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UoB is a national leading institution for the delivery of clinical trials and associated health and methodological research. Its advantages as a clinical trial centre include very close integration with nearby NHS Trusts, particularly with its key partner the University Hospitals Birmingham NHS Foundation Trust (UHB), and access to one of the largest and most diverse patient catchment regions in Europe, and to a wide range of very well-characterised patient cohorts.

Birmingham Centre for Clinical Trials (BCCT)

We have three large, well-established Clinical Trials Units (CTUs), each fully registered with the UKCRC’s CTU network (such registration requires a track record of coordinating and delivering high quality multi-centre trials). These are the Cancer Research UK CTU, the Birmingham CTU and the Primary Care Clinical Research and Trials Unit, which all operate under the umbrella of the Birmingham Centre for Clinical Trials (BCCT).

The BCCT hosts one of the largest concentrations of trials expertise found in the UK, providing comprehensive, complementary expertise in cancer and non-cancer, primary and secondary care settings, and early and late phase. In the last five years we have conducted trials sponsored by almost all of the world’s top 20 pharma/biotech companies. The BCCT has a dedicated Early Drug Development team with expertise in industry-sponsored and academic-led trials, adult and paediatric oncology, solid cancers and haematology, liver medicine, molecularly targeted therapy, cellular immunotherapy and gene therapy.

The extensive and diverse portfolio of trials that has developed over many years is backed by a wealth of expertise in research governance and Birmingham contributes to national initiatives on trial conduct. Each of the three CTUs has a comprehensive Quality Management System in place and is committed to running trials to high quality standards.

The Cancer Research UK CTU

The Cancer Research UK CTU, established in 1984, is a centre of excellence for early and late phase trials in a wide range of rare and common cancers. It was one of the first National Cancer Research Institute accredited units, and receives core funding from Cancer Research UK. The unit has experience in running early and late phase trials
Clinical Trials and Translational Medicine Infrastructure
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involving Investigational Medicinal Products (including first in man studies), radiotherapy, devices, surgery, allogeneic stem cell transplantation, gene
therapy, immunotherapy, pharmacokinetics and pharmacodynamics, and biomarkers.

The unit’s early phase trials portfolio incorporates trials from the Experimental Cancer Medicine Centre Network, which is a CRUK-NIHR funded initiative to drive the development of new cancer treatments across the UK. The Unit has longstanding expertise in haematology and hosts the National Leukemia Research Fund Phase II Team that provides support to clinicians in the development of Phase II trials in haematology.

Birmingham is the coordinating hub of the Trials Acceleration Programme, a national trials network for blood cancers established in 2012 by the charity Leukemia and Lymphoma Research to speed up access to life-saving drugs. Cancer in children is another of the Unit’s particular strengths, and 152 trials previously managed by the Children’s Cancer and Leukemia Group were transferred to the Unit in 2010.

The Birmingham CTU

The Birmingham CTU researches the best treatment in a wide range of medical problems, specialising in large-scale trials in chronic conditions such as Alzheimer’s, Parkinson’s and renal disease. The Unit has grown rapidly since its inception in 1997, having been awarded funding of over £30m and now has 45 staff running some 20 trials. It provides the scientific, technical and computing expertise needed to support clinical trial research from conception through to completion, offering an open access consultancy service covering all aspects of trial design, management and analysis. The Department of Health, which provides core funding for the Unit, rated its research activities “world class in terms of quality and significance for health” at its review in 2007.

The Primary Care Research and Clinical Trials Unit

The Primary Care Research and Clinical Trials Unit is one of the largest and longest running academic primary care facilities in Europe for trials and longitudinal epidemiology in community population settings. It coordinates large and small community-based clinical trials, providing expertise in patient selection, recruitment, training, randomisation, data monitoring and data validation. It specialises in the prevention and management of cardiovascular disease and stroke, the early diagnosis of cancer, chronic major disease care, and behavioural interventions. The trials are mainly conducted within the Midlands Research Practices Consortium, a network of over 500 practices with populations that are representative of England and Wales which is managed by the Unit. The unit also hosts the Central England Primary Care Research Network, which it works with to facilitate primary care research.

