THESE ARE THE 10 REASONS WHY SPAIN IS A WORLD LEADER IN CLINICAL TRIALS
Spain is a benchmark country in the world and the first in Europe to conduct clinical trials to test the safety and efficacy of new drugs.
The pandemic brought this activity closer to the general public, who are increasingly familiar with the importance of these studies, which are the last step in demonstrating the efficacy and safety of a medicine that, on many occasions, changes the lives of patients with serious illnesses and no treatment options.
The clinical trial, which in the vast majority of cases (almost nine out of ten in Spain) is driven by the pharmaceutical industry, represents the final stage of a complex, lengthy and risky long-distance race in the R&D of new drugs, which begins when researchers identify a promising compound in the pre-clinical stage and culminates 10-12 years later when, if all goes well, the new drug is made available to patients.
Thus, of the 2,491 clinical trials authorised in the European Union through the new centralised registration system CTIS (which started on 31 January 2022, but only became mandatory in 2023), Spanish centres have participated in 1,136, 45.6% of the total, ahead of France with 978 participations and Germany with 914 (see graph).
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The clinical trial is one of the best examples of how by joining forces with the same objective, which is none other than to achieve new drugs to improve people’s health, very diverse sectors and agents are capable of generating a virtuous dynamic that benefits society as a whole, although these benefits are sometimes little known.
But what are the reasons why Spain has become one of the world leaders in clinical trials? These are the keys:
1. PIONEERS IN REGULATION
Our country was the first in Europe to adopt the 2014 Clinical Trials Regulation, with Royal Decree 1090/2015, which led to the simplification, streamlining and harmonisation at national level of the procedures for conducting these studies before any other Member State; a greater role for patients; an increase in early phase trials, which are those that require a higher level of complexity; and a greater commitment to research in rare diseases and in the paediatric population.
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2. AEMPS: A COMMITTED REGULATORY AGENCY
The Spanish Agency for Medicines and Health Products (Aemps), attached to the Ministry of Health, is the competent authority for the authorisation of clinical trials. Its pioneering and proactive attitude to promote and preserve research activity, guaranteeing patient safety; the search for solutions; and the attitude of constant dialogue with the pharmaceutical industry that promotes the studies, among other issues, have facilitated the implementation of trials in our country in recent years.
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3. A SOLID NATIONAL HEALTH SYSTEM
Spain has one of the most solid and highest quality healthcare systems in the world. In addition to almost 13,000 health centres and almost 800 public and private hospitals (although not all of them conduct clinical trials), there are 35 health research institutes accredited by the Carlos III Health Institute, spread across 13 autonomous communities and with a total of more than 29,000 researchers. The Spanish model has another great virtue: a quality pharmaceutical service, one of the most comprehensive on an international scale.
4. EXCELLENT HEALTHCARE PROFESSIONALS
Spain has highly qualified healthcare professionals to take on the challenge of clinical research with the highest standards of quality, thanks to their commitment to ongoing training and patient care. Moreover, clinical trials allow doctors, nurses, pharmacists, etc. to be at the forefront of knowledge and improve the provision and service within the NHS.
Healthcare professionals are an indispensable part of clinical research. Participating in a trial is an important decision, as well as understanding them to make the decision to join a trial, and healthcare professionals are the ones who bring research closer to patients and open the first window of hope.
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5. PATIENT INVOLVEMENT AND GENEROSITY
Some 170,000 people in Spain are currently participating in an active clinical trial, according to estimates by the pharmaceutical industry. The participation of patients in clinical trials is a great demonstration of altruism, solidarity and generosity, because even if the study does not have a direct benefit for them, it will have a direct benefit for future patients.
More and more people in Spain are getting involved in clinical trials and this is another great cornerstone of research: without patient collaboration, there is no research.
