Source: farmaindustria.es
In recent years, Spain has established itself as a world leader in clinical trials, with 85% of them promoted by the pharmaceutical industry, according to the latest data from the Spanish Clinical Trials Register (REEC) at the end of November 2022. However, the excellence achieved in Spain in clinical research in hospitals has not followed the same trend in primary care, where from 2004 to 2021 participation in clinical trials has fallen from 14% to 7.5%.
To reverse this trend, Farmaindustria has promoted the creation of a mixed working group on clinical research in primary care, with the participation of the scientific societies of this level of care, researchers, autonomous communities and pharmaceutical companies. The aim is to analyse current strengths and weaknesses and define a roadmap to establish criteria of excellence for conducting clinical trials with medicines at this level of care, as well as to identify good practices that are already underway.
The first meeting of this group was held this Thursday at Farmaindustria’s headquarters in Madrid, with the participation of the Association’s Deputy Director General, Javier Urzay; the Director of the Department of Relations with the Autonomous Communities, José Ramón Luis-Yagüe, and the Associate Director of Clinical and Translational Research at Farmaindustria, Amelia Martín Uranga. Representatives from the three primary care scientific societies – the Spanish Society of General and Family Physicians (SEMG), the Spanish Society of Primary Care Physicians (Semergen) and the Spanish Society of Family and Community Medicine (Semfyc) -, from foundations and research institutes, and from the administration of five autonomous communities and eight pharmaceutical companies also attended.
In addition to extending Spanish excellence in clinical trials to primary care, this project facilitates bringing clinical trials closer to the patient in a context of proximity to their doctor. In this way, it can respond to the necessary decentralisation of clinical research, with the possibility of providing greater equity of access to all patients, regardless of where they live. This can be of great interest for Phase 3 clinical trials – the last phase before a drug is put on the market – where thousands of patients are recruited and a large number of centres are involved.
It can also be particularly useful for certain diseases that are treated at this level of care, such as cardiovascular, inflammatory or respiratory pathologies, among others. Moreover, these diseases are usually diagnosed and treated in primary care at earlier stages and with a large number of patients, which can facilitate their recruitment for clinical trials in these therapeutic areas.
In addition, promoting the participation of primary care in clinical research offers the opportunity to increase the number of cooperative trials between care levels, coordinated between health centres and hospitals, in areas such as rheumatology, oncology and endocrinology, among others.
This project is an opportunity for a country that already leads clinical trials in Europe, and this participation in research is a stimulus for the training and retention of primary care professionals, while at the same time offering an opportunity for patients to access treatments that can change the course of the disease. It thus promotes social and territorial cohesion and equity in our country.
Research in primary care also requires, as was addressed at this first meeting, the need to train professionals in this area, to provide the centres with resources to enable research and to achieve good coordination with the regional health authorities.