Spain is the country with the highest participation in clinical trials of new drugs in Europe
Of the 1,944 clinical trials authorised in the European Union through the new European Information System, Spanish centres participated in 845, or 43% of the total.
In addition, the Spanish Medicines Agency was responsible for coordinating the authorisation of 350 multinational trials, making Spain the leader in this field, ahead of Germany with 314 and France with 248.
Spain was the first country in the European Union to implement the European Clinical Trials Regulation, in application since 2022, which harmonises the submission, evaluation and supervision processes throughout the EU.
Farmaindustria.es
In recent years, Spain has become a benchmark in clinical trials of new medicines. Now, after the first year of mandatory application of the new European Clinical Trials Regulation, the annual figures published for the first time jointly by the European Medicines Agency (EMA) have confirmed this position. Thus, of the 1,944 clinical trials authorised in the European Union through the new CTIS centralised registration system (which started on 31 January 2022, but only became mandatory on 31 January 2023), Spanish centres participated in 845, 43% of the total, making Spain the leading country in Europe in this area, ahead of France with 734 trial participations and Germany with 697 (see graph).
In addition, Spain also leads in the coordination and authorisation of multinational trials within the European Medicines Agency. Thus, through the Spanish Medicines Agency (AEMPS), Spain was responsible for coordinating the authorisation – known as Reporting Member State – of 350 clinical trials in the European Union, a figure that puts us ahead of Germany with 314 and France with 248.
farmaindustria.es
From 2023, all clinical trial applications in the European Union (EU) must be submitted through the Clinical Trials Information System (CTIS). In the past, trial sponsors (86% of which are pharmaceutical companies in Spain) had to submit separate clinical trial applications to national competent authorities and ethics committees in each country to obtain regulatory approval to conduct a clinical trial. With CTIS, sponsors can apply for approvals in up to 30 EU countries at the same time and with the same documentation.
This new European platform is the result of the new Clinical Trials Regulation (CTR). “Our country was the first in the European Union to adopt this Regulation, with Royal Decree 1090/2015, and this has led to the simplification and harmonisation of procedures at national level before any other Member State; a reduction in the time required to start studies; an increase in early-stage trials, which are those that require a higher level of complexity, and a greater commitment to research into rare diseases and the paediatric population”, highlights Amelia Martín Uranga, director of Farmaindustria’s Translational Research Department.
The Spanish Medicines Agency, a leader in Europe
According to data from the Spanish Medicines Agency, collected in the Spanish Clinical Trials Register (REEC), more than half of the clinical trials (58%) that are launched in Spain are in early phases (I and II); one in four trials is focused on rare diseases; and paediatric clinical trials now account for up to 15% of all trials launched in our country.
Spain, as these figures show, currently has a competitive advantage over other countries to underpin its leadership in clinical trials. “However, we run the risk of falling behind if we do not implement improvements to make investment in clinical research in our country more attractive. For example, competition among European countries to host clinical trials in their hospitals has grown in recent years. “The CTIS data reflect a growing number of trials in countries that until now had no role in this field, such as Croatia, Estonia, Latvia, Lithuania and Romania,” he says. “We also have to be concerned as a European region, as there is a lot of competition from other parts of the world, especially the US and the Asia-Pacific region, which are making a major commitment to clinical research.
Along these lines, Farmaindustria’s Director of Clinical and Translational Research highlights a series of challenges and priorities that the Association has set this year to ensure that Spain becomes a true hub for biomedical innovation. “For example, Spain is one of the best countries in phase I and II trials, and that is great news for patients, because testing a drug at an early stage is a door to hope for patients with serious diseases. The problem is that there are already countries in Europe that have opted for a fast track (expedited procedure) for phase I trials, which can move research out of Spain. Farmaindustria has called for such an accelerated mechanism in Spain”.
In this context, and in order to strengthen Spain’s leadership, Farmaindustria has designed an action plan for 2024, which includes several lines of action. Among them, the promotion of clinical research in primary care centres and in collaboration with hospitals; the promotion of networked clinical trials; advancing in decentralised elements of trials; continuing to work with patients and hospital pharmacy services; and trying to streamline and reduce bureaucracy in the management of this research. “For all this, collaboration and cooperation with other stakeholders with whom the Association is already working, such as the Spanish Medicines Agency, the Ethics Committees for Research with Medicines, researchers, hospital centres, patients and research managers, among other agents, is essential. Undoubtedly, part of the success of the work carried out in recent years lies in this public-private collaboration, which now more than ever needs to be intensified in order to consolidate leadership,” he concludes.
