Source: farmaindustria.es
In the 18th century, sailors died of scurvy during long voyages by ship. In search of a solution, Scottish physician James Lind tested different treatments in 1747 in what is considered the first clinical trial of the modern era. Since then, 276 years have passed and clinical research has only grown in importance: it is the last and fundamental step in proving the safety and efficacy of new treatments that allow medicine to advance.
20 May, the day Lind selected patients to test the best treatment for scurvy, is the date chosen to commemorate International Clinical Trials Day. “These studies are a hope for today’s patients and will allow us to have the drugs of tomorrow,” explains Amelia Martín Uranga, associate director of Clinical and Translational Research at Farmaindustria.
In recent years, Spain has strengthened its leadership in clinical trials, which allows Spanish patients to access treatments still under investigation at an early stage, and to benefit from their effects. In some cases, participating in a trial is their only therapeutic option.
Spain launched more than 900 clinical trials in 2022, according to data from the Spanish Clinical Trials Register (REEC), a figure that is on the rise and exceeds pre-pandemic levels, with a special focus on cancer, followed by neurological and immune system diseases. “Another area where more clinical trials have been registered is in rare diseases. One out of every four trials being developed in our country is already with orphan drugs, which is especially valuable if we take into account that for the vast majority of rare pathologies there is still no treatment available,” reports Martín Uranga.
The pharmaceutical industry plays a leading role in this field, as it finances 86% of clinical trials and 96% in the case of rare diseases, according to REEC data. In the case of paediatric clinical trials, the industry promotes 88% of the total, a figure that increased by 24% in 2022.
The clinical trial is one of the best examples of how by joining forces with the same objective – which is none other than to achieve new drugs to improve people’s health – very diverse agents are capable of generating a virtuous circle that benefits society as a whole, although these benefits are sometimes little known. Our National Health System, the high level of training of healthcare professionals and their commitment to research, an active group of patients, the sensitivity of the Health Administration, through the Medicines and Health Products Agency (AEMPS), and the strong commitment of pharmaceutical companies are what make this Spanish leadership in clinical research possible: Spanish hospitals now participate in three out of every ten trials carried out in Europe.
However, patients are undoubtedly the cornerstone for the development of new treatments. Currently, some 170,000 Spaniards are participating in an active clinical trial, according to pharmaceutical industry estimates. “The participation of patients in clinical trials is a great demonstration of altruism, solidarity and generosity, as well as a hope and a benefit for many of them,” says Martín Uranga, who adds that “research cannot be done only for patients, but with patients.
“Our goal for more than a decade has been to work with patient organisations in R&D activities for new medicines to improve their involvement, because patients should be part of the whole process of developing what will be their treatments. The progress we have made shows us that we are on the right track to continue responding to their needs,” he says.
In this regard, in recent years Farmaindustria has published two guidelines with recommendations to improve patient participation in clinical trials, one for adults and the other for children and adolescents, which aim to ensure a better experience for patients and contribute to further orienting research to their needs, which will have an impact on the quality of research.
Spain has consolidated its leadership in clinical trials in recent years and is confidently facing new challenges, such as adapting to the new European Regulation on clinical trials, the need to promote cross-border clinical research and the decentralisation of trials with the aim of bringing them closer to the patient’s home.