Written answers
Tuesday, 8 July 2025
Department of Health
Clinical Trials
Frank Feighan (Sligo-Leitrim, Fine Gael)
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868. To ask the Minister for Health for an update on the implementation of the interim recommendations she received from the National Clinical Trials Oversight Group; and if she will make a statement on the matter. [37769/25]
Frank Feighan (Sligo-Leitrim, Fine Gael)
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869. To ask the Minister for Health for an update on the proportion of clinical trials initiated in Ireland since 2023 that have met the 42-days key performance indicator for regulatory approval, ethics approval and contracting, in tabular form; and if she will make a statement on the matter. [37770/25]
Frank Feighan (Sligo-Leitrim, Fine Gael)
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871. To ask the Minister for Health to report, on a hospital-by-hospital basis, on utilisation by public hospitals of clinical research organisation services, and on associated charging overheads, in tabular form; and if she will make a statement on the matter. [37772/25]
Frank Feighan (Sligo-Leitrim, Fine Gael)
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872. To ask the Minister for Health with reference to governance of clinical trials in which public hospitals participate, if national guidance has been issued for data impact assessments; if she will report, on a hospital-by-hospital basis, if hospitals are following national guidance, in tabular form; and if she will make a statement on the matter. [37773/25]
Jennifer Carroll MacNeill (Dún Laoghaire, Fine Gael)
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I propose to take Questions Nos. 868, 869, 871 and 872 together.
The National Clinical Trials Oversight Group (NCTOG) was established in July 2024 with the primary aim of increasing the number of clinical trials taking place in Ireland, particularly those involving investigational medicinal products.
The NCTOG's Interim Recommendations were published at the end of October 2024, and were noted by Government in November 2024. The interim recommendations identified three key areas (Contracts, Costings, and Data Protection), where streamlining and clarification of administrative processes would help alleviate several barriers faced by those parties wishing to conduct and participate in clinical trials in Ireland. The NCTOG and its members' respective organisations and partner organisations have been continuing to work towards implementing the recommendations wherever possible, and this work is ongoing (Outputs of the National Clinical Trials Oversight Group) www.gov.ie/en/department-of-health/collections/outputs-of-the-national-clinical-trials-oversight-group/.
On contracts, streamlined Clinical Trial Agreement templates have been developed for use across the healthcare system, which will help improve efficiency and time to start-up of clinical trials. In terms of data protection, my Department has recently published guidance which was developed in partnership with the NCTOG and the Data Protection Commission, which will guide organisations in terms of responsibilities for performing Data Protection Impact Assessments by providing a unified understanding on the interpretations of the regulations. Specific work on clinical trial costings has also been carried out through a sub-group of the NCTOG who have been developing recommendations in this area, which will be among the NCTOG's final recommendations that will be published later this year.
A central recommendation in the NCTOG's interim report was the creation of a dashboard platform to significantly improve transparency regarding performance and availability of trials across the clinical trials landscape. Progress is ongoing with initial phases of the dashboard's development focused on integrating key metrics and streamlining data flow from various stakeholders. As implementation is ongoing, specific data on these metrics are not yet available.
I look forward to updating my colleagues in Government in the coming weeks on the final recommendations of the NCTOG and moving forward with the all important implementation phase as we continue to transform the clinical trials landscape in Ireland for better patient outcomes.
Frank Feighan (Sligo-Leitrim, Fine Gael)
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870. To ask the Minister for Health the number of dedicated WTE clinical research staff employed by the Health Service Executive; the plans for additional recruitment in 2025 and 2026 of dedicated clinical research staff; and if she will make a statement on the matter. [37771/25]
Jennifer Carroll MacNeill (Dún Laoghaire, Fine Gael)
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As this is a service matter, I have asked the Health Service Executive to respond to the Deputy directly, as soon as possible.
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