Pregnant and breastfeeding individuals have long been excluded from clinical drug development, leaving physicians and patients to make critical treatment decisions with limited human data. In this timely article, Nonclinical Considerations for Support of Pregnancy and Lactation in Clinical Trials, an international team of experts (including Aclairo’s Ron Wange) explores how drug development can move beyond routine exclusion and toward the safe, ethical inclusion of these underserved populations.
The authors examine how current developmental and reproductive toxicity testing (DART) requirements can be adapted to support earlier enrollment of pregnant and lactating individuals in clinical studies. They propose pragmatic, risk-based nonclinical strategies tailored to factors such as treatment duration, route of administration, and stage of pregnancy, while also highlighting innovative approaches including physiologically based pharmacokinetic (PBPK) modeling, alternative study designs, and emerging in vitro methods.
As global regulators increasingly encourage the inclusion of pregnant and breastfeeding populations in clinical research, this article offers valuable insights for pharmaceutical developers, regulators, clinicians, and patient advocates seeking to close longstanding evidence gaps and improve therapeutic decision-making for mothers and their children.