FAQs - NHS Cancer Programme Innovation Open Call

The call is open to innovations meeting the following requirements:

• CE mark or equivalent regulatory approval obtained (if required for your innovation), AND/OR

• In use in at least 1 NHS provider in standard routine care (non-research)

Applicants will be required to submit evidence of safety and efficacy (e.g., sensitivity, specificity, positive and negative predictive values (PPV and NPV respectively)) as part of the application process. This could include peer reviewed publications, conference proceedings and/or reports. All evidence should be clearly referenced. Any preliminary evidence of clinical effectiveness should be also submitted, where available.

More information on the eligibility criteria can be found in the challenge brief.

The call is open to all innovations, including medical devices, in vitro diagnostics, digital health solutions, behavioral interventions, software, artificial intelligence, or new care models.

The priority for this call is diagnosing cancer early at stages one or two, but the NHS Cancer Programme will also consider applications for innovations which reduce the proportion/absolute number of people diagnosed at stage four.

Innovations can be tumour specific or multi-cancer.

Applications that address specific tumour sites where early diagnosis rates are poorest, and applications from multi-cancer innovations which could have a bigger impact on early diagnosis rates, are particularly welcome.

Eligibility Criteria are detailed on the challenge brief available on the competition webpage.

Yes, any innovation that improves early diagnosis rates is eligible. There are no cancers that are excluded from this competition. The priority for this call is increasing the proportion of cancers that are diagnosed early, at stages one or two, but the NHS Cancer Programme will also consider applications for innovations which reduce the proportion/absolute number of people diagnosed at stage four. If your innovation targets a cancer type with high earlier diagnosis rates, you will need to demonstrate how you will improve earlier diagnosis beyond the current standard.

Both - additional tests and/or innovations replacing the current standard of care are eligible for this competition.

Applicants are strongly encouraged to explain how the innovation could be rolled out and implemented in the NHS, and the competitive advantages over current practice.

The Innovation must be:

• CE mark or equivalent regulatory approval obtained (if required for your innovation), and / or

• In use in at least 1 NHS provider in standard routine care (non-research).

If the application for regulatory approval has been submitted by the application deadline, you may apply to the competition, but regulatory approval must be obtained and the SBRI Healthcare Programme Management Office (PMO) notified by 25 June 2024. If regulatory approval has not been obtained by the 25 June 2024, the application will be rejected based on eligibility.

Innovation projects that focus only on increasing diagnostic efficiency and freeing up resources are not eligible for this call.

Applicants are encouraged to consider how their tool could be implemented to have a greater impact on early diagnosis and increase the proportion of cancers diagnosed at stage one or two. This might involve implementing the innovation at an earlier stage in the pathway (i.e., in primary care), or aiming to increase uptake of the tool.

Applicants will be asked to provide evidence indication that the innovation is effective for the proposed patient cohort or disease area and that there is regulatory approval for the innovation to be deployed for the proposed new patient cohort.

Eligibility Criteria are detailed on challenge brief available on the competition webpage.

Liquid biopsy innovations are eligible for this call. It is strongly encouraged that applicants describe how their innovation would provide a competitive advantage over other solutions. All innovations must meet the standard eligibility criteria described in the challenge brief.

We would be interested in primary care educational work packages that are part of a wider intervention/pathway re-design that demonstrate an impact on cancer referrals with the aim of improving early diagnosis. Eligibility Criteria are detailed in the challenge brief available on the competition webpage.

The cancer programme will consider applications for innovations which reduce the proportion/absolute number of people diagnosed at stage four, but the priority for this call is diagnosing cancers at stage one and two.

The cancer programme will consider applications for innovations which can demonstrate an increase in survival amongst unstaged cancers, but the priority for this call is increasing the proportion of cancers diagnosed at stages one and two.

Applicants must provide evidence to demonstrate that the proposed innovation can improve the proportion of cancers diagnosed at stage one or two. If the educational or clinical decision support tools are intended for primary care use, applicants must demonstrate that their innovation can improve conversion from GP referrals to cancer diagnosis.

