Last year Spain authorized more than 900 clinical trials with medicines, according to the Spanish Registry of Clinical Studies (REEC), which is coordinated by the Spanish Agency for Medicines and Health Products. The figure – which could still increase when the definitive data is closed – is higher than that registered in 2018 and 2019, years prior to the pandemic in which 800 and 833 clinical studies were authorized, respectively.
86% of these trials were promoted by pharmaceutical companies, whose investment in this item has been increasing in recent years to 789 million euros, 60% of the total investment in R&D in the sector in Spain, as reflected the latest Survey on R&D Activities. This item has increased at an average cumulative annual rate of 5.3% in the last 10 years, going from 470 million euros in 2011 to nearly 800 million euros in 2021.
In this sense, investment in clinical research generates a great virtuous circle, since it implies investment in hospitals by the companies promoting the trials; It contributes to the qualification of health professionals, thereby increasing the quality of the provision of our health system, and opens up new possibilities for Spanish patients, for many of whom participation in a clinical trial can be a unique opportunity to cure his disease.
Likewise, more than a third of the trials (328) focus on drugs to treat cancer, the area with the most studies, followed by diseases of the nervous system and pathologies of the immune system. Respiratory, haematological, viral and cardiovascular diseases were next in number of trials in 2022, according to REEC data.
Another piece of data of great value for our country is that referring to rare diseases, which already account for 25% of the clinical trials carried out in 2022, with a total of 230. This data has evolved significantly in recent years, from so that in 2018 there were 73 studies aimed at testing orphan drugs and in 2019, 117. Despite progress, rare diseases are an important area of development for biomedical research, since only 5% of these pathologies have an available treatment. However, current European legislation, based on a system of incentives for research by pharmaceutical companies, has managed to go from the 8 orphan drugs available in the year 2000 to more than 130 today.
We are facing the opportunity to further promote Spain’s leadership in this area
Javier Urzay
Deputy General Manager of Farmaindustria
On the other hand, a total of 166 clinical trials had children or adolescents as patients. The pediatric area is also one of the areas that has grown the most in Spain in recent years, with a number of studies on the rise since 2016, when 108 trials with pediatric drugs were registered, 35% less than last year.
The necessary impulse to the early phases
Of the 906 trials published by the REEC in 2022, more than half (525) are framed in the early phases of research, the ones considered the most complex within the clinic and whose momentum poses a challenge in our country, once its leadership has been consolidated. in the later phases.
«In recent years Spain has become a world benchmark in clinical trials, thanks to the commitment of the pharmaceutical industry that finances and promotes more than 86% of the studies, but also thanks to the solidity of the health system, the high qualification of its professionals, pioneering legislation and increasingly involved patients”, assesses the deputy director general of Farmaindustria, Javier Urzay.
«The companies established in Spain have the adequate structure, experience, results and disposition to continue growing and consolidate the reference position of our country,» he adds. The Strategic plan of the Pharmaceutical Industry, which we are already working with the Government after the meeting held last December in La Moncloa, will help us provide Spain with the best environment to achieve this”, adds Urzat.
In line with the latest data released by the REEC, it should be remembered that the emergence of Covid-19 led to an increase in the numbers of clinical trials in our country during 2020 and 2021, making Spain the fourth country in the world and first in Europe by volume of studies against SARS-CoV2 and exceeding a thousand trials in these years.