More Trials, Increased Focus on Rare Diseases

According to the Spanish Clinical Trials Registry (REEC), coordinated by the Spanish Agency of Medicines and Medical Devices (Aemps), Spain authorized no less than 924 clinical trials in 2022.

While COVID-19 led to an increase in the number of clinical trials in the country in 2020 and 2021, making Spain the fourth country in the world and the first in Europe with respect to the volume of studies relating to SARS-CoV2, the number for 2022 is higher than those recorded for 2018 and 2019, when 800 and 833 clinical trials were authorised, respectively.

In recent years, Spain has become a global leader in clinical trials, thanks to the commitment of the pharmaceutical industry, and the successful model of public-private collaboration

Amelia Martín Uranga, director of Clinical and Translational Research, Farmaindustria

Although more than a third of the 2022 trials (328) were focused on drugs to treat cancer, making oncology the area that saw the largest number of studies, Spain stands out for its rare disease trials. Accounting for 25 percent of 2022’s clinical trials, a total of 230 studies were carried out for rare diseases.

“This data has seen significant growth in recent years, with 73 studies aimed at testing orphan drugs in 2018 and 117 in 2019,” said Amelia Martín Uranga, director of Clinical and Translational Research at Farmaindustria, Spain’s leading pharma industry association, in a recent interview.

 

Pharma Industry Driving Growth

The industry was behind much of the growth and a large percentage of the trials conducted in Spain in 2022 were initiated by the pharmaceutical companies: 86 percent in total. These studies represented an investment of EUR 789 million, and based on Farmindustria’s latest R&D activities survey, 60 percent of the total R&D investment in the sector in Spain.

Moreover, investment in clinical trials over the past ten years has increased at a cumulative average annual rate of 5.3 percent from EUR 470 million in 2011 to nearly EUR 800 million in 2021.

 

A Solid Healthcare System

One of the factors attracting investment into clinical research in Spain is the quality of the country’s healthcare system. As Ana Argelich Hesse, Merck Sharp & Dohme’s managing director for Spain asserted in a PharmaBoardroom interview, the fact that the affiliate’s R&D department participates in 80 percent of MSD’s global clinical trials “reflects the excellence of the Spanish healthcare system, one of the best in the world.” For Argelich Hess clearly “the reason why MSD in Spain is a global leader in clinical trials is because of the country’s top-notch physicians, researchers, and hospital infrastructure.”

Apart from its excellent healthcare system, Spain has successfully implemented new European legislation around clinical trials and adapted its own legislation accordingly. “It was the first country in Europe to anticipate this legislation with a national regulation as a result of working together with the Spanish Agency of Medicines and Medical Devices (AEMPS) as well as the hospitals and clinicians to establish a good environment for clinical trials,” said Javier Urzay, deputy general manager of Farmaindustria, in a 2022 PharamBoardroom interview.

The country has also effectively built a public-private collaboration model. “In recent years, Spain has become a global leader in clinical trials, thanks to the commitment of the pharmaceutical industry, and the successful model of public-private collaboration,” claims Farmindustria’s Martín Uranga. “This model, which we have been working on for years with authorities, regulators, research centres, hospitals, healthcare professionals, and patients, is what has set us apart from other countries in our region and made us a global reference in clinical research.”

 

More to Do

While Spain has made major strides in becoming a leading clinical research destination, Urzay claims that there is more to be done. “We have the opportunity to further boost Spain’s leadership in this area.”

“If we want to continue gaining ground and consolidate our leadership, we must continue improving infrastructure and increasing resources dedicated to research. It is an opportune time for this, and as a country, we must all work towards achieving it,” Martín Uranga agrees.