We are actively involved in a range of methodological research and other projects.
Our projects and partnerships help us to keep improving how NICE works. They also help us anticipate and adapt to policy developments, including changes in health and social care delivery.
IMI and H2020 Grant funded projects
The EHDEN project aims to set up a European federated network of data sources standardised to a common data model.
The network will enable observational research and the generation of high quality, real world evidence through open collaboration.
The ERA4TB project's main objective is to create a European open platform to accelerate the development of new regimens for the treatment of tuberculosis. The project consortium will do this through a new community-focused platform on tuberculosis translational research and knowledge integration.
During the project, NICE will act as an interface with key stakeholders to maximise uptake and impact of ERA4TB's results. The stakeholders are mainly:
- HTA agencies
- regulatory authorities
The project activity will complement our ongoing work in the area of antimicrobial resistance.
HARMONY PLUS, launched in October 2020, builds on the success of HARMONY in using big data and analytics to deliver knowledge that will improve the care of patients with several blood cancers.
The project expands the focus to additional blood diseases that were not covered by HARMONY and further deploys artificial intelligence techniques on an expanded big data platform.
The project aims to create and test a framework for ‘next generation’ health technology assessment to support patient-centred, societally oriented, real-time decision-making on access to and reimbursement for health technologies throughout Europe.
The framework will provide solutions for a broad range of challenges, such as:
- personalised medicine
- combination therapies
- big data and artificial intelligence (AI).
In recent years, there has been an exponential growth in the generation of data that could be harnessed for use in healthcare delivery and research. However, accessing, integrating, and analysing these data to maximise their value for patient care and research is extremely challenging.
IDERHA aims to create a scalable platform for the seamless integration or linkage of diverse data at scale to support healthcare professionals, patients, and researchers with new capabilities to improve patient outcomes. With an initial focus on Lung Cancer, the project aims for its outputs to be applicable across multiple disease settings in the future.
NICE is leading on tasks focused on engaging key internal and external stakeholder to develop consensus on policy recommendations to improve both access to data and the acceptability of heterogenous evidence for regulatory and HTA use.
VALUE-Dx will facilitate and accelerate the rigorous assessment and implementation of diagnostic technologies into healthcare settings. It will do this by establishing the methods, processes and approaches needed to understand, evaluate, and assess the value of diagnostics in the context of optimising antibiotic use. VALUE-Dx has a particular focus on community-acquired acute respiratory tract infections (CA-ARTI).
The project will produce recommendations on how to improve existing pricing and funding policies to ensure timely accessibility of cost-effective diagnostics to reduce antimicrobial resistance .
Science policy projects
Carer Quality of Life
We’re leading work to develop NICE’s thinking on the measurement and valuation of carer health-related quality of life.
This is a methodological area where there are many opportunities to improve practice. A report from our Decision Support Unit in 2019 found that carer health effects were only included in the cost-effectiveness modelling of 4% of NICE technology appraisals and highly specialised technologies. As part of NICE’s review of its methods for health technology evaluation, a dedicated task and finish group considered the evidence on carer health-related quality of life and recommended that more work is needed to advise on when and how to include carer effects. NICE intends to provide more detailed guidance on methods for measurement, valuation and modelling approaches in the future.
Children's Quality of Life
We're developing better methods for measuring and valuing health-related quality of life in children and young people. The aim is to ensure that we use economic models that reflect the experiences of children and young people with the relevant condition or disease.
Reports from our Decision Support Unit show that a range of methods are used in NICE appraisals which include this age group. But further research is needed before NICE can recommend which measures and valuation approaches should be used in the future.
We are collaborating with several researchers who are developing and evaluating methods in this area.
NICE has a strategic objective to examine the potential to include environmental impact data in our guidance to reduce the carbon footprint of health and care. We have been working with academic partners to help us scope a framework for considering environmental sustainability information. We are also working closely with system partners to ensure our environmental sustainability work complements other similar work undertaken across the healthcare landscape.
In collaboration with NHS England and NHS Improvement (NHSE&I) and Department of Health and Social Care (DHSC), we’re working on a project to develop and test models that pay companies for antimicrobials based primarily on assessment of their value to the NHS as opposed to the volumes used.
