28 August 2012

'Gold Standard' for Clinical Trials Unit

Tayside Clinical Trials Unit (TCTU) - a joint initiative between the University of Dundee and NHS Tayside - has been given 'gold standard' full registration status by the UK Clinical Research Collaboration.

The UKCRC is the national body overseeing clinical trial units in the UK. To receive full registration a unit such as TCTU has to demonstrate to an international panel of experts that it can coordinate multi-centre clinical trials and deliver them to the highest quality standards as well as publish the results in quality journals.

"This is effectively placing a gold standard against the work of the Unit and is a major achievement that can bring significant benefits to Tayside," said Professor David Bearn, co-Director of TCTU.

"It means we are internationally recognised as operating to the best standards in handling major clinical trials. That can only help attract further research funding."

TCTU was only formed in June 2008 and granted initial registration by the UK Clinical Research Collaboration in 2009.

The Unit brings together the expertise needed to undertake a clinical trial, including clinicians, statisticians, software developers and trial managers. Working across a broad spectrum of indications not limited to drug trials, TCTU is also active in dental projects, paediatric studies and healthy lifestyle interventions.

Clinical trials have been a key part of establishing Tayside as a major centre of world-class medical research. They bring benefits to patients by allowing researchers to develop better treatments and improve prevention of major diseases such as cancer, diabetes, cardiovascular diseases and others.

"Clinical trials are a key part of research and we are lucky in Tayside to have enjoyed extremely strong public support for the work done here," said Professor Peter Donnan, Co-Director of TCTU.

"Running a trial is a complex process and registered Units must have the expertise to design, coordinate and analyse multi?centre clinical trials, ensuring that they are conducted in line with appropriate standards and regulations. But perhaps the most important thing is that we must have the trust and support of the general public as we cannot do these trials without them."

NOTES TO EDITORS

The UKCRC (UK Clinical Research Collaboration) is a partnership consisting of representatives of academic and NHS researchers, funders of medical research and the pharmaceutical industry, established with a key aim of ensuring high quality design, conduct and analysis of clinical trials carried out in the UK. In order to achieve this, the UKCRC established a Registration Process for Clinical Trial Units (CTUs).

To help achieve this, a Registration Process has been established for CTUs responsible for coordinating multi-centre clinical trials and other well-designed studies. The UKCRC Registration process is designed to help improve the quality and quantity of available expertise to carry out clinical trials in the UK.

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