Why Pregnant Women Are Still Excluded From Clinical Trials

Pregnant women represent one of the most consistently underserved populations in clinical research. Despite the fact that many women require medical treatment during pregnancy — for chronic conditions, infections, or pregnancy-specific complications — randomized controlled trials have historically excluded them. This leaves clinicians navigating complex treatment decisions with little more than observational data, case reports, and extrapolation from non-pregnant populations.

This JAMA paper by Locquet and Dogné directly addresses this problem, examining the current state of randomized trials conducted in pregnancy. Published ahead of print in July 2026, the piece appears to survey the methodological, ethical, and regulatory landscape that has shaped — and constrained — the evidence base available for treating pregnant women.

The core issue is that exclusion of pregnant women from trials, while often framed as protective, paradoxically exposes them to greater risk. When drugs must be used during pregnancy, physicians are forced to act without robust trial data on dosing, efficacy, or fetal safety. This is especially concerning given physiological changes in pregnancy that alter drug pharmacokinetics significantly.

The authors from the University of Namur bring expertise in clinical pharmacology and toxicology, suggesting the paper may pay particular attention to pharmacological interventions and the regulatory frameworks governing their study in pregnant populations. They likely argue for reform — both in trial design approaches that can safely include pregnant women and in the regulatory incentives that currently discourage sponsors from doing so.

For clinicians and researchers, this paper is a call to action. Generating high-quality evidence for pregnant women requires ethical frameworks that balance protection with inclusion, adaptive trial designs, and institutional commitment to closing this long-standing gap in reproductive medicine.