ClinicalTrials.gov Needs Pregnancy, Lactation Fields — SkimNews
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- ClinicalTrials.gov lists over 600,000 studies and draws 3 million monthly visitors, but lacks structured fields for pregnancy or lactation eligibility — forcing the authors to use large language models and phone calls to study coordinators just to extract basic data.
- Researchers parsed 44,160 randomized drug trials open to women ages 18-45, finding 0.8% explicitly permitted pregnant participants while 75% excluded them; 24% left pregnancy unspecified but typically implied exclusion.
- The authors' prior research found fewer than 1% of drug development clinical trials enroll pregnant patients — a figure that did not move over 15 years of data.
- The FDA released draft ICH E21 for public comment in July 2025 alongside regulators in Europe, Japan, and other ICH regions, shifting drug development from presumptive exclusion to early planning for pregnancy data; final adoption is expected around early 2028.
- The 2024 National Academies report found ClinicalTrials.gov could not be used to measure pregnant or lactating trial participation, and both NAS and the federal Task Force on Research Specific to Pregnant Women and Lactating Women called for improved data infrastructure.
- Trump administration officials have criticized the lack of drug safety evidence in pregnancy around antidepressants and acetaminophen; the authors note a politically diverse group now agrees more pregnancy studies are needed.
Why it matters: Pregnant patients and clinicians cannot identify trial options on a database of 600,000+ studies, and neither the National Academies nor the federal task force could measure participation rates using existing data. Two new fields would be inexpensive, let regulators evaluate ICH E21's 2028 impact, and respond to rare bipartisan agreement.
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