EQ-5D-5L valuation set for England
We’re advising on a valuation study to generate a new EQ-5D-5L value set for the UK. The study is being undertaken by a research team comprising investigators from across the UK, and is being overseen by a steering group which includes representatives from EuroQol, NICE, the Department of Health and Social Care, and NHS England.
EQ-HWB (EQ Health and Wellbeing instrument) is a new standardised measure of of health and wellbeing that was created following the Extending the QALY research project that NICE contributed to.
The EQ-HWB has not been developed as a replacement for the EQ-5D, but as a different instrument that captures a broader range of impacts on people, their families and carers. Research is underway to validate the EQ-HWB and compare it with existing instruments. NICE supports this important research, which will help us to decide whether and how to use EQ-HWB to inform NICE evaluations in the future.
MHRA-NICE Effective Regulation and Evaluation of Digital Mental Health Technologies
We are collaborating with the MHRA on a Wellcome-funded project to explore issues around regulation and evaluation of digital mental health technologies, ranging from diagnostic and monitoring tools, self-help CBT apps and websites, and virtual reality and AI based therapies.
There has been a large increase in the number of digital mental health tools on the market in recent years. However, these products present challenges for regulation and health technology assessment, including whether technologies are medical devices, how they should be classified, and higher levels of uncertainty around effectiveness and cost-effectiveness.
Across five work packages, the project will explore the digital mental health landscape and consider issues around qualification and classification, clinical evaluation, and post-market surveillance and lifecycle assessment. At each stage, we will engage with and learn from people with lived experience and other subject experts, as well as working with international partners to help drive shared learning and international consensus.
NICE Listens is our new programme of deliberative public engagement. It's been developed to give us an understanding of public opinion on moral, ethical and social value issues.
Using best practice methods, we work with external contractors who specialise in public engagement.
A new sample of members of the public is invited to take part in each project. They are given time to learn and become familiar with the topic area, before discussing it in detail and making recommendations. These recommendations are then be used by our executive team and board to inform various aspects of our work.
NICE methods guidance states that the default perspective for economic evaluations should be that of the NHS and personal social services, but a broader set of effects can be included in exceptional circumstances when they are deemed especially relevant and when requested by the Department of Health and Social Care in the remit for the evaluation.
The aim of this project is to explore the need for and challenges of adopting a societal perspective in NICE’s assessments.
Australia, Canada, New Zealand and United Kingdom HTA collaboration
NICE has a collaboration arrangement with eight partner organisations in Australia, Canada, New Zealand and the United Kingdom. This arrangement preserves the governance arrangements and independence of each of the agencies, whilst creating greater opportunities to explore collaboration in five priority areas:
- COVID 19-related intelligence sharing
- future-proofing of HTA systems
- collaborating with regulators
- work-sharing and efficiency gains
- digital and AI.
The collaborating HTA agencies are:
- National Institute for Health and Care Excellence (NICE) in England.
- Canadian Agency for Drugs and Technologies in Health (CADTH).
- Australian Government Department of Health, together with the Pharmaceutical Benefits Advisory Committee (PBAC) and the Medical Services Advisory Committee (MSAC).
- Health Improvement Scotland, including the Scottish Medicines Consortium (SMC) and the Scottish Health Technologies Group (SHTG).
- Health Technology Wales (HTW), hosted by Velindre University NHS Trust.
- All Wales Therapeutics and Toxicology Centre
- Institut national d’excellence en santé et en services sociaux
Handling confidential clinical data
Health technology evaluations must strike a critical balance between ensuring transparency of the evidence and decision-making and protecting confidential information. NICE has worked with HTA agencies in Canada (CADTH) and the US (ICER) to create a more consistent approach to handling clinical data.
The agencies have published a joint position statement on the confidentiality of clinical data. The principles in the statement are operationalised in the guide describing the interim methods and process changes that we have implemented as a result of the proportionate approach to technology appraisals work.
