Spain, a global power in clinical trials
One out of every three tests carried out in Europe takes place in Spain. Investment has grown by 5.3% annually since 2011, to almost 800 million euros
Source: cincodias.elpais.com
Spain continues on its path to becoming one of the global powers in clinical trials. In fact, it is the second country preferred by the pharmaceutical sector to carry out clinical trials, after the United States. The figures bear this out. Last year, 906 trials were launched, according to data from the Spanish Clinical Trials Register (REEC). This figure served to surpass that registered in 2018 and 2019, when 800 and 833, respectively, were authorised. Currently, some 170,000 Spaniards are participating in a study.
Of these, 86% were driven by pharmaceutical companies, a percentage that rises to 96% in the area of rare diseases. The comparison is made with the years prior to the pandemic because the health emergency caused them to skyrocket to an all-time high of 1,027 in 2020.
According to the survey on R&D activities of the Spanish National Statistics Institute (INE), a total of 789 million euros were invested in clinical trials last year, accounting for 60% of total industry R&D investment. Looking at these figures, Spain’s evolution and attractiveness in the clinical research sector is clear. Even more so if we take into account that, since 2011, the amount invested has risen from 470 million to the current almost 800 million, at an average annual rate of 5.3%.
A sector-wide effort
There are several reasons why pharmaceutical companies choose the country to carry out these tests. According to the US laboratory MSD, Spain “is a very interesting country because of the universal coverage of the National Health System, the quality of its professionals and the presence of world-class scientific leaders”. Lilly also points out that it is a good option “because of the quality of the science and the regulatory framework, which guarantees patients, but is sufficiently flexible”.
With the ultimate goal of contributing to people’s health through the development of new drugs and treatments for different diseases, all the actors involved have increased their efforts and have opted for Spain to carry out these trials, including private healthcare.
In 2022, private centres have participated in 50% of the studies.
Private centres have collaborated in more than 1,430 and, since 2016, a total of 105 have participated in the development of a study, which represents almost 29% of the total, according to the Institute for the Development and Integration of Health (IDIS Foundation). In 2022, private hospitals and clinics increased their collaboration to 50%, explaining that most of the cases have been in early stages and related, above all, to oncology, neurosciences and haematology, and highlighting Madrid, Catalonia and the Valencian Community as the regions with the greatest activity. Its director general, Marta Villanueva, acknowledges that Spain has positioned itself among the countries in the world “with the best conditions for the development of clinical drug trials”.
Leadership
The employers’ association Farmaindustria points out that one out of every three studies developed in Europe is carried out in Spain, but believes that its potential is even greater thanks to its capacity to anticipate and its innovative approach.
It also highlights that a large part of the current position is due to the BEST project, launched in 2006 by the same association together with 60 pharmaceutical companies, 13 autonomous communities, 52 public and private hospitals and six clinical research groups to improve the efficiency and competitiveness of the processes carried out in this activity.
It should be noted that the country is in an advantageous position due to the implementation of the new European clinical trial information system (CTIS), which seeks to harmonise the submission, evaluation and monitoring processes in Europe, thanks to Royal Decree 1090/2015, which made it the first country in the European Union to adopt the regulation in which the CTIS is framed and one of the first to carry out the necessary training for the use of the new platform.
All European countries will have to use this system from 31 December, giving them the remainder of the year to adapt. According to data from the European Medicines Agency, Spain is the European country that has worked the most with the CTIS from January 2022 to April 2023, with almost 450 studies adapted to the new regulation, ahead of France and Germany.
