Cathal Crowe (Clare, Fianna Fail)
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935. To ask the Minister for Health the reason that there is no HRB funding granted to Galway or Limerick hospitals to run clinical trials; if there are plans to change this; and if he will make a statement on the matter. [54302/22]

Stephen Donnelly (Wicklow, Fianna Fail)
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The conduct of clinical trials is different from all other types of health research. Trials require access to specialised facilities, skills, coordination services and supports and they are typically highly regulated.

In 2021, the HRB Board approved a multi-year €23M investment as part of an open, competitive call for investment in Clinical Research Facilities/Centres (CRF/C) in Ireland, following an extensive application and international peer review process. This includes funding of €3M for the Clinical Research Facility at University College Hospital Galway. The Panel did not recommend significant funding at that juncture for Limerick as they concluded that Limerick first requires a broader-based investment in health research capability and supports, similar to that advocated in the HSE Action Plan for Health Research (2019–2029). If this occurred, it could over time support the specific ambition to have a high-performing, diverse and active trials portfolio led out of the region. In the interim, and while work continues to explore how research can be more explicitly supported and integrated into the establishment of the new HSE regional health areas, the HRB provided some grant funding to Limerick to enable it to maintain links with the HRB-funded National Clinical Trials Office and other clinical trial facilities nationally to support collaboration and participation in multi-centre trials.

The HRB also concluded an extensive strategic and scientific review of its investment in cancer clinical trials infrastructure and supports during 2021. Prior to that time, the HRB awarded funds to Cancer Trials Ireland (previously ICORG), who in turn managed funding to hospitals across the country to ensure their ability to lead/participate in trials. The review by the HRB recognised (1) the opportunity and synergies for cancer clinical trials afforded by the now well-developed, staffed and resourced clinical trials facilities/centres in many hospitals around the country (2) that participation in cancer clinical in Ireland remains low and the ambition set out in the National Cancer Strategy (2017-2026) is to double the numbers of patients on clinical trials from 3% to 6% and (3) funding for the conduct of clinical trials is best separated and made distinct from funding for the underlying infrastructure and support staff/services at sites or funding for networks.

Applications for infrastructure and support services at sites were reviewed by an International panel of experts according to the pre-published assessment criteria and the HRB Board subsequently announced a total investment of €21.6M, comprising support for a National Cancer Clinical Trials Network and funding for six cancer trials groups or clusters. The Panel raised a number of concerns about the applications from the SAOLTA University Healthcare Group and from University Hospital Limerick Group and these concerns were not resolved through the applicant’s written response to the Panel nor during the Panel interview with the applicant team. The Panel noted that many of the barriers to achieving the quality/performance/governance threshold set for this cancer clinical trials investment programme are inextricably linked to first order concerns and challenges regarding clinician capacity, breadth, and resources in the Hospital Groups. The HRB therefore did not fund these sites as cancer clinical trials clusters but provided modest ‘Enabling’ funding for a limited period to enable the sites to take stock with all relevant stakeholders (including hospital and hospital group management, the National Cancer Control Programme, the Department of health and the National Clinical Trials Network), to reflect on the feedback and to develop a roadmap and associated interventions to ensure that these sites could reasonably address the concerns raised in any future application process. It is hoped that progress is being made locally/regionally to address the concerns raised. Meanwhile, the HRB continues to engage with the Department and the NCCP to discuss next steps towards a potential re-assessment of capability at Galway and Limerick at some point in the future.

Finally, as highlighted above, the HRB disentangled funding for the conduct of investigator-led cancer clinical trials from the funding available for infrastructure support. In its most recent dedicated funding stream for clinical trials and health intervention studies (DIFA awards), the HRB opened a specific cancer stream with €3M available for cancer clinical trials and interventions. Applications are open to any and all investigators or sites to apply for this funding.