Developing target product profiles to support better cancer tests

Detecting and diagnosing cancer earlier often leads to improved survival, as it means doctors can offer people more treatment options. That’s why leaders across the cancer community, including Cancer Research UK, champion a focus on early detection as a way of ensuring more people can live longer, better lives beyond a cancer diagnosis. It’s also why England, Scotland, Wales and Northern Ireland have all made the early detection and diagnosis of cancer a health policy priority. 

Across the UK, optimising and properly resourcing existing services can make a significant difference to earlier cancer diagnosis in both the short and the long term. Still, without new tools for quickly and accurately diagnosing cancer, progress will stall before we meet our strategic goals. 

Unfortunately, turning scientific discoveries into practical healthcare technologies is fraught with challenges, particularly in the case of diagnostic tests. Often, technology-driven development trumps a clinical need-based approach, which means that new diagnostic tests are often not fit for purpose. Equally, high research and development costs, significant regulatory hurdles, and unclear adoption pathways mean tests that do show promise can face unnecessary delays before reaching patients, if they ever get that far. 

Our Early Detection and Diagnosis of Cancer Roadmap, which we developed with the wider cancer and health system community, highlighted how target product profiles (TPPs) for new diagnostic tests can help overcome those barriers. By laying out exactly what the health system needs from a new cancer test, TPPs provide a blueprint researchers can use to take a promising new technology from the bench to the bedside.

What are target product profiles (TPPs) for diagnostic tests?

Target product profiles are documents that outline the desired characteristics for a new technology (in this case, a diagnostic test) to address a specific unmet clinical need. To develop one, an organisation needs to scope and identify the problem (or problems) at hand through clear articulation of the current diagnostic pathway and where a new test would sit within it, as well as the target population, condition and setting for testing. The TPP itself can then provide a detailed description of the characteristics a new diagnostic test would need to have to address the problem(s). This may include factors relating to analytical and clinical validity, clinical utility, cost-effectiveness, infrastructural requirements and human factors, among others. 

By outlining the desired “profile” or characteristics of a diagnostic test, TPPs offer benefits across the research and development pipeline, as well as in the healthcare context. For example, they can be used by: 

• Industry – as planning tools that guide the development of new tests towards desired characteristics. 
• Regulators – to evaluate products submitted for regulatory approval. 
• Research funders – to set research and development targets for new diagnostics. 
• Health system & policymakers – as a demand signalling tool to guide innovators’ research and development activities and catalyse funding to find solutions for unmet needs and address other barriers to adoption. 

In short, TPPs can help align all the groups involved in developing, evaluating and implementing a cancer diagnostic, thereby improving and streamlining the process of bringing new diagnostics to the people who could benefit.

What progress is being made for TPPs for cancer diagnostics? 

Most TPP development for tests has so far focused on infectious diseases. Although there are some TPP efforts underway for different cancers, to our knowledge none have been completed and adopted. 

To push things forward, in 2023 Cancer Research UK invested in a research project to explore how TPPs should be developed for cancer diagnostics. The research team, from RAND Europe and the Office of Health Economics, undertook desk-based research and extensive stakeholder engagement, with contributions from over 100 individuals across diverse stakeholder groups.  

The findings confirmed that TPPs can be important tools for signalling demand and guiding innovation. However, they also highlighted a lack of formal guidance for developing TPPs for diagnostic tests, and inconsistencies and a lack of transparency in the methodologies used by different groups.  

To address these issues, the team produced a guide and an early economic modelling tool for developing TPPs for cancer diagnostics, both of which are important resources for the future. As Dr Amanda Cole, the research team’s lead health economist, explains, “By considering health economic value, we can ensure the diagnostic test is designed and developed to meet health system and patient needs in a sustainable and cost-effective way – which is imperative for subsequent adoption.” 

Overall, the research has helped us amass the knowledge and insight we need to apply TPPs to cancer diagnostics.   

But we haven’t stopped there… 

Building on the 2023 research, we have now commissioned a further project to create practical resources for developing TPPs that can be used to bring new cancer diagnostics to the screening and primary care settings. The aims of this activity, which is being led by Professor Bethany Shinkins from the University of Warwick and Dr Jacqueline Dinnes of the University of Birmingham, are four-fold. 

First, the team will identify and prioritise the areas where there is an unmet need for new tests and tools to facilitate the earlier diagnosis of cancer. This will build on the work Cancer Research UK has already done in this space and will involve bringing together our in-depth knowledge of cancer evidence and data, as well as our existing internal strategic frameworks, to find the areas where TPPs could make the biggest difference to cancer outcomes.  

What else is happening in this space?

TPPs are not the only tool that could help with implementing promising cancer diagnostics into the NHS. In 2023, the National Institute for Health and Care Excellence (NICE) began piloting an Early Value Assessment (EVA) pathway to facilitate rapid assessment of medical technologies in key priority areas, including the early detection of cancer. EVA aims to give the NHS a clear signal about which technologies work, offer good value for money and meet system need by quickly reviewing the available evidence and providing a recommendation about whether they can be considered for early use.  As part of each EVA, NICE provides an evidence generation plan that identifies the evidence gaps that innovators and health system leaders need to fill before a technology can be given a full recommendation. The EVA pathway is now a standard offering from NICE, having assessed over 70 innovations since its inception.

NICE’s Science Policy and Research team (SP&R) are also actively involved in methodological research, for example through their HTA Lab, which works to develop ‘creative solutions to complex problems in health technology assessment’. They have recently published a report outlining their thoughts about the utility of Target Product Profiles for digital and other types of health technologies. Bethany has recently started a part-time role as a Senior Scientific Advisor in the NICE SP&R team, which will give her the opportunity to consider the potential role of TPPs from a policy-maker’s perspective.

The Medicines and Healthcare products Regulatory Agency (MHRA) is also piloting a new pathway, the Innovative Devices Access Pathway (IDAP), to bring new technologies and solutions that address unmet clinical needs to the NHS. It allows UK and international developers access to the NHS to generate evidence for their product to support a future business case, along with access to a team of experts who will help develop a product-specific target development profile (TDP) roadmap.

What’s next?

Supporting the development of TPPs is a key strategic priority for Cancer Research UK. It’s clear we need more effective tests to address the challenges of detecting and diagnosing cancers in their earlier stages, and we believe TPPs could help bring those tests to patients. If they’re well designed and appropriately embedded into the diagnostic development pipeline, TPPs could work as an important demand signalling tool for highlighting unmet needs to innovators and bridging the gaps between industry, research funders and the health system. However, developing TPPs is complex and there are few resources available to those wishing to undertake this process. Across this programme of work, we hope to create greater awareness of the value of TPPs and drive forward thinking on how they could be used within the cancer ecosystem.