Tuberculosis is a deadly disease that not only sickens or kills millions every year in low-income countries, but continues to threaten populations in high-income countries with multi-drug resistant strains. The FDA highlighted TB in its guidance on neglected tropical diseases and joined other stakeholders in accelerating drug development through the Critical Path Institute (C-Path).

CPTR came to PharmaStat for technical assistance with standards development and, together, we drafted work products that became a CDISC therapeutic area standard in June 2012. This work has promoted the adoption of CDISC/TB data standards by CDC, NIH, and non-government sponsors, and has led to more opportunities for PharmaStat consultants to be involved in public health projects.