Methods research areas

Our priority areas

1. Data science and analytics

We aim to harness the principles of data science to further our knowledge, using big data and real-world data (RWD) for the benefit of the wider health and social care system. Our projects (such as EHDEN, HARMONY and HTx) explore how to analyse and interpret real-world data collected outside randomised controlled trials in observational studies.

We're open to collaboration with external organisations and data and analytics companies on use cases that show the potential for using RWD to inform our guidance development.

2. Measuring and valuing quality of life

We're supporting research exploring how to measure and value quality of life in children and in carers. We're also part of the steering group for the EQ-5D-5L valuation study in the UK and are supporting the development of the EQ-HWB instrument which can be used to measure quality of life across health and social care. 

3. Precision medicine

We're working on projects that assess how optimal outcomes can be achieved by tailoring treatments received to individual level needs using prediction modelling (EHDEN, HTx) and point of care diagnostics (VALUE-Dx). Using artificial intelligence (AI) and machine learning methods to develop these models is also explored as part of the EHDEN and HTx projects.

We've also previously carried out an assessment of whether our methods need to be adapted to evaluate oncology drugs that are licensed based on a biomarker rather than a tumour location (histology-independent indications).

4. Digital health

We recently updated the evidence standards framework (ESF), which now includes artificial intelligence (AI) and data-driven technologies.

This was a collaboration between our Office for Digital Health, Imperial College, University of Birmingham and the Alan Turing Institute. Additionally, through our HORIZON 2020 funded project, HTx, we are working with the ISPOR CHEERS (Consolidated Health Economic Evaluation Reporting Standards) Task Force to create an AI extension (CHEERS-AI).

We have recently been awarded funding to work on a project, in collaboration with MHRA, which aims to improve the regulation of digital health technologies for mental health and enable safe and effective access. This project is funded by the Wellcome Trust.

We also studied the ideal approach for utilisation of digital endpoints and data generated using wearables in neurodegeneration research projects, from a HTA perspective, as part of the recently completed NEURONET project.

5. Antimicrobials and antimicrobial resistance

We're involved in projects to support the development of new antimicrobials and to tackle antimicrobial resistance. This includes our work on evaluation and payment models for new antimicrobials in collaboration with NHS England and and the Department of Health and Social Care after successfully piloting a new payment model.

Our project VALUE-Dx looks into the value of point of care diagnostics to guide prescribing antibiotics for lower respiratory tract infections appropriately and combat antimicrobial resistance. We are also partners in the IMI ERA4TB project which is a public-private initiative devoted to accelerating the development of new treatment regimens for tuberculosis.

We have also developed best practice guidance for the assessment of diagnostics and therapeutics, including antivirals, for COVID-19 as part of HTx project. Within the EHDEN project, we are collaborating with our project partners to support regulatory and HTA response to the COVID-19 pandemic by monitoring real-life use of these antimicrobials and understanding current practice through conducting large epidemiological studies such as CHARYBDIS.

Understanding and preparing for the challenges that face HTA agencies and clinical guideline developers when responding to similar infectious disease pandemics, in order to support pandemic preparedness, is a key objective of our work in this area. With collaborators from the HTx project, we have published an article summarising these challenges and continue to work on developing practical solutions and guidance to address them.

6. Environmental sustainability

Our guidance affects the way that health and care services are delivered. And the way that services are delivered has an impact on the environment. We're exploring ways to incorporate information on environmental impact in our guidance so as to reduce the carbon footprint of health and care.

We want to ensure that our environmental sustainability work complements other similar work undertaken across the healthcare landscape.

7. Innovative access pathways

These allow patients early access to new and urgently needed treatments. We're currently engaged in the operation and strategic development of the Innovative Licensing and Access Pathway (ILAP) with the Medicines and Healthcare products Regulatory Agency (MHRA), Scottish Medicines Consortium (SMC) and All Wales Therapeutics and Toxicology Centre (AWTTC).

We've also played leading roles in adaptive pathways initiatives ADAPT-SMART, MIT NewDIGS, and the European Medicines Agency adaptive pathways pilots.

8. Patient and public views and involvement

Our committees make moral, ethical and social value judgements as well as scientific ones. The views of the public inform these types of judgements and provide the basis of the NICE Principles. We collaborate with external researchers studying how our guidance on social values is interpreted by our committees. NICE Listens is our new programme of public engagement that will help us to make sure that our policies on complex and controversial issues reflect the values of informed members of the public.

In terms of evidence on the views of people with lived experience, we are developing the patient public evidence framework aiming to improve the use of this type of evidence at all stages of producing our guidance. Beyond this, we are collaborating with Warwick University on a NIHR-funded research project looking at developing a role for patients and the public in the implementation of evidence into practice.

As well as involving the public, we prioritise studying people's preferences for treatment options. We completed a project funded by Myeloma UK to understand how patient preference data can be collected and used in decisions about new medicines and treatments. We have also published an article summarising NICE’s perspective on the role of patient preference studies in HTA decision making. Additionally, as part of HTx we involved clinicians and people with a variety of conditions to better design tools that enable shared decision making.

9. Surrogate outcomes

Surrogate outcomes are used in clinical research to approximate a measure of effect. We are currently involved in methods research focused on how to report and evaluate these measures and have updated our guidance in this area. In collaboration with the University of Glasgow, we are advising on the development of reporting guidelines for trials using surrogate endpoints.

We're also working with a group of organisations that make recommendations for the use of new drugs in other countries to develop more guidance on the use of surrogate outcomes when analysing cost-effectiveness. 

10. Supporting a learning healthcare system

Producing useful and usable guidance and supporting a learning healthcare system is another major area of our methods research.

Our move to developing “digital living recommendations” and the challenges associated with it is another methodological research area of interest where we are engaged in external collaborations with guideline developers. We are also seeing topics through our Health Technology Assessment innovation Laboratory (HTA Lab). This is a safe space for collaboratively developing solutions to complex HTA issues with healthcare system partners.

We also offer a range of support to help health and social care professionals put our guidance into practice. Our research aims to establish which implementation strategies are most effective and help us understand what works in practice. A recent project collaborated with THIS Institute on research to understand and reduce implementation barriers in end of life care, by gathering implementation information on NICE’s end of life care guideline. This is an area where several NICE recommendations have been poorly implemented in the past.

NICE Transformation is another ambitious and organisation-wide change programme that has been established to deliver our 5-year strategy 2021-2026. It brings together a complex range of activities that include technical innovation, new approaches to data and content management, enhanced digital enablers, and process improvement. We are currently exploring how artificial intelligence and machine learning could be utilised to identify evidence.