WHO Task Force Aims to Include Pregnant and Breastfeeding Women in Clinical Trials by 2030

Pregnant and breastfeeding women have historically been underrepresented in medical research, leading to significant gaps in knowledge regarding the safety and efficacy of medications and vaccines for this population. Recognizing this critical issue, the World Health Organization (WHO) established a global task force with the ambitious goal of achieving the timely and ethical inclusion of pregnant and breastfeeding women in clinical research for medical health products by 2030.

The Historical Exclusion of Women in Clinical Trials

For decades, women, particularly those who are pregnant or breastfeeding, have been systematically excluded from clinical trials. This exclusion stems from historical concerns, such as the thalidomide tragedy in the late 1960s, where the drug caused severe birth defects. While intended to protect vulnerable populations, this cautious approach has resulted in profound data gaps and clinical uncertainty.

Prior to 1993, women were not even permitted to participate in clinical trials in the United States. This systemic bias continues to impact healthcare, with women often receiving less preventive counseling and experiencing delays in diagnosis for conditions like cardiovascular disease and Alzheimer’s disease. Studies have shown women can face up to 30% longer wait times for heart attack evaluations .

Why Inclusion is a Scientific Imperative

Excluding pregnant and breastfeeding women from research isn’t simply a matter of ethics; it’s a scientific imperative. Women metabolize drugs differently than men, and pregnancy introduces further complexities. Without data on how medications affect pregnant and breastfeeding individuals, healthcare providers are often forced to make treatment decisions based on limited information, potentially prescribing medications “off-label” without adequate safety data. As Sheila Diamond, digital health strategist at Medidata, notes, uncertainty can be just as harmful as exposure.

The Global Observatory on Health Research and Development analysis reveals that only 4% of clinical trials over the past decade allowed the inclusion of pregnant women. This lack of representation hinders the development of precision medicine, which aims to tailor treatments to individual characteristics, including sex and pregnancy status.

Best Practices for Increasing Inclusion

Addressing this disparity requires a multi-stakeholder approach involving the WHO, regulators, sponsors, physicians, scientists, and trial patients. Several best practices can be implemented to increase the inclusion of pregnant and breastfeeding women in clinical trials:

• Smarter Trial Designs: Utilizing designs that allow for the inclusion of pregnant populations after initial safety data is established.
• Adaptive Trial Designs: Employing real-time adjustments to study protocols based on emerging data, modifying eligibility criteria, and adjusting randomization to include specific subgroups.
• Pregnancy Exposure Registries: Collecting health information on exposure to medications and therapies during pregnancy.
• Ethical and Regulatory Guidance: Establishing clearer guidelines for the ethical and safe inclusion of pregnant and breastfeeding women in research.
• Multi-Stakeholder Collaboration: Fostering collaboration among all parties involved in clinical trials.
• Increased Funding: Investing in women’s health research.

The Role of Technology and AI

Advanced analytics, simulation modeling, and artificial intelligence (AI) are playing an increasingly important role in designing safer inclusion criteria and evaluating potential risks. These technologies can help researchers identify signals earlier and reduce unnecessary exposure, paving the way for more responsible and data-driven inclusion strategies.

Looking Ahead

The WHO’s 2030 target represents a significant step towards addressing the historical underrepresentation of pregnant and breastfeeding women in clinical research. By embracing innovative trial designs, fostering collaboration, and leveraging the power of technology, the global health community can ensure that all individuals have access to safe and effective medical treatments, regardless of their reproductive status.