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NIHR i4i & OLS Real World Evidence FAQs

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Published: 06 February 2024

Version: 2.0 March 2024

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This document outlines answers to questions asked by applicants to the NIHR i4i & OLS RWE Programme. More information is available in our guidance for applicants and in our Supporting information for applicants.

Please be aware the OLS RWE call closed on the 27/03/2024. Please contact the OLS RWE team i4i-rwe@nihr.ac.uk if you have any further questions.

Eligibility

Could you clarify if EVA is part of this call or is it a pre-requisite to compete on this call?

A recommendation for early use in the NHS through NICE EVA is a pre-requisite for technologies submitting to this Call.

Where can I read more information about each technology that has been through EVA which is eligible?

See the full list of technologies which have been recommended for early use in the NHS through NICE EVA. To be eligible for this Call, the guidance must be published by Call close.

Does the Evidence Generation Plan (EGP) also have to be published (not just the EVA recommendation)?

Yes, to be eligible for this Call, the technology must be recommended for early use in the NHS through NICE EVA and the guidance must be published by Call close.

Will there be a requirement for products to have relevant market authoriation (MHRA etc) and be DTAC assessed (if digital) - and how will this be assured?

Yes, digital health technologies must be DTAC compliant by the time of use in the NHS as part of the project. Products must also have a CE mark or equivalent, if and as appropriate, with justifications provided in the application, which will be assessed by the committee.

I have a technology that has had health tech evaluation but needs real world evidence. Can they apply?

Only technology that has been recommended for early use in the NHS through NICE EVA may be included in this Call. See the full list of technologies which have been recommended for early use in the NHS through NICE EVA.

Can the analytical partner and technology partner be the same entity?

The aim for this Call is to form 3-way consortia with an independent analytical partner with experience in real world evidence study design, conduct and analysis leading the application. As such, the analytical partner and technology partners should be different entities.

Can an analytical partner be the same as the adopting site looking to lead, coordinate and host testing of the product?

The aim for this Call is to form 3-way consortia with an independent analytical partner with experience in real world evidence study design, conduct and analysis leading the application. As such, the analytical partner and adopting site should be different entities.

Can the analytical partner be a commercial entity? The presentations seem to focus on selecting HEI as analytical partners. Can you please confirm if HEI is preferable?

Any organisation, so long as they have the necessary experience in real world evidence study design, conduct and analysis, can be the analytical partner. There is no preference as to organisation type.

The eligibility guidance for an analytical lead states that 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) can apply. For large organisations is there a limit on headcount and turnover or does this only apply to SMEs? Is there a limit on turnover and headcount for subcontractors?

Any size commercial organisation can apply or be a subcontractor. There is no limit on headcount, this is only included in the guidance to support the definition of a small or medium-sized enterprise.

Can there be two analytical partners - i.e. a HEI and a Health Innovation Accelerator working in partnership? Is this encouraged?

The application should be lead by one analytical partner with experience in real world evidence study design, conduct and analysis. Additional expertise may be provided by other collaborators where required and justified.

Do analytical partners already need to have a technology partner to submit, or can they submit as separate entities to form a constortia selected by NIHR?

The application must include all consortia members - an analytical partner, technology partner(s) and site(s)/service(s); NIHR is not putting the consortia together. If you are an analytical or technology partner looking for an analytical/technology partner, you can register for the matchmaking event or contact the support listed in the Supporting information on the website.

Will analytical partners be eligible to lead more than one consortium? Will there be a limit on the number of applications an entity can collaborate on for this call?

There is no limit on the number of applications an analytical partner may submit or a partner may collaborate on, however, it is recommended that lead applicants focus on their strongest application. If submitting multiple applications, you should clearly indicate the differences, and where applicable, potential synergies. You would have to ensure you had resource to complete all activities if funded. Overlap for activities and costs would not be allowed.

Can a technology partner appear in more than one bid? For example if multiple NHS regions/HIN's want to do a study on our technology.

There is no limit on the number of applications a technology partner may collaborate on. However, you would need to ensure you had sufficient resource to complete all projects, if successful. If you are involved in multiple applications, you should justify the strategy for multiple projects (rather than one project with multiple sites,) and clearly indicate the differences, and where applicable, potential synergies. Overlap for activities and costs would not be allowed.

We are a mental health trust and would would be very open to collaborate, do we have to complete a partnering form too?

You can contact the eligible technologies from the list directly to initiate collaboration discussions. You may also send your details to i4i-rwe@nihr.ac.uk with confirmation that you agree to your details being shared with potential analytical and technology partners. This list will be available to attendees at the matchmaking event or on request from potential analytical or technology partners.

