Press release
Minister for Health announces plans to implement National Oversight Group recommendations to support expansion of clinical trials
From Department of Health
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Minister for Health, Stephen Donnelly, has published recommendations from the National Clinical Trials Oversight Group (NCTOG) to support the expansion of clinical trials in Ireland.
The recommendations were brought to Cabinet, earlier this week.
In July of this year, Minister Donnelly established the Group of experts to develop recommendations to increase the number of commercial and non-commercial clinical trials of investigational medicinal products taking place in Ireland.
The Minister has stated he wants to double the number of clinical trials taking place in Ireland in order to bring Ireland into line with other top European performers, such as Denmark. This would improve clinical outcomes for patients, increase the effectiveness of our health service, and provide economic benefits to the State.
The current landscape in Ireland for clinical trials is overly complex with duplication and delays across the administrative processes and structures that support their start-up. Difficulties encountered include reaching legal agreement to commence a trial, and varied understanding among stakeholders around roles and responsibilities covering GDPR and data protection legislation.
Following the request from the Minister to provide interim recommendations, the Group has made the following recommendations which focus on critical steps in the set-up of clinical trials, under the specific headings of Contract, Costings, and Data Protection:
- The Group is recommending that a pre-arranged template for the contract itself which could be mandated and adopted as standard, along with Key Performance Indicators (KPIs) around timelines and rates of approval.
- The Group is also recommending that work be undertaken around cost standardisation, and adoption of a unified costing framework.
- Lastly, the Group is recommending the development of a clear national policy, which it will now develop, to address the complex process of ensuring appropriate compliance with data protection regulations.
Minister Donnelly said:
“In July this year, I appointed the National Clinical Trials Oversight Group to discuss and find solutions to expand the number of clinical trials taking place in Ireland. This is all about improving patients’ access to the latest cutting-edge treatments and therapies.
“I’d like to thank the Group’s Chair, Professor Donal Brennan, as well as all members of the Group, for achieving this within the short time span of just a few months.
“Implementing these recommendations will bring significant benefits to both patients and the research infrastructure which supports clinical trials in Ireland, with the added benefit of generating more awareness of Ireland’s reputation as an international centre of excellence in clinical research.”
Chair of the National Clinical Trials Oversight Group, Professor Donal Brennan, said:
“I believe that these recommendations are the first step towards our goal of increased clinical trial activity in Ireland and will allow us to develop Ireland as a competitive destination for commercial and academic clinical trials going forward. I would like to thank all the members of the NCTOG for their hard work to-date and Minister Donnelly for his ongoing support of this important initiative”
National Clinical Trials Oversight Group - Interim Recommendations
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The NCTOG will be operational for a period of one year. The Group comprises key stakeholders including patient and civil society representatives, clinical research professionals, industry and regulatory experts, hospital and academic leaders, and funders.
In line with the Programme for Government (PfG), the commitment to expanding clinical trials in Ireland is embedded strategically across key policy initiatives including the National Cancer Strategy, the National Strategy for Accelerating Genetics and Genomics, and Impact 2030: Ireland’s Research and Innovation Strategy.