Ireland continues to lag peer European countries in attracting clinical trials, according to IPHA

• Denmark attracts almost three times as many industry clinical trials when compared to Ireland.
• IPHA calls for reform of the system to ensure patients in Ireland get access to breakthrough life-saving medicines through clinical trials.

Ireland is attracting fewer clinical trials than some European countries with similar populations and economic performances, according to a report by the Irish Pharmaceutical Healthcare Association (IPHA), the representative body for the research-based biopharmaceutical industry.

The 2024 IPHA Clinical Trials Performance Report, which captures data across 10 years (2014 to 2023), saw Ireland attracting fewer all-industry sponsored interventional clinical trials than Finland and Denmark whose populations and economic wealth are similar to ours.

Of 2,411 interventional clinical trials carried out in the three countries across the 10 years, 19% were conducted in Ireland (460) compared to 27% in Finland (661) and 54% in Denmark (1,290).

Clinical trials are used to evaluate the safety and effectiveness of medicines including vaccines. A strong clinical trial infrastructure gives patients access to sometimes life-saving treatments.

The Report shows that IPHA member companies sponsored or collaborated in 292 out of 460 listed all-industry sponsored interventional clinical trials during this period. Most (68%) of these interventional clinical trials were in Phase III. Cancer accounted for just over half of all IPHA member-sponsored interventional clinical trials with other therapy areas such as gastroenterology, immunology and endocrinology accounting for 21%.

However, in Ireland there has been a decrease of over 40% in the number of all-industry sponsored interventional clinical trials taking place in 2022 compared to 2021, and a similar trajectory is evident for 2023.

 

Dr Rebecca Cramp, Director of Code and Regulatory Affairs at IPHA, said reforms are needed in the clinical trials process in Ireland and, if we get them right, more patients will benefit from breakthrough innovation in medicines.

“Healthcare providers in Irish hospitals and academic institutions have shown that they have the ability to drive world-class research. We believe that Ireland can play a leading role in the provision of clinical trials in Europe. However, this can only be achieved through a predictable, transparent and efficient clinical research system which is necessary to attract more clinical trials. Patients in Ireland deserve a strong clinical research infrastructure to provide access to sometimes life-saving treatments.”

To accelerate the conduct of clinical trials and increase the number of them carried out in Ireland, IPHA has already developed a new standardised Clinical Trial Agreement between the site and the Sponsor. The Model Clinical Trial Agreement, or mCTA, which is a first for Ireland, is an efficiency initiative, which can reduce delays, cut costs, increase standardisation and enable the faster commencement of more clinical trials – all aimed at significantly improving patient outcomes.

However, further collaboration by all stakeholders including the Government, hospitals, academic institutions and industry is required to reform the clinical trial process and help accelerate new medicines’ development, thereby raising standards of care for patients in Ireland. IPHA continues to urge for this reform through the following five steps:

1. Provide standardised clinical trial start-up requirements (including Data Protection Impact Assessments) and timelines for hospitals;
2. Designate specific clinical trial signatories in each hospital and a standard, timely sign-off process;
3. Appoint one permanent clinical research nurse post for each teaching hospital;
4. Ring-fence clinical trial funding and working time for multidisciplinary research; and,
5. Protect dedicated clinical research time.

Access the IPHA Clinical Trials Activity Comparison Report 2024 here.

Access the Making Ireland a European Leader in Clinical Research document here.