Untapped potential: rethinking Ireland's approach to clinical trials

By April Lara

June 12, 2024

IPHA forum

Putting patients at the heart of how clinical trials are run and giving clinicians more certainty over their short-term funded positons will make Ireland a leader in clinical trials.

These were just two of the lessons from the Irish Pharmaceutical Healthcare Association’s (IPHA) online forum that examined the country’s approach to clinical trials and identified areas for improvement.

The discussion, held on June 11, 2024, was facilitated by Mary Harney, a former Tánaiste (deputy prime minister) currently serving as a Hanover Communications senior advisor.

The discussion featured a diverse range of perspectives. Guest speakers included:

• Caitriona Walsh, country president and managing director of Novartis Ireland
• Jane Lynne, a patient advocate for chronic lymphocytic leukemia (CLL)
• John O’Neill, representing the Department of Health
• Professor Frank Sullivan, chief medical officer of Whyze Health

The forum aimed to identify ways to make Ireland a more attractive location for clinical trials.

Ireland’s clinical trial landscape

Walsh presented findings from the IPHA research, which looked into the level of clinical research activity in Ireland compared to two other European countries that are comparable in population size and economic wealth: Denmark and Finland.

Using data from clinicaltrials.gov and EudraCT, the research showed that Ireland had significantly fewer industry-sponsored trials (460 between 2014 and 2023) than its European counterparts.

Oncology dominated clinical trials in Ireland (42%), followed by neurology, gastroenterology, immunology, and respiratory combined (over 25%). Notably, 68% were Phase 3 trials, indicating late-stage research.

Despite this activity, a concerning trend emerged. Ireland lagged in attracting industry-sponsored trials compared to Denmark and Finland, especially post-COVID.

Patient experience

Lynne, a patient advocate, shared a powerful account of her experience. Diagnosed with an incurable disease, she faced significant challenges in accessing clinical trials within Ireland. The standard treatment options available were chemotherapy and immunotherapy, but these offered limited hope. As a mother facing health struggles, childcare became an additional burden. Financial concerns also loomed large, as treatments for her condition were expensive.

Lynne's search for more effective treatment led her to the UK, where she participated in a clinical trial with the assistance of her hematologist in Ireland. This trial demonstrably improved and extended her quality of life. However, the journey was far from easy.

Despite the proximity to the UK, travel took a toll on her already compromised health – the waiting time for the trial to begin also added to the stress.

Lynne emphasised the critical need for increased access to clinical trials within Ireland. As she anticipates needing another trial, having readily available options closer to home is crucial.

She passionately advocated for patient representation in the early stages of clinical trial development. “We need to take into consideration what affects patients, like the distance to travel, the amount of scans that might be necessary, blood tests, waiting around. Maybe there’s a way we could do it all in one day, instead of coming three times in a week.”

Proposed reforms

Walsh's report outlined a clear path for improving the number of clinical trials conducted in Ireland. The focus was on streamlining the current processes, which can often be cumbersome and delay trials. She emphasised the importance of standardisation – implementing uniform requirements for initiating trials across the board would remove unnecessary complexities.

Additionally, designating specific individuals in each hospital as clinical trial signatories and a clear and timely sign-off process would expedite approvals. Walsh also highlighted the need to invest in dedicated staff. Appointing a dedicated clinical research nurse at each teaching hospital would provide essential personnel to manage trials effectively.

Finally, she stressed the importance of protecting resources. Ring-fencing funding and working time for multidisciplinary research activities ensure these crucial endeavours have the necessary resources. Furthermore, safeguarding dedicated clinical research time for staff would incentivise their participation in research activities. By implementing these proposals, Ireland can create a more efficient and streamlined clinical trial environment, attracting more sponsors and benefiting patients.

Despite the challenges, Walsh also highlighted improvements that have been made, such as the one in national research ethics, “… they’re backed up now to, I think, they have four committees and they’re adhering really, really well to regulation timelines in terms of processing the reviews, we’ve seen big improvements there.”

She commended recent collaborations with IPHA groups and HSEs, citing their standardised model clinical trial agreement from 2022 as a positive step towards streamlining processes. This agreement, known as a tripartite agreement, typically involves the commercial sponsor, a Contract Research Organisation (CRO), and the hospital, ensuring clear roles and responsibilities for each party.

Walsh emphasised the importance of collaboration, “Collaboration is absolutely key for progress and it is going to really take everybody working together - the CROs, industries, healthcare system, department of health, HSE, as well as our world-class clinicians and patient groups as well— to really work together to see what can we do to improve things and to aspire to be more Denmark-like, I guess, in terms of our clinical trial aspirations in Ireland.”

Learning from Denmark and Finland

The forum also explored how Ireland can learn from its European counterparts. Harney queried O’Neill about best practices from Denmark and Finland, known for their higher number of clinical trials. O'Neill acknowledged their efforts in ongoing discussions with EU member states to identify successful strategies.

