Claire Temple
Clinical Trials Portfolio Lead (Executive Assessor), Health Products Regulatory Authority (HPRA)
Clinical trials are essential to establish how well new treatments work and their safety. They are also important for patients to gain early access to new medicines.
Before they begin, clinical trials are approved by regulatory bodies and ethics committees. This is to ensure they are designed to answer a specific research question and that participants in clinical trials are optimally protected.
Clinical trial regulation in Ireland
In Ireland, clinical trials for both medicines and medical devices are assessed and approved by the Health Products Regulatory Authority(HPRA) in collaboration with the National Research Ethics Committees (NREC). For medicines, the process is conducted using a single online platform known as the Clinical Trials Information System (CTIS).
Since 31 January 2025, all ongoing trials have been regulated by the new Clinical Trial Regulation (CTR), which replaced the Clinical Trials Directive (CTD). One benefit of the CTR for patients is the increased transparency of information mandated by the regulation. The CTIS platform also includes a public portal with searchable information for the public.
It is now possible for members of the
public to search for clinical trials that
are running in Ireland and recruiting.
Clinical trial public portal functionality
The portal’s functionality was improved at the end of 2024. The accessibility of the clinical trial information was enhanced; it is now possible for members of the public to search for clinical trials that are running in Ireland and recruiting. Users can also filter to search for clinical trials in a certain therapeutic indication and specific eligibility criteria such as gender or age group. If a clinical trial of interest is found, it is possible to view the ‘location and contact points’ to find out the location and Principal Investigators involved (usually a hospital consultant). The new interactive clinical trials map makes it even easier to search for clinical trials in a particular location.
Improving clinical trial accessibility for Irish patients
As of January 2025, 97 clinical trials are recruiting in Ireland, 45 of which relate to the therapeutic area of cancer. Other common therapeutic areas include cardiovascular diseases (10), and musculoskeletal diseases (4).
Clinical trials in Ireland are run in a wide range of hospitals and primary care settings, including Children’s Health Ireland hospitals, Cork University Hospital, St Vincent’s University Hospital and University Hospital Waterford. It is hoped that CTIS’s new features will help improve the accessibility of clinical trials for patients in Ireland.
