Boosting clinical research in Primary Care, an opportunity for patients, professionals and the health system
Farmaindustria presents the ‘Guide of good practice recommendations for the promotion of clinical research in Primary Care’, which will bring new treatment opportunities to patients in health centres.
Spain’s leadership in clinical research at the hospital level is not reflected at the health centre level, where only 7.5% of studies are carried out.
“Clinical research in PC brings the trial closer to the patient, facilitates equity and improves the quality of these studies, especially in diseases treated at this level of care and at earlier stages”, stresses Jesús Ponce, president of Farmaindustria.
Malaga hosts the 1st National Conference on Clinical Research in Primary Care with the attendance of almost two hundred participants, including representatives of administrations, professionals, patients and the pharmaceutical industry.
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A clinical trial is a research study conducted in people to find out how a new medicine works against a disease. It is used to find out how effective a medicine is, whether it causes any unwanted effects or what dose provides the maximum benefit to patients.
Moreover, the clinical trial generates a virtuous circle in the healthcare system, because it opens up new opportunities for patients, especially relevant in serious cases that do not respond to the available therapeutic arsenal; it facilitates equity in access to medicines in the initial stages of research, while allowing healthcare professionals to participate in the scientific vanguard and also apply it to their healthcare work; it attracts funding from the pharmaceutical companies that promote the participating centres, and provides savings to the administrations.
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 any of those active in our country. This situation allows patients early access to treatments under investigation, which in many cases is the only option to alleviate their disease or improve their quality of life.
However, this situation is not reflected in primary care (PC). In recent years, only 7.5% of studies in Spain have involved at least one PC centre. And there has been a fall in the participation of health centres in these studies (2%) and a high concentration of participants at regional level in just a few autonomous communities.
Promoting the participation of research in this field is not only a necessity, but also an opportunity for the National Health System (NHS). The Guide of recommendations of good practices for the promotion of clinical research in Primary Care, promoted by Farmaindustria and presented this Thursday at the Official College of Doctors of Malaga in the framework of the 1st National Conference on Clinical Research in Primary Care, was born from this desire.
This working document has been made possible thanks to the selfless collaboration of more than 50 professionals who, representing all the autonomous communities, PC scientific societies, patient organisations and organisations and the pharmaceutical industry, have contributed to the publication of this guide.
Their contributions have made it possible to identify strengths, weaknesses, barriers and opportunities for clinical research with medicines in PC, which, in turn, have resulted in eight recommendations, based on successful experiences, whose implementation in the healthcare system will help to promote clinical trials in healthcare centres.
This impulse is particularly relevant at the present time, when the NHS is facing challenges such as the recruitment, motivation and retention of professionals in PC. In particular, the increase in cooperative trials between care levels is an opportunity to continue to strengthen Spain’s role as a preferential location for conducting clinical research with drugs at an international level.
As highlighted by the president of Farmaindustria, Jesús Ponce, at the opening of the conference: “Clinical research in primary care brings the trial closer to the patient, facilitates equity and improves the quality of these studies, especially in diseases treated at this level of care and at earlier stages”. “We must take advantage of the network of primary care health centres (more than 3,000 in our country), which provides enormous potential for leading clinical studies and represents an opportunity to bring clinical trials closer to patients’ homes,” he added.
In this regard, Isaac Túnez, Secretary General for Public Health and R&D&I of the Andalusian Regional Ministry of Health and Consumer Affairs, stressed that “clinical trials are the paradigm of public-private collaboration. We must take care of all the agents that make them possible, because they are the only opportunity for patients who have no other way out”.
Involvement of the Autonomous Regions, PC doctors, pharmaceutical companies and patients.
The Guide, which has been developed using a participatory methodology, has made it possible to contrast and enrich the analysis carried out by the group of experts with the contributions of professionals and those responsible for the different autonomous communities. Representatives from the Spanish Society of Primary Care Doctors (Semergen), the Spanish Society of Family and Community Medicine (Semfyc) and the Spanish Society of General and Family Doctors (SEMG) also participated, as well as experts from nine pharmaceutical companies.
Also noteworthy is the involvement of the heads of the Platform of Patients’ Organisations (POP), the Spanish Patients’ Forum and the European Patients’ Academy (Eupati). Their presence responds to the importance and value of patient organisations and entities participating in the entire process of research and development of new medicines. This was possible because patients and relatives, through their associations and representatives, have been demanding greater influence and decision-making capacity in R&D, and because pharmaceutical companies increasingly appreciate the added value that these groups bring to these activities.
Furthermore, in addition to the eight recommendations, the document includes a list of contacts for the management of clinical trials in PC in the different communities and specific examples of initiatives already implemented in some autonomous regions to promote research with medicines in PC.
All these issues and the value of the new Guidelines presented in Malaga were analysed in depth at the 1st National Conference on Clinical Research in Primary Care, which was attended by almost thirty specialists in the field and nearly two hundred experts, including representatives of administrations, professionals, patients and the pharmaceutical industry.
