Collaboration between the healthcare system and the pharmaceutical industry, key for Spain to consolidate its leadership in clinical trials

Representatives of the Spanish Medicines Agency, patient associations, hospitals and the pharmaceutical industry debate in a webinar on how to promote clinical research in Spain
Measures forced by the pandemic such as sending medication to the home or monitoring trials remotely, possible advances for the future

Promote clinical research in primary care and in the CCAA with less activity, among the opportunities to continue advancing

Source: www.farmaindustria.es

Spain is a reference country for conducting clinical trials of new drugs, as has been demonstrated in the research effort deployed to deal with the current coronavirus pandemic. This was revealed in the webinar “How to promote research in Spain”, which brought together representatives of patient associations, hospitals, the Spanish Agency for Medicines and the pharmaceutical industry on Tuesday at a meeting organized by the New Medical Economics magazine with the collaboration of Farmaindustria.

It was highlighted that currently in Spain there are 82 clinical trials underway on the efficacy of drugs against Covid-19 and up to a hundred other observational studies on the disease. “These figures place our country in the leading group of clinical trials on coronaviruses worldwide and confirms the fact that Spain has long been a world reference country in clinical research,” said Amelia Martín Uranga, head of the Platform of Pharmaceutical Industry Innovative Medicines. “This very high number of trials against Covid-19 has been possible thanks to the work and agility of the Spanish Medicines Agency,” he explained, to the public commitment to research and to the role of numerous pharmaceutical companies established in our country that they coordinate these trials or collaborate in others of public initiative, providing the necessary medication.

In fact, today up to one in three of the clinical trials carried out in Europe with new drugs has Spanish participation. “This leap in medical research has been possible thanks to the existence of a solid healthcare system; the prestige of Spanish researchers and doctors; administrations and an industry committed to R&D, and patient organizations increasingly involved, “said Martín. “In any case,” she added, “in a context of strong international competition, we have to think of new strategies to maintain and, where appropriate, strengthen Spain’s progress in this area.”

The meeting was also attended by María Antonia Serrano, head of Clinical Trials of the Spanish Agency for Medicines and Health Products (Aemps); José Soto, managing director of the Hospital Clínico San Carlos, Madrid, and Carina Escobar, president of the Platform of Patient Organizations. The participants highlighted the fact that Spain was the first European country to apply a large part of the new European regulation on clinical trials thanks to the entry into force of the new Royal Decree on Clinical Trials of 2015. The role of the Spanish Registry of Clinical Trials (REEC), which allows the identification of all clinical trials launched in Spain since 2013, with information on participating promoters and centers and which encourages collaborations between researchers and promoters, as well as greater information for patients.

Opportunity to attract investment

During the talk, the opportunity for Spain to be in this privileged position in carrying out these tests was revealed. “In this health crisis, the need to bet on sectors that generate knowledge has been seen, and investment in research can provide us with that leap in quality to improve our patient care and also attract investment to our country in the field of R + D, a fact that may also be essential to reactivate our economy, “said Martín.

The participants agreed to highlight that some of the changes that have occurred during these months in the conduct of clinical trials due to the pandemic, such as the delivery of medication to patients’ homes or remote monitoring of trials with verification of Source data is a step in the right direction and some of these measures may continue to be in place after the health crisis.

In this sense, some of the opportunities that Spain has to continue consolidating its international reference role in clinical research were put on the table, such as the promotion of research in primary care (vaccines and phases III of some pathologies); the commitment to testing in autonomous communities that are currently below what would correspond to them; attracting more initial phases of trials (a greater challenge for researchers and more options for early access to the drug by patients); more adaptive tests (with flexible designs, more typical of precision medicine), and reinforce qualitative and quantitative metrics that help to identify areas for improvement, to be more predictable and to gain in competitiveness. In short, Spain is prepared to respond to the scientific and organizational challenges that have become apparent in recent weeks, it is all a matter of commitment and intensifying collaboration between public and private initiative.

At Distefar we believe that close collaboration between the healthcare system and the pharmaceutical industry is essential to promote clinical research in Spain.