6. AN ACTIVITY BASED ON ETHICS AND TRANSPARENCY
The Ethics Committees for Research on Medicinal Products (CEIm) are accredited independent bodies that guarantee the ethical and scientific quality of clinical studies with medicinal products. In Spain, there are more than 65 members of the current system, and their good functioning and the professionalism of their members have contributed significantly to the fact that clinical trials are conducted in Spain under the strictest ethical criteria.
Likewise, two years ago, the Spanish Data Protection Agency (AEPD) approved the Code of Conduct regulating the processing of personal data in the field of clinical trials and other clinical research and pharmacovigilance, promoted by Farmaindustria, which is the first sectoral code of conduct of its kind in Europe and which is a further demonstration of the Spanish pharmaceutical industry’s commitment to transparency and the sector’s respect for the fundamental rights of citizens in the processing of personal data.
7. A PHARMACEUTICAL INDUSTRY THAT IS COMMITTED TO SPAIN
The pharmaceutical industry is one of the industrial sectors that invests most in research in our country. Patients benefit above all from this investment, because 60% (of the almost 1,400 million euros in 2022) is dedicated to launching clinical trials, which means that thousands of people in Spain are gaining early access to the treatments of the future.
For many pharmaceutical companies, Spain is already the second country in the world in terms of clinical trial activity, behind only the United States, and participates in one out of every three trials launched in Europe.
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8. THE BEST PROJECT, A CATALYST FOR CLINICAL RESEARCH
In addition to all the above reasons, Spain has had an important catalyst in the field of clinical trials. Farmaindustria launched the Best Project in 2006, after detecting a loss of competitiveness based on pre-2015 regulations. It is a strategic project in which all public and private actors involved are integrated to create a platform of excellence in clinical drug research in our country.
From the outset, its objective was to promote investment in R&D by objectifying and monitoring the situation of clinical trials in Spain, identifying the different practices, and taking consequent measures to improve their efficiency and competitiveness. Before this initiative, up to sixteen countries in Europe started a clinical trial earlier than Spain. Now, in many cases, Spain is the first country in Europe to recruit the first patient for a trial.
9. A HARMONISED EUROPEAN SYSTEM
The way clinical trials are conducted in the European Union (EU) is undergoing important changes for the benefit of patients. Since 31 January 2022, the new Clinical Trials Information System (CTIS) has been operational. It harmonises the submission, assessment and monitoring processes for clinical trials in the region, with the aim of speeding up these studies and, consequently, getting new, effective and safe medicines to the people who need them sooner.
With CTIS, clinical trial sponsors can request authorisation for a clinical trial simultaneously in all EU countries with a single application that covers submissions to national competent authorities, ethics committees and public registration of the clinical trial. Our country has also been among the first to provide the necessary training for the use of this new platform and the AEMPS is one of the best positioned regulatory agencies in this area.
10. A SUCCESSFUL MODEL BASED ON PUBLIC-PRIVATE COLLABORATION
Public-private collaboration is the main axis for the promotion of biomedical research in Spain. Clinical trials are a true paradigm of the success of this cooperative model between health authorities, hospitals, researchers and healthcare professionals, patients and pharmaceutical companies. The pharmaceutical industry allocated almost half of its R&D investment in 2022, 633 million euros, to research contracts with hospitals, universities and public and private centres.
Continuing to foster scientific-business alliances is key to achieving a real transfer of knowledge and for companies to be able to exert their full leverage so that new medicines reach the patients who need them as soon as possible.
The Spanish clinical research model, driven by these 10 keys, works, although it has a number of challenges ahead that need to be addressed in order not to lose its leadership. On the one hand, the promotion of clinical trials in Primary Care, as well as implementing the decentralised elements of clinical trials, and that these can be conducted in a network, so that more patients in more autonomous communities and provinces of Spain can benefit from medical advances. Furthermore, procedures must continue to be simplified in order to be competitive in terms of the speed with which they can be implemented.
And, on the other hand, the general public needs to be aware of the value of clinical trials, as they attract resources and savings for the National Health System, allow healthcare professionals to gain knowledge and provide patients with early access to new drugs, which for many of them may be their last chance to cure or chronify their illness.
