“The pandemic has shown that more Autonomous Communities can host clinical trials of drugs, which is hopeful for many patients”

More than 50% of the trials with new treatments are currently concentrated in Madrid and Barcelona

Spain, a benchmark in clinical research, should also bet on greater digitization in these studies to gain competitiveness, says the associate director of Clinical and Translational Research at Farmaindustria

Source: www.farmaindustria.es

Before the pandemic, Spain was already a world reference country in clinical drug research, and after that it has consolidated this position, becoming the first country in Europe in number of clinical trials against coronavirus and the fourth in the world. “This prominent position of Spain on the world map is the result of the collaborative work carried out for years by health administrations, hospitals, researchers, ethics committees, patients and the pharmaceutical industry. For many large companies, our country is the second in the world where more clinical research is carried out, only behind the United States, and this allows our hospitals to participate in the most cutting-edge international trials, which benefits our patients above all ” . This was highlighted by Amelia Martín Uranga, Associate Director of Clinical and Translational Research at Farmaindustria, in the Colloquium Clinical Research: What did we learn from the pandemic ?, organized by New Medical Economics, with the collaboration of Farmaindustria.

Now is the time, he assured, to take advantage of the best practices and lessons learned in this context of the health crisis to continue working towards greater openness and try to make the drug R&D process more efficient, with its new challenges and greater requirement from the scientific and regulatory point of view. “And in this field Spain is facing an unprecedented opportunity; not only as a sector, but as a country, since there is scope to strengthen and promote this research ”.

According to Martín Uranga, the real challenge is to increase the participation of the autonomous communities that carry out clinical research in their hospitals. “Currently, more than 50% of clinical trials with new drugs are concentrated in Madrid and Catalonia, but the pandemic has shown that this research can be done in more hospitals. And we have to take advantage of it, because in many cases we are talking about the lives of patients. It is not fair that one patient can access a trial, which can save his life, just because of her zip code and another does not have that opportunity, “she explained.

This greater participation of the rest of the autonomous communities in clinical trials, she added, involves incorporating hospitals and health centers of medium or small size into clinical research, which would result in an increase in the recruitment capacity of Spanish patients. “It involves investing so that the centers have support services for clinical research, because conducting clinical trials is a complex task that requires specialized resources,” she insisted. This expansion of the number of patients in trials would also achieve greater territorial cohesion in Spain, one of the objectives, she recalled, of the Strategic Project for the recovery and economic transformation (Perte) Salud de Vanguardia, approved these days by the Government.

Bet on digitization to gain competitiveness

Furthermore, the representative of Farmaindustria explained that, given the existing international competition in this field, Spain must bet on a greater digitization of clinical trials: “Spain has been in recent years a very interesting country to carry out clinical research, due to its legislation , the high scientific level of researchers and the commitment of patients and pharmaceutical companies to attract research. Now is the time to introduce greater innovation also in the processes of clinical trials, in the operational part and to move towards more decentralized models focused on the patient. And here digitization is what can help us ”.

There are already countries such as Denmark, Sweden and Switzerland that are working in this line, she added: “We at Farmaindustria have also set up a working group to advance changes in the operation of the trials, not only in the scientific part. We need to introduce new elements, some already tested satisfactorily during the pandemic ”. Among these improvements in digitization, already proven with success, the remote monitoring stands out, with the possibility of combining visits to the hospital of patients in trials with virtual consultations; the use of electronic informed consent models, as well as the possibility of taking the medication home to patients through nursing services, instead of going to the hospital for it, or taking advantage of the use of new mobile applications.

“It is time to innovate in the most operational part of clinical trials, taking into account the needs of the patient and always taking into account privacy and data protection”, summarized Martín Uranga.

Juan Estévez, Head of Service in the Agency’s Clinical Trials Area, also participated in the colloquium, held via telematics and moderated by José María Martínez, president of New Medical Economics.

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