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Clinical Trials Unit
Leicester CTU is a UK Clinical Research Collaboration (UKCRC) registered clinical trial unit working with Investigators from across a range of therapeutic areas.
LCTU works in collaboration with researchers, investigators and clinicians to design and conduct high quality multi-site randomised controlled trials (RCTs), and has expertise in the following: trial methodology and design; site set-up and central trial management; IT and data management; trial statistics and conducting of final data analysis.
The primary remit of the Leicester ECMC is to support early phase oncology clinical trials and translational research programmes. Our early phase trial portfolio is run through the Hope Clinical Trials Centre which is directed by our ECMC clinical lead, Professor Anne Thomas. HCTC benefits from ECMC-funded trials pharmacy and nursing support. On average each year, the facility hosts nearly 4000 patient visits.
Visit the ECMC Network website
Clinical trial planning and work-up
HCTC has capability to deliver first-in-man and early phase academic and commercial trials which are often part of key national and international multi-site studies. If you wish to bring a study into the portfolio, all enquiries should be directed to Professor Anne Thomas or Lydianne Lock in the first instance.
Prior to any formal trial work-up for progression to Green Light status, project approval must be obtained through the Cancer Research Strategy Board to ensure that there is sufficient capacity and staffing to undertake the proposed work.
Statistical support in trial design, sample size calculation, writing and reviewing statistical analysis plans (SAP), trial end-point analyses and dissemination can be applied for through our ECMC trials statistician based at the Leicester Clinical Trials Unit. The Statistician has a particular interest in statistical programming and automation of results procedures to improve data output efficiency. Applications can be made by filling out the ECMC stats collaboration request form.
ECMC study support
The ECMC research and tissue collection team are able to support study-related paperwork and ethical submissions for non CTIMPs. In addition, applications can be made to support sample collection and processing from across Leicester’s hospital sites. Priority will be given to support: phase I clinical trials; multi-centre consortia; short term support to accelerate research outputs; support for new academics; where key staff are on long-term leave; where samples support numerous research projects.
All enquiries should be directed to the ECMC translational research manager, Dr Lynne Howells in the first instance.
Our capacity and expertise in delivering first-in-man, phase I and phase II trials has been the successful driver for our large portfolio of key national and international studies, ensuring we deliver critical ECMC objectives which revolve around expediting patient benefit from new treatments.
Additionally, we provide critical support for non-interventional studies which underpin our research themes to deliver our translational and reverse-translational research objectives.
Outputs for which ECMC support has been critical cover a wide range of malignancies, chemo, radiological, biological and immune therapies. A selection of key clinical and translational research outputs are listed below.
Haematological malignancies (Phase I/II)
Chronic lymphocytic leukaemia (Danilov et al, 2020; Walter et al, 2017; Walter et al, 2016), Mantle cell lymphoma (Rule et al, 2019); Diffuse large B cell lymphoma (Walter et al, 2019).
Solid tumours (Phase I/II)
Colorectal cancer (Howells et al, 2019;), Oesophagogastric cancer (Thomas et al, 2020; Iveson et al, 2014), Breast cancer (Robertson et al, 2020), Mesothelioma (Szlosarek et al, 2017)
Translational research studies (Non-interventional)
Chronic lymphocytic leukaemia (Chen et al, 2019; Chen et al, 2017), T-cell prolymphocytic leukaemia (Smith et al, 2020), Diffuse large B cell lymphoma (Smith et al, 2019), Breast (Seibold et al, 2019; Page et al, 2017; Johnson et al, 2017), Non-small cell lung cancer (Hanjani et al, 2017; Abbosh et al, 2017).
East Midlands Forensic Pathology Unit (EMFPU)
The research lead and Chief Forensic Pathologist for the Unit is Professor Guy Rutty.
EMFPU is a research intensive unit, providing wide-ranging aspects of forensic pathology research in conjunction with forensic pathology service provision to the East Midlands and other national and international organisations.
Service provision encompasses suspicious and homicide forensic pathology services, autopsy services, investigation of road-related fatalities, and injury opinion work. Our research focuses on forensic imaging, and in particular, the utility and diagnostic accuracy of post-mortem computed tomography.
