Malcolm Byrne (Wicklow-Wexford, Fianna Fail)
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821. To ask the Minister for Health the progress in increasing the number of clinical trials across the health sector; and if she will make a statement on the matter. [34050/25]

Jennifer Carroll MacNeill (Dún Laoghaire, Fine Gael)
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My Department is continuing its efforts to transform the clinical trials landscape in Ireland including measures to increase the number of clinical trials taking place. The National Clinical Trials Oversight Group (NCTOG) was established in July 2024 to investigate the challenges of undertaking clinical trials in Ireland, and to formulate solutions to meet those challenges. The Group published its interim recommendations www.assets.gov.ie/static/documents/national-clinical-trials-oversight-group-interim-recommendations.pdf in October 2024, and these were noted by Government on 7th November 2024.

The NCTOG's Interim Recommendations directly address some of the core administrative barriers which have been hindering the wider roll out of clinical trials in Ireland. Improvements in areas such as contracts, costings, and data protection are already evident, signaling that we are on the right track in looking to boost our competitiveness as a premier destination for high-quality clinical trials.

In the area of streamlining clinical trials agreements, a revised Clinical Trial Agreement contract template has been created by the HSE in partnership with the Irish Pharmaceutical Healthcare Association (IPHA). This is now in use at HSE hospitals, and thanks to the efforts of the NCTOG, discussions are underway to implement these contracts more widely across our healthcare system. These solutions are being applied in real-world settings, and users are reporting that it is improving the speed at which contracted parties can reach agreement to undertake clinical trials and thus provide the potential for better patient outcomes.

This measurable progress has also been noted by the recent "Clinical Trials Activity Comparison Report" published by the IPHA in May 2025 which highlighted encouraging trends across Ireland's clinical trial landscape.

The NCTOG has also established sub-groups to work on costings and workforce planning, with the aim of developing recommendations that can assist in establishing a standardised model of clinical trials costing, increase predictability and help ease the process of setting up trials, as well as supporting clinicians and research staff through supportive frameworks that will improve recruitment, reduce attrition rates, and support career pathways for researchers.

Notwithstanding the progress that has been made, challenges remain. The Group is currently deliberating on their final recommendations which will build on the success to date achieved with the publication of the Interim Recommendations. I hope to be in position shortly to bring the final recommendations to Government for approval and continuing this journey in seeking to transform the clinical trials landscape in Ireland for the benefit of Irish society.