The World Health Organization (WHO) has launched a new toolkit to ensure the inclusion of pregnant and breastfeeding women in clinical trials and research studies.
Traditionally excluded from drug trials, this initiative aims to provide safety data and timely access to medications for these populations.
Dr. Meg Doherty, WHO Director for Global HIV, Hepatitis, and STI Programs, highlighted the importance of involving pregnant and breastfeeding women in research stating, “It provides them with the opportunity to benefit earlier from new medicines and contribute to a better understanding of their safety and efficacy.”
The toolkit, named the Antiretrovirals in Pregnancy Research Toolkit, targets research investigators, clinical trialists, and program implementers focusing on HIV, hepatitis, and STIs.
Dr. Elaine Abrams, a Professor of Pediatrics and Epidemiology at Columbia University, emphasised the need for quality data on pregnancy and infant outcomes to assess the risks and benefits of new medicines.
“This toolkit provides a roadmap to accelerate the study of new agents in pregnant people, leading to earlier and safer access to optimal medicines for their health and that of their children,” Dr. Abrams stated.
In a publication released by WHO on Friday, the toolkit offers access to various high-quality materials and guidance on standardized measurements related to pregnancy and breastfeeding. Developed by the WHO HIV, Hepatitis, and STIs Pregnancy and Breastfeeding Therapeutics Working Group, the toolkit will be continuously updated and expanded to include resources from the STI and viral hepatitis fields
