Pregnant Women: An Underrepresented Group In Clinical Trials

By Kristin Tolbert, AVP Health Equity Service, Jumo Health

Pregnant women remain underrepresented in clinical research, comprising less than 1% of study participants despite accounting for over 20% of the U.S. population. This exclusion has created a dangerous knowledge gap—only 10% of FDA-approved drugs have sufficient safety data for use during pregnancy. As a result, physicians and patients are forced to make high-stakes medical decisions with minimal evidence, often in the context of serious conditions like cancer, lupus, and psychiatric disorders. Historical and ethical concerns, notably the legacy of thalidomide, have driven caution, yet mounting evidence suggests that the risks of exclusion may outweigh those of inclusion. Pregnancy introduces complex physiological changes that affect drug absorption, metabolism, and efficacy—factors that cannot be reliably extrapolated from non-pregnant populations.

Integrating pregnant women into clinical trials through strategic partnerships, accessible trial locations, and robust informed consent processes is essential. Ethically, scientifically, and legally, the tide is turning: inclusion is not only feasible, but imperative. To advance equitable and evidence-based care, the clinical trials industry must reframe risk, embrace inclusion, and design trials that reflect the realities of pregnancy. The true ethical failure lies not in studying this population—but in continuing to ignore it.