Functions and Services of Registered CTUs
Key roles of CTUs
Clinical Trials Units (CTUs) are specialist units which 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, epidemiological and other methodological advice and coordination to undertake successful clinical trials. In additon, most CTUs will have 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. CTUs which have been awarded UKCRC Registration were required to provide evidence to an international panel of experts of their capability to centrally coordinate multi-centre clinical trials (i.e. having overall responsibility for the design, development, recruitment, data management, publicity and analysis of a portfolio of trials), and that they had established robust systems to ensure conduct and delivery of clinical trials to the highest quality standards.
Further details about the criteria used in the CTU Registration Process can be found in the section on CTU Registration Process.
Functions and services provided by Registered CTUs
Registered CTUs will usually work with the Chief Investigator of a clinical study on the following:
- Development of new trials
- Identification of the right questions and appropriate design
- Systematic reviews (when appropriate)
- Discussions with different disciplines for different trial components e.g. quality of life, health economics, associated translational research
- Development of sub-studies
- Costing the trial and planning the staffing required to develop and manage the trial
- Communication with the Clinical Research Networks regarding feasibility and levels of interest
- Consideration of regulatory and governance issues
- Negotiations with international collaborators, if applicable
- Negotiations with industry, if applicableCoordination and preparation of the grant applicationManagement of funded trials
- Coordinating protocol development and design of Case Report Forms (CRFs)
- Liaising with potential centres, identifying and initiating participating centres, and maintaining good communication with each centre
- Setting up the trial and obtaining relevant permissions (ethics approval, MHRA approval, etc)
- Recruiting clinical sites in order to identify and recruit eligible trial patients and allocating a trial entry number and treatment to trial patients
- Central coordination and management of essential trial documents and patient data collected from participating clinical sites
- Data monitoring
- Conducting interim and final analyses
- Preparation of reports (e.g. for funding bodies, NRES, MHRA, Data Monitoring Committees, Trial Steering Committees)
If you are interested in working with a Registered CTU, you should contact them as early as possible in the process. Ideally, this should be at least 3 months before a research grant deadline in order to provide the CTU with adequate time to schedule the work required and ensure the CTU is able to offer the full benefit of its experience and knowledge from the initial stages of study development.If you would like to work with a Registered CTU, you will need to provide them with information about your study. The CTU collaboration request proforma shows the type of information a CTU will require from you. Once you have contacted a CTU you can complete this form to provide details about the study. However, some CTUs have their own collaboration request form in place, so please contact them before completing this form.
The contact details for the Registered CTUs are available in the Resource Finder of this website. CTU staff also have other roles such as representation on national and international advisory and review committees, and membership of Data Monitoring Committees and Trial Steering Committees for trials run by other CTUs. Registered CTUs do not directly recruit participants into clinical trials. This is carried out by the investigators and research staff in the Clinical Research Networks.
Other clinical research resources available to researchers
In addition to CTUs, other organisations which are also available to advise and collaborate with researchers include:
Experimental Medicine Facilities
These facilities provide expertise in the design and conduct of experimental medicine and early phase clinical trials. Further information about these resources can be found on the UKCRC Experimental Medicine Resources website.
NIHR Research Design Services (RDS)
The Research Design Service provides design and methodological support to health and social care researchers across England in order to help them develop grant applications for NIHR and other national peer-reviewed funding programmes. RDS advisers in bases across England offer a unique breadth of experience and a proven track record in improving research applications. Advice is confidential and free of charge. Further information about NIHR Research Design Services can be found here.
MRC Hubs for Trials Methodology Research
These are UK-wide regional centres of excellence that will undertake high-quality research into clinical trial methodology. The methodology hubs will have close links with those carrying out clinical trials. Individual hubs will offer specific clinical and methodological expertise. Further information about MRC Hubs for Trials Methodology Research can be found here.