A total of 40 clinical trial units (CTUs) have successfully completed a registration process introduced by the UK Clinical Research Collaboration (UKCRC) to help improve the quality and quantity of expertise available to carry out studies in the UK.

A call for applications to register suitable clinical trial units with the UKCRC went out in March 2007. Of the 40 CTUs across the UK that met the criteria for the Clinical Trials Unit Registration Process, 26 were awarded Full Registration and 14 Provisional Registration. CTUs granted Provisional Registration were “clearly working towards developing sufficient expertise to enable Full Registration” but did not yet fulfil all of the requirements around infrastructure, resources and experience, the UKCRC said.

The registration process was co-ordinated by the UK Clinical Research Network (UKCRN) Coordinating Centre. Applications for registration were assessed by an international review panel led by Professor Adrian Grant, chair of the Institute of Applied Health Sciences at the University of Aberdeen.

To qualify for Full Registration, CTUs had to demonstrate a number of key competencies including a track record of co-ordinating multicentre clinical trials and other well-designed studies; a team of expert staff to develop these studies; robust quality-assurance systems and processes; sufficient resources to provide adequate and stable infrastructure as well as senior staff; and evidence of long-term viability to co-ordinate clinical trials. Eligible CTUs had to be capable of taking overall responsibility for the design, conduct and analysis of a trial as well as data management and publicity.

Vital component
Developing and maintaining high-quality capacity for specialist trial design, conduct and analysis is a vital component of the UKCRC’s programme to re-engineer the environment for clinical research in the UK, the partnership noted. Not only are these standards needed to meet regulatory and governance requirements for clinical trials, but they help to ensure there is sufficient national capacity to develop and manage the growing number of studies generated through the activities of the UKCRN and the UKCRC, the latter pointed out.

Next year the UKCRC will undertake a modelling exercise to review the CTU capacity requirements in the UK. A second call for applications to register clinical trial units under the UKCRC scheme is planned for May 2009.