National Institute for Health Research (NIHR) – Written evidence (COV0041)
The Department of Health and Social Care invests over £1 billion a year in health and care research through the National Institute for Health Research (NIHR) to improve the health and wealth of the nation.
How the NIHR has responded to COVID-19
The NIHR has played and continues to play a critical role in prioritising, funding and delivering research into COVID-19. This submission focuses on areas defined for this Inquiry.
To ensure the best use of NHS resources for clinical research during the acute phase of the pandemic, the NIHR established a single UK-wide process to prioritise COVID-19 research as Urgent Public Health Research. This process covered funded studies (whether funded by the public sector, industry or charities).
Through this process the NIHR Clinical Research Network is providing support to expedite delivery of urgent public health research, including phase II and phase III clinical trials, by fast tracking the local set-up, management and delivery of COVID-19 studies and placing them onto the NIHR CRN Portfolio. Early in the pandemic a decision was taken to pause the set-up of non-urgent studies in the CRN. The UPH system ensured that recruitment would continue for urgent studies. This system also ensures that these studies will be supported to recruit during a possible second wave, when other studies may need to be paused again.
Over 100,000 participants have been enrolled by NIHR in urgent COVID19 research studies. A total of 48 studies that will deliver an impact within 12 months have been prioritised (https://www.nihr.ac.uk/covid-studies/). The system was designed initially for studies on therapeutics and vaccines. In May 2020 the decision was taken to extend the remit so that mental health studies are eligible for UPH badging. Two such studies have been approved to date.
Now that the numbers of new COVID-19 cases have declined substantially, the NIHR is working towards the restoration of a diverse and active portfolio of research funded and/or supported by the NIHR – including both non-COVID-19 research and important COVID-19 research which does not meet our urgency criteria. To help initiate this process, the NIHR has developed a ‘Framework for restart’ (https://www.nihr.ac.uk/documents/restart-framework/24886), which is a guidance document to support local decision-making.
The NIHR and UKRI have committed £24.6 million to UK researchers through a joint Rapid Response Call run during February and March 2020. Twenty-seven awards were made in response to this call: four on vaccines; four on therapeutics; four on diagnostics and underpinning platforms; eight on epidemiology; and seven on social science. All have a delivery date of 12 months or less.
Since early April the NIHR and UKRI have been running a Rapid Response Rolling Call for research (delivering within 12 months) that could make a significant contribution to the understanding, prevention and/or management of the COVID-19 outbreak. The selection panel meets weekly to consider applications.
As part of the Rolling Call, NIHR has published a number of highlight notices to seek research proposals on high-priority areas, and separate subpanels have been set up to consider applications.
So far 23 projects have been agreed for funding through the Rolling call. Substantial investments in immunology and in the longer-term effects of COVID-19 on patients are being made. The call closes to applications at the end of June 2020. A list of all projects from the rapid call and those from the rolling call currently in the public domain is at Annex A. An updated list of the funded projects will be sent to the Committee when the call ends.
The NIHR also funds infrastructure to provide capacity to support high-quality early translational, clinical and applied research. This infrastructure includes:
These centres and facilities are supporting the early phase trials to rapidly assess new candidates as treatments or vaccines for COVID-19.
The Clinical Research Network (CRN) provides the infrastructure to support the set-up and timely delivery of commercial and non-commercial studies and trials throughout England, enabling patients and health professionals to participate in relevant research. The CRN provides efficient support for the initiation and delivery of funded research, including providing services to assist industry and contract research organisations. The NIHR CRN provides capacity to support clinical studies and trials, across the country (outside of the traditional research centres) as has been pivotal in supporting the delivery of numerous clinical trials and studies for COVID-19 including the Phase III platform trials such as RECOVERY.
The NIHR Applied Research Collaborations have been contributing to research and service change, evaluating newly emerging service models and reconfigurations, enhancing the ability of the NHS to deliver effective care during the pandemic and develop an evidence base to support recovery and learning in the health and care system.
Analytical and clinical evaluation of diagnostics for COVID19 in hospital and community settings is being supported by a new platform (CONDOR) developed by the NIHR Medtech and In vitro diagnostics Co-operatives.
DHSC provides long term support to a number of NIHR Health Protection Research Units (HPRUs), each a partnership between a university and Public Health England, with additional collaborating institutions. These Units undertake multi-disciplinary research to inform the delivery of PHE’s objectives and functions for the protection of the public’s health. The NIHR has 14 specific HPRUs which are funded for five years to research high priority areas, including: antimicrobial resistance; emerging infections; emergency preparedness, resilience and response and immunisation. They also retain a responsive research capacity in the event of a major health protection incident and to respond to emerging health protection research requirements.
The HPRUs are undertaking a broad portfolio of research in response to the COVID-19 pandemic. Five key units are making a particularly significant contribution to COVID-19 research. These are:
A rapid prioritisation process has been developed for the NIHR Policy Research Programme (PRP) to assess requests for policy research and analysis related to immediate COVID-19 policy questions from within the Department of Health and Social Care and ALBs, as well as suggestions for research from Policy Research academics. The requests and suggestions are currently reviewed on a weekly basis. A range of projects have been approved through this process, with the titles published on the NIHR website: https://www.nihr.ac.uk/documents/policy-research-programme-covid-19-research/24757.
The NIHR has launched a call for research to inform recovery and learning from and responses to the COVID-19 pandemic. This extends across NIHR’s Research Programmes and includes an NIHR Policy Research Programme initiative to inform national policies for recovery, renewal and reset of the health and care system.
