Should Pregnant People Be in Clinical Trials?

94%

of pregnant people use medications

0.8%

of drug trials include them

<10%

of drugs have safety data

The Cost of Exclusion

Thalidomide
99.6%

of birth defects preventable with a trial

COVID Vaccines
8%

of 2021 maternal deaths preventable with earlier RCT

Dolutegravir
3,228

deaths from delayed uptake of life-saving HIV drug

In each case, trial benefits far outweighed costs (~$100M vs. $1-33B in preventable harm)

Policy Solutions

FDA Draft Guidance

Adopt ICH E21 draft guidance and make pregnancy planning requirements binding

Require Research

Require pregnancy data like we require pediatric data under existing law (PREA)

Incentivize Studies

Offer exclusivity incentives for pregnancy studies, as done for children (BPCA)

Public Funding

Fund trials for off-patent drugs where market incentives are insufficient

Exclusion doesn't protect pregnant people—it just prevents learning when they take medications anyway.

JAMA: Ethics Annals: Health Impact AJOG: Trial Data
STAT: The case for including pregnant women in RCTs STAT: Acetaminophen use in pregnancy

Research by Bilinski, Emanuel & Ciaranello