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Brighton & Sussex Medical School

Brighton and Sussex CTU

BSMS > Research > Brighton and Sussex CTU

Brighton and Sussex CTU

The Brighton and Sussex Clinical Trials Unit (CTU) has been established in order to provide support and expertise for clinical researchers in the south east and beyond.

The CTU can support clinical research across a range of disciplines that will contribute to the evidence base for the diagnosis, management and prevention of disease. We aim to attract multi-centre, randomised controlled trials, but other well-designed studies will be considered. The Brighton and Sussex CTU is a collaboration with the Universities of Brighton and Sussex, BSMS, Brighton and Sussex University Hospitals NHS Trust and the NIHR Research Design Service South East.

The team can assist in the development of funding applications, trial design (including patient-related outcomes), study management, quality assurance, data analysis, dissemination and trial close-down. 

What is a CTU?

A CTU is a specialist unit that has been set up to support the design, conduct, analysis and publication of clinical trials and other well-designed studies.

It has the capability to provide specialist expert statistical, epidemiological and other methodological advice and coordination to undertake successful clinical trials.

In addition, most CTUs have expertise in the coordination of trials that involve investigational medicinal products. These trials must comply with UK regulations that govern the conduct of clinical trials, as resulting from the EU directive.

Sponsorship

The CTU cannot act as a sponsor. Please contact your R&D Manager to ascertain who will take on the role of sponsor. Written confirmation is required for CTU support.

What do we support?

The UK Clinical Research Collaboration (UKCRC) Registered Clinical Trials Units Network requires that CTUs provide specialist support around the design, conduct, analysis and publication of clinical trials and other well-designed studies.

In order to meet the criteria as a CTU, we need to ensure we have a balanced portfolio of studies and that the following criteria are met:

  • Source of funding must be awarded via a competitive process with evidence of appropriate level of peer review (potentially eligible for adoption on to CRN portfolio)
  • Mixed portfolio of studies: multi-centred RCT (phases II-IV) and other well-designed study
  • RDS or evidence of similar level of methodology support provided in development of grant, including statistics
  • Evidence of support from a sponsor (eg BSUH, SPT)
  • Evidence of statistician from core CTU management team involved from design through to dissemination
  • Evidence of other members of CTU core management team involved in grant development as required
  • CTU time and support clearly budgeted
  • Members of CTU team involved in final publications, as appropriate (agreed at study start up)
BACKGROUND IMAGE FOR PANEL

Current Studies

Find out more information about the studies currently supported by the Brighton and Sussex Clinical Trials Unit.

Read more > 

Costs

CTU costs need to be included in all grant applications and approved prior to submission.

Costs may include:

  • Statistician/statistical support costs
  • Trial managers/study oversight
  • Overheads to cover: use of data management systems, randomisations systems (if applicable), monitoring visits, travel and management of multi-centered studies

You will still need to contact the finance/award teams at your host organisation for full costing of the project.

Standard operating procedures

Standard Operating Procedures (SOPs) are written documentation of processes that require a standard of quality and consistency.

SOPs are an essential element for the control of clinical research from planning through to study closure, and for all the activities which support the clinical research process. All investigators accessing CTU support will be expected to adhere to CTU SOPs.

The advantages of a SOP system are to provide:

  • a standardised approach
  • a structure for systems development and continuous improvement
  • a best practice and processes in line with current legislation
  • an integration and training platform for individuals
  • a transparency in approach
  • an audit trail.

Example SOPs include: an SOP on SOPs • protocol development • risk assessment and monitoring • trial master file/site file (investigator and pharmacy) • regulatory approvals • trial initiation and site set up • data management • trial supplies • safety reporting/pharmacovigilance (if IMPs) • quality management systems • patient Information • training • registration/randomisation (if applicable) • statistics • IT/database • trial closure • end of trial reporting • archiving

Contacts

CTU staff include Prof Kevin Davies, Nicky Perry, Justine Boles, Debbie Lambert, Dr Stephen Bremner and David Crook.

Get in touch >