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AI Competition 1 - Stage 2 Applicant Webinar Q&A

 

Contents

 

What kind of evidence do we need to submit? Does it have to be a published paper?
Evidence of clinical need or entry TRL doesn't need to be in the form of a published paper. As long as the evidence is relevant it can be any type, e.g. unpublished data, results from a survey or focus group with patients/clinicians, letter of support from a trust.

 

Word limit for detailed project plan is 8,000 words in the online form. I think I heard Dr. Gan say 16,000 words?
Phase 1 has a word limit of 8,000, phases 2 & 3 have a word limit of 16,000

 

Other NIHR Stage 2 bids I have submitted (e.g. real-world implementation) have a word limit of ~5,000 words for the main project plan question. This one has a word limit of 16,000 words. Are you expecting much more detail for this application, e.g full clinical trial protocol?
The word count limit is 8,000 words for Phase 1 and 16,000 words for Phase 2-3. The 16,000 word limit is similar to other i4i programmes (such as the Product Development Award) and we would expect a similar level of detail as is included in those.

 

Do you expect ethics and CAG approvals to be in place when the second round application is submitted?
If approvals are in place, please provide details in your application. If approvals are not yet in place, please explain where you are in the process and include details on how you will obtain these approvals in your project plan.


Can supporting image/figures be embedded in-line (i.e. in the Detailed Project Plan box). The web form suggests they can (there is an icon for it)
Supporting images/figures can be embedded. We recommend that you check the PDF of the application form before submitting to ensure it's rendering correctly and as you expect. We ask that you do not use images to circumvent the word count; these should be images/diagrams

It is unlikely that at Phase 1 a full pricing strategy will be available, should this just be estimated?
The commercialisation and marketing strategy should be scaled as appropriate to the phase.


Can you clarify the potential to change/amend the plan and costings from the EoI for the stage 2 submission?
The Stage 2 application may change, for example, to accommodate the Stage 1 feedback, information in the guidance document or webinar. However, a very large increase in time or cost would need significant justification within the application and applicants should keep in mind that Panels will consider value for money when assessing applications.


The feedback we received was at a very high level, as opposed to details. Is it possible to get a more detailed feedback or score on the different sections of the EoI application?
No scores were given to specific sections of the EOI applications. Please email the AI helpdesk to see if there is any further detailed feedback available for your application.


Is it possible to extend the list of partners?
The list of partners can be extended if you justify this appropriately.


Is the level of detail required for the IP and Commercialisation strategy appropriate to the application stage? Can stage 1 applications be less detailed here?
We understand that you may not have all the necessary answers, particularly in Phase 1 and Phase 2 applications. However, we expect applicants to have an idea of who the future customers are, for example, CCG or private sale direct to consumer. Your application should show evidence that manufacturing/scale-up /distribution issues are being considered where applicable.


Does the commercialisation strategy have to include adoption in the NHS?
Commercialisation Strategy and Adoption in the NHS should both be considered under their respective headings in the Detailed Project Plan. Commercialisation strategy should include adoption in the NHS but may also cover other elements such as private sales.


It has often worked against the application in the past when NHS adoption has been a key part of commercialisation. Could you please clarify if the commercialisation for this application has to revolve around how we will sell to the NHS?
This is a specifically NHS directed call so this will not be a problem. However, please be aware of other markets and, if that is in your plan, say so and what you are doing about it. We would be very happy for you to be going after FDA as well as EMA/MHRA approvals


One significant question will be regarding the effect of the C19 pandemic on the process (including application deadline) and ensuring that those of us who are clinically involved are not disadvantaged?
We understand that some applicants may be under clinical pressure currently. You are strongly encouraged to submit your application if you can. Please let us know if you are going to struggle to make the current deadline and we will do our best to work with you.


Is it possible to delay submission due to current clinical pressures? And would this penalise the applicant?
It is not possible to delay submission.


When we were asked whether we could make the submission deadline, if the answer is NO - then that means CANNOT be included in this round? 
Applicants who cannot make the current submission deadline will be moved onto the wait list. Your application will be retained and you may be invited to submit a full Stage 2 application later in the year, with sufficient time in which to complete your application.


