NIHR/OLS Cancer Mission: Early Cancer Diagnosis Clinical Validation and Evaluation Call

Support for UK organisations for clinical validation and evaluation of breakthrough technologies that can increase the proportion of cancers that are detected earlier in the disease course and/or target health inequalities in the stages of cancer diagnosis.

Established in 2006 and primarily funded by the Department of Health and Social Care, the National Institute for Health and Care Research (NIHR) funds health and care research in the UK.

The NIHR Invention 4 Innovation (i4i) Programme is a translational research funding scheme aimed at medical devices, in vitro diagnostic devices and digital health technologies addressing an existing or emerging health or social care need.

NIHR i4i, in collaboration with the Office for Life Sciences (OLS), invites applications to the Cancer Mission: Early Cancer Diagnosis Clinical Validation and Evaluation Call. The Cancer Mission is led by OLS and aims to make the UK a leading testbed for oncology innovation by accelerating the development and commercialisation of a new generation of cancer diagnostics and therapeutics, enabling patients to be diagnosed earlier and offered therapies specifically designed to target their cancer. At the end of 2022, the UK Government committed £22.5 million to deliver the Cancer Mission. This £12 million funding call forms one element of the Mission.

The aim of the call is to support the clinical validation and evaluation of breakthrough technologies that can increase the proportion of cancers that are detected earlier in the disease course (stages 1 and 2) and/or target health inequalities in the stages of cancer diagnosis. Validation is taken to mean assessing that the approach does what it is intended to do, accurately and reproducibly, in real people in a clinical setting; evaluation means assessing whether the approach informs clinical practice in the intended way and/or has clinical impact on patient outcomes.

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. Applications that address health inequalities in early cancer diagnosis are particularly welcomed. Proposals may focus on a single cancer or target multiple cancer sites.

The expected objectives of this scheme are to:

• Improve patient outcomes – innovative technologies to support earlier, more efficient and faster diagnosis. This is an area of unmet healthcare need and will increase the effectiveness of an existing public service and improve cancer survival.
• 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.
• Reduce health inequalities in cancer detection and diagnosis by harnessing innovations that will reduce inequalities in early diagnosis rates, tackling a contributor of the socioeconomic life expectancy gap by decreasing inequalities in cancer outcomes.
• 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.
• 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.
• 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 the right skills to harness the potential of new technologies in the future.

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:

• 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.
• 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.
• Support ongoing engagement and completion of diagnostic pathways, and 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, while 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.
• 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.
• Approaches to address existing inequalities in stage of cancer diagnosis between socioeconomic, geographic, demographic or other subpopulations.

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 (eg sensitivity, specificity, positive or negative predictive value), impact on stage of cancer diagnosis, impact on referral pathways and service demand.
• Clinical utility studies covering eg usability, tolerability and user acceptance.
• Patient and Public Involvement and Engagement (PPIE) activities.

Though not limited to these approaches, this call could be suitable for:

• Innovations that have been already in use or clinically tested outside the UK, but that still require clinical validation and evaluation for cancer in the NHS settings.
• Repurposing of approaches from a cancer area to another (eg biomarkers well validated for different cancers, but needing more evidence in a new area; or extend new pathways to other cancers etc), or from other therapeutic areas to cancer diagnosis and detection.

This call is open to innovations that are approaching their first clinical human testing, as well as more mature products (which might have CE or UKCA mark) but need to generate further evidence before starting their real-world implementation, implementation research or confirmatory trials in the NHS.

Innovations must already be at a minimum TRL of 4 and must have been validated in the laboratory or other appropriate setting. Innovations must have a prototype for human testing ready, or only a minimum amount of product development required.

Funding body	National Institute for Health and Care Research (NIHR)
Maximum value	Discretionary
Reference ID	S25737
Category	Medical Research Science and Technology Engineering and Physical Sciences
Fund or call	Fund