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.

Current research and projects

GetReal Initiative

The GetReal Initiative is an Innovative Medicines Initiative (IMI) project which aims 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 will establish a real-world evidence Think Tank, which will gather 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 follows on from successful completion in March 2017 of the IMI GetReal project on the use of real-world evidence in effectiveness research.

Extending the QALY 

The Extending the QALY (E-QALY) project aims to develop a broad measure of quality of life for use in economic evaluations across health and social care, for both patients and carers.

The project will explore 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.

By developing a new measure of quality of life it will be possible to undertake more meaningful economic evaluations that incorporate the value of wider societal benefits, which are currently excluded from existing methods.

IMPACT-HTA

IMPACT HTA proposes new and improved methods, tools and guidance for decision-makers across ten research areas in the context of health technology assessment and health system performance measurement. This will contribute to the understanding of costs and health outcomes variations within and across countries and to costs and health outcomes data integration from different sources.

NICE’s role in the project includes assessing the performance of a range of statistical methods used to analyse non-randomised studies, and provide 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 NICE’s methods guides in relation to the use of non-randomised studies, sometimes referred to as ‘real-world studies’.

EHDEN: Electronic Health Data & Evidence Network

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.

NEURONET: Efficiently Networking European Neurodegeneration Research

NEURONET is a coordination and support action (CSA) project which provides support to a broad portfolio of IMI projects on neuro-degenerative diseases. The project will identify research gaps, look at the impact of the IMI neuro-degenerative portfolio, and will facilitate links with related initiatives in Europe and worldwide.

Value Dx: The value of diagnostics to combat antimicrobial resistance by optimising antibiotic use

VALUE-Dx will facilitate and accelerate the rigorous assessment and implementation of diagnostic technologies into healthcare settings. It will to 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 anti-microbial resistance (AMR).

HTx: 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 project aims to create and test a framework for ‘next generation’ health technology assessment that will provide solutions for a broad range of challenges, such as personalised medicine, combination therapies, big data and artificial intelligence (AI).

Histology Independent Licencing

In May 2017, the US Food and Drug Administration approved a cancer treatment based on a biomarker rather than the location in the body where the tumour originated (referred to as a histology independent or tumour-agnostic licensing). This novel way of licensing drugs could potentially be used in the future in Europe. NICE is working with internal and external partners to commission methods research that will:

  • explore the extent to which NICE’s existing approaches can be applied and any changes that might be required
  • establish the evidence that is typically available at the point of initial marketing authorisation
  • develop guidance to establish the evidence and analyses required to help inform NICE decisions.
EQ 5D 5L valuation set for England

The science policy and research team is leading NICE’s work on whether to adopt the EQ-5D-5L valuation set for England. Our blog explains why this work matters and explains our next steps.

For more information see this blog.

Update to NICE Principles

NICE is creating a new document describing the overarching principles that guide the development of NICE guidance and standards. The new document sets out why and how we work in the way that we do and aims to replace the Social Value Judgements. We consulted the public about a draft version of the NICE Principles in Spring 2019 and are currently revising the text.

HARMONY (Big Data for Better Outcomes): Healthcare Alliance for Resourceful Medicines Offensive against Neoplasms in Haematology

The HARMONY alliance aims to use big data and big data analytics to deliver knowledge that will improve the care of patients with several blood cancers. Specifically, this project will gather high quality patient data into a database where it will be harmonised and analysed to improve patient care and increase treatment options The project’s database will also help improve decision making for policy makers and clinicians, to help them to give the right treatment to the right patient at the right time.

Past research and projects

ADAPT-SMART

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 now engage with pharmaceutical companies via our Office for Market Access and the Accelerated Access Collaborative.

IMI GetReal

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 RWE in the development and assessment of new drugs.

Exploring the assessment and appraisal of regenerative medicines and cell therapy products

In April 2015, NICE launched an exploratory study to highlight key issues in the evaluation of regenerative medicines 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.

The NICE Regenerative Medicines and Cell Therapy report summarises key findings from the study, considers implications for NICE and makes a number of recommendations.

Patient Preferences

We worked in partnership with Myeloma UK to explore potential quantitative methods for capturing and using patient preferences within HTA decision-making. This initial ‘proof of concept’ project was funded by Myeloma UK and focused on patients with multiple myeloma. For more information, read our blog about patient preferences which outlines the findings from this project.

Do IT (Big Data for Better Outcomes)

The DO>IT project was launched to provide a coordination platform for the BD4BO programme, exploiting synergies across the projects and maximising its impact on healthcare systems. With the aim to aggregate learnings and disseminate findings from the projects; develop minimum data privacy standards; engage with key stakeholders; and recommend areas for future collaborative research. The project delivered a toolkit to support the other BD4BO projects in the identification, selection and measurement of outcomes.

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, that provides an interactive overview of European data sources that capture outcomes relevant for Alzheimer’s disease. Find the Data Cube here.

Our partners 

Manchester Academic Health Sciences Centre (MAHSC)

We have a memorandum of understanding with Manchester Academic Health Science Centre (MAHSC), in partnership with Health Innovation Manchester (HInM), the University of Manchester and the Greater Manchester Academic Health Science Network (GMAHSN).

The memorandum of understanding sets out a shared commitment to improving the overall health of the population through research and informing health policy and practice, as well as through the development and evaluation of health technologies. Collaboration between the three parties will also focus on teaching, training and education.

A key project which will be 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, such as anonymised data derived from patient records, may be used to evaluate the effectiveness of medicines, new technologies and interventions in the development of NICE guidance.

New Drug Development Paradigms (NEWDIGS) program

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.