This call focusses on improving early diagnosis of cancer. While prevention and cancer treatment are important areas for NHS England, these are not within the scope of this call.

Further details are provided in the challenge brief available on the competition webpage.

The focus of projects is real world implementation studies to gather evidence for adoption in the NHS, and not activities to gather evidence for regulatory approvals.

However, applicants can consider including regulatory work packages to meet new or emerging regulatory requirements if these would strengthen their case for adoption and spread.

National, regional and local implementation projects will be considered, with a preference for national or regional projects. The focus of projects is real world implementation studies to gather evidence for adoption in the NHS and projects that can demonstrate uptake in various geographical locations will have stronger evidence for spread and adoption. However, applicants need to ensure that the project is feasible to deliver in 24 months, so proposals will need to manage the balance between feasibility and impact.

Assessment criteria are detailed in the Invitation to Tender document available on the competition webpage.

The project must involve implementing the innovation at clinical sites in England. However, the call is open to single companies or organisations from the private, public and third sectors, including charities, based in UK and/or Europe.

Please note, commercialisation/adoption and spread is one of the NHS Cancer Programme’s scoring criteria; therefore, it is expected that a route to commercialisation, further implementation, and/or adoption is clearly described irrespective of the type of organisation leading the application. Details on eligible organisations are available in the challenge brief.

No, but you will need to adequately explain your future plans for sustainable spread and adoption of your solution. The purpose of the NHS Cancer Programme’s Innovation Open Call is to accelerate the adoption and spread of innovations that will improve early diagnosis in England. One of the assessment criteria for this call is therefore appropriateness of the proposed commercialisation and adoption strategies, which must include a comprehensive sustainability plan for carbon reduction to align to the new NHS net zero requirements for procurement in the UK.

The longer-term plan would need to explicitly include the feasibility of adoption into the NHS. Applicants are also invited to consider the environmental impact of their innovations to support the net-zero commitment that the NHS has set in the Delivering a ‘Net Zero’ National Health Service report.

The Health Innovation Networks can also aid in addressing the NHS Net Zero agenda, procurement implications, carbon calculators and health inequalities.

All applicants must describe the environmental impact that your solution will have on the NHS in the application. Specifically, you are asked to:

• Describe the environmental impact that your innovation may have in the care pathway/or care delivery it is intending to operate in.

• Detail how the innovation may contribute to reducing NHS emissions (as explained in the Delivering a net zero NHS report, pages 11 and 12) and outline the quantified projected carbon savings including the methodology you used to estimate them. If you do not have any estimate, please articulate the methodology that you will adopt to quantify carbon emissions’ reductions and consider including a work package on this as part of the project.

• At an organisation level, please provide an outline on how you intend to fulfil the NHS Sustainable Supplier Roadmap, your organisation carbon reduction targets and the timelines to fully achieve the requirements set by the NHS Supplier Roadmap.

Applicants must ensure that there is sufficient existing evidence to suggest the innovation is effective for the proposed patient cohort or disease area and that there is regulatory approval for the innovation to be deployed for the proposed new patient cohort.

Applicants will be required to submit evidence of safety and efficacy (e.g., sensitivity, specificity, positive and negative predictive values (PPV and NPV respectively)) as part of the application process. This could include peer reviewed publications, conference proceedings and/or reports. All evidence should be clearly referenced. Any preliminary evidence of clinical effectiveness should be also provided along with the application, where available.

The innovation must meet the specifications detailed in the challenge brief.

The NHS Cancer Programme welcomes applications from and for any NHS healthcare setting, provided the innovations address the challenge brief and meet the entry eligibility criteria. There is no preference for primary, secondary, tertiary, or community care.

At the end of the project, the innovation should be embedded into practice in a number of NHS locations, there should be a high-quality independent evaluation report, and a well-defined plan for further work and/or scale-up, as appropriate.

