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The purpose of a TPP is to identify, upfront, the essential characteristics of a test for it to fulfil a pre-specified, unmet clinical need. This should, in turn, increase the likelihood that the test will be adopted into clinical practice and reimbursed . A TPP should also account for contextual aspects that might affect the test's real-world performance , defining infrastructural and technical constraints that impact on the implementation into clinical practice. This review shows that TPPs to date have primarily been developed for global health applications, as the main funding organisations are WHO, UNICEF and Bill and Melinda Gates Foundation. The primary focus on infectious diseases may be explained by the remit of the global organisations who fund TPPs. WHO included HIV/AIDS, neglected tropical diseases, tuberculosis and malaria as priority diseases . Further to this, WHO established the 'R&D Blueprint', which aims to promote R&D activities (tests, vaccines, medicines) during epidemics . After having identified pathogen to target first, TPPs are usually commissioned to guide the development process of new healthcare products which will address the high-priority pathogen . More research is also required to understand how to better incorporate the assessment of desirable clinical utility and cost-effectiveness of innovative tests into TPPs. One possible way forward could be exploring how and if care pathway analysis and early economic modelling could be integrated into the development of TPPs. Care pathway analysis would provide clarity on the mechanisms by which a test could impact on downstream patient outcomes. Early economic modelling could be used to define desirable values for certain test characteristics (e.g. test price, diagnostic sensitivity and specificity) based on cost-effectiveness . Therefore, integrating care pathway analysis and early economic modelling into TPP development might provide more evidence-based information to the test developers.
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