Exclusion by Design: Regulatory Reform and Evolving Frameworks for Clinical Trials in Pregnancy
- 1Department of Pediatrics, The Anne Burnett Marion School of Medicine at Texas Christian University, 1100 Rosedale Street, Fort Worth, TX 76104 USA
- 2Concept Foundation, Geneva, Switzerland
Abstract
Maternal–fetal pharmacology remains a critically underdeveloped domain, largely because ethical, regulatory, and methodological barriers impede evidence generation in pregnant populations (hereafter women). Pregnant women continue to be routinely excluded from clinical trials, creating both a knowledge and an evidence gap that can adversely affect maternal and neonatal outcomes. Despite significant regulatory advances in both encouraging trial inclusion and improving labeling [1], for example through the implementation of the US Pregnancy and Lactation Labeling Rule, substantial gaps and a lack of harmonization persist in pharmacologic, safety, and efficacy data for medications used during pregnancy and lactation. This targeted commentary examines the current state of medication use in pregnant women and their fetuses, the regulatory landscape, and the challenges that impede the development of new research in maternal–fetal pharmacology. We also identify the regulatory conundrum in selected countries worldwide and propose new strategies to improve evidence generation and regulatory decision making for this protected population.
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BibTeX
@article{kearns2026exclusion,
title = {{Exclusion by Design: Regulatory Reform and Evolving Frameworks for Clinical Trials in Pregnancy}},
author = {Gregory L. Kearns and Agnes Saint-Raymond},
journal = {Paediatric Drugs},
year = {2026},
month = sep,
doi = {10.1007/s40272-026-00779-w},
url = {https://doi.org/10.1007/s40272-026-00779-w},
note = {CC BY-NC 4.0},
}
RIS
TY - JOUR
TI - Exclusion by Design: Regulatory Reform and Evolving Frameworks for Clinical Trials in Pregnancy
AU - Gregory L. Kearns
AU - Agnes Saint-Raymond
PY - 2026
DA - 2026/09/30
JO - Paediatric Drugs
DO - 10.1007/s40272-026-00779-w
UR - https://doi.org/10.1007/s40272-026-00779-w
AB - Maternal–fetal pharmacology remains a critically underdeveloped domain, largely because ethical, regulatory, and methodological barriers impede evidence generation in pregnant populations (hereafter women). Pregnant women continue to be routinely excluded from clinical trials, creating both a knowledge and an evidence gap that can adversely affect maternal and neonatal outcomes. Despite significant regulatory advances in both encouraging trial inclusion and improving labeling [1], for example through the implementation of the US Pregnancy and Lactation Labeling Rule, substantial gaps and a lack of harmonization persist in pharmacologic, safety, and efficacy data for medications used during pregnancy and lactation. This targeted commentary examines the current state of medication use in pregnant women and their fetuses, the regulatory landscape, and the challenges that impede the development of new research in maternal–fetal pharmacology. We also identify the regulatory conundrum in selected countries worldwide and propose new strategies to improve evidence generation and regulatory decision making for this protected population.
SN - 1174-5878
SN - 1179-2019
ER -