Examples of potential exit points include:

• Health economics assessment
• Innovation independently evaluated to demonstrate its impact in real-world settings
• Collation of evidence for NICE approval or endorsement (i.e., Health Technology Guidance)
• Completion of procurement business cases to support transition into business-as-usual via standard commissioning routes
• Evidence for national commissioning initiatives (e.g., MedTech Funding Mandate)
• Inclusion on national procurement frameworks
• Registration to Innovation Service website

Research, Innovation and Development Advisory Committees (RIDAC) act as a support and advisory body within the three cancer screening programmes (breast, bowel, and cervical). They will help researchers and innovators with proposals for evaluation by assessing the potential impact of the proposed project to ensure participant benefit and safety, clinical service continuity, minimal service/workforce burden, that it is technically possible within the current IT systems and whether the data request is necessary, proportionate, and legal.

RIDAC does not provide approval for projects but will provide a set of recommendations to ensure the project aligns with the priorities of the screening programmes. All projects relating to breast, bowel and/or cervical screening programmes will need to consult the RIDAC process and obtain a letter of recommendation before beginning the project.

The RIDAC team in the NHS England Vaccination and Screening Directorate is the point of contact and will help applicants through the required RIDAC application process. 

Applicants are strongly encouraged to contact the team early in their planning so that specific, constructive advice can be given to help refine the proposal and pre-empt the committee’s queries. You can contact the RIDAC team at england.screening.research@nhs.net.

The call is open to single companies or organisations from the private, public and third sectors, including charities, based in UK and/or Europe. However, the project must involve implementing the innovation at clinical sites in England.

Please note, commercialisation and/or adoption is one of the NHS Cancer Programme’s scoring criteria; therefore, it is expected that a route to commercialisation, further implementation, and/or adoption is clearly described irrespective of the type of organisation leading the application.

The lead organisation of an application must be a legal entity. Cancer Alliances are not legal entities and are hosted by NHS Trusts. NHS Trusts are eligible to apply. Cancer Alliances may contribute to the application as a co-applicant. Cancer Alliance engagement and support is strongly encouraged.

Yes. Please ensure the feedback provided in the outcome letter(s) is taken into consideration when you prepare the new proposal.

Nevertheless, it should be emphasised that the NHS Cancer Programme Innovation Open Call does not have a formal resubmission process and any subsequent application would be treated as a new submission which may receive comments from different reviewers and be considered by a Panel consisting of different members.

The NHS Cancer Programme’s Innovation Open Call will not fund the same project that is supported by other funders. If the proposed project is different from an existing project and meets the challenge brief and eligibility criteria, you may apply. However, any funding overlap should be made clear in the application.

Clinical trials aiming to evaluate only the effectiveness of a product are not eligible for this call. Trials that aim for multicenter implementations after proof of efficacy and safety have already been established are eligible. Eligibility Criteria are detailed in the challenge brief available on the competition webpage.

The Call is focused on adoption and spread of early cancer diagnosis innovations. For this reason, the following types of projects are excluded from this competition:

• Clinical trials (including randomised control trials) aimed solely at determining effectiveness of a product.

• Basic research.

• Procurement exercises. Projects funding purchase of a product without plans to generate real-world evidence and conduct implementation studies/evaluations.

• Projects that focus on improving efficiency only. Applicants with a diagnostic efficiency tool are encouraged to consider whether the proposed innovation can improve earlier diagnosis by implementing the tool earlier in the pathway, in a different setting or by designing a solution that improves access and/or uptake of their intervention.

• Research that only aims to inform or influence NICE guidelines. For example, innovations that mine GP and other records, to build evidence on features of cancer risk.

NHS Cancer Programme Innovation Open Call winners will be assigned a Project Management Officer (PMO). Specific milestones will be agreed during the due diligence phase and added to the contract. Awardees will be required to attend regular monthly meetings to monitor progress against agreed milestones, as well as submit monthly and quarterly progress reports.

Awardees will also be required to undertake a comprehensive independent evaluation for the project which includes:

• Completing an evaluation strategy with support of the NHS Cancer Programme Cancer Analysis and Insights Team and submitting interim and final evaluation reports. More information about the evaluation strategy and the minimum thresholds can be found on the competition webpage.

