On the occasion of World Clinical Trials Day, which is celebrated on May 20, AELMHU once again publishes the Annual Report on Clinical Trials in Rare Diseases in Spain, corresponding to the year 2023.
During this period, 834 clinical trials were authorized in Spain, which is 10% less than in 2022. In the field of rare diseases (RRD), 190 trials were authorized, a worrying decrease of 19% compared to the previous year.
Although the total number of clinical trials authorized in Spain has decreased, clinical trials for minority diseases represent a significant percentage of the total (23%).
As for the number of participants in clinical trials, 40,907 people were registered, down 14% compared to the previous year. On the other hand, 2,884 people participated in clinical trials for rare diseases in particular, down 34% compared to 4,380 in 2022. In percentage terms, participants in clinical trials for rare diseases accounted for 7% of the total number of participants in 2023, two points less than the previous year (9%).
With regard to the therapeutic areas addressed by trials in rare diseases, research in oncology stands out with 30%, followed by hematology with 13%, the immune system with 12% and the nervous system with 11%, all of them with outstanding positions.
At the territorial level, all the Autonomous Communities, except La Rioja, have participated in clinical trials in minority pathologies. Catalonia tops the list with a total of 158 trials, followed by Madrid with 130, and Andalusia and Valencia with 79 and 61 trials, respectively.
Finally, 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 again highlighted that commercial sponsors are the main drivers of clinical trials in rare diseases in Spain. Of the 190 clinical trials for rare diseases, 96% were promoted by them, evidencing their clear commitment to research in this field, despite the various difficulties faced by the sector.
You can learn more details of the report in this infographic
