Spain: A Global Leader in Clinical Trials
Spain leads in the number of clinical trials conducted in the European Union. Of the 2,491 clinical trials authorized in the EU through the CTIS system, Spanish centres participated in 1,136 trials, representing 45.6% of the total. This places Spain ahead of France, with 978 trials, and Germany, with 914 trials.
Spain has become a global leader in clinical trials due to the strength of its healthcare system and professionals, pioneering regulatory work, public-private collaboration, and the generosity of patients. Farmaindustria highlights these factors, especially on International Clinical Trials Day, while also pointing out new challenges to maintain this leadership.
One of the key reasons for Spain's success is its pioneering attitude towards regulation. Spain was the first in Europe to adopt the 2014 Clinical Trials Regulation with Royal Decree 1090/2015, simplifying and harmonizing procedures nationally. This led to greater patient involvement, an increase in early-phase trials, and a commitment to rare diseases and paediatric research.
The Spanish Agency for Medicines and Health Products (AEMPS) has played a crucial role with its proactive approach, facilitating the initiation of trials. The robust National Health System (SNS) is another pillar, offering high-quality healthcare and pharmaceutical services.
Highly qualified healthcare professionals in Spain ensure clinical research meets top standards due to their ongoing training and dedication to patient care. They are essential for explaining trials to patients, helping them understand and decide on participation.
Patient involvement is another cornerstone, with around 170,000 individuals currently participating in active clinical trials in Spain. Without patient collaboration, research would not be possible.
Ethics Committees for Clinical Research (CEIm) also contribute significantly. There are over 65 CEIm in Spain, and their effective functioning and professionalism have been vital.
The pharmaceutical industry in Spain is heavily invested in research, with the sector being one of the top investors in the country. Spain is second only to the U.S. in clinical trial activity and is involved in one-third of European trials.
Farmaindustria's Best Project, launched in 2006, has created a platform of excellence in clinical research by integrating all public and private stakeholders. This initiative helped Spain regain competitiveness following earlier regulatory challenges.
The EU's Clinical Trials Information System (CTIS), operational since 2022, allows simultaneous trial authorizations across EU countries, simplifying processes. Spain has been proactive in adopting this system, with AEMPS being a well-positioned regulatory body.
Lastly, public-private collaboration is crucial for biomedical research in Spain. In 2022, the pharmaceutical industry invested nearly half of its R&D budget, €633 million, in research contracts with hospitals, universities, and public and private centres, showcasing the success of this cooperative model.
Written by Jorge
Decisive Dialogue 4th June 2024
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