Clinical Trials in Ireland: Is Ireland The Place To Be?
Significant progress has been made in recent years in Ireland to advance the capability in design, conduct, analysis and reporting of clinical trials. Patients, researchers, academics, clinicians and industry along with the Health Research Board have worked tirelessly to develop this framework. Yet, with all of these developments, Ireland still only participates in less than 2% of studies in Europe (clinicaltrials.gov).
Clinical Research in Ireland
ICORG (all Ireland Cooperative Oncology Research Group) created the template for research in Ireland. More than 10,000 Irish cancer patients have participated in Irish cancer trials and enable access to treatments and changed the landscape of cancer care in Ireland. This has not been replicated in general medical clinical trials. Some works have been completed to address this with namely the Health research board (HRB) funding three clinical research centre facilities (CRFs) in accordance with three centres of excellence (SVUH, CUH and UCHG), alongside two research centres (CRCs) that complement these CRFs (Mater and Beaumont). These world-class centres of excellence facilitate the infrastructure, specialist research staff and practical knowledge needed to carry out the research. With this infrastructure, gaps still exist and there is a need for research dedicated clinicians in line with other countries. This vital link has been missing for so long.
Funding for the Sector
In January, 2017, Ireland secured €13m in funding from a combination of The Wellcome Trust and HRB, HSE and the Health and Social Care Research Development office, Northern Ireland, and their partner Universities. This funding will enable a fundamental change in the training of future clinicians on an all-Ireland basis. Eight postgraduate trainee doctors per year, over a period of 5 years will be provided with fully integrated clinical and research training up to consultant level. This programme will identify, recruit and mentor doctors during their postgraduate training who have the potential to become future academic leaders. This programme will position Ireland to meet the future challenges and demands in excellence and clinical innovation in healthcare, and the diverse needs of patients.
With this dedicated continued investment and focus on the grassroots of clinical research in Ireland, the future is extremely bright and enables Ireland to obtain access to more than the 2% of the studies that we currently have access to.
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Further Reading: Clinical & PV Articles
What Are Post-Marketing Surveillance Studies?
Post-marketing surveillance studies are defined in Article 1(15) of Directive 2001/83/EC as studies carried out after a medicine has been authorised to obtain further information on a medicine’s safety or to measure the effectiveness of risk-management measures. In this article, our Medical Manager, Dr. Danica Cvetkovic, looks at post-marketing surveillance studies and the link with Risk Minimisation Plans (RMP’s)
Pharmacovigilance of Medicines for Rare Diseases
Dr. Danica Cvetkovic looks at the issue of pharmacovigilance for orphan or rare diseases. Many issues associated with the sector are challenged by the small patient population. This article looks at the commonly used strategies for evaluation of post-approval safety and the effectiveness of rare and orphan drugs.
Veterinary Clinical Trials: New EU Law & Global Approaches
Clinical studies are intended to advance animal health care by identifying the most effective therapies and practices for a given condition, or by advancing our basic understanding of the disease. Much like a clinical study in the human population, a veterinary clinical study involves research that gains information from animal patients.
Download Our Clinical Trials E-Book
Acorn Regulatory is a leading regulatory, pharmacovigilance and clinical consultancy company headquartered in Ireland. Our Clinical & Medical team works with the largest and the leading companies in life sciences to assist them in bringing their products to market. The team, led by Dr. Danica Cvetkovic, has written extensively on the issue. In the latest e-book from Acorn Regulatory, we look at the best and most popular articles from our Clinical & Medical team.