Equity and health: the inclusion of pregnant and breastfeeding women in clinical trials

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 during these critical periods. This exclusion has led to fragmented health policies and inconsistent clinical recommendations for prevention and treatment. The UN’s Special Programme in Human Reproduction (HRP) and the World Health Organization (WHO) are working to reduce these preventable deaths by promoting best practices to include pregnant and breastfeeding women in research in an ethical way. “Pregnancy introduces significant physiological changes that can impact the absorption, distribution, metabolism and elimination of certain medicines,” explained Mariana Widmer, Maternal Health Scientist at WHO and HRP. “Pregnant women have the right to timely access to medicines that will work for them, which means they need to have been specifically tested for their needs.” An analysis run 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, WHO has established a global Task Force to tackle this long-standing issue, aiming at achieving the timely and ethical inclusion of pregnant and breastfeeding women in clinical research for medical health products by 2030. The Task Force builds on ongoing efforts for specific diseases such as malaria, TB and HIV as well as WHO’s resolution WHA75.8 and the vision of the WHO Global Clinical Trials Forum, which explicitly calls for the inclusion of underrepresented groups, particularly pregnant women, children, and older persons, in clinical research. The Task Force will serve as a collaborative platform to align WHO approaches in promoting safe and ethical inclusion of pregnant women in clinical trials, reduce duplication, and foster partnerships with international stakeholders to overcome regulatory, ethical, and operational barriers. Studies show that the pipeline for maternal health innovations is sparse and slow-moving. The median time to achieve even a 20% uptake of a new product in low- and middle-income countries is 13.5 years, a delay that costs lives. Currently, a woman dies every two minutes due to pregnancy or childbirth. To accelerate progress, WHO will continue convening global stakeholders, building consensus, and translating research into action. A clear programme of work with tangible outputs has been designed to build on ongoing efforts and expand a long-lasting chance to transform policies and practice. “The paradigm must shift,” said Martina Penazzato, from the Research for Health Department at WHO. “Imagine having a chronic condition when you're pregnant and not knowing if you can safely continue your medication – that is the reality for many women today. Inclusion is no longer optional; it’s time to translate our joint commitment and shared vision into concrete actions to safeguard the health of both pregnant women and future generations.” Global action plan for clinical trial ecosystem strengthening Advancing maternal and perinatal health through clinical trials: key insights from a WHO global consultation Why should we include pregnant and lactating women in clinical trials? Dr. Teesta Dey explains About the WHO Task Force About the UN’s Special Programme in Human Reproduction (HRP)