• Complete and submit a health equity assessment tool (HEAT) and attend a 1:1 meeting with the NHS Cancer Programme health inequalities and patient community engagement team.

An overview of the Monitoring Expectations for Awardees is provided on the Invitation to Tender document available on the competition webpage.

All awardees will be required to undertake a comprehensive independent evaluation as part of the project within the duration of the project.

You will need to describe your evaluation plan and submit a logic model as part of your application. You must demonstrate in the application that your evaluation is robust and can undergo independent scrutiny. The evaluation should be delivered by an organisation independent from the project team.

All awardees must submit an evaluation strategy, which must be reviewed and signed off by NHS England. Interim evaluation reports are expected to be shared with SBRI Healthcare PMO and NHS England during the project. A final evaluation report must be provided at the end of the project along with a final report summarising project findings.

Further information on the requirements of the independent evaluation can be found on the competition webpage.

Applicants

An online preparatory session called “GET READY TO APPLY '' will be held on 4 April 2024 at 10:00 a.m. approximately one week before the call opens to applications. Attendees will hear advice and tips on how to draft a robust evaluation plan, which is requested in the application. During the event, attendees will also receive insight on how to effectively use data to outline the potential impact of their innovations on early diagnosis, consider health inequalities and prepare a competitive application. Potential applicants will meet representatives from the:

• SBRI Healthcare PMO
• NHS Cancer Programme Innovation team
• NHS England Cancer Analysis and Insight (CAIT) team
• NHSE Health Inequalities and Patient Community Engagement teams

Awarded projects

• All awarded project teams will attend individual session(s) with the NHS England Cancer Analysis and Insight (CAIT) – Evaluation team to discuss how their evaluation strategy can be improved to ensure it’s in line with the NHS Cancer Programme’s expectations.

• All awardees are expected to submit an evaluation strategy alongside the relevant documentation (i.e., revised logic model, evaluation mapping table and data metric mapping), which will be reviewed by the NHS England CAIT – Evaluation team. Evaluation strategies must meet minimum thresholds in order to be approved by NHS England (minimum thresholds will be discussed with awarded project teams).

Further information on the evaluation strategy can be found on the competition webpage.

If applicants require guidance on how to commission an evaluation partner, applicants are encouraged to contact the SBRI Healthcare PMO to ask for further information.

Awardees are expected to actively engage in tackling healthcare inequality and actively involve patients and community. The awarded project teams will be invited to attend individual sessions with the NHE England Health Inequalities and Patient Community Engagement teams to discuss their health inequalities and patient community engagement strategy.

All awarded project teams will be asked to submit a health inequalities and patient community engagement strategy, which will be reviewed by NHS England who might provide comments to address.

If the proposal is coming from the NHS, Higher Education Institution (HEI) or other organisations, involvement of the company that developed the innovation is not mandatory, but strongly encouraged, as this could address some implementation barriers, which can be key contributors to the adoption and spread of the findings associated to innovations.

Projects interested in adoption and spread to multiple locations must demonstrate how this project will generate new evidence and address existing evidence gaps. Procurement activities are not eligible for this call.

Due to the nature of the projects supported by this call, all proposals are expected to have partnerships in place with at least one NHS organisation, if they are not already led by one.

The most successful applicants often have an existing relationship with named clinician(s) or clinical expert(s) at the time of application. The clinical partner(s) will likely help you develop the clinical aspect of the project, identify suitable NHS Trust or Cancer Alliance partners, and build the relationship with the chosen clinical sites. Although clinical partners can be based anywhere in Europe, it is strongly recommended that the clinical partner is based in the UK to ensure the project is appropriately delivered in the NHS setting. Clinical partners outside of the UK will need to be fully justified. Clinical sites in this project must be based in England.

Ideally there will be a named NHS member of staff with whom you have had initial discussions about the feasibility of your project. Please note, the composition of the project team is one of the assessment criteria, and sufficient detail should be provided to assure the panel that the project team will have the appropriate expertise to plan and deliver the project.

