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July 1, 2016

Breaking news: Five centres form National Clinical Research Framework

Pictured is Catriona Creely, HRB. Fennell Photography Copyright 2013By Lloyd Mudiwa.

The five university-based clinical research facilities (CRFs) in the Republic are developing an integrated clinical trial network, provisionally referred to as the National Clinical Research Framework (NCRF), meant to enhance Ireland’s capacity for conducting innovative high quality clinical research for the benefit of people’s health and the economy.

The Health Research Board (HRB), fresh from supporting a record-breaking year for cancer clinical research, is backing up some of the facilities or centres, which on the campuses of Cork University Hospital (University College Cork), Galway University Hospitals (NUI Galway), St James’s Hospital (Trinity College Dublin), St Vincent’s University Hospital (University College Dublin) and Beaumont Hospital (RCSI).

It supports the centres at GUH and CUH. The HRB also jointly supports the one at St James’s with The Wellcome Trust.

The Network will advance the care of patients by enabling a connected and coordinated Clinical Trial Network. This network will provide the skills, expertise and infrastructure to design, conduct and analyse multi-centre clinical trials involving human participants in Ireland. It will support both academic and industry-initiated clinical trials involving pharmaceuticals, neutriceuticals or clinical care pathways as well as clinical investigation of medical devices.

“Through the NCRF, the HRB want to leverage existing expertise at the five national clinical research facilities in Ireland to enhance capacity for multi-site clinical trials in Ireland,” said Dr Caitriona Creely, Programme Manager, Clinical and Applied Biomedical Research, HRB. “The framework will also help integrate all recent investments in clinical research and infrastructure nationally. Ireland has great potential to build a reputation internationally for innovative, high-quality clinical research that will benefit people’s health, patient care and the economy.”

Supporting the appointment of the Development lead is the next positive step in making this happen, Dr Creely said.

To facilitate this development the HRB has provided funding for the employment of a Development Lead to be based within the RCSI. This is for an initial eight-month period, however the successful candidate may well have the opportunity to serve a longer-term role within the NCRF, once established, according to the HRB.

Over the eight-month development period the successful candidate will work principally with the five facilities, but also with the HRB and other potential funding bodies, the Dublin Centre for Clinical Research and the Irish Clinical Research Infrastructure Network.

The position is for a high-calibre candidate to drive the development and delivery of a five-year business plan in line with the NCRF strategic objectives, working in close collaboration with the CRF/CRC Directors.

“This business plan will be subject to evaluation by the funders and, if successful, will lead to funding to establish the NCRF. The development of the business plan will require to compare and ultimately integrate within the NCRF, the current individual policies and procedures of the five CRFs/Cs and their associated universities with regard to interactions with potential funders, strategic policy development, business development approach, governance and reporting structures, staffing requirements, project resource allocation, costing models, indirect costs policy, sponsorship requirement, intellectual property rights and technology transfer agreements, quality management, IT platforms and security, external vendor approval and publication policies.”

The Development Lead will facilitate the undertaking of a small number of demonstrator industry-funded clinical trials between the CRF/CRCs and will engage with potential users of the NCRF such as national and international clinical trials networks, academic and philanthropic funding bodies and industry, around future business opportunities.

The position will be funded by HRB by means of a grant, which will be administered by the RCSI on behalf of the CRF directors group.