Clinical trials in Ireland: the framework
Great progress has been made in recent years to advance capability in Ireland in the design, conduct, analysis and reporting of clinical trials. The Health Research Board (HRB), patients, researchers, industry and clinician representatives have worked together for this. Ireland participates in fewer than 2 per cent of trials in Europe (ClinicalTrials.gov), but we have the potential to do much more.
The HRB funds three clinical research facilities (CRFs): one in Dublin with the Wellcome Trust, one in Galway and one in Cork. These complement two other clinical research centres (CRCs) in the Mater and Beaumont hospitals. These facilities provide the infrastructure, specialist staff and practical knowledge needed to carry out patient-focused research in a safe manner and an appropriate environment. Many trials need the participation of more than one CRF/CRC to reach the number of participants needed. This will soon be coordinated centrally by HRB Clinical Research Coordination Ireland (CRCI).
The All-Ireland Cooperative Oncology Research Group (Icorg) was the first major network established in the area of cancer. To date, more than 10,000 Irish cancer patients have participated in Icorg trials. The results of some trials have changed the way clinical care is delivered for all cancer patients. This has driven the 10 per cent improvement in five-year-survival in breast cancer between 1994 and 2012 (iti.ms/1HjmAva). The HRB will soon announce four new networks in other specialties. The HRB-funded network includes the HRB-Trials Methodology Research Network (HRB-TMRN), which aims to make trials more relevant, accessible and influential for patients, practitioners, policymakers and the public.
Where a clinical trial involves the use of a medicinal product or a medical device, supporting medical, scientific and pharmaceutical data must be submitted to the Health Products Regulatory Authority (HPRA) for approval before the trial can take place. The HPRA is a State agency that governs and regulates the use of health products in Ireland to ensure their safe use in human and veterinary medicine. All applications to conduct a clinical trial must also be approved by one of Ireland’s 12 research ethical approval committees. Data from clinical trials is subject to data-protection legislation.
The Irish Platform for Patient Organisations, Science and Industry (Ipposi) is a patient-led organisation that works with patients, Government, industry, science and academia to put patients at the heart of policy and medicines. Since its establishment in 2001, Ipposi has had strong engagement in policymaking in Ireland, as well as involvement with the European Patients’ Academy on Therapeutic Innovation (Eupati), working to involve patients as partners in the development of new treatments. The Medical Research Charities Group (MRCG) is an umbrella group of more than 30 medical research and patient-support charities.
Dr Sandra Galvin is co-ordinator of HRB-TMRN and Dr Anne Cody is head of clinical and applied biomedical research at HRB