As we all know, clinical research, including trials, is fundamental to healthcare innovation. It’s how we turn cutting edge science into more effective disease diagnosis, treatment, and prevention, and is also linked very closely to improving quality of care and patient outcomes. However, it is often overlooked that trials can also improve the efficiency of health service delivery and healthcare systems. This is why, with our partners, the HRB has been investing in building our collective capacity for trials since 2002.

Driving excellence and innovation

Our most recent investment is detailed in our Strategy 2021-2025, Health research – making an impact. Within this, Clinical Trials Infrastructure (CTI) is supported through our Strategic Objectives 1 (invest in research that delivers value for health, the health system, society, and the economy) and 4 (build a strong and supportive environment for health research in Ireland). 
Overall, we’re aiming to drive the excellence and innovation required to benefit patients, the health system, society, and the economy, through faster, better quality, and more diverse clinical trials. We also aim to see these trials delivered in an environment that is pro-innovation and where research is integrated across the healthcare system as a core part of effective patient care. To lead on this, we have established a unit for Research and Innovation Infrastructures (RAII) within our Research Strategy and Funding (RSF) Directorate. 

Achievements so far

So, when we pose the question, ‘a coordinated clinical trials ecosystem in Ireland – are we there yet?’, it’s valuable to examine where Ireland has come from, where we are now, and how we will continue moving forward. 
Collectively, across the whole system, we have already achieved a lot. In fact, through support and funding from the Department of Health, the HRB has invested more than €150 million in clinical trials infrastructure to date. This is hugely positive, and below follows a timeline of our key investments:

2002: Invested in cancer trials infrastructure via the All-Ireland Cooperative Oncology Research Group (ICORG, now Cancer Trials Ireland)

2005: Entered a co-funding arrangement with the Wellcome Trust, which in 2008 led to Ireland’s first Clinical Research Centres/Facilities (CRF/Cs)

2014: Funded Ireland’s first Trials Methodology Research Network (the HRB-TMRN) and disease-specific Clinical Trial Networks (CTNs)

2015: Funded a national coordinating centre (the HRB CRCI), which was a precursor to today’s National Clinical Trials Office (NCTO)

2018: Conducted a detailed review of CTI in Ireland to inform the next phase of funding over the current strategic period

2021: Made a series of new investments in clinical research facilities and networks valued at approximately €55 million over five years. And this is only HRB funding. There’s additional co-investment from the Health Service Executive (HSE), universities, and other partners, and it all fits together, working in harmony for the benefit of researchers and patients. These infrastructures are as follows: 

Five CRF/Cs: These provide the infrastructure, governance, skills and expertise to enable high quality, safe trials and other interventions. They have been funded to the tune of €21 million by the HRB, as well as co-investment from other partners in a 1:1 ratio.

Six cancer trials groups and a national cancer clinical trials network: This investment provides support and enabling infrastructure for Irish patients to access safe and high quality cancer clinical trials. There’s over €22 million HRB invested in this, as well as co-funding from partners for the cancer trials groups.

Seven CTNS: These are cohesive networks established in specific thematic areas (dementia, diabetes, critical care, primary care, paediatrics, rare diseases and infectious diseases) and which devise an agreed research strategy to design, lead and conduct a portfolio of internationally competitive, investigator-led, registered clinical trials. These are funded by the HRB to the tune of €7 million, and there is further partner co-funding.

The NCTO: This is a central point of contact for multicentre clinical trials in Ireland which provides excellent signposting, advice and support to the community. Importantly, it also offers access to the European Clinical Research Infrastructure Network (ECRIN). 

The HRB-TMRN: Led out of the University of Galway, this national network aims to strengthen the methodology, quality and reporting outcomes of trials in health and social care in Ireland. Co-investment comes from university partners also.
I’d also like to mention our Definitive Interventions and Feasibility Awards (DIFA) scheme. We have committed approximately €10 million over the next few years to this, the only public funding source for investigator led clinical trials in Ireland.  

Ensuring a thriving clinical trials ecosystem

This latest HRB investment from 2021 to 2025 is building on our previous investment since 2002. We want to ensure that Ireland’s clinical trial ecosystem is not just working well, but that it is thriving, focuses on quality, and that we have a comprehensive framework in place to improve and ensure the quality of clinical trials and infrastructures. 

The cornerstone of this is HRB investment with partner co-funding, which provides all the required expertise, facilities, training, and technology to enable research and innovation to thrive. But we also need to show results and demonstrate success, as this will enable us to secure future investment and continue delivering improved healthcare. 

This work has already started. We have established ongoing engagement with a standing advisory group of international experts to work with us and advise us in this area; we have new contract templates for infrastructures to incentivise integration and co-investment; and, importantly, we have active support from hospital CEOs through participation in formal engagement forums. We’re now continuously monitoring and reporting activity with key performance metrics and working towards an international comparative assessment that will further showcase our achievements in this space. 

In summary

So, back to the original question – ‘A coordinated clinical trials ecosystem in Ireland – are we there yet?’ Well, this obviously remains a work in progress. But looking back to where we started in 2002, to where we are now, what’s in place, the work done, and the ongoing work, I think it’s fair to say we are well on our way. Certainly, as we mark ICTD 2023, there’s plenty to take pride in and excellent grounds for optimism. 

ENDS

This blog was adapted from a talk given by HRB Chief Executive, Dr Mairéad O’Driscoll, at the 2022 NCTO ICTD conference. You can view the full talk here on our YouTube Channel.   

Visit the NCTO website.

Read more about HRB investment in a world class clinical trials ecosystem.