Spain, a clinical trials powerhouse
Spain is at the forefront of research. Experts discuss the potential of new medicines at a forum organised by EL PAÍS and Farmaindustria.
Elpais.com
In the European panorama of clinical trials for new drugs, Spain stands out as a benchmark. Of the 2,500 trials carried out in the region last year, 45% were conducted in Spanish research centres. This strength comes after years of collaborative work between health authorities, research hospitals, patients and pharmaceutical companies. After the USA, Spain is the second country in this field and participates in one out of every three trials launched in Europe. To maintain this position, we must remain alert, continue to invest in R&D and overcome the existing gap between public research and its translation into clinical phases.
Leadership is due, to a large extent, to the solid healthcare structure: not very fragmented and with a strong presence throughout the territory, said Javier Padilla, Secretary of State for Health, during the event organised this week by EL PAÍS and Farmaindustria. “There is something that is in our idiosyncrasy, that is in the DNA of our country, which is the structure of our national health system,” said Padilla. The cohesion of the system, the secretary added, allows for the high accumulation of data, which is essential to identify patterns and trends in patient response to treatment, as well as providing critical evidence on the safety and efficacy of the tests or interventions under study.
Spain, according to Padilla, cannot miss the opportunity and must continue to make progress in clinical research. “We must have the capacity to assemble this leadership in R&D with a leadership that also extends to the field of drug production and continue with the entire chain, which would be related to access and sustainability,” he emphasised. Collaboration between key sectors is essential to boost an industry that could spearhead an entire sector. He also indicated that Spain has the capacity to continue advancing in precision medicine, such as advanced cell therapies. Regulatory adaptation is key to taking this step forward.
Juan Cruz Cigudosa, Secretary of State for Science, Innovation and Universities. PABLO MONGE
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“Today no one doubts the value of clinical trials any more,” said Juan Cruz Cigudosa, Secretary of State for Science, Innovation and Universities. During the health crisis, the country emerged as a leader in clinical trials against covid-19 in Europe. This milestone, as Cigudosa described it, was “probably the biggest scientific project in history”, which highlighted the value of collaborative science and innovation. However, Cigudosa identifies two key challenges. The first is the transfer of science produced in Spain into tangible solutions for society, and the second is to convert clinical research into innovations produced in the country. “We need industry,” he stressed. In response to these challenges, he said that collaborative instruments have been put in place to promote scientific and clinical activity. “Without science there is no future and we are working on it.
“We are world leaders,” added Juan Yermo, director general of Farmaindustria. This position has been achieved thanks to years of working together with the public administration and the national and European medicines agencies, which have streamlined processes to enable the development of various projects, said the industry representative. Currently, there are between 4,000 and 5,000 projects underway and some 170,000 people participating in any of the active projects. The healthcare professionals and patients who have placed their trust in these projects have been fundamental in achieving this milestone, Yermo stressed. “And, of course, the pharmaceutical industry itself has been key, as it supports 90% of the funding for the trials.
“We have arrived through hard work, effort and collaboration,” stressed María Victoria Mateos, haematologist at the University Hospital of Salamanca and president of the Spanish Society of Haematology and Haemotherapy (Sociedad Española de Hematología y Hemoterapia). “When I explain this to participants in clinical trials, I start with one sentence: the process that a drug takes from the time it is discovered to the patient’s home, to the patient’s medicine cabinet, is a long, complex and expensive process,” she added.
For her part, Raquel Yotti, commissioner of Perte (strategic project for economic recovery and transformation) for Vanguard Health, commented that a greater effort should be made to extend clinical trials beyond the main cities. “They are still concentrated in large cities, in Madrid and Barcelona,” he said. The promotion of decentralised and networked clinical trials represents a bold step towards democratisation and access to therapeutic innovation. Decentralisation, Yermo explained, is happening thanks to remote monitoring, telemedicine. “Using more digital tools to allow patients from different parts of Spain to participate in the clinical trial,” he said.
Networked clinical trials, on the other hand, are conducted through collaboration and coordination between multiple healthcare sites, such as hospitals, clinics and research centres. Rather than being confined to a single site, they are conducted simultaneously at multiple sites that are interconnected to share data, resources and participants. “Networked trials are absolutely necessary, although they are not easy to implement, because it means investing in training for the professionals at the satellite sites,” Mateos argued.
Javier Padilla, Secretary of State for Health. PABLO MONGE
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