New signpost to clinical trial expertise
Press release issued: 29 October 2008
A new comprehensive online resource listing national expertise in the design and conduct of clinical trials is launched today. The UKCRC Registered Clinical Trials Units website provides, for the first time, centralised information on Clinical Trials Units (CTUs) in the UK – including the Bristol Randomised Trials Collaboration (BRTU) at the University of Bristol.
The UKCRC Registered Clinical Trials Units website provides, for the first time, centralised information on Clinical Trials Units (CTUs) in the UK – including the Bristol Randomised Trials Collaboration (BRTC) and the Clinical Trials and Evaluation Unit (CTEU) at the University of Bristol.
The new website will be a valuable resource for clinical researchers and funders wishing to identify CTUs that can help them to design and run high quality trials for the benefit of patients. It has been developed and funded by the National Institute for Health Research (NIHR) Clinical Research Network Coordinating Centre on behalf of the UKCRC Partners.
Developing and running a clinical trial is a complex process and CTUs are specialist units that bring together the experts needed to design, manage and analyse a trial. These include clinicians, statisticians and trial managers who together ensure that clinical trials are conducted in line with appropriate standards and regulations.
The Bristol Randomised Trials Collaboration (BRTC) and the Clinical Trials and Evaluation Unit (CTEU) are two of forty CTUs listed on the website, all of which have achieved UKCRC Registration status.
BRTC is a long-standing collaboration between the University’s Departments of Community Based Medicine and Social Medicine in the design and conduct of high quality phase III randomised trials, and provision of training courses in trial methodologies.
Dr Alan Montgomery, Director of the BRTC said: “We conduct trials in both primary and secondary care settings, and in many different disease areas, including mental health, diabetes, child health, and cancer. The methodological expertise within BRTC comprises statistics, economics and social science.
“Areas of particular interest include complex trial design, and the application of social science to improve recruitment, design and conduct. As members of academic departments, our approach is to establish full and formal academic collaboration at all stages of a project, including design, development, conduct, analysis and reporting.”
The CTEU was formed in 2002 to coordinate randomised trials being carried out in the Bristol Heart Institute. Many of these trials aim to evaluate cardiac surgery innovations. The CTEU is the Trial Management Centre for a large MRC-funded CRISP trial, which will use surgical-expertise based randomisation to evaluate on versus off pump coronary surgery in high risk patients. The CTEU is also at the heart of the NIHR Biomedical Research Unit for Cardiovascular Disease recently awarded to the University Hospitals Bristol and the University of Bristol, coordinating eight early phase trials that form the majority of the research programme.
Dr Chris Rogers, Co-Director of the CTEU said: “While cardiac trials are our primary focus we do not work exclusively on cardiovascular studies. For example, the CTEU is also coordinating multi-centre trials on blood conservation and treatments for age-related macular degeneration, including the IVAN trial.”
The trials expertise of the University (including both the Trials Units and a new MRC-funded trials methodology centre led from the Department of Social Medicine) will be showcased at a regional event in the spring .
The new UKCRC Registered Clinical Trials Units website will allow researchers and funders to easily locate CTUs by name or location or find suitable CTUs by disease research areas (eg diabetes, mental health), methodological research areas (eg economic evaluation, systematic reviews and meta-analysis) or specific types of clinical research study (eg surgical trials, trials of investigational medicinal products). CTUs can also be identified by their experience of working with particular funders of clinical research.
Professor Janet Darbyshire, Joint Director of the NIHR Clinical Research Network Coordinating Centre, said “Working with Clinical Trials Units can help to increase the quality of clinical trials which ultimately means that the results are more meaningful. The UKCRC Registered Clinical Trials Units website provides an easy route for researchers and funders to tap into the fantastic experience and expertise that these units provide.”
Dr Liam O’Toole, Chief Executive of the UKCRC, said: “Easy access to the kind of information provided by this website will help researchers and funders, including the pharmaceutical industry, to easily identify CTUs which can help their studies. The launch of this website is part of a range of measures to ensure that the UK is at the forefront of carrying out high quality research for the benefit of patients.”