Ireland’s National Clinical Trials Office

introduction

Health Research Board-National Clinical Trials Office (HRB-NCTO) is a national integrated clinical research network of seven university-based Clinical Research Facilities/Centres (CRF/C) in the Republic of Ireland:

HRB CRF-University College Cork at Cork University Hospital, Mercy University Hospital & University Hospital Waterford
HRB CRF Galway at University Hospital Galway
Royal College of Surgeons Ireland CRC at Beaumont Hospital
University College Dublin CRCs at Mater Misericordiae University Hospital and St. Vincent’s University Hospital
Wellcome Trust – HRB CRF at St. James’s Hospital
HRI-CRSU:Health Research Institute Clinical Research Support Unit at University Hospital Limerick, Co Limerick.
Children’s Health Ireland (CHI)-CRC at Children’s Health Ireland

Overall Aim

With the support of Ireland’s’ Health Research Board (HRB), host institution (University College Cork), Enterprise Ireland and the seven CRF/Cs the NCTO will deliver on the aims of the National Clinical Trials Coordination Programme 2021 over the 3-year term of its funding award.

This programme was developed to build on the positive achievements of previous investments in clinical trials coordination and future investments in national clinical trials infrastructures. The overall aim of this investment is to ensure that Ireland has the capacity to conduct innovative high quality clinical research for the benefit of people’s health and the economy. HRB NCTO, as an integrated Clinical Trial network, will be aligned to the local supports of the existing clinical trials infrastructures to ensure a harmonised strategic national approach to the conduct of high-quality clinical trials in Ireland.

Services and Activities

The HRB NCTO provides overarching support and expertise, through a range of services and activities to academia and industry. The partner CRF/Cs in Ireland provide the infrastructure, physical space and facilities, experienced research and specialist support staff and the necessary quality and oversight programs that are critical for the successful conduct of world-class patient-focused research.

The HRB NCTO services and activities have been developed to help address the unmet needs in clinical research in Ireland at present. We are working to address the clinical research needs of research participants, healthcare professionals, the life sciences industry and academia.

HRB NCTO are involved in activities to support all aspects of clinical research and offers services to academia and industry such as:

Signposting – Primary point of contact for clinical innovation and research, facilitating industry and academia.
Advisory – Consultation on regulatory pathways and provision of advice on conduct of clinical research in all fields.
Study start-up – Range of supports available to optimise start-up activities, including central coordination and dedicated resource in CRF/Cs accelerating all aspects of the process at the site level.
Recruitment – Tracking/monitoring of recruitment targets. Collation of metrics across CRF/Cs and provision of advisory support.
Consultancy – Consultancy support from product concept to commercialisation.

The HRB NCTO National Study Feasibility Programme connects academic and industry sponsors with potential investigators. HRB NCTO act as the channel through which study feasibility assessments can be distributed and completed efficiently. The HRB NCTO Investigator Membership Database and the Irish CRF/C network is utilised to significantly reduce the time taken to identify investigator sites and to assess study feasibility. For Oncology Studies, we collaborate with Cancer Trials Ireland and Cancer Trials Research Units across Ireland on these feasibility assessments.

The HRB NCTO works with and supports a number of clinical research networks. Clinical research networks are groups of clinicians and scientists from across Ireland who have come together around a particular disease, or clinical interest. Investigators agree on research activities that are best conducted as a large group nationally rather than in isolation.