National Institute for Health Research (NIHR)
The National Institute for Health Research (NIHR) is a UK government agency that funds research into health and care. With a budget of over £1 billion, it is the largest national clinical research funder in Europe. The NIHR offers a focused source of research funding for the health systems across England, with the devolved nations participating in some of these programmes. The NIHR provides support and facilities to the NHS for delivery of research by funding a range of infrastructure such as the Clinical Research Network and Biomedical Research Centres. It was created in 2006.
Clinical Research Network (CRN)
The NIHR Clinical Research Network (CRN) supports patients, the public and health and care organisations across England to participate in high-quality research, advancing knowledge and improving care. The CRN is comprised of 15 Local Clinical Research Networks and 30 Specialties who coordinate and support the delivery of high-quality research both by geography and therapy area. National leadership and coordination are provided through the CRN Coordinating Centre. The CRN enables high-quality health and care research in England by meeting the costs of additional staff, facilities, equipment and support services so that research is not subsidised with funding that has been provided for health and care treatments and service. The CRN also provides a vast range of national and local resources and activities that support health and care organisations, staff, and patients and service users to be research active, such as specialist training, information systems to manage and report research, patient and public involvement and engagement initiatives, and communications expertise. The CRN supported over 6,100 studies and recruited over 870,000 participants in 2018/2019. The NIHR offers a study support service for industry. NOTE: Some 2,700 research projects and clinical trials have been halted by the current COVID-19 crisis so that research staff can either be diverted to COVID-19 treatment and vaccine programmes or moved to frontline hospital duties.
Experimental Cancer Medicine Centres (ECMCS)
A network of Experimental Cancer Medicine Centres (ECMC) has been established across the UK to drive the development of biomarkers and new anti-cancer treatments. Launched in 2006, this is a joint initiative between Cancer Research UK and the Departments of Health in England, Scotland, Wales and Northern Ireland. ECMC brings together world-leading clinical experts, working collaboratively to deliver pioneering, early-phase clinical trials and translation of scientific discoveries into new cancer treatments for patients. The network is made up of 18 adult centres (including in Glasgow, Edinburgh, Belfast, Cardiff, Newcastle, Liverpool, Manchester, Leicester, Birmingham, Cambridge, Oxford, Southampton, Institute of Cancer Research, Imperial, King’s College) and 11 paediatric locations across the UK (Glasgow, Newcastle, Leeds, Manchester, Liverpool, Birmingham, Bristol, Southampton, Institute of Cancer Research, UCL, and Great Ormond Street). It is based in Cancer Research UK and supported by the NIHR.
Health Research Authority (HRA)
The Health Research Authority (HRA) is an executive non-departmental public body of the Department of Health and Social Care. It exists to provide a unified national system for the governance of health research. The HRA’s core purpose is to protect and promote the interests of patients and the public in health and social care research. To do this, it makes sure that research is ethically reviewed and approved, promotes transparency in research, oversees a range of committees and services, and provides independent recommendations on the processing of identifiable patient information where it is not always practical to obtain consent, for research and non-research projects.
NIHR BioResource
The NIHR BioResource (National Institute for Health Research) is a unique resource for studying disease mechanisms and investigating the links between genes, the environment, health and disease; enabling scientific discoveries and facilitating translational medicine for the benefit of patients. Its mission is to facilitate human health research and its transformation into medical practice. There are 13 NIHR BioResource Centres—located in Birmingham, Cambridge, Exeter, Leeds, Leicester, London (includes Barts, Guy’s & St Thomas’, Maudsley, Moorfields, and UCLH), Manchester, Newcastle and Southampton. Each BioResource has established groups of healthy volunteers and patients with common or rare diseases who have provided samples (of blood, saliva or other) and agreed to be recalled by genetic make-up (genotype) and/or physical characteristics (phenotype) to participate in medical research and trials. Currently they have recruited over 100,000 volunteers and aim to recruit 300,000 by end of March 2022.
NHS DigiTrials
NHS DigiTrials is the Health Data Research Hub for clinical trials and is part of a number of new services being developed to enable more efficient and effective clinical trials. NHS Digital saw a valuable opportunity to support clinical trials while protecting patient privacy with the scale and reach of the data held in trust for the nation. Working in partnership with the University of Oxford Big Data Institute, IBM and Microsoft, and commissioned by Health Data Research UK through the UKRI Industry Strategy Challenge Fund, it has created the NHS DigiTrials Service to provide data, expertise and infrastructure specific to clinical trials. The first release of the service focuses on enabling a rapid feasibility assessment of the number and location of eligible patients through secure analysis of clinical and demographic data sets. This service aims to enable more opportunities for participation in research, to reduce the cost and complexity of developing new treatments, and to reduce drug costs to the NHS by improving the quality of evidence on the effectiveness and safety of new treatments for patients and their doctors. Further phases, subject to funding, will look at identification, communication and outcomes.
NOTE: Data from NHS Digital is being used by researchers in the fight to find treatment for patients diagnosed with coronavirus. The Randomised Evaluation of COVid-19 Therapy (RECOVERY) trial run by scientists at the University of Oxford is using data from NHS Digital’s Secondary Uses Service and other data sets, to help assess the effectiveness of a number of potential treatments for Covid-19.
