About Us

Excellence in Clinical Trial Design and Conduct

 

Establishment of the LCTU at the University of Leicester

The clinical trials unit was set up in 2009 by the University of Leicester, with core funding provided through the  College of Life Sciences. Following a rigorous registration process we achieved 'full registration' status in 2013 and were re-accredited in 2017.

The LCTU functions as a partnership between the University and the University Hospitals of Leicester NHS Trust in the delivery of clinical trials. It provides an infrastructure to bring together the expertise of many academic clinicians and other health service researchers in Leicester, the East Midlands and beyond.

 

Remit of the LCTU

The LCTU is a UK Clinical Research Collaboration (UKCRC) registered clinical trial unit working with Investigators from across a range of therapeutic areas.

Our aim is to work in in collaboration with researchers, investigators and clinicians to design and conduct high quality multi-site randomised controlled trials. We have expertise in trial methodology and design, site set-up and central trial management, IT and data-management, and finally, trial statistics and conducting final data analysis.

Establishing and maintaining an on-going relationship with investigators is a priority area for us. We like to invest a significant level of commitment to each grant application with the common goal of succeeding in high quality grant applications, the delivery of first class research, and the development of an track-record of success.GCP image text

All CTUs are managed under a strict UKCRC operating framework and are performance monitored on a yearly basis. Therefore, the trials we support must contribute to the on-going registration process we are mandated to undergo in order to retain our UKCRC registration. This is achieved by engaging in a true collaboration between us and the investigator, rather than simply providing a stand-alone services.

Whilst one of our key performance areas is the support of NIHR funded multi-site randomised controlled trials with central CTU oversight (as demonstrated below with an extract from the UKCRC website), we are committed to assessing each collaboration request on its merits, whilst considering our current workload commitments.

 

Academic research

world mapAs an academic research unit, the we are particularly interested in supporting studies that reduce the uncertainties facing doctors and patients in daily clinical practice. These studies are typically funded from external sources, such as the National Institute for Health Research (NIHR) grant schemes and the medical charities.

The aim of the LCTU is to facilitate the conduct of high quality clinical research and ensure the generation of reliable evidence for the management of a wide range of diseases

 

 

Core competencies

We support investigators by providing access to the core competencies of

  • Trial design
  • Multi-site trial management
  • Database provision and data management
  • Statistics

The services available from the LCTU include contribution to grant applications, trial design, sample size calculations, protocol development, ethics committee and regulatory submissions, database build and data management, randomisation, trial management, data entry, analysis, interpretation and statistical reporting.

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