Registered Clinical Trials Units

Expertise in the design, conduct and analysis of clinical trials and other well-designed studies is vital to ensure high quality and successful timely trial conduct, and to meet regulatory and governance requirements. Clinical Trials Units (CTUs) can provide the full spectrum of expertise required to deliver high quality clinical research. Such high quality expertise is key to the development of research activity within UKCRC and UKCRN and in response to this, the UKCRC has developed a registration process which recognises CTUs capable of centrally coordinating multi-centre clinical trials to the highest standards.

The first call for applications was made in March 2007, with applications being invited from any CTU in the UK with overall responsibility for the design, recruitment, data management, publicity and analysis of multi-centred randomised controlled trials or other well-designed studies, working in any disease/topic area.

Two levels of registration were offered to CTUs: Full and Provisional registration.

Full Registration
In order to obtain Full Registration status, CTUs 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 (e.g. the principles of Good Clinical Practice, the NHS Research Governance Framework, the Data Protection Act and the UK regulations that implement the EU Directive for Clinical Trials)
evidence of longer-term viability of capacity for trials coordination and the development/maintenance of a trials portfolio, including core funding or evidence of a rolling programme of grants, with evidence of commitment from the host institution.

CTUs which were already accredited by the National Cancer Research Institute (NCRI) for the conduct of multi-centre cancer clinical trials automatically became eligible for Full UKCRC Registration provided that they agreed to commit to the UKCRC Registered Trials Units best practice principles as outlined below.

Provisional Registration
It was recognised that new and evolving CTUs may be developing relevant expertise and experience that is worth building on, but that these CTUs may currently fall short of the full complement of infrastructure, resources, and experience required for Full Registration status. Therefore, evaluation criteria for Provisional Registration were developed for CTUs that did not meet the criteria for Full Registration status, but that are working towards possessing sufficient expertise to enable Full Registration. These CTUs were granted Provisional Registration if they were able to demonstrate clear evidence of the competencies for Provisional Registration.

Review of applications
The assessment of applications was carried out by an international review committee comprising clinical trial experts as well as representatives from key UKCRC partner funding bodies. Applications were considered with reference to specific key competencies and evaluation criteria developed and approved by a committee of UKCRC Partners. These formed the basis by which proposals were assessed.

Units Awarded Full UKCRC Registration

Birmingham Clinical Trials Unit (University of Birmingham)
Bristol Randomised Trials Collaboration (University of Bristol)
Cancer Clinical Trials Unit Scotland (CACTUS) (ISD Cancer Clinical Trials Team, Edinburgh and Cancer Research UK Clinical Trials Unit, University of Glasgow)
Cancer Prevention Trials Unit (Barts and The London School of Medicine and Dentistry, London)
Cancer Research UK & UCL Cancer Trials Centre (University College London, London)
Cancer Research UK Clinical Trials Unit (University of Birmingham)
Centre for Healthcare Randomised Trials (CHaRT) (University of Aberdeen)
Children’s Cancer and Leukaemia Group (CCLG) (University of Leicester)
Christie Clinical Trials Unit (Christie Hospital, Manchester and MRC Clinical Trials Unit, London)
Clinical Trials Research Centre (University of Liverpool)
Clinical Trials Research Unit (University of Leeds)
Diabetes Trials Unit (Churchill Hospital, Oxford)
Edinburgh Clinical Trials Unit (University of Edinburgh and NHS Lothian Health Board)
Glasgow Clinical Trials Unit (University of Glasgow)
Institute of Cancer Research Clinical Trials & Statistics Unit (The Institute of Cancer Research, Surrey)
Medical Research Council Clinical Trials Unit (London)
Medical Research Council General Practice Research Framework & University College London Primary Care & Mental Health Clinical Trials Unit (London)
Newcastle Clinical Trials Unit (Newcastle University)
North Wales Organisation for Randomised Trials in Health (NWORTH) (University of Wales, Bangor)
Oxford Clinical Trials Research Unit (University of Oxford)
Oxford Clinical Trials Unit for Mental Illness (OCTUMI) (University of Oxford)
Peninsula Clinical Trials Unit (Peninsula College of Medicine & Dentistry, Plymouth)
Pragmatic Clinical Trials Unit (Barts and The London School of Medicine and Dentistry, London)
University of Southampton Clinical Trials Unit (University of Southampton and MRC Clinical Trials Unit, London)
Wales Cancer Trials Unit (Velindre Hospital, Cardiff)
Warwick Medical School Clinical Trials Unit (University of Warwick)

Units Awarded Provisional UKCRC Registration

Clinical Research & Trials Unit (Norfolk and Norwich University Hospital)
Clinical Trials and Evaluation Unit (University of Bristol)
International Centre for Circulatory Health Trials Unit (Imperial College London, London)
National Perinatal Epidemiology Unit (NPEU) (University of Oxford)
Northern Ireland Cancer Clinical Trials Unit with Northern Ireland Clinical Research Support Centre (Belfast City Hospital and Royal Hospitals, Belfast)
Northern Ireland Clinical Research Support Centre (Royal Hospitals, Belfast)
Nottingham Clinical Trials Support Unit (University of Nottingham)
Oxford Respiratory Trials Unit (Churchill Hospital, Oxford and MRC Clinical Trials Unit, London)
Oxford Vaccine Group (University of Oxford)
Primary Care Clinical Trials and Research Unit (University of Birmingham)
Sheffield Clinical Trials Research Unit (University of Sheffield)
South East Wales Trials Unit (Cardiff University)
The Keele Primary Care Musculoskeletal Trials Unit (Keele University)
York Trials Unit (University of York)

Best Practice Principles for UKCRC Registered CTUs
All UKCRC Registered CTUs are expected to collaborate within the framework of the UKCRC, i.e. committed to working towards the aims and objectives of the UKCRC and UKCRN and to collaborate on the various initiatives being developed. The application process required applicants to agree to the following principles:

A commitment to working with UKCRN to support clinical research, e.g. contribution to national Clinical Trials Unit committees and working groups
A commitment to providing study information and monthly accrual data to the UKCRN Portfolio Database for UKCRN portfolio studies
An organisational commitment to patient/public involvement.

Review of Registration Status
UKCRC Clinical Trials Unit Registration status will apply for 3 years (Full and Provisional). A review of all UKCRC Registered CTUs will be carried out every 3 years, to ensure that CTUs can still demonstrate the required competencies for Registration status. CTUs with Provisional Registration status will be able to apply for Full Registration status at the review.

Another call for UKCRC CTU Registration is anticipated early 2009 if there is sufficient interest. This will allow CTUs to apply when they are confident that the evaluation criteria for Full or Provisional Registration will be met.

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