Patient Recruitment Centres
The NHS Patient Recruitment Centres represent an initiative set up in response to the 2018 Life Sciences Industrial Strategy – Sector Deal Two to achieve the vision of increasing the NHS’s capacity to deliver research, enabling significant growth and opportunities for patients to benefit from early access to innovation. In October 2019, the NIHR Clinical Research Network launched the first stage of a competition to establish five new Patient Recruitment Centres which are set to shape the future of commercial clinical trials in the NHS. NHS organisations have been invited to bid to host one of the five Centres across England. Each Centre will operate on a national franchise-like model, using predefined standard operating procedures and technology to enable a digital-first approach to recruitment into clinical trials. A consistent approach to operations will allow sign-off to facilitate the rapid set-up of studies. A Programme Office is being established to oversee the delivery of the five new Centres.
UK Clinical Research Collaboration (UKCRC)
The UK Clinical Research Collaboration (UKCRC) brings together the NHS, research funders, industry, regulatory bodies, Royal Colleges, patient groups and academia in a UK-wide environment to facilitate and promote high quality clinical research for the benefit of patients and to establish the UK as a world leader in clinical research. It provides a forum for all the Partners–major stakeholders influencing clinical research—to work together to transform the clinical research environment in the UK. The forum promotes a strategic approach to identifying opportunities and obstacles to clinical research and their resolution. The Partnership brings together the major stakeholders that influence clinical research in the UK. The Partners: Academy of Medical Sciences, Association of British Healthcare Industries (ABHI), Association of the British Pharmaceutical Industry (ABPI), Association of Medical Research Charities (AMRC), Academy of Medical Royal Colleges, BioIndustry Association (BIA), BEIS, Cancer Research UK, Department for Employment and Learning Northern Ireland, DHSC, Health Research Authority, Research England, Higher Education Funding Council for Wales, Economic & Social Research Council, NIHR INVOLVE, MHRA, MRC, NICE, Public Health Agency for Northern Ireland, NHS England, PHE, Scottish Funding Council, Scottish government Health Directorate, Wellcome Trust, and Welsh Assembly Government.
Exemplar Longitudinal Studies
Accelerating Detection of Disease
The Accelerating Detection of Disease challenge is recruiting a world-leading cohort of up to 5 million participants by 2024 to support research intended to improve the early detection, risk stratification, and early intervention of chronic diseases in individuals, before symptoms present. The cohort aims to collect biological (blood) samples and health related data on all 5 million participants, with plans to collect repeat samples from a subset. By using AI and data, research in early diagnosis can be accelerated, leading to better prevention and treatment of disease. The pioneering programme is unparalleled – in the UK and globally – in its attempt to tackle the challenge of early diagnosis of major chronic illness in an entire population. The challenge will develop a major enduring national resource that will support new AI approaches to early diagnosis and biomarker discovery while enabling the development, testing and validation of new diagnostic tools at scale. Funding: £79 million from the Industrial Strategy Challenge Fund with an expectation matched funding of £160 million from industry.
NIHR BioResource
The NIHR BioResource is comprised of volunteers from around the country who have given a biological sample and consent to access their medical notes or health related records, while expressing a willingness to be approached to participate in research studies and trials on the basis of their genotype and/or phenotype. There are 13 NIHR BioResource local centres at NIHR Biomedical Research Centres throughout England located in Birmingham, Cambridge, Exeter, Leeds, Leicester, London (includes Barts, Guy’s and St Thomas’, Maudsley, Moorfields and UCLH), Manchester, Newcastle and Southampton. Each centre will recruit people with and without health conditions. Currently they have recruited over 100,000 volunteers.
Avon Longitudinal Study of Parents & Children (ALSPAC)
The Avon Longitudinal Study of Parents and Children (ALSPAC), also known as the ‘Children of the 90’s’, is a cohort study of children born in the former county of Avon during 1991 and 1992. Based at the University of Bristol, ALSPAC is the most detailed study of its kind in the world, providing a rich resource for the study of the environmental, biological and genetic factors that affect health and development. The initial recruits included 15,247 pregnant women with estimated dates of delivery between April 1991 and December 1992. Since then the fathers, siblings and children of the participants have also begun to be studied and the study has launched Children of the Children of the 90’s as a new generation is born. Examples of findings: In the study, 2.5% of 4,000 people born in 1991 and 1992 were found by ultrasound scanning at the age of 18 to have non-alcoholic fatty liver disease (NAFLD). Five years later transient elastography (fibroscan) found over 20% to have the fatty deposits on the liver of steatosis, indicating NAFLD, and half of those were classified as severe. The scans also found that 2.4% has the liver scarring of cirrhosis. ALSPAC data is accessible to bona fide researchers by applying through the ALSPAC online proposal system.
Salford Lung Study in COPD
The Salford Lung Study in COPD was a 52-week, prospective, comparative, open-label, randomized controlled trial conducted in Salford on the outskirts of Manchester. The study generated effectiveness and safety data for a new treatment, GlaxoSmithKline’s Relvar, in a population of COPD patients intended to represent that seen in everyday clinical practice. It was the first study of its kind with a broad and inclusive patient population with varied lifestyles and comorbidities, a Randomised Controlled Trial (RCT) considered to be the first of its kind globally as a large, prospective, real-world trial conducted across a patient population within a single geographic setting. RCTs are viewed as the gold standard in clinical trials.