What about timelines and feasibility in light of current national halt on clinical trials. Shall we write assuming all Covid-related halts are lifted by start of project?
You may wish to take into account COVID-19 related delays when considering your project start date.


CTU’s are very busy with COVID.. getting on to engage will be very difficult.
Although encouraged, their collaboration is not mandatory?
We encourage you to collaborate prior to submission as much as is possible. However, where this is not possible, you should explain in your application what collaborations you will seek at a later date once you are able.


Is it possible for us to extend the use case scope of our project to encompass a COVID-19 application of our technology? It is related to the original use case scope, but an extension
If the technology is something that would be required in the next 12 months then applicants may wish to seek funding from more appropriate sources, including NIHR's rapid response Covid call and UKRI's rolling call. If the technology would have further applications on a longer time trajectory, then the AI call would be suitable.


So are you saying there is no delay to the application process due to COVID-19?
This process hasn't been delayed at all? We are working to the published timetable on the website.


If we delay submission because of NHS Trust/CTU submission, when is the next deadline we can enter?
There are no confirmed dates for Competition 2 yet. Updates will be published on our website as they become available.


So covid-related delaying, as you advise, has currently no guarantee that it will be treated equally as a present submission.
We are discussing how best to manage this including a possible fast track to Stage 2 of Call 2 but this is not yet agreed. We do not want to disadvantage anyone because of the situation but neither do we wish to stop delivery of some technologies that may benefit patients.


Does this funding stream attract RCF?
This a standard award so there is no Research Capability Funding alongside this. The costs that you include in your application should reflect the costs that the project will need and eligibility for those costs can be found in the guidance for applicants.


Can the project costs be different from the costs that we estimated in the EOI stage? And if yes, how much different?
We acknowledge that some costs may change, particularly if you did not have the chance to obtain accurate detailed costings prior to submitting your Expression of Interest application. Phase 1 applicants should keep in mind the hard funding limit of £150,000. Phase 2 and Phase 3 applicants are not subject to a funding limit but should still fully justify their costs. A difference of more than 10% would require strong justification.


Can you clarify if we do increase length of project whether costs (e.g. staff time) can increase proportionately, or is the budget listed in our outline what has to be hit?
Costs can be amended if the duration of the application is amended. However, applicants should keep in mind the £150,000 funding limit for Phase 1 and all changes, regardless of phase, should be fully justified.


Can the funding be split with a university outside of the UK, or should the funding remain within UK organisations?
International co-applicants are allowed, but justification would need to be provided as to why this organisation is best placed to fulfill the role over other UK organisations.


Will user groups/workshops with clinicians & other SMEs be funded as part of this call? The answer to the question about SME time would seem to suggest that it will be funded?
You should engage with end users throughout and these costs will be funded as part of the application.


Can we enhance our team by including new partners such as health economists? If so, will we need to stay within the EOI budgets?
Applicants can increase the budget as long as this is fully justified in the application. For Phase 1, the increase should not take the total budget over £150,000.


Are we allowed to know the budget for this round and the names/affiliations of the panel we will be presenting to please?
The budget will be decided during the ratification process. We hope to fund as many of the applications deemed fundable by the Panel as possible. The details of Panel members can be found on our website.


Can you clarify if SME are applying for 100% of eligible costs or 70% (as per innovate UK) and if it is 70% is the £150K the 70% value
As with other NIHR awards such as i4i, SMEs are eligible for 100% of full economic costs and there is no requirement for match funding.


Is full SoECAT required for everyone (lead and coapplicants) industry/charity/NHS. or is front page of SoECAT
One SoECAT is required per application - this should cover the full set of partners.


Can an NHS Trust complete the SoECAT form? Or does it have to be a CRN?
An NHS Trust can complete the SoECAT but you do need to have CRN sign off. If this is not possible within the timeframe, please submit what you have and sign off can be sought post funding decision.


What category of cost would time required by clinicians to participate in product development user groups fall into and would this be covered by the grant directly?
You should check the guidance for further information on cost categories as this depends whether the clinician is a co-applicant or simply being involved as a contractor. The Finance template will also help. If these do not answer the question, please contact the AI enquiries email helpdesk to follow up.


