knowledge 28 November 2025 |

Clinical Trials Reform: Ireland’s Blueprint for Transforming the Clinical Trials Landscape

Central to the NCTOG’s vision is embedding clinical trials into standard care. Research-active health systems tend to be at the forefront of medical advances and innovation, leading to better patient access and outcomes.

In her comments on the Report’s launch, Minister for Health Jennifer Carroll MacNeill TD noted that supporting the NCTOG’s work “…underscores our dedication to sustained growth of the pharmaceutical, medtech, and biotech industries” as part of the broader life sciences agenda.

As with the planned National Life Sciences Strategy (which is the subject of an ongoing public consultation), the recommendations reflect a key commitment in the Programme for Government 2025 to increase the number of clinical trials (the Programme also noted Ireland’s “strong competitive advantage” in the pharma and medtech areas).  For more insights from our Life Sciences Group on plans for the Irish strategy, read our recent alert here: Charting Ireland’s Life Sciences Strategy: Scope and Policy Priorities.

The immediate priority area is the establishment of a Clinical Trials Advisory Council (CTAC) by Q1 2026, which will in turn manage the transition to a National Clinical Trials Body by Q3 2027. The latter will be responsible for supporting sponsors, participants and investigators on commercial clinical trials and promoting Ireland as a clinical trials destination. It will also publish performance metrics on setting up and completing clinical trials in Ireland and engage with key stakeholders to ensure alignment with national policy, including the upcoming National Life Sciences Strategy. 

The other 5 priority areas are:

Creating Agile and Responsive Systems

The Report recommends an agile approach to clinical trials, focusing on streamlining various aspects including contracting and data protection.

On contracting, trial start-up in Ireland is often delayed by arduous contractual negotiations between sponsors and hospitals. To simplify the contracting process, the Report recommends the use in Ireland of a universal clinical trial contract. The use of standardised or model agreements for clinical trials is common in many other jurisdictions and Ireland has been making moves towards this recently, including by adopting a model bipartite clinical trial agreement between hospitals and commercial sponsors and also a model tripartite agreement for clinical trials involving a sponsor, hospital and contract research organisation. These model agreements are currently in use in HSE hospitals. The Report acknowledges the progress made and notes that further refinements to the model agreements may be made as the roll-out widens across institutions and organisations, and some aspects are currently under review.

Data protection was identified by the NCTOG, in its Interim Recommendations, as causing roadblocks to the sign-off of clinical trials in Ireland due to the time taken to reach agreement on data protection arrangements and, in particular, responsibility for data protection documentation (e.g. Data Protection Impact Assessments). The NCTOG’s interim recommendation for data protection guidance has been largely addressed by work carried out following the Interim Recommendations. In conjunction with the Data Protection Commission, guidance was published in June 2025 to clarify organisations’ responsibilities around Data Protection Impact Assessments when setting up clinical trials. The Report recommends that further additional work is undertaken to assess the viability of developing a ‘risk assessment compliance tool’ to support data protection compliance for clinical trials.  The Report does not envisage a more sweeping overhaul of data protection law in Ireland applicable to clinical trials.

Enhancing Patient and Public Engagement

The Report recommends:

• improving public awareness of clinical trials to increase participation and leveraging existing pathways, including the HSE Health App, to do so, and
• incorporating clinical trial performance metrics and KPIs into routine reporting systems to ensure that the importance of clinical trial activity is recognised.

Promoting Value and Incentivising Activity

Clinical research centres are funded and governed differently resulting in variances in the costs of conducting clinical trials across centres which has led to unpredictability. The Report’s recommendations focus on standardising costs, adopting a unified costing framework and harmonising approaches across organisations.  The goal is to build shared standard costing approaches that can be adopted by sponsors, research facilities, and academic institutions. The Report also notes that the Final Report of the Costings Sub-Group of the NCTOG will be published in Q4 2025.

Strategic Workforce Development

Clinical trials involve multidisciplinary teams, from pharmacists to research assistants, which brings with it different skill sets and variations in permanency. The Report recognises that there are national shortages in key skill sets among clinical research organisations and that some staff are engaged on short-term contracts, which creates challenges for stability and turnover. These workforce planning issues can impact on the ability to conduct clinical trials efficiently and consistently. The Report further notes that an unstructured approach to workforce planning not only impacts staff, but also impacts the overall success of a trial.

The Report’s recommendations to build a strong, skilled and sustainable clinical trials workforce include:

• collecting workforce data to understand current and future capacity and needs,
• establishing stable roles with clear career paths, and
• retention strategies and strategies to attract new talent.

Promoting the use of Innovative Technologies

Embracing the use of technology in clinical trials can have a transformative impact. The Report highlights the absence of a national electronic health record (EHR) as a major barrier to progress and notes that it is a key component of the clinical trial ecosystem.  It emphasises that the implementation and roll-out of EHRs should be a strategic priority for the Irish health system as it will support critical infrastructure for clinical trials through supporting enhanced patient recruitment and improved data accuracy. As stakeholders will know, progress in this area is long overdue but Ireland is making progress via the Health Information Bill 2024 which would empower the HSE to create and assign a national EHR to each patient. On 19 November 2025, the Bill passed the final stage of Dáil Eireann and will now progress through the Seanad.

Looking forward

Overall, the Report is welcome as it paves the way to reform Ireland’s clinical trials landscape, making it a more attractive destination for clinical trials, while building on progress already made (e.g. the proposed adoption of EHRs).  

There are other indicators that Ireland’s clinical trials environment is starting to improve: the IPHA Clinical Trials Activity Comparison Report May 2025 showed a 34% increase in pharmaceutical industry sponsored clinical trials initiated in Ireland in 2024 compared with 2023, and a substantial drop in the “time to first patient enrolled’ statistic from 67 days in 2023 to 46 days in 2024.  Notably, the European Commission in conjunction with the European Medicines Agency and Heads of Medicines Agencies announced two new targets for clinical trials in September 2025: that a further 500 multinational clinical trials be added to the average of 900 that are already authorised in the EU each year, and that two thirds (66%) of clinical trials begin recruiting patients within 200 calendar days or less from the date of application submission (compared with 50% at the time of the announcement).  The European announcement was made in the context of the Accelerating Clinical Trials in the EU initiative, and is linked to complementary initiatives such as the Clinical Trials Regulation Collaborate Project. 

The scale of reform proposed by the Report is significant and Ireland will need to ensure a focused implementation effort, in particular in terms of the swift establishment and operationalisation of CTAC, aligning with the plans for a National Life Sciences Strategy, and implementing the wider recommendations.

Experts from our Life Sciences Group will be helping clients navigate the potential impact of the Report’s recommendations on their businesses.  Please get in touch with one of our key contacts below if you would like to discuss the Report’s implications and what’s on the horizon for your business and the wider life sciences sector in 2026.