Internet Explorer is no longer supported by Microsoft. To browse the NIHR site please use a modern, secure browser like Google Chrome, Mozilla Firefox, or Microsoft Edge.

NIHR i4i & OLS Real World Evidence FAQs

Contents

Published: 06 February 2024

Version: 1.0 February 2024

Print this document

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.

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?

The full list of technologies which have been recommended for early use in the NHS through NICE EVA can be found at this link. 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. The full list of technologies which have been recommended for early use in the NHS through NICE EVA can be found at this link.

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.

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 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.

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.

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 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.

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.

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.

Innovators may apply for further funding from organisations such as NIHR, SBRI Healthcare and NHS Cancer. It is recommended to sign up to funding newsletters to be kept updated on future funding opportunities, e.g. https://www.nihr.ac.uk/about-us/stay-up-to-date.htm; https://sbrihealthcare.co.uk/

IP

Can I please ask how IP can be / should be managed in the project? If the project is a research study led by the evaluation partner, the lead partner (sponsor) will be owner of the arising IP and data; this is a recurrent problem in collaborative projects.

The NIHR's preferred position is that the contracted institution owns all Foreground IP resulting from the project. However, alternative ownership of Foreground IP may be necessary due to pre-existing arrangements or to simplify the route to patient benefit. The partners should determine the most appropriate ownership and management of IP and provide justification that this is the best route for achieving patient and public benefits.

Consortia

How can you sign up as an analytical partner?

There is no need to register separately to be an analytical partner. Analytical partners should be the lead applicant and have experience in real world evidence study design, conduct and analysis. The full list of technologies which have been recommended for early use in the NHS through NICE EVA can be found at this link if you wish to make contact directly with a technology partner, or you may register to attend the matchmaking event.

Is there any portal for information sharing/contact between the technologies and potential analytical partners/adopting sites prior to the matchmaking event? Presumably all 59 technologies are well aware of this fund?

Potential consortia members are welcome to contact potential partners at any time prior to call close. The list of technologies which have been recommended for early use in the NHS through NICE EVA can be found at this link. Interested sites are welcome to send their details to i4i-rwe@nihr.ac.uk with confirmation that they agree to their 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. All eligible technology partners have been contacted directly by NICE and made aware of this call.

Is there a list of qualified analytical partners for other eligible partners to refer to? Or are we waiting for those who have submitted EoI to NIHR / wait for matchmaking event?

NIHR does not have an exhaustive list of analytical partners and does not provide direct matching. Applicants are encouraged to take advantage of the matchmaking event and offerings by the Business Development team at NIHR to initiate discussions. They can also contact HINs, MICs, ARCs, HEIs or commercial companies directly as potential analytical partners.

Interested in hearing more about the process for potential 'match' between suppliers and analytical partners and the advice being provided to potential suppliers.

Partners will form consortia independently of NIHR and this Call, however, to support this process, we are holding a networking event for potential analytical partners and eligible technologies to initiate discussions.

If we already know what Analytical Parter we would like to use (we are a Technology Partner), then is the matchmaking event on Feb 13th not useful? Or is there some other match matching taking place there (e.g. with participating NHS trusts?)

The matchmaking event is primarily to support networking between potential analytical and technology partners who do not already have partners. However, there will also be talks from Innovators who have previously navigated late-stage product evaluations and NICE commenting on common issues and pain points.

What do I do if several companies want me to be a partner? How do I manage that?

It is up to partners to discuss options and select the best partners for the evidence generation requirements. There is no limit to the number of applications a partner may collaborate on, however, it is recommended that applicants focus on their strongest application. If submitting multiple applications, you should clearly justify the strategy, 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.

What is the intended outcome if the expected patient and system benefits are met? Will the test sites have to commission the technology longer term?

Evidence collected during the project may support full NICE evaluation and/or adoption. There is no obligation for sites to continue using the technology following the completion of the project. This should be discussed amongst partners themselves.

Application