Geneva, Oct. 14: The World Health Organization (WHO) has launched a specialised research toolkit designed to improve the inclusion of pregnant and breastfeeding women in tuberculosis studies, aiming to strengthen the scientific evidence needed to provide safer and more effective care to women and their infants.
Announced on October 13, the online resource offers practical guidance for researchers, clinical trial sponsors, ethics committees, regulatory authorities and other stakeholders involved in developing and evaluating tuberculosis medicines and vaccines.
The initiative addresses a longstanding gap in medical research: pregnant and breastfeeding women have often been excluded from clinical trials, leaving healthcare professionals with limited evidence about the safety, appropriate dosage and effectiveness of certain interventions for these populations.
The absence of adequate research can delay the introduction of improved treatments for women who need care during pregnancy or after childbirth. It can also make clinical decisions more difficult when doctors must assess the potential benefits and risks of available medicines without sufficient population-specific data.
The WHO said the new toolkit is intended to encourage a more systematic, evidence-based approach to research participation, helping ensure that scientific advances benefit women and their children without unnecessary delays.
Addressing gaps in tuberculosis research
Tuberculosis, commonly known as TB, is an infectious disease that primarily affects the lungs but can also involve other parts of the body. It remains a significant public health challenge, particularly in communities where access to timely diagnosis and treatment is limited.
The disease during pregnancy and the postpartum period requires particular attention because maternal illness can affect both the woman and her child. According to the WHO’s toolkit, an estimated 336,900 pregnant and postpartum women are affected by TB annually.
The organisation has highlighted links between tuberculosis during pregnancy and adverse outcomes, including maternal and infant mortality, premature birth and low birth weight. Early diagnosis and appropriate treatment can improve outcomes, making access to reliable medical evidence especially important.
However, researchers have historically faced challenges in enrolling pregnant and breastfeeding women in trials involving TB medicines and vaccines. As a result, important questions about drug safety, dosage, the way medicines are processed by the body and treatment effectiveness have remained unanswered.
These gaps can have practical consequences. A medicine’s performance in the general adult population does not automatically establish the most appropriate dosage or safety profile for women during pregnancy, after delivery or while breastfeeding.
Limited evidence can also complicate decisions involving drug-resistant tuberculosis, where treatment options may be more complex and the potential risks associated with medicines require careful consideration.
The WHO’s new resource aims to help researchers address these challenges through better-designed studies and more appropriate inclusion of women at different stages of pregnancy and lactation.
Practical guidance for researchers and trial sponsors
The toolkit brings together recommendations and resources covering several stages of the research process. These include ethical considerations, community engagement, preclinical research, clinical trial design, recruitment, participant retention, regulatory requirements and the monitoring of outcomes.
It also addresses pharmacokinetics, which refers to how a medicine is absorbed, distributed, metabolised and eliminated by the body. Understanding these processes is important because physiological changes during pregnancy and after childbirth can affect how medicines behave.
Researchers need reliable evidence to determine whether existing treatment regimens are suitable or whether adjustments may be necessary. The toolkit is intended to support the generation of that evidence through appropriately designed studies.
Another area covered by the resource is the selection of outcome measures and sample sizes. Well planned studies must be capable of producing meaningful findings while protecting participants and accounting for the specific characteristics of the population being studied.
The toolkit also provides guidance on tuberculosis vaccine trials, surveillance systems and registries. These approaches can help researchers gather information over time, identify safety concerns and improve understanding of treatment outcomes among pregnant and breastfeeding women.
Recruitment and retention strategies are another important component. Clinical research involving pregnant women requires careful communication, informed consent and appropriate support so that participants understand the purpose of a study, its possible risks and the protections available to them.
By bringing these considerations together, the WHO aims to make it easier for research teams to plan studies that are both scientifically robust and ethically appropriate.
Protecting mothers and infants through ethical research
The inclusion of pregnant and breastfeeding women in clinical trials requires careful safeguards. The objective is not to expose participants to unnecessary risks but to ensure that decisions about treatment are supported by evidence relevant to their circumstances.