What is a reasonable range to avoid under/over costing team members? I imagine it varies by grade/seniority.
You should cost team members according to their salary and the realistic amount of FTE they will contribute to the project.


Could we please make the slides available as well as the recording? The notes are very useful.
Slides and Q&As will be available on the website as soon as possible.


If a phase 3 project is based on a novel device with inbuilt AI that addresses a major clinical need is it an advantage or disadvantage if this comes from a commercial partner rather than "invented here".
In terms of dissemination/distribution/scaling for NHS as the goal, a commercial partner is much better set and likely quicker to achieve this goal. It is acceptable for a product to have originated from a commercial partner.


Are you still planning to run multiple rounds of this scheme, and if so would you consider it appropriate for a Phase 1 application to plan for a subsequent Phase 2... application(s) in subsequent rounds? Or are you expecting 1 application to this scheme and then progressing the work via other funding streams?
It may be possible for applicants to progress through the phases of the AI Award in this way if the projects are particularly short. However, at the moment the AI Award is only timetabled to run over 3 years so we can't guarantee that calls will be available to applicants after this time. There are other NIHR funding schemes which applicants could apply to instead, if this is the case.


We are planning to apply for the real-world implementation competition as well, for a different project (focused less on AI development and more on efficacy evidence). Will we disadvantage ourselves by applying for both competitions?
No but you should ensure there are no overlaps between the two projects, as we will check for this. You also need to make it clear that you can adequately resource the projects and no-one is over used as a resource.


Are the assessment criteria weighted?
Assessment criteria are not weighted.


Is there preference to deliver projects using labour rather than subcontract for development?
There is no preference as such, we would expect you to use whoever is the best placed / has the most expertise to deliver the work. But if you are subcontracting you would need to justify why you are using subcontractors (i.e. you don't have the expertise in your team, etc.)


We qualify for Phase 3 and Phase 4 (we have been asked to submit an eligibility response for Phase 4). When will we find out if our application is going forward in Phase 4? Does this negate the Phase 3 submission?
We are working with the AAC team around how this will be resolved and we and/or they will be in contact.


Is it ok if the start of the project is put for 1 December 2020? Or would this be too late?
We can agree this if you are awarded but happy for you to put Dec 1 as a proposed start if this makes sense - as with all things, please justify why.


If funded, when can we expect an award letter? And what is the latest acceptable date for the Project to start, if funded?
Award letters will be distributed as per the timetable. We will negotiate with you on a time for actual project start.


Is Health Economic analysis required for *Phase 1* proposals? Or is it one of the expected outcomes instead?
At Phase 1 we would not expect a full analysis, but we do expect you to consider the issue, looking at your anticipated research pathway and start to build a model that you will be able to populate once you are able to generate some data. If you are a Phase 2 applicant, we would expect to see a work package which will allow you to build a health economics model. If you are a Phase 3 applicant, we would expect you to have a reasonable health economics model that you would be able to populate with your data. A strong health economic outcome will be crucial in ensuring the product of the research is taken up into the NHS.


In our feedback, we are asked to provide plans to commission an independent health economics study. Does it mean that only plans to commission or are we expected to now embed a health economist in revised costs?
It would be advisable to include a health economist and include revised costings, which should be fully justified.


Are we penalised for <3min video pitch? For example if it is 1 to 2 mins?
As long as all the necessary information is included, the length of the video pitch can be anything up to the limit of 3 minutes.


When you say a video pitch? Are you looking for a presentation with a narrative overlaid or a video of the people speaking?
We are looking for a video of people speaking, in the style of an 'elevator pitch'.


Just confirming phase 2 does NOT require video
Phases 2 & 3 do not require a video - this section has been removed from the Phase 2 & 3 application form


What is the situation for applicants in the 'waiting room'?
Applicants on the waitlist who have not already been contacted will not be asked to submit for the May deadlines now. Your application will be retained and you may be invited to submit a full Stage 2 application later in the year, with sufficient time in which to complete your application.