Infrastructure and expertise for translational research

The three CTUs within the BCCT are embedded within a very extensive infrastructure and expertise for translational research provided by UoB and UHB, the close integration of which was formally reflected in the formation of an operational alliance, Birmingham Health Partners, in 2011. This infrastructure includes: the MRC Hub for Trials Methodology Research; the Health Economics Unit; the Public Health, Epidemiology and Biostatistics Unit; the National Horizon Scanning Centre; the NIHR-Wellcome Trust Clinical Research Facility; the Health Research Bus; the NIHR Liver Biomedical Research Unit; the Advanced Therapies Facility; the Human Biomaterials Resource Centre; the NIHR Surgical Reconstruction and Microbiology Research Centre; and the Centre for Translational Inflammation Research. The role and expertise of these units is described briefly below.

UoB is a centre of excellence for trials methodology and hosts the Midlands Hub for Trials Methodology Research, one of seven such hubs in the MRC Network. This facility is dedicated to providing research, training, and advice on methodology to trial practitioners. Key areas of expertise and research activity include: quality of life evaluation for clinical and health economic assessment; discovery and evaluation of diagnostic, prognostic and predictive biomarkers; phase II clinical trials; evaluation of non-drug interventions, particularly radiotherapy; trials in rare diseases; time-to-event analysis; issues in trial conduct; Bayesian methods; systematic reviews and decision modelling for clinical and health economic evaluation.

The Public Health, Epidemiology and Biostatistics Unit

The Public Health, Epidemiology and Biostatistics Unit has an extensive programme of research allied to clinical trials, and in particular is an international centre of excellence for diagnostic research. This research focuses on the development and investigation of methods for evaluating medical tests in healthcare, including both primary and secondary research. The group provides methodological and statistical support for clinical projects evaluating particular tests.

The Health Economics Unit

UoB has a strong tradition in the field of health economics, with research and teaching in this field spanning some 30 years. The Health Economics Unit seeks to inform policy and resource allocation in the NHS, to guide research methodology, and to inform decision making on the development, commercialisation and adoption of new health interventions. It receives core funding from the NIHR and is one of the main health economics centres in the UK. It has major research strengths in the methodological area of modelling, evaluative spaces and the capability approach, and makes a major contribution to the NHS and NIHR at both national and local levels. It has an extensive teaching and learning programme aimed at building health economics research capacity and providing skills for people working in the health sector.

The National Horizon Scanning Centre

The National Horizon Scanning Centre, which is funded by the NIHR, aims to supply timely information to key policy and decision makers within the NHS about emerging technologies that may have a significant impact on patients or the provision of health services in the near future. It has a remit to identify key emerging pharmaceuticals, therapeutic vaccines, medical devices and equipment, diagnostic and predictive tests and procedures, rehabilitation aids and therapy, and public health activities.

The NIHR-Wellcome Trust Clinical Research Facility

The NIHR-Wellcome Trust Clinical Research Facility (WTCRF) is a joint initiative between UoB, UHB and Birmingham Children’s Hospital NHS Trust. It provides state-of-the-art facilities for experimental medicine and is the main platform for early phase, cutting edge translational research in Birmingham. It includes facilities for adult patients at UHB and for children at Birmingham Children’s Hospital. It is designed to be adaptable and supports study types across many different clinical specialities, including rare diseases as well as cancer, diabetes, stroke, dementia and obesity. More than 370 clinical research studies have been conducted in it, involving over 80,000 patients. In March 2012 the WTCRF was awarded £12.8m of the £100m funding awarded by the NIHR to the 19 CRFs in the UK, the largest award. The funding is being used on research nurses, technicians and facilities.

The NIHR WTCRF also has the UK’s first Health Research Bus (HRB), a pioneering mobile research facility launched in June 2010. It comprises a bespoke, high-specification, medical trailer unit containing state-of-the-art clinical research equipment. It contains clinic and procedure rooms, a bone density scanner and sample processing rooms, and is fully equipped for studies in both adults and children. The HRB facilitates research in the community, directly engaging the multi-ethnic population of Birmingham in clinical research and allowing investigators to take the latest developments from the laboratory to clinical practice as rapidly as possible. It provides easy access for potential volunteers, many of whom find accessing hospitals difficult, time-consuming and in some cases intimidating. We anticipate that the HRB will become an integral part of our outreach activities in schools and difficult to reach communities.