All enquiries should be made to the EMFPU practice manger Wendy Pitts (email@example.com).
The Ernest and Helen Scott haematological research institute
The Ernest and Helen Scott haematological research institute was established in 2014 and is directed by Professor Martin Dyer, who holds a chair in Haemato-Oncology. One of the principal aims of the Institute is to expedite the clinical development and assessment of new precision medicines for the treatment of lymphoid malignancies.
Hope Against Cancer
Founded in 2002, Hope Against Cancer supports cutting-edge cancer research in the Leicestershire and Rutland area, striving for a future where more local people survive cancer.
Hope Against Cancer funds innovative research that leads to improved treatments and better outcomes for local people.
The Hope Clinical Trials Centre (HCTC) is based in the Osborne Building at Leicester Royal Infirmary, and provides a dedicated area for patients participating in clinical research studies, particularly those at the early stages of development. The mission of HCTC is to deliver excellence in clinical cancer research. Clinical trials offer hope for many people and an opportunity to help researchers find better treatments for others in the future.
Opened by Martin Johnson in May 2012, the Trials Centre is directed by Professor Anne Thomas and has been funded by the local Leicestershire and Rutland cancer charity Hope Against Cancer, the University Hospitals of Leicester NHS Trust and the National Institute for Health Research.
The ultimate aim of the LCRC translational research programme is to be able to offer patients more effective options in the early detection, prevention and treatment of cancer.
Clinical trials are a crucial way of determining whether a new treatment or test may offer patient benefit. The Hope Clinical Trials Centre plays an integral part in delivering clinical research and impact across all of our research themes.
Early phase studies
A comprehensive list of early phase studies that have been undertaken at Leicester can be found on the clinical trials government website.
Patient and public involvement
Patient and public involvement is at the heart of our early phase clinical trial strategy. The HCTC and Leicester ECMC have worked closely to involve patients when designing new studies via the Patient and Carer’s Advisory Group.
Together, we have designed materials that make understanding trials and the trial pathway more patient friendly. Our ‘What is…’ series gives an overview of some of the questions that patients new to a clinical trial might be interested in.
Hope Against Cancer Charity
Hope Against Cancer is the local cancer research charity for Leicestershire and Rutland, and is an important partner for The University Hospitals of Leicester and University of Leicester. The charity raises funds to support research aligning with the LCRC strategic themes for early detection, prevention and treatment of cancer.
In addition, Hope Against Cancer provides crucial and enabling funding for the Hope Clinical Trials Centre, and is a key supporter of our early career researchers.
Institute for Precision Health
The Institute for Precision Health (IPH) is directed by Professor Don Jones, and brings together the research expertise and facilities of the University of Leicester and University Hospitals Leicester NHS Trust with industry to advance new medicines and medical technology innovations to impact on healthcare in our multi-ethnic population.
The Leicester Drug Discovery and Diagnostics (LD3) translates the University’s high quality biomedical research into medicines, therapies and diagnostic tests with ‘real world’ benefit for patients.
LD3 works with industrial partners to deliver novel medicines and diagnostics with strong academic leadership and support from knowledge transfer professionals. The LD3 has dedicated staff and state-of-the-art laboratories and has received a number of MRC Confidence in Concept Awards.
Leicester Molecular Diagnostics (LMD)
The Leicester Molecular Diagnostics facility was established within the Leicester Cancer Research Centre to:
- provide a comprehensive service for molecular oncology testing
- undertake associated contract research for companies
- beta-test new kits, reagents, equipment or companion diagnostics
- support translational research aspects of clinical trials
LMD is committed to providing a highly specialised service, utilising the latest technology and taking into account the needs and requirements of our users. The laboratory is currently operating to GCLP standards but is working towards ISO 15189:2012 Medical Laboratory accreditation
Mesothelioma Research Programme
Professor Dean Fennell holds a chair in Thoracic Medical Oncology and is the Director of the Leicester Mesothelioma Research Programme. The goal of the Mesothelioma Research Programme is to improve clinical outcomes for patients with malignant mesothelioma by translating new scientific advances in biology, through local, national and international collaborations, with academic, charitable, and industrial sectors.