Clinical trials boost demanded so Irish get faster access to life-saving treatments

By Chris Wheal

May 15, 2024

Ireland needs a a predictable, transparent and efficient clinical research system

The Irish Pharmaceutical and Healthcare Association (IPHA) is demanding a shake-up of clinical trials practices that it says deny Ireland access to breakthrough life-saving medicines.

The trade body for Ireland’s research-based biopharmaceutical industry analysed reported clinical trials in two similarly sized countries, Denmark and Finland. It found Ireland lagged behind both countries. All three nations have seen the number of clinical trials declining in the past few years.

Denmark attracts almost three times as many industry clinical trials compared with Ireland.

Change needed

The IPHA has already developed a model agreement between medics and sponsor firms. But its latest report includes proposals to:

• Provide standardised clinical trial start-up requirements (including data protection impact assessments) and timelines for hospitals
• Designate specific clinical trial signatories in each hospital and a standard, timely sign-off process
• Appoint one permanent clinical research nurse post for each teaching hospital
• Ring-fence clinical trial funding and working time for multidisciplinary research 
• Protect dedicated clinical research time.

Dr Rebecca Cramp, director of code and regulatory affairs at the IPHA, said the right reforms in Ireland would result in more Irish patients benefiting 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,” she said.

A decade of missed opportunity

The 2024 IPHA Clinical Trials Performance Report looks at a decade of stats from 2014 to 2023. It found Ireland attracting fewer all-industry sponsored interventional clinical trials than Finland and Denmark, whose populations and economic wealth are similar.

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

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 more than 40% in the number of all-industry sponsored interventional clinical trials taking place in 2022 compared with 2021, and a similar trajectory is evident for 2023.

Standardised approach to raise standards

To accelerate the conduct of clinical trials and increase the number of them carried out in Ireland, the IPHA has already developed a new standardised clinical trial agreement between the site and the sponsor. The IPHA says its Model Clinical Trial Agreement, or mCTA, which was a first for Ireland, is an efficiency initiative that can reduce delays, cut costs, increase standardisation and enable the faster commencement of more clinical trials.

But the IPHA said: “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 medicine development.” It claimed this would raise standards of care for patients in Ireland. 

Data source

The analysis was based on data from www.clinicaltrials.gov. It is provided by the US National Library of Medicine’s National Center for Biotechnology Information, and contains details of privately and publicly funded clinical trials conducted worldwide. Additionally, the EudraCT database and HPRA Annual Reports were analysed to obtain further information on the trends in the clinical trial landscape in Ireland.

Further details highlighted included:

Analysis of the Healthcare Products Regulatory Authority (HPRA) annual reports showed that in 2021 there were 107 applications authorised for clinical trials of human medicine under the EU Clinical Trials Directive. In 2022, this figure reduced to 64 clinical trials authorised under the EU Clinical Trials Directive and three authorisations under the new EU Clinical Trials Regulation. From 2021 to 2022 there was a 37% decrease in applications authorised by the HPRA.

The data from the 292 IPHA-member sponsored clinical trials in Ireland was divided into phase status. Nearly three-quarters of IPHA-member sponsored clinical trials took place during phase III (73%), followed by phase II (17%).

Looking at all-industry figures, the majority of clinical trials that took place were in oncology (192), which included blood cancers. This represented 42% of all industry-sponsored clinical trials (460). Neurology, gastroenterology, immunology and respiratory, combined, represented just over a quarter of clinical trials carried out during 2014 to 2023.

Oncology including blood cancer trials (147) made up half of the IPHA-member sponsored clinical trials(292) that were conducted in this time period. Gastroenterology, immunology and endocrinology accounted for 21% of clinical trials,

For all three countries, the majority of clinical trials were phase 3. Out of 460 clinical trials that took place in Ireland, 311 (68%) were phase 3 and 97 (21%) phase 2. Out of 1,290 clinical trials that occurred in Denmark, 675 (52%) were phase 3 and 333 (26%) phase 2. Finland had 661 clinical trials, with 390 (59%) phase 3 and 130 (20%) phase 2.

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