Frank Feighan (Sligo-Leitrim, Fine Gael)
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873. To ask the Minister for Health the status of the work of the National Clinical Trials Oversight Group; when her Department will publish the planned interim report on challenges of conducting trials in Ireland; when it is intended to produce a final report proposing solutions to the issues impacting clinical research in Ireland; and her observations on the way to reduce administrative burdens and improve standardisation in research. [7417/25]

Kieran O'Donnell (Limerick City, Fine Gael)
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The National Clinical Trials Oversight Group (NCTOG) was established in July 2024 to examine the clinical trials landscape in Ireland with the aim of supporting better clinical outcomes through increasing the number of trials taking place and improving access to domestic and international trials for trial participants. This will ultimately improve clinical outcomes for patients allowing them to access cutting-edge therapies that are not yet available through standard care.

My Department published the Interim Recommendations Report of the NCTOG in October 2024 and the recommendations were noted by Government in November 2024. The Interim Recommendations Report can be found on gov.ie - National Clinical Trials Oversight Group - Interim Recommendations.

The NCTOG is continuing its deliberations with a view to finalising recommendations which will inform the final report from the Oversight Group. The final report, which builds on the interim recommendations report, will look to propose measures which can help streamline the regulatory process of setting up trials by addressing issues relating to trial contracts, costing of trials, and data protection. The final report is due to be published by the end of Q2 2025.

As Minister of Health, I am fully committed to progressing the work of this group and I will continue to engage with the Oversight Group over the coming months to ensure we have potential solutions proposed in the final report which are implementable in providing better clinical outcomes for patients.