Pregnant woman sitting across desk from doctor wearing scrubs and holding a pen

Excluding Pregnant People From Clinical Trials Reduces Patient Safety and Autonomy

By Jenna Becker

The exclusion of pregnant people from clinical trials has led to inequities in health care during pregnancy. Without clinical data, pregnant patients lack the drug safety evidence available to most other patients. Further, denying access to clinical trials denies pregnant people autonomy in medical decision-making.

Pregnant people still require pharmaceutical interventions after becoming pregnant. Until maternal health and autonomy is prioritized, pregnant people will be left to make medical decisions without real guidance.

The Exclusion of Pregnant People from Clinical Trials

With the rapid rollout of the COVID-19 vaccine this year, many commentators have noted the exclusion of pregnant people from vaccine trials. Despite the increased risk of severe illness in pregnant people, vaccine developers and public health entities have not prioritized studying COVID-19 vaccine safety during pregnancy. Pregnant women are now left to decide whether to take the vaccine without evidence or clear recommendations from public health experts

The exclusion of pregnant people extends beyond COVID-19 vaccines to vaccine and drug development more generally. For example, certain therapies used to treat multiple sclerosis have not been well-studied on pregnant people. This lack of data has caused physicians to recommend that pregnant people halt certain MS treatments altogether. 

The exclusion of pregnant women from clinical trials may be grounded in legitimate concerns for fetal safety. But these concerns do not necessitate a broad exclusion of pregnant people from clinical trials. Instead, I argue the exclusion demonstrates the prioritization of fetal health over maternal health in the U.S.

History of Exclusion

We may point to the history of drugs like thalidomide when considering why pregnant women are excluded from clinical research. Thalidomide was prescribed to pregnant women around the world in the 1950s to treat morning sickness. Within a few years, the use of thalidomide during pregnancy was associated with certain congenital disabilities. 

The fallout associated with thalidomide directly led to changes in U.S. Food and Drug Administration (FDA) regulations. In 1977, based on fears that new drugs would harm fetuses, the FDA excluded all “women of childbearing potential” from Phase I and early Phase II clinical trials. Although the FDA eventually walked back that broad ban in the 1990s, the agency still generally excludes pregnant individuals from drug trials. The FDA, per 2018 draft guidance, allows pregnant people to be included in clinical trials in certain circumstances. Still, this inclusion is minimal, as the FDA’s guidance creates significant barriers. 

Why Are Pregnant People Excluded, Really?

The history of thalidomide may lead some to argue that early trial exclusion protects against unknown fetal harm. However, it’s difficult to divorce the exclusion of pregnant women from clinical trials from the general prioritization of fetal health over maternal health.

This exclusion pushes pregnant people to avoid necessary treatment during pregnancy due to a lack of evidence. Maternal access to necessary medications is limited because of unsubstantiated concerns that a drug will cause fetal harm. By not allowing pregnant people to decide whether to participate in clinical trials, the autonomy of the excluded pregnant people to make medical decisions is diminished, as is the autonomy of all pregnant people who may need that medication in the future.

Despite a lack of data, many individuals continue to take medications and receive vaccinations during pregnancy. Yet the FDA and other entities still do not prioritize clinical trials on pregnant people. Instead, pregnant people must blindly navigate complex medical decisions surrounding drug usage and vaccine administration without evidence. Until institutions like the FDA prioritize maternal health and autonomy, we will continue to leave pregnant people seeking treatment in the dark.

Jenna Becker

Jenna Becker is a 2L at Harvard Law School with a background in healthcare software.

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