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pre-pandemic levels are exceeded

Spain authorized more than 900 clinical trials with medicines in 2022, according to the Spanish Registry of Clinical Studies (REEC). The number is higher than that recorded in 2018 and 2019, years before the pandemic in which 800 and 833 clinical studies were authorized, respectively.

Clinical trials in 2022: surpassing pre-pandemic levels

A technician from the Basque biopharmaceutical company Oncomatryx, during an analysis of a new anti-cancer drug in Zamudio (Biscay). EFE/Luis Teixit

86% of the clinical trials carried out in 2022 (906) were promoted by pharmaceutical companies, whose investment in this item has increased in recent years to 789 million euros, 60% of the total investment in R&D of the sector in Spain.

These are data collected at the end Survey on R&D activities what Farmindustria carried out every year among the associates.

This item has increased at a cumulative average annual rate of 5.3% in the last 10 years, from 470 million euros in 2011 to nearly 800 million euros in 2021.

Also, more than a third of the trials (328) focus on drugs to treat the cancerthe most studied area, followed by diseases of the nervous system and pathologies of the immune system.

Respiratory, hematological, viral and cardiovascular diseases were the next in number of trials in 2022, according to data from the Spanish Registry of Clinical Studies (REEC), which coordinates the Spanish Agency for Medicines and Health Products (AEMPS).

Clinical trials in 2022 for rare diseases

Rare diseases account for 25% of clinical trials, a total of 230, a notable increase compared to the 73 conducted in 2018 to test orphan drugs and the 117 in 2019.

Rare diseases, despite the advances, still have a further development path for biomedical research, since only 5% of these pathologies have an available treatment.

However, the current European legislation, based on a system of incentives for research by pharmaceutical companies, has managed to go from the eight orphan medicines available in 2000 to more than 130 today.

clinical trials 2022
A researcher in a laboratory working on so-called “orphan drugs” for rare diseases. PHOTO EFE/ Julio Muñoz

Tests in children and adolescents

A total of 166 clinical trials had children or adolescents as patients.

The pediatric area is also one of those that has grown the most in Spain in recent years, with an increasing number of studies since 2016, when 108 trials with pediatric drugs were registered, 35% less than the last year.

Boost in the early stages

Of the 906 essays published by the REEC in 2022, more than half (525) are framed in the early phases of the investigation, which are considered the most complex and whose momentum represents a “challenge” for Spain, according to Farmaindustria.

“In recent years, Spain has become a world reference in clinical trials, thanks to the commitment of the pharmaceutical industry which finances and promotes more than 86% of the studies, but also thanks to the solidity of the health system, the high qualification of its professionals, pioneering legislation and increasingly involved patients”, he says deputy director general of Farmaindústria, Javier Urzay.

The covid-19 pandemic led to an increase in the number of clinical trials in Spain in 2020 and 2021, which placed the country at the top of the world and first in Europe for the volume of studies against SARS-CoV-2 and surpassing them by a thousand years.

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