Study Design

Our field evaluations follow recommended guidelines for evaluating novel screening/triage, diagnostic and drug resistance tests. For screening/triage and diagnostic tests, we include a comprehensive reference standard for pulmonary TB, additional testing to assess for extra-pulmonary TB and clinical follow-up for up to 6 months to help clarify potential false-positive results from novel tests. For drug resistance tests, we include comprehensive phenotypic drug susceptible testing at reference laboratories and whole genome sequencing.

For all novel tests, we design studies to reflect their stage of development. We nest smaller feasibility studies of earlier prototypes within large, multi-center evaluations of design-locked products to provide timely feedback to product developers.

Cost and Impact Modeling

The costs, cost-effectiveness, and affordability of implementing novel diagnostics are a key consideration at early and late stages of development. Our modeling and analysis team, led by Patrick Phillips (UCSF), David Dowdy (Johns Hopkins University) and Jason Andrews (Stanford University) assesses the incremental value – in terms of potential costs and epidemiological impact – of novel TB diagnostics along and in combination with other tests.