Written answers

Thursday, 26 June 2025

Photo of Shane MoynihanShane Moynihan (Dublin Mid West, Fianna Fail)
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55. To ask the Minister for Health the measures being taken to increase clinical trials and better support clinicians, researchers and staff to focus on clinical trial activity; and if she will make a statement on the matter. [34618/25]

Photo of Jennifer Carroll MacNeillJennifer Carroll MacNeill (Dún Laoghaire, Fine Gael)
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I thank the Deputy for creating this opportunity for me to provide an update on the ongoing work within my Department to increase Clinical Trials in Ireland. The National Clinical Trials Oversight Group (NCTOG) was set up 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 in October 2024, and these were noted by Government on 7th November 2024.

As a focused group of experts in the area of clinical trials of investigational medicinal products, the NCTOG is well-placed to make recommendations that will have a transformative impact on the clinical trials landscape in Ireland, helping improve access to life-saving cutting-edge medicines and ultimately providing better patient outcomes. I had the pleasure of meeting with them in February, and their commitment to achieve these core objectives is clearly evident.

The NCTOG's Interim Recommendations directly address core administrative barriers hindering our clinical trial capabilities. 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. 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 Irish Pharmaceutical Healthcare Association (IPHA) in May 2025 which highlighted encouraging trends across Ireland's clinical trial landscape.

Key Findings from the IPHA Report:

  • Increase in Trials: There was a 34% increase in the number of pharmaceutical industry-sponsored clinical trials commenced in Ireland between 2023 and 2024.
  • Faster "First Patient In": The average time to recruit the first patient into a trial significantly improved, dropping by 31% from 67 days in 2023 to 46 days in 2024.
The NCTOG has also established sub-groups to work on costings and workforce planning, which are currently finalising their recommendations to be included in the final report of the Group. These recommendations will aid in establishing a standardised model of clinical trials costing, to increase predictability and help ease the process of setting up trials. The recommendations are also looking to support clinicians and research staff through supportive frameworks that will improve recruitment, reduce attrition rates, and support career pathways for researchers. In this regard, it is imperative that we continue to do all we can to ensure that both rewarding and sustainable career pathways are in place for those wishing to pursue and maintain careers across clinical research, including clinical trials.

I would also like to take this opportunity to thank the Data Protection Commission (DPC), who have contributed significantly to the work of the NCTOG in creating clarity and guidance on the various parties' responsibilities in relation Data Protection, the various interpretations of which have been a serious impediment to progressing clinical trial agreements in the past.

Notwithstanding the progress that has been made, challenges remain. The Group is currently deliberating on their final recommendations which will build on the successes 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 I look forward to implementing next steps and continuing this journey in seeking to transform the clinical trials landscape in Ireland for the benefit of Irish society.

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