Research - Clinical Trials Unit

The unit currently has 30 active recruiting trials, and plans are in place to not only increase this number but also to improve the service experienced by Principle Investigators and the logistics and design of trials.

“The CTU will make conducting top quality clinical research easier for PIs within the CUHP partners, and encourage more people to do clinical research and realise their ideas. Regulatory and legal affairs can be complicated, particularly for drug trials, and the CTU can provide expert advice and help to ensure compliance with GCP and the UK legislation. By providing such a service, and also expert help with design and management, we hope to encourage more people into research.” said Dr Wilkinson.

Alongside Dr Wilkinson and his Assistant Director Dr Sabine Kläger, the unit employs seven Clinical Trial Coordinators, three Monitors, and a QA manager and a senior statistician. This number is set to grow with the appointment of a data managers and a safety lead and the transfer of staff from other already existing trial teams across the institutions.

The work of the CTU staff is organised under three work streams, namely:

a)      Clinical Trial Management and Coordination

b)      Quality Control and Safety

c)      Data Management and Statistics

Dr Ian Wilkinson, the Director of the Cambridge Clinical Trials Unit (CCTU)

“The CTU should be a core facility for all researchers across the partners - and being part of CUHP will facilitate this - it will avoid duplication, allow common ways of working and should foster collaborative research and recruitment between partners and hopefully affiliates.”

At present the CTU portfolio has mainly CUH and University of Cambridge sponsored CTIMPs. These include trials like the multi-centre Pathway Trial led by Morris Brown, Professor of Clinical Pharmacology at the University of Cambridge and funded by the British Heart Foundation. This trial is designed to inform future NICE guidelines about the best drug regimes for the treatment of resistant hypertension. It will address whether to patients should have 1 or 2 antihypertensive drugs, and identify the best treatment for resistant hypertension.

The CTU is funded by the Biomedical Research Council, Cambridge University Hospital and Cambridge and Peterborough Foundation Trust as well as receiving funds raised by investigators/studies in relationship to trials.

The CTU aims to manage the whole process of conducting the research from conception to close down and publication including:

• The grant application with appropriate resource-costing and identification of necessary resources;
• protocol development, study design, statistics;
• preparation of submissions to Ethics (REC) and MHRA for ethical and regulatory approval;
• to data capture (paper CRFs or electronic data capture by eCRFs);
• data base set-up and data base management;
• development of plans of analysis;
• data analysis;
• IMP sourcing;

The Unit is already very active in multi-centre trials, and will seek formal NIHR accreditation at the next call. A successful application being an important step as it will enable the Unit to be better placed to make large HTA and NIHR grant applications.

As Dr Wilkinson concludes: "We are excited for the future of the Clinical Trials Unit. It provides an excellent opportunity for the CUHP partners to work together in the pursuit of high-quality research which will in turn lead to better treatments for patients, better outcomes and improved population health."

Trial highlights

Below are some of the current trials managed by the Clinical Trials Unit: