress in drug development.
- Strategic Geographic Location
Spain’s position at the crossroads of Europe, Africa, and the Americas makes it a hub for global clinical trials.
Its infrastructure supports international logistics, ensuring efficient management of trial supplies and global study coordination.
By combining scientific expertise, operational efficiency, and patient-centric approaches, Spain offers an ideal environment for conducting clinical trials, advancing medical research, and accelerating access to innovative treatments worldwide.
How Many Clinical Trials are Conducted in Spain Compared to Other European Countries?
Spain is a leading destination for clinical trials in Europe, consistently demonstrating its strong position in this field.
In 2023, Spain authorized over 900 clinical trials, making it one of the most active countries in Europe for clinical research.
Notably, it is one of the most active countries globally in terms of clinical trial participation, with about one-third of European trials involving Spain.
This robust performance highlights Spain’s prominence in the global clinical trial landscape.
The country excels due to its efficient public-private collaboration model, top-tier healthcare infrastructure, and well-trained clinical professionals.
Additionally, Spain has a comprehensive legal framework that aligns with European clinical trial regulations, further facilitating research activities.
By comparison, other European countries also actively participate in clinical trials, but Spain’s commitment and strategic approach to fostering partnerships between pharmaceutical companies and healthcare institutions set it apart as a preferred hub for clinical research.
Spain is positioned among the top four countries conducting clinical trials in Europe.
According to ClinicalTrials.gov, by December 2024, these were the EU countries with highest clinical trial participation:
- France: 37,919 studies
- Germany: 26,190 studies
- Italy: 22,068 studies
- Spain: 22,025 studies
Is it Cheaper to Run a Clinical Trial in Spain Compared to the United States?
Running a clinical trial is generally cheaper in Spain compared to the United States.
The costs in the U.S. are driven by high labor, site fees, and regulatory expenses, while Spain offers a more cost-effective environment for conducting trials without compromising quality.
Cost Differences
United States
The U.S. is among the most expensive countries for clinical trials.
Per-patient costs can range from $36,500 to over $60,000 depending on the phase and complexity of the study.
Key contributors to these costs include high salaries for clinical staff, expensive site management fees, and the extensive regulatory burden.
Spain
Spain offers significantly lower costs for clinical trials, with estimates often 30-40% less than in the U.S.
The country benefits from a high-quality but less expensive healthcare system, streamlined regulatory processes, and lower operational costs.
Per-patient costs in Spain are often cited as being around $15,000 to $25,000, varying by trial phase and complexity.
Key Factors Contributing to Lower Costs in Spain
- Public-Private Collaboration: Efficient partnerships reduce overhead costs.
- Streamlined Regulatory Environment: Faster and simpler approval processes lower administrative expenses.
- Centralized Healthcare System: Spain’s national healthcare structure allows for better coordination and cost control.
Additional Considerations
While costs in the U.S. are higher, it remains a preferred destination for trials targeting large, diverse patient populations and access to advanced technologies.
Spain, on the other hand, offers a balance of cost efficiency and access to a well-regarded research ecosystem, making it an attractive alternative for many sponsors.
Is it Cheaper to Run a Clinical Trial in Spain Compared to Other European Countries?
Yes, Spain is often considered one of the more cost-effective countries in Europe for conducting clinical trials.
While costs vary depending on the specific therapeutic area, trial phase, and site requirements, Spain generally offers lower operational costs compared to other Western European nations like Germany, the UK, or France.
Reasons for Spain’s Cost Advantages
- Lower Labor Costs: Salaries for clinical staff and investigators in Spain are typically lower than in countries like Germany or the UK, which reduces overall personnel expenses.
- Efficient Healthcare System: Spain’s centralized healthcare infrastructure allows for easier recruitment and coordination of trials, saving time and money.
- Streamlined Regulatory Processes: Spain’s regulatory framework is faster and less complex than some other European countries, reducing administrative delays and associated costs.
- Government Support: Public-private collaboration initiatives and government incentives further reduce the financial burden on sponsors conducting trials in Spain.
Comparison to Other European Countries
- Germany: Known for its high-quality trials but higher costs due to stricter regulatory requirements and higher salaries.
- UK: While the UK offers advanced infrastructure and research expertise, trial costs are significantly higher, especially post-Brexit due to additional regulatory complexities.
- Eastern Europe: Countries like Poland, Slovakia, or Hungary, among others, may offer even lower costs than Spain but might lack the same level of healthcare infrastructure and research experience.
