Spain, a country of reference in conducting clinical trials

Via: www.immedicohospitalario.es

Clinical trials mobilize financial resources, allow health professionals to add research experience to their care activity and provide patients with early access to new treatments.

This Thursday, May 20, the Clinical Trial Day is celebrated around the world. The pandemic has brought this concept closer to the general society, increasingly familiar with the importance of these studies, as they are the last step to demonstrate the efficacy and safety of a treatment that could change the lives of many patients or, as is being seen with Covid-19, of the world population.

The collaborative work between the Administration, the system and health professionals, patients and pharmaceutical companies, in short, between the public and private initiative, “has made Spain a benchmark country in conducting clinical trials,” explains Javier Urzay, deputy director General of Farmaindustria and co-president of the Technological Platform of Innovative Medicines-. The great research mobilization to seek a therapeutic solution against the coronavirus confirms this reality, the result of years of previous work in other therapeutic areas “.

1,019 approved studies

In fact, Spain has become the fourth country in the world and first in Europe in clinical trials against the coronavirus. Pharmaceutical companies and hospitals in Spain are currently participating in more than 170 studies of potential treatments and vaccines, in around 170 Spanish hospitals, public and private, which have managed to involve some 28,000 patients.

This impulse, linked to the pandemic but also to the research effort of innovative companies in the rest of the therapeutic areas, has allowed the record number of a thousand clinical trials authorized by the Spanish Agency for Medicines and Health Products to be surpassed in 2020 ( Aemps). Specifically, of the 1,019 approved studies, 34% correspond to drugs to treat different types of cancer, followed by trials for Covid-19. “Once again, the collaboration between the health administration, through the Aemps, clinicians and researchers, patients and pharmaceutical companies has been key not only to respond quickly to the launch of treatment trials against Covid-19 – Urzay points out – but so that the crisis, with the collapses in the hospitals and the confinement measures, would not slow down research in non-Covid pathologies. It is a success of all that shows the solidity of the Spanish model of clinical research “.

713 million euros dedicated to clinical studies

The pharmaceutical industry based in Spain, which promotes eight out of ten clinical trials, dedicates 60% of all investment destined to R&D of new drugs to this activity. Of the 1,211 million that were invested in 2019 -the historical maximum-, more than 713 were dedicated to clinical studies, according to the latest Survey on R&D Activities that Farmaindustria carries out each year among its associates. Likewise, investment in research carried out by the pharmaceutical industry in this phase has increased at a cumulative annual average rate of 4.8% in the last 10 years.

It is especially relevant that, of those 713 million invested in clinical research, 36.5% already correspond to early phases (I and II), and this proportion is constantly growing. In fact, according to the latest data from the BEST Project, an initiative of Farmaindustria to promote clinical research in Spain, 56% of the trials promoted last year by pharmaceutical companies in our country already correspond to the early phases. It is a great boost to position Spain as an international reference in the field of early clinical research, as it already is in later phases.

Quality for the healthcare system and opportunities for patients

The most important aspect of this reality is the multiplication of opportunities for patients. In the last decade, Spain has participated in more than 3,400 clinical trials, in which 145,000 patients have taken part. “They are Spanish patients who are being treated with what will be the drugs of the future,” says Javier Urzay. “And this early access of patients to new treatments – he adds – is even more important in cases of serious pathologies that have not responded to the therapies already approved, since it may be the last chance to cure or control the disease” .

Along with the value for patients, clinical trials imply investment of resources in the health system and contribute directly to improving its quality, since they help health professionals be at the scientific forefront and can transfer that research experience to their care work.

The solidity of the health system in Spain, the high qualification of health professionals, the growing involvement of patients and the strong commitment of pharmaceutical companies are some of the keys to the positive evolution, to which Urzay adds the commitment of the Administration sanitary, which has endowed our country with a very agile regulation. In fact, agility, he emphasizes, is another proof of Spanish leadership. Thus, as indicated by the data from the BEST Project, at the end of 2020, the improvements made in the dynamics for conducting clinical trials, such as the digitization of processes, have made it possible to significantly reduce both start-up times and deadlines. of signing contracts between companies and hospitals, going from 175 to 154 days and from 104 to 92 days, respectively, compared to 2019. The reduction of these deadlines has only one purpose: earlier access of patients to promising therapies , which is the ultimate goal of any clinical trial.

This reality, insists the representative of Farmaindustria, should encourage us to continue working, based on cooperation between public and private initiative, and define an appropriate strategy to make Spain a pole of attraction for international investment in biomedical research: “We have the knowledge and experience to make a significant leap.”