Ethics committees, regulators and investigators have an important role in evaluating study protocols, assessing potential risks and ensuring that participants receive clear information before agreeing to take part.
The WHO toolkit addresses these considerations as part of a broader effort to improve the quality and relevance of medical research.
Community engagement is also important. Women and families need understandable information about why research is necessary, how participation works and what protections are in place. Such engagement can help address concerns, improve trust and support appropriate participation.
The resource includes case studies and selected materials from completed and ongoing research initiatives, providing practical references for stakeholders developing future studies.
According to the WHO, the toolkit builds on a global consensus process that involved expert working groups and consultations during 2024 and 2025. That process examined barriers to including pregnant and breastfeeding women in TB research and identified approaches for improving the evidence base.
The work led to a consensus statement and a call to action published in August 2025. Developing a tuberculosis-specific research toolkit was identified as one of the priorities emerging from that process.
Supporting better treatment decisions
The lack of population-specific evidence can leave clinicians with difficult decisions when treating tuberculosis during pregnancy or breastfeeding. They must consider the risks associated with the disease while assessing the available information about treatment options.
For drug-resistant TB, the challenge can be greater because treatment may involve medicines with more complicated safety considerations. Insufficient evidence can limit the ability of healthcare professionals to select the most appropriate regimen for an individual patient.
The WHO’s initiative seeks to improve the evidence available to guide these decisions. More comprehensive research could help clarify appropriate dosages, identify potential safety concerns and support the development of treatment recommendations tailored to pregnant and breastfeeding women.
Better evidence may also help reduce unnecessary uncertainty surrounding breastfeeding and the use of TB medicines. Decisions about treatment and infant feeding should be based on appropriate clinical guidance and the circumstances of the individual patient rather than assumptions arising solely from a lack of research.
The toolkit itself does not constitute a new treatment or replace established clinical guidelines. Instead, it provides a framework intended to help researchers generate the information needed to improve future recommendations and care.
A broader approach to inclusive clinical trials
The tuberculosis resource forms part of the WHO’s wider effort to improve the participation of pregnant and breastfeeding women in clinical research across different health conditions.
The organisation has developed a broader knowledge portal containing general guidance on including these populations in clinical trials. The new TB toolkit translates those overarching principles into considerations specific to tuberculosis medicines, vaccines and public health research.
This approach recognises that research requirements can differ between diseases and interventions. A framework developed for one condition may need to be adapted to account for particular safety questions, drug characteristics, trial designs and clinical outcomes associated with another.
The TB resource is intended to help researchers incorporate these differences into their planning while maintaining appropriate ethical and regulatory safeguards.
Successful implementation will require cooperation among research institutions, pharmaceutical developers, funding agencies, health authorities, clinical investigators and communities affected by tuberculosis. Adequate funding and the willingness to conduct appropriately designed studies will also be important.
Next steps for global TB research
The launch marks a step towards addressing a gap that has affected the development of evidence-based care for pregnant and breastfeeding women. However, the practical impact will depend on how widely the toolkit is used and whether it leads to more relevant research findings.
Researchers will need to apply its guidance to suitable studies, while regulators and ethics committees will continue to assess the safety and scientific quality of proposed trials. The resulting evidence must then inform clinical guidance and treatment decisions.
For public health programmes, improving knowledge about tuberculosis during pregnancy and lactation could support more responsive services for women who face barriers to diagnosis or treatment.
The WHO’s initiative underscores the importance of ensuring that medical research reflects the needs of the populations expected to benefit from its findings. By encouraging earlier and more systematic inclusion of pregnant and breastfeeding women, the organisation aims to narrow evidence gaps and accelerate progress towards better tuberculosis prevention and treatment.
Ultimately, the goal is to ensure that women and their infants are not left waiting for scientific advances simply because earlier research did not adequately represent their circumstances.