He also touched on streamlining patient enrollment. Denmark's innovative model was highlighted, featuring a single entry point for clinical trials.

He said that one of the things is to make it easy for patients to enrol in clinical trials.

“Denmark is kind of interesting in that it has one entry point for clinical trials, it’s very patient-centric, to allow that entry in. It’s very user-friendly towards participants in the actual clinical trials themselves.”

Sullivan also pinpointed patient enrollment as a significant hurdle hindering Ireland's progress. He highlighted the stark difference in readily available trials compared to the UK, raising concerns about accessibility for Irish patients.

Sullivan offered a stark illustration, citing a recent discussion with a colleague: "In any given month on a call with clinical research organisations, he will hear about anywhere from 50-80 of trials open for enrollment in the UK, while there are zero open for enrollment in Ireland." This significant disparity underscores the need for Ireland to improve its clinical trial environment.

This patient-centric approach simplifies the process for individuals seeking to participate in research. O'Neill emphasised the need for a cohesive system within Ireland, where all elements work together seamlessly. He expressed optimism that the upcoming Health Information Bill, scheduled for release this year, would contribute to this goal by promoting data integration.

The Health (Miscellaneous Provisions) Bill 2024 was introduced in the Irish Parliament (Oireachtas) in February 2024 and is currently in the legislative process. The bill might not directly address clinical trials, but its focus on the health information system suggests it could improve data integration, which could ultimately benefit clinical research in Ireland.

Digital technologies in clinical trials

The potential of digital technologies to enhance clinical trial activity in Ireland also came up. O’Neill, emphasised the importance of the "digital side of things.”

Sullivan raised concerns about healthcare data as many patients seek care on various platforms. While Ireland has adopted electronic health systems, the data remains frustratingly siloed within individual facilities. This fragmented approach hinders research efforts.

As Sullivan emphasised, dedicated resources at each teaching hospital level could significantly improve data accessibility and make hospitals more effective contributors to research.

However, despite it being a problem, Sullivan sees it as an opportunity to take advantage of technology, such as machine-learning to strengthen IT infrastructure in healthcare.

“For me, a big challenge would be to tackle these technical deficits. That creates much more efficiencies and allows already-busy clinicians to become much more involved in clinical trials. I think that’s one way we can make some real gains very quickly here,” he said.

O’Neill suggested looking into Ireland’s own infrastructure and learning from others. He also said to take advantage of what’s already there, linking things and looking into data at a more national level. He pointed to the potential of curating centralised registries instead of relying on these siloed datasets. This would streamline data collection and analysis and ultimately improve the efficiency of research endeavours.

Sullivan echoed this sentiment, stating that "research shouldn't be considered a nice-to-have anymore, it should be essential." This powerful statement underscores the need to prioritise research and leverage digital tools to make it more efficient and impactful.

Clinician involvement in clinical trials

The discussion also acknowledged the current pressures on the healthcare system, with Harney highlighting challenges like waiting lists and patient volume. However, Sullivan offered a positive perspective. He emphasised that Ireland has a wealth of experienced clinicians who are well-exposed to research and are strongly willing to participate in clinical trials.

Walsh identified another key challenge – the lack of a clear career path for clinicians interested in dedicating themselves to research. Most current research roles are temporary, which creates uncertainty and discourages long-term commitment.

Walsh proposed establishing more permanent positions with defined processes and timelines for getting trials up and running. This increased clarity and predictability would incentivise clinicians and boost efficiency in initiating and conducting research.

Addressing patient reluctance

Lynne said that there are, indeed, patients who are reluctant to clinical trials due to the stigma that they will be “experimented on, some sort like a lab rat.”

She suggested, “We need to work really hard to change the perception of what a clinical trial actually is. The reality is that it’s a gateway to tomorrow’s treatment today effectively.” She also mentioned that the care patients receive during these trials is often superior to the standard of care they would receive in hospitals.

Raising awareness

The IPHA forum concluded with a call to action from Harney. She expressed concern about the lack of awareness surrounding the importance of clinical trials among Irish politicians, her "former colleagues", as she referred to them.

Harney urged the political class to recognise the significance of fostering a robust clinical trial environment in Ireland. She emphasised the need for a life science strategy to be explicitly included in the manifestos of every political party. This strategy would demonstrate a commitment to clinical research and its potential to improve healthcare outcomes for Irish citizens.

This strategy would raise awareness of the importance of clinical trials and lead to concrete actions. The government could allocate dedicated funding for research initiatives, streamline regulations to expedite approvals, and launch public awareness campaigns. Investing in clinical research offers a double benefit: it provides patients with access to innovative treatments and fosters economic growth through job creation and attracting investment in the life sciences sector.

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