Dr Donal O’Connor
Clinical Manager, HPRA
Find out how clinical trials for medicines and devices are regulated in Ireland.
The Health Products Regulatory Authority (HPRA) regulates medicines and devices for the protection and benefit of patients and the public. An important part of our role is the review of clinical trials. Trials are conducted to develop medicines and devices intended to benefit patients with new treatments or diagnosis.
Clinical trial approval steps
Many clinical studies involving medicines or devices may require approval from the HPRA as regulated clinical trials before they can commence in Ireland. These include:
- Pre-market studies to assess the safety and benefit of new drugs or devices in development before they receive market approval and are licensed or certified.
- Post-marketing studies on approved drugs or devices to examine their use in other conditions.
- Studies to examine longer-term benefits or potential side effects.
Ensuring safe, valid trials
We review trials conducted in Ireland only as well as larger multinational studies. The latter could include, for example, international trials for a new cancer drug or heart valve that include patients in Irish hospitals. For medicines specifically, there is also a new European Regulation for coordinating the conduct of clinical trials throughout the EU.
Our primary aim is to ensure the safety of trial participants. Data generated must also be scientifically valid and reliable so that the assessment of new treatments is based on good-quality clinical evidence.
Trial design is reviewed to ensure that risks
to trial participants are reduced as far as possible.
For market approval, and before becoming available for wider use, it must be shown that the benefits of new treatments outweigh any risks. As part of this process, we review the medicine or device to check that appropriate testing, such as laboratory studies, was conducted prior to the clinical trial.
Trial design is reviewed to ensure that risks to trial participants are reduced as far as possible. This assessment is conducted by HPRA medical doctors, pharmacists, engineers and other scientists. Trials are also independently assessed by the national research ethics committee.
Safeguarding innovation and public safety
Only studies where potential benefits outweigh the risks involved for participants are permitted. After approval, trials will be monitored carefully to ensure continuing safety. This involves a review of reports of side effects or adverse events, progress reports or inspection visits to study sites.
We are committed to supporting innovation while protecting public and patient safety. We offer support to developers of new and potentially beneficial medicines and devices wishing to conduct clinical trials in Ireland. As well as our guidance documents, we facilitate meetings to assist innovators and clinical investigators in preparing clinical trial applications to the highest standards.