Item of Interest: NIH-Funded Report Recommends Strategies to Advance Inclusion of Pregnant and Lactating Women in Clinical Research

A report issued today by the National Academies of Science, Engineering, and Medicine (NASEM) makes recommendations to improve the safe and ethical inclusion of pregnant and lactating women in clinical research while reducing the risk of liability—the legal responsibility for causing harm. The report was developed by a committee of medical and legal experts convened by NASEM to examine the real and perceived risks of liability arising from research conducted with these populations. The Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), part of the National Institutes of Health, provided funding for the committee’s work.

Pregnant and lactating people are often excluded from clinical studies evaluating drugs and vaccines, forcing them and their health care providers to make decisions in the absence of robust scientific evidence. Between 2010 and 2019, only 11% of approved medications had available clinical data to guide prescribing for pregnant people. Lack of information about a medication’s safety, efficacy, and proper dosage during pregnancy and lactation leads many people to forego necessary treatment, and those who do choose to use the medication must contend with uncertainty about its effects. Enhancing inclusion of pregnant and lactating people in clinical research promises to help people and their health care providers make informed choices.

One frequently cited reason for not enrolling pregnant and lactating people in clinical studies is the possibility of legal liability should research participants, or their children, experience negative effects from or be harmed by the study medication. The NASEM committee found limited evidence of such liability. Rather, they concluded that marketing medical products without relevant information from research with pregnant and lactating women may increase the potential for harm, and thus liability.

Their report provides nine recommendations for action by Congress, federal agencies, and clinical investigators to support the appropriate inclusion of pregnant and lactating women in clinical research. These recommendations address approaches to directly mitigate liability, diminish the potential for liability by minimizing harm, and allay other concerns that discourage the inclusion of pregnant and lactating women in clinical research.

The committee’s report builds on the work of the congressionally mandated, NICHD-led Task Force on Research Specific to Pregnant Women and Lactating Women (PRGLAC), which in 2018 made recommendations to promote inclusion of pregnant and lactating people in clinical trials and issued an implementation plan. NICHD currently leads a working group to monitor and report on the implementation of the PRGLAC recommendations.

Reference

National Academies of Sciences, Engineering, and Medicine. Advancing clinical research with pregnant and lactating populations: Overcoming real and perceived liability risks. The National Academies Press DOI: 10.17226/27595 (2024)