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NIHR Invention for Innovation (NIHR i4i) & OLS : Real World Evidence Programme - Research Specification

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Published: 02 January 2024

Version: 1.0 January 2024

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This document provides information on the call specification for an application to the NIHR Invention for Innovation (i4i) and Office for Life Sciences (OLS) Real World Evidence Programme.

The NIHR i4i Programme, in collaboration with OLS and The National Institute for Health and Care Excellence (NICE), invites applications to the Real World Evidence Programme. Applications must demonstrate how the proposed work will address evidence gaps and accelerate the widespread adoption of technologies recommended for early use in the NHS through NICE Early Value Assessment (EVA). 

The Real World Evidence Programme involves a one-stage call inviting applications for projects up to 36 months in duration, with no upper funding limit. 

The call is open to consortia consisting of 

  • An analytical partner (lead applicant) – which will lead and coordinate the generation of evidence required
  • The technology partner(s) – with the EVA products for which evidence must be generated
  • Adopting site(s) – which will give access to sites, or services, for testing of the products.

Organisations must be a UK legal entity and can be based anywhere in the UK.

Introduction

The NIHR Invention for Innovation (i4i) Programme, in collaboration with the Office for Life Sciences (OLS) and the National Institute for Health and Care Excellence (NICE), invites applications for a funding call aimed at generating evidence in real world settings for those products that have been recommended for early use in the NHS through the NICE Early Value Assessment (EVA) process.  

The Life Sciences Vision (LSV), published in July 2021, co-developed by the Government, the NHS, and the Sector, sets out our shared ambition to make the UK a Life Science Superpower. The Vision outlined how, through building on the UK’s existing strengths and potential, and harnessing the lessons of the Life Science response to COVID-19, there was an opportunity to significantly enhance the UK’s competitiveness and drive value creation for the public and private sectors. The Vision sets out ambitions for healthcare missions - selected as disease areas and conditions that drive significant mortality and morbidity in the UK and globally.

The Real World Evidence Programme is being led by OLS as part of the UK Government’s Life Sciences Vision and is backed by £10m of government funding. The Programme aims to make the UK a leading testbed for late-stage innovations, to allow them to generate the real world evidence required to both achieve full NICE guidance, and to enable and accelerate uptake within the NHS, resulting in faster benefits for patients and service users.

The call is open to consortia consisting of 

  • An analytical partner (lead applicant) – which will lead and coordinate the generation of evidence required (must be a UK legal entity).
  • The technology partner(s) – which will provide the EVA products for which evidence must be generated
  • Adopting site(s) – which will give access to sites, or services, for testing of the products.

Specialist services or expertise may be brought into the team through consultancy or sub-contract arrangements with appropriate justification. Collaborators and sub contractors may be based outside of the UK if the required expertise or service cannot be reasonably contracted from within the UK. Involvement of international companies as sub-contractor and/or collaborator, if working with a lead UK partner, are welcomed with justification.

The proposed research must show potential, and be appropriate, for rollout and use in the UK.

Projects must partner with at least one NHS organisation/adopting site to ensure delivery of the project in line with NHS clinical needs. Engagement with NIHR MedTech and In-Vitro Diagnostics Cooperatives (MICs), HealthTech Research Centres, HRCs, from April 2024)NIHR Applied Research Collaboration and/or Health Innovation Networks (formerly Academic Health Science Networks (ASHNs)) is encouraged.

Support with research design and forging partnerships is available to all prospective applicants through the NIHR research support services, detailed below. All prospective applicants are encouraged to engage with these services at the earliest opportunity. 

Background

Scope and Aims

The aim of the call is to address the evidence gap required for the widespread adoption of technologies that have received a recommendation for early use in the NHS from NICE EVA, as well as developing guidance to support innovators to generate quality real world evidence that NICE and commissioners require for adoption and roll-out. The programme is open to all products with a recommendation for early use in the NHS from NICE EVA, but we particularly encourage submissions aligned with the Life Sciences Vision and its Healthcare Missions.

The expected objectives of this investment are to:  

  1. Undertake late-stage evidence generation of products identified through NICE’s EVA programme to allow products to generate the real-world evidence required to both achieve full NICE guidance and to enable and accelerate uptake within the NHS.
  2. Draw together and optimise existing infrastructure to improve real world evidence generation capabilities, assessing how they operate most effectively to help future innovators.
  3. Capture generalisable learnings from this evidence generation and develop broader guidance that will support future innovators.

Areas in Scope 

  1. The generation of real world evidence required by the NICE EVA programme for a product, or products under a topic, to achieve a full NICE evaluation, in line with NICE EVA recommendations and Evidence Generation Plans
  2. The generation of real world evidence required by commissioners to encourage increased uptake and use of technologies within the NHS (in addition to NICE evaluation requirements). 
  3. Activities to capture learnings for generalisable guidance for innovators 

This can include funding for:

  • Activities associated with the design and delivery of evaluations for innovations in real world settings 
  • Small changes to a technology that might be needed for its optimisation during the lifetime of the project, for example any adaptations deemed required for end user acceptance as part of the evaluation (but not requiring any further regulatory approvals)
  • Training associated with the implementation of the new technology, including the development of training resources, usage guidelines and other materials
  • Implementation research costs, including design of implementation strategy and management of studies associated with this, clinical pathway analysis, sustainability evaluation and data analysis
  • Implementation cost analysis
  • Market analysis and development of a business case for adoption
  • Project management and stakeholder engagement activities
  • Activities associated with data collection, analysis, management and governance (including infrastructure to support this)
  • Patient and public involvement and end user engagement
  • Activities associated with the dissemination of outputs
  • Activities associated with developing product agnostic generalisable guidance on generating evidence for NICE and commissioners.

