The World Health Organisation (WHO) has launched a toolkit to address the exclusion of pregnant and lactating women from tuberculosis (TB) drug and vaccine trials, a practice that has created critical gaps in evidence needed to guide their treatment and care.

The toolkit provides practical guidance for researchers, trial sponsors, ethics committees, regulators and other stakeholders to strengthen the inclusion of these women in research and improve prevention and treatment for them and their infants.

Their historical exclusion has limited knowledge of the safety, pharmacokinetics, appropriate dosing and effectiveness of TB interventions during pregnancy and breastfeeding, leaving women and their infants among the last to benefit from advances in prevention and treatment.

Director of WHO’s Department for HIV, Tuberculosis, Hepatitis and Sexually Transmitted Infections, Dr Tereza Kasaeva, said the underrepresentation of pregnant and lactating women in TB research continued to create evidence gaps, delaying access to medical innovations and optimal care.

She said the toolkit would promote their inclusion in research, ensure that they and their infants benefited from scientific advances, and accelerate progress towards ending TB.

The resource guides ethical considerations, community engagement, preclinical research, trial design and pharmacokinetics during pregnancy, postpartum and lactation.

It also covers outcome measures, sample size, recruitment and retention strategies, regulatory requirements, TB vaccine trials, surveillance and registries. Case studies and curated materials from completed and ongoing research initiatives are included to help stakeholders apply the recommendations.

WHO said the toolkit followed a global consensus process on the early and optimal inclusion of pregnant and lactating women in TB research. During working groups and consultations in 2024 and 2025, experts from all WHO regions examined barriers to participation and identified practical approaches to improve evidence generation for the group.

The agency said the resource complements its broader knowledge portal, which provides general guidance on including pregnant and lactating women in clinical research across health conditions.

While the portal outlines overarching principles, the new toolkit translates them into practical guidance for TB drug and vaccine trials.