WHO launches TB in pregnancy and lactation research toolkit

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.

The toolkit offers practical guidance on:

• ethical considerations and community engagement
• preclinical considerations relevant to TB research
• trial design and pharmacokinetics during pregnancy, postpartum and lactation
• outcome measures and sample size considerations
• recruitment and retention strategies
• regulatory aspects
• TB vaccine trial considerations, and
• surveillance and registries.

The toolkit is supported by case studies and curated resources drawn from completed and ongoing research initiatives.

Toolkit development process

The toolkit was developed as a direct follow-up to the WHO-led global consensus process on the early and optimal inclusion of pregnant and lactating women in TB research. Through a series of working groups and consultations held during 2024 and 2025, experts from all WHO regions examined barriers to inclusion and identified practical approaches to strengthen the generation of evidence for this important population. The process culminated in the publication of the consensus statement Optimal and early inclusion of pregnant and lactating women in tuberculosis research and the accompanying Call to action: Accelerating research to end tuberculosis in pregnant and lactating women in August 2025. Development of a TB-specific research toolkit was identified as one of the priority actions in the Call to Action.

The TB toolkit complements a broader WHO knowledge portal that provides generic guidance on the inclusion of pregnant and lactating women in clinical research across health conditions. While the broader knowledge portal outlines overarching principles and approaches, the TB toolkit translates these into practical considerations specific to TB research. Additional information on the broader WHO initiative is available from the Human Reproduction Programme (HRP): Sexual and Reproductive Health and Research (SRH) .