‘Clinical trials in primary care improve patients‘ health’.
Farmaindustria and Levante-EMV hold a meeting with experts to discuss the creation of the ‘ICAP Guide’ of good practices for the promotion of clinical research in Primary Care.
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Spain is a leader in clinical trials with medicines, with 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 those active in our country.
Patients are the main beneficiaries of these trials, because thanks to them they can have early access to the most innovative, as yet unauthorised treatments, which in certain serious pathologies and when other treatments have failed can mean survival itself.
However, this biomedical research is usually carried out in hospitals and primary care, the health centres, are left out. In recent years, only 8% of studies in Spain have involved at least one primary care centre, and the trend is downward.
In an attempt to reverse this situation, Farmaindustria, the association representing innovative pharmaceutical companies in Spain, launched a project a few months ago to promote this research in health centres from a public-private collaboration approach.
From this desire, the Guide of good practice recommendations for the promotion of clinical research in Primary Care (ICAP Guide) was born. To find out more about this project, as well as the possibilities of our region in this type of biomedical research, Levante-EMV and Farmaindustria held the meeting ‘Transforming Primary Care through clinical trials’ on Wednesday 11 December.
‘We are facing an exciting national project which, in order to set it in motion, we created a mixed working group with the different representatives of the healthcare sector and when we had this guide ready, we consulted with the heads of the 17 autonomous communities’, explained Amelia Martín, Director of Clinical and Translational Research at Farmaindustria, in a round table discussion led by Silvia Tomás, Director of Institutional Relations at Prensa Ibérica in Valencia.
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According to Amelia Martín, the working group began on 1 December 2023 and on 5 November 2024 the second national conference was held. ‘It is time to commit to clinical research in primary care, in the European Union we maintain hospital leadership, but the same does not happen in health centres’.
‘In this government team there is a specific directorate general for Primary Care, which was a declaration of intent on the part of the Generalitat and the Conselleria de Sanitat,’ said Mariola Penadés, director general for Innovation and Research of the Conselleria de Sanitat, who stated that there are many challenges that are still unresolved. ‘This is a year to build strong foundations, to increase the capacity for action of primary care, to optimise this care, the consultation time of doctors is limited and the experience of citizens is declining, it is a priority that this care improves’. When this improves, according to Penadés, a specific strategy for clinical research in primary care will be drawn up.
Benefit for patients
For Javier Díez-Domingo, head of vaccine research at Fisabio, research in primary care ‘is fundamental’. ‘If we only do clinical trials in hospitals, we are developing drugs for complex cases and we forget about the person who starts their diagnosis and the management should be different from the person with a more advanced disease. Therefore, developing drugs for primary care patients is essential, because they can not only treat them but also prevent them from reaching hospital, as in the case of diabetes, and therefore improve their quality of life,’ said the doctor.
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The meeting also served to describe the benefits for patients of participating in clinical trials. ‘If a patient participates in a clinical trial with a drug that is being developed for their level of disease, and that they can possibly control with few side effects, they will benefit from that drug long before it is authorised,’ he explained.
Díez-Domingo also provided data from a UK study showing that patients in clinical trials and patients whose doctors participate in trials have a much better health outcome than other patients. ‘Participating in a trial is already predisposing you to a better health status because you are being treated with innovative drugs and with stricter monitoring of your pathology and more continuous support from the research team than if you don’t participate,’ the researcher said.
‘I have 30 years of experience doing clinical trials with vaccines and I am proud of the number of patients who have avoided disease thanks to their participation in clinical trials. We estimate that we have avoided 10-20 shingles and some meningitis,’ he added.
Therefore, the value that Javier Díez gives to the Farmaindustria guide is ‘total’ as it reflects the need for clinical trials in primary care and the possibility of doing them. ‘It provides measures so that this research in the Valencian Community, which was extraordinary fifteen years ago, can be recovered by analysing today’s society’.
For Mariola Penadés, one of the strengths of the guide is ‘order’. ‘One of the things the guide does is to organise and bring together very valuable information from different sources, with more than fifty professionals from all the autonomous communities. It puts on the table in a structured way not only the background and the state of the situation, but also suggestions for global and local strategies’. In this way, for the Director General for Innovation and Research, global strategies are important in order to have a ‘national project’, but also local ones in order to ‘bring them down to each community with its particularities’.
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Penadés explained that in one year, they have tried to ‘improve the conditions of researchers in the Valencian Region’ with the publication of a Decree Law on 20 March that establishes professional categories ‘in a pioneering way in the entire national panorama, for each of the research ranks with equitable salaries’. ‘All this is tilling the soil well so that both in primary care and in research we can continue to move towards the path we want,’ he added.
More advanced communities
Another of the aspects highlighted by this meeting is that not all the regions are at the same point. Amelia Martín highlights Catalonia with a network that is ‘very well structured and very agile in the management of research’. In fact, according to Martín, 50% of the clinical research carried out in primary care is done in centres in Catalonia. ‘The aim is to decentralise and take the model to other communities. Andalusia is another leading region. ‘It has established a roadmap to attract more clinical trials in primary care and this is beginning to be noticed. There is also great interest in Galicia and we are starting to see a movement at different levels.
‘When there are researchers like Javier in the community, it is much easier to promote this research, because you have the people, Farmaindustria can take the lead, but we need the people to carry out the project’. Likewise, the Director of Clinical and Translational Research at Farmaindustria defended public-private collaboration as a guarantee of success. ‘The way we work in our country, with mixed working groups, are forms that do not yet exist in other countries’. This collaboration will continue in 2025 with the aim of making clinical trials in primary care a reality throughout Spain.
