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Spain has become a continental powerhouse in clinical trials, the studies and research involving patients that make it possible to assess the efficacy and safety of a new drug or diagnostic or therapeutic procedure, usually the last step before it is authorised for use in the patients who need it.
Spanish research centres, laboratories, hospitals and clinics started 485 new clinical trials last year, ousting the all-powerful Germany from first place in the European Union, which started 417 studies in 2023, 14 per cent fewer than the Spanish health sector.
The Spanish leap in this ranking is very striking, as only five years ago it was in third place on the continent, but far behind the clinical research capacities of the Germans and the British, who were far ahead, according to the study carried out by Iqvia, the leading consultancy in this sector, for the European federation of pharmaceutical industries.
These experts consider that the data shows that Spain has become a model of success in this type of trial, which should be emulated by many of its continental partners, where applied clinical research is in clear decline.
The document indicates that Spain has managed to build an attractive clinical trial ecosystem for investors, who have contributed to its take-off with an average annual increase in contributions of close to six per cent in the last decade, which has allowed it to go from financing projects worth 479 million in 2012 to 834 million in 2022, the last year computed.
Behind this successful model lie several key elements: the swift transposition of European regulations on these trials into Spanish legislation, in which Spain was a pioneer in 2016; the significant collaboration between the private pharmaceutical industry and public institutions; and the high capacity and quality of the Spanish healthcare system, featuring research centres and hospitals of excellent professional calibre and well-developed infrastructure.
To these basic factors should be added, according to the experts, the growing involvement of primary care professionals and centres in trials, and the commitment to streamlining and reducing management and bureaucratic processes. All together, they say that this enables a clinical research network that is "proactive, coordinated, and cross-cutting".
However, despite the positive leap made by the Spanish health system, the report reveals that the European Union and other members of its economic area such as Great Britain are lagging behind in applied clinical research in an alarming way, in a scientific race in which the United States, China and other emerging powers are already clearly ahead of them.
Two facts show the evidence of the problem. Clinical trials worldwide have increased by 38 per cent in the last five years, but the international weight of trials initiated in the EU has almost halved. They went from 22 per cent of the total in 2018 to 12 per cent in 2023.
If we look at another of the basic elements, the number of patients recruited for the testing of new drugs or procedures, the picture is similar. While worldwide the number of volunteers increased by 12 per cent in the last decade, in the EU it fell by 20 per cent. This, the authors of the paper explain, translates into some 60,000 European patients losing the opportunity to access new experimental drugs between 2018 and 2023 alone.
Western Europe has gone from being the world's second largest clinical trial leader, not far behind the United States, to fifth last year, clearly overtaken by the rise of China, but also overtaken by emerging Asia and even by the Russian bloc and non-EU European states.
The decline in new clinical trials in the last decade has occurred in most fields of work. There are clear declines in studies on oncology therapies, immunisation, rare diseases, and cell and gene therapies, which in some cases even account for half of all new work. The decline is also notable in phase 1 trials (the initial ones), which will exacerbate the problem in the coming years.
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