ICON Public Company (ICLR) Status Update summary

Key challenges and barriers

• Ethical concerns, especially risk aversion and fetal risk, are the primary barriers to recruiting pregnant women for clinical trials, as confirmed by 85% of poll respondents.

• Historical exclusion of pregnant women from trials was driven by safety incidents (e.g., thalidomide) and reinforced by regulatory and ethical frameworks.

• Lack of clear guidance, conflicting information, and limited safe medication options contribute to uncertainty and anxiety among pregnant individuals.

• Mistrust, gender bias, and logistical challenges further hinder inclusion in research.

Data gaps and consequences

• Fewer than 10% of medications approved since the 1980s have safety profiles for use during pregnancy or lactation.

• Most drugs lack adequate human data for use in pregnancy and lactation, leading to off-label use and self-modification of medication without professional guidance.

• 36% of pregnant women who changed medication during pregnancy did so without consulting healthcare professionals, often due to fear of birth defects or miscarriage.

Regulatory and global initiatives

• Regulatory agencies (FDA, EMA, WHO, ICH) have issued and updated guidance to encourage inclusion of pregnant and lactating women in clinical trials.

• The ICH is developing a harmonized global guideline to support inclusion and retention of pregnant and breastfeeding individuals in trials, with a draft expected in 2025 and final guidance in 2026.

• The FDA is conducting demonstration projects to optimize use of real-world evidence and pregnancy safety data, with new guidance expected by 2027.