Nonclinical Considerations for Support of Pregnancy and Lactation in Clinical Trials

HESI Global’s Developmental and Reproductive Toxicology (DART) Committee is pleased to share a newly published paper that proposes a shift from routinely excluding pregnant and breastfeeding individuals from clinical trials to a more proactive, evidence-based inclusion strategy. This can be done by leveraging nonclinical developmental and reproductive toxicity studies, innovative study designs, and emerging modeling approaches earlier in drug development to support the safe enrollment and retention of these populations in clinical research. The paper provides a practical roadmap for generating pregnancy and lactation data sooner, closing longstanding evidence gaps, improving treatment decision-making, and ultimately expanding access to safe and effective therapies for pregnant and breastfeeding patients.

Key highlights include:

• Advocating for inclusion: Pregnant and breastfeeding individuals should be proactively included in clinical trials, rather than routinely excluded, to address critical evidence gaps in medication safety and efficacy.

• Earlier, risk-based nonclinical testing: DART studies can be tailored to the intended clinical use, enabling informed decisions about enrolling or retaining pregnant participants during drug development.

• Innovative tools and study designs: Adapting DART studies, physiologically based pharmacokinetic (PBPK) modeling, and other new approach methodologies (NAMs) could accelerate the generation of pregnancy and lactation data while maintaining safety.

The proposed framework supports a shift from exclusion to evidence-based inclusion, helping improve treatment decisions and labeling information for pregnant and breastfeeding patients.

Read the full paper here: Stanislaus et al., 2026. A New Framework for Including Pregnant and Breastfeeding Individuals in Clinical Research. Birth Defects Research.  https://doi.org/10.1002/bdr2.70074

Learn more about the DART Committee here.