WHO is releasing a new toolkit to facilitate and support the inclusion of pregnant and breastfeeding women in clinical trials and other research studies.
Pregnant and breastfeeding women have traditionally been excluded from clinical trials of new drugs, including antiretrovirals for HIV treatment and prevention and medicines for treating viral hepatitis and sexually transmitted infections (STIs). This has led to a lack of safety data and long delays in access to medicines for use in these populations.
"Including women who are pregnant or breastfeeding in clinical studies of new medicines provides women with the opportunity to benefit earlier from new medicines. It also enables them to contribute to building a better understanding of the safety and efficacy of those medicines," said Dr Meg Doherty, WHO Director for the Department of Global HIV, Hepatitis and STI Programmes. "This toolkit provides access to the resources needed to set up studies inclusive of pregnant and breastfeeding women, ensuring that women are empowered to make informed choices about their involvement in research."
The toolkit is primarily aimed at research investigators, clinical trialists and programme implementers conducting research on new or existing medications for treating HIV, hepatitis and STIs. It provides access to numerous high-quality materials from research teams with experience involving pregnant and breastfeeding women in research. It also provides guidance on standardized measurements and definitions of exposures and outcomes relating to pregnancy and the breastfeeding period.
"Good quality data on pregnancy, birth and infant outcomes are essential to gaining a full understanding of the risks and benefits of new medicines," said Dr Elaine Abrams, Professor of Pediatrics and Epidemiology at Columbia University. "It provides a roadmap to accelerate the study of new agents in pregnant people which will lead to earlier and safer access to optimal medicines to protect their health and that of their children."
WHO will continue to update the toolkit for HIV prevention and treatment and will expand it to encompass study materials and resources from the STI and viral hepatitis fields. New materials will be added as they become available.
The Antiretrovirals in Pregnancy Research Toolkit was developed by the WHO HIV, Hepatitis and STIs Pregnancy and Breastfeeding Therapeutics Working Group.
