International Clinical Trials Day: Driving healthcare innovation through Artificial Intelligence

Every year on May 20, the International Clinical Trials Day commemorates the first documented clinical trial conducted by Scottish physician James Lind in 1747. This date highlights the vital role of clinical trials in the development of new medicines and treatments, ensuring their efficacy and safety before approval and commercialization.

Today, Spain has established itself as one of the leading countries in conducting clinical trials. In 2024, the Spanish Agency for Medicines and Medical Devices (AEMPS) authorized a total of 930 studies, making it the top regulatory body in Europe in terms of approved clinical trials—surpassing countries like France and Germany. Spain leads the EU in cancer drug research, with 336 oncology trials in 2024 (37.6% of all studies authorized nationwide), followed by immune system disorders (8.6%) and nervous system conditions (7%). Moreover, 22% of clinical trials conducted in Spain focused on rare diseases. Notably, Spain also leads Europe in research on advanced therapy medicinal products, with 52 authorized trials last year.

However, the sector faces critical challenges, including the need to improve the efficiency and accuracy of clinical data coding. Effective data management is essential to ensure the quality and reproducibility of clinical trials. In this context, the TerminAI project emerges as a key initiative aiming to optimize healthcare data management through the implementation of an AI-assisted system.

This system leverages advanced natural language processing (NLP) and machine learning technologies to analyze, interpret, and contextualize clinical data, thereby improving the accuracy and efficiency of data coding. The project is spearheaded by the Basque Health Cluster and involves a consortium including NorayBio, BIOLAN, Vicomtech, EProcessMed, AseBio, and the start-up Devol. It falls under the Ministry of Industry and Tourism’s support program for innovative business clusters.

The project also aims to apply bioinformatics tools, artificial intelligence, and advanced digital technologies to automate and optimize genetic data processing—enhancing disease diagnosis and prevention. It includes the digitalization of informed consents to facilitate access and reduce errors, and it will assess system integration with existing health data spaces to ensure interoperability, security, and compliance with European regulations.

The implementation of tools like TerminAI not only enhances the quality of clinical trials but also accelerates the development of effective, personalized treatments—directly benefiting patients.

On International Clinical Trials Day, it is crucial to acknowledge and support initiatives that drive excellence in medical research and promote the adoption of emerging technologies to address the sector’s current challenges.