May 23. 2024. 8:36

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Ireland’s clinical trials scorecard outpaced by Denmark, says biopharma trade body

Ireland is attracting fewer clinical trials than some European countries with similar populations and economic performances, according to a new report by the Irish Pharmaceutical Healthcare Association (IPHA). Denmark attracts almost three times as many industry clinical trials compared to Ireland.

IPHA the representative body for the research-based biopharmaceutical industry is calling for reform of the system to ensure patients in Ireland get access to breakthrough life-saving medicines through clinical trials.

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.

Improving patient outcomes

Dr Rebecca Cramp, Director of Code and Regulatory Affairs at IPHA, told Euractiv: “Patient outcomes are significantly improved when they are involved in clinical trials. We need to ensure that, through collaboration, reform of the system occurs and that patients in Ireland receive the care they deserve.”

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.

Commenting on the Danish success story, which starts with the extraction of insulin in 1921, Jakob Bjerg Larsen, head of clinical trials and pharmaceutical manufacturing policy at the Danish Association of the Pharmaceutical Industry, is quoted by the journal Nature as observing: “There is widespread political and industry support for strengthening the Danish hospital system and public-private collaboration to make it easier to run the large-scale trials that are needed to bring new treatments to market”

A notable outcome of the Danes’ strategy is Trial Nation, an online database of clinical trials that recruits patients in Denmark.”

Ireland needs to recalibrate

Ireland’s approach, while significant and globally competitive, needs to recalibrate to compete head-to-head with Denmark.

The IPHA says 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.

To achieve this, the Irish trade body recommends five steps: providing standardised clinical trial start-up requirements (including Data Protection Impact Assessments) and timelines for hospitals; designating specific clinical trial signatories in each hospital and a standard, timely sign-off process; appointing one permanent clinical research nurse post for each teaching hospital; ring-fencing clinical trial funding and working time for multidisciplinary research; and, protecting dedicated clinical research time.

The European Union (EU) mandates that all ongoing clinical trials transition to the Clinical Trials Information System (CTIS) by 30 January 2025, marking the end of a three-year transition period. Sponsors of trials expected to continue post-deadline must account for the evaluation procedure’s duration, potentially up to three months. Member States will implement expedited procedures for transitioning trials to the Clinical Trials Regulation (CTR) where possible. Importantly, ongoing trials need not be halted or terminated during this transition from the Clinical Trials Directive to the CTR.

Sponsored interventional clinical trials

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.

Medicine innovation breakthroughs

Dr Rebecca Cramp said reforms are needed in the clinical trials process in Ireland and, if Ireland gets them right, more patients will benefit from breakthrough innovation in medicines.

She remarked: “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.

[By Brian Maguire | Euractiv’s Advocacy Lab ]

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