Overview

The NIHR i4i Programme, in collaboration with the Office for Life Sciences (OLS), invites applications to the Cancer Mission: Early Cancer Diagnosis Clinical Validation and Evaluation Call. Proposals must demonstrate how the selected innovation will increase the proportion of cancers diagnosed at stages 1 and 2. Proposals aiming to directly address health inequalities in stage of cancer diagnosis are particularly sought.

The Cancer Mission: Early Cancer Diagnosis Clinical Validation and Evaluation Call is a one-stage call inviting applications for projects up to 36 months in duration, with no upper funding limit.

The call will be open to organisations which are UK legal entities, that have an innovative solution with the potential to increase the proportion of cancers diagnosed at stages 1 and 2. This call is open to small/medium commercial entities, NHS and Third Sector Service Providers, charitable organisations, local government bodies, as well as universities and research institutions.

Scope

The aim of the call is to support the clinical validation and evaluation of breakthrough technologies that can increase the proportion of cancers which are detected earlier in the disease course and/or target health inequalities in stage of cancer diagnosis.

Funding will be deployed to facilitate the generation of evidence on safety, test performance characteristics, clinical efficacy and/or effectiveness that can support regulatory approvals requirements and subsequent clinical implementation or implementation research.

The expected objectives of this investment are to:

1. Improve patient outcomes – innovative technologies to support earlier, more efficient and faster diagnosis. This is an area of unmet healthcare need (as set out above). This will increase the effectiveness of an existing public service and improve cancer survival.
2. Reduce the economic cost of healthcare through earlier diagnosis by utilising innovative technologies to detect cancer earlier and reduce the proportion of cases requiring the expensive, longer-term therapy that is necessary for treating late-stage disease.
3. Reduce health inequalities in cancer detection and diagnosis by harnessing innovations that will reduce inequalities in early diagnosis rates, tackling a contributor of the socio-economic life expectancy gap by decreasing inequalities in cancer outcomes.
4. Position the NHS as a strong innovation partner able to drive and inform the development of innovative diagnostics and services by testing innovative products and care models to support wider uptake.
5. Support the commercialisation of innovative life sciences technologies in the UK and stimulate wider investment into R&D from the private, charity and philanthropic sectors.
6. Improve understanding and research into oncology and supporting the UK’s position as a leader in cancer research – the outputs created through R&D will stimulate the development of a rich evidence base for the further development of new treatments and services. In addition, R&D funding may support further training opportunities to ensure that the sector has right skills to harness the potential of new technologies in the future.

Areas in Scope

Types of eligible innovations include, but are not limited to, medical devices, in vitro diagnostics, NICE classified Tier C digital health solutions, software, artificial intelligence, behavioural interventions and new models of care.

Applicants may wish to consider the following (non-exclusive) potential solutions to improving early diagnosis of cancer:

1. Identifying and testing asymptomatic patients who are most at risk. This includes innovations that:
   • Proactively case find and/or risk stratify populations for whom there is no current screening programme.
   • Use risk stratification to more effectively target, improve uptake/adherence, or reduce unwarranted variation in existing screening programmes.
   • Screen asymptomatic individuals at risk.
2. Encouraging early symptomatic patients to self-assess and present to primary care or other appropriate services. This includes innovations that:
   • Proactively identify those with early signs and symptoms that put them at high risk.
   • Improve awareness/vigilance of the signs and symptoms of cancer (including non-specific symptoms), particularly for those cancers, or specific populations, where early presentation is still very low.
   • Encourage patients to self-present, including in populations that typically under refer.
3. Support ongoing engagement and completion of diagnostic pathways.Decision support and assessment of risk in early symptomatic patients presenting to primary care. This includes innovations that:
   • Risk stratify patients or diagnose patients that present with less severe and non-specific symptoms.
   • Support GP decision making and reduce unwarranted variation in referrals (to increase appropriate faster referral and early diagnosis rates, whilst being mindful of avoiding unnecessary referral and attendant cost).
   • Identify and alert clinicians to changes in a patient’s presentation, behaviour or symptomatology, or repeated attendances, that warrant consideration.
4. Detection/diagnostic technologies for use in referral contexts for patients with non- specific symptoms or under suspicion of particular cancers which lack optimal diagnostic pathways and approaches.
5. Approaches to address existing inequalities in stage of cancer diagnosis between socioeconomic, geographic, demographic or other subpopulations. Applicants may find it helpful to refer to the Core20PLUS5 approach for further information on population groups.

Funding is available for validation and evaluation of the potential to detect and diagnose earlier, in an NHS setting, either directly in individuals or in samples/data taken from these.

This can include, but is not limited to, funding for:

• Validation of markers, technologies or approaches in clinical samples or patients.
• Evaluation of markers/tests/technologies/approaches in a clinical setting, intended to deliver evidence on performance characteristics (e.g., sensitivity, specificity, positive or negative predictive value), impact on stage of cancer diagnosis, impact on referral pathways and service demand.
• Clinical utility studies covering e.g., usability, tolerability and user acceptance.
• PPIE activities.