Spain provides an excellent balance of affordability, quality, and efficiency, making it a competitive choice for clinical trials in Europe.
For sponsors aiming to reduce costs without compromising trial quality, Spain is a preferred destination compared to many Western European countries.
What Approvals are Needed to Run a Clinical Trial in Spain?
To conduct a clinical trial in Spain, sponsors must secure regulatory and ethics approvals in compliance with national and European Union (EU) regulations.
These include approval from the Spanish Agency of Medicines and Medical Devices (AEMPS) and a favorable opinion from an accredited ethics committee.
- Regulatory Approval: AEMPS
The Spanish Agency of Medicines and Medical Devices (AEMPS) is the primary regulatory authority overseeing clinical trials in Spain.
Sponsors must submit a Clinical Trial Application (CTA) to AEMPS, which evaluates:
- The safety and quality of the investigational medicinal product (IMP).
- The study design and protocol compliance with EU guidelines and Good Clinical Practice (GCP).
- The suitability of the investigator and the trial site.
AEMPS adheres to the EU’s harmonized regulatory process, governed by EU Clinical Trial Regulation 536/2014, which came into full effect in January 2022.
This regulation streamlines submissions through the EU Clinical Trials Information System (CTIS), enabling a single application for all EU member states.
- Ethics Committee Approval
In addition to AEMPS approval, clinical trials require a favorable opinion from a Research Ethics Committee (REC).
Key responsibilities of the REC include:
- Ensuring participant safety and rights.
- Evaluating the informed consent process and document.
- Reviewing the ethical aspects of the trial design.
In Spain, ethics review is typically conducted by a Hospital Ethics Committee (Comités de Ética de la Investigación con Medicamentos, CEIm) located at one of the trial sites.
The sponsor must ensure the committee reviewing the application is accredited for clinical trials.
- Key Submission Documents
The following documents, among others, are needed for clinical trial submissions in Spain:
- The trial protocol.
- Investigator’s Brochure (IB).
- Participant Information Sheet (PIS) and Informed Consent Form (ICF).
- Data protection compliance documentation.
- Investigational Medicinal Product Dossier (IMPD).
- Proof of clinical trial insurance coverage.
- Timelines
- AEMPS: Typically reviews applications within 60 days, although this may vary depending on the complexity of the trial.
- REC: Reviews are often conducted in parallel with AEMPS and timelines may range from 30–45 days, depending on the committee.
Which Hospitals Carry Out the Most Clinical Trials in Spain?
Spain is a leading country in Europe for clinical trials, with significant activity concentrated in specific regions and hospitals.
Catalonia, for instance, participates in approximately 60-70% of all clinical trials in Spain, with 1,242 active trials in 2022, positioning it as a major hub for research excellence.
In Madrid, the Hospital Universitario La Paz is notable for its extensive research activities.
It hosts the Institute for Health Research (IdiPAZ), which encompasses over 50 research groups across six strategic areas, facilitating numerous clinical trials.
Additionally, Spain’s participation in clinical trials is highly concentrated, with certain regions offering a significant number of trials, while others have limited access.
In the following list you can see the main hospitals conducting clinical trials in Spain:
- Hospital Universitario La Paz, Madrid
- Hospital Universitario 12 de Octubre, Madrid
- Hospital Universitario Gregorio Marañón, Madrid
- Hospital Clínico San Carlos, Madrid
- Hospital Universitari Vall d’Hebron, Barcelona
- Hospital Clínic, Barcelona
- Hospital de la Santa Creu i Sant Pau, Barcelona
- Hospital Politècnic i Universitari La Fe, Valencia
- Hospital Universitario Virgen del Rocío, Seville
- Hospital Universitario Miguel Servet, Zaragoza
Conclusions
Spain is one of the most sought-after destinations for clinical trials due to its advanced healthcare infrastructure, diverse patient population, and supportive regulatory environment.
It is positioned among the top four countries conducting clinical trials in Europe.
Running a clinical trial is cheaper in Spain compared to the United States.
Some Eastern Europe countries may offer even lower costs than Spain but might lack the same level of infrastructure and experience.
To conduct a clinical trial in Spain, sponsors must secure regulatory and ethics approvals in compliance with national and EU regulations.
There are many high-quality clinical sites in Spain to run clinical trials. The largest sites are in Madrid, Barcelona, Seville, and Valencia.
