NEWS

New report on clinical trials in rare diseases

New report on clinical trials in rare diseases

On the occasion of World Clinical Trials Day, which is celebrated on May 20, the association publishes, once again, the annual report on clinical trials in rare diseases in Spain during the year 2022.

During this time, one in four authorized clinical trials investigated some rare disease, increasing by 3% over 2021 and marking an all-time high with 233 trials dedicated to these minority pathologies.

According to this study, in 2022 an increasing trend in the percentage of trials focused on rare pathologies was maintained for the third consecutive year, despite the fact that the overall count of authorized HCCs in Spain fell by 8%, from 996 in 2021 to 923 in the following year.

In terms of participation, although decreases were experienced in both cases, in trials focused on rare diseases this decrease barely reached 5%, from 4,436 participants in 2021 to 4,207 in 2022, representing 9% of the total. In authorized trials as a whole, the number of participants fell by 30% compared to the previous year, from 65,504 in 2021 to 46,087 in 2022.

Regarding the therapeutic areas that have been addressed by trials in the USA, research in oncology stands out, accounting for 24%, in the nervous system 12%, in hematology 10% and in the immune system another 10%.

However, in terms of growth, research on genetic phenomena is particularly noteworthy , with an 80% increase over the previous year, with 10 clinical trials in this field.

With regard to territorial distribution, it should be noted that all the Autonomous Communities, with the exception of La Rioja, have participated in some of the 233 studies in minority pathologies, with Catalonia standing out with a total of 200 trials, followed by Madrid with 175, and Andalusia and Valencia, both participating in 98 trials, taking into account that these are multicenter studies.

On the other hand, according to AELMHU data based on the Spanish Registry of Clinical Studies (REEC), which depends on the Spanish Agency of Medicines and Health Products (AEMPS), it is once again clear that the pharmaceutical industry is the main promoter of clinical trials on rare diseases in Spain. Of the 233 trials, 97% were promoted by these companies, demonstrating a clear commitment to research in this field and despite the various difficulties involved in the sector.

You can learn more about the report in this infographic.