Advancing the Development and Use of Diagnostic Target Product Profiles for Cancer

The context: Tackling cancer is a priority for health system decisionmakers. Early and improved cancer detection and diagnosis are central to improving long-term patient prognosis and outcomes. Achieving timely and accurate diagnosis depends, in part, on developing and adopting innovative diagnostic tests. Innovators need a clear steer on the diverse requirements for novel diagnostic tests for cancer. Diagnostic Target Product Profiles (TPPs) help provide such clarity. Those who might use and pay for diagnostic tests must give innovators a clear demand signal on test types needed so they can respond to areas of unmet need. Diagnostic TPPs are product-specification documents that can serve as a tool to achieve this. There is growing interest in their use to support the development of novel diagnostic tests for cancer. To the best of our awareness, TPPs in the diagnosis space have been developed in other areas (most notably infectious diseases) but not in cancer. Research aims and approach: Cancer Research UK commissioned RAND Europe and the Office of Health Economics (OHE) to research and establish a guide for developing diagnostic TPPs for cancer. The research aimed to advance practical knowledge on approaches to developing diagnostic TPPs for cancer, focusing particularly on the UK context. Cancer Research UK commissioned the research in light of the growing interest in supporting innovation to improve cancer diagnosis. The project sought to produce a 'general' (tumour-site agnostic or for cancer generally regardless of where it started in the body) guide for developing cancer TPPs that can serve as a tool and resource for future efforts to design bespoke TPPs for specific cancers, test types and use cases. We used a mixed-methods approach combining scoping desk research and interviews, workshops with diverse stakeholder communities and an early economic modelling tool to inform the requirements of a TPP for cancer and develop the guide.