The Liver Biomedical Research Unit

The Liver Biomedical Research Unit is part of the translational research infrastructure shared between UoB and UHB. It was established in partnership with UHB in 2008 and has core funding from the NIHR. It houses a dedicated team which includes clinical research fellows, senior biomedical scientists, a trials coordinator, a trials statistician, research nurses and an MRI physicist. Its facilities include: a clinical leukapheresis machine to allow safe isolation of blood cells from patients; a cell analyser to phenotype therapeutic cells; a 3T MRI machine to study the trafficking of labelled cells after infusion into patients; and a GCLP standard laboratory for the reception, processing and storage
of clinical specimens with blood and tissue processing equipment and a real-time PCR analyser to allow rapid analysis of patient samples. Ongoing translational research programmes in the Unit include those in immune modulation and inflammation; anti-HCV therapies; liver regeneration, repair and stem cells; liver cancer immunotherapy; metabolic and fatty liver disease; and hepatocellular carcinoma.

The Advanced Therapies Facility (ATF)

The Advanced Therapies Facility (ATF), which is adjacent to the WTCRF, is a specialised facility for preparation of biological therapies for clinical trials. It houses a clean room suite to prepare both cell therapy and gene therapy products to GMP standard. It is anticipated that the facility will receive accreditation and licensing from the MHRA for manufacture of Investigational Medicinal Products and Advanced Therapy Medicinal Products early in 2013. One of only a few such facilities for GMP manufacture of cell therapies in the UK, it allows supply of novel biological therapies to the WTCRF and other clinical settings in the vicinity.

The Human Biomaterials Resource Centre (HBRC)

The Human Biomaterials Resource Centre (HBRC) is a tissue bank located in a brand new purpose-built facility funded by the Regional Development Agency, UHB, UoB and the MRC. Licensed by the Human Tissue Authority, the HBRC provides appropriately consented, quality-assured biomaterials for biomedical research in both academia and industry. It collects and stores samples in line with local and national research strategies, but also carries out bespoke tissue collection where there is a specific research need. It is approved to collect samples from most NHS Trusts in the West Midlands and from patients in a wide variety of disease settings. All samples are annotated with appropriate demographic and clinical data. The HBRC also provides a tissue sample hosting service and a range of histopathological research services, including fixation, paraffin embedding and sectioning, immunohistochemistry, in-situ hybridiation, nucleic acid preparation and PCR.

The NIHR Surgical Reconstruction and Microbiology Research Centre

The NIHR Surgical Reconstruction and Microbiology Research Centre (SRMRC) is a groundbreaking £15m trauma care initiative based at the Queen Elizabeth Hospital, where all returning injured UK military personnel are treated. It is a collaboration between UoB, UHB, the Ministry of Defence and the Department of Health, intended to share medical research and advanced clinical practice for the benefit of both military and civilian trauma patients at an early stage of injury. The CSRM brings together pioneering advances in surgery and infection by both military and civilian scientists as well as clinicians to deliver innovative treatments in this complex area of acute care. Its research focuses on the most urgent challenges of trauma, including: identifying effective resuscitation techniques; surgical care after multiple injuries or amputation; and fighting wound infections. With regard to treating infections, the CSRM is applying state-of-the-art microbiological, genetic and immunological techniques, including rapid DNA sequencing of bacterial genomes.

The Centre for Translational Inflammation Research (CTIR)

The Centre for Translational Inflammation Research (CTIR) is a joint strategic initiative between UoB and UHB. Also located at the Queen Elizabeth Hospital, it brings together translational inflammation research programmes on rheumatology, ageing, respiratory medicine, nephrology, ophthalmology, immune senescence and trauma. The CITR incorporates the Birmingham Chronic Disease Resource Centre, which is aimed at systematic studies on well-defined cohorts of patients from different inflammatory disorders from the viewpoint of common pathogenesis and treatment in a holistic and unified manner.

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