Epidemiology Studies and Clinical Trials
A critical challenge facing the TB vaccine field is the accurate measurement of TB epidemiology at sites where TB vaccine trials are conducted. The quality of such data in many high disease burden countries is entirely absent or weak. Even when available, there can be significant variations in data quality within a single country. Quality TB epidemiology data are necessary for estimating sample size in planning a clinical trial (i.e., “powering a study”). Failure to appropriately power clinical trials can impede the ability to obtain reliable efficacy results.
Before a planned clinical trial commences at a particular site, Aeras conducts targeted epidemiology data collection at that site to estimate TB prevalence and/or incidence under real-world trial conditions. In addition, Aeras-sponsored studies may use an adaptive trial design in which disease incidence data are monitored during the clinical trial to allow for power recalculations during the study. Epidemiology data collected prior to and during a study are shared with local partners with the aim of furthering knowledge and understanding of TB disease at each site.
For global tuberculosis epidemiology data, view the World Health Organization's Global Tuberculosis Report 2012.