Yes, subcontracted work outside of England or the UK is accepted. However, applicants must demonstrate how this will benefit UK healthcare and the economy. Subcontracts may include contract research organisations, consultants, or manufacturers (this is not an exhaustive list).

A virtual matchmaking event is being hosted on 12 March 2024 to initiate conversations with organisations and Cancer Alliances. Please visit the competition webpage and Sign up here.

A list of Cancer Alliance websites and contacts is available HERE.

A list of the Health Innovation Networks and contacts is available HERE.

Involvement of Cancer Alliances is not mandatory, but strongly encouraged. The Cancer Alliances have cancer expertise and will be able to facilitate links to NHS Trusts and expert clinicians within their area. Please note that every NHS Trust in England is associated with a Cancer Alliance. As each Cancer Alliance has their own priorities, applicants are encouraged to investigate and determine the Cancer Alliance that is best positioned to support the proposed innovation. A list of Cancer Alliance websites and contacts is available HERE.

Please note, the composition of the project team is one of the assessment criteria, and sufficient detail should be provided to assure the panel that the project team will have the appropriate expertise to plan and deliver the project.

Please submit one application per innovation, regardless of the number of Cancer Alliances involved in the project. The host organisation may involve as many clinical sites as necessary, subject to justification and that it is realistic, in the project proposal. If you are working with more than one Cancer Alliance, please clearly state each of their roles in the application.

Involvement of the Health Innovation Network (or “the Network”) is not mandatory, but strongly encouraged. The Health Innovation Networks have expertise to help with the commercialisation and deployment of innovations. However, it is recognised that similar expertise can be provided by other entities. Therefore, it is not essential to include a Health Innovation Network on the application.

Please note, the composition of the project team is one of the assessment criteria, and sufficient detail should be provided to assure the panel that the project team will have the appropriate expertise to plan and deliver the project.

A list of the Health Innovation Networks and contacts is available HERE.

Applicants should provide sufficient evidence to demonstrate that the innovation can address the challenge, provide clear clinical benefits, and can demonstrate advantages compared to the current standard of care.

Applicants must submit evidence of safety and efficacy (e.g., sensitivity, specificity, positive and negative predictive values (PPV and NPV respectively) as part of the application process. This could include peer reviewed publications, conference proceedings and/or reports. All evidence should be clearly referenced. Preliminary evidence of clinical efficacy and safety should be also provided, where available.

The NHS Cancer Programme has developed a model to assess the impact of innovations on early diagnosis. This is calculated using the “Early diagnosis impact assessment”. The template is available on the competition webpage. Applicants are asked to complete and submit this form along with the application.

This analysis will form a central part of the assessment process and it is essential that all applicants complete the template with as much information as possible to enable a quantitative assessment of your innovation’s potential impact on earlier diagnosis. If a template has not been completed, contains missing information, or inaccurate information, this may affect the impact assessment which will be shared with the assessment Panel.

The clinical evidence can be derived from anywhere in the world and would be considered as appropriate provided the evidence is applicable to cancer patients in England.

Irrespective of where the evidence was derived, applicants should ensure the innovation meets the challenge brief, entry criteria, and are suitable for or could be adapted for the NHS.

All eligible applications will be reviewed by a selected Panel of experts who will provide feedback on the applications according to the assessment criteria described in the Invitation to Tender document, which is available on the competition webpage.

Bids will be also reviewed by NHS England to assess whether proposals align with the NHS Cancer Programme’s priorities.

Shortlisted applicants will be notified after the shortlisting meeting and invited to an interview meeting to present their proposal to the Interview Panel, which will be made of a subgroup of the Panel of experts that participated in the shortlisting process.

The interview takes the form of a short presentation (typically 10-15 minutes) followed by a question-and-answer session with the Panel members. Ahead of the Panel interview, shortlisted applications will undergo further assessment, including:

• Independent external peer and public reviews.

• An impact analysis of the innovation on early diagnosis of cancer, performed by the NHS England Cancer Analysis and Insight (CAIT) Team. The analysis will be completed based on the data and information submitted in the application and in the “Early diagnosis impact assessment”. Please note: The NHS England CAIT may engage with the applicants between the shortlisting and interview Panel to ensure a robust and fair impact analysis can be completed.

