The last few years has been an exciting time of development for the Northern Ireland Clinical Trials Unit (NICTU).
Since its launch in 2013, the NICTU, under the leadership of Prof Danny McAuley (Director) and Ms Lynn Murphy (Manager), has dealt with a large number of requests for collaboration and support from researchers in NI and the UK. It has established itself as a highly successful UKCRC registered unit with a portfolio that continues to expand and cover a broad spectrum of disease areas, which range from feasibility to late phase studies of investigational medicinal products (IMP) or in the area of public health research.
Not all the studies which the CTU agrees to support are eventually funded, however the number of high quality clinical research studies now running in the NICTU has steady grown. For example, fourteen full grant applications with NICTU involvement were submitted during 2014, of which 10 have now been awarded, a total of over £7M. Currently in the NICTU there are 14 studies in set-up, 9 studies open and recruiting, and 9 closed studies in follow-up. Many of these are complex Randomised Controlled Trials (RCTs) recruiting tens to hundreds of patients across multiple sites in the UK. An examples of an NICTU supported study is highlighted below...
There are now nearly 50 highly skilled clinical trial staff members in the NICTU helping researchers by providing expert advice and input at the research planning and grant application stage, and providing specialist services such as statistics, health economics, trial management, data management and monitoring for particular studies on a fee for service basis following the award of a grant. The role of CTU staff is also now being recognised in a number of the outputs and publications arising from the supported studies.
This is an exciting time for the development of clinical research in Northern Ireland and the NICTU is playing a key role in providing the infrastructure and capacity in the delivery of high quality clinical research.
If you wish to collaborate with the NICTU please click here. The NICTU is focused on providing full trial co-ordinating services undertaking trial management, statistics and data management for research studies which are targeting major funders such as National Institute of Health Research (NIHR), research councils and charities. Due to the rapid success of the CTU, there is a need to prioritise studies for support. If the NICTU are unable to support your research study directly, then through their involvement within the UKCRC Network of registered CTUs they will try and help you identify another appropriate CTU that could support your study.
In addition to core funding provided by the PHA HSC R&D Office, the work of the NICTU is supported from a variety of different funding sources including the National Institute of Health Research (NIHR), Cancer Research UK (CRUK), Arthritis Research UK, the Alzheimer's Society and British Heart Foundation.
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Queen’s University Belfast (QUB) was awarded the grant by the National Institute of Health Research Efficacy and Mechanism Evaluation Programme (NIHR EME) and the study commenced in December 2010. The Belfast Health and Social Care Trust (BHSCT) and the National University of Ireland (NUI) Galway sponsored the study under the leadership of Professor Danny McAuley and Professor John Laffey and in collaboration with the Northern Ireland Clinical Trials Unit.
Acute lung injury (ALI) is a common devastating clinical syndrome characterised by lifethreatening respiratory failure requiring mechanical ventilation and multiple organ failure. There are in vitro, animal studies and pre-clinical data suggesting that statins may be beneficial in ALI. The Hydroxymethylglutaryl-CoA reductase inhibition with simvastatin in Acute lung injury to Reduce Pulmonary dysfunction (HARP-2) trial was a multicenter, prospective, randomised, allocation concealed, double-blind, placebo-controlled clinical trial which aimed to test the hypothesis that treatment with simvastatin would improve clinical outcomes in patients with ALI.
The study recruited 540 patients, with 259 patients assigned to simvastatin and 281 to placebo. Simvastatin therapy, although safe and associated with minimal adverse effects, did not improve clinical outcomes in patients with ARDS. Patients were followed for 12 months and we await the final report in relation to the long term follow up data which will inform the effects on health related quality of life (QoL) and cost effectiveness. We would like to thank all the patients and their legal representatives who participated in the trial, and all the research nurses, pharmacists and medical staff in participating centres who cared for patients and collected data.