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ClinicalTrials.gov lacks structured data on pregnant and lactating trial participants

Advocates urge ClinicalTrials.gov to add a checkbox flagging studies that enroll pregnant or lactating people.

Opinion: ClinicalTrials.gov needs a pregnancy and lactation checkbox
File photo Opinion: ClinicalTrials.gov needs a pregnancy and lactation checkbox Photo: STAT

Current website limitations for specific groups

The federal registry lists over 600,000 drug trials since late 2007. Users can currently filter results by age, sex, diagnosis, and location. However, the site does not show if pregnant or breastfeeding individuals are eligible to join.

Proposed changes to eligibility criteria

Researchers suggest adding a field to the participation module that flags these specific populations. This update would track how many such people enrolled in each study. The change aims to help clinicians find relevant trials for their patients.

Growing concern over medical evidence

There is increasing worry about a lack of high-quality medical evidence regarding drug safety in pregnancy. Tracking these studies accurately would address concerns about publication bias and trial composition. Clearer data would support better decisions for patients considering clinical trial participation.

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