The Brighton and Sussex Clinical Trials Unit (BSCTU) has been awarded provisional registration from the UK Clinical Research Collaboration (UKCRC) Registered CTUs Network.
Clinical trials units (CTUs) are specialist units that have been set up with a specific remit to design, conduct, analyse and publish clinical trials and other well-designed studies. They have the capability to provide specialist expert statistical, and other methodological advice and coordination to undertake successful clinical trials.
The BSCTU team were required to provide evidence to an international panel of experts of the unit’s capability to centrally coordinate multi-centre clinical trials and demonstrate that they had established robust systems to ensure conduct and delivery of clinical trials to the highest quality standards.
Nicky Perry, Operational Manager for the unit said: "Receiving provisional registration is recognition of the involvement that the BSCTU has provided to support high quality research across a range of therapy areas. The unit plays an important role in helping clinical trials to evaluate whether treatments are safe and effective, ultimately leading to an improvement in the health and quality of life for patients. We will continue to develop in order to meet the criteria for full registration in three years' time.”
As a member of the national network of clinical trials units, the BSCTU will now have the opportunity to work with other units, and gain a national profile that will attract researchers from across the UK.
The BSCTU is among 51 units registered following the 2017 Registration Review Process by thenetwork. The unit also has expertise in the coordination of trials involving investigational medicinal products, which must be conducted in compliance with the UK Regulations governing the conduct of clinical trials resulting from the EU Directive for Clinical Trials.
Professor Kevin Davies, Head of the Department of Clinical and Experimental Medicine at BSMS and Interim Director of the unit, said: " I am delighted that we have received provisional registration. This is a tribute to all the hard work that the team have put in over the last three years. The CTU will, I am sure, make a huge difference to clinical research at BSMS, and within the wider regional health economy."
Sir Kent Woods, Emeritus Professor at the University of Leicester and Chair of the International Review Committee said: "The International Registration Review Committee is delighted to see the clear impact of this programme on the quality of conduct of clinical trials research in the UK."