University of Leicester’s clinical trials expertise highlighted in international review

Posted by ap507 at Aug 29, 2017 10:18 AM |
Leicester’s Clinical Trials Unit successfully re-registers with the UKCRC CTU Network

Issued by University of Leicester Press Office on 29 August 2017­

The UK Clinical Research Collaboration (UKCRC) Registered Clinical Trials Units Network has announced that 46 clinical trials units - including the University of Leicester’s Clinical Trials Unit - have been successfully registered following the 2017 Registration Review Process which was led by an International Review Committee of experts. 

The Leicester Clinical Trials Unit functions as a partnership between the University of Leicester and Leicester’s Hospitals.

The outcome of the 2017 round brings the total number of UKCRC Registered Clinical Trials Units to 51.

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 bring together the expertise needed to undertake a clinical trial, including 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.

Professors Melanie Davies and Kamlesh Khunti, Co-Directors of the Leicester Clinical Trials Unit, commented: “We are delighted with the outcome that the Leicester Clinical Trials Unit continues to receive full registration.”

Clare O’Loghlen, the Unit’s Operations Director, added: “Continuing registration reflects Leicester Clinical Trials Unit’s experience and expertise in the design and delivery of large-scale, multi-centre clinical trials. It provides evidence to all our stakeholders that we work to high quality standards and make an important contribution to the successful delivery of clinical trials in a complex, challenging and ever-changing clinical research landscape.”

Professor Nigel Brunskill, Director of Research and Innovation at Leicester’s Hospitals, said: “I am delighted that Leicester Clinical Trials Unit has retained its status as a UKCRC Fully Registered CTU. It is a testament to the excellent staff at the unit who have demonstrated their ability to manage large scale, multi-centre clinical trials in Leicester and beyond.”  

Sir Kent Woods, Emeritus Professor at the University of Leicester and Chair of the International Review Committee said: “The International Registration Review Committee is delighted to see the clear impact of this programme on the quality of conduct of clinical trials research in the UK.”

The registration process was coordinated in the University of Leeds by the UKCRC Registered CTU Network Secretariat on behalf of the UK Clinical Research Collaboration.

Professor Julia Brown, Director of the UKCRC Registered CTU Network, said: “The University of Leeds is delighted to host the UKCRC Registered CTUs Network which we see as key to underpinning the delivery of high quality clinical trials research in the UK.”

A full list of the Registered Clinical Trials Units is available at www.ukcrc-ctu.org.uk

Results of the 2017 Registration Review Process are available at http://www.ukcrc-ctu.org.uk/page/Results2017

ENDS

For further information contact:

Clare O'Loghlen

Operations Director

Clinical Trials Unit, University of Leicester

Tel: 0116 258 8631

Email: col3@leicester.ac.uk

Saeeda Bashir

Programme Manager

Tel: 0113 3439132

Email: S.M.Bashir@leeds.ac.uk

NOTES TO EDITORS

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.

Further information on the UKCRC Clinical Trials Unit Registration Process is available at www.ukcrc‐ctu.org.uk.

2)   A list of all currently registered clinical trials units is available at www.ukcrc‐ctu.org.uk.

3)   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. Detailed information on UKCRC activities can be found on the UKCRC website at www.ukcrc.org.

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