Press release issued 8 October 2012
Clinical Trials Units play an important role in helping to deliver quality research projects and two units in Bristol have been awarded full registration by the UK Clinical Research Collaboration (UKCRC).
The units were two of 46 clinical trials units (CTU) that have been registered following the 2012 review process, which was led by an International Review Committee of experts.
Professor Tom Walley, Director of the National Institute for Health Research (NIHR) Evaluation, Trials and Studies Programmes, said: “The NIHR continues to recognise the important and crucial role played by Clinical Trials Units (CTUs) in helping to deliver quality research projects. This registration process confirms the international standard quality of units in the UK and that the units are capable of delivering the high-standard required. The NIHR looks forward to continuing activities in support of these registered units.”
Dr Alan Montgomery, Director of BRTC and Dr Chris Rogers, Director of CTEU, said: “We are delighted to be awarded full registration. UKCRC registration is a measure of quality and only awarded to CTUs that can demonstrate a track record of experience in co-ordinating multi-centre trials, expert staff to develop studies, robust quality assurance systems and evidence of long-term viability of capacity for trials co-ordination.”
Dr Mary Perkins, UH Bristol Deputy Director of Research and Innovation, added: "We are delighted that both these clinical trial units have been awarded full registration by the UKCRC. It is a testament to the hard work from the teams within the units and to the quality of their work."
The registration process, which has been running since 2007, is designed to signpost the available high-quality expertise to carry out clinical trials in the UK. Clinical Trials Units are specialist units that include statisticians, trial managers, information technology specialists and clinicians. The Registered Units form a network of UK wide Clinical Trials Units some of which have been registered since the first round of the process in 2007. To be eligible to apply, the Units had to demonstrate they were capable of centrally coordinating multi-centre clinical trials and other well-designed studies, taking overall responsibility for the design, conduct, data management, publicity and analysis of a trial in line with appropriate standards and regulations.
The registration process was co-ordinated in the University of Leeds by the UKCRC Registered CTU Network Secretariat on behalf of the UK Clinical Research Collaboration.
1. The Clinical Trials Units are required to meet a number of key competencies, which are assessed against detailed evaluation criteria and reviewed by an international panel. These include a track record of experience in coordinating multi‐centre clinical trials, presence of expert staff and robust quality assurance systems, and evidence of long term viability of capacity for trials coordination. Clinical Trials Units that meet all these criteria will receive Full Registration. Those that were clearly working towards developing sufficient expertise to enable Full Registration but which do not yet meet all the criteria relating to infrastructure, resources and experience will receive Provisional Registration.
2. The Bristol Randomised Trials Collaboration (BRTC) has a particular interest in trials that are considered ‘hard to do’ because of perceived recruitment and other logistical difficulties, and in trials involving:
• complex interventions;
• complex trial designs;
• multidisciplinary methodological and clinical input;
• ‘hard to reach’ patient groups.
3. The Clinical Trials and Evaluation Unit carries out:
• studies to evaluate the effects of treatments and risk factors in patients with cardiovascular disease;
• methodological research to improve the way in which evaluations are conducted;
• studies to quantify the effects of treatment and risk factors include both randomised controlled trials (RCTs) and observational studies.
4. The UK Clinical Research Collaboration (UKCRC), established in 2004, is a partnership of organisations working together to establish the UK as a world leader in clinical research by harnessing the potential of the NHS. The Partners include the key stakeholders that shape the health research environment, including research funders, the NHS, government, industry, academia, regulators, charities and patients.
UKCRC registration is a measure of quality and only awarded to CTUs that can demonstrate a track record of experience in co-ordinating multi-centre trials, expert staff to develop studies, robust quality assurance systems and evidence of long-term viability of capacity for trials co-ordination.