The King's Clinical Trials Unit has been awarded full CTU registration by the UK Clinical Research Collaboration (UKCRC) 

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.

 

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)

What is a Fully Registered Unit?

In order to obtain Full Registration status, Clinical Trials Units were required to demonstrate:

·     A track record and experience of coordinating multi-centre randomised controlled trials or other well-designed studies.

·     Presence of a core team of expert staff to develop studies.

·     Presence of robust quality assurance systems and processes to meet appropriate regulations and legislation.

·    Evidence of longer-term viability of capacity for trials coordination and the development/maintenance of a trials portfolio.

A CTU may also be awarded provisional status - evaluation criteria for Provisional Registration were developed for Units that did not meet the criteria for Full Registration status, but that are working towards possessing sufficient expertise to enable Full Registration in the future. A full list of Registered Units (both provisionally and fully registered) can be found at www.ukcrc-ctu.org.uk

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 NIHR is establishing a new network of Research Design Services (RDS) to help researchers develop and design high quality research proposals for submission to national, peer-reviewed funding competitions for applied health or social care research (e.g. the NIHR Research for Patient Benefit Programme and Programme Grants for Applied Research). 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.