Entry Criteria

The call is open to consortia consisting of 

  • An analytical partner (lead applicant) – who will lead and coordinate the generation of evidence required
  • The technology partner(s) – who will provide the EVA products for which evidence must be generated
  • Adopting site(s) – who will give access to sites, or services, for testing of the products.

Analytical partner

The analytical partner must act as lead applicant and will coordinate the project. They could be an academic institution, a Health Innovation Network (formerly AHSN), MIC/HRC, ARC or other organisation experienced in real world evidence study design, conduct and analysis. To note the lead organisation must be a UK legal entity.

Technology Partner(s)

Products provided by technology partners for this funding competition must be recommended for early use in the NHS through NICE EVA, have generated appropriate levels of clinical safety and effectiveness, and have CE mark or equivalent.

Adopting Site(s)

The adopting sites, or services, must be identified and be part of the application as co-applicants to ensure the delivery of the study. Clinical partners can be based anywhere in the UK. 

Expected Exit Points

Although it is recognised that the exit point(s), i.e., the evidence and outputs generated by the end of the proposed project, will be different depending on the type of product, its level of maturity, and recommendations from EVA, the principle aim of the funding is to facilitate the generation of evidence in real-world settings to support a NICE evaluation and subsequent NHS implementation and roll-out, hence applicants must demonstrate clear progress towards that aim.

Applicants will be asked to define the expected exit points they intend to reach upon project completion. Examples of potential exit points include:

  • Collation of evidence for NICE evaluation 
  • Technology validated in real-world settings, potentially ready for scale up, and/or to approach commissioners 
  • Evidence for national commissioning initiatives (e.g. MedTech funding mandate)
  • Evidence of health and financial impact (through health economic assessment) to support future NHS adoption
  • Inclusion on national procurement frameworks
  • Insight into user acceptance through PPIE activity
  • NHS business case
  • Partnership developed for implementation in multiple sites
  • Climate sustainability assessment
  • Equality and health inequalities impact assessment
  • Other relevant evidence to ensure local, regional and facilitate wider adoption, following project completion
  • Capturing of generalisable learnings to develop best practices and guidance that will support future innovators by improving the clarity and quality of real-world evidence.

Areas out of Scope

Technologies that have NOT been recommended for early use in the NHS through NICE EVA and have negative or research-only recommendations from NICE are excluded from this call.

Call Details 

Applicant Eligibility 

Applicants are welcome from organisations which are a UK legal entity and include:

  • Higher Education Institutions (HEI), including universities and research institutes.
  • NHS and social care service providers, including Trusts, primary care and community care providers and tertiary care centres.
  • Commercial organisations including large enterprises and Small and Medium Enterprises (SMEs with a staff headcount no greater than 250 and an annual turnover no greater than €50 million, including start-up or spin-out companies).
  • Not-for-profit organisations, including charities and Community Interest Companies.

Specialist services or expertise may be brought into the team through consultancy or sub-contract arrangements with appropriate justification. Collaborators and sub-contractors may be based outside of the UK if the required expertise or service cannot be reasonably contracted from within the UK. Involvement of international companies as subcontractor and/or collaborator, if working with a lead UK partner, are welcomed if justified.

Applicants must review the NIHR standard research contract before application submission and agree in principle with its core terms and conditions as they are non-negotiable.

Applicant organisations can be based anywhere in the UK, and the proposed research must take place in the UK and show potential, and be appropriate, for rollout across the UK. 

Consultation with individuals who have current or lived experience is expected. 

Multidisciplinary project teams, involving relevant collaborations between technology developers, data scientists and clinical staff, are particularly welcome. 

For this Call, applications should be made by consortia with an analytical lead as described above. The lead organisation should have full access to the background IP required for the project. 

Budget and Duration

There is no upper funding limit. Proposed projects may be up to 36 months in duration. Each proposal will be judged on its merits and value for money. 

NIHR funding covers 100% costs for commercial entities, not-for-profit organisations, local government bodies, and primary care providers, 100% of the direct research costs for NHS service providers, and 80% FEC for higher education institutions. Large enterprises are expected to provide some in-kind contribution.

Support for Applicants and Awardees 

Support with research design and forging partnerships is available to all prospective applicants through the NIHR research support services and wider, detailed below. All prospective applicants are encouraged to engage with these services at the earliest opportunity.

  • Health Innovation Networks (formerly Academic Health Science Network (AHSNs) – support developing real-world evaluation, roll-out and adoption
  • InSites Programme - help with finding NHS collaboration sites among the NHS InSites peer network.

* Please note that the RSS service is only available to applicants based in England. Applicants with a project partner based in England are able to access the service, but if you are based in the UK but outside of England, and are not partnered with an organisation based in England you may wish to explore the below services. The NIHR Business Development Team is available to all UK based applicants and you may wish to contact them in seeking a partner based in England.

Once awarded, the Data for R&D Team within NHS England’s Transformation Directorate will be able to provide signposting to relevant NHS data and organisations who will be able to support awardees in generating evidence.

Key dates and Contacts

  • Launch:31 January 2024
  • Deadline for submission of applications: 1pm, 27 March 2024
  • Assessment & Shortlisting: April/May 2024
  • Peer review (if shortlisted): May/June 2024
  • Interview Committee:July 2024 
  • Projects start: October 2024

For any enquiries email: i4i-rwe@nihr.ac.uk