The World Health Organization (WHO) has launched the TB in pregnancy and lactation research toolkit, a new online resource designed to support the earlier and optimal inclusion of pregnant and lactating women in tuberculosis (TB) research. The toolkit provides practical guidance and tools for researchers, trial sponsors, ethics committees, regulators and other stakeholders involved in TB drug and vaccine research.

”Pregnant and lactating women continue to be underrepresented in TB research, resulting in critical evidence gaps that delay access to innovations and optimal care,” said Dr Tereza Kasaeva, Director of WHO’s Department for HIV, Tuberculosis, Hepatitis and Sexually Transmitted Infections. ”This new WHO toolkit will help close these gaps by advancing their inclusion in research, ensuring that women and their infants benefit from scientific advances and accelerating progress towards ending TB for everyone.”

Pregnant and lactating women have historically been excluded from TB drug and vaccine trials, contributing to critical evidence gaps related to the safety, pharmacokinetics, dosing and effectiveness of interventions used during pregnancy and lactation. As a result, women and their infants are often among the last to benefit from advances in TB prevention and treatment. The new toolkit aims to facilitate a more systematic and evidence-based approach to inclusion, helping researchers generate the data needed to inform policies and improve care.