Doctors and the industry are calling for a push to boost clinical research in healthcare centres in order to optimise treatments for the most common conditions and bring cutting-edge medicine closer to patients

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Jesús González, a GP at the Cabra Health Centre (Córdoba), highlights a paradox that exists in the field of clinical trials in our country: “Virtually all the medicines we use every day to treat the most common conditions have been brought to market on the basis of research carried out in hospital settings, with patients who have different characteristics to those we usually see in our surgeries.”

Clinical trials create a virtuous circle within the healthcare system because they open up new opportunities for patients – something particularly relevant in serious cases that do not respond to the available range of treatments – whilst also enabling healthcare professionals to participate at the forefront of scientific research and apply this knowledge to their clinical practice. Furthermore, they attract funding from the pharmaceutical companies sponsoring the trials.

For all these reasons, according to the experts, it would be highly desirable for clinical trials to be carried out in both hospital and primary care settings, so that as many patients and healthcare professionals as possible could benefit from them. “There is a huge disparity between the clinical trials carried out in hospitals and those carried out in health centres, despite the fact that the vast majority of clinical consultations take place in primary care,” warns González.

Spain’s leadership in clinical research is not yet reflected in health centres. According to data from Farmaindustria, in Spain barely 8% of clinical trials involving medicines involve health centres.

For medicines that are used much more frequently in primary care than in hospital settings – such as treatments for high blood pressure, diabetes, heart failure or chronic obstructive pulmonary disease, amongst other conditions – “studies carried out in primary care provide more representative (generalizable) results and are preferable to applying those obtained at other levels of care”, notes González. His health centre in Cabra currently has three active phase III clinical trials in the fields of cardiovascular medicine and pulmonology, with a strong focus on the cardiometabolic area.

Ease of recruitment in the waiting room

Ernest Vinyoles, a primary care doctor and coordinator of the Agency for the Management of Clinical Research in Primary Care — the IDIAPJGol network that manages clinical trials conducted in primary care in Catalonia, involving more than 300 professionals — emphasises that research and primary care participation in clinical trials is in its early stages.

Vinyoles highlights another advantage of conducting trials in primary care: the greater ease with which patients can be recruited at this level and the quality of the pre-selection process.

In an effort to improve the current situation, an initiative has been launched, promoted by Farmaindustria, the health authorities and primary care scientific societies, to revitalise clinical research at this level of care. This strategy began with the presentation of the ICAP Guide (Clinical Research in Primary Care) and the establishment of a working group, which is already yielding its first results with the recent launch of the first Map and the first Observatory of Clinical Research in Primary Care, developed in collaboration with the seventeen autonomous communities with the aim of raising the profile of clinical research carried out in health centres across the country.

Researchers working in groups and networks to achieve more

Jesús González and Ernest Vinyoles point out that, for research in primary care to cease being merely anecdotal, it is essential that all stakeholders (political groups, healthcare managers, healthcare professionals and the general public) gain a proper understanding of what pharmaceutical research entails, both for the healthcare system and for the population.

In particular, working in groups and networks is crucial, as it facilitates the optimisation of resources, as well as providing the opportunity to have a study coordinator to support the group. “Furthermore, it would be helpful to improve the availability of and access to specific online courses on conducting clinical trials, as there are very specific aspects of this type of study that are not covered in standard research methodology courses, such as training in good clinical practice, ALCOA criteria and how to conduct clinical trials in primary care (peer training),” says González.

According to Vinyoles, key areas for improvement include boosting professionals’ motivation, facilitating training, recognising this activity within professional development frameworks and, above all, ensuring that the demand for care is treated with due respect in order to reduce a workload that leaves little time for other activities.

Lack of awareness in outpatient clinics

Both specialists agree that, as far as the general population is concerned — with the exception of those patient groups suffering from very specific conditions for which there are few treatment options, such as certain cancer patients or those with rare diseases — there is very limited and biased understanding of what taking part in a clinical trial entails.

“In fact, it is still quite common that, when we ask them to take part in one of these studies, they ask us if we are asking them to be guinea pigs, believing that they will be exposed to a product that has barely been studied, and being sceptical from the outset about the safety of these studies. It would therefore be very useful to run campaigns to raise awareness of the different stages of new drug development, and the benefits and risks of taking part in late-stage clinical trials, prior to a drug’s market launch,” says Jesús González.

“Probably all those involved—from the authorities to the pharmaceutical industry, including healthcare professionals and the general public we care for every day—will agree that research is essential for providing safe and efficient healthcare. When it comes to research into the development of new medicines and clinical trials involving medicines in particular, it is clear to everyone that they are fundamental to the advancement of medicine and to improving the quality of life of our population,” concludes González.