Supporting all aspects of clinical trial research from concept to analysis and reporting 

Establishment of the CTU 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 Medicine, Biological Sciences and Psychology.

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

Remit of the Leicester CTU

To provide support for the design, conduct, analysis and reporting of clinical trials and other well-designed studies of health, social and educational intervention, or technologies.

Trials are taken on by the CTU, where timing and resource permits, on the basis that the research asks an important health question and is both scientifically and ethically sound.

Academic research

As an academic research unit, the Leicester CTU is 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 CTU 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 CTU include assistance with grant applications, trial design, sample size calculations, protocol development, ethics committee and regulatory submissions, randomisation, trial management and monitoring, pharmacovigilance reporting, and data entry, analysis, interpretation and reporting.