Spain registers more than 900 clinical trials in 2022, above pre-pandemic levels

25% of the studies authorised last year are already for orphan drugs to combat rare diseases

86% of trials are driven by the pharmaceutical industry

Javier Urzay, Deputy Director General of Farmaindustria, recalls that “we have the opportunity to further boost Spain’s leadership in this area”

Source: farmaindustria.es

Spain authorised more than 900 clinical trials with medicines last year, according to the Spanish Clinical Trials Register (REEC), which is coordinated by the Spanish Agency for Medicines and Health Products (Agencia Española de Medicamentos y Productos Sanitarios). The figure – which could still increase when the final data are finalised – is higher than that recorded in 2018 and 2019, the years prior to the pandemic when 800 and 833 clinical studies were authorised, respectively.

Eighty-six percent of these trials were driven by pharmaceutical companies, whose investment in this item has been increasing in recent years to 789 million euros, 60% of the sector’s total R&D investment in Spain, as reflected in the latest R&D Activities Survey. This item has increased at an average annual cumulative rate of 5.3% in the last 10 years, 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 involves investment in hospitals by the companies promoting the trials; it contributes to the qualification of healthcare professionals, thereby increasing the quality of the provision of our healthcare system, and opens up new possibilities for Spanish patients, for many of whom participation in a clinical trial may represent a unique opportunity to cure their disease.

In addition, 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 immune system pathologies. Respiratory, haematological, viral and cardiovascular diseases were next in number of trials in 2022, according to REEC data.

This figure has evolved significantly in recent years, so that in 2018 there were 73 studies aimed at testing orphan drugs and in 2019, 117. Despite the advances, rare diseases are an important area of development for biomedical research, as only 5% of these pathologies have a treatment available. However, current European legislation, based on a system of incentives for research by pharmaceutical companies, has managed to increase the number of orphan drugs available from 8 in 2000 to more than 130 today.

On the other hand, a total of 166 clinical trials had children or adolescents as patients. The paediatric area is also one of the fastest growing in Spain in recent years, with an increasing number of studies since 2016, when 108 trials with paediatric drugs were registered, 35% less than last year.

The necessary boost to early phases

Of the 906 trials published by REEC in 2022, more than half (525) are in the early phases of research, which are considered the most complex in clinical trials and whose promotion is a challenge in Spain, once its leadership in later phases has been consolidated.

“In recent years, Spain has become a world leader in clinical trials, thanks to the commitment of the pharmaceutical industry, which finances and promotes more than 86% of the studies, but also thanks to the strength of the health system, the high qualification of its professionals, pioneering legislation and increasingly involved patients”, says the Deputy Director General of Farmaindustria, Javier Urzay.

The companies established in Spain have the structure, experience, results and willingness to continue to grow and consolidate our country’s position as a benchmark,” he adds. The Strategic Plan for the Pharmaceutical Industry, which we are already working on with the Government after the meeting held last December in La Moncloa, will help us to provide Spain with the best environment to achieve this”, adds Urzat.

In line with the latest data provided by REEC, it is worth remembering that the introduction of Covid-19 led to an increase in the number of clinical trials in Spain during 2020 and 2021, making Spain the fourth country in the world and the first in Europe in terms of volume of studies against SARS-CoV2 and exceeding a thousand trials in these years.