Why It Is Unethical Not to Conduct Randomized Trials in Pregnancy, JAMA, 2026, Alyssa Bilinski
The author argues that pregnant women have been systematically excluded from randomized clinical trials, leaving clinicians to rely mostly on observational data that are slower, biased, and often contradictory. Less than 1% of drug-development trials include pregnant participants, and fewer than 10% of medications approved since 1980 have adequate pregnancy safety evidence. The central claim is that exclusion from trials does not protect pregnant women because medications are still used in practice, but instead prevents reliable learning about safety and effectiveness.
My Comment
The ethical pivot of the paper is important: it reframes pregnancy research from “risk of participation” to “risk of ignorance.” That is a valid bioethical concern, and obstetrics lives with the consequences daily when counseling about common drugs, vaccines, or dosing. However, the article treats randomized trials as a relatively straightforward corrective, while the real difficulty is not philosophical but methodological, liability-based, and biologic heterogeneity across gestation. A medication at 6 weeks, 20 weeks, and 36 weeks is effectively a different fetal exposure, which makes classical RCT design unusually complex in pregnancy compared with general adult medicine. The paper correctly identifies the problem but underestimates how challenging valid and ethically acceptable trial structures actually are in obstetrics.
Bottom line
The current evidence gap in pregnancy therapeutics is real and clinically harmful. Randomized trials should be expanded, but they are not a simple ethical obligation alone; they require redesigned trial methodology specific to gestation and fetal development. The solution is inclusion with specialized safeguards, not routine replication of standard adult RCT models.