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Brighton & Sussex Medical School

Brighton and Sussex CTU

BSMS > Research > Clinical and experimental medicine > Brighton and Sussex CTU

Brighton and Sussex CTU

The Brighton and Sussex Clinical Trials Unit (CTU) provides 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 University of Brighton and University of 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. 

We received provisional registration from the UK Clinical Research Collaboration (UKCRC) in May 2018. 

Group photo of staff from the CTU department, showing off their accreditation certificate

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?

We need to ensure the following criteria are met in order to be able to provide CTU support for your project:-

  • 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

Costings

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.

Getting started

If you would like to use the services of the CTU, you will need to complete the CTU proforma.

Download the CTU pro forma >

A useful resource for clinical trial development is the NIHR clinical trials toolkit.

A flowchart about how to use CTU services. Text description below.

Outline Description 

Flowchart on how to get started using CTU services.

Top of the chart begins Q: “Have you discussed your project with the Research Design Service www.rds-se.nihr.ac.uk and BSMS/BSHU finance team?” (2 options)

  1. If Yes “RDS can assist you with project design.
  2. If Yes “If you would like CTU support email BSCTU@bsms.ac.uk” (1 option)
  3. “Complete CTU proforma and send to BSCTU@bsms.ac.uk

Second section of the chart follows, begins Q: “Form reviewed by CTU group” (2 options)

  1. If Yes “CTU will confirm level of support and costings”
  2. If No “Contact your local host organisation/Trust R&D”

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

BACKGROUND IMAGE FOR PANEL

Publications

The latest publications from the Brighton and Sussex CTU.

A phase IV randomised, open-label pilotstudy to evaluate switching from proteaseinhibitorbased regimen to Bictegravir/Emtricitabine/Tenofovir Alafenamide singletablet regimen in Integrase inhibitor-naïve,virologically suppressed HIV-1 infectedadults harbouring drug resistancemutations (PIBIK study): study protocol fora randomised trial >

Protocol for a phase IV, open-labelfeasibility study investigating non-invasivemarkers of hepatic fibrosis inpeople living with HIV-1 and non-alcoholicfatty liver disease randomisedto receiving optimised backgroundtherapy (OBT) plus maraviroc orOBT alone >

Low-Intensity Guided Help Through Mindfulness (LIGHTMIND): study protocol for a randomised controlled trial comparing supported mindfulness-based cognitive therapy self-help to supported cognitive behavioural therapy self-help for adults experiencing depression >

Treatment of White Coat HYpertension in the Very  Elderly Trial (HYVET 2) - Feasibility of a Randomized  Controlled Trial (Study Protocol) >

Reducing Implant Infection in Orthopaedics (RIIiO): Results of a pilot study comparing the influence of forced air and resistive fabric warming technologies on postoperative infections following orthopaedic implant surgery >

Palliative long-term abdominal drainsversus repeated drainage in individualswith untreatable ascites due to advancedcirrhosis: study protocol for a feasibilityrandomised controlled trial >

How can we optimise inhaled beta2agonist dose as ‘reliever’ medicine forwheezy pre-school children? Study protocolfor a randomised controlled trial > 

Reducing Implant Infection in Orthopaedics(RIIiO): a pilot study for a randomisedcontrolled trial comparing the influence offorced air versus resistive fabric warmingtechnologies on postoperative infectionrates following orthopaedic implant surgeryin adults >