• An assessment of the strategic alignment of the proposed solution to existing NHS programmes and the potential impact on the specified cancer pathway, performed by NHS England Internal Peer Reviewers.

• An assessment of the proposed evaluation plan and logic model, performed by NHS England Cancer Analysis and Insight – Evaluation team.

The applicants will have access to the anonymised reviewers’ comments and are encouraged to use the Panel interview opportunity to address them during their interview.

Further information is provided in the Invitation to Tender document available on the competition webpage.

All applicants will be informed after the assessments have been concluded. We anticipate the outcome will be announced in October/November 2024.

No. Costs should be calculated to reflect fair market value.

The call is a pre-commercial procurement process, and the resulting development contract is subject to VAT. While applicants must submit the NET cost (excluding VAT), it is the invoicing business’s responsibility to determine whether VAT should be applied in invoices.

An element of overheads may be included in project costs. However, such an element must be realistic. Assessors will consider financial costs in terms of ‘value for money’ at the assessment stage.

Projects showing costs that are considered unreasonable will be rejected on these grounds.

General guidance on Costs guidance for Small Business Research Initiative (SBRI) is available here.

All bids must be submitted using the Research Management System (RMS). You must create a login using your email address and a password. You are strongly recommended to read relevant documents available on the competition webpage before completing the application form.

The application must be submitted via the Research Management System (RMS) along with the following documents:

• Finance spreadsheet. The template is available on the competition webpage (mandatory).

• A completed “Early diagnosis impact assessment”. The template is available on the competition webpage (mandatory).

• Pathway map showing the innovation disrupted pathway against the normal clinical pathway (must not exceed 1 single side of A4), including all steps in the pathway (including triage/analysis etc.) and statistics or percentages of patients/referrals going down the different routes within the pathway, if possible (mandatory).

• A completed logic model (2 single sides of A4). The template is available on the competition webpage (mandatory).

• Gantt chart for the project (must not exceed 1 single side of A4), including steps required to obtain relevant review(s) and/or approval(s), if applicable (mandatory).

• Relevant documentation to support regulatory approval/compliance claims made in the proposal (mandatory).

• List of Reference (mandatory).

• List of evidence on safety and efficacy (e.g., sensitivity, specificity, positive and negative predictive values) for the proposed solution (i.e., peer reviewed publications, conference proceedings, reports, etc.) (mandatory).

• Additional supporting document (2 single sides of A4, optional).

13:00 GMT, 29 May 2024.

Organisations are welcome to submit more than one application if they have multiple innovations that address the challenge brief and meet the entry criteria. There must be significant differences between the innovations submitted to this call.

Intellectual property rights are retained by the applicant although certain rights of usage may be applied by the funding authority including royalty-free, non-exclusive license rights and the right to require licenses to third parties, at a fair market price.

No. Where public authorities buy research and development from organisations at a fair market price, not for their exclusive use and where the call is advertised in an open market, there is no advantage and consequently no element of state aid.

Applicants can make an enquiry at sbri@lgcgroup.com relating to specific clinical pathways before submitting their application. Applicants are invited to attend:

Virtual matchmaking event with Cancer Alliances and Health Innovation Networks – 12 March, 2 pm – 5pm. This is a unique opportunity for innovators, Cancer Alliances and the Health Innovation Networks to meet and form new partnerships. Please Sign up here.

“GET READY TO APPLY”: Online preparatory session – 4 April, 10am - To hear insights, advice and tops tips on how to draft your evaluation plan, to effectively use data to outline the potential impact of your innovation on cancer early diagnosis, consider health inequalities and prepare a competitive application. Please register here.

Q&A session on 18 April 2024, 11am - Opportunity for potential applicants to ask questions about the competition. Please register here.

Additional information will be published on the competition webpage as it becomes available. Applicants are encouraged to consult with all published materials when completing their application to ensure that the appropriate information is provided to assist with the assessment process.