New WHO Knowledge Portal Aims to Include Pregnant and Lactating Women in Clinical Trials
WHO says pregnant and lactating women have historically been excluded from clinical research.
The World Health Organization and its HRP research programme have launched a knowledge portal to support the inclusion of pregnant and lactating women in clinical trials. For oral-health research, the relevant question is whether studies of medicines and preventive interventions can generate evidence for groups often left out of trials, while setting out safeguards for participants and infants.
The evidence gap
As a result, evidence on medicine and vaccine safety and efficacy during pregnancy and breastfeeding is limited. The organization also links that gap to uncertainty in clinical decisions and widespread off-label use.
Exclusion does not remove exposure to treatment decisions. It can leave clinicians and patients making choices with less trial evidence available. WHO’s framing is therefore an ethical and methodological one: inclusion should be pursued with appropriate protections, rather than treating exclusion as a sufficient way to manage risk.
What the portal is intended to provide
The portal brings together ethical, scientific and operational resources for researchers, regulators, ethics committees, product developers and other stakeholders. WHO describes it as support for timely, responsible inclusion; the announcement does not specify particular trial requirements or provide outcome data demonstrating the portal’s effect.
For readers following oral-health evidence, the practical point is to check whether research explicitly addresses pregnancy or lactation, and whether its conclusions apply to those groups. A general trial result should not be read as direct evidence for pregnant or breastfeeding participants when they were not represented.
What remains to be assessed
The launch signals an effort to address an evidence gap, but the available announcement does not establish how quickly the resources will be adopted or whether inclusion will increase. Nor does it describe any specific dental study, fluoride intervention or water-fluoridation research.
The unresolved test is implementation: whether the portal helps research teams produce usable evidence while maintaining safeguards. Until those results are reported, its launch is a framework for responsible inclusion, not proof that the evidence gap has closed.