Leicester’s Clinical Trials Unit gains full National registration

Posted by er134 at Nov 26, 2013 12:25 PM |
Unit dedicated to high quality clinical trials meets the 'gold standard' set by UK’s Clinical Research Collaboration

Issued by University of Leicester Press Office on 26 November 2013

Leicester’s Clinical Trials Unit, a partnership between the University of Leicester and Leicester’s Hospitals, was awarded the UK’s Clinical Research Collaboration (UKCRC) Full Registration in October 2013.

The UKCRC Registered CTU Network hosted by the University of Leeds established a national registration process for Clinical Trials Units (CTUs) in 2007, with full registration now the gold standard against which CTUs are measured.

Running high quality trials which meet regulatory and governance requirements is a complex process and depends on expert design, conduct and analysis. CTUs are specialist units set up with a specific remit to bring together the expertise needed to undertake a clinical trial, including clinicians, statisticians, IT programmers and trial managers.

In order to obtain Full Registration status, the Leicester CTU (LCTU) was required to provide evidence to an international review panel of experts that we had met the UKCRC’s stringent competency criteria. Over the last 12 months the Unit has concentrated its efforts on:

  • Working with local investigators to develop and increase the number of active trials managed through the Unit.  There is now a growing portfolio across a range of therapeutic areas such as cardiovascular disease, diabetes, gastroenterology and respiratory care, with other specialities coming on-board all the time.
  • Increasing the number of local grant applications supported by the Unit.  In the last 6 months there has also been an increase in the number of requests from investigators outside of Leicester to support this function.
  • Demonstrating the emergence of a growing publications library, which has included several papers from the diabetes group and others in preparation from other therapeutic areas.
  • Increasing the LCTU workforce to ensure all UKCRC specified posts were in place prior to submission of the application. The Unit now has statisticians, trial managers, data managers and IT programmers.

Professor Melanie Davies, Director of the Leicester CTU, said: “We are absolutely delighted to have secured this recognition for our CTU, which now puts Leicester at the forefront of running large scale high quality clinical trials.  This will not only be of great benefit to our patients, but also for our local Investigators who now have access to a fully registered local Unit and who have previously had to look for clinical trial support from outside of Leicester.

“The LCTU team, with support from the University of Leicester and Leicester’s Hospitals, has worked incredibly hard over the last 12 months to ensure that we met all of the accreditation and competency criteria required by the international review panel. The University of Leicester has put high quality clinical research as part of its long term strategic planning, and we are all looking forward to taking the Unit from strength to strength.”

Ends

Notes to editors:

For more information contact Yvonne Docherty at: yed3@le.ac.uk

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