Optimal and early inclusion of pregnant and lactating women in tuberculosis research: consensus statement

In 2024, the World Health Organization Global Programme on Tuberculosis & Lung Health (WHO/GTB) led a consensus building process to advance the earlier and optimal inclusion of pregnant women in TB research. The process is aligned with broader global developments to transform clinical trial practices, including addressing the needs of underrepresented populations.  

This consensus statement summarizes the consensus process, which included five thematic working groups (covering preclinical TB research, TB therapeutics research, TB vaccine research, maternal TB surveillance systems and advocacy), evidence reviews to address gaps in data and knowledge and a consensus meeting in February 2025. The approaches to earlier and optimal inclusion arising from the consensus process include crosscutting actions as well as approaches specific to each working group theme.  

An accompanying call to action specifies actions needed to ensure full implementation of the consensus statement.