The NIHR is also supporting either through direct funding or co-funding and/or through the Clinical Research Network a number of other studies. These include:
The NIHR has launched the Global Effort on COVID-19 Health Research funding call to tackle COVID-19 in low- and middle-income countries (LMICs), in partnership with UKRI. This call will use ODA (Official Development Assistance) research funding to support applied health research to understand the pandemic and mitigate its health impacts in LMICs.
The NIHR is also supporting a number of other funding calls with global partners focusing on COVID-19 research in LMICs. The NIHR has contributed to efforts by the Coalition for Epidemic Preparedness and Innovation (CEPI) to fund and coordinate vaccines research, and to an emergency call for research in sub-Saharan Africa and capacity strengthening for pandemic responses through the European and Developing Countries Clinical Trials Partnership.
In addition, the NIHR is working with the Department for International Development on a rapid response research call through its Research for Health in Humanitarian Crises (R2HC) partnership, to support the COVID-19 response in humanitarian settings.
Engaging and involving patients, carers and the public in order to improve the reach, quality and impact of research is a fundamental operating principle of NIHR. New commitments for patient and public engagement during covid-19 pandemic were published. https://www.nihr.ac.uk/news/nihr-reaffirms-its-support-for-patient-and-public-involvement-engagement-and-participation-during-the-covid-19-pandemic/24641
The NIHR has published information about COVID-19 for patients in the Be Part of Research section of its website, (https://bepartofresearch.nihr.ac.uk/) including how to get involved and information on supporting research in Black, Asian and minority ethnic communities (https://www.bepartofresearch.nihr.ac.uk/COVID-19-Research/COVID-19-for-BAME-communities/).
The NIHR has also supported the development of a website by UK Research and Innovation - Coronavirus: the science explained (https://coronavirusexplained.ukri.org/en/)- that lays out the evidence and the facts about the virus, the disease, the epidemic, and its control.
NIHR Research in Key Areas of interest to the S&T Committee
Studies funded through the NIHR/UKRI Rapid Response and Rolling Calls (to be updated)
Virology and research needs
A protease activity profiling strategy to inhibit cell-to-cell transmission of SARS-CoV-2
Understanding environmental and airborne routes of transmission
Epidemiology, modelling and testing
nCoV: Serological detection of past SARS-CoV-2 infection by non-invasive sampling for field epidemiology and quantitative antibody detection
COVID-19 National DiagnOstic Research and Evaluation Platform (CONDOR)
University College London
Virus Watch: Understanding community incidence, symptom profiles, and transmission of COVID-19 in relation to population movement and behaviour.
University College London
Healthcare Workers: an in depth virological analysis and behavioural study during the outbreak
Coronavirus STORY (Serum Testing of Representative Youngsters)
Early Assessment of COVID-19 epidemiology and Vaccine/anti-viral Effectiveness (EAVE II)
nCoV: A global registry of women affected by COVID-19 in pregnancy, understanding natural history to guide treatment and prevention
Transmission and mathematical modelling:
London School of Hygiene and Tropical Medicine
Understanding the dynamics and drivers of the COVID-2019 epidemic using real-time outbreak analytics
MRC Biostatistics Unit, University of Cambridge
Estimating severity from multiple data sources using Bayesian evidence synthesis
University of Exeter
Spatial heterogeneity in transmission and the impact of interventions: a mathematical modelling approach
Martie van Tongeren
University of Manchester
Chinese gig workers: unsung heroes and a strategic role in national response to the COVID-19 epidemic
Mathematical modelling and adaptive control to inform real time decision making for the COVID-19 pandemic at the local, regional and national scale
Vaccines and treatments
nCoV: Rapid Clinical Development of ChAdOx1 nCoV-19
saRNA SARS-CoV-2 vaccine
Alexander (Sandy) Douglas
Enabling availability for clinical use of 1 million doses of chimpanzee adenovirus-vectored COVID-19 vaccine by summer 2020
Underpinning assays and animal models
Development of an NHP model of infection and ADE with COVID-19 (SARS-CoV-2)
nCoV: Developing CoV-bnMABs for therapy of highly pathogenic coronaviruses including SARS-CoV-2
Development of an ovine polyclonal immunoglobulin therapy against COVID-19.
Repurposing FDA-Approved Drugs for Treatment of 2019-nCoV-induced Disease
University of Edinburgh
ISARIC - Coronavirus Clinical Characterisation Consortium (ISARIC-4C)
*Note: Convalescent plasma arms of RECOVERY and another phase III platform trial, REMAP-CAP, have been funded by NIHR but do not constitute an award made through the UKRI-NIHR joint call.
Other – behaviour and social science research:
A mixed-methods evaluation of advice on isolation and health-seeking to contain transmission
Understanding Chinese government containment measures and their societal impacts
Rapid co-design, implementation and evaluation of a digital behaviour change intervention to improve hand hygiene and limit spread of the COVID-19 outbreak
nCoV: Understanding the dynamics of policy development and healthcare worker behaviour in the UK during the Covid-19 public health emergency
Strengthening & Accelerating the Global Research Response to COVID-19 by Sharing Methods and Knowledge Between Countries, Networks and Organisations
Ethnicity and COVID-19:
Five studies have been funded. Details are to follow.
Mental health applications are being considered in early July 2020
Other – health and care
Irene J Higginson,
King's College London
Rapid evaluation of the COVID-19 pandemic response in palliative and end of life care: national delivery, workforce and symptom management (CovPall)