Dáil Éireann Debate, Tuesday - 22 March 2022
843. Deputy Colm Burke asked the Minister for Health if consideration will be given to building further links with an association (details supplied) in order to integrate Ireland's participation in clinical trials with other European partners; and if he will make a statement on the matter. [14061/22]
Amharc ar fhreagraInternational evidence shows that patients benefit from having access to high quality clinical trials and overall outcomes are better in health systems that support clinical trials. The COVID-19 pandemic clearly demonstrated the strong link between people’s health, the capacity of our health and social care system, and the economy. My Department, and the Health Research Board (HRB) a statutory body which operates under the aegis of the Department Health, continuously builds linkages with European partners and stakeholders to integrate Ireland’s participation in clinical trials internationally.
Since 2010, the Health Research Board (HRB) has been driving the growth of clinical trials in Ireland and putting in place the supporting research infrastructure with the overall aim of facilitating clinical trials in Ireland that can benefit patients, the healthcare system, and the economy. Facilities are located at hospital sites to enable the conduct of trials and intervention studies, to provide specialist support services and to link with clinical trial networks and to provide trial design and methodology supports. Clinical trial facilities provide a single point of access to resources, knowledge and skills, and are a key part of the national research landscape.
As part of this vision, the Department of Health secured in 2018 Government approval to fund Ireland’s membership of the ECRIN-ERIC network (European Clinical Research Infrastructure Network - a European Research Infrastructure Consortium) to increase access for Irish patients to multi-national clinical trials. ECRIN membership also makes it easier for Irish researchers to extend their own trials internationally and help improve patient safety and quality of care. Membership gives Irish researchers full access to all the tools and services within ECRIN-ERIC, such as trial preparation, protocol review, trial management, data centre certification, capacity building projects, and ECRIN supported trials. The HRB funds Irish membership of the ECRIN-ERIC network.
The HRB also provides the only dedicated funding stream (i.e., Definitive Interventions and Feasibility Awards) for clinical trials and interventions in Ireland, which supports studies evaluating a full scale, definitive trial of an intervention of any appropriate design to provide high quality evidence on the efficacy, effectiveness, cost and broad impact of the intervention. In the previous strategy (2016-2020) HRB made a total investment of €22M across 33 studies. Applicants can apply for HRB funding for trials and interventions for rare diseases and given the importance of international collaboration for rare disease trials, HRB can also support costs for patients outside of Ireland.
Under the current strategy (2021-2025) the HRB will continue to invest in Clinical Research Facilities and centres nationally to improve the quality and quantity of trials in Ireland, to support a single point of access for multi-site clinical trials in Ireland (the National Clinical Trials Office) and to fund Clinical Trials Networks to bring groups of clinicians and patients together to enable trials.
The HRB announced a new investment in a Rare Disease Clinical Trial Network (RD-CTN) on 28th February this year. The RD-CTN will allow people with rare disease greater opportunities for participation in the latest research and more access to innovative new therapies that will improve outcomes and transform treatment and care. The objectives of the RD-CTN are to act as a collaborative hub for trials in rare diseases, facilitate and support the conduct of trials in rare disease and increase the opportunities for patients to access high-quality clinical trials.
This investment builds on prior investments by the HRB to advance research in rare diseases (€14M in the last decade), including through the HRB-HRCI Joint Funding Scheme, our contribution to the work of IPPOSI, the European Joint Programme in Rare Diseases, European Joint Transnational Calls in Rare Diseases.
In January 2022 (Minister Donnelly) welcomed news that Ireland is a new member of 15 European Reference Networks (ERNs), including one dedicated to rare neurological diseases, which supports Huntington’s Disease. ERNs are virtual networks for clinicians and researchers across the EU to share expertise, knowledge and resources on rare diseases. ERNs convene virtual advisory panels of medical specialists across different disciplines, using a dedicated IT platform and telemedicine tools, to review a patient with a rare disease’s diagnosis and treatment. They are important hubs for research on rare diseases and provide a basis for collaborative research across the EU, including for clinical trials.
In parallel with this development the HRB is engaged in the intensive discussions underway in Europe around a proposed Rare Diseases Partnership, which has the stated ambition of improving the health and well-being of people living with a rare disease by making Europe a world leader in innovation to address the unmet needs of 30 million persons living with a rare disease in Europe. An aim of the Partnership is to enable every consenting patient living with a rare disease to be findable and enrolled in a suitable clinical study; generating advances in prevention, diagnosis, understanding of diseases and developing treatments. Emphasis in these discussions has focused on how to overcome challenges associated with rare disease clinical studies and trials, how to create capacity and infrastructure to facilitate this, of the need for European clinical research networks working in this area and in particular networks that could leverage and expand the research capacities of ERNs.
In summary, the HRB-supported RD-CTN can build on the prior significant investment by the HRB in specialist clinical trial facilities, support services and networks, develop strong collaborative links through the European Reference Networks to further develop and support the research agenda in rare diseases and can support and complement the strategic agenda of the EU Rare Disease Partnership and all associated stakeholders and organisations.