Past research and projects
ADAPT-SMART aimed to design new collaborative approaches to the development of medicines, known as Medicines Adaptive Pathways to Patients (MAPPs).
We've played a leading role in this and other projects, and we now engage with pharmaceutical companies via our Office for Market Access and the Accelerated Access Collaborative.
DO->IT (Big Data for Better Outcomes)
The DO->ITproject was launched to provide a coordination platform for the BD4BO programme, exploiting synergies across the projects and maximising its impact on healthcare systems. It aimed to:
- aggregate learnings and disseminate findings from the projects
- develop minimum data privacy standards
- engage with key stakeholders
- recommend areas for future collaborative research.
The project delivered a toolkit for the identification, selection and measurements of outcomes (PDF) to support the other BD4BO projects.
Exploring the assessment and appraisal of regenerative medicines and cell therapy products
In April 2015, we launched an exploratory study to highlight key issues in the evaluation of regenerative medicines (PDF) and consider the suitability (or otherwise) of current methods. The study responds to recommendations from the Department of Health Regenerative Medicine Expert Group (RMEG).
NICE has worked in collaboration with the Centre for Reviews and Dissemination and Centre for Health Economics, University of York, who have produced an extensive independent report (PDF).
The NICE Regenerative Medicines and Cell Therapy report (PDF) summarises key findings from the study, considers implications for NICE and makes a number of recommendations.
The E-QALY project aimed to develop a broad measure of quality of life for use in economic evaluations across health and social care, for both patients and carers.
It explored the importance of non-health aspects (such as social and emotional wellbeing) in addition to physical and mental health so that important benefits, other than those related to health, are captured.
The partnership between NICE and Flatiron Health aimed to explore if and how real world evidence can inform the clinical and cost effectiveness of health technologies. An initial research project compared survival estimates from clinical trials to survival data observed in actual patient records to evaluate opportunities to reduce uncertainty in the estimation of long-term outcomes.
The collaboration tested how additional sources of evidence could complement trial and research data in NICE's technology appraisals, especially in helping to resolve uncertainty in the evidence.
The GetReal Initiative was an Innovative Medicines Initiative (IMI) project which aimed to develop tangible solutions to key challenges associated with using real world data in drug development and subsequent regulatory and health technology assessment.
The project established a real world evidence Think Tank, which gathered international thought leaders to discuss, assess and give recommendations on the opportunities and barriers to the generation, use and acceptability of real world evidence.
This project followed on from successful completion of the IMI GetReal project on the use of real world evidence in effectiveness research.
The HARMONY alliance aimed to use big data and big data analytics to deliver knowledge to improve the care of patients with several blood cancers.
A key output from this project was the HARMONY BigData platform. As of April 2023, this held datasets of approximately 156,000 patients. This platform harmonises and analysis these data sets, with the aim of accelerating the development of more effective treatments for people with blood cancer.
Histology independent cancer drugs
The European Medicines Agency approved the first histology independent cancer drug in 2019. The clinical evidence on the effectiveness of these drugs makes it hard to assess:
- the level of benefit to patients
- if the drug provides value for money to health systems such as the NHS.
We initiated methods research through the National Institute for Health Research health technology assessment programme. This addressed the following questions:
- Can we apply our existing technology appraisal approaches and are any changes required?
- What evidence will be available at the point of initial marketing authorisation for these drugs?
- What guidance is needed to establish the evidence and analyses required to inform our recommendations?
Read the pre-publication report and recommendations (Word) from researchers at the University of York and the University of Sheffield.
GetReal aimed to develop a clearer understanding of how real-world evidence (RWE) can contribute to pharmaceutical research and development and healthcare decision-making.
As part of GetReal, we worked with the University of Manchester and the Association of British Pharmaceutical Industry (ABPI) to publish a report of recommendations for advancing the UK's capability for data science research in healthcare.
We also developed the RWE Navigator, an online platform to support better understanding of the potential of real world evidence in the development and assessment of new drugs.
IMPACT HTA proposed new and improved methods, tools and guidance for decision-makers across 10 research areas in the context of health technology assessment and health system performance measurement. This contributed to the understanding of:
- costs and health outcomes variations within and across countries
- costs and health outcomes data integration from different sources.
