Advances the strategy to promote clinical trials in primary care centres, which will bring new treatment opportunities to patients in Spain.
One year after the presentation of the ‘Guide of good practice recommendations for the promotion of clinical research in primary care’, promoted by Farmaindustria, successful initiatives have already been identified in different autonomous communities.
This work has become a ‘country project’, which aims to transfer Spain’s leadership in clinical research in the hospital setting to health centres, which currently only participate in 7% of the studies.
Santiago de Compostela hosts the 2nd National Conference on Clinical Research in Primary Care with the participation of more than a hundred experts including representatives of administrations, health professionals, patients and the pharmaceutical industry.
Farmaindustria.es
Spain continues to take steps forward to consolidate its leading position in clinical trials on the European and international stage. And it is doing so thanks to the impetus and collaborative work carried out to promote biomedical research in Primary Care (PC), especially in the last year, which has become a national project in which the Spanish Medicines Agency (Aemps), health research institutes accredited by the Carlos III and more than 50 professionals representing all the autonomous communities, PC scientific societies (Semfyc, SEMG, Semergen, AEP, Aepap, Sepeap), entities and patient organisations and the pharmaceutical industry are contributing.
This was made clear at the 2nd National Conference on Clinical Research in Primary Care, organised by Farmaindustria and held this Tuesday in Santiago de Compostela in the presence of the Galician Minister of Health, Antonio Gómez Caamaño. ‘Research is the main tool we have to generate knowledge, and knowledge is what allows us to progress in order to provide more health for the population. Research means prestige and access to new medicines. Research also allows us to transfer economic wealth, which translates into social welfare. And research is essential to boost PC care. It is known that health centres with good research and teaching are centres that produce better care, and this is undeniable. That is why the Regional Ministry of Health will support any initiative that has to do with promoting research’, said Gómez Caamaño at the inauguration of the conference.
Spain currently has more than 4,000 studies underway – eight out of ten are promoted by the pharmaceutical industry – and some 170,000 patients participating in some of them. This situation makes it easier for patients to access research treatments at an early stage, when, in many cases, it is the only option to alleviate their disease or improve their quality of life. However, this remarkable development ‘is not reflected in the primary care setting. Between 2020 and 2024, 328 clinical trials were launched in which at least one primary care centre participated, which represents only 7.4% of the total number of trials promoted by the industry in that period (4,456)’, recalled Farmaindustria’s vice-president, Cristina Henríquez de Luna.
‘The challenge is great, but so is the will of those of us who are part of this project. That is why we want to continue working with the government, the healthcare system, the scientific community, patients and society as a whole to put medicines in their rightful place and define the right strategy so that Spain and its patients can have the latest therapeutic advances at their disposal to improve their lives and those of their families,’ Henríquez de Luna stressed. ‘We are convinced that this work will help us to promote clinical research in PA, to which the pharmaceutical industry is very committed to launching clinical trials in vaccines and in the cardiovascular, infectious and immunology areas, among others,’ he added.
Successful initiatives
One year on from the presentation by Farmaindustria of its Guide of good practice recommendations for the promotion of clinical research in Primary Care, the main advances and successful initiatives carried out by the different agents in accordance with the work plan established by the promoters of the guide over the last year have been shared. For example, the development of regional strategies, training and patient involvement initiatives, decentralisation projects and the digital transformation of clinical trials through telemonitoring, real-life outcome measurement (RWE) and process improvement. While it is true that the level of implementation of the recommendations of the Guidelines is different in each autonomous region, all of them have welcomed the project with great interest and are developing it at different speeds.
As reported by Farmaindustria’s Director of Clinical and Translational Research, Amelia Martín Uranga, the company is also working in collaboration with the Carlos III Health Institute and Health Research Institutes, as well as with the Network of Clinical Research Management Entities (Regic), which encompasses most of the R&D&I management entities in the bio-health field and represents a high percentage of clinical research in the country. These entities not only work together to streamline administrative management, but also on the need for a one-stop shop, a map of researchers and centres, the promotion of network trials, as well as other issues related to the training of research and management teams.
A catalogue of training activities has also been drawn up, promoted mainly by health institutions and scientific societies of doctors at this level of care, of which there are already more than thirty. ‘This catalogue is the starting point to advance in a common training programme that can be adapted to the different agents. The involvement and contribution of research organisations, professionals, patients, health administrations and pharmaceutical companies has been key to the great progress made this year. There is still a lot of work to be done, but the foundations we are building are solid, which will allow us to take advantage of the opportunity offered by our country’s leading position in clinical trials,’ said Arantxa Sancho, Director of Farmaindustria’s Medical-Scientific Affairs Department.
An opportunity and a necessity to gain competitiveness
In fact, in addition to the opportunity it represents for patients, the NHS and society in general, Spain needs to promote clinical trials in PA because Europe is losing competitiveness. ‘To achieve excellence, we need to be agile and efficient in terms of approval times, initiation and patient recruitment to avoid losing competitiveness against the United States and Asia, identifying bottlenecks and simplifying regulation,’ said Martín Uranga.
This is precisely one of the recommendations made in the Draghi Report – commissioned by the European Commission to the Italian economist and former president of the European Central Bank, Mario Draghi, to assess the state of Europe’s competitiveness in comparison with other regions of the world – which recognises the worrying trend of the continent losing ground to other regions of the world and highlights the contribution of the pharmaceutical industry to R&D and the EU’s balance of trade.
In this regard, the promoters of this project to promote clinical research in PC have already drawn up an action plan for 2025, which has more than ten lines of development, including continuing to promote the creation of working groups in the autonomous communities and the creation of catalogues of centres interested in conducting clinical trials; working on the map of clinical research activity in PC and disseminating it; promoting the identification of trials in PC within the framework of the Spanish Clinical Trials Register (REEC); starting up the ICAP Observatory to develop specific strategies, and trying to establish a coordinated training programme adaptable to each region, centre, scientific society, etc.
The 2nd National Conference on Clinical Research in Primary Care, held at the headquarters of the Galician Ministry of Health, was attended by more than thirty specialists in the field and more than a hundred experts, including representatives of administrations, healthcare professionals, patients and the pharmaceutical industry.
