Background
Location(s)
23 countries globally
Indication(s)
Tuberculosis
Situation overview
A highly efficacious tuberculosis (TB) vaccine is critical to reducing the global burden of TB, and a global phase 3 clinical trial of an investigational TB vaccine required potential sites to be assessed to support the study.
Challenge
Identifying multiple sites globally that have both high incidence of TB and capacity to conduct a clinical trial
How we helped
We implemented an integrated biosurveillance methodology that was used to ensure a more robust data science approach to conducting global site feasibility for a phase 3 TB vaccine trial.
This approach included:
- Incorporating systematic assessments of TB epidemiology
- Identification of catchment areas that are hotspots for TB transmission
Outcomes
This objective, data-driven evaluation of site feasibility resulted in identification of sites with high TB burden that might not have been previously considered. The systematic data evaluation enabled objective site assessments and minimization of bias.
Ultimately, this methodology enhanced the equitable assessment of sites, which can contribute to improving equity and accessibility of clinical trials for under-represented populations globally.