Our role in the project included:
- assessing the performance of a range of statistical methods used to analyse non-randomised studies
- providing recommendations on which methods are likely to produce valid and unbiased estimates of relative effectiveness of interventions.
The methodological recommendations produced in this project will be useful for informing future updates of our methods guides in relation to the use of non-randomised studies, sometimes referred to as ‘real world studies’.
NEURONET was a coordination and support action project setup to provide support to a broad portfolio of IMI projects on neuro-degenerative diseases.
A key output from the project is an interactive Knowledge Base. This brings together key information about the 18 projects in the IMI neuro-degenerative diseases portfolio, including links to project publications, tools, and deliverable reports.
The Knowledge Base is an integral part of NEURONET's endeavour to boost collaboration across the research portfolio and enhance its visibility with related initiatives in Europe and worldwide.
NICE led work on the Regulatory and HTA Decision Tool, which provides a clickable overview of the processes and procedures for HTA and regulatory interactions at different stages of the development pipeline. This will help ensure that the outputs being developed by projects are relevant for regulatory and HTA settings, where applicable.
We worked in partnership with Myeloma UK to explore potential quantitative methods for capturing and using patient preferences within health technology assessment decision-making. This initial ‘proof of concept’ project was funded by Myeloma UK and focused on patients with multiple myeloma.
ROADMAP (Big Data for Better Outcomes)
The ROADMAP project worked on improving real world evidence in Alzheimer's disease.
The project launched the Data Cube in 2019, which provides an interactive overview of European data sources that capture outcomes relevant for Alzheimer's disease.
We are involved in several EuroQol-funded projects. As well as jointly overseeing and advising on the new UK EQ-5D-5L valuation study, and contributing to the development of the new EQ-HWB instrument, we are participating in a number of research studies seeking to improve methods for measuring and valuing health-related quality of life.
We have a memorandum of understanding with Manchester Academic Health Science Centre (MAHSC), in partnership with:
- Health Innovation Manchester (HInM)
- The University of Manchester
- Greater Manchester Academic Health Science Network (GMAHSN).
This sets out a shared commitment to improving the overall health of the population through:
- research and informing health policy and practice
- the development and evaluation of health technologies.
Collaboration between the 3 parties will also focus on teaching, training and education.
A key project undertaken through the partnership is ‘Data Lab’. Building on Greater Manchester's extensive expertise and numerous digital and data assets, the Data Lab will explore how routinely collected information may be used to evaluate the effectiveness of medicines, new technologies and interventions in the development of NICE guidance. For example, anonymised data derived from patient records.
The Better Methods, Better Research (BMBR) panel is a partnership co-funded by the Medical Research Council (MRC) and the Department of Health and Social Care’s National Institute for Health and Care Research (NIHR). The aim of BMBR is to ensure, via provision of funding, that optimal research methods are being used to advance biomedical-, health- and care-related research and policies. NICE has an advisory role at panel meetings, highlighting proposals of interest that align with our research priorities or address current methodological challenges in guideline development. NICE can partner with researchers applying for funding from the MRC BMBR panel in several ways.
NICE meets regularly with NIHR to share information about our respective research priorities, and seeks NIHR’s input to ensure our research recommendations are clear and actionable. We also work closely to fast-track, co-produce and advertise research briefs which are jointly agreed as key priorities. In addition to these fast-tracked key priorities, NIHR also reviews all NICE guidance and advertises research calls against NICE research recommendations through individual programme commissioned workstreams. NIHR has been screening NICE guidance for nearly 20 years to identify topics suitable for commissioning research. In 2021, NIHR launched a researcher-led rolling funding call, which will complement existing commissioning workstreams. The rolling research call aims to build on the success of the relationship between NIHR and NICE, and further develop the evidence base supporting guidance development.
NICE is part of a global group of organisations who want to speed up the development and delivery of new, effective and affordable drugs.
The programme brings together pharmaceutical companies, academic researchers, patient advocacy groups, government agencies and other experts.