Clinical Researcher—June 2023 (Volume 37, Issue 3)

EUROPEAN PERSPECTIVE

Prof. Frank Sullivan, MB, MRCPI, FFRRSCI, MSc

 

Across Europe, we continue to see a declining trend in the number of clinical trials taking place, most notably since the European Union Clinical Trials Directive (CTD) was established in 2004. Among other countries, the decline in clinical trials in Ireland is a major concern, as it means that fewer people are given access to potentially life-saving treatments. This can have long-term effects on the quality of care being provided, as well as making it harder for new treatments to be developed and tested.

The CTD has had long-felt ramifications for all European patients and clinical researchers, with regulatory burdens and insurance requirements growing even more burdensome as time passed. At the same time, the global COVID-19 pandemic also affected the number of clinical trials, which decreased by 19.6% in Europe between August and October of 2020 compared to 2019. However, the effects of this decrease in access to clinical trials are being felt more severely in countries like Ireland, which have far fewer trials than their peers.

In this article, we explore the causes of decreased access to ground-breaking trials in Ireland and how to improve the quality of healthcare to create a healthier, more efficient system that better serves the Irish population.

The Current Landscape of Research in Europe and at Home in Ireland

Despite Ireland’s significant spend in its healthcare system, diverse population, and heavy inbound investment from the pharma and med-tech sectors, the country is not able to keep up with its European counterparts in terms of clinical trial participation. According to the Central Statistics Office of Ireland, foreign direct investment in Ireland increased by €109 billion to €1,208 billion in 2021, a large proportion of that coming from the pharmaceutical and med-tech sectors. Compared to Finland and Denmark, which both have similar populations and economic wealth, Ireland has only seen 18% of the 2,290 clinical trials conducted between 2013 to 2021 in the three countries. In contrast, Finland and Denmark have respectively seen 29% and 53% of these clinical trials.

Ireland is not alone; the number of clinical trials in the United Kingdom (UK) has also declined significantly in recent times, with the Association of British Pharmaceutical Industry reporting that the number of industry-backed clinical trials started in the UK each year fell by 41% between 2017 and 2021. This steep drop is due largely to a combination of factors, including slow set-up times, increased staff fatigue and turnover, and a reduction in research capacity in the UK National Health Service. Unfortunately, this means that the UK and Ireland are lagging behind many of their European counterparts in attracting clinical trials.

The main barrier for Ireland when it comes to clinical trials is the need for more resources, both in terms of funds and personnel. Clinical trials require a significant amount of time from both researchers and practitioners to be successful. However, due to budgetary constraints, they are often forced to make do with limited personnel or wait for additional funding. Further, the infrastructure needed to support clinical trials is often expensive and difficult to obtain.

Addressing Barriers in the Current Clinical Trial System

Bureaucratic Impediments

To reverse the trend of declining clinical trials in Ireland, the government has taken steps to address the administrative barriers to clinical trial participation in the country. One significant improvement is the centralization of ethics and standardizing the clinical trial process. The National Clinical Trials Office (NCTO) was established to facilitate clinical trial research in Ireland. The NCTO provides a centralized infrastructure to support the set-up and management of clinical trials, including a clinical trial management system (CTMS), which allows researchers to track patient recruitment, trial progress, and data management.

Private-Public Expansion

Through the Health Research Board infrastructure, Ireland has invested heavily in clinical research facilities, generally based in and around the public hospital university system, but penetration in the private healthcare delivery system is patchy at best. Up to one half of the Irish population carries healthcare insurance and receives some or all of its healthcare in the private system. There is clear scope to expand the pool of patients accessing trials, through measures designed to include all eligible patients, treated in both the private as well as public sectors in Ireland.

Data Issues

Finally, there is a clear need to modernize the data infrastructure, to allow for advances in artificial intelligence (AI) and machine learning to bring further increases in access and retention to clinical trials. We will address this issue here.

Changing Clinical Trials in Ireland

Of crucial importance to the issues discussed in the previous section, a significant barrier to clinical trial participation in Ireland is the lack of patient access to digitized personal health records and control over their own medical data. Patients should have access to their medical records and be able to move from one treatment center to another and to obtain access to trials. This is particularly important for patients with rare diseases, who may need to travel outside their local area to access the best treatments and trials.

A suitably designed digital platform can provide a solution to this problem by allowing patients to access their personal medical records and connect with their healthcare providers to learn about new treatments and clinical trials. Such a platform enables real-time (real-world) monitoring of patients’ conditions, which can help patients and healthcare providers make more informed decisions about treatment options. Furthermore, this platform’s digital asset management system encourages long-term patient participation in trials, providing opportunities for healthcare providers to extend their reach and increase their revenue through research and clinical trial involvement. In short, such a platform is designed to unify health and research to advance both knowledge areas.

There are good clinical reasons to promote this kind of activity. Evidence suggests that being treated in a center where trials are offered is associated with better patient outcomes. Patients who are treated at centers with clinical trials have access to the latest treatments and technologies, which can improve their health outcomes. Better outcomes lead to better value to the overall health sector. Therefore, improving access to clinical trials in Ireland is critical for improving the quality and value of care provided to Irish patients.

Increasing the quality of the health interventions through clinical trials improves patients’ outcomes. Improved outcomes lead to improved value to the overall system. Improved value through clinical trials leverages the substantial foreign direct investment incoming to Ireland through the pharmaceutical and med-tech investments.

For these reasons and more, the clinical research enterprise should focus on patient-centered solutions that encourage patients to connect with their healthcare providers, allowing them access to information about new treatments and clinical trials and real-time monitoring of their conditions. Such access is particularly beneficial for those who may not have been previously aware that participation in clinical trials was a viable option, or who had yet to be invited by their healthcare providers into opportunities to benefit from state-of-the-art treatments.

Real-World Evidence Driving Quality and Value in Healthcare

The kind of platform we have been discussing further collects data in a digital health and research data “lake” that is used for post-market surveillance of medical products to improve patient outcomes even more, and to increase the overall quality of the healthcare delivered in Ireland. As new treatments are used in the country, payers can track the longer term effects of these interventions, to ensure only the best treatments continue to receive financial support.

As the platform grows and continues to incentivize patient participation, it can help bridge the gap between high-performing healthcare systems in Europe and their counterparts in America and Asia, allowing patients access to ground-breaking treatments and creating improved health outcomes for all. This amplifies the return on investment Ireland derives from the substantial foreign direct investment from pharmaceutical and med-tech sectors and provides a much-needed solution to the problems posed by a lack of European access to clinical trials. This is truly the time for a change, and Ireland can rise in the forefront meeting these challenges.

Conclusion

Increasing clinical trials activity in Ireland is a healthcare priority. Direct benefits include improved outcomes and value for the patients and the healthcare system. Byproducts come in the form of increase in return on foreign direct investment for Ireland. Improvements in digital health platforms including AI and machine learning can help drive this important change.

 

Prof. Frank Sullivan, MB, MRCPI, FFRRSCI, MSc, is Director of Radiation Oncology for the Prostate Cancer Institute at National University of Ireland, Galway at Galway Clinic and Founding Chief Medical Officer for WHYZE Health.