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  • Clinical Trials
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Spain, before a historic opportunity in the commitment to clinical trials

Source: Farmaindustria.es

Have highly qualified, motivated and experienced professionals, have the ability to achieve patient participation and have processes digitized as electronic medical records. These are some of the main requirements that must be met by hospitals seeking to become centers of excellence in clinical research, according to representatives of Farmaindustria on Thursday in the conference Towards excellence in biomedical innovation, organized by the Institute for Development and Integration of Healthcare (IDIS) and held at the HM Sanchinarro University Hospital, Madrid. Other essential factors for hospitals to perform clinical trials with the highest quality guarantees are the ability to process all documentation with agility and efficiency, having a pharmacy service very involved and committed to clinical research, have an adequate risk monitoring methodology and have adequate facilities for the whole process. On these bases, the general director of Farmaindustria, Humberto Arnés, celebrated the “great effort that have made in recent years l Spanish hospitals, both public and private, to be at the forefront of clinical research, aware of the multiple benefits that trials can bring to the centers themselves, to professionals and, above all, to patients. “” That bet , which adds to the impulse experienced in Spain in preclinical research -he pointed out-, has found the right response in the pharmaceutical industry, which has broken its historical record in investment in R & D with almost 1,150 million in 2017. ” “Of that number,” he added, “almost 700 million are allocated each year to the implementation of clinical trials in our country, which are developed primarily in collaboration with hospitals and both public and private centers. And of those trials, more than half (52%) are already in the early stages, which are the ones with the highest level of complexity, which gives an idea of ??the leap in quality that Spain has made in this field in recent years.
Arnés highlighted the joint effort of the agents involved (Administration, hospitals, researchers, clinicians, patients and industry), thanks to which Spain has managed to be in the leading group of clinical research in Europe (three out of ten trials in the continent already has Spanish participation) and international reference, and encouraged to persevere in this commitment to biomedical research in general and clinical research in particular. “A country bet,” he said. And not only for the future; also present. “” Clinical trials, “he explained,” generate a virtuous circle that translates into an immediate return for Spanish healthcare: one, they attract economic investments for health centers and savings; two, bring reputation and experience to health professionals, who add their research work to the care, and three, most importantly, generate new hope for patients, who, thanks to the trials, can have access to early state-of-the-art treatments, which in certain pathologies can mean survival itself, especially when previous treatments have failed. “Together with this reality, an opportunity opens up for Spain that Arnés described as historic:” The work done in recent years It puts us in a privileged position to become one of the world leaders in this field. We have magnificent health centers; we have highly qualified health professionals and international experience; patient organizations are contributing information to facilitate participation in the trials, and we even have, thanks to the Administration’s vision, a standard that streamlines the procedures for implementation. “” The commitment of the pharmaceutical industry is clear, “he said. Much remains to be done, but we must take advantage of this competitive advantage to, with the collaboration of all and an ambitious strategic vision, take the big leap to which we are called and thus put in value all the knowledge and experience we accumulate. ”

Participation of private centers

The general director of Farmaindustria also referred specifically to the growing participation of hospitals and private centers in clinical research: “In recent years has increased significantly the percentage of clinical trials that have the participation of a center private sector, which now stands at 48.5%, compared to 36.4% a decade ago “.

Together with the greater presence of private hospitals in the whole of clinical research, it should be noted that these centers also have “a high participation in the initial moments of the investigation”, according to Amelia Martín Uranga, head of the Platform for Innovative Medicines. of Farmaindustria, in one of the round tables of the day. “Some of them are already prepared to respond to the new designs of clinical trials and the demands of the pharmaceutical industry in this area,” he added.

Likewise, the private centers have a start-up period for clinical trials of 135 days, that is, 10 days less than the average of public hospitals, and they are also more agile when achieving the participation of patients in the trials, on all from the entry into force, in 2016, of the new Royal Decree that regulates this field of research.

In Distefar we echo this news that explains that clinical trials generate a virtuous circle that translates into an immediate return for Spanish healthcare.

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