Pregnant and breastfeeding women have historically been excluded from medical research, resulting in substantial gaps in evidence on the safety and efficacy of medicines and vaccines.
Analysis led by the Global Observatory on Health Research and Development of all clinical trials in the International Clinical Trials Registry Platform (ICTRP) reveals that just 4% of clinical trials over the past decade allowed the inclusion of pregnant women. As a result, many pregnant and breastfeeding women are left without treatment options or take prescription medicines off-label, without adequate data to inform safe use.
In response, the World Health Organization (WHO) established a global task force to tackle this, with the aim of achieving timely and ethical inclusion of pregnant and breastfeeding women in clinical research for…