Ireland’s landscape for clinical trials is “overly complex” with duplication of work and delays across the administrative system and confusing around data protection, a report on the topic has found.
Last July, Minister for Health Stephen Donnelly established the National Clinical Trials Oversight Group (NCTOG), a team of experts to develop recommendations to increase the number of clinical trials of investigational medicinal products taking place in Ireland.
Research from the industry has consistently found Ireland is attracting fewer clinical trials than some European countries with similar populations and economic performance.
The group identified a number of 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.
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The NCTOG presented interim recommendations to Government this week, among which is a recommendation to introduce a pre-arranged template for the contract which could be mandated and adopted as standard “to accelerate the costing and contracting activities for clinical trial sponsors”.
There would also be key performance indicators (KPIs) around timelines and rates of approval. The group also recommended the work be undertaken around cost standardisation, and adoption of a unified costing framework.
Lastly, the group recommended 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.
Mr Donnelly said implementing the recommendations would “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”.
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