Researchers have developed a new method that uses real-world evidence from the NHS Man Van pilot – a community cancer testing service - to identify and specify the requirements needed for new diagnostic pathways to work safely and effectively in practice.
Promising new cancer diagnostics are frequently being developed, but many never become part of routine healthcare. While the quality of the science behind a new test drives innovation, translating it into clinical practice is far more complex than demonstrating that the technology works.
Researchers from the Cancer Research UK Convergence Science Centre have developed a new method to help address this challenge. Led by members of the Centre's Cancer Technology Catalyst Team, the study brought together colleagues from The Institute of Cancer Research, London, The Royal Marsden NHS Foundation Trust and Imperial College London. The findings have been published in Implementation Science Communications.
Known as an implementation-aware Target Product Profile (iTPP), the method looks beyond the diagnostic test itself to consider the entire care pathway needed to deliver it safely in practice. Importantly, rather than simply identifying implementation challenges, the approach uses evidence from patients, clinicians and delivery teams to translate real-world experiences into an auditable, structured set of requirements that can be considered during diagnostic development.
The framework was developed through a convergence partnership connecting Dr Patrick Kierkegaard's Cancer Research UK Early Detection & Diagnosis Primer Award with Professor Nick James' NHS Man Van pilot, co-led by Professor Declan Cahill and Dr Masood Moghul.
The NHS Man Van provides mobile prostate-specific antigen (PSA) testing and health checks in community settings across six London boroughs. The pilot provided the team with real-world evidence of the practical challenges involved in delivering cancer diagnostics outside traditional healthcare environments.
Using interviews with patients, clinicians and those involved in planning and delivering the service, the researchers identified requirements for a safe and workable cancer testing pathway. These were organised into a register of 42 pathway attributes across six areas, with requirements classified according to whether they were essential (MUST), desirable (SHOULD) or dependent on particular circumstances (IF-WHEN). Questions that could not yet be answered from the available evidence were identified for further investigation rather than being treated as assumptions.
This means that, rather than waiting for problems to emerge after a service has been introduced, potential barriers can be identified and addressed while there is still an opportunity to influence the diagnostic, trial design or service pathway.
The study highlighted several practical considerations that can affect whether community-based cancer testing works safely and effectively.
One key finding was the importance of clearly defining clinical responsibility. Simply sending a test result to a GP does not necessarily mean that responsibility for the patient's follow-up has been transferred. The iTPP therefore defines ‘loop closure’ as the point at which a named receiving service formally accepts clinical responsibility, helping to reduce the risk of patients falling between services or additional work being transferred to primary care without prior agreement.
The research also highlighted the importance of designing services around the realities of delivery. Staffing capacity, patient flow and privacy all need to be considered alongside access. For example, the team found that the physical limitations of mobile testing environments can create challenges for privacy, while visible NHS branding and trusted communication can help build confidence in community settings.
Together, these findings demonstrate how the iTPP can turn broad implementation challenges into specific requirements that can inform the design of both the diagnostic test and the pathway in which it will be used.