The Irish Pharmaceutical Healthcare Association (IPHA) has welcomed encouraging growth in clinical trial activity in Ireland, while highlighting that system reforms are needed to ensure the country can compete internationally and maximise benefits for patients.

New data shows that a total of 165 pharmaceutical industry-sponsored clinical trials were commenced in Ireland between 2023 and 2025, with numbers rising year-on-year — from 41 in 2023 to 51 in 2024 (up 24 per cent), and a further increase to 73 in 2025 (up 44 per cent). However, IPHA cautioned that Ireland continues to underperform relative to comparable countries. Denmark, with a similar population and economic profile, initiated over two-and-a-half times as many clinical trials (425 versus 157) over the same period.

Clinical trials start-up time following EU Clinical Trial Regulation (CTR) approval is ideally as short as possible. However, significant challenges also persist in clinical trial set-up times in Ireland. In fact, Ireland ranked as the slowest of all EU member states for the time from EU CTR approval to the first clinical trial site being ready (213 days), for studies commenced between 2023 and 2025.

To accelerate progress, IPHA is calling for five priority reforms:

• Establish a Clinical Trials Advisory Council (CTAC) with clear authority and political backing to oversee implementation of the NCTOG recommendations;
• Introduce a universal Clinical Trial Contract and standardised costing template to reduce administrative burdens, inconsistencies and delays;
• Develop national guidance on data protection responsibilities and designated officer sign-off to improve consistency across clinical trial sites;
• Create a national open-access clinical trials dashboard with key performance Indicators, integrated into HSE reporting, to enhance transparency, accountability and monitoring; and
• Plan strategically for workforce needs, including clear career pathways with stable job roles to attract, motivate and retain clinical research talent.