Does NIHR allow for NHS sites to use two products on the EVA? We have been approached to have our product tested against another EVA

The aim of the call is to generate real world evidence to support full NICE evaluation and widespread adoption. There is no restriction on the number of technologies to be deployed at a site, and any number of technologies under one EVA topic can be included on one application, so long as there is resource to complete all proposed activities if multiple applications are funded.

Is it possible to have several adoption sites (any limit?)

There is no limit to the number of sites you may include in your study. The overall strategy and design of your project should be outlined within your application, as well as how the chosen locations and types of settings are suited to address the evidence needs of the product(s). A maximum of 15 co-applicants can be included in each application. If you have more sites than you can include, please detail the extras in the 'Detailed Project Plan' section.

I presume this call is open to organisations in Scotland (some of the previous slides only showed English and Welsh networks)?

Yes, all partners, including adopting sites, can be based anywhere in the UK

Can partners in the consortia come from outside of the UK?

Proposals should be led by an analytical partner that is a UK legal entity partnered with UK sites/services. Technology partners should be those that have been recommended for early use in the NHS through NICE EVA. Other collaborators or sub-contractors may be from outside the UK if suitable justification is provided.

Can you submit applications that covers multiple EVAs on one theme (ie 4 mental health EVAs) or would this need to be 4 separate applications

Yes, you may submit one application containing any number of eligible technologies under one NICE EVA topic.

There are a number of EVAs in consultation that are likely to be published in the very near future - will they be included if published before the closing date for applications or not? Will there be another round of funding?

Only the technologies included on the list are eligible for this call. However, you will notice a "status update" column showing Draft or Published. If the draft guidance of the technologies on the list is published by the close date, they are included and can apply. The i4i NIHR & OLS RWE call is a one-off competition and at the moment further rounds have not been planned.

For the virtual ward technologies, the guidance seems to suggest that in addition to the 13 technologies listed, other technologies are potentially also eligible to apply. Can you confirm that this is the case please?

Although the Virtual ward platform technologies for acute respiratory infections assessment acknowledged the existence of multiple technologies, the virtual ward platform technologies eligible for the NIHR i4i & OLS RWE Call are only the 13 technologies (included on the list of eligible technologies) where developers participated in the NICE evaluation and provided information to NICE and have as such been reviewed and recommended for early use in the NHS whilst further evidence is generated.

The virtual ward platform technologies EVA is focused specifically on acute respiratory infection but evidence gaps exist for other pathways. Could the submission be expanded to include other conditions?

One of the main aims of this funding call is to generate the evidence for the full NICE evaluation and those required by the commissioners for the widespread adoption. While there may be gaps for the evidence of virtual wards in other pathways, acute respiratory infection is the use case evaluated by NICE EVA and recommended for further evidence generation. Therefore, the projects should include only activities related to the specific use case recommended by NICE.

Would you be able to confirm what conditions you would class as being covered by the Virtual Wards for acute respiratory infections EVA? For instance, would addressing COPD exacerbations fall under this?

The NICE Early Value Assessment guidance on virtual ward platform technologies is for acute respiratory infections. COPD exacerbations where caused by acute respiratory infections could be considered a relevant subpopulation, but is not specifically mentioned in the guidance or evidence generation plan.

We are interested in looking at Virtual Wards for acute respiratory infections in children, will that be permitted?

Please check the scope of the conditional recommendations. For example, in this case they apply to people over 16 with acute respiratory infection

We have programmes listed in the NICE EVA for adults and in the one for children and young people. Is it possible to submit 2 applications, one for each population, since they are too distinct to be submitted under one. If so, would it be detrimental to have 2 applications or would the 2 have the same chances of getting funded?

Only technologies included under the same EVA topic can be included in the same application to this funding competition. If the technologies are under two different EVA topics then two separate applications would be required. Each application will be reviewed against the assessment criteria and awarded based on its own merit. However, if considering partnering on more than one application, you would need to ensure you had sufficient resource to complete all projects, if successful. You should also clearly indicate the differences, and where applicable, potential synergies. Overlap for activities and costs would not be allowed.

Within our application for the children and young people programmes, would it be possible to include our parenting suite of programmes to be considered within the evaluation framework of the project as we anticipate it would be leveraging the same infrastructure as the adolescent programmes?

Please check the scope of the conditional recommendations. For example, in this case they apply to self-help digital cognitive behavioural therapy (CBT) technologies used as an initial treatment option for children and young people (aged 5 to 18) with mild to moderate symptoms of anxiety or low mood.

Question related to the digital weight management technologies to support weight-management medicine EVA – the cost of weight-management medications (GLP1RAs etc) is substantial – did I understand correctly that drug costs cannot be included in the costing for this call and that funding for this must be sourced elsewhere?

The weight management medicine is commissioned, and the technologies themselves are used to support the prescription and monitoring of these treatments. Therefore, since the impact of interest is from the technologies supporting the medicines rather than the medicines themselves, companies would not be expected to have to cover this cost.

Why is HTE12 Artificial intelligence-derived software to analyse chest X-rays for suspected lung cancer in primary care referrals: early value assessment, not included on the list of eligble EVA technologies?

Only technologies that have been approved through EVA for early use in the NHS are included and those that have research-only recommendation (such as HTE12) are not within the scope of this call

We are already virtual ward tech in clinical practice in the NHS. Are we already too mature? Is this call more for more nascent technology?

This Call is for real world evidence generation activities to support full NICE guidance, as well as real world evidence to encourage increased uptake and use of technologies within the NHS, and to capture generalisable learnings. If you are an eligible technology and wish to carry out such activities (see supporting information for further information) then you are welcome to form a consortia and submit an application.

Should the site be at a pre-adoption stage, or would it be suitable for site to carry out post-adoption evaluation? E.g. if a site is currently trialling a tech, can we use this opportunity to collect data and perform evaluation?

If the data collected post-adoption can address the evidence gap then there is no reason why post-adoption data cannot be used. However, in some cases additional data may be needed, for example, a suitable comparison population receiving standard care alone. Funding is available to support evidence generation to address NICE EVA recommendations and also to support widespread adoption for eligible technologies.

Can a company be completing one NIHR grant and start this one?

All applications will be assessed for overlap by the NIHR team, therefore, ensure that there are no funding or project overlap between existing awards and your application for this competition.

Finance

Whilst you note no upper limit on budget, with 13 eligible EVA topics, it would be helpful to have some guidance on total budget pot available for this call. Are you able to provide an anticipated budget per project?

The Real World Evidence Programme is backed by £10m government funding. Project budget will vary by activities proposed as well as number of technologies and sites/services included so we do not have a specific guide but all costs should be justified.

Is there funding and ambiton to short list all projects for all the technologies listed in the EVA? if you are not short listed is there any opportunity to reapply?

The Real World Evidence Programme is backed by £10m funding. This is not enough to support all eligible technologies. Proposals will be reviewed against the assessment criteria (included in the Supporting information) and recommended for funding based on individual merit. This is a one-off pilot call but other funding mechanisms exist to support real world evidence generation, such as NIHR i4i, SBRI Healthcare and NHS Cancer Programme.

Is this competition structured as a grant? I.e. does the grant go to the company and then it is on the company to run their evidence generation program and distribute directly to trusts? Or do we go through a procurement channel where the technology can then be procured directly by trusts?

The funding from this Call is an award. Funding will be disbursed to the Lead Applicant (analytical partner) as outlined in the contract, subject to agreed milestones being met. The funds are then distributed by the analytical partner to the technology providers, sites and any other subcontractor as necessary. This is not a procurement process.

Does the funding cover the cost of the equipment/technology that we would use to genererate RWE

Cost of the technology to generate the real world evidence, but without any profit attached, would be eligible if justified (large organisations would be expected to provide the technology in kind). The supporting information and finace guidance provide further information for eligible costs.

In addition to costs of the technology, would any additional implementations costs be covered?

Implementation costs would be eligible if justified. The supporting information and finace guidance provide further information for eligible costs.

As a very small technology partner, what costs of the technology partner are acceptable in the application? Which of these might be included: technical support, software development, usability studies, product development, server rental, software licences, ... ? Are any of these reimbursed at 100% or are all costs reimbursed at 50%?

Cost of the technology to generate the real world evidence, but without any profit attached, would be eligible if justified (large organisations would be expected to provide the technology in kind). Costs of the technology partner to provide and support the technology during the project would be eligible, this can include technical support, software licenses, etc for the specific EVA-recommended product(s) used. 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) could also be considered. All eligible costs are reimbursed at 100%.

Will the NIHR fund treatment costs?

NIHR Awards do not include NHS support and/or treatment costs. These costs, including costs for Social Care research, are funded via Clinical Research Networks (CRNs) and should be detailed in the Schedule of Events Cost Attribution Tool (SoECAT). Further support with treatment costs can be provided by your local CRN.

Can salaries be covered for technology or adopting site partners, or only for analytical partners?

Salaries for